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Aug 11
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Advent Life Sciences announces sale of its portfolio Company KaNDy Therapeutics to Bayer AG for USD 425M upfront plus USD 450M in potential development milestones followed by further potential commercial milestones.

By Advent Life Sciences, Press Release
Press Release.

 

KaNDy’s lead asset NT-814 is a potential novel non-hormonal oral treatment option for women during menopause

11th August, London – Advent Life Sciences, a leading European life sciences venture capital firm, today announced the sale of its portfolio company, KaNDy Therapeutics Ltd, (“KaNDy”), to Bayer AG for an upfront consideration of USD 425 million plus potential milestone payments of up to USD 450 million until launch followed by potential additional triple digit million sales milestone payments.

KaNDy recently completed the Phase IIb with NT-814, a once-daily, oral neurokinin-1,3 receptor antagonist, publishing positive data for the treatment of frequent symptoms of the menopause, hot flashes and night sweats (vasomotor symptoms). The start of Phase III clinical trial is expected to commence in 2021. Once the deal completes, Bayer AG, a global leader in women’s healthcare, will assume full responsibility for completing Phase III studies of NT-814, registration, and marketing and sales.

KaNDy Therapeutics is a spin-out from NeRRe Therapeutics, a Stevenage, UK, based Company, which Advent Life Sciences co-founded with Mike Trower in 2012 based on a portfolio of Neurokinin modulators.  Advent Life Sciences has supported the company since inception and remained the largest shareholder throughout. In 2015, Dr Mary Kerr, then an Operating Partner at Advent Life Sciences, became full time CEO of NeRRe and in 2017 Advent introduced Andrew Kay (previously CEO of Algeta, a realised Advent portfolio company) as Chairman.

Kaasim Mahmood, General Partner at Advent Life Sciences, said:

“KaNDy is another example of our hands-on approach to achieving our twin objectives – to provide strong returns to our Investors while enabling the discovery and development of truly innovative medicines. We hope that NT-814 will fulfil the potential shown in the Phase IIb studies and provide a much-needed non-hormonal treatment for the alleviation of menopause symptoms.”

Mary Kerr, CEO and Co-Founder of KaNDy, said:

“Advent Life Sciences has played a central role in building this company from the very beginning, leveraging its extensive network to introduce new investors and providing strategic guidance to advance this potential novel medicine and become an important non-hormonal treatment option for women suffering debilitating symptoms of the menopause.”

Closing is subject to customary conditions, in particular anti-trust approval, and is expected by September 2020.

ENDS

Contact details:

Katja Stout, Scius Communications
katja@sciuscommunications.com
+447789435990

Kasim Mahmood, Advent Life Sciences
Kaasim.mahmood@adventls.com
+442079322100

About Advent Life Sciences
Advent Life Sciences founds and invests in early- and mid-stage life sciences companies that have a first- or best-in-class approach to unmet medical needs. The investing team consists of experienced professionals, each with extensive scientific, medical and operational experience, a long-standing record of entrepreneurial and investment success in the US and Europe and is particularly focused on supporting entrepreneurs and founders to take innovative new medical entities from concept to approval. The firm invests in a range of sectors within life sciences, principally drug discovery, enabling technologies and med tech, always with an emphasis on innovative, paradigm-changing approaches. Advent Life Sciences has a presence in the UK, US and France.  For more information, please visit www.AdventLS.com

About KaNDy Therapeutics
KaNDy Therapeutics Ltd. is a UK-based private clinical-stage biotech that was founded in 2017 as a spin-off from NeRRe Therapeutics Ltd. It is led by an experienced management team and backed by internationally recognised life sciences investors: Advent Life Sciences, Fountain Healthcare Partners, Forbion Capital Partners, OrbiMed and Longitude Capital. KaNDy Therapeutics is based at the state-of-the-art Stevenage Bioscience Catalyst, a leading location for companies to develop and commercialise cutting edge therapeutics.

About NT-814
NT-814 is a non-hormonal, orally administered, potent and selective small molecule dual antagonist of both the neurokinin-1 and 3 receptors. NT-814 addresses vasomotor symptoms by modulating a group of oestrogen sensitive neurones in the hypothalamus in the brain (the KNDy neurones), that in menopausal women due to the absence of oestrogen, become hyperactive and consequently disrupt body heat control mechanisms resulting in the debilitating vasomotor symptoms of hot flashes and night sweats.

Aug 06
Love0

Acutus Medical Announces Pricing of Initial Public Offering

By Acutus Medical, Press Release, Publicly Listed
Press Release.

 

August 6, 2020

CARLSBAD, Calif., Aug. 05, 2020 (GLOBE NEWSWIRE) — Acutus Medical, Inc. (“Acutus”) (NASDAQ: AFIB) today announced the pricing of its initial public offering of 8,823,529 shares of its common stock at a price to the public of $18.00 per share. All of the shares are being offered by Acutus. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Acutus, are expected to be approximately $158.8 million. The shares are expected to begin trading on The Nasdaq Global Select Market on August 6, 2020, under the symbol “AFIB.” The offering is expected to close on August 10, 2020, subject to the satisfaction of customary closing conditions. In addition, Acutus has granted the underwriters a 30-day option to purchase up to an additional 1,323,529 shares of Acutus’ common stock at the initial public offering price, less the underwriting discounts and commissions.

