Vedanta Biosciences Announces the Appointment of Jeffrey Silber, M.D. as Chief Medical Officer

On September 16, 2020 Vedanta Biosciences, a leading clinical-stage company developing a new category of therapies for immune-mediated diseases based on rationally-defined consortia of human microbiome-derived bacteria, reported the appointment of Jeffrey Silber, M.D., as chief medical officer (Press release, Vedanta Biosciences, SEP 16, 2020, View Source [SID1234565238]). An accomplished leader in drug development, Dr. Silber brings deep experience across multiple therapeutic areas at Merck, AbbVie and EMD Serono and will guide the advancement of the company’s clinical programs. Nancy Chiu Wilker, Ph.D., J.D., also joins as vice president of legal, where among other responsibilities, she will oversee and expand the company’s foundational portfolio of patents around live biotherapeutic products.

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"We are thrilled to welcome Jeff to Vedanta. Jeff’s depth of experience in the full lifecycle of product development and across therapeutic areas will be very important to our team as we continue to advance our pipeline of defined bacterial consortia," said Bernat Olle, Ph.D., co-founder and chief executive officer of Vedanta Biosciences. "We are also delighted to welcome Nancy, whose extensive experience in building IP portfolios of innovative biotechs will fill a crucial role."

Dr. Silber comes to Vedanta Biosciences from EMD Serono, where he served as senior vice president of global development. While there, he was a member of the portfolio-level governance and franchise leadership committees, and he co-chaired the committee overseeing the design for all clinical studies. He previously served as vice president of strategic portfolio development at AbbVie. Dr. Silber started his industry career in clinical development at Merck, where he assumed multiple strategic roles including leading anti-infective clinical development programs, the vaccine therapeutic area, and the neuroscience pipeline and program management team. During his career, Dr. Silber has overseen multiple regulatory submissions and approvals worldwide and held departmental head responsibilities spanning clinical research, project management, program leadership, pharmacovigilance, biostatistics, epidemiology and translational medicine. He has been recognized with numerous academic and professional awards, including the highest honors awarded by Merck Research Laboratories and by Merck & Co. Dr. Silber earned his B.A. in biology from Harvard University and his M.D. from Albert Einstein College of Medicine of Yeshiva University. He received additional academic training in internal medicine at New York University/Bellevue Hospital and infectious diseases at the University of Pennsylvania. He began his career as an assistant professor of medicine at the Robert Wood Johnson Medical School.

"I see tremendous potential for microbiome-based therapeutics to address serious unmet needs across multiple therapeutic areas," Dr. Silber said. "Vedanta has led the way in harnessing the power of the microbiome for drug development and pioneering a new class of live biotherapeutic products. I’m excited to join the team and to help guide the advancement of the impressive pipeline."

Dr. Wilker previously served as vice president and lead IP counsel for Fog Pharmaceuticals, where she was responsible for the company’s intellectual property portfolio. She has also held IP counsel roles at Biogen and Seqirus and was a partner at the legal firm Sunstein LLP, where she served as IP counsel for numerous biotech companies. Dr. Wilker received her B.S. in biology and biochemistry from Colorado State University, her Ph.D. in immunology from Harvard University and her J.D. from Suffolk University Law School.

"Vedanta has built a leading IP position in microbiome therapeutics based on live bacteria," said Dr. Wilker. "I’m looking forward to joining the team as we continue to protect and expand our foundational patent portfolio."

Vedanta Biosciences also secured a $15 million loan facility from Oxford Finance to support its pipeline development, which includes four clinical-stage product candidates currently being evaluated for the treatment of high-risk C. difficile infection, inflammatory bowel disease (IBD), food allergy and advanced and metastatic cancers (in combination with Bristol Myers Squibb’s checkpoint inhibitor, Opdivo).

IMV CEO to Participate at the Vaccines Panel of the Sachs Associates 20th Annual Biotech in Europe Forum

On September 16, 2020 IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical-stage biopharmaceutical company pioneering a novel class of cancer immunotherapies and vaccine against infectious diseases, reported that company’s Chief Executive Officer, Frederic Ors will participate at the Vaccines Panel of the 20th Annual Biotech in Europe Forum held on September 21-24, 2020 (Press release, IMV, SEP 16, 2020, View Source [SID1234565237]).

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The Vaccines Panel will be held on Monday September 21 at 13:05 CET (7.05 am ET) and will be chaired by Thomas Shrader, Managing Director & Healthcare Analyst, BTIG, LLC.

Other panelists include:

Andrei Floroiu, President & CEO, Vaxart Inc.

Andrew Allen, Co-Founder, President & CEO, Gritstone Oncology, Inc.

Johan Van Hoof, Global Therapeutic Area, Head of Infectious Diseases & Vaccines, and Managing Director, Janssen Vaccines & Prevention B.V.

The 20th Annual Biotech in Europe Forum is recognized as the leading international stage for investing and partnering in the biotech and life science industry. This highly transactional event draws together an exciting cross-section of early-stage/pre-IPO, late-stage, and public companies with leading investors, analysts, money managers, and pharma licensing executives. Under current circumstances, including travel restrictions, #Sachs_BEF will be held in a digital format. Please, note that it is a private event—registration on the event website.

Oasmia to present at Sachs Associates’ 20th Annual Biotech in Europe Forum

On September 16, 2020 Oasmia Pharmaceutical’s CEO, Dr Francois Martelet reported that it will present at the 20th Annual Biotech in Europe Forum from 21 – 24 September organised by Sachs Associates (Press release, Oasmia, SEP 16, 2020, View Source [SID1234565236]). The presentation will be available on Oasmia Pharmaceutical’s new website from Monday, September 21.

