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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.

"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.

IMV to Provide Updated Clinical Data at 2019 ASCO Annual Meeting on Lead Candidate DPX-Survivac in Ovarian Cancer and Other Solid Tumors

On April 18, 2019 IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical stage immuno-oncology corporation, reported that two of its abstracts have been accepted for presentation at the upcoming 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which takes place May 31 – June 4 in Chicago, IL (Press release, IMV, APR 18, 2019, View Source [SID1234535206]).

"Despite advances in other cancer treatment regimens, ovarian cancer remains a particularly difficult-to-treat disease, and one that represents one of the most underserved areas of the treatment landscape," said Frederic Ors, Chief Executive Officer at IMV. "Our presentations at ASCO (Free ASCO Whitepaper) will allow us to update this important scientific audience on the potential of DPX-Survivac monotherapy and on the progress we have made since our groundbreaking ASCO (Free ASCO Whitepaper) 2018 presentation."

Presentation details are as follows:

Poster Title: "DPX-Survivac and intermittent low-dose cyclophosphamide (CPA) with or without epacadostat (E) in the treatment of subjects with advanced recurrent epithelial ovarian cancer (DeCidE1 trial): T cell responses and tumor infiltration correlate with tumor regression."
Abstract Number: 5576
Session Title: Gynecologic Cancer
Date and Time: June 1, 2019, 1:15 – 4:15 p.m. CT

Poster Title: "Early response assessment through multiparametric MRI based endpoints in a phase II multicenter study evaluating the efficacy of DPX-Survivac, intermittent low dose cyclophosphamide (CPA) and pembrolizumab combination study in subjects with solid tumors."
Abstract Number: e14245
Session Title: online publication only on May 15, 2019, 5:00 p.m. ET

ASCO will publish the official abstracts on its meeting website in advance of the ASCO (Free ASCO Whitepaper) Annual Meeting at 5:00 p.m. ET on May 15. The cut-off date for inclusion of data in the abstract was February 12, 2019. The final conference presentation will include additional data collected between the abstract submission cutoff and the presentation itself.

Obsidian Therapeutics Announces Leadership Transition and Appoints Paul K. Wotton, Ph.D., as Chief Executive Officer

On April 18, 2019 Obsidian Therapeutics, a biotechnology company developing cell-based therapeutics with controllable operating systems, reported the appointment of Paul K. Wotton, Ph.D., as Chief Executive Officer (Press release, Obsidian Therapeutics, APR 18, 2019, View Source [SID1234535205]). He succeeds Michael Gilman, Ph.D., who will focus on Arrakis Therapeutics and continue to serve on Obsidian’s Board of Directors .

"I am thrilled that we are able to bring an outstanding leader like Paul to Obsidian," said Dr. Gilman. "Paul’s substantial experience, his strategic business savvy, together with his in-depth of knowledge of cell and gene therapies make him a natural choice to lead the Obsidian team and advance its next generation cell and gene therapies into the clinic."

Dr. Wotton brings significant global biotechnology and pharmaceutical industry leadership experience spanning scientific research, product development and corporate growth gained over a thirty-year career. Dr. Wotton most recently served as the Founding President and CEO of Sigilon Therapeutics, Inc. Prior to Sigilon, Dr. Wotton served as President and Chief Executive Officer of Ocata Therapeutics until its acquisition by Astellas Pharma where he was also Co-Chairman of the Office of Integration. In previous roles, he served as President and Chief Executive Officer of Antares Pharma as well as Chief Executive Officer of Topigen Pharmaceuticals. Dr. Wotton is a named inventor on numerous patents and was the Ernst & Young Entrepreneur of the Year Regional (NJ) Winner Life Sciences in 2014. He serves on the Boards of Directors of Vericel Corporation (NASDAQ: VCEL), Veloxis Pharmaceuticals A/S (Copenhagen: VELO) and Cynata Therapeutics (ASX: CYP).

"We welcome Paul to lead Obsidian through its next phase of growth," said Peter Barrett, Ph.D., Chairman of the Board of Obsidian and Partner at Atlas Venture. "His deep experience in managing platform growth opportunities will be invaluable in building Obsidian to its full potential. The Board would also like to thank Mike Gilman for leading Obsidian’s significant progress to date and building a strong company foundation."

"I am excited to be joining Obsidian Therapeutics at a pivotal time for the company," said Dr. Wotton. "Mike and the team have built a world-class organization, executed on a strategic transformative partnership, and established Obsidian’s technology as the premier synthetic biology platform for regulating gene and cell-based therapeutics. It is clear that Obsidian is well positioned for future growth, and I look forward to working with the Board and the team to execute on our shared vision and advance this breakthrough technology rapidly to improve therapeutic outcomes substantially for many patients with life-threatening diseases, including cancer."

MATEON ENTERS INTO MERGER AGREEMENT WITH ONCOTELIC

On April 18, 2019 Mateon Therapeutics, Inc. (OTCQB:MATN) and Oncotelic Inc., a privately-held, late clinical-stage cancer immunotherapy company, reported that they have entered into a definitive agreement with respect to a merger, creating a publicly traded immuno-oncology company with a robust pipeline of first in class TGF-β immunotherapies for late stage cancers such as gliomas, pancreatic cancer and melanoma (Press release, Mateon Therapeutics, APR 18, 2019, View Source [SID1234535204]).

