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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

Aura Biosciences Announces Publication of Data in Cancer Immunology Research Supporting the Immune Mediated Mechanism of Action of the Virus-Like Drug Conjugate (VDC) Technology Platform with Broad Application in Cancer Treatment

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

 

  • Results Support VDCs induction of Pro Immunogenic Cell Death and the Generation of Long Lasting Adaptive Anti-Tumor Immunity –
  • Combination of VDCs with Checkpoint Inhibitors Achieves a High Complete Response Rate and Prevents Long Term Tumor Recurrence

CAMBRIDGE, MA – April 14, 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 online publication of data in the peer-reviewed medical journal Cancer Immunology Research, a journal of the American Association for Cancer Research, that supports the broad application of the Company’s proprietary VDC technology platform for treating cancer. The manuscript, titled, “Virus-like Particle-drug Conjugates Induce Protective, Long-lasting Adaptive Anti-Tumor Immunity in the Absence of Specifically Targeted Tumor Antigens,” describes promising long term anti-tumor activity of AU-011, the Company’s lead VDC candidate, as a monotherapy and in combination with checkpoint inhibitor antibodies in preclinical studies conducted in collaboration with the Center for Cancer Research at the National Cancer Institute of the National Institutes of Health.

“Collectively, these promising results confirm treatment of AU-011 resulted in targeted tumor cytotoxicity with hallmarks of immunogenic cell death that may promote a durable anti-tumor immune response,”

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

“Additionally, the additive activity of AU-011 in combination with checkpoint inhibitors has shown a high level of durable complete responses and prevention of tumor recurrence, warranting continued research into its potential clinical utility to effectively treat multiple types of tumors like non-muscle invasive bladder cancer as a primary treatment and further prevent metastatic disease.”

Key findings from the manuscript include:

  • In vitro and in vivo studies in immunocompetent murine tumor models demonstrated a dose-dependent cytotoxic response of AU-011 with an upregulation of the markers of immunogenic cell death like caspase-1 and calreticulin surface expression demonstrating that AU-011 mediated cell death was able to generate potent immune stimulatory conditions within the tumor microenvironment.
  • A single in vivo dose administration of AU-011 caused rapid cell death leading to long term complete responses in 50% of all animals.  Combination with immune checkpoint inhibitor antibodies improved therapeutic efficacy resulting in 70-100% complete response rate that was durable 100 days post-treatment with 50-80% of those animals displaying protection from secondary tumor re-challenge.
  • Depletion studies of CD4+ or CD8+ T-cells at the time of AU-011 treatment or tumor re-challenge confirmed the involvement of both cell populations in the mechanism of action of AU-011 and the promotion of long-lasting anti-tumor protection.

“These promising findings further reinforce the therapeutic advantages of VDCs in treating cancer compared to other available treatments, which include the broad tumor selectivity and multivalent binding of the virus-like particles compared to antibodies, the ability to deliver hundreds of cytotoxic molecules and the generation of long-lasting anti-tumor immunity,”

said Elisabet de los Pinos, Ph.D., Chief Executive Officer of Aura.

“While our initial clinical focus has been in ocular oncology, our VDC approach has wide application as a single agent and as a combination therapy in a variety of solid tumors, including non-muscle invasive bladder cancer, which is expected to enter the clinic in 2022 We remain focused on advancing our novel VDC approach to transform the treatment of tumors and improve outcomes for patients with cancer.”

About AU-011 (belzupacap sarotalocan)
AU-011 is a first-in-class virus-like drug conjugate (VDC) therapy in development for the first line treatment of choroidal melanoma. The virus-like component of the VDC selectively binds unique heparan sulphate proteoglycans (HSPGs) that are modified and overexpressed on the tumor cell surface of choroidal melanoma (and other tumor types) and 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 melanoma 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. The possibility of early treatment intervention and the activation of the immune system could lead to a reduction in the metastases rate for patients with this life-threatening disease. 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 has been granted Orphan Drug and Fast Track designations by the U.S. Food and Drug Administration and is currently in Phase 2 clinical development.

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.

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

Aura Biosciences Expands Executive Leadership Team with the Appointment of Mark De Rosch, Ph.D., as Chief Operating Officer

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

 

March 24, 2021

CAMBRIDGE, MA – March 24, 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 Mark De Rosch, Ph.D. as Chief Operating Officer. In his role, he will be responsible for leading Aura’s global operations and regulatory strategy.

