Forbius Announces First Patient Dosed in Phase 2a Triple Negative Breast Cancer (TNBC) Trial of AVID100, a Novel, Tumor-Specific Anti-EGFR ADC

On April 22, 2019 Forbius, a clinical-stage company that develops novel biologics for the treatment of cancer and fibrosis, reported that the first patient has been dosed in a Phase 2a triple negative breast cancer (TNBC) clinical trial with AVID100, a novel, tumor-selective anti-epidermal growth factor receptor (EGFR) antibody-drug conjugate (ADC) (Press release, Forbius, APR 22, 2019, View Source [SID1234535316]).

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Approximately 20% of TNBC patients have tumors that highly overexpress EGFR. No targeted therapy is approved for EGFR-overexpressing TNBC.

The multicenter, dose-expansion Phase 2a trial (AVID100-01; NCT03094169) will evaluate the efficacy, safety, and tolerability of AVID100 in patients with advanced, EGFR-overexpressing TNBC (IHC 2+/3+). This is the third cohort that has been launched and follows the previously announced cohorts evaluating AVID100 in patients with advanced squamous non-small cell lung cancer (sqNSCLC) and squamous cell carcinoma of the head and neck (SCCHN). In total, approximately 100 patients will be evaluated across three EGFR-overexpressing tumor types: sqNSCLC, SCCHN, and TNBC.

About AVID100 and the AVID100-01 Trial
AVID100 is a highly potent EGFR-targeting ADC engineered to achieve enhanced anti-tumor efficacy without a corresponding increase in toxicity in skin or other EGFR-expressing normal tissues. In preclinical studies, AVID100 demonstrated significant anti-cancer activity in EGFR-overexpressing tumor models resistant to marketed EGFR inhibitors. AVID100 is the most advanced, broadly active anti-EGFR ADC in clinical development and targets both wild-type and mutant forms of EGFR.

A recommended Phase 2 dose (RP2D) of 220 mg/m2 (~6mg/kg) was established for AVID100 in a completed Phase 1 study. This RP2D is expected to be in the therapeutically active range based on preclinical efficacy studies. The majority of treatment-related adverse events in the Phase 1 trial at the RP2D were well-tolerated and grade 1 or 2 in severity.

AVID100-01 (NCT03094169) is an open-label, multicenter, dose-expansion study to evaluate the efficacy, safety, and tolerability of AVID100 in patients with confirmed EGFR-overexpressing sqNSCLC (IHC 3+), SCCHN (IHC 3+), and TNBC (IHC 2+/3+) (more than 50% of cells with EGFR 3+ or more than 75% of cells with EGFR 2+ staining).

Moleculin Announces Conference Call to Discuss Significant Discovery For Lung Cancer and FDA Activity on Wednesday, April 24, 2019

On April 22, 2019 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, reported it will host a conference call to discuss its significant discovery for lung cancer, FDA Fast Track Designation and recent corporate events (Press release, Moleculin, APR 22, 2019, View Source [SID1234535317]). The call will be at 4:30 p.m. ET on Wednesday, April 24, 2019.

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Participants can dial (800) 860-2442 or (412) 858-4600 to access the conference call, or can listen via a live webcast, which is available in the Investor Relations section of the Company’s website at www.moleculin.com. The Company will field live questions from equity analysts in a Q&A segment of this call. Participants may submit questions in advance for the Company to address in the Q&A segment by sending them to [email protected]. A webcast replay will be available in the Investors section of the Company’s website at www.moleculin.com for 90 days. A teleconference replay will be available at (877) 344-7529 or (412) 317-0088, confirmation code 10130980, through May 1, 2019.

Poseida Therapeutics Raises $142 Million in Series C Financing

On April 22, 2019 Poseida Therapeutics Inc., a clinical-stage biopharmaceutical company leveraging proprietary non-viral gene engineering technologies to create life-saving therapeutics, reported closing of a Series C financing round, raising $142 million led by a $75 million equity investment from Novartis Pharma AG, and joined by several new investors including Aisling Capital Management, Pentwater Capital Management, Perceptive Advisors as well as additional undisclosed institutional investors (Press release, Poseida Therapeutics, APR 22, 2019, View Source [SID1234536252]). Current investors Malin Corporation plc., Longitude Capital, Vivo Capital and Boxer Capital, LLC also participated in the financing.

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"We welcome the support and investment from Novartis, a leader in the cell and gene therapy field," said Eric Ostertag M.D., Ph.D., chief executive officer of Poseida. "They are joined by an impressive group of new investors whose commitment enables us to accelerate the pursuit of our bold vision to create gene therapy product candidates that could result in single-treatment cures for numerous oncologic indications and orphan genetic diseases, with an initial focus on chimeric antigen receptor T cell (CAR-T) therapies."

The company’s CAR-T product candidates are manufactured with Poseida’s non-viral piggyBac DNA Modification System, resulting in a high percentage of stem cell memory T cells (TSCM). Tscm cells are the only T cell that is self-renewing and long-lived, potentially resulting in product candidates that are more efficacious, less toxic and more durable. Poseida is currently developing the following CAR-T product candidates:

P-BCMA-101 is an autologous CAR-T therapy for the treatment of relapsed/refractory multiple myeloma, currently enrolling patients for a Phase 2 registrational trial with initial dosing expected in the first half of 2019.

P-PSMA-101 is an autologous CAR-T product candidate targeting PSMA-specific cancer cells in castrate resistant prostate cancer, with filing of an IND anticipated in the second half of 2019.