J.P. Morgan and BofA Securities are acting as joint book-running managers. William Blair is also acting as book-running manager. Canaccord Genuity and BTIG are acting as co-managers.

Registration statements relating to these securities have been filed with the Securities and Exchange Commission and became effective on August 5, 2020. The offering is being made only by means of a prospectus. Copies of the final prospectus, when available, may be obtained from J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (866) 803-9204, or by email at prospectus-eq_fi@jpmchase.com; BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attention: Prospectus Department, or by email at dg.prospectus_requests@bofa.com; or William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, IL 60606, by telephone at (800) 621-0687, or by email at prospectus@williamblair.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 of these securities under the securities laws of any such state or jurisdiction.

About Acutus Medical, Inc.
Acutus Medical is an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated. Acutus is committed to advancing the field of electrophysiology with a unique array of products and technologies which will enable more physicians to treat more patients more efficiently and effectively. Through internal product development, acquisitions and global partnerships, Acutus has established a global sales presence delivering a broad portfolio of highly differentiated electrophysiology products that provide its customers with a complete solution for catheter-based treatment of cardiac arrhythmias. Founded in 2011, Acutus is based in Carlsbad, California.

Investor Contact:
Caroline Corner
Westwicke ICR
D: 415-314-1725
Caroline.corner@westwicke.com

Holly Windler
M: 619-929-1275
media@acutusmedical.com

Caution Regarding Forward-Looking Statements
This press release includes statements that may constitute “forward-looking” statements, usually containing the words “believe,” “estimate,” “project,” “expect” or similar expressions. These forward-looking statements include, without limitation, references to Acutus’ expectations regarding the commencement of trading on The Nasdaq Global Select Market and the completion, timing and size of the public offering. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Factors that would cause or contribute to such differences include, but are not limited to, risks and uncertainties related to completion of the public offering and the satisfaction of customary closing conditions related to the public offering. Additional factors that would cause or contribute to such differences include, but are not limited to, the Company’s ability to continue to manage expenses and cash burn rate at sustainable levels, continued acceptance of the Company’s products in the marketplace, the effect of global economic conditions on the ability and willingness of customers to purchase its systems and the timing of such purchases, competitive factors, changes resulting from healthcare policy in the United States, including changes in government reimbursement of procedures, dependence upon third-party vendors, timing of regulatory approvals, the impact of the recent coronavirus (COVID-19) pandemic and our response to it, and other risks discussed in the Company’s periodic and other filings with the Securities and Exchange Commission. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this release

Jul 16
Love0

Zikani Therapeutics Appoints Chief Scientific and Medical Officer

By Press Release
Press Release.

 

Vijay Modur, M.D., PhD, to Lead Company’s TURBO-ZMTM Technology Platform
into First in Human Trials

WATERTOWN, MA – JULY 16, 2020 – Zikani Therapeutics, a company leveraging its unique TURBO-ZMTM platform to develop novel ribosome modulating agents (RMAs) for the treatment of rare, nonsense mutation-driven diseases, today announced the appointment of Vijay Modur M.D., Ph.D., as its Chief Scientific and Medical Officer to lead the company in advancing its ribosome-modulating scientific platform into the next stage of drug development.

Dr. Modur was previously Global Project Head in Rare Disease Clinical Development at Sanofi-Genzyme where he oversaw key functions responsible for advancing venglustat  for the treatment of conditions caused by lysosomal dysfunction and other investigational therapies for several rare diseases, many with the potential for accelerated approval. Before joining Sanofi-Genzyme, Dr. Modur served as Chief Medical Officer and Vice President of Translational Research for HTG Molecular. Dr. Modur previously held clinical development leadership roles at Novartis and Merck.

“Zikani’s top priority is to advance its current nonsense mutation readthrough programs from lead optimization to candidate selection for first in human clinical trials following the positive, pre-clinical data demonstrated in multiple disease areas,”

said Sumit Aggarwal, President and CEO, Zikani Therapeutics.

“We’re optimistic about the opportunity to impact diseases with limited or no treatment options including: APC mutant colon cancer, familial adenomatous polyposis (FAP), class 1 cystic fibrosis, and recessive dystrophic and junctional epidermolysis bullosa (RDEB and JEB), and Vijay’s experience and leadership will strengthen our capabilities to pursue this important work,”

added Aggarwal.

“Zikani has focused its technology on where it holds the most promise and with the addition of Vijay is building a leadership team that will advance the company into the next phases of preclinical and clinical development,”

said Alan Walts, Ph.D., Executive Chairman of Zikani’s Board of Directors.

