On February 11, 2019 NeoTX Therapeutics, Ltd reported that it has entered into a clinical collaboration with AstraZeneca Group Plc (NYSE: AZN) global biologics research and development arm, MedImmune, to support Phase 1b/2 studies investigating NeoTX’s naptumomab estafenatox ("naptumomab") in combination with IMFINZI (durvalumab) (Press release, NeoTX, FEB 11, 2019, View Source [SID1234640360]). These studies are expected to begin in 2019. Naptumomab is the lead drug in NeoTX’s novel Selective T cell Redirection ("STR") platform.

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Naptumomab’s dual mechanism of action coats the tumor with a target that can be easily identified by T cells and then primes and redirects specific activated T cells that can identify that target, to the tumor.

Durvalumab is a human monoclonal antibody that blocks the immune checkpoint protein, programmed death-ligand (PD-L1), and allows activated T cells to attack tumor cells.

The Phase 1b/2 studies will determine the maximum tolerated dose (MTD) of naptumomab in combination with durvalumab, evaluate the clinical response, safety and tolerability of the combination, as well as test for multiple pharmacodynamic parameters.

Under terms of the agreement, NeoTX and AstraZeneca will collaborate on a non-exclusive basis to evaluate the combination of the two drugs in solid tumors. NeoTX will sponsor the study, while AstraZeneca will supply durvalumab. Up to 195 patients are planned to be enrolled in this multicenter, open-label study.

"We are pleased to work with AstraZeneca addressing the high unmet medical need of patients with tumors for which checkpoint inhibitor therapy has had little success," said Asher Nathan, NeoTX Therapeutics’ Chief Executive Officer. "The safety profile of naptumomab alone and in combination with interferon has been demonstrated in clinical studies in hundreds of patients with solid tumors. Naptumomab can enhance T cell activation and infiltration in tumors and can remodel the immunosuppressive tumor microenvironment. In preclinical models, naptumomab has a synergistic effect with checkpoint inhibitors which could translate into durable responses in patients."

On February 11, 2019 AbbVie (NYSE: ABBV), Teneobio, Inc. and its affiliate TeneoOne, Inc. reported that they have entered a global strategic transaction to develop and commercialize TNB-383B, a BCMA-targeting immunotherapeutic for the potential treatment of multiple myeloma (Press release, AbbVie, FEB 11, 2019, View Source [SID1234533234]).

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B-cell maturation antigen (BCMA) has emerged as an attractive target for multiple myeloma therapeutics. TNB-383B is a bispecific antibody that simultaneously targets BCMA and CD3, utilizing Teneobio’s unique anti-CD3 platform. Through this dual targeting mechanism, TNB-383B is designed to direct the body’s own immune system to target and kill BCMA expressing tumor cells. Teneobio is expected to begin the clinical program for TNB-383B in the first half of 2019.

Roland Buelow, CEO of Teneobio, Inc. and TeneoOne, Inc. added, "We are excited to partner with AbbVie on our first clinical candidate, TNB-383B, which targets BCMA using our unique T-cell redirecting platform. Combined with AbbVie’s commitment to scientific advancement and bringing oncology products to the world-wide commercial market, we will be able to quickly progress the development of TNB-383B for patients in need."

"Developing novel targeted treatments for patients with cancer continues to be our key priority," said Mohit Trikha, Ph.D., vice president and head, oncology early development, AbbVie. "Multiple myeloma is one of the most common hematological cancers and an area of significant medical need. Teneobio’s novel approach to T-cell redirection with TNB-383B has the potential to be a treatment option that may offer new hope for myeloma patients."

Under the terms of the agreement, TeneoOne will receive an upfront payment of $90 million and will continue developing TNB-383B through Phase 1. AbbVie will hold the exclusive right to acquire TeneoOne and lead subsequent global development and commercialization of TNB-383B. If AbbVie exercises its right to acquire TeneoOne, the former stockholders of TeneoOne will also be eligible for regulatory and commercial sales milestones.

On February 11, 2019 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported that the Spanish Agency for Medicine and Health Products has granted final approval for the forthcoming AWARE-1 window of opportunity study in breast cancer (Press release, Oncolytics Biotech, FEB 11, 2019, View Source [SID1234533214]). This study, which represents the first application of Oncolytics’ master clinical supply agreement with Roche for the combination of pelareorep with a leading immune checkpoint inhibitor atezolizumab (Tecentriq), is a precursor to Oncolytics’ previously announced phase 3 breast cancer study and will add to the company’s growing critical mass of biomarker data. The final study design and protocol will be announced when the first patient is enrolled in the near future.

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"This study should corroborate recently identified biomarker data and confirm whether the virus’ ability to promote tumor inflammation can be enhanced by the addition of checkpoint blockade," said Matt Coffey, President and CEO of Oncolytics Biotech. "This information not only increases the likelihood of success in a registration study but could reduce both timelines and costs. The biomarker data should provide the information required for investigators to be able to quickly differentiate between patients that are responding, and patients that are better served by another treatment."

Under the supply agreement, Roche will supply Tecentriq for the study with both parties having access to the clinical data. Initial biomarker and safety data from the first cohort of patients should be available by mid-2019.

