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Abeona Therapeutics Appoints João Siffert, M.D. Chief Executive Officer

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.

Recombinetics announces new CEO

On February 11, 2019 Recombinetics reported that named Mark Platt the organization’s Chief Executive Officer (Press release, Recombinetics, FEB 11, 2019, View Source [SID1234533249]).

"Recombinetics is at the forefront of innovative research and development to address issues of global significance, like feeding the hungry, improving population health and the humane treatment of animals," Platt says. "I’m joining at this transformational time to ensure the organization and its strategic investors thrive, with all aligned to positively impact people, places and animals at home and abroad."

"Our organization will benefit greatly from Mark’s leadership experience," says Peter Hajas, chairman of the Board, Recombinetics. "Mark brings an excitement for the possibilities of our innovative work and is the right person to guide our corporate culture and nurture relationships with key stakeholders to achieve goals of improving human lives, feeding the world’s growing population, and reducing animal suffering."

Platt’s experience includes his time as President and CEO of Multistack, LLC, in Sparta, Wis., where he provided strategic long-term direction of the company and was directly involved in emerging technology, research and development. From 2002 to 2012, Mark led the company through its highest period of growth, with total revenue increasing by more than 1,000 percent.

Most recently Executive Sales Leader at the Trane, Inc. Midwest sales office, Platt played a role in doubling the organization’s market share in less than two years. He was also Senior Vice President of Business Services for Gundersen Health System from November 2013 to April 2017. In this role, Platt oversaw business development and marketing, government relations, supply chain, facility operations and community wellness initiatives. He has also served on the Gundersen Board of Trustees.

Platt received his bachelor’s degree in electrical engineering from Vanderbilt University, Nashville, Tenn. He was also a commissioned officer in the U.S. Air Force with 17 years of service and held the rank of captain in the U.S. Air Force Reserve.

Tammy Lee, who served as President and CEO of Recombinetics since August 2017, is taking a leave of absence from the company. Recombinetics thanks Lee for her leadership, which included securing $34 million for the company’s Series A financing round.

Progenics Acquires AZEDRA® (iobenguane I 131) Radiopharmaceutical Manufacturing Facility

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.

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."

AbbVie and Teneobio Announce a Strategic Transaction to Develop a New Treatment for Multiple Myeloma

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]).

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.

Active Biotech’s partner NeoTX enters clinical collaboration with AstraZeneca to evaluate ANYARA in combination with IMFINZI® (durvalumab) in the upcoming Phase 1b/2 study

On February 11, 2019 Active Biotech (NASDAQ STOCKHOLM: ACTI) reported that their partner NeoTX enters a clinical collaboration with AstraZeneca Group Plc (NYSE: AZN) global biologics research and development arm, MedImmune, to support Phase 1b/2 studies investigating ANYARA in combination with AstraZeneca’s IMFINZI (Press release, Active Biotech, FEB 11, 2019, View Source [SID1234533232]). IMFINZI (durvalumab) is a human monoclonal antibody that blocks the immune checkpoint protein programmed death-ligand (PD-L1). 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, which is planned to start during 2019.

"We are very pleased with NeoTX’s progress in the ANYARA project. The collaboration with AstraZeneca validates the project and is an important step towards start of the clinical study" says Helén Tuvesson, CEO, Active Biotech AB.

See also www.neotx.com for NeoTX’s communication related to this information.

ABOUT ANYARA

ANYARA (Naptumumab, Naptumomab estafenatox,) is a tumor targeting immunotherapy that enhances the ability of the immune system to recognize and kill the tumor. ANYARA induces the activation and expansion of specific T cells outside of the tumor microenvironment and redirect the T cells to attack the tumor cells. Preclinical data demonstrate that ANYARA has synergistic effect with checkpoint inhibitors in various tumor models.

Active Biotech has an agreement with NeoTX Therapeutics Ltd since October 2016 for the global development and commercialization of ANYARA for the treatment of cancer.

About NeoTX
NeoTX Ltd. is a clinical-stage biopharmaceutical company dedicated to developing promising therapeutic candidates in the field of immuno-oncology. The Company in-licenses novel compounds, primarily from academic institutions and biotech companies.

Lund February 11 2019

Helèn Tuvesson
President & CEO

For further information, please contact:
Helén Tuvesson, CEO
Tel +46 46 19 21 56

Hans Kolam, CFO
Tel +46 46 19 20 44