Dr. De Rosch brings to Aura more than 30 years of experience in leading global regulatory and development strategies across many therapeutic areas, including oncology and ophthalmology. He has expertise in transitioning companies from early-stage to late-stage and in building effective teams to achieve clinical and corporate objectives.

“Mark joins our team during an exciting time at Aura. His decades of experience with global regulatory strategy, as well as building successful teams and pipelines, will be invaluable as we work to realize the full potential of our VDC technology platform,” said Elisabet de los Pinos, Ph.D., founder and CEO of Aura. “His proven track record and strong scientific acumen aligns well with our goals as we advance AU-011 toward late-stage pivotal development.”

“I am delighted to join Aura at this important time in the Company’s history and I look forward to being part of its promising future, as we work to become a leader in ocular oncology,”

said Dr. De Rosch.

“Aura’s experienced team and the novel VDC technology make this a compelling opportunity. I look forward to contributing my global regulatory, operational and organizational expertise to grow the Company and advance this leading technology to transform the outcomes for cancer patients.”

Dr. De Rosch joins Aura from Epizyme, where he served as Chief Regulatory Officer and led regulatory efforts for their first approved product, TAZVERIK® (tazemetostat). Prior to Epizyme, Dr. De Rosch served as Senior Vice President, Regulatory Affairs and Quality Assurance for Nightstar Therapeutics (acquired by Biogen in 2019), where he developed and implemented global regulatory roadmaps for their gene therapy programs in choroideremia and retinitis pigmentosa. Prior to Nightstar, he served as Senior Vice President, Regulatory Affairs, Quality Assurance and CMC at Akebia Therapeutics.  Before that, Dr. De Rosch served in roles of increasing responsibility at several life science and healthcare consulting firms. Dr. De Rosch holds a Ph.D. and an M.S. in inorganic chemistry from the University of California, San Diego and a B.S. in chemistry/biochemistry from the University of Wisconsin-Parkside.

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 pioneering discoveries of NIH distinguished investigator Dr. John Schiller of the Center for Cancer Research at the National Cancer Institute (NCI), recipient of the 2017 Lasker-DeBakey Award. 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 that have no drugs approved. 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. In a Phase 1b/2 study, AU-011 demonstrated compelling efficacy, including high rates of tumor control and vision preservation including patients with tumors close to the fovea and optic disk, along with a favorable safety profile. 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:

Joseph Rayne

Argot Partners

617.340.6075 | joseph@argotpartners.com

Aura Biosciences Announces Oversubscribed $80 Million Financing

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

 

Proceeds to Support Pivotal Program of AU-011 for the First Line Treatment of Choroidal Melanoma and Expansion of Virus-like Drug Conjugate (VDC) Platform in additional Ocular Oncology Indications and Solid Tumors

Lead Investors Matrix Capital Management and Surveyor Capital (a Citadel company) are Joined by New Investors Rock Springs Capital and Adage Capital Management LP, Along with All Existing Institutional Investors

CAMBRIDGE, MA – March 18, 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 closing of an oversubscribed $80 million financing. The financing was led by Matrix Capital Management and Surveyor Capital (a Citadel company) with participation from new investors, including Rock Springs Capital, Adage Capital Management LP and Velosity Capital. Existing investors Medicxi, Advent Life Sciences, Lundbeckfonden Ventures, Arix Bioscience, Chiesi Ventures, Ysios Capital and Columbus Venture Partners also participated in the round.

Aura intends to use the proceeds from this financing to advance the clinical development of its VDC technology platform, including the pivotal Phase 3 program for AU-011, the Company’s lead candidate in development for the first line treatment of choroidal melanoma, and ongoing research for additional programs in ocular oncology, as well as expanding the VDC technology into bladder cancer, the first non-ophthalmic solid tumor indication.

“Aura is pioneering the development of a new class of targeted therapies for life-threatening cancers with our novel VDC technology platform. This funding from a syndicate of distinguished investors enables us to advance AU-011 into a pivotal Phase 3 program for the first line treatment of choroidal melanoma, a rare, life- and vision-threatening form of cancer with no drugs approved. It also allows us to continue to expand the reach of our VDC technology in additional ocular oncology indications and in the treatment of solid tumors like bladder cancer where there is a high unmet medical need for better targeted therapies to treat early and reduce the incidence of metastasis,”

said Elisabet de los Pinos, Ph.D., Chief Executive Officer of Aura.