The study, facilitated by SOLTI, will be coordinated by Dr. Aleix Prat, Head of Medical Oncology at the Hospital Clínic of Barcelona, Associate Professor of the University of Barcelona and the Head of the Translational Genomics and Targeted Therapeutics in Solid Tumors Group at August Pi i Sunyer Biomedical Research Institute (IDIBAPS) and member of Oncolytics’ Scientific Advisory Board. SOLTI has a network of more than 300 professionals, mostly medical oncologists, in over 80 hospitals in Spain, Portugal, France and Italy.

About Breast Cancer

Breast cancer is the most common cancer in women worldwide, with over two million new cases diagnosed in 2018, representing about 25 percent of all cancers in women. Incidence rates vary widely across the world, from 27 per 100,000 in Middle Africa and Eastern Asia to 85 per 100,000 in Northern America. It is the fifth most common cause of death from cancer in women globally, with an estimated 522,000 deaths.

Breast cancer starts when cells in the breast begin to grow out of control. These cells usually form a tumor that can often be seen on an x-ray or felt as a lump. The malignant tumor (cancer) is getting worse when the cells grow into (invade) surrounding tissues or spread (metastasize) to distant areas of the body.

Genomic research has led to a better understanding of how genes and proteins classify breast cancer as hormone receptor positive, human epidermal growth factor receptor 2 negative (HR+/HER2-), hormone receptor positive, human epidermal growth factor receptor 2 positive (HR+/HER2+), hormone receptor negative, human epidermal growth factor receptor 2 positive (HR-/HER2+) or triple negative breast cancer (TNBC).

About Pelareorep

Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

About SOLTI

SOLTI is a non-profit association with more than 20 years of experience in conducting innovative clinical and translational research to address unmet medical needs in breast cancer that answer questions of major scientific interest and relevance in the field of oncology. SOLTI has a network of more than 300 professionals, mostly medical oncologists, distributed in over 80 hospitals in Spain, Portugal, France and Italy. For more information, please visit www.gruposolti.org.

On February 11, 2019 Progenics Pharmaceuticals, Inc. (NASDAQ:PGNX), an oncology company developing innovative medicines and imaging analysis technology for targeting and treating cancer, reported that it has acquired the Somerset, NJ manufacturing facility for AZEDRA (iobenguane I 131) for cash consideration of $8.0 million (Press release, Progenics Pharmaceuticals, FEB 11, 2019, View Source [SID1234533235]). AZEDRA is the first and only FDA-approved radiopharmaceutical indicated for the treatment of pheochromocytoma and paraganglioma, ultra-rare cancers.

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This Somerset site serves as the launch facility for AZEDRA and will also provide manufacturing support for the Company’s development stage radiopharmaceuticals, including 1095. The production of AZEDRA uses a proprietary Ultratrace process which concentrates the MIBG targeted radiolytic activity by eliminating non-therapeutic "cold" MIBG molecules, giving AZEDRA a uniquely high specific activity.

Progenics has also secured the long-term supply of iodine necessary for the production of both AZEDRA and 1095.

"This strategic transaction extends our leadership position in radiopharmaceuticals, establishing the infrastructure and manufacturing capabilities to label multiple types of isotopes, including iodine-131," stated Mark Baker, CEO of Progenics. "With this transaction, we are building the capabilities to ensure the supply of AZEDRA."

On February 11, 2019 Abeona Therapeutics Inc. (Nasdaq: ABEO), a leading clinical-stage biopharmaceutical company developing novel cell and gene therapies for serious diseases, reported the appointment of João Siffert, M.D. as Chief Executive Officer (CEO), effective immediately (Press release, Abeona Therapeutics, FEB 11, 2019, View Source [SID1234533293]). Dr. Siffert joined Abeona as Head of Reasearch & Development (R&D) and Chief Medical Officer (CMO) in 2018, and has served as interim CEO since November of last year. Dr. Siffert will retain his responsibilities as Head of R&D and CMO until a clinical development lead is identified.

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"The Board is confident that João has the right mix of character, leadership, and knowledge to focus Abeona on achieving near-term goals that will pave the way to long-term value for the company," said Steven H. Rouhandeh, Chairman of the Board and Executive Chairman. "His track record of leading successful therapeutic development programs and his experience at the Board level in gene therapy are well-suited to the opportunities that lie ahead for Abeona."

"I am honored to assume the role of CEO and thankful for the Board’s confidence in me. I look forward to leading and standing alongside a dedicated team of employees who are committed to bringing transformative treatments for patients in need," said Dr. Siffert. "The combination of important clinical milestones on the near term horizon, a world-class cell and gene therapy manufacturing facility, and the therapeutic potential of the next-generation AIM vector platform make this an exciting time to take the helm."

Dr. Siffert has successfully led multiple drug development programs from pre-clinical to regulatory approvals and commercial launches in the U.S. and Europe, and has held several scientific leadership positions in biotech and pharma, including programs in gene therapy. In 2017, Dr. Siffert was appointed to the Board of Directors of gene therapy developer AveXis, which was subsequently acquired by Novartis. He served as Chief Medical Officer for Ceregene from 2007 to 2011, where he was responsible for clinical development of adeno-associated viral (AAV2)-based gene therapies for Parkinson’s and Alzheimer’s diseases. Dr. Siffert also led the R&D and medical organizations at Avanir Pharmaceuticals and Avera Pharmaceuticals before most recently guiding translational research, clinical development, regulatory, and medical affairs and health economics as Chief Scientific and Medical Officer for Nestle Health Science. Before joining industry, Dr. Siffert spent seven years in academic practice as a neuro-oncologist. He holds an M.D. from the University of São Paulo and an MBA from Columbia Business School.