"We believe that the merger of Oncotelic and Mateon will create a combined company that can generate shareholder value through a promising pipeline of next generation immunotherapies targeting several significant cancer markets where there is a paucity of therapeutic options and lack of an effective immunotherapy protocol," said Vuong Trieu, Ph.D., Co-Founder, Chairman and Chief Executive Officer of Oncotelic. "We chose Mateon due to the synergies between the two organizations’ pipelines, including the natural synergy of Mateon’s CA4P necrotic cell death product candidate and Oncotelic’s proprietary self-immunization protocol (SIP) platform, particularly our TGF-β inhibitor OT-101."

"Our priority has been to continue our mission to help patients and to provide meaningful value to our stockholders," said William D. Schwieterman, M.D., Mateon’s President and Chief Executive Officer. "After a review of their pipeline, and a thorough consideration of potential strategic alternatives, we have concluded that a merger with Oncotelic, which has multiple late clinical-stage product candidates in areas of unmet medical need, offers our best opportunity to create such value. I look forward to completing this merger expeditiously and working with the full Oncotelic team as clinical trial milestones occur in 2019 and beyond."

SIP Platform

Oncotelic’s SIP Platform is based on novel and proprietary sequential treatment of cancers with OT-101, an antisense against TGF-β2 combined sequentially with widely used chemotherapies. This sequential treatment has resulted in many instances in patients’ self-immunization against their own tumors, resulting in robust response and survival. In some cases, this was curative. The use of OT-101 has lifted the immunosuppression in local tumor environment allowing for effective initial priming of the immune response. The subsequent chemotherapy-released neoantigens have served as a boost to bolster the immune system against the tumors. Judicious placement of immune expanders such as IL-2 and/or checkpoint inhibitors within the immunization protocol is expected to have dramatic impact on survival.

Growing Product Pipeline

Oncotelic is developing OT-101 in combination with chemotherapy for the treatment of gliomas and pancreatic cancers. Oncotelic plans to initiate several Phase 3 registration trials for OT-101 in multiple cancer indications, including gliomas and pancreatic cancers.

During phase 2 clinical trials in gliomas (Study G004) and pancreatic cancer, melanoma, and colorectal cancers (Study P001), meaningful clinical benefits were observed with favorable safety profiles. These clinical benefits included long term survival as well as tumor reduction. These findings have been presented at recent scientific conferences recently and are available for viewing at www.oncotelic.com.

Merger Terms

In the transaction, Mateon will issue 41,000,033 shares of common stock and 193,713 shares of newly designated Series A preferred stock to Oncotelic shareholders. Each share of Series A preferred stock will be convertible into 1,000 shares of common stock, and will be automatically converted into common stock following stockholder approval of additional authorized shares of common stock or a reverse split. Assuming the conversion of all preferred shares, current Oncotelic stockholders would own 85% of the combined company, and current Mateon stockholders will own 15%.

In addition to their ownership position in the newly combined company, Mateon stockholders of record as of the business day immediately preceding the closing date of the merger will receive a contingent value right (CVR) related to Mateon’s drug candidates OXi4503 and CA4P. CVR holders are entitled to receive 75% of the net proceeds in excess of $0.5 million from a sale of assets relating to these two drug candidates for a four-year period following the merger. The CVRs will not be registered to trade on any stock exchange, and new discoveries related to these drug candidates are not subject to payment obligations under the CVR.

The merger is subject to customary conditions to closing including the approval by Oncotelic’s shareholders. Approval is expected within one business day, and the merger is expected to close on or about April 22, 2019.

In connection with the merger agreement, the company has entered into a series of bridge financing agreements for the issuance of debentures with a face amount of up to $1.2 million. The first tranche of convertible debentures with a face value of $600,000 is expected to fund shortly following the closing of the merger. A second tranche of convertible debentures, also aggregating $600,000, is available if requested by the company. The debentures will be issued at a discount of 10% and convertible into common stock at a fixed price of $0.10 per share for six months, if not repaid by the company. The company can repay the debentures in accordance with a sliding schedule of premiums over a six month period, after which the debentures are convertible into common stock at a discount to the stock price at the time of conversion.

Management Team

Following the close of the merger transaction, the management team will be comprised of

Chief Executive Officer – Vuong Trieu, PhD, Co-Founder, Chairman, CEO of Oncotelic
Chief Medical Officer – Fatih Uckun, MD, PhD
Chief Technology Officer – Chulho Park, PhD, Co-Founder and Chief Business Officer of Oncotelic
Chief Financial Officer – Matthew M. Loar, currently Chief Financial Officer of Mateon.
Board of Directors

At the close of the merger, the board of directors will consist of Vuong Trieu, PhD, Co-Founder, Chairman, CEO of Oncotelic and William D. Schwieterman, M.D., President and Chief Executive Officer of Mateon.

Following a requisite period of notice to stockholders, additional directors will include:

Steve King, formerly CEO of Peregrine and its subsidiary Avid Bioservices for over 15 years during which time the company advanced its lead compound though phase 3 development while growing annual revenues to over $55M
Anthony Maida MBA PhD, Audit chair at three Nasdaq listed companies. Dr. Maida has been involved in the clinical development of immunotherapy for 27+ years at various C levels.