On August 16, 2021 Gracell Biotechnologies Inc. (NASDAQ: GRCL) ("Gracell"), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, reported an exclusive license agreement with FutureGen Biopharm ("FutureGen"), an innovative biopharmaceutical company, to develop engineered immune cell therapies targeting Claudin 18.2 ("CLDN18.2") in solid tumors (Press release, Gracell Biotechnologies, AUG 16, 2021, View Source [SID1234586657]).

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The collaboration aims to leverage Gracell’s extensive experience in immune cell therapy in synergy with FutureGen’s fully human CLDN18.2 antibodies to develop, manufacture and commercialize novel immune cell therapies for the treatment of patients with CLDN18.2 positive cancers.

CLDN18.2 is a tumor-specific marker that is overexpressed in a variety of tumor tissues, including in gastric or gastroesophageal junction cancers, pancreatic cancers and esophageal cancers, but rarely expressed in normal human tissues. This feature supports the therapeutic potential of CLDN18.2 as a key target for immune cell therapies. In particular, gastric cancer (around 70%[1] CLDN18.2 expression) is among the most frequently diagnosed malignancies worldwide and the second leading cause of cancer-related death. An estimated 1,033,701 new cases and 782,685 deaths occurred in 2018[2], representing a highly unmet medical need in treating gastric cancer.

"Gracell has been making significant progress in developing innovative CAR-T therapies for solid tumors as well as hematological malignancies," Dr. William (Wei) Cao, Founder, Chairman and Chief Executive Officer of Gracell said. "This partnership with FutureGen marks another key milestone in our persistent efforts for treating solid tumors. Moving forward, we expect to explore more strategic alliances to identify additional targets that maximize the value of our highly differentiated technology platforms and eventually benefit cancer patients worldwide."

"Gracell has been optimizing its proprietary Enhanced CAR technology to improve CAR-T cell persistence and efficacy in solid tumors. The preliminary clinical investigator-initiated trial data of our first generation Enhanced CAR-T for solid tumors has shown tolerability and preliminary efficacy. These initial results have been accepted to be published soon in Cellular & Molecular Immunology," said Dr. Lianjun Shen, Senior Vice President, Head of Research and Development at Gracell. "We are very excited to partner with FutureGen to develop next generation immune cell therapies against CLDN18.2-expressing malignancies, and hope to unlock significant potential of our next generation Enhanced CAR-T therapies for solid tumors, one of our founding missions."

Dr. Zhaoyu Jin, the Founder and Chief Executive Officer of FutureGen said, "The specific CLDN18.2 antibody has been developed through our innovative STEP and CAP technology platforms. The fine-tuned affinity of antibody for CAR-T application may eliminate CLDN18.2 positive tumor cells more specifically with better safety profile. We are very excited to collaborate with Gracell, a lead company in the cell and gene therapy industry, to leverage their innovative Enhanced CAR-T technology platform and experience in the field and our proprietary cutting-edge technologies to develop advanced treatments across solid tumors."

Under the terms of the agreement, FutureGen will receive an upfront payment and will be eligible to receive additional payments based on the achievement of non-clinical validation, clinical development and commercialization milestones, as well as low single-digit royalties.

About CLDN18.2

CLDN18.2, a small transmembrane protein with four transmembrane domains and two extracellular loops, is overexpressed in a significant proportion of gastric cancers and esophageal adenocarcinomas. The restricted expression makes it a promising target for the treatment of gastric or gastroesophageal junction cancers, pancreatic cancers, etc. Overall, CLDN18.2 is prevalently expressed in the cancer tissues of approximately 70% of gastric cancer patients and approximately 60% of pancreatic cancer patients. CLDN18.2-specific antibodies developed to target CLDN18.2 have exhibited anti-tumor activity in preclinical studies.[3]

About Enhanced CAR

Enhanced CAR is Gracell’s proprietary technology that further strengthens the functionality of CAR-T cells, for example by overcoming the immunosuppressive tumor micro-environment (TME) and/or increasing cytokine signaling. Gracell utilizes gene editing technologies to edit some check point inhibitor(s) or/and cytokine(s) or cytokine receptor(s) on CAR-T cells to release potential suppression from tumor cells and other suppressive immune cells in tumor tissue to enhance CAR-T cells’ functionality. Our second generation Enhanced CAR technology can be implemented to many other targets in several types of solid tumors.

On August 16, 2021 Jubilant Therapeutics Inc., a biopharmaceutical company advancing small molecule precision therapeutics to address unmet medical needs in oncology and autoimmune diseases, reported the appointments of Leila Alland, M.D. to its Board of Directors, and Jeremy Barton, M.D. as Strategic Advisor and Interim Chief Medical Officer (Press release, Jubilant Therapeutics, AUG 16, 2021, View Source [SID1234586656]).

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Jubilant Therapeutics Strengthens Board of Directors with Addition of Leila Alland, M.D. and Announces Appointment of Jeremy Barton, M.D., as Strategic Advisor and Interim CMO
Jubilant Therapeutics Strengthens Board of Directors with Addition of Leila Alland, M.D. and Announces Appointment of Jeremy Barton, M.D., as Strategic Advisor and Interim CMO
"It is a pleasure to welcome Dr. Alland to the Jubilant Therapeutics board and Dr. Barton to the team," said Hari S Bhartia, Chairman, Jubilant Therapeutics Inc. "They join at an exciting time as we progress towards the clinic and I look forward to their engagement and support in guiding our objectives."

"Dr. Alland and Dr. Barton’s combined experience in strategic oncology drug development will help propel the company towards our goal to bring innovative small molecule modulators to patients with cancer," said Syed Kazmi, Ph.D., President and Chief Executive Officer of Jubilant Therapeutics Inc.

