On October 15, 2019 Abalos Therapeutics reported a EUR 12 million Series A financing round establishing its operations and leadership (Press release, Abalos Therapeutics, OCT 15, 2019, View Source [SID1234542275]). The Company’s objective is to develop new immuno-oncology therapeutics based on a specific arenavirus strain that preferentially infects and proliferates in cancer cells generating a strong anti-tumor immune response. The Series A round was co-led by Boehringer Ingelheim Venture Fund (BIVF) and Gruenderfonds Ruhr, with participation from NRW.BANK and High-Tech Gruenderfonds (HTGF). Representatives from all investors will join the company’s newly formed Supervisory Board.

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Concurrent with the financing, Abalos announced the appointment of experienced entrepreneurs Dr. Marcus Kostka as Chief Executive Officer and Dr. Jörg Vollmer as Chief Scientific Officer.

"Abalos’ goal is to capture the potent immune activation and highly specific tumor tropism of the arenavirus to propel a differentiated immuno-oncology approach towards clinical evaluation," said Dr. Marcus Kostka, CEO of Abalos Therapeutics. "After funding and supporting a range of biotechnology companies over the years, this promising technology and the chance to build a company with Jörg as a highly-experienced immunology expert made this opportunity extremely attractive."

The proceeds from the financing will be used to advance Abalos’ arenavirus-based lead candidates towards clinical testing. The Company will develop the initial product candidates using its proprietary Fast Evolution platform, which will generate virus strains with optimized anti-tumoral properties. These candidates will be selected based on their ability to re-program the immune system to specifically and efficiently eliminate the malignant tumor tissue. The approach is based on the innovative research of immunologists Prof. Dr. Karl Lang, Chair of Immunology at the Medical Faculty, University Duisburg-Essen and Prof. Dr. Philipp Lang, Director of the Department of Molecular Medicine II, University Düsseldorf. Abalos builds on a close collaboration with the Universities Duisburg-Essen and Düsseldorf.

Dr. Aristotelis Nastos from Gruenderfonds Ruhr commented: "Immuno-oncology continues to make very exciting progress, however, developing drug candidates that can more fully harness the power of the immune system remains a challenge, in particular, addressing not only the main tumor but also distant metastases. We look forward to supporting Abalos’ experienced management team and its dedicated researchers to work on an arenavirus-based solution."

Dr. Marcus Kostka is a highly seasoned industry expert bringing over 20 years and a range of experiences from Boehringer Ingelheim (BI), where he held positions defined by the ability to locate and advance innovation. Most recently, he was Venture Fund Partner at BI and held board positions at several companies and participated in the successful exits of Rigontec and ICD Therapeutics.

In his role as CSO, Dr. Jörg Vollmer brings to Abalos Therapeutics significant knowledge and experience in the areas of immunology, oncology and infectious diseases, which he obtained in various R&D and executive positions over the course of his career. Most recently, Jörg was CSO at Rigontec where he helped advance a novel immuno-oncology treatment approach into the clinic and led the company’s R&D efforts until the acquisition by MSD in 2017.

On October 15, 2019 Aro Biotherapeutics Company reported that co-founder and Chief Scientific Officer Karyn O’Neil, PhD, debuted ABX300, the company’s lead Centyrin-pan-KRAS siRNA program, during a presentation today at the 2019 Oligonucleotide Therapeutic Society (OTS) meeting in Munich, Germany (Press release, Aro Biotherapeutics, OCT 15, 2019, View Source [SID1234542274]).

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In her presentation entitled, "Cell Specific Centyrin Targeting of Oligonucleotides for Cancer," Dr. O’Neil highlighted preclinical data demonstrating ABX300’s efficacy in treating KRAS-driven epithelial tumors. ABX300 comprises the Company’s proprietary Centyrin protein scaffold technology, conjugated to a pan-KRAS small-interfering RNA (siRNA).

KRAS has been one of the most elusive and difficult to drug targets in cancer. Various point mutations can occur in the KRAS oncogene, resulting in persistent KRAS activation, which drives tumor growth. Recent reports on preclinical and clinical results with small molecule KRAS G12C mutant inhibitors have shown promise; however, this mutant represents only about 12 percent of all KRAS mutations. In contrast, ABX300 is designed to address all known KRAS mutations identified in human tumors.

"Tumor cells treated with ABX300 internalized the Centyrin-siRNA conjugate and exhibited potent, sustained knockdown of mutant KRAS RNA and protein that persisted for days, resulting in complete inhibition of proliferation," said Dr. O’Neil. "This long-term intracellular activity reflects the unique stability and biochemical properties of Centyrins inside the cellular microenvironment."

ABX300 contains two Centyrin-based binding domains that allow for selective targeting of the KRAS siRNA to epithelial-derived tumor cells. ABX300 was shown in preclinical studies to selectively reduce KRAS mRNA levels in cell lines with KRAS G12C, G12D, G12S and G12V mutations, providing proof of concept for broad KRAS inhibition with a single therapeutic.

Sue Dillon, PhD, co-founder and Chief Executive Officer of Aro, commented, "Dr. O’Neil’s presentation at the OTS Meeting is an important milestone for Aro Biotherapeutics. As demonstrated by ABX300 in our research to date, Centyrin-siRNA targeting is a powerful approach to addressing disease target genes in specific cell types, broadly expanding opportunities for RNA medicines."

Building a Pipeline of Life Changing Therapies

Centyrins are small, structurally simple, ultra-stable, highly soluble proteins. These characteristics enable the discovery of medicines with new mechanisms of action for cancer and other devastating diseases. This first-of-its-kind combination of properties is designed to address unmet medical needs by targeting drug payloads in high concentration to the site of disease, while lowering the toxicity to non-target organs. The company holds an exclusive worldwide license for research, development, manufacturing and commercialization of Centyrin protein therapeutics.

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.

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]).

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"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.

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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"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"

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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.