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Aura Biosciences Receives FDA Fast Track Designation for Belzupacap Sarotalocan (AU-011) for the Treatment of Non-Muscle Invasive Bladder Cancer

By Aura Biosciences, Press Release, Publicly Listed
Press Release.

 

CAMBRIDGE, Mass. — (BUSINESS WIRE) — Aura Biosciences, Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for belzupacap sarotalocan (AU-011), Aura’s first VDC product candidate, for the treatment of Non-Muscle Invasive Bladder Cancer (NMIBC).

“We are pleased that belzupacap sarotalocan has been granted Fast Track designation. We believe that, given that NMIBC presents such a high unmet medical need, the opportunity for more frequent interactions with Division of Oncology at FDA and the potential for Priority Review will be valuable as we advance further into clinical development in patients with NMIBC,”

said Dr. Mark De Rosch, Chief Operating Officer and Head of Regulatory Affairs of Aura.

“NMIBC has no approved targeted therapies, and patients experience high levels of recurrence and progression, ultimately leading to cystectomy or the removal of the entire bladder,”

said Dr. Cadmus Rich, Chief Medical Officer and Head of R&D of Aura.

“This milestone supports our goal to advance the development of belzupacap sarotalocan for patients with NMIBC in need of better and earlier targeted treatment options with the potential to help preserve the bladder.”

Aura’s planned Phase 1 clinical trial with belzupacap sarotalocan in this indication will evaluate the safety and early proof of mechanism, assess distribution, local necrosis and evidence of immune activation. Aura expects to initiate the trial in the second half of 2022, with initial Phase 1 data expected in 2023.

Fast Track designation is an FDA process designed to facilitate the development of products that address high unmet medical needs and may expedite the review of drugs intended to treat serious or life-threatening diseases. Features of Fast Track designation include opportunities for more frequent interactions with the FDA review team and, if supported by clinical data, eligibility for Priority Review. Belzupacap sarotalocan has also been previously granted Fast Track and Orphan Drug designations by the FDA for the treatment of choroidal melanoma and is currently in Phase 2 clinical development in this indication.

 

About Aura Biosciences

Aura Biosciences, Inc., is a clinical-stage biotechnology company developing virus-like drug conjugates (VDCs), a novel class of therapies, for the treatment of multiple oncology indications. Aura’s lead VDC candidate, belzupacap sarotalocan (AU-011), consists of a virus-like particle conjugated with an anti-cancer agent. Belzupacap sarotalocan is designed to selectively target and destroy cancer cells and activate the immune system with the potential to create long-lasting anti-tumor immunity. Belzupacap sarotalocan is currently in development for ocular cancers, with an ongoing Phase 2 dose escalation clinical trial evaluating it as a first-line treatment of choroidal melanoma, a vision- and life-threatening form of eye cancer where standard of care with radiotherapy leaves patients with severe comorbidities, including major vision loss. Aura plans to pursue development of belzupacap sarotalocan across its ocular oncology franchise including for the treatment of patients with choroidal metastases. In addition, leveraging Aura’s technology platform, Aura is developing belzupacap sarotalocan more broadly across multiple cancers, starting with a planned Phase 1 clinical trial in patients with non-muscle invasive bladder cancer (NMIBC). Aura is headquartered in Cambridge, MA.

For more information, visit aurabiosciences.com, or follow us on Twitter and LinkedIn.

 

Forward Looking Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, and other federal securities laws. Any statements that are not statements of historical fact may be deemed to be forward looking statements. Words such as “may,” “will,” “could”, “should,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “seeks,” “endeavor,” “potential,” “continue” or the negative of such words or other similar expressions that can be used to identify forward-looking statements. These forward looking statements include express or implied statements regarding Aura’s future expectations, plans and prospects, including, without limitation, statements regarding the therapeutic potential of belzupacap sarotalocan for the treatment of cancers including choroidal melanoma and NMIBC and expectations with respect to the clinical development of belzupacap sarotalocan, including expectations regarding the potential benefits conferred by Fast Track designation and initiation of a Phase 1 clinical trial.

The forward-looking statements in this press release are neither promises nor guarantees, and investors should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Aura’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements, including, without limitation, an improved quality of life of patients after treatment with belzupacap sarotalocan; a potential paradigm shift in the approach to the treatment of choroidal melanoma; the urgent need for a vision preserving targeted therapy; the potential of belzupacap sarotalocan compared to the existing standard of care for patients with choroidal melanoma; uncertainties inherent in clinical trials and in the availability and timing of data from ongoing clinical trials; the expected timing for submissions for regulatory approval or review by governmental authorities; the risk that the results of Aura’s clinical trials may not be predictive of future results in connection with future clinical trials; whether Aura will receive regulatory approvals to conduct trials or to market products; whether Aura’s cash resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements; risks, assumptions and uncertainties regarding the impact of the continuing COVID-19 pandemic on Aura’s business, operations, strategy, goals and anticipated development and review timelines; Aura’s ongoing and planned pre-clinical activities; and Aura’s ability to initiate, enroll, conduct or complete ongoing and planned clinical trials. These risks, uncertainties, and other factors include those risks and uncertainties described under the heading “Risk Factors” in Aura’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Aura with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, Aura disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Aura’s current expectations and speak only as of the date hereof and no representations or warranties (express or implied) are made about the accuracy of any such forward-looking statements.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220630005254/en/

 

Contacts
Investor and Media Contact:
Matthew DeYoung
Argot Partners
212-600-1902 | aura@argotpartners.com

Aura Biosciences Announces Publication of Preclinical Data of the Combination of VDCs with Immune Checkpoint Inhibitors at the 2022 ASCO Annual Meeting

By Aura Biosciences, Press Release, Publicly Listed
Press Release.

 

CAMBRIDGE, Mass.(BUSINESS WIRE)— Aura Biosciences Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, today announced the publication of preclinical data on AU-011, its first VDC product candidate, in combination with immune checkpoint inhibitors. AU-011 is being developed for the treatment of life-threatening cancers with high unmet need, including primary choroidal melanoma and non-muscle invasive bladder cancer (NMIBC). The abstract has been published online as part of the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, being held June 3-7, 2022, in Chicago, IL.

“These data show that AU-011, a first in class VDC, in combination with immune checkpoint inhibition is effective against both primary tumors and distant metastases in a preclinical model, demonstrating its clinical potential for the treatment of choroidal melanoma and certain other cancers. This includes the potential to treat both the primary tumor in early-stage disease and to treat metastatic lesions, whether clinically present or not at initial treatment.”

“We are so appreciative of our collaboration with the scientists and clinicians at Leiden University Medical Center in The Netherlands, one of the top European clinical and research centers in ocular oncology,”

said Dr. Cadmus Rich, Chief Medical officer and Head of R&D of Aura Biosciences.

 

“It is promising to see the results of these experiments, as we have shown that in murine models, the previously observed positive effects of AU-011 as a single agent could be enhanced with the addition of immune checkpoint inhibitors,”

said Dr. Martine Jager, Professor of Ophthalmology at Leiden University.