P-BCMA-ALLO1 is an allogeneic, or universal donor, CAR-T product candidate, manufactured using Poseida’s proprietary Cas-CLOVER site specific gene editing system and is being developed as a treatment for relapsed/refractory multiple myeloma, with an IND filing anticipated by late 2019 or early 2020.

P-MUC1C-101 is an autologous CAR-T product candidate in late-stage preclinical development for numerous solid tumor indications, including ovarian, breast, lung, colorectal, pancreatic and renal cancers, with filing of an IND anticipated in 2020.

Poseida plans to broadly advance its current CAR-T programs and emerging pipeline programs, including gene therapies for orphan genetic diseases.

Geneos Therapeutics Secures $10.5 Million in Series A Financing to Develop the Next Generation of Neoantigen-Targeting Cancer Immunotherapies

On February 21, 2019 Geneos Therapeutics reported that it has closed its Series A round raising $10.5 Million in financing (Press release, Geneos Therapeutics, FEB 21, 2019, View Source [SID1234535369]). This funding will launch its operations as a standalone entity to develop the next generation of neoantigen-targeting cancer immunotherapies. Geneos, created as a spinout of Inovio Pharmaceuticals, Inc. (NASDAQ: INO) will leverage a proven immunotherapy platform ("Geneos Platform") under an exclusive license from Inovio in the field of personalized treatments for cancer. The Series A Financing, which includes a committed initial investment and a milestone driven option, is led by Santé Ventures and joined by Inovio.

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Cancer neoantigens – the mutations and genomic changes that accumulate as tumors develop – have been recognized as important targets in the development of immune mediated treatments for cancer. These are recognized by the immune system as being foreign and generate immune responses directed at the cancer. The Geneos Platform allows the company to develop exquisitely personalized therapies tailored to each patient’s own tumor mutations. The Geneos Platform is poised to deliver the following key advantages: ability to drive potent and broad T cell immune responses, capability to target an unprecedented number of neoantigens in a single formulation, and a rapid manufacturing turnaround time. Geneos, along with its collaborators at The Wistar Institute, recently published preclinical, proof-of-concept animal model data in the prestigious journal, Cancer Immunology Research, demonstrating the advantages of the Geneos Platform.

Dr. Niranjan Y. Sardesai, Chief Operating Officer of Inovio Pharmaceuticals, co-founded Geneos and has served as the company’s Chief Executive Officer. "Geneos holds the potential to become the leader in the development of personalized cancer immunotherapies to provide patients the chance for a cure" said Dr. Sardesai. "My confidence in this start-up, based on industry leading technology, rests on the fact that Geneos can create neoantigen-targeting immunotherapies against any cancer. Our immunotherapies can activate – in vivo – strong T cell responses (both CD4+ and CD8+). In addition, Geneos cancer fighting treatments can be designed in days instead of months or years. This funding will allow us to demonstrate clinical proof-of-concept for treating cancer at an individual patient level. I invite you to learn more about Geneos by visiting www.geneostx.com." Concurrently with the Series A financing, Dr. Sardesai resigned as Inovio COO and will dedicate all his efforts as Geneos’ CEO.

The Series A financing will enable the company to establish its operations and complete IND enabling activities towards the initiation of first-in-human clinical trials. As part of the new financing, Geneos will no longer be a wholly-owned subsidiary of Inovio Pharmaceuticals.

Geneos’ leaders begin operations with a track record of success in building immunotherapy-based companies. Backed by an extensive portfolio of globally issued or filed patents and regulatory experience in Phase I-III clinical development, Geneos takes an exclusive license of Inovio’s DNA-based immunotherapy platform for personalized cancer immunotherapy; while Inovio will continue to develop and commercialize population based (non-personalized) cancer immunotherapies and infectious disease vaccines based on its proprietary SynCon design. To date, the platform technology has demonstrated in multiple clinical trials, animal models, and peer-reviewed publications the ability to elicit a potent and tumor-specific immune response to fight cancer.

Dr. J. Joseph Kim, CEO, Inovio Pharmaceuticals, said, "Establishing Geneos with a patient-specific direction allows Inovio to focus on executing our strategies to develop and commercialize DNA-based vaccines and immunotherapies to attack the major cancer types and challenging infectious diseases affecting global populations. Geneos will build on Inovio’s technology offering patient-specific, tumor-targeted immunotherapies to the world, one patient at a time."

Dr. Sam Broder (former Director of the National Cancer Institute), joins Geneos’ founding Board of Directors alongside Dr. Sardesai, Dr. Kim, Dr. Casey Cunningham (CSO, Santé Ventures) and Dr. James Eadie (Partner, Santé Ventures). Leading the Series A investment, Dr. Eadie said, "We are pleased to be in at the start of Geneos as a standalone company. Neoantigens are increasingly recognized as an important area for therapeutic development and the Geneos platform addresses many of the current limitations to this approach. Niranjan and his team bring a wealth of experience in this area and we look forward to working with them as they build upon Inovio’s great work."

In addition to Dr. Broder, Geneos is advised by a world-leading group of inter-disciplinary experts spanning oncology basic research, clinical development, and commercialization who believe in the potential of the Geneos Platform to impact personalized cancer treatment. Joining the company on its Advisory Board are:

Dr. David B. Weiner, W. W. Smith Endowed Chair in Cancer Research, The Wistar Institute. Dr. Weiner will serve as the Chair of the company’s Advisory Board.
Dr. Chi Van Dang, Scientific Director, Ludwig Institute for Cancer Research and Professor, The Wistar Institute; and
Ms. Shawn Tomasello, former Chief Commercial Officer of Kite Pharmaceuticals and Pharmacyclics; and former President of the Americas, Hematology and Oncology, for Celgene

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 .

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"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."