AqVida and Phyton Biotech Receive Approval from European Directorate of Quality Medicines for AqVida’s Cancer-fighting Paclitaxel Injectable Finished Dosage Formulation

On April 18, 2019 Phyton Biotech, a German/North American Plant Cell Fermentation (PCF) technology company, and AqVida, a German oncology Finished Dosage Formulation (FDF) manufacturer, reported that they have received European approval from the EDQM (European Directorate of Quality Medicines) for AqVida’s paclitaxel injectable FDF (Press release, Phyton Biotech, APR 18, 2019, View Source [SID1234535211]).

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Phyton Biotech is the world’s leading manufacturer of paclitaxel active pharmaceutical ingredient (API), utilizing its prorprietary PCF technology process. Under the strategic partnership with AqVida, Phyton Biotech will be the exclusive supplier of paclitaxel API for AqVida’s Taxol generic formulation, which is produced in AqVida’s new state-of-the-art injectable manufacturing facility located in Dassow, Germany. AqVida’s ultramodern robotic manufacturing line, designed for filling cytotoxic injectables, will be utilized to produce AqVida’s generic oncology medicines to treat common types of cancer.

"We chose to work with Phyton because of the company’s superior quality fermentation-produced API, in comparison to naturally extracted or semi-synthetically produced alternatives," says Wolfgang Heinze, who is the Chief Executive Officer (CEO) of AqVida. "Approval of ourpaclitaxel injectable FDF by the European Directorate of Quality Medicines is a major milestone for our company."

Recognized for its innovative and broad portfolio of generic oncology medicines, AqVida is a leading German oncology medication supplier that distributes its products globally.

"We are proud to partner with AqVida and assist with the expansion of its oncology product line," says Colin Marr, president of Phyton Biotech. "Phyton is committed to working with trusted pharmaceutical partners who seek to improve the quality of oncology medicines."

ImmunoGen Announces Conference Call to Discuss Its First Quarter 2019 Operating Results

On April 18, 2019 ImmunoGen, Inc., (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that the Company will host a conference call at 8:00 a.m. ET on Friday, May 3, 2019 to discuss its first quarter operating results (Press release, ImmunoGen, APR 18, 2019, View Source [SID1234535210]). Management will also provide a brief update on the business.

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Conference Call Information
To access the live call by phone, dial 323-994-2093; the conference ID is 8980567. The call may also be accessed through the Investors and Media section of the Company’s website, www.immunogen.com. Following the webcast, a replay of the call will be available at the same location through May 17, 2019.

Vaxiion Therapeutics Initiates Phase 1 Clinical Trial of VAX014 for the Treatment of Non-Muscle Invasive Bladder Cancer in the United States

On April 18, 2019 Vaxiion Therapeutics, the industry leader in bacterial minicell-based targeted therapeutics, reported that the U.S. Food and Drug Administration (FDA) has concluded its 30-day review of the Investigational New Drug application (IND) for VAX014, and the company will now initiate a Phase 1 clinical trial for the treatment of non-muscle invasive bladder cancer (NMIBC) (Press release, Vaxiion Therapeutics, APR 18, 2019, View Source [SID1234535209]). VAX014 is a first-in-class recombinant bacterial minicell-based oncolytic immunotherapy that is engineered to selectively target a pair of NMIBC-associated cell-surface integrin heterodimers.

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The study is a multi-center open label dose escalation with dose expansion Phase 1 trial evaluating the safety, tolerability, and initial anti-tumor activity in patients with NMIBC.

"Advancing our first product candidate into clinical trials is a major milestone, signifying Vaxiion’s transition to a clinical stage company," said Vaxiion President, Matthew Giacalone. "We are now one step closer to achieving our ultimate goal of filling the unmet needs existing in the gaps of the current non-muscle invasive bladder cancer treatment algorithm."

In preclinical models of NMIBC and other cancer types, VAX014 has repeatedly demonstrated durable anti-tumor immunotherapeutic activity resulting in complete tumor regressions and the development of long-term anti-tumor immunologic memory. In nonclinical safety studies, VAX014 was well tolerated following repeat dose administration in the clinically relevant dose range.

This first-in-human Phase 1 study will consist of two segments: a dose escalation segment and a dose expansion segment. Additional information about the trial can be found at View Source

VAX014 is the first clinical product candidate generated from Vaxiion’s proprietary recombinant bacterial-minicell delivery platform.

Alpine Immune Sciences Appoints Stanford Peng to President and Head of Research and Development

On April 18, 2019 Alpine Immune Sciences, Inc. (Nasdaq: ALPN) ("Alpine"), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer, autoimmune/inflammatory, and other diseases, reported Stanford Peng, M.D. Ph.D., has been appointed President and Head of Research and Development of Alpine, effective April 16, 2019 (Press release, Alpine Immune Sciences, APR 18, 2019, View Source [SID1234535208]).

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Dr. Peng, who served as Alpine’s Executive Vice President of Research & Development and Chief Medical Officer since 2016, succeeds Mark Litton, Ph.D., whose role as President and Chief Operating Officer ended effective April 16, 2019.

"It is with great pleasure I announce Stanford’s appointment to the role of President and Head of Research and Development," said Mitchell H. Gold, M.D., Executive Chairman and Chief Executive Officer of Alpine. "Stanford has a proven ability to consistently execute at a high level. Under his leadership, Alpine defined a clear research and development pathway, driving our lead autoimmune/inflammatory program, ALPN-101, into the clinic earlier this year and advancing ALPN-202, our lead oncology program, which we expect to submit for authorization to begin clinical trials later this year. As a practicing physician, patients are truly the focus behind Stanford’s drive—a drive he has instilled within the entire Alpine organization from day one. It’s a privilege to continue working together in his expanded role."