“In addition, we show that not only the primary tumor, but also distant lesions, are targeted. Our survival data in murine models show that the combination of VDCs with immune checkpoint inhibitors is a potential new treatment modality that may generate a potent targeted cytotoxicity on local tumors as well as potential metastases.”

 

Abstract details:

Title: A novel Virus-Like-Drug Conjugate (VDC) in combination with immune checkpoint inhibitors for the treatment of primary tumors and distant metastasis
Authors: Ruben Victor Huis in ‘t Veld1, Sen Ma1, Rhonda Kines2, Anneli Savinainen2, Cadmus Collins Rich2, Ferry Ossendorp3, Martine Jager1; 1Leiden University Medical Center, Leiden, Netherlands; 2Aura Biosciences, Cambridge, MA; 3Department of Immunology, Leiden University Medical Center, Leiden, Netherlands
Session Category: Publication – 2022 ASCO Annual Meeting Proceedings
Session Title: Developmental Therapeutics – Immunotherapy
Abstract Number: e14544
The published abstract is available here.

 

About Aura Biosciences

Aura Biosciences, Inc. is a clinical-stage biotechnology company developing virus-like drug conjugates (VDCs), a novel class of therapies, for the treatment of multiple oncology indications. Aura’s lead VDC candidate, AU-011 (belzupacap sarotalocan), consists of a virus-like particle conjugated with an anti-cancer agent. AU-011 selectively targets and destroys cancer cells and activates the immune system with the potential to create long-lasting anti-tumor immunity. AU-011 is currently in development for ocular cancers, with an ongoing Phase 2 dose escalation clinical trial evaluating first-line treatment of choroidal melanoma, a vision- and life-threatening form of eye cancer where standard of care with radiotherapy leaves patients with severe comorbidities, including major vision loss. Aura plans to develop AU-011 across its ocular oncology franchise including for the treatment of patients with choroidal metastases. In addition, leveraging Aura’s technology platform, Aura is developing AU-011 more broadly across multiple cancers, starting with a planned Phase 1 clinical trial in patients with non-muscle invasive bladder cancer. Aura is headquartered in Cambridge, MA.
For more information, visit aurabiosciences.com, or follow us on Twitter and LinkedIn.

 

Forward Looking Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, and other federal securities laws. Any statements that are not statements of historical fact may be deemed to be forward looking statements. Words such as “may,” “will,” “could”, “should,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “seeks,” “endeavor,” “potential,” “continue” or the negative of such words or other similar expressions that can be used to identify forward-looking statements. These forward looking statements include express or implied statements regarding Aura’s future expectations, plans and prospects, including, without limitation, statements regarding the therapeutic potential of AU-011 for the treatment of cancers including choroidal melanoma and NMIBC and expectations with respect to the clinical development of AU-011.

The forward-looking statements in this press release are neither promises nor guarantees, and investors should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Aura’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements, including, without limitation, uncertainties inherent in clinical trials and in the availability and timing of data from ongoing clinical trials; the expected timing for submissions for regulatory approval or review by governmental authorities; the risk that the results of Aura’s clinical trials may not be predictive of future results in connection with future clinical trials; whether Aura will receive regulatory approvals to conduct trials or to market products; whether Aura’s cash resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements; risks, assumptions and uncertainties regarding the impact of the continuing COVID-19 pandemic on Aura’s business, operations, strategy, goals and anticipated timelines; Aura’s ongoing and planned pre-clinical activities; and Aura’s ability to initiate, enroll, conduct or complete ongoing and planned clinical trials. These risks, uncertainties, and other factors include those risks and uncertainties described under the heading “Risk Factors” in Aura’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2022 filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Aura with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, Aura disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Aura’s current expectations and speak only as of the date hereof and no representations or warranties (express or implied) are made about the accuracy of any such forward-looking statements.

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20220526005604/en/

 

Contacts
Investor and Media Contact:
Matthew DeYoung
Argot Partners
212-600-1902 | aura@argotpartners.com

Aura Biosciences Presents Preclinical Data Highlighting AU-011’s Anti-Tumor Activity in Choroidal Metastasis, an Additional Ocular Oncology Indication at the 2022 ARVO Annual Meeting

By Aura Biosciences, Press Release, Publicly Listed
Press Release.

 

Preclinical studies support further development of AU-011 for choroidal metastasis

CAMBRIDGE, Mass.–(BUSINESS WIRE)– Aura Biosciences Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, today announced the presentation of preclinical data for its first VDC product candidate, AU 011. AU-011 is in development for the treatment of multiple ocular oncology indications, including primary choroidal melanoma and choroidal metastasis. The results presented today highlight AU-011’s targeted cytotoxicity towards tumor cells derived from the most common cancer types known to metastasize to the choroid. The results were presented as part of the 2022 Association of Research in Vision and Ophthalmology (ARVO) Annual Meeting taking place in Denver, CO on May 1 – 4 and virtually on May 11 – 12.

“The data presented at ARVO demonstrates AU-011’s potent cytotoxicity in human cancer cell lines as well as in multiple in vivo tumor models including breast, renal and colon cancer which are well known to metastasize to the choroid,” said Elisabet de los Pinos, Ph.D., Chief Executive Officer of Aura. “These results support our commitment to build our ocular oncology franchise and provide a potential novel treatment for patients with cancers in the eye. We look forward to submitting the IND in choroidal metastases in the second half of this year.”

In vitro potency was observed across a panel of human cancer cell lines. Cells were treated with AU-011 followed by light activation, and dose-dependent cell binding and cytotoxicity were noted. Addition of heparin to the binding studies prevented AU-011 association with the tumor cells demonstrating AU-011’s specific targeting of tumor associated heparan sulfate proteoglycans (HSPGs). Syngeneic murine models of breast, colon, and renal cancer were employed to evaluate AU-011’s anti-tumor activity in vivo and dose-dependent efficacy was observed across all models. The studies herein support further development of AU-011 for choroidal metastasis.

Details for the presentation are as follows:

Title: A first in class Virus-Like Drug Conjugate (VDC) shows anti-tumor activity in Cancers that Commonly Metastasize to the Choroid
Presentation Number: 2616
Presenter: Anneli Savinainen, Aura Biosciences
Session Title: Where art thou tumor? – Ocular tumor physiology and metastases
Date and time: Tuesday, May 3 at 3:00 – 3:17 PM ET
Location: 1AB Mile High Ballroom (Denver Convention Center)

The presentation can be accessed by visiting the “Scientific Presentations” section of “VDC Platform” page of the Aura Biosciences website.

About Aura Biosciences

Aura Biosciences, Inc. is a clinical-stage biotechnology company developing virus-like drug conjugates (VDCs), a novel class of therapies, for the treatment of multiple oncology indications. Aura’s lead VDC candidate, AU-011 (belzupacap sarotalocan), consists of a virus-like particle conjugated with an anti-cancer agent. AU-011 selectively targets and destroys cancer cells and activates the immune system with the potential to create long-lasting anti-tumor immunity. AU-011 is currently in development for ocular cancers, with an ongoing Phase 2 dose escalation clinical trial evaluating first-line treatment of choroidal melanoma, a vision- and life-threatening form of eye cancer where standard of care with radiotherapy leaves patients with severe comorbidities, including major vision loss. Aura plans to develop AU-011 across its ocular oncology franchise including for the treatment of patients with choroidal metastases. In addition, leveraging Aura’s technology platform, Aura is developing AU-011 more broadly across multiple cancers, starting with a planned Phase 1 clinical trial in patients with non-muscle invasive bladder cancer. Aura is headquartered in Cambridge, MA.