In connection with this financing, Karan Takhar, Senior Managing Director of Matrix Capital Management, will join Aura’s Board of Directors.

Mr. Takhar said,

“Matrix believes in the long-term potential of Aura’s VDC technology to further strengthen the Company’s position as a leader in ocular oncology and beyond within other types of cancers in need of better treatment options. We look forward to supporting Aura’s leadership team through this next stage of pipeline growth and transition into late-stage development with the commencement of the AU-011 pivotal program.”

About AU-011 (belzupacap sarotalocan)

AU-011 is a first-in-class virus-like drug conjugate (VDC) therapy in development for the first line treatment of choroidal melanoma. The virus-like component of the VDC selectively binds unique heparan sulphate proteoglycans (HSPGs) that are modified and overexpressed on the tumor cell surface of choroidal melanoma cells (and other tumors) and 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 melanoma cells with a pro-immunogenic cell death that is believed to 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. The possibility of early treatment intervention and the activation of the immune system could lead to a reduction in the metastatic rate for patients with this life-threatening disease. 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 has been granted Orphan Drug and Fast Track designations by the U.S. Food and Drug Administration and is currently in Phase 2 clinical development.

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 pioneering 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 that have no drugs approved. 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.

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

Aura Biosciences Appoints David Johnson to Its Board of Directors

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

 

CAMBRIDGE, MA –January 5th, 2021– Aura Biosciences, a clinical-stage oncology company developing a novel class of drug conjugate therapies for multiple oncology indications, today announced the appointment of David Johnson to its Board of Directors. Mr. Johnson is a biopharmaceutical business leader with more than 25 years of experience in drug development and currently serves as Chief Executive Officer at VelosBio, a clinical-stage oncology company developing novel antibody-drug-conjugates and bispecific antibodies.

“With David’s impressive track record in oncology and as an accomplished CEO, his engagement and guidance will help Aura drive AU-011 for the treatment of choroidal melanoma to registration and commercialization,”

said George Golumbeski, Ph.D., Chairman of the Board of Aura Biosciences.

“In the last few years, David has led several biopharma transactions, including the acquisition of VelosBio by Merck for $2.75 billion. He has also successfully raised over $500 million in capital for his last two companies. We are really excited to have David’s strategic guidance as we work to accelerate the clinical development of our pipeline of innovative oncology therapies.”

“I am excited to be joining Aura’s Board of Directors during such an important period of growth for the Company,”

said Mr. Johnson.

“I look forward to leveraging my extensive clinical, business development, operational and executive leadership experience in the biotechnology industry to support Aura’s Board of Directors and leadership team in achieving their goal of advancing a new class of oncology drugs for life-threatening cancers.”

Prior to founding VelosBio, Mr. Johnson was the Chief Executive Officer at Acerta Pharma, an oncology-focused pharmaceutical company, where he led the Company through a critical phase of growth from approximately 40 to over 150 employees and from a signal-seeking, first-in-human trial to more than 20 active clinical studies. Under his leadership, Acerta designed and launched three registration-directed trials, including two global Phase 3 trials for acalabrutinib, an irreversible oral Bruton’s tyrosine kinase (BTK) inhibitor initially focused on hematological malignancies. Mr. Johnson and his leadership team ultimately led the acquisition of Acerta by AstraZeneca in a deal valued at up to $7 billion.

Before Acerta, Mr. Johnson held roles with increasing responsibility within commercial, pipeline development, medical affairs, and clinical development organizations at various healthcare companies including Hoffman-La Roche, Immunex (acquired by Amgen), Millennium (acquired by Takeda), Favrille, Gloucester (acquired by Celgene), and Calistoga (acquired by Gilead). He has made significant contributions to drugs ultimately garnering regulatory approvals, including bortezomib (Velcade®), romidepsin (Istodax®), idelalisib (Zydelig®), and acalabrutinib (Calquence®). In addition to Aura’s Board, Mr. Johnson serves on the Board of Directors of Zentalis Pharmaceuticals, a clinical-stage biopharmaceutical company focused on discovering and developing small molecule therapeutics targeting fundamental biological pathways of cancers. Mr. Johnson received a Bachelor’s degree from Indiana University.

