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.

On September 16, 2020 Volastra Therapeutics, a biotechnology company developing novel therapies to treat and prevent the formation of metastatic disease, reported that it has named Charles Hugh-Jones, MD, FRCP, as its Chief Executive Officer (Press release, Volastra Therapeutics, SEP 16, 2020, View Source [SID1234565252]). Dr. Hugh-Jones brings a strong leadership background from across both multinational pharmaceutical organizations and smaller biotechnology companies. Over the course of his career, he has built extensive expertise in the development and commercialization of medicines.

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"We are incredibly fortunate that Charles is joining the team. His breadth of experience and scientific acumen will be vital in fulfilling our mission," said Volastra Executive Chair Sandra Peterson, former Group Worldwide Chairman of Johnson & Johnson, current Partner at Clayton, Dubilier, and Rice, and current board member of Microsoft.

Dr. Hugh-Jones, a board-certified physician, began his career at Schering AG, Enzon Pharmaceuticals and Sanofi, where he held various positions of increasing responsibility. He then joined Pfizer Oncology division as their Chief Medical Officer where he had medical oversight of all late-stage drug development and commercialization activities. Most recently, Dr. Hugh-Jones was global Chief Medical Officer of Allergan PLC, where he led complex interdisciplinary teams and supported the launch of novel medicines in multiple therapeutic areas.

"We are excited to have Charles at the helm as we tackle chromosomal instability, a pervasive feature of metastatic cancers," said Volastra Co-founder and Advisor Lewis Cantley, PhD, Professor of Cancer Biology in Medicine and Meyer Director of the Sandra and Edward Meyer Cancer Center at Weill Cornell Medical College. "Our goal is to further uncover novel insights into chromosomal instability and its clear association with the formation, progression, and maintenance of metastasis to ultimately develop new therapies."

"I’m inspired by Volastra’s mission to bring new therapies to patients with metastatic solid tumors, which are notoriously among the toughest to treat with existing therapies," said Dr. Hugh-Jones. "There is a tremendous unmet need in this patient population, and Volastra’s novel research holds great promise. I look forward to working with the entire team to build upon the scientific discoveries of its founders and grow a pipeline of potential therapies that can make a difference in patients’ lives."

Volastra Therapeutics launched earlier this year with $20 million in financing. Polaris Partners led the financing with additional investment from Vida Ventures, ARCH Venture Partners, DROIA Oncology Ventures, and the Global Health Sciences (GHS) Fund (Quark Venture LP and GF Securities). As a cornerstone tenant in a new biotech development, the company recently secured 11,000 square feet of laboratory and office space in West Harlem, New York. Dr. Hugh-Jones will lead the growing team at this new location.

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

On September 16, 2020 The Institute of Cancer Research reported that Results from an early-stage trial demonstrate that using a combination of two precision medicines to target hard-to-treat cancers was safe and showed promise in a range of solid tumour types (Press release, The Institute of Cancer Research, SEP 16, 2020, View Source [SID1234565271]).

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The trial, led by a team at the Institute of Cancer Research (ICR) in London and the Royal Marsden NHS Foundation Trust, combined AstraZeneca/Merck’s PARP inhibitor Lynparza (olaparib) with the investigational medicine capivasertib, an AKT Kinase inhibitor.

The researchers used the drug combination to target two weaknesses in cancer, namely a damaged system for repairing DNA and ‘addiction’ to the AKT molecule which fuels tumour growth.

In the Phase I trial, researchers gave 64 patients with advanced solid tumours, including those with breast cancer, ovarian cancer and prostate cancers, combinations of Lynparza and capivasertib.

The trial found that the drug combination was safe to use and also efficiently hit the specified targets, and showed promise against a variety of advanced cancers, including those that had become resistant to chemotherapy.

According to the ICR, many of the patients who responded to the treatment had mutations in the genes involved in repairing DNA, including the BRCA genes.

"This new clinical trial is a terrific example of how we can now translate scientific discoveries about the biology of cancer cells into innovative new cancer treatments with real benefits for patients," said Professor Paul Workman, Chief Executive of the ICR.

"It’s also an example of the pioneering strategy we have adopted at the ICR of targeting cancer evolution and drug resistance – often through the use of combination treatments to hit multiple targets at once and block off escape routes, just as is done with diseases like HIV," he added.

The trial was funded by AstraZeneca, with the backing of the Cancer Research UK Experimental Cancer Medicine Centre Combinations Alliance.

Following the promising early results, later-stage clinical trials are planned to assess the drug combination’s benefit and to study its effect in patients whose tumours do not have faults in the AKT gene or related to DNA repair.

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.