For more information, visit aurabiosciences.com, or follow us on Twitter and LinkedIn.

Forward Looking Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, and other federal securities laws. Any statements that are not statements of historical fact may be deemed to be forward looking statements. Words such as “may,” “will,” “could”, “should,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “seeks,” “endeavor,” “potential,” “continue” or the negative of such words or other similar expressions that can be used to identify forward-looking statements. These forward looking statements include express or implied statements regarding Aura’s future expectations, plans and prospects, including, without limitation, statements regarding the therapeutic potential of AU-011 for the treatment of choroidal metastasis, and expectations with respect to the anticipated timing of the submission of an IND in choroidal metastases.

The forward-looking statements in this press release are neither promises nor guarantees, and investors should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Aura’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements, including, without limitation, uncertainties inherent in clinical trials and in the availability and timing of data from ongoing clinical trials; the expected timing for submissions for regulatory approval or review by governmental authorities; the risk that the results of Aura’s clinical trials may not be predictive of future results in connection with future clinical trials; whether Aura will receive regulatory approvals to conduct trials or to market products; whether Aura’s cash resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements; risks, assumptions and uncertainties regarding the impact of the continuing COVID-19 pandemic on Aura’s business, operations, strategy, goals and anticipated timelines; Aura’s ongoing and planned pre-clinical activities; and Aura’s ability to initiate, enroll, conduct or complete ongoing and planned clinical trials. These risks, uncertainties, and other factors include those risks and uncertainties described under the heading “Risk Factors” in Aura’s most recent Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Aura with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, Aura disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Aura’s current expectations and speak only as of the date hereof and no representations or warranties (express or implied) are made about the accuracy of any such forward-looking statements.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220503005212/en/

Investor and Media:
Matthew DeYoung
Argot Partners
212-600-1902 | aura@argotpartners.com

 

Aura Biosciences to Present Preclinical Data Highlighting AU 011’s Potential to Target a Broad Number of Tumor Types at the 2022 AACR Annual Meeting

By Aura Biosciences, Press Release, Publicly Listed
Press Release.

 

CAMBRIDGE, Mass.–(BUSINESS WIRE)– Aura Biosciences Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, today announced the presentation of preclinical data for its first VDC product candidate, AU-011 which is being developed for the treatment of life-threatening cancers with high unmet need, including primary choroidal melanoma and non-muscle invasive bladder cancer. The results demonstrate the potential wide applicability of AU-011 in targeting a number of solid tumor types and will be presented as part of the 2022 American Association for Cancer Research (AACR) Annual Meeting, being held April 8-13, 2022 in New Orleans, LA.

“The data that will be presented at AACR provide evidence for AU-011’s activity in tumors that express specifically modified heparan-sulfate proteoglycans on the tumor cell surface. Activity was observed in every tumor type tested, indicating that there are numerous solid tumors we can consider to expand the clinical development of AU-011, including those derived from neural or epithelial lineages,” said Dr. Cadmus Rich, Chief Medical Officer and Head of R&D of Aura Biosciences. “The correlative gene expression analysis has deepened our understanding of the genes and biological pathways involved in the expression of HSPGs by different types of tumor cells.”

Details for the poster presentation are as follows:

Title: Biological Assessment of the Virus-Like Drug Conjugate AU-011 to Specifically Target a Breadth of Human Cancer Types
Presenter: Rhonda Kines, Aura Biosciences
Poster Session: ETO1 Drug Discovery
Date and time: April 8, 2022, 1:00 PM ET
Location: E-poster
Session Category: Experimental and Molecular Therapeutics
Session Title: Drug Discovery
Abstract Number: 5331

About Aura Biosciences

Aura Biosciences, Inc. (NASDAQ: AURA) is a clinical-stage biotechnology company developing virus-like drug conjugates (VDCs), a novel class of therapies, for the treatment of multiple oncology indications. Aura’s lead VDC candidate, AU-011 (belzupacap sarotalacan), consists of a virus-like particle conjugated with an anti-cancer agent. AU-011 selectively targets and destroys cancer cells and activates the immune system with the potential to create long-lasting anti-tumor immunity. AU-011 is currently in development for ocular cancers, with an ongoing Phase 2 clinical trial evaluating first-line treatment of choroidal melanoma, a vision- and life-threatening form of eye cancer where standard of care with radiotherapy leaves patients with severe comorbidities, including major vision loss. Aura plans to develop AU-011 across its ocular oncology franchise including for the treatment of patients with choroidal metastases. In addition, leveraging Aura’s technology platform, Aura is developing AU-011 more broadly across multiple cancers, starting with a planned Phase 1a clinical trial in patients with non-muscle invasive bladder cancer. Aura is headquartered in Cambridge, MA.

For more information, visit aurabiosciences.com, or follow Aura on Twitter and LinkedIn.

Forward Looking Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, and other federal securities laws. Any statements that are not statements of historical fact may be deemed to be forward looking statements. Words such as “may,” “will,” “could”, “should,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “seeks,” “endeavor,” “potential,” “continue” or the negative of such words or other similar expressions that can be used to identify forward-looking statements. These forward looking statements include express or implied statements regarding Aura’s future expectations, plans and prospects, including, without limitation, statements regarding the therapeutic potential of AU-011 for the treatment of a number of solid tumor types and expectations with respect to any future clinical trials and clinical development plans for AU-011.

The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Aura’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements, including, without limitation, uncertainties inherent in clinical trials and in the availability and timing of data from ongoing clinical trials; the expected timing for submissions for regulatory approval or review by governmental authorities; the risk that the results of Aura’s clinical trials may not be predictive of future results in connection with future clinical trials; whether Aura will receive regulatory approvals to conduct trials or to market products; whether Aura’s cash resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements; risks, assumptions and uncertainties regarding the impact of the continuing COVID-19 pandemic on Aura’s business, operations, strategy, goals and anticipated timelines; Aura’s ongoing and planned pre-clinical activities; and Aura’s ability to initiate, enroll, conduct or complete ongoing and planned clinical trials. These risks, uncertainties, and other factors include those risks and uncertainties described under the heading “Risk Factors” in Aura’s most recent Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Aura with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, Aura disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Aura’s current expectations and speak only as of the date hereof and no representations or warranties (express or implied) are made about the accuracy of any such forward-looking statements.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220308006137/en/

Contacts
Investor and Media Contact:
Matthew DeYoung
Argot Partners
212-600-1902 | aura@argotpartners.com

Aura Biosciences Presents Final Phase 1b/2 Data for its first Virus-Like Drug Conjugate, AU-011, in Patients with Choroidal Melanoma at the American Academy of Ophthalmology

By Aura Biosciences, Press Release, Publicly Listed
Press Release.

