On September 16, 2020 Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) reported that President and CEO Todd C. Brady, M.D., Ph.D., Chief Financial Officer Joshua Reed, and Chief Commercial Officer David McMullin will be participating in a fireside chat and hosting one-on-one meetings at Oppenheimer’s Fall Healthcare Life Sciences & MedTech Summit, which is being held in a virtual format (Press release, Aldeyra Therapeutics, SEP 16, 2020, View Source [SID1234565251]).

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The fireside chat is scheduled to begin at 2:30 p.m. ET Wednesday, September 23, 2020. A live webcast of the event will be available on the investor relations page of the company’s corporate website at View Source After the live webcast, the event will remain archived on the Aldeyra Therapeutics website for 90 days.

On September 16, 2020 Samsung Biologics (207940.KS) reported that it has entered into a service agreement with Panolos Bioscience to develop PB101, an Fc-fusion protein intended to treat solid tumors (Press release, Samsung BioLogics, SEP 16, 2020, View Source [SID1234565269]).

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Under this agreement, Samsung Biologics will provide a full scope of its development services from cell line development, process development, to non-clinical and clinical material manufacturing.

According to Panolos, PB101 is expected to suppress tumor angiogenesis more effectively by targeting VEGF-A and PlGF simultaneously, overcoming the limitations of existing treatments. Leveraging Samsung Biologics’ robust capabilities and expertise in developing complex proteins, Panolos intends to achieve successful IND approval for validation to further establish the substance as the new platform known as αARTTM(anti-angiogenesis-based Artifact Re-targeting Tri-specifics) to treat various VEGF related illnesses.

Dr. Hyeseong Lim, CEO of Panolos Bioscience stated, "PB101 is itself a promising candidate as a treatment for solid tumors and VEGF-related diseases. Furthermore, it is also a platform technology that has demonstrated its versatility as a foundation on which multi-specific biologics can be developed. Through close collaborative efforts, Panolos will endeavor to deliver quality biopharmaceuticals to address global unmet medical needs."

"We are extremely proud to be partnering with Panolos in bringing PB101 closer to market," said Dr. Tae Han Kim, CEO Samsung Biologics. "By delivering faster and better development services and helping our clients focus on discovery, we will continue supporting biotech companies in their efforts to help patients in need all around the globe."

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, OncBioMune Pharmaceuticals, Inc. (the "Company") reported that it entered into a Securities Purchase Agreement (the "SPA") with an investor to purchase an aggregate amount of 1,000 shares of a newly created Series E Convertible Preferred Stock of the Company (the "Series E Preferred") for an aggregate investment amount of $2,000,000 (Filing, 8-K, Oncbiomune, SEP 16, 2020, View Source [SID1234565461]). Our new Series E Preferred Stock has a stated value of $2,000 per share and shall accrue, on a quarterly basis in arrears, dividends at the rate of 8% per annum on the stated value. The dividends shall be paid quarterly at the option of the holder of the Series E Preferred in either cash or shares of common stock of the Company. The Series E Preferred is convertible at any time after the date that is two days after the filing of an amendment to the Company’s certificate of incorporation with the Secretary of State of the State of Nevada to increase the Company’s authorized common stock to 12,000,000,000. The number of shares of common stock issuable up on conversion of the Series E Preferred is determined by dividing the stated value of the number of shares being converted, plus any accrued and unpaid dividends, by the lesser of: (i) $0.00375 and (ii) 75% of the average closing price of the Company’s common stock during the prior five trading days; provided, however, the conversion price shall never be less than $0.0021.

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The foregoing description of the SPA and the Series E Preferred does not purport to be complete, and is qualified in its entirety by reference to Exhibits 10.1 and 3.1 hereto, which are incorporated by reference herein.