Dr. Modur earned his MBBS at Karnatak University, Dharwad, India and his Ph.D. in Experimental Pathology at the University of Utah. He completed his residency at Washington University, St. Louis where he served as Chief Resident, Laboratory Medicine. Dr. Modur is board certified in Clinical Pathology.

“The promise of impacting rare diseases through such novel technology that builds upon the science of modulating protein translation is compelling,”

said Modur.

“The TURBO-ZMTM technology platform and the proof of cellular concept demonstrated across multiple disease states provides a compelling approach to treating rare diseases. I’m excited to join the team and look forward to making an impact on behalf of patients,”

added Modur.

Ribosomal RNAs form the translation machinery that generates function proteins from genetic sequences. Ribosome modulation provides a therapeutic approach to addressing a number of diseases, but the development of disease-specific ribosome modulators has been a challenge.

About Zikani Therapeutics
Zikani Therapeutics is an emerging leader in the science of ribosome modulation, leveraging its innovative TURBO-ZMTM chemistry technology platform to develop novel ribosome modulating agents (RMAs) as therapeutics for people with limited treatment options. Zikani’s TURBO-ZMTM platform allows rapid synthesis of novel compounds that can be optimized to modulate the ribosome in a disease specific manner. As the company evolves its focus from early-stage to clinical-stage research, Zikani is actively moving into pre-clinical development to target select rare diseases including inherited diseases and cancers caused by nonsense mutations. For more information, visit zikani.com.

Contact
Outcomes Communication Group
Laureen Cassidy
laureen@outcomescg.com

Jun 24
Love0

Artax Biopharma Announces the Formation of Scientific Advisory Board to Advance Autoimmune Disease Therapy AX-158

By Artax Biopharma, Press Release, Private Companies
Press Release.

 

Renowned Global Leaders are Experts in Immunology, Autoimmune Disease, and T Cell Signaling

Cambridge, Mass., June 24, 2020 – Artax Biopharma, Inc., a biotechnology company focused on transforming autoimmune disease treatment, today announces the formation of their Scientific Advisory Board (SAB). The SAB is comprised of experts in Immunology, Autoimmune Disease, and T Cell Signaling, and was formed to guide the company as it proceeds into future clinical trials with a first-in-class, oral small molecule autoimmune disease immunomodulator AX-158.

Artax Biopharma is poised to enter clinical trials with the small molecule AX- 158, a novel approach to treat multiple autoimmune diseases without causing the immunosuppression commonly associated with current autoimmune disease therapies.

Balbino Alarcón, PhD, Chairman of Artax’s Scientific Advisory Board, commented,

“I am privileged to lead Artax’s Scientific Advisory Board, which mobilizes global leaders in Immunology, Autoimmune Disease, and T Cell Signaling. Collectively we are enthusiastic to collaborate on, and contribute to, important development initiatives related to Artax’s innovative approach to autoimmune disease treatment.”

“Artax Biopharma’s Nck inhibitor AX-158 has shown impressive experimental biologic and mechanistic impact on T cell modulation – managing autoimmune disease without inducing the profound immunosuppression or interference with memory response associated with conventional or biological therapies,”

stated Dr. Lawrence Steinman, Stanford University Zimmerman Professor of Neurology and Neurosciences, Pediatrics, and Genetics and Scientific Advisory Board member.

“Convening a Scientific Advisory Board is a critical step as we accelerate our clinical development program,”

stated Artax Biopharma Chief Executive Officer Joseph Lobacki.

“The clinical expertise and knowledge of these experts is unparalleled and will be instrumental in informing our development strategy across several autoimmune diseases.”

The SAB will be comprised of five experts, and is being led by
Professor Balbino Alarcón, PhD, co-founder of Artax Biopharma:

Balbino Alarcón, PhD
Dr. Alarcón is Program Director at the National Research Council of
Spain (CSIC) and Head of the TCR-mediated Signal Transduction
Laboratory.

Raif Geha, MD
Dr. Geha is the James L. Gamble Professor of Pediatrics at Harvard
Medical School and Chief of the Allergy/Immunology/Rheumatology and
Dermatology Division at Children’s Hospital in Boston.

Menno de Rie, MD
Prof. de Rie is a board-certified dermatologist and vice-chair of the
department of Dermatology of the Amsterdam University Medical Centres/
University of Amsterdam.

Lawrence Steinman, MD
Dr. Steinman is the George A. Zimmermann professor of Neurology
and Neurological Sciences, Pediatrics, and Genetics at Stanford University.

Cox Terhorst, PhD
Dr. Terhorst is Chief of Immunology at Beth Israel Deaconess Medical
Center and Professor at Harvard Medical School.

About Immunomodulation
A healthy immune system eliminates harmful foreign pathogens, while
being tolerant of self-tissues and organs. When the immune system
malfunctions, cells (T Cells) attack self-tissues and organs, causing
autoimmune disease. Current autoimmune disease therapies suppress the
immune system, helping to minimize these self-attacks, but also raise
susceptibility to harmful foreign pathogens. Immunomodulation, the process
in which the immune system reduces self-attacks while properly reacting to
fight foreign pathogens, holds great potential for autoimmune disease.