 

Aura Biosciences Presents Final Phase 1b/2 Data for its first Virus-Like Drug Conjugate, AU-011, in Patients with Choroidal Melanoma at the American Academy of Ophthalmology 2021 Annual Meeting

Presentations Include Final Safety and Efficacy Data from the Phase 1b/2 Trial using Intravitreal Administration and Updated Safety Data from the Phase 2 Trial using Suprachoroidal Administration

CAMBRIDGE, Mass.–(BUSINESS WIRE)– Aura Biosciences, a clinical-stage oncology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, today announced the presentation of data evaluating its first VDC, AU-011, in indeterminate lesions (ILs) and choroidal melanoma (CM), including final safety and efficacy data from the Phase 1b/2 trial using intravitreal (IVT) administration, as well as updated safety results from the Phase 2 trial using suprachoroidal (SC) administration. The results are presented as part of the American Academy of Ophthalmology (AAO) 2021 Annual Meeting.

“The final safety and efficacy data from the Phase 1b/2 trial using intravitreal administration presented today, along with the data from the Phase 2 trial using suprachoroidal administration, provide a high level of confidence for further clinical development in patients with indeterminate lesions or choroidal melanoma,”

said Carol Shields, MD, Chief of the Ocular Oncology Service at Wills Eye Hospital and Professor of Ophthalmology at Thomas Jefferson University.

“I believe AU-011 may offer patients a safe, effective first-line therapy for early-stage disease that preserves vision, a critical component in patients’ quality of life often neglected with today’s current treatment options.”

Final 12-Month Safety and Efficacy Data from Phase 1b/2 Trial with IVT administration

The Phase 1b/2 trial (NCT03052127) evaluated the safety and efficacy of AU-011 using IVT administration for the treatment of ILs and CM. A total of 56 patients were enrolled in the Ph1b/2 trial including the single and multiple dose escalation cohorts and received up to two cycles of therapy (therapeutic regimen). As part of an enrichment strategy agreed with FDA, patients with small tumors with active growth were enrolled in the Phase 2 part of the study (expansion cohort). This group of patients (n=14) received the therapeutic regimen and were evaluated for the tumor growth rate, tumor control, and visual acuity preservation as the efficacy endpoints. These endpoints have been agreed with FDA and are planned to be used in the pivotal program. The results at 12 months showed a statistically significant reduction in the tumor growth rate (-0.483 mm/yr, p = 0.018) compared to each patient’s documented growth rate at study entry, and a 64% (9/14) tumor control rate. In addition, the visual acuity preservation rate was 71%, which is unprecedented compared to the current standard of care with radiotherapy. Overall, AU-011 demonstrated a favorable safety and tolerability profile. The majority of adverse events (AEs), which included intraocular inflammation and increased intraocular pressure, were transient and resolved without clinical sequelae. A large number of patients (43/56) had tumors close to the fovea and optic disk and only two patients with juxta-foveal tumors had a treatment related serious adverse event (SAE) of vision loss. No other treatment related SAEs were observed in the trial. These safety and efficacy results indicate that AU-011 may offer a targeted vision preserving therapy for the first line treatment of CM.

Safety Data from Phase 2 Trial with SC Administration

This Phase 2 trial (NCT04417530) includes an open-label, dose escalation phase assessing the safety and efficacy of AU-011 via SC administration in patients with ILs and CM and plans to enroll up to 22 patients. In this preliminary safety data review of the initial dose escalation cohorts (n=14), no treatment related SAEs, dose limiting toxicities (DLTs), or grade 3/4 AEs were reported. Preliminary results indicate a positive safety and tolerability profile for AU-011 via SC administration.

Details for the AAO 2021 Presentations are as follows:

Title: A Phase 1b/2 Trial of AU-011, a First in Class Targeted Therapy for the Treatment of Choroidal Melanoma via Intravitreal Administration
Presenter: Carol L. Shields, Wills Eye Hospital
Session: OP10 Ocular Pathology and Oculoplastics Original Paper Session
Date and time: Monday, November 15 from 9:45 – 9:52 AM CT
Location: 255-257

Title: A Phase 2 Trial of a First in Class Targeted Therapy for Choroidal Melanoma via Suprachoroidal (SC) Administration
Presenter: Hakan Demirci, Kellogg Eye Center
Session: PD08 Ocular Pathology and Oculoplastics Poster Discussion
Date and time: Available on demand beginning Friday, November 12, 2021, at 7:30am PT
Location: Virtually on demand

The presentations can be accessed by visiting the “Scientific Presentations” section of “VDC Platform” page of the Aura Biosciences website.

About Choroidal Melanoma

Choroidal melanoma is a rare and aggressive type of eye cancer. Choroidal melanoma is the most common primary intraocular tumor in adults and develops in the uveal tract of the eye. No targeted therapies are available at present, and current radiotherapy treatments can be associated with severe visual loss and other long-term sequelae such as dry eye, glaucoma, cataracts, and radiation retinopathy. The most common current treatment is plaque radiotherapy, which involves surgical placement of a radiation device on the exterior of the eye over the tumor. The alternative is enucleation, or total surgical removal of the eye. Choroidal melanoma metastasizes in approximately 50 percent of cases with liver involvement in 80-90% of cases and, unfortunately, metastatic disease is universally fatal. There is a very high unmet need for a new vision sparing targeted therapy that could enable early treatment intervention for this life-threatening rare disease given the mortality rate in metastatic disease, lack of approved therapies, and the comorbidities of radioactive treatment options.

About AU-011

AU-011 is a first-in-class virus-like drug conjugate (VDC) therapy in clinical development for the first line treatment of choroidal melanoma. The virus-like component of the VDC selectively binds unique heparin sulphate proteoglycans (HSPGs), which are modified and overexpressed on the tumor cell surface of malignant cells in the choroid and AU-011 delivers a potent cytotoxic drug that is activated with infrared light. Upon activation with an ophthalmic laser, the cytotoxic drug rapidly and specifically disrupts the cell membrane of malignant cells with a pro-immunogenic cell death that can activate the immune system generating long term anti-tumor immunity. The unique specificity of tumor binding by the VDC enables the preservation of key eye structures, which may allow for the potential of preserving patients’ vision and reducing other long-term complications of radiation treatment. AU-011 can be delivered using equipment commonly found in an ophthalmologist’s office and does not require a surgical procedure, pointing to a potentially less invasive, more convenient therapy for patients and physicians. AU-011 for the treatment of choroidal melanoma is currently in Phase 2 clinical development and the company plans to expand the clinical program into choroidal metastasis.

About Suprachoroidal Administration

The suprachoroidal space (SCS®) injection treatment approach offers unprecedented access to the back of the eye where sight-threatening disease often occurs. Aura believes that delivering AU-011 into SCS within the eye, has the potential to offer certain advantages, including higher bioavailability at the tumor site and reduced exposure of non-targeted tissues, which may lead to an improved therapeutic index for AU-011. Collectively, these features could allow for the treatment of a wider range of tumor sizes, and, therefore, a larger number of patients may be treatable. The Company is partnered with Clearside Biomedical for use of Clearside’s SCS Microinjector® for administration of AU-011 into the SCS.

