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CEL-SCI Reports Recent Data Review by the Independent Data Monitoring Committee for Its Pivotal Phase 3 Head and Neck Cancer Study

On October 15, 2019 CEL-SCI Corporation (NYSE American: CVM) reported that the Independent Data Monitoring Committee (IDMC) for the Company’s pivotal Phase 3 head and neck cancer study of its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection) has completed its recent review of the Phase 3 study data (Press release, Cel-Sci, OCT 15, 2019, View Source [SID1234542272]). The IDMC meets periodically to review the safety and efficacy of the ongoing Phase 3 study.

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The data from all 928 enrolled patients were provided to the IDMC by the clinical research organization (CRO) responsible for data management of this Phase 3 study. At the most recent IDMC meeting in October 2019 the IDMC reviewed "progression free and overall survival and limited demographic and safety data available for the aforementioned protocol."

The IDMC made the following recommendation:

The IDMC recommendation "is to continue the trial until the appropriate number of events has occurred".
IDMCs are committees commonly used by sponsors of clinical trials to protect the interests of the patients and the integrity of the study data in ongoing trials, especially when the trials involve patients with life threatening diseases, and when, as in cancer clinical trials, they extend over long periods of time.

Checkmate Pharmaceuticals Announces Additions to Management Team

On October 15, 2019 Checkmate Pharmaceuticals Inc., a clinical stage biopharmaceutical company focused upon activation of innate immunity to treat cancer, reported the appointments of James Wooldridge, MD, as Chief Medical Officer and Steven Hamburger, PhD, as Vice President of Regulatory Affairs (Press release, Checkmate Pharmaceuticals, OCT 15, 2019, View Source [SID1234542271]).

"In the past year, we have made tremendous progress in advancing the development of our lead compound, CMP-001, that is currently in clinical trials in combination with anti-PD-1/L1 antibodies for multiple solid tumor types. I am very pleased to welcome Jim and Steven to the team to continue this momentum," commented Barry Labinger, President and CEO of Checkmate Pharmaceuticals. "Their experience in setting and executing clinical development and regulatory strategies for a variety of cancer therapeutics will be invaluable to us as we advance the development of CMP-001 and build a leading immuno-oncology company."

Dr. Wooldridge has more than 20 years of drug development experience in academia and pharmaceutical and biotechnology companies. He will have responsibility for overall clinical strategy and medical affairs, including regulatory activities and submissions, which will be led by Dr. Hamburger. Prior to joining Checkmate, Dr. Wooldridge served as Chief Medical Officer at Aeglea BioTherapeutics, Inc., where he oversaw development programs in oncology and rare genetic diseases. Previously, he spent 11 years in cancer research at Eli Lilly and Company (Eli Lilly), where he led Oncology US Medical Affairs and more recently served as the Chief Scientific Officer for Immuno-oncology Clinical Development. Prior to Eli Lilly, Dr. Wooldridge conducted clinical and translational research as a faculty member of the University of Missouri in Columbia and the University of Iowa. Dr. Wooldridge is a graduate of William Jewell College, received his MD from Tulane University, and completed his post-graduate training in Internal Medicine and Medical Oncology at the University of Iowa.

Dr. Hamburger was most recently Vice President, Regulatory Affairs & Quality Assurance at Tarveda Therapeutics, Inc. During his career, he has led global regulatory and quality efforts for both emerging biotechnology and large pharmaceutical companies including Baxalta, Castle Creek Pharmaceutical Holdings, Inc., Immunomedics, Inc., Johnson & Johnson, Millennium/Takeda, Savient Pharmaceuticals and Eli Lilly. Dr. Hamburger has played a leadership role in the development and registration of numerous successful drugs, including several in oncology. He holds a PhD in Pharmacology and Toxicology from Indiana University School of Medicine, an MS from Butler University and a BS from the University of Iowa.

Takeda Agrees to Divest Select OTC and Non-core Assets to Acino for Over $200 Million USD

On October 15, 2019 Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) ("Takeda") reported that it has entered into an agreement to divest a portfolio of select over-the-counter (OTC) and prescription pharmaceutical assets in a number of Near East, Middle East and Africa (NEMEA) countries within its Growth and Emerging Markets Business Unit to Acino for a total value in excess of $200 million USD (Press release, Takeda, OCT 15, 2019, View Source [SID1234542269]). This is the third transaction in FY19 that furthers Takeda’s strategy to focus on business areas core to its long-term growth and facilitate rapid deleveraging following its acquisition of Shire.

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"The divestment of non-core assets sold in NEMEA represents the continued execution of our strategy to optimize our portfolio, invest in the defined core business areas, and accelerate our progress toward reaching our target leverage ratio," said Costa Saroukos, Chief Financial Officer, Takeda.

While these products continue to play important roles in meeting patient needs, they are primarily outside of Takeda’s chosen business areas – Gastroenterology (GI), Rare Diseases, Plasma-Derived Therapies, Oncology and Neuroscience – core to its global long-term growth.