"The Jubilant Therapeutics team is making great strides in developing precision oncology therapeutics and I am honored to be joining their Board and supporting them in advancing their exciting pipeline into the clinic," said Leila Alland, M.D.

Dr. Alland currently serves as Chief Medical Officer of PMV Pharmaceuticals where she is responsible for leading the company’s clinical stage precision anticancer therapies. Previously, she served as Chief Medical Officer at Affimed and Tarveda Therapeutics and held leadership positions at AstraZeneca, Bristol-Myers Squibb, Novartis and Schering-Plough. Dr. Alland completed her fellowship in pediatric hematology-oncology at the New York Hospital and Memorial Sloan-Kettering Cancer Center and served as Assistant Professor of Pediatrics at Albert Einstein College of Medicine, where she was awarded the James S. McDonnell Foundation Scholar Award and pursued basic cancer research while also caring for children with cancer and blood disorders.

"I am excited to be working with Jubilant Therapeutics and contributing to advancing their pipeline of novel therapeutics to address unmet needs in patients with cancer and autoimmune diseases," said Jeremy Barton, M.D.

Dr. Barton brings to Jubilant Therapeutics over 29 years of experience across all phases of oncology drug development from major pharmaceutical companies in Switzerland, the United Kingdom and the United States. He currently works as a consultant advising biotech companies on strategic oncology drug development. Previously, Dr. Barton served as Chief Medical Officer at Biogen Idec, eFFECTOR Therapeutics, and Mirati Therapeutics. He served as the Head of early Oncology Development at Pfizer for where he oversaw the transition of all oncology compounds from research to IND and then to proof-of-concept studies. Dr. Barton is Board Certified in Internal Medicine and Clinical Oncology, a Member of the Royal College of Physicians, a Fellow of the Royal College of Radiologists (Clinical Oncology) and a Member of Faculty of Pharmaceutical Medicine. He earned his Master’s in Physiology from Oxford University, and his M.D. degree at University College Hospital Medical School in London.

On August 16, 2021 Angel Pharmaceuticals Ltd. ("Angel Pharma") reported that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted its IND application for the initiation of a Phase 1/1b clinical trial of its small molecule ITK inhibitor CPI-818 for treatment of relapsed/refractory T-cell lymphomas (Press release, Angel Pharmaceuticals, AUG 16, 2021, View Source [SID1234586655]). Angel Pharma plans to initiate the trial before the end of 2021.

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CPI-818, the first-and-only ITK inhibitor in clinical development in China, has been shown to selectively inhibit ITK (interleukin-2-inducible T-cell kinase) without effect on related kinases such as RLK (resting lymphocyte kinase) and BTK (Bruton’s tyrosine kinase). ITK is a 72 kDa protein kinase that plays an essential role in the activation, differentiation and proliferation of T-cells. There is evidence that ITK may play a role in the development and growth of T-cell lymphomas. Based on these properties, ITK is a promising treatment target for autoimmune diseases and for lymphoproliferative diseases such as T-cell lymphomas (TCL), which comprise an aggressive and heterogeneous subtype of non-Hodgkin lymphoma.

Angel Pharma licensed the rights to CPI-818 from Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS) for development, manufacturing and commercialization in China. Corvus is studying CPI-818 in a multi-center Phase 1/1b clinical trial in patients with several types of TCL in the U.S. and Asia. As of February 17, 2021, 25 patients (16 in dose escalation and 9 in expansion) have received CPI-818 treatment. Overall, CPI-818 has been shown to be well-tolerated, and has shown anti-tumor activity in peripheral T-cell lymphomas (PTCL) and in cutaneous T-cell lymphomas. As reported at the annual meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in December 2020, 2 of 7 patients with refractory PTCL experienced responses to treatment with CPI-818; one complete response and one partial response.

"The NMPA’s acceptance of the IND for CPI-818 is an important step towards bringing this innovative product candidate to patients in China," said Richard A. Miller, M.D., co-founder and chairman of Angel Pharmaceuticals. There is a need for novel effective therapies for patients with T-cell lymphoma since current treatment options are limited and outcomes are often poor. Angel Pharma has a robust pipeline and the advancement of CPI-818 is only the first step in developing several potential first-in-class therapeutic opportunities. T-cell lymphomas are more common in China than in the U.S., highlighting the potential synergies of the collaboration between Angel Pharma and Corvus, which could accelerate development of our drugs for global markets."

Dr. Ted Wang, co-founder and general manager of Angel Pharmaceuticals, commented, "The aspiration of Angel Pharma is to gather world-class resources to bring innovative therapies to benefit Chinese people. With CPI-818, we will be able to potentially provide a safer, highly differentiated therapy for patients suffering from T-cell lymphoma and potentially other indications such as autoimmune diseases."

Separately, Angel Pharma announced the launch of its research centers in China and the U.S in July 2021. The new research center in China, based in Jiaxing, Zhejiang Province, occupies over 3,000 square meters of state-of-the-art research and development facilities including chemistry, molecular biology and pharmaceutical development laboratories. The U.S. research center, located in Burlingame, CA, occupies more than 1,000 square meters dedicated to research and development. Since its launch in October 2020, Angel Pharma has built an experienced R&D team, including expertise in clinical sciences, clinical operations, pharmacovigilance, CMC, regulatory, early discovery and pharmacology.

On August 16, 2021 Quest Diagnostics (NYSE: DGX), the world’s leading provider of diagnostic information services, reported that its Board of Directors declared a quarterly cash dividend of $0.62 per share, payable on October 20, 2021 to shareholders of record of Quest Diagnostics common stock on October 