About Artax-158
AX-158 is a first-in-class, oral small molecule, preclinical
immunomodulating agent in development for the treatment of autoimmune
diseases. AX-158 employs a novel mechanism of action that selectively
modulates, or adjusts, T cell responses that play a critical role in immune
system function. By selectively inhibiting Nck, a protein, AX-158 selectively
modulates self-directed T Cell activation which is a cause of autoimmune
disease. Importantly, data suggest AX-158 is not immunosuppressive and
does not impact the immune system’s ability to mount a strong response to
foreign pathogens and infections. Further, AX-158’s ability to modulate T cell
responses allows the possibility to broadly target several autoimmune
diseases, therefore potentially transforming autoimmune disease treatment.

About Artax Biopharma
Artax Biopharma is a biotechnology company transforming
autoimmune disease treatment. Artax is a life science industry leader in
autoimmune disease immunomodulation science, developing an
innovative small molecule approach to treat autoimmune disease that
modulates the immune system to both treat autoimmune disease and
allow the body to fight foreign pathogens. The company is examining a
first-in-class oral immunomodulating agent as a new way to treat multiple
autoimmune diseases without causing the immune suppression commonly
associated with currently available autoimmune disease therapies. For
more information, please visit www.artaxbiopharma.com.

Contacts:
Karen LaRochelle, MBA
Chief Business Officer
Artax Biopharma
klarochelle@artaxbiopharma.com

Media:
Linda Phelan Dyson, MPH
+1 973-986-5873
ldyson@artaxbiopharma.com

Jun 04
Love0

Artax Biopharma Announces Series B Financing Extension to Advance First-in-Class Autoimmune Disease Therapy

By Artax Biopharma, Press Release, Private Companies
Press Release.

 

– Extension Brings in Additional Investor –

Cambridge, MA, June 4, 2020 – Artax Biopharma, Inc., a biotechnology company focused on transforming autoimmune disease treatment, today announces the completion of an extension to its Series B financing led by Columbus Venture Partners.

AX-158 is a first-in-class, oral small molecule, immunomodulating agent in development for the treatment of autoimmune diseases. AX-158 employs a novel mechanism of action that selectively modulates, or adjusts, T cell responses that play a critical role in immune system function.  Proceeds from the financing will be used to support activities for a planned Q4 2020 filing of a Clinical Trial Application (CTA) with the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) for AX-158.

“We are pleased to welcome Columbus Venture Partners as a new investor,”

said Joseph Lobacki, Chief Executive Officer of Artax Biopharma.

“The support of Columbus Venture Partners is a testament to the transformative potential of our science, which has the potential to address autoimmune disease without causing immunosuppression.

” Javier García, Founder and Partner with Columbus Venture Partners, stated, “Columbus Venture Partners is pleased to have led the extension to this round of financing. We believe Artax’s highly experienced leadership team is well positioned to deliver on a truly innovative therapeutic program.”

About Immunomodulation

A healthy immune system eliminates harmful foreign pathogens, while being tolerant of self-tissues and organs.  When the immune system malfunctions, cells (T Cells) attack self-tissues and organs, causing autoimmune disease. Current autoimmune disease therapies suppress the immune system, helping to minimize these self-attacks, but also raise susceptibility to harmful foreign pathogens.Immunomodulation, the process in which the immune system reduces self-attacks while properly reacting to fight foreign pathogens, holds great potential for autoimmune disease therapies.

About Artax-158

AX-158 is a first-in-class, oral small molecule, preclinical immunomodulating agent in development for the treatment of autoimmune diseases. AX-158 employs a novel mechanism of action that selectively modulates, or adjusts, T cell responses that play a critical role in immune system function. By selectively inhibiting Nck, a protein, AX-158 selectively modulates self-directed T Cell activation which is a cause of autoimmune disease. Importantly, data suggests that AX-158 is not immunosuppressive and does not impact the immune system’s ability to mount a strong response to foreign pathogens and infections. Further, AX-158’s ability to modulate  T  cell  responses  allows  the  possibility  to  broadly  target  several autoimmune diseases, therefore potentially transforming autoimmune disease treatment.

About Artax Biopharma

Artax Biopharma is a biotechnology company transforming autoimmune disease treatment.  Artax is a life science industry leader in autoimmune disease immunomodulation science, developing an innovative small molecule approach to treat autoimmune disease that modulates the immune system to both treat autoimmune disease and allow the body to fight foreign pathogens.  The company is examining a first-in-class oral immunomodulating agent as a new way to treat multiple  autoimmune  diseases  without  causing  the  immune  suppression commonly associated with currently available autoimmune disease therapies. For more information, please visit www.artaxbiopharma.com.