About Aura Biosciences

Aura Biosciences, Inc. is a clinical-stage oncology company developing a novel technology platform based on virus-like drug conjugates (VDCs) to target and destroy cancer cells selectively while activating the immune system to create long lasting anti-tumor immunity. The VDC technology platform is based on the discoveries of NIH Distinguished Investigator Dr. John Schiller of the Center for Cancer Research at the National Cancer Institute. The company has the goal of developing this technology in multiple cancer indications with an initial focus on primary choroidal melanoma, a rare disease for which there are no approved drugs. Aura’s lead product candidate belzupacap sarotalocan (AU-011) is currently in Phase 2 development for the first line treatment of primary choroidal melanoma, a vision and life-threatening form of eye cancer where standard of care radioactive treatments leave patients with major vision loss and severe comorbidities. AU-011 was well tolerated in a Phase 1b/2 trial, demonstrating high rates of tumor control and vision preservation. Future pipeline applications for Aura’s technology include additional ocular oncology indications like choroidal metastases and solid tumor indications like non-muscle invasive bladder cancer. Aura is headquartered in Cambridge, MA.

Forward Looking Statement

This press release may contain forward-looking statements and information within the meaning of The Private Securities Litigation Reform Act of 1995 and other federal securities laws, including express or implied statements regarding Aura’s future expectations, plans and prospects, including, without limitation, statements regarding expectations and plans for presenting clinical data, projections regarding our long-term growth, the anticipated timing of our clinical trials and regulatory filings, the development of our product candidates and advancement of our clinical programs, as well as other statements containing words such as “may,” “will,” “could”, “should,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “seeks,” “endeavor,” “potential,” “continue” or the negative of such words or other similar expressions that can be used to identify forward-looking statements. The express or implied forward-looking statements included in this press release are only predictions and are subject to a number of risks, uncertainties and assumptions, including, without limitation: uncertainties inherent in clinical trials and in the availability and timing of data from ongoing clinical trials; whether interim results from a clinical trial, including the Phase 2 SC administration trial, will be predictive of the final results of the trial; whether results from pre-clinical studies or earlier clinical studies will be predictive of the results of future trials, including regarding AU-011’s ability to offer vision preserving therapy for the first line treatment of choroidal melanoma; the expected timing of the expansion phase of the Phase 2 SC administration trial; the expected timing for submissions for regulatory approval or review by governmental authorities; whether Aura will receive regulatory approvals to conduct trials or to market products; whether Aura’s cash resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements; risks, assumptions and uncertainties regarding the impact of the continuing COVID-19 pandemic on Aura’s business, operations, strategy, goals and anticipated timelines, Aura’s ongoing and planned pre-clinical activities, Aura’s ability to initiate, enroll, conduct or complete ongoing and planned clinical trials, Aura’s timelines for regulatory submissions and Aura’s financial position. These and other risks and uncertainties are described more fully in the section titled “Risk Factors” set forth in Aura’s filings with the Securities and Exchange Commission. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this press release may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. Although Aura believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur. Moreover, except as required by law, neither Aura nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements included in this press release. Any forward-looking statement included in this press release speaks only as of the date on which it was made. Aura undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20211115005138/en/

Contacts

Investor and Media:
Matthew DeYoung
Argot Partners
212-600-1902 | aura@argotpartners.com

Source: Aura Biosciences

Aura Biosciences Announces Pricing of Initial Public Offering

By Aura Biosciences, Press Release, Publicly Listed
Press Release.

 

October 28, 2021 09:39 PM Eastern Daylight Time

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Aura Biosciences, Inc. (“Aura”), a clinical-stage oncology company developing a novel class of virus-like drug conjugate therapies for multiple oncology indications, today announced the pricing of its initial public offering of 5,400,000 shares of common stock at a public offering price of $14.00 per share. The gross proceeds of the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Aura, are expected to be $75.6 million. All of the shares are being offered by Aura. In addition, Aura has granted the underwriters a 30-day option to purchase up to an additional 810,000 shares of common stock at the initial public offering price less underwriting discounts and commissions.

The shares are expected to begin trading on the Nasdaq Global Market on October 29, 2021 under the ticker symbol “AURA.” The offering is expected to close on November 2, 2021, subject to the satisfaction of customary closing conditions.

Cowen, SVB Leerink and Evercore ISI are acting as joint book-running managers for the offering, and BTIG is acting as lead manager for the offering.

The registration statements relating to these securities became effective on October 28, 2021. The offering will be made only by means of a prospectus, copies of which may be obtained from Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, by telephone at (833) 297-2926, or by email at PostSaleManualRequests@broadridge.com; SVB Leerink LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at syndicate@svbleerink.com; or Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, New York 10055; by telephone at (888) 474-0200, or by email at ecm.prospectus@evercore.com.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Aura Biosciences

Aura Biosciences, Inc. is a clinical-stage oncology company developing a novel technology platform based on virus-like drug conjugates (VDCs) to target and destroy cancer cells selectively while activating the immune system to create long lasting anti-tumor immunity. The VDC technology platform is based on the discoveries of NIH Distinguished Investigator Dr. John Schiller of the Center for Cancer Research at the National Cancer Institute. The company has the goal of developing this technology in multiple cancer indications with an initial focus on primary choroidal melanoma, a rare disease for which there are no approved drugs. Aura’s lead product candidate belzupacap sarotalocan (AU-011) is currently in Phase 2 development for the first line treatment of primary choroidal melanoma, a vision and life-threatening form of eye cancer where standard of care radioactive treatments leave patients with major vision loss and severe comorbidities. AU-011 was well tolerated in a Phase 1b/2 trial, demonstrating high rates of tumor control and vision preservation. Future pipeline applications for Aura’s technology include additional ocular oncology indications like choroidal metastases and solid tumor indications like non-muscle invasive bladder cancer. Aura is headquartered in Cambridge, MA.

Contacts

Investor and Media Contact:
Matthew DeYoung
Argot Partners
212-600-1902 | aura@argotpartners.com

Aura Biosciences Presents Interim Phase 2 Safety Data Evaluating Suprachoroidal Administration of AU-011 in Patients with Choroidal Melanoma at the ASRS 2021 Annual Meeting

By Aura Biosciences, Press Release, Publicly Listed
Press Release.

 

CAMBRIDGE, Mass.–(BUSINESS WIRE)— Aura Biosciences, a clinical-stage oncology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, today announced the presentation of interim Phase 2 data with 7 months average follow up evaluating the safety of suprachoroidal (SC) administration of AU-011, the Company’s lead product candidate for the first-line treatment of primary choroidal melanoma, as a part of the American Society of Retina Specialists (ASRS) 2021 Annual Meeting.

There have been no related serious adverse events, dose limiting toxicities, or grade 3 adverse events observed during the study.

“These interim data presented today demonstrate that suprachoroidal administration may improve the therapeutic index and optimize treatment parameters,”

said Prithvi Mruthyunjaya, MD, MHS, Associate Professor of Ophthalmology and Director, Ocular Oncology Service, Byers Eye Institute at Stanford University, and presenter of the abstract.