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The 20th Annual Biotech in Europe Forum is recognized as the leading international stage for those interested in investing and partnering in the biotech and life science

Poseida Therapeutics to Present CAR-T Manufacturing Process Optimization Data at CAR-TCR Digital Week 2020

On September 16, 2020 Poseida Therapeutics, Inc., (Nasdaq: PSTX), a clinical-stage biopharmaceutical company dedicated to utilizing proprietary gene engineering platform technologies to create next generation cell and gene therapeutics with the capacity to cure, reported that it will present data related to its proprietary manufacturing process designed to optimize its CAR-T product candidates (Press release, Poseida Therapeutics, SEP 16, 2020, View Source [SID1234565235]). The Company will also illustrate the impact of these optimizations with preclinical data and preliminary clinical analysis with a focus on P-BCMA-101, its autologous CAR-T product candidate for multiple myeloma. The findings will be presented today at CAR-TCR Digital Week 2020 being held September 14-17, 2020.

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Utilizing its proprietary piggyBac DNA Modification System, Poseida’s non-viral manufacturing process can produce highly purified CAR-T treatment candidates comprised of a high percentage of stem cell memory T, or TSCM, cells. These high-TSCM product candidates may improve therapeutic response and tolerability profile as compared to existing CAR-T therapies using viral-based manufacturing methods.

In ongoing efforts to optimize manufacturing, the Company was able to demonstrate increased transposition frequency by using Nanoplasmid technology licensed from Nature Technology Corporation, which, when compared to a standard plasmid, yields more CAR-positive cells at the start of the process. In turn, this reduces manufacturing timelines, has resulted in a higher proliferative capacity in patients, and has the potential to create more efficacious CAR-T products with less toxicity.

Poseida also conducted a preliminary clinical analysis of P-BCMA-101 to test the impact of using a Nanoplasmid in its manufacturing process compared to a standard plasmid. The analysis conducted at a .75 X 10E6 per kg dose found that all patients (n=3) responded to treatment with Nanoplasmid-manufactured P-BCMA-101 and that responses were deep, showing a 100 percent overall response rate (ORR) as compared to an ORR of 50-67% in patients that received P-BCMA-101 manufactured using a standard plasmid at that same dose (n=3, 2 evaluable by IMWG criteria; third patient with plasmacytomas and significant response by PET scan). The three patients given Nanoplasmid-produced P-BCMA-101 at this dose reached a very good partial response (VGPR) or stringent complete response (sCR) compared to a partial response (PR) achieved with the standard plasmid. Notably, using a Nanoplasmid in the manufacturing process did not impact the safety profile of P-BCMA-101 and no incidence of cytokine release syndrome of any grade was observed in patients.

"At Poseida, we are always looking at innovative ways to further improve the performance of our CAR-T product candidates while maintaining an exceptionally low rate of cytokine release syndrome and other potential toxicities," said Eric Ostertag, M.D., Ph.D., Chief Executive Officer of Poseida. "As our most advanced product candidate, we look forward to providing further updates to our clinical program for P-BCMA-101 later in the year."

P-BCMA-101 has received regenerative medicine advanced therapy (RMAT) status and orphan drug designation from the FDA and is currently being tested in an expanded Phase 1 clinical trial for the treatment of patients with relapsed/refractory multiple myeloma to inform the potentially registrational Phase 2 clinical trial. Poseida’s portfolio includes allogeneic and autologous CAR-T product candidates in both hematological and solid tumor oncology indications, as well as liver-directed gene therapy programs in orphan genetic diseases.

Nanoplasmid-produced product candidates P-BCMA-101 for multiple myeloma and P-PSMA-101 for castrate resistant prostate cancer have both demonstrated robust expansion in patients to date. The Company is now utilizing Nanoplasmid technology to manufacture all autologous and allogeneic product candidates across its portfolio and continues to evaluate additional manufacturing optimizations that may further improve the performance of its product candidates.

The full presentation at CAR-TCR Digital Week will be available on Poseida’s website at the end of the meeting on Thursday, September 17.

Pascal Biosciences to Present at International Cannabinoid Derived Pharmaceutical Summit

On September 16, 2020 Pascal Biosciences Inc. (TSX.V:PAS) ("Pascal") reported that has been invited to present at the International Cannabinoid Derived Pharmaceutical (ICDP) Summit (Press release, Pascal Biosciences, SEP 16, 2020, View Source [SID1234565234]). Today Dr. Patrick Gray, CEO of Pascal Biosciences, will present advancements in each of Pascal’s three cannabinoid programs. The title of his presentation is "Identifying and Validating Mechanism of Action In Vivo and In Vitro".

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The Third Annual ICDP conference is the premier format for presentation of ground-breaking discoveries in cannabinoid drug development. As in past years, this conference is hosting top cannabinoid pharmaceutical experts developing therapeutics derived from cannabis. In addition to describing progress for Pascal’s programs in glioblastoma and coronavirus, Dr. Gray will also discuss plans for developing PAS-393 for treatment of cancer in combination with checkpoint inhibitors. This will be a collaborative effort with SōRSE Technology and aims to characterize the safety, pharmacology, and pharmacokinetics of PAS-393 in a Phase 1a clinical trial.

"I am very pleased for the invitation to present Pascal’s work at this impressive conference," commented Dr. Gray. "This validates the importance of our efforts, and we will be featured with other companies making significant advancements in developing cannabis-based medicines."

The session featuring Pascal’s presentation is focused on preclinical testing of cannabinoid therapeutics. Dr. Gray will also participate in a panel discussion titled "Achieving the Ideal Pharmacokinetic and Pharmacodynamic Profiles in Drug Formulation".