Contacts:
Karen LaRochelle, MBA
Chief Business Officer
Artax Biopharma
klarochelle@artaxbiopharma.com

Media:
Linda Phelan Dyson, MPH
+1 973-986-5873
ldyson@artaxbiopharma.com

Jun 03
Love0

Axonics® Announces U.S. Food & Drug Administration Approval of Wireless Patient Remote Control with SmartMRI Technology

By Axonics, Press Release
Press Release.

 

June 3, 2020 at 6:00 AM EDT

IRVINE, Calif.–(BUSINESS WIRE)–Jun. 3, 2020– Axonics Modulation Technologies, Inc. (NASDAQ: AXNX), a medical technology company that has developed and is commercializing novel implantable Sacral Neuromodulation (SNM) devices for the treatment of urinary and bowel dysfunction, today announced U.S. Food & Drug Administration (FDA) approval of its new wireless patient Remote Control with SmartMRI™ technology for the Axonics r-SNM® System under a premarket approval (PMA) supplement.

The new Remote Control simplifies the process by which patients can receive a full-body MRI. An MRI technician can perform a simple check using a patient’s Remote Control immediately prior to an MRI, avoiding the need for the patient to visit their implanting physician’s office or involving personnel from Axonics. The new patient Remote Control with SmartMRI technology will be included in all new orders of the Axonics r-SNM System in the United States beginning this month.

The Axonics r-SNM System is approved for 1.5T full-body MRI scans in the United States and both 1.5T and 3.0T full-body MRI scans in Canada and Europe. In April 2020, Axonics submitted a PMA supplement to the FDA for the purpose of gaining full-body MRI conditional labeling for 3.0T MR scanners in the United States. The FDA review of this expansion of labeling is expected to be completed in early Q4 2020.

Raymond W. Cohen, CEO of Axonics commented,

“Delivering a superior experience to patients, physicians and their staff has been the key focus of our product development initiatives since Axonics’ founding. The introduction of this new patient Remote Control provides for significant convenience and reduces the burden on physician practices. This FDA approval follows the recent approval of both our next generation implantable neurostimulator and programmer and is part of a cadence of product enhancements that we are committed to pursuing.”

About Axonics Modulation Technologies, Inc.

Axonics, based in Irvine, Calif., has developed and is commercializing novel implantable SNM devices for patients with urinary and bowel dysfunction. These conditions are caused by a miscommunication between the bladder and the brain and significantly impact quality of life. Overactive bladder affects an estimated 87 million adults in the U.S. and Europe. Another estimated 40 million adults are reported to suffer from fecal incontinence/accidental bowel leakage. SNM therapy has been employed to reduce symptoms and restore pelvic floor function for the past two decades. Reimbursement coverage is well established in the U.S. and Europe. The Axonics System is the first long-lived rechargeable SNM system approved for sale in the world, and the first to gain full-body MRI conditional labeling. For more information, visit the Company’s website at www.axonics.com.

Forward-Looking Statements

Statements made in this press release that relate to future plans, events, prospects or performance are forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. Words such as “planned,” “expects,” “believes,” “anticipates,” “designed,” and similar words are intended to identify forward-looking statements. While these forward-looking statements are based on the current expectations and beliefs of management, such forward-looking statements are subject to a number of risks, uncertainties, assumptions and other factors that could cause actual results to differ materially from the expectations expressed in this press release, including the risks and uncertainties disclosed in Axonics filings with the Securities and Exchange Commission, all of which are available online at www.sec.gov. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, Axonics undertakes no obligation to update or revise any forward-looking statements to reflect new information, changed circumstances or unanticipated events.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200603005156/en/

Neil Bhalodkar
Investor Relations
949-336-5293
ir@axonics.com

Source: Axonics

May 21
Love0

Amphista Therapeutics appoints leading protein degradation pioneer, Ian Churcher as CSO

By Amphista Therapeutics, Press Release, Private Companies
Press Release.

 

Glasgow, Scotland, 21 May 2020 – Amphista Therapeutics, a biopharmaceutical company creating first-in-class cancer therapeutics that harness the body’s natural processes to remove disease causing proteins selectively and efficiently, today announced the appointment of Dr Ian Churcher as Chief Scientific Officer (CSO).

Amphista’s CEO Dr Nicola Thompson said,

“I’m delighted to welcome Ian to the team. As an internationally recognised leader in the field of targeted protein degradation (TPD) as a therapeutic modality, Ian’s scientific leadership will be a tremendous addition to the Amphista team as we progress our TPD pipeline to the clinic. Ian’s appointment so soon after last month’s $7.5m Series A financing signals Amphista’s determination to deliver on its vision to create a world-leading protein degradation company delivering ground-breaking new medicines in areas of high patient need.”

Ian commented on his appointment,

“I’ve long sought out novel approaches to address traditionally undruggable targets in areas of high patient need. Amphista has a unique approach to targeted protein degradation and Nicola has quickly built a high-quality team. I’m excited by the opportunity to help Amphista develop its novel platform further and rapidly advance its lead projects into the clinic. As Amphista’s approach is very different to existing targeted degradation approaches, it offers significant potential to address a wide range of targets to ultimately help patients across many hard to treat diseases.”