“I believe this approach may provide an opportunity for patients who need a new first line treatment for early-stage disease, where all current treatments are extremely invasive and unfortunately result in severe vision loss in many patients.”

Phase 2 Trial Design and Timing

The Phase 2 trial is comprised of an open-label, dose escalation phase and a randomized, masked dose expansion phase that is assessing the safety and efficacy of ascending single- and repeat-doses of AU-011 via SC administration, followed by one or two laser applications per treatment. The randomized, dose expansion portion will be masked, sham-controlled and is designed to evaluate the safety and efficacy of the highest dose regimen of AU-011. Cohorts 1-5 have been fully enrolled (13 patients) and cohort 6 is currently enrolling in the Phase 2 study. The primary objective of the study is to assess safety and efficacy of AU-011 via SC administration for purposes of treating primary indeterminate lesions and choroidal melanoma.

The randomized phase of the trial is planned to begin in the second half of 2022 in patients with documented growth to establish the safety and efficacy of AU-011 and serve as the first pivotal trial for the treatment of indeterminate lesions and choroidal melanoma. The maximum treatment regimen anticipated for the randomized phase is three cycles of three weekly treatments of AU-011 at a dose of 80µg with 2 laser administrations.

Details from the ASRS 2021 Presentation:

Title: A Phase 2 Safety and Efficacy Trial of AU-011, a Virus-Like Drug Conjugate (VDC), with a Dose Escalation and a Randomized, Masked Expansion Phase
Presenter: Prithvi Mruthyunjaya, Stanford University
Session: Ocular Oncology Symposium
Date and Time: Monday, October 11, 2021 at 4:35pm ET

The presentation can be accessed by visiting the “Presentations” section of “News and Publications” page of the Aura Biosciences website.

About Choroidal Melanoma

Choroidal melanoma is a rare and aggressive type of eye cancer. Choroidal melanoma is the most common primary intraocular tumor in adults and develops in the uveal tract of the eye. No targeted therapies are available at present, and current radiotherapy treatments can be associated with severe visual loss and other long-term sequelae such as dry eye, glaucoma, cataracts, and radiation retinopathy. The most common current treatment is plaque radiotherapy, which involves surgical placement of a radiation device on the exterior of the eye over the tumor. The alternative is enucleation, or total surgical removal of the eye. Choroidal melanoma metastasizes in approximately 50 percent of cases with liver involvement in 80-90% of cases and, unfortunately, metastatic disease is universally fatal (source: OMF). There is a very high unmet need for a new vision sparing targeted therapy that could enable early treatment intervention for this life-threatening rare disease given the mortality rate in metastatic disease, lack of approved therapies, and the comorbidities of radioactive treatment options.

About AU-011

AU-011 is a first-in-class virus-like drug conjugate (VDC) therapy in clinical development for the first line treatment of choroidal melanoma. The virus-like component of the VDC selectively binds unique heparin sulphate proteoglycans (HSPGs), which are modified and overexpressed on the tumor cell surface of malignant cells in the choroid and AU-011 delivers a potent cytotoxic drug that is activated with infrared light. Upon activation with an ophthalmic laser, the cytotoxic drug rapidly and specifically disrupts the cell membrane of malignant cells with a pro-immunogenic cell death that can activate the immune system generating long term anti-tumor immunity. The unique specificity of tumor binding by the VDC enables the preservation of key eye structures, which may allow for the potential of preserving patients’ vision and reducing other long-term complications of radiation treatment. AU-011 can be delivered using equipment commonly found in an ophthalmologist’s office and does not require a surgical procedure, pointing to a potentially less invasive, more convenient therapy for patients and physicians. AU-011 for the treatment of choroidal melanoma is currently in Phase 2 clinical development and the company plans to expand the clinical program into choroidal metastasis.

About Suprachoroidal Administration

The suprachoroidal space (SCS®) injection treatment approach offers unprecedented access to the back of the eye where sight-threatening disease often occurs. Aura believes that delivering AU-011 into SCS within the eye, has the potential to offer certain advantages, including higher bioavailability at the tumor site and reduced exposure of non-targeted tissues, which may lead to an improved therapeutic index for AU-011. Collectively, these features could allow for the treatment of a wider range of tumor sizes, and, therefore, a larger number of patients. The Company is partnered with Clearside Biomedical for use of Clearside’s SCS Microinjector® for administration of AU-011 into the SCS. In preclinical research presented as part of the ARVO 2020 virtual program, AU-011 showed excellent distribution in the SCS, complete necrosis of tumors following laser activation in an animal model of choroidal melanoma and no clinical signs of anterior segment or posterior segment inflammation.

About Aura Biosciences

Aura Biosciences, Inc. is a clinical-stage oncology company developing a novel technology platform based on virus-like drug conjugates (VDCs) to target and destroy cancer cells selectively while activating the immune system to create long lasting anti-tumor immunity. The VDC technology platform is based on the discoveries of NIH Distinguished Investigator Dr. John Schiller of the Center for Cancer Research at the National Cancer Institute (NCI). The company has the goal of developing this technology in multiple cancer indications with an initial focus in ocular oncology, a group of rare diseases for which there are no approved drugs. Aura’s lead product candidate belzupacap sarotalocan (AU-011) is currently in Phase 2 development for the first line treatment of choroidal melanoma, a vision and life-threatening form of eye cancer where standard of care radioactive treatments leave patients with major vision loss and severe comorbidities. AU-011 was well tolerated in a Phase 1b/2 trial, demonstrating high rates of tumor control and vision preservation. Future pipeline applications for Aura’s technology include additional ocular oncology indications like choroidal metastases and solid tumor indications like non-muscle invasive bladder cancer. Aura is headquartered in Cambridge, MA. For more information, visit www.aurabiosciences.com or follow us on Twitter.

Investor and Media Contact:
Matthew DeYoung
Argot Partners
212-600-1902 | matthew@argotpartners.com

Aura Biosciences Expands Executive Leadership Team and Board of Directors

By Aura Biosciences, Press Release, Publicly Listed
Press Release.

 

Chris Primiano, J.D., Appointed as Chief Business Officer
Antony Mattessich Appointed to the Board of Directors

CAMBRIDGE, MA – September 29,2021 – Aura Biosciences, a clinical-stage oncology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, today announced the appointment of Chris Primiano, J.D., as Chief Business Officer and the appointment of Antony Mattessich to its Board of Directors.

“We are delighted to welcome Chris to our team and Antony to the Board during an important transformational period for Aura. Both of their experiences in strategic advisory, drug development and commercialization in oncology and ophthalmology will be crucial as we work to advance AU-011 to pivotal development and expand our oncology pipeline,”

said Elisabet de los Pinos, Ph.D., founder and CEO of Aura.

“I am eager to be joining the Aura team to help expand its novel targeted oncology platform and global reach across multiple indications,”

said Mr. Primiano.