"Takeda remains committed to this region, as we continue our work in accelerating access to our life-changing portfolio of innovative products to meet the needs of patients. We will do this via our commercial activities and Takeda’s Access to Medicines program," said Ricardo Marek, President, Growth and Emerging Markets Business Unit, Takeda. "We are confident that Acino is best positioned to provide uninterrupted access and supply of the divested products to patients."

Takeda intends to use the proceeds from this divestiture to reduce debt and continue to deleverage towards its target of 2.0x net debt/adjusted EBITDA over the next three to five years. Takeda is committed to rapid deleveraging driven by strong cash flow and divestiture proceeds, while also simplifying its portfolio.

Transaction Details

Takeda has agreed to sell a portfolio of approximately 30 select prescription pharmaceutical and OTC products sold in the NEMEA region to Acino, a Swiss pharmaceutical company headquartered in Zurich, with a clear focus on selected markets in the Middle East, Africa, the CIS Region, and Latin America. The following key countries are included in the agreement: Egypt, Saudi Arabia, South Africa, Turkey, Ukraine and United Arab Emirates, as well as other countries.

Under the terms of the agreement, Acino will acquire the rights, title, and interest to the products in the portfolio exclusive to these countries. It is anticipated that primarily sales and marketing professionals supporting the portfolio will transition to Acino at closing of the transaction. The parties will also enter into a multi-year manufacturing and supply agreement, under which Takeda will continue to manufacture the products on behalf of Acino.

The transaction is expected to close in Q4 FY19 (January – March 2020), subject to the satisfaction of customary closing conditions including receipt of applicable antitrust approvals. Until then, these products will continue to be made available by Takeda.

Takeda is being advised by BofA Securities (financial advisor), White & Case (legal advisor), and Deloitte (financial consultant) in this transaction.

CohBar to Present at the 2019 BIO Investor Forum

On October 15, 2019 CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company developing mitochondria based therapeutics to treat age-related diseases and extend healthy lifespan, reported that its Chief Executive Officer, Steven Engle, will present at the 2019 BIO Investor Forum, which is being held October 22-23 at the Westin St. Francis Hotel in San Francisco, CA (Press release, CohBar, OCT 15, 2019, View Source [SID1234542268]). The BIO Investor Forum explores investment trends and opportunities in life sciences, with a focus on venture-stage growth and emerging public companies as well as those poised to join the growth "watch list" in 2020.

Presentation details:
Wednesday, October 23rd 11:15 AM PT
Westin St. Francis Hotel, Yorkshire conference room

Webcast: The presentation may be accessed via webcast at the scheduled time, or after the presentation, using the following link: CohBar Presentation.

OncoSec Announces New Peer-Reviewed Data for TAVO™ in Virus-Associated Skin Cancer Published in Clinical Cancer Research

On October 15, 2019 OncoSec Medical Incorporated ("OncoSec") (Nasdaq: ONCS), a company developing late-stage intratumoral cancer immunotherapies, reported the publication of new data in Clinical Cancer Research which highlighted TAVO (intratumoral plasmid IL-12 with electroporation) as a safe, feasibility and clinically meaningful therapy in patients with Merkel cell carcinoma (MCC), an aggressive form of skin cancer (Press release, OncoSec Medical, OCT 15, 2019, View Source [SID1234542267]).

"These data demonstrate that intratumoral delivery of plasmid interleukin-12 with electroporation (TAVO) as a monotherapy has the potential to have a durable impact on skin cancers such as Merkel cell carcinoma. I’m encouraged by these initial findings and believe that TAVO is a treatment approach that merits further exploration in MCC," commented Shailender Bhatia, M.D., associate professor, medical oncology, Department of Medicine, University of Washington/Fred Hutchinson Cancer Research Center, Seattle, Washington and lead investigator and author of the study.

The single-arm, open label pilot study evaluated 15 patients with MCC receiving TAVO intratumorally in two cohorts (Cohort A N=3 and Cohort B N=12). Cohort A patients had locoregional MCC and received one treatment cycle prior to a definitive surgery. Cohort B patients had metastatic MCC and received four cycles of TAVO. Results showed that 25% of Cohort B patients experienced an overall response, with two patients receiving durable effect over 16 and 55+ months, respectively. Two Cohort A patients (one with pathologic complete remission) were recurrence-free at 44+ and 75+ months.

"We continue to explore the broad therapeutic potential of TAVO across various cancer types and believe this study underscores the power of TAVO monotherapy in solid tumors such as MCC," said Daniel J. O’Connor, president and chief executive officer of OncoSec. "We remain encouraged by the growing body of clinical evidence for TAVO in multiple cancer indications both as a monotherapy and in combination with leading checkpoint inhibitors. We look forward to providing further data updates as we continue to advance our ongoing pivotal clinical trial with TAVO in metastatic melanoma and our phase 2 trial in triple negative breast cancer."

An online version of the publication is available here: View Source