Between 2012-2017, Ian led the Protein Degradation Discovery Performance Unit at GSK where, in collaboration with Professors Craig Crews and Alessio Ciulli, they pioneered the use of VHL-dependent PROTACs, culminating in landmark publications. Ian has also led teams developing drug discovery technologies and advancing medicines across multiple therapy areas during an R&D career at Merck & GSK. More recently, Ian led research at biotechnology companies aiming to change the way drug R&D is carried out, including as SVP Drug Discovery at BenevolentAI. There, working closely with machine learning and data science experts, he advanced a portfolio of programmes and helped develop novel AI-led methods for target identification and chemical optimisation. Ian holds an MA and D.Phil. in Chemistry from the University of Oxford where he was also Visiting Professor in the Department of Chemistry.

Amphista’s TPD small molecules instruct cells to degrade disease-causing target proteins directly, giving a clear therapeutic advantage over simple target inhibition. Specifically, Amphista’s platform is independent of traditional E3 ubiquitin ligases used by the field, potentially expanding the available target scope of TPD approaches and should overcome recently identified PROTAC® resistance mechanisms.

–    Ends   –

Media contacts:

Amphista Therapeutics
CEO NicolaThompson
+447464974714
nicki@amphista.com

Scius Communications
Katja Stout
+447789435990
katja@sciuscommunications.com

About Amphista Therapeutics

Amphista Therapeutics is a biopharmaceutical company creating first-in-class therapeutics that help harness the body’s natural processes to selectively and efficiently degrade and remove disease causing proteins. The company’s pipeline of novel small molecules that cause targeted protein degradation (TPD) is focused on challenging diseases including cancer. Amphista is a spin-out of renowned TPD expert Professor Alessio Ciulli’s labs at the University of Dundee, and is based in BioCity Glasgow, Scotland. The company is funded by leading life science investors including Advent Life Sciences, the European Investment Fund, the Scottish Investment Bank, and BioMotiv. For more information, visit http://www.amphista.com/

May 13
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Artax Biopharma Appoints Joseph Lobacki as Chief Executive Officer, Announces Expanded Management Team

By Artax Biopharma, Press Release, Private Companies
Press Release.

 

Autoimmune Disease Company Hires Life Science Industry Experts to Lead Company
Through Next Stage into Human Clinical Studies with Novel Oral Small Molecule AX-158

Cambridge, MA, May 13, 2020 – Artax Biopharma, Inc., a biotechnology company
focused on transforming autoimmune disease treatment, announces their
expanded management team, being led by newly appointed Chief Executive Officer
(CEO) Joseph Lobacki. Comprised of immunology industry leaders and scientists,
the team represents deep expertise in drug discovery, development and
collaborations from some of the world’s most prestigious institutions.

Artax Biopharma is poised to enter clinical trials with the small molecule AX-
158, a novel approach to treat multiple autoimmune diseases without causing the
immune suppression commonly associated with current autoimmune disease
therapies.

Joseph Lobacki assumes the helm of Artax Biopharma after more than three
decades of leadership including research, development, and commercial
experience in executive roles across large and small biopharmaceutical companies,
including Sanofi Genzyme, Medivation, Verastem, and Micromet. The former CEO,
Damia Tormo, will continue as a member of the Board of Directors and we thank
Dr. Tormo for his years of work in founding and building Artax.

“We are thrilled to have such a strategic and experienced leader as Joseph
Lobacki steering Artax from our new US headquarters at this seminal time,”

stated Artax Biopharma’s Executive Chairman of the Board Alan Walts, Ph.D.

“His deep experience will prove invaluable as Artax’s first oral agent to treat autoimmune
disease prepares to enters the clinic.”

The Artax Biopharma management team includes Joseph Lobacki, CEO; Chris
VanDeusen, Ph.D., Chief Scientific Officer (CSO); Richard P. Polisson, M.D., MHSc,Chief Medical Officer (CMO); Karen LaRochelle, MBA, Chief Business Officer (CBO), and Andres Gagete, Ph.D., Chief Operating Officer, (COO).

“I am excited to lead these incredibly talented and experienced professionals
in our Cambridge location as we fulfill the Artax mission to make our treatments
available as quickly as possible to patients who suffer from autoimmune diseases.
This team possesses the critical knowledge and experience to progress our novel
immunomodulator into clinical development and to drive this important mission
forward,”

added Mr. Lobacki.

Prior to Artax, Mr. Lobacki most recently served as Executive Vice President
and Chief Commercial Officer for Verastem, Inc.; Chief Operating Officer of Finch
Therapeutics Group, and Chief Commercial Officer and Executive Council Member
of Medivation, where he led a period of strong revenue growth for prostate cancer
treatment Xtandi®. Mr. Lobacki also held previous roles as Senior Vice President
and Chief Commercial Officer of Micromet, Inc., and Senior Vice President and
General Manager at Genzyme Corporation. Mr. Lobacki served as a director of
Celator Pharmaceuticals (acquired by Jazz Pharmaceuticals) and is currently on the
Boards of Sutro Biopharma and Artax Biopharma.