“AU-011 presents an opportunity to offer a new therapy that may eliminate the need for treatment with local radiotherapy for many patients with choroidal melanoma. This could be transformative in preserving vision and improving quality of life for these patients. I look forward to working with the rest of the management team to achieve Aura’s goal of advancing innovative oncology therapies to patients with life-threatening cancers.”

“It is a privilege to join the Board at this exciting time in the Company’s evolution,”

said Mr. Mattessich.

“I look forward to working alongside the Board and supporting Aura’s executive team as it lays the groundwork to transform Aura into a commercial-stage oncology company.”

Mr. Primiano joins Aura from Karyopharm Therapeutics, where he served in roles of increasing responsibility, most recently as Executive Vice President, Chief Business Officer, General Counsel and Secretary. Mr. Primiano played an important role in transitioning Karyopharm from 40 employees in a preclinical and early clinical development setting to 400 employees commercializing XPOVIO® (selinexor) across multiple indications. Prior to Karyopharm, Mr. Primiano was Counsel in the Boston office of Wilmer Cutler Pickering Hale and Dorr LLP. Mr. Primiano holds a Juris Doctor from Boston College Law School, a Master of Business Administration from the Boston College Carroll School of Management and a Bachelor of Arts in Political Economy and English from Georgetown University. He is a member of the bars of the Commonwealth of Massachusetts and the State of New York.

Mr. Mattessich is currently the Chief Executive Officer at Ocular Therapeutix. Prior to Ocular Therapeutix, he was Managing Director of Mundipharma International based in Cambridge, England. Previous to his time at Mundipharma, Mr. Mattessich ran the U.S. respiratory, dermatology and pediatrics group at Novartis. He also held several positions at Bristol-Myers Squibb, among them, Managing Director roles in Malaysia/Singapore and The Netherlands, and Head of Operations for the International Medicines Group. Mr. Mattessich holds a BA from the University of California at Berkeley and a master’s in international affairs from Columbia University.

About Aura Biosciences

Aura Biosciences, Inc. is a clinical-stage oncology company developing a novel technology platform based on virus-like drug conjugates (VDCs) to target and destroy cancer cells selectively while activating the immune system to create long lasting anti-tumor immunity. The VDC technology platform is based on the discoveries of NIH Distinguished Investigator Dr. John Schiller of the Center for Cancer Research at the National Cancer Institute (NCI). The company has the goal of developing this technology in multiple cancer indications with an initial focus in ocular oncology, a group of rare diseases for which there are no approved drugs. Aura’s lead product candidate belzupacap sarotalocan (AU-011) is currently in Phase 2 development for the first line treatment of choroidal melanoma, a vision and life-threatening form of eye cancer where standard of care radioactive treatments leave patients with major vision loss and severe comorbidities. AU-011 was well tolerated in a Phase 1b/2 trial, demonstrating high rates of tumor control and vision preservation. Future pipeline applications for Aura’s technology include additional ocular oncology indications like choroidal metastases and solid tumor indications like non-muscle invasive bladder cancer. Aura is headquartered in Cambridge, MA. For more information, visit www.aurabiosciences.com or follow us on Twitter.

 

Investor and Media Contact:

Matthew DeYoung
Argot Partners
914-330-6516 | matthew@argotpartners.com

Source: Aura Biosciences

Aura Biosciences Assembles New Bladder Cancer Focused Scientific Advisory Board

By Aura Biosciences, Press Release, Publicly Listed
Press Release.

 

Prominent, Multi-Disciplinary Clinicians and Scientists Bring Extensive Strategic Expertise in Urologic Oncology Across All Stages of Research and Development

CAMBRIDGE, Mass.–(BUSINESS WIRE)– Aura Biosciences, a clinical-stage oncology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, today announced the formation of a new, urologic oncology focused Scientific Advisory Board (SAB). The new SAB will work closely with Aura’s senior management team to advance the Company’s novel VDC technology for the treatment of non-muscle invasive bladder cancer (NMIBC).

The new SAB will be comprised of seven members: John T. Schiller, PhD, Deputy Chief and Head of the Neoplastic Disease Section, Laboratory of Cellular Oncology at the National Cancer Institute (NCI), National Institutes of Health (NIH); Piyush K. Agarwal, MD, Director, Bladder Cancer Program, University of Chicago; Trinity J. Bivalacqua, MD, PhD, Director, Urologic Oncology, Johns Hopkins Medicine; Isaac Kim, MD, PhD, MBA, Chief, Urologic Oncology, Rutgers Cancer Institute of New Jersey; Seth P. Lerner, MD, Beth and Dave Swaim Chair in Urologic Oncology, Baylor College of Medicine; and Andrea B. Apolo, MD, Head, Bladder Cancer Section, Genitourinary Malignancies Branch, NCI, NIH. This newly formed SAB builds upon Aura’s existing ocular oncology focused SAB that has helped advance the Company’s lead development candidate belzupacap sarotalocan (AU-011) into a Phase 3 ready asset for the treatment of choroidal melanoma.

“The creation of this Scientific Advisory Board is an important step for our continued growth as a leading innovative oncology company,”

said Cadmus Rich, MD, MBA Chief Medical Officer and Head of R&D of Aura Biosciences.

“We are both excited and fortunate to have brought together such an esteemed group of prominent oncology advisors as we advance our VDC platform for the treatment of bladder cancer. These newly assembled members of the SAB bring complementary areas of urologic oncology, drug development and strategic expertise and will be invaluable as we reach the next phase of growth at Aura.”

“On behalf of all of the members of the new SAB, we look forward to working together with the Aura senior leadership team to draw on our complementary expertise and insights to support a shared vision for Aura and drive innovation for patients with bladder cancer,”

said Dr. Agarwal.

The following is more detail about the Aura SAB members:

John T. Schiller, PhD – Dr. Schiller is Deputy Chief and Head of the Neoplastic Disease Section, Laboratory of Cellular Oncology at the National Cancer Institute, NIH, and an NIH Distinguished Investigator. He has received numerous awards for his contributions to papillomavirus virus molecular biology and HPV vaccine development, including the Lasker DeBakey Award in 2017, the American Society for Microbiology’s Joseph Public Health Award in 2014, and National Medal of Technology and Innovation in 2014. Dr. Schiller graduated from the University of Wisconsin-Madison with a B.S. in molecular biology and received a Ph.D. from the Department of Microbiology of the University of Washington in Seattle.

Piyush K. Agarwal, MD – Dr. Agarwal is a highly respected urologic surgeon who specializes in the multidisciplinary management of bladder cancer as Director of both the Bladder Cancer Program and the Urologic Oncology Fellowship. He is also an expert in all urologic cancers and was the previous Head of the Bladder Cancer Section in the Center for Cancer Research of the National Cancer Institute. He has conducted several investigator-initiated clinical trials and has served on the U.S. Food and Drug Administration’s oncologic drug advisory committee.Dr. Agarwal earned his MD degree from Weill Cornell College of Medicine in New York, completed his residency in Urology at University Hospital Cleveland Medical Center in Cleveland and his Urologic Oncology fellowship at MD Anderson Medical Center in Houston.

