On July 1, 2019 Cytori Therapeutics, Inc. (NASDAQ: CYTX) reported an update on the development of its proprietary drug, ATI-1123, based on recently obtained feedback from the United States Food and Drug Administration (FDA) (Press release, Cytori Therapeutics, JUL 1, 2019, View Source [SID1234537339]). ATI-1123 is a substantially redesigned and reformulated new drug based in part, on the active pharmaceutical ingredient, docetaxel. ATI-1123 may have future clinical utility in a number of difficult to treat cancers.

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The purpose of the Company’s submission was to clarify certain key aspects of the future development plan including: (1) the suitability of the 505(b)(2) pathway for approval of the proposed ATI-1123 drug product, including the proposed listed drug (LD), (2) the adequacy of the referenced clinical, nonclinical and pharmaceutical quality information, in combination with the proposed drug development program, to support the new drug application and (3) any concerns that the FDA may have with regard to other filing issues specific to the product.

Key feedback from the FDA included that a 505(b)(2) application appears to be an acceptable regulatory approach with docetaxel injection as a potentially acceptable LD. Furthermore, the FDA agreed that the completed nonclinical studies are sufficient to support the initiation of the clinical trial of ATI-1123 in patients with platinum-sensitive small cell lung cancer who have progressed at least 60 days after initiation of first-line therapy.

"Small cell lung cancer is an aggressive neuroendocrine malignancy characterized by high metastatic potential and poor relative outcomes," said Dr. Marc H. Hedrick, M.D. "Due to the propensity of small cell lung cancer to metastasize widely and early in the disease course, it is considered the most lethal lung cancer subtype and new therapies such as ATI-1123, are desperately needed for these patients."

ATI-1123 has completed a phase I trial. Based on the FDA feedback, the Company plans to proceed with a follow-on phase II trial in platinum-sensitive small cell lung cancer who have progressed at least 60 days after initiation of first-line chemotherapy.

On July 1, 2019 Century Therapeutics, a Versant Ventures-created company developing allogeneic or off-the-shelf immune cell therapies for cancer, reported with USD 250 million in financing commitments from Bayer, Versant and Fujifilm Cellular Dynamics Inc. (FCDI) (Press release, Bayer, JUL 1, 2019, View Source [SID1234537338]). The proceeds will enable Century to advance multiple programs into the clinic for hematologic and solid malignancies.

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Century’s foundational technology is built on induced pluripotent stem cells (iPSCs) that have unlimited self-renewing capacity. This enables multiple rounds of cellular engineering to produce master cell banks of modified cells that can be expanded and differentiated into immune effector cells to supply vast amounts of allogeneic, homogeneous therapeutic products. This platform differentiates Century from competitors that are developing cell therapies made from non-renewable donor-derived cells.

Today’s announcement establishes Leaps by Bayer as an integral partner in Century’s investor syndicate. Leaps by Bayer, the venture investment arm of the global life sciences company Bayer, is dedicated to making paradigm-shifting advances in the life sciences.

Curing and preventing cancer is one of the main focus areas of Leaps by Bayer, since this disease still represents one of today’s biggest health concerns with limited curative or preventative therapies available. Dr. Juergen Eckhardt, head of Leaps by Bayer, said: "We are very excited about the potential of Century’s platform. It represents a unique opportunity in the development of next generation cell therapies that promise to address previously incurable cancers."

Century was founded by Versant in 2018 and later that year formed a strategic partnership with FCDI, a subsidiary of Fujifilm Corporation, to develop iPSC-derived immune effector cells for cancer. FCDI’s vertically integrated iPSC platform has been optimized over the last 15 years to include the foremost reprograming technology that uses genome integration-free methods to generate GMP grade iPSC lines. Century also has exclusive access to FCDI’s leading immune effector cell differentiation protocols and intellectual property to manufacture GMP-grade immune effector cells at commercial scale. Under the terms of the iPSC platform license agreement, FCDI will serve as the primary manufacturer of Century’s cellular products.

"Versant believes that allogeneic reagents represent the next wave of innovation in cell therapy and created Century to engineer truly off-the-shelf products to treat both hematologic and solid tumors," said Carlo Rizzuto, PhD., a Versant partner and Century director. "Today’s financing marks an important milestone in our effort to enable cell therapies to treat a much broader array of cancer patients."

"Fujifilm’s mission is to bring new value to society through innovation and the creation of new technologies, products and services. We are confident that FCDI’s cutting edge iPSC technologies and promising regenerative medicine solutions currently under development, can create new value to fulfill unmet medical needs and improve the lives of patients around the world," said Toshikazu Ban, Corporate Vice President of Fujifilm Corporation. "By accelerating development of new cancer immunotherapies using allogeneic iPSC through Century, we aim to deliver the therapy to patients as soon as possible."

"The financial support and expertise from this consortium of partners will enable Century to realize the full potential of our iPSC platform and expand patient access to cell therapy," said Lalo Flores, PhD., CEO of Century. "I am grateful to have their experience to guide the development of our promising allogeneic cell therapies for cancers with high unmet need."

In addition to Dr. Flores, Century has attracted a highly experienced team in cell therapy research and development that includes Hyam Levitsky, MD, President of Research and Development; Luis Borges, PhD., Chief Scientific Officer; and Adrienne Farid, PhD., Chief Development Officer. The company also has a pair of world renowned scientific co-founders including Marcela Maus, MD, PhD., assistant professor of medicine at Harvard Medical School and director of the Cellular Immunotherapy Cancer Center at Massachusetts General Hospital, and Hiro Nakauchi, MD, PhD., professor of genetics at Stanford University School of Medicine.