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.

On June 30, 2019 LSK BioPharma (or "LSKB"), a US-based biopharmaceutical firm and Jiangsu Hengrui Medicine, Co., Ltd. (SHA:600276, or "Hengrui"), one of the largest and most innovative fully-integrated biopharmaceutical companies based in China, reported the first patient has been enrolled in a pivotal global phase 3 clinical study of PD-1 antibody camrelizumab (SHR-1210) plus rivoceranib (commonly known as apatinib) versus sorafenib as a first-line therapy in subjects with advanced hepatocellular carcinoma (HCC) (Press release, LSK BioPharma, JUN 30, 2019, View Source [SID1234537337]). Rivoceranib, a selective VEGFR-2 inhibitor commonly known as apatinib, was approved in 3rd line gastric cancer in China in December 2014. Camrelizumab is a humanized anti-PD-1 monoclonal antibody which recently received the approval in China for classic Hodgkin’s Lymphoma (cHL).

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"We are excited to study the potential synergies of rivoceranib with immunotherapy and demonstrate the benefits to HCC patients in a first line setting," said Dr. Steve Norton, Vice President of Drug Development at LSKB.

Hengrui has been conducting an open-label, single arm multicenter phase 2 study (NCT03463876) to evaluate the efficacy and safety of the combination of camrelizumab and apatinib in patients with advanced HCC in China, where Hengrui has received approval of apatinib monotherapy for advanced gastric cancer. At ASCO (Free ASCO Whitepaper) 2018, it was reported that the objective response rate (ORR) and disease control rate (DCR) were 50.0% and 85.7%, respectively, among 14 evaluated advanced HCC patients treated by camrelizumab in combination with apatinib in an open-label, phase 1 study in China (Xu et al., NCT02942329). In addition, camrelizumab and apatinib combination therapy is also being evaluated by Hengrui for multiple indications including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and gastric cancer (GC) in China.

Based upon earlier studies, it is hypothesized that the combination of rivoceranib and camrelizumab may enhance the immune system, aiding the fight against cancer. In addition to the known anti-angiogenic effects of rivoceranib, it may also enhance camrelizumab’s anti-tumor activity by normalizing tumor vasculature and reversing the tumor suppressive immune microenvironment.

About Rivoceranib (Apatinib)

Rivoceranib, also known as apatinib or Aitan (brand name) in China, is the first successful small-molecule angiogenesis inhibitor in gastric cancer. Rivoceranib is investigational outside of China including in the United States; and safety and efficacy have not been established. It acts by inhibiting angiogenesis, a critical process in cancer growth and proliferation. Specifically, rivoceranib selectively inhibits VEGFR-2 which mediates the primary pathway for tumor-mediated angiogenesis.

Hengrui, who owns the China rights to rivoceranib, received the approval from China National Medical Products Administration (NMPA, formerly known as CFDA) in 2014 to market the drug under the brand name Aitan in China for advanced gastric cancer. LSKB, which holds the global rights (ex-China), has completed enrollment of a global (12 countries including US, Japan, Korea, Italy, Germany, and Russia) phase 3 clinical trial of rivoceranib in advanced or metastatic gastric cancer patients. Rivoceranib (apatinib) is currently listed in 264 clinical studies on www.clinicaltrials.gov with over 20,000 patients enrolled or planned to be enrolled in trials targeting numerous cancers including GC, colorectal cancer (CRC), HCC, NSCLC, esophageal cancer, thyroid cancer, mesothelioma, and neuroendocrine tumors. It has also shown potential to improve outcomes in combination with chemotherapeutics and immunotherapy, as well as for maintenance therapy. LSKB has received notification designating rivoceranib as an orphan medicinal product for the treatment of gastric cancer from the European Commission in the European Union, the US FDA, as well as the MFDS in South Korea.

Rivoceranib was developed by Advenchen Laboratories in Southern California under the designation YN968D1. The compound was exclusively licensed to Hengrui in China (2005) and LSKB (2007) for rest of the world.

About Camrelizumab (SHR-1210)

Camrelizumab (SHR-1210) is an investigational humanized monoclonal antibody recognizing the programmed death-1 (PD-1) receptor. Camrelizumab functions as an immune checkpoint inhibitor by specifically blocking the interaction between PD-1 and PD-L1 and reversing the immunosuppressive signal of PD-1 on the T cell. Approximately 72 clinical studies on camrelizumab in multiple indications including lung cancer, liver cancer, gastric cancer, esophageal cancer, nasopharyngeal carcinoma, lymphoma, melanoma and other advanced solid tumors are being conducted in China and Australia as monotherapy or in combination with other therapeutic agents. A marketing application for camrelizumab for relapsed/refractory classic Hodgkin’s Lymphoma was submitted by Hengrui to China NMPA, which was accepted in April 2018, and is currently under review.

On June 28, 2019 Thyas reported that it raised JPY 200 million in Series A1 financing on September 06, with participation from Kyoto University Innovation Capital Co., Ltd., and SMBC Venture Capital Co., Ltd. (Press release, Thyas , JUN 28, 2019, View Source [SID1234629213]).

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The funds will be used for accelerating the research and development including establishment of cell production methods and preparation of preclinical studies of iPS cell-derived T cell therapy for the treatment of solid cancers.

On June 28, 2019 Athenex, Inc. (Nasdaq: ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer, reported that the Company has strategically expanded its presence in Europe and Latin America to grow its global clinical research and development capacity (Press release, Athenex, JUN 28, 2019, View Source [SID1234573890]). The Company believes these initiatives have the potential to enhance Athenex’s capacity to conduct global clinical studies and support its regional marketing decision process. They are part of the Company’s strategy to build on its current strong presence in U.S. and Asia, and help maximize the global potential of its pipeline.

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Athenex’s oncology-focused pipeline currently has nine clinical candidates, including two drug candidates in Phase III development. In line with the Company’s goal to expand its capability and bandwidth to optimize global development and commercialization of its pipeline products, Athenex has been evaluating operational opportunities in Europe and Latin America.

As part of Athenex’s strategy to establish operations in Europe, the second largest healthcare market in the world, the Company has formed a subsidiary in the United Kingdom and established offices in Manchester. The Company is currently conducting clinical studies in the United Kingdom and intends to continue expanding its research and development capabilities in the region.

In Latin America, Athenex recently entered into a definitive agreement to acquire certain assets of CIDAL Limited in exchange for shares of Athenex common stock, subject to customary closing conditions. CIDAL is a contract research organization with headquarters in Guatemala and operations in various countries in Latin America. CIDAL has provided important CRO services and support to Athenex, including for its Phase III study of oral paclitaxel and encequidar for metastatic breast cancer. The asset purchase is expected to strengthen Athenex’s clinical research and operations capabilities and support the Company’s clinical development worldwide.

"These initiatives represent an important step in our ongoing strategic efforts to expand our clinical research and operations for global development, with the potential for increased clinical research efficiencies and cost-effectiveness" said Dr. Johnson Lau, Chairman and Chief Executive Officer of Athenex. "Our office in Manchester will enable us to evaluate the best strategy for Europe, an important market for Athenex. We have been engaging with many experienced pharma/biotech specialists who are already contributing to our research programs and look forward to working more closely with these talents. We are also delighted to extend our operations in Latin America through CIDAL, which we believe will increase our bandwidth for clinical research and regulatory development. We believe having a stronger presence in these territories will position us well to evaluate new R&D and commercialization opportunities in Europe and Latin America."