Andrea Apolo, MD – Dr. Apolo is an internationally recognized expert in bladder cancer research who is a Lasker Clinical Research Scholar in the Genitourinary Malignancies Branch of the Cancer Research Center at the NCI, NIH. She is Head of the Bladder Cancer Section and the Director of the Bladder Cancer and Genitourinary Tumors Multidisciplinary Clinic. She holds an MD degree from Albert Einstein College of Medicine, completed her internal medicine residency at New York-Presbyterian Hospital/Weill Cornell Medical Center and a medical oncology fellowship at Memorial Sloan Kettering, all in New York.

Trinity J. Bivalacqua, MD, PhD – Dr. Bivalacqua is the R. Christian B. Evensen Professor of Urology and Oncology and Director of Urologic Oncology at the James Buchanan Brady Urologic Institute. As a member of the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Dr. Bivalacqua participates in multidisciplinary approaches to the treatment of a variety of genitourinary cancers. He has a special interest in cancers of the prostate and bladder. His research laboratory focuses on the tumor immune microenvironment and mechanisms of BCG-resistance namely T-cell signaling and macrophage polarization. He holds graduate and medical degrees from Tulane University, completed his general surgery and urology training at Johns Hopkins Hospital in Baltimore and completed an American Urological Association (AUA) Foundation post-doctoral fellowship from the AUA Care Foundation in Linthicum.

Isaac Kim, MD, PhD, MBA – Dr. Kim is a board certified urologist who serves as the Chief and Associate Professor of the Division of Urology at Rutgers Robert Wood Johnson Medical School and Chief of the Section of Urologic Oncology and director of the Prostate Cancer Center at the Rutgers Cancer Institute of New Jersey. He runs a thriving clinical practice and has established a robust research program focused on the biology of castration-resistant prostate cancer. He holds a PhD and MD from Northwestern University, completed a urology residency at Baylor College of Medicine in Houston, a research fellowship in Urologic Oncology at the National Cancer Institute in Bethesda and clinical fellowship in endourology, laparoscopy and robotics at the University of California in Irvine.

Seth P. Lerner, MD – Dr. Lerner is Professor of Urology and holds the Beth and Dave Swalm Chair in Urologic Oncology, in the Scott Department of Urology, Baylor College of Medicine. He is Director of Urologic Oncology and the Multidisciplinary Bladder Cancer Program and Vice-chair for Faculty Affairs for Urology. His clinical practice, education, and research activities are devoted to urologic oncology and particularly lower and upper tract urothelial cancer. He holds an MD from Baylor College of Medicine in Houston and completed a two-year fellowship at the University of Southern California in urologic oncology and reconstructive surgery in Los Angeles.

About Aura Biosciences

Aura Biosciences, Inc. is a clinical-stage oncology company developing a novel technology platform based on virus-like drug conjugates (VDCs) to target and destroy cancer cells selectively while activating the immune system to create long lasting anti-tumor immunity. The VDC technology platform is based on the discoveries of NIH Distinguished Investigator Dr. John Schiller of the Center for Cancer Research at the National Cancer Institute (NCI). The company has the goal of developing this technology in multiple cancer indications with an initial focus in ocular oncology, a group of rare diseases for which there are no approved drugs. Aura’s lead product candidate belzupacap sarotalocan (AU-011) is currently in Phase 2 development for the first line treatment of choroidal melanoma, a vision and life-threatening form of eye cancer where standard of care radioactive treatments leave patients with major vision loss and severe comorbidities. Aura has demonstrated the efficacy and safety of AU-011 in a Phase 1b/2 trial, including high rates of tumor control and vision preservation. Future pipeline applications for Aura’s technology include additional ocular oncology indications like choroidal metastases and solid tumor indications like non-muscle invasive bladder cancer. Aura is headquartered in Cambridge, MA. For more information, visit www.aurabiosciences.com or follow us on Twitter.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210617005134/en/

Contacts
Investor and Media Contact:
Joseph Rayne
Argot Partners
617.340.6075 | joseph@argotpartners.com

Aura Biosciences Appoints Sapna Srivastava, Ph.D., to its Board of Directors

By Aura Biosciences, Press Release, Publicly Listed
Press Release.

 

June 08, 2021 07:00 AM Eastern Daylight Time

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Aura Biosciences, a clinical-stage oncology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, today announced the appointment of Sapna Srivastava, Ph.D., to its Board of Directors.

“Sapna is a recognized leader in the biopharmaceutical industry with over two decades of broad experience in corporate and financial strategy,”

said David Johnson, Chairman of the Board of Aura Biosciences.

“We welcome Sapna to the Board and look forward to her contributions as we look to further build our position as a leader in ocular oncology and expand the research of our VDC technology into additional cancers in need of better treatments to improve patient outcomes.”

“I believe that Aura’s novel approach to treat ocular cancers while preserving vision can transform the treatment paradigm for patients with these life-threatening diseases,”

said Dr. Srivastava.

“It is a privilege to be joining Aura’s Board of Directors as the Company advances into a pivotal program for the early treatment of choroidal melanoma and prepares for this next phase of growth.”

Dr. Srivastava is currently the Chief Financial and Strategy Officer at eGenesis. Prior to eGenesis, she held similar roles as the Chief Financial and Strategy Officer at Abide Therapeutics (acquired by Lundbeck) and at Intellia Therapeutics. In these positions, she has played a key role in equity financings including a successful initial public offering, strategic alliances, mergers and acquisitions, and shaping the strategic direction of the company. Before Intellia, Dr. Srivastava spent more than a decade on Wall Street as a senior biotechnology analyst for Goldman Sachs, Morgan Stanley and ThinkEquity Partners. She began her career as a research associate at J.P. Morgan. Dr. Srivastava received her Ph.D. in neuroscience from the New York University School of Medicine and her B.S. in biology from St. Xavier’s College at the University of Mumbai.

About Aura Biosciences

Aura Biosciences, Inc. is a clinical-stage oncology company developing a novel technology platform based on virus-like drug conjugates (VDCs) to target and destroy cancer cells selectively while activating the immune system to create long lasting anti-tumor immunity. The VDC technology platform is based on the discoveries of NIH Distinguished Investigator Dr. John Schiller of the Center for Cancer Research at the National Cancer Institute (NCI). The company has the goal of developing this technology in multiple cancer indications with an initial focus in ocular oncology, a group of rare diseases for which there are no approved drugs. Aura’s lead product candidate belzupacap sarotalocan (AU-011) is currently in Phase 2 development for the first line treatment of choroidal melanoma, a vision and life-threatening form of eye cancer where standard of care radioactive treatments leave patients with major vision loss and severe comorbidities. Aura has demonstrated the efficacy and safety of AU-011 in a Phase 1b/2 trial, including high rates of tumor control and vision preservation. Future pipeline applications for Aura’s technology include additional ocular oncology indications like choroidal metastases and solid tumor indications like non-muscle invasive bladder cancer. Aura is headquartered in Cambridge, MA. For more information, visit www.aurabiosciences.com or follow us on Twitter.

Contacts

Investor and Media Contact:
Joseph Rayne
Argot Partners
617.340.6075 | joseph@argotpartners.co