"I am honored to be appointed to this new role," said Dr. Peng. "This is a particularly exciting time for Alpine as we continue to advance our programs towards and into the clinic. I look forward to continuing to work alongside the Alpine team in our shared mission of bringing novel, meaningful therapies to patients."

"On behalf of Alpine’s Board and the entire company, I want to thank Mark for his contributions during his time as President and Chief Operating Officer. We wish him the very best in his next endeavors," said Dr. Gold.

Dr. Peng is an industry veteran with basic, clinical, and biomedical research and development experience across large pharma, startups, biotech, academia, and clinical practice. Prior to joining Alpine, he was Chief Medical Officer at StemCentrx, where he provided strategic oversight of the company’s clinical and translational programs prior to its acquisition by AbbVie. Earlier, he served as Executive Medical Director and Head of Inflammation and Translational Medicine at Seattle Genetics, Head of the Rheumatology Clinical Research Unit and Clinical Associate Member at the Benaroya Research Institute in Seattle, and held various senior positions at ARYx Therapeutics and Roche. Dr. Peng has also held clinical positions as a member physician at Virginia Mason Medical Center in Seattle and as an assistant professor in the Division of Rheumatology at the Washington University School of Medicine in St. Louis, Missouri. Dr Peng received his BA in Music and BS in Biological Sciences from Stanford University, his M.D. from Yale University School of Medicine, and his Ph.D. in biology from Yale University. He completed his residency in internal medicine at the Hospital of the University of Pennsylvania School of Medicine in Philadelphia followed by a clinical and research fellowship in rheumatology at Brigham and Women’s Hospital in Boston.

Arrakis Therapeutics Announces $75 Million Series B Financing to Advance a New Class of Small-Molecule Medicines Targeting RNA

On April 18, 2019 Arrakis Therapeutics, a biopharmaceutical company pioneering the discovery of a new class of small-molecule medicines that directly target RNA, reported that it has completed a $75 million Series B financing co-led by venBio Partners and Nextech Invest, with participation by new investors Omega Funds, HBM Healthcare Investments, GV (formerly Google Ventures), WuXi AppTec Venture Fund, and Alexandria Venture Investments, as well as all existing investors, Canaan Partners, Advent Life Sciences, Pfizer Ventures, Celgene Corporation, Osage University Partners and the estate of Henri Termeer (Press release, Arrakis Therapeutics, APR 18, 2019, View Source [SID1234535207]). In addition, the company announced that Michael Gilman, Ph.D., will expand his role to full-time Chief Executive Officer in addition to continuing to serve as Chairman of the Board of Directors.

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"With this financing and outstanding syndicate of investors, Arrakis will leap to the next stage of realizing our vision of creating a new class of medicines with RNA-targeted small molecules, or rSMs," said Dr. Gilman. "We have built an end-to-end platform for the discovery of rSMs by creating or adapting tools that allow us to predict and validate the structure of RNA targets, locate druggable pockets, identify drug-like hits, and conduct medicinal chemistry programs to improve potency, selectivity, and safety. We are now operating this platform at scale to create a pipeline of utterly novel rSM medicines. I am excited to commit my full effort, along with the Arrakis team and our investors, to drive our discoveries into powerful new medicines for patients."

The proceeds from the Series B financing will enable Arrakis to build a pipeline of novel RNA-targeted small molecules, with the goal of reaching clinical testing with one or more candidates. The company will focus its internal drug development in oncology and genetically validated targets in other disease areas. In addition, the funding will enable Arrakis to continue to refine and expand its first-in-industry rSM discovery platform, including a high-throughput, comprehensive suite of computational tools, biophysical and cellular assays, and chemical libraries that are uniquely designed to create new small-molecule drugs for RNA targets.

"Arrakis Therapeutics is the clear leader in the emerging rSM field. We are pleased to support their differentiated strategy to transform the drug discovery toolkit to focus on RNA and open hundreds of important new targets to therapeutic intervention. Arrakis’ deeply experienced team is uniquely qualified to execute this strategy," said Richard Gaster, M.D., Ph.D., Principal at venBio Partners.

"The demand for more effective and better tolerated cancer drugs is high, creating the biggest and fastest growing market in healthcare. RNA is now a validated therapeutic target, and drugging RNA with conventional small-molecule medicines can provide cancer patients with options not achievable by any other means," said Jakob Loven, Ph.D., Partner at Nextech Invest.

In conjunction with the Series B financing, Dr. Gaster and Dr. Loven will join the Arrakis Board of Directors.

In its next stage of growth, Arrakis will employ its proprietary rSM drug discovery platform to discover novel RNA-targeted small molecules and advance lead candidates toward clinical testing. Since the company’s inception, Arrakis has systematically reconfigured drug discovery tools for RNA targets and achieved the following:

A systematic approach to identify and validate druggable RNA targets, enabling the company to target multiple aspects of RNA biology; these approaches include:

in silico tools to identify druggable RNA targets at scale;
high-throughput molecular biology tools to validate these targets.
Multiple screening methods for identifying tractable targets and chemical matter, including:

screening of hundreds of targets to date;
identification of druggable RNA binding pockets;
deriving the principles of molecular recognition of RNA.
Advancement of rSM drug programs against novel RNA targets and with strong intellectual property, including:

launch of four programs against RNA targets that encode proteins that are otherwise undruggable;
chemical biology tools to elucidate the mechanism of action and selectivity of drug candidates;
an intellectual property estate comprising new methods, compounds and targets.