About Aura Biosciences

Aura Biosciences, Inc. is a clinical-stage biopharmaceutical company developing a new class of oncology therapies based on a novel drug conjugate technology for initial application in ocular and bladder cancers with the potential to treat other cancers. The Company’s proprietary technology platform utilizes virus-like drug conjugates (VDCs) that have a dual mechanism of action with targeted necrosis of cancer cells, followed by a T-cell mediated anti-tumor response. This novel technology platform uses Virus-Like Particles to bind to a novel tumor cell surface target and can deliver hundreds of cytotoxic molecules selectively to tumor cells, while sparing surrounding healthy tissue. 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 for which there are currently no approved therapies. In a Phase 1b/2 study, AU-011 demonstrated compelling efficacy, including high rates of tumor control and vision preservation, along with a favorable safety profile, in patients with choroidal melanoma. Future pipeline applications for Aura’s technology include choroidal metastases and 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:

Joseph Rayne

Argot Partners

617.340.6075 | joseph@argotpartners.com

Aura Biosciences Completes $40 Million Series D Financing

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

 

CAMBRIDGE, MA – April 2, 2019 – Aura Biosciences, a leader in the development of novel targeted therapies in ocular oncology, today announced that it closed a $40 million Series D financing. New investor Medicxi led the round, with current investors also participating.

The Company plans to use the proceeds from the Series D financing to support the late stage clinical development of their lead asset, light-activated AU-011, for the treatment of primary choroidal melanoma.

“The additional funding provided by this Series D financing enables Aura to continue to execute on our goals of developing the first targeted treatment for patients with primary choroidal melanoma, a life and vision threatening rare disease with no drugs approved,”

said Elisabet de los Pinos, Ph.D., Chief Executive Officer of Aura.

“We are delighted to have the support from lead investor Medicxi, along with our existing investors, as we enter this next stage of the company’s growth.”

In conjunction with the closing of the financing, Giovanni Mariggi, Ph.D., a Partner at Medicxi, will join Aura’s Board of Directors.

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 commercially available at present. The most common current treatment for choroidal melanoma is plaque radiotherapy, which involves surgical placement of a radiation device on the exterior of the eye over the tumor and is associated with severe visual loss and other long-term sequelae such as dry eye, glaucoma, cataracts and radiation retinopathy. The only other 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 lack of approved therapies, and the comorbidities of radioactive treatment options.

About Light-Activated AU-011

AU-011 is a first-in-class targeted therapy in development for the primary treatment of choroidal melanoma. The therapy consists of proprietary viral-like particle bioconjugates (VPB) that are activated with an ophthalmic laser. The VPBs bind selectively to unique receptors on cancer cells in the eye and are derived from technology originally pioneered by Dr. John Schiller of the Center for Cancer Research at the National Cancer Institute (NCI), recipient of the 2017 Lasker-DeBakey Award. Upon activation with an ophthalmic laser, the VPB rapidly and specifically disrupts the cell membrane of tumor cells while sparing 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 has been granted orphan drug and fast track designations by the U.S. Food and Drug Administration and is currently in clinical development.

About Aura Biosciences

Aura Biosciences is developing a new class of therapies to selectively target and destroy cancer cells. Its lead program, AU-011 in primary choroidal melanoma, is being developed under a CRADA with the National Cancer Institute (NCI), part of the National Institutes of Health. Current institutional investors participating in the financing includes Advent Life Sciences, Arix Bioscience, Chiesi Ventures, Columbus Venture Partners, Lundbeck Ventures and Ysios Capital. For more information, visit www.aurabiosciences.com.

About Medicxi

Medicxi is a European venture capital firm with the mission to create and invest in companies along the full drug development continuum. Medicxi was established by the former Index Ventures life sciences team, which has been active for over 20 years, and invests in both early and late-stage assets with a product vision that can fulfill a clear unmet need. GSK, Johnson & Johnson, Novartis and Verily, an Alphabet company, have invested in Medicxi funds. Please see www.medicxi.com for more information.

Contacts:

Media:

David Rosen

Argot Partners

212.600.1902 | david.rosen@argotpartners.com

Investors:

Joseph Rayne

Argot Partners

617.340.6075 | joseph@argotpartners.com