As CSO, Dr. VanDeusen will lead Artax’s scientific, research and translational
areas. Dr. VanDeusen brings more than 15 years of biopharmaceutical experience
and extensive expertise in drug discovery and development. He is also an inventor
and key contributor to multiple preclinical development compounds. Previously,
Dr. VanDeusen headed the chemistry division and was a global project team leader
within Tissue Protection and Repair at Sanofi Genzyme.
Dr. Polisson, in his role as Artax’s CMO, will direct the company’s clinical
development strategy. With 30 years of clinical and translational research
experience, Dr. Polisson joins Artax from the Sanofi Genzyme Research and
Development Center where he was Senior Vice President and Translational
Medicine Head directing discovery and translational medicine efforts across
multiple therapeutic areas. Previously, Dr. Polisson served as Associate Professor
of Medicine, Arthritis Unit Clinical Director at Massachusetts General Hospital and
Harvard Medical School.

As Chief Business Officer, Karen LaRochelle, MBA will lead all partner- and
investor-related interactions. With more than 25 years of biopharmaceutical
strategy and collaborations experience, her expertise in mergers & acquisitions
includes a deep history transacting for biotech companies, with several
transactions exceeding $1 billion. Prior to Artax, Ms. LaRochelle was Chief Business
Officer of PsiOxus Therapeutics. Previously in her career, Ms. LaRochelle spent
nearly 20 years with Bristol-Myers Squibb focused on strategy and transactions.

Dr. Gagete, as Artax’s COO, is currently coordinating research &
development and operations for Artax. Dr. Gagete has more than a decade of
experience in the biotech and academic sectors and was previously the Innovation
Director for Bioncotech Therapeutics.

About Immunomodulation

A healthy immune system eliminates harmful foreign pathogens, while being
tolerant of self-tissues and organs. When the immune system malfunctions, cells
(T Cells) attack self-tissues and organs, causing autoimmune disease. Current
autoimmune disease therapies suppress the immune system, helping to minimize
these self-attacks, but also raise susceptibility to harmful foreign pathogens.
Immunomodulation, the process in which the immune system reduces self-attacks
while properly reacting to fight foreign pathogens, holds great potential for
autoimmune disease.

About Artax-158

AX-158 is a first-in-class, oral small molecule, preclinical immunomodulating
agent in development for the treatment of autoimmune diseases. AX-158 employs
a novel mechanism of action that selectively modulates, or adjusts, T cell responses
that play a critical role in immune system function. By selectively inhibiting Nck, a
protein, AX-158 selectively modulates self-directed T Cell activation which is a
cause of autoimmune disease. Importantly, AX-158 is not immunosuppressive and
does not impact the immune system’s ability to mount a strong response to foreign
pathogens and infections. Further, AX-158’s ability to modulate T cell responses
allows the possibility to broadly target several autoimmune diseases, therefore
potentially transforming autoimmune disease treatment.

About Artax Biopharma

Artax Biopharma is a biotechnology company transforming autoimmune
disease treatment. Artax is a life science industry leader in autoimmune disease
immunomodulation science, developing an innovative small molecule approach to
treat autoimmune disease that modulates the immune system to both treat
autoimmune disease and allow the body to fight foreign pathogens. The company
is examining a first-in-class oral immunomodulating agent as a new way to treat
multiple autoimmune diseases without causing the immune suppression
commonly associated with currently available autoimmune disease therapies. For
more information, please visit www.artaxbiopharma.com.

Contacts:
Karen LaRochelle, MBA
Chief Business Officer
Artax Biopharma
klarochelle@artaxbiopharma.com

Media:
Linda Phelan Dyson, MPH
+1 973-986-5873
ldyson@artaxbiopharma.com

Apr 23
Love0

Nalu Medical, Inc. Appoints New Chief Executive Officer: Earl R. Fender Joins as President & CEO

By Nalu Medical, Press Release, Private Companies
Press Release.

 

CARLSBAD, Calif. (PRWEB) April 23, 2020

Nalu Medical, Inc. (“Nalu”), a global medical device company that provides miniaturized, battery-free implantable solutions for the treatment of chronic pain in Spinal Cord Stimulation (SCS) and Peripheral Nerve Stimulation (PNS), announced today that Earl R. Fender has been appointed President and Chief Executive Officer and member of the Board of Directors. Mr. Fender succeeds Keegan Harper, who has stepped down as CEO but will remain as Chairman of the Board.

“We are very excited to welcome Earl Fender to the Nalu team,”

said Mr. Harper.

“I cannot think of a stronger person to lead Nalu as it enters its full commercialization and growth phase than Earl. He brings over 30 years of successful experience in building and leading medical technology companies. For the last 12-years, he worked in the chronic pain space as the CEO of Vertiflex, Inc., which was acquired by Boston Scientific in June 2019. He brings a wealth of experience in building industry-leading, high growth companies and I am excited to have him join the Nalu team.”

“I am very excited and proud to join Nalu’s illustrious team who has developed such differentiated technology to positively impact the lives of patients in the U.S. and abroad,”

said Mr. Fender.

“The uniquely miniaturized, battery-free and easily upgradable Nalu implantable pulse generator system will help expand patient acceptance in both spinal cord and peripheral nerve stimulation.”

“We are very excited to welcome Earl Fender to the Nalu team. I cannot think of a stronger person to lead Nalu as it enters its full commercialization and growth phase than Earl. He brings over 30 years of successful experience in building and leading medical technology companies.”

Mr. Fender added,

“The Board thanks Keegan for his years of dedicated service to Nalu since founding the Company in 2014. As Nalu’s co-founder and CEO, Keegan built a strong team, developed a sophisticated product in record time, launched a successful first in human study in Australia, received FDA clearance in SCS and PNS, received CE mark approval, and completed a successful limited clinical launch in the U.S. We look forward to his continued leadership as Nalu’s Chairman.”

About the Nalu Neurostimulation System
The Nalu neurostimulation system is a battery-free, micro-implantable pulse generator (iPG) currently cleared by the FDA for both Spinal Cord Stimulation (SCS) and Peripheral Nerve Stimulation (PNS) for mitigating chronic pain. The system is highly capable and easily upgradeable, providing a menu of therapy options. To learn more, please visit http://www.nalumed.com.

About Nalu Medical
Nalu Medical, Inc. is a privately held early-stage medical device start-up company based in Carlsbad, California. The team of seasoned entrepreneurs, engineers and scientists are developing the next generation of medical devices to address a number of poorly treated clinical conditions. Nalu Medical’s vision is to modernize and enhance medical device technology to improve people’s lives.

Apr 20
Love0

Zikani Therapeutics Completes Series A-1 Funding

By Press Release
Press Release.

 

Company Poised to Advance its TURBO-ZMTM Technology Platform to Develop Novel Ribosome Modulators to Treat Rare Nonsense Mutations

 

WATERTOWN, MA – APRIL 20, 2020 – Zikani Therapeutics, a company dedicated to leveraging its unique TURBO-ZM platform to develop novel ribosome modulating agents (RMAs) for the treatment of rare, nonsense mutation-driven diseases, today announced the close of a $7.5 million Series A-1 financing. Advent Life Sciences, Gurnet Point Capital and Roche Venture Fund supported the funding.

“We’re pleased to support Zikani as an emerging company that is using the strength of its science and a refined strategy to develop novel ribosome modulators for rare diseases caused by nonsense mutations,”

said Raj Parekh of Advent Life Sciences.

Zikani will use the proceeds to advance its current nonsense mutation readthrough programs from lead optimization to candidate selection. The company has demonstrated positive, pre-clinical data in multiple disease areas, including: APC mutant colon cancer,  familial adenomatous polyposis (FAP), class 1 cystic fibrosis, and recessive dystrophic and junctional epidermolysis bullosa (RDEB and JEB).

“Zikani has generated promising data that validates its TURBO-ZMTM platform and addresses a completely unmet need in oncology therapeutics: restoring expression of a major tumor suppressor gene,”

said Keith Flaherty, M.D., Director of Clinical Research at Massachusetts General Hospital Cancer Center and a senior advisor to Zikani.

Ribosomal RNAs form the translation machinery that generates function proteins from genetic sequencies. Ribosome modulation provides a therapeutic approach to addressing a number of diseases, but the development of disease-specific ribosome modulators has been a challenge. Zikani’s proprietary platform TURBO-ZMTM allows rapid synthesis of novel RMAs that can be optimized to target the human ribosome in a disease specific manner.

“We’re highly encouraged by the data we’ve generated to date and are working rapidly to advance compounds into pre-clinical development. This financing, particularly in this volatile financial market, is a vote of confidence for our promising technology platform. As we look ahead, our focus is to maximize the funding and take the steps necessary to generate greater recognition for RMAs and form collaborations with partners that will benefit from our scientific platform,”

said Sumit Aggarwal, President and CEO, Zikani Therapeutics.

About Zikani Therapeutics

Zikani Therapeutics is an emerging leader in the science of ribosome modulation, leveraging its innovative TURBO-ZMTM chemistry technology platform to develop novel Ribosome Modulating Agents (RMAs) as therapeutics for people with limited treatment options. Zikani’s TURBO-ZMTM platform allows rapid synthesis of novel compounds that can be optimized to modulate the ribosome in a disease specific manner. As the company evolves its focus from early-stage to clinical-stage research, Zikani is actively moving into pre-clinical development to target select rare diseases including inherited diseases and cancers caused by nonsense mutations. For more information, visit zikani.com.

Contact

Outcomes Communication Group
Laureen Cassidy
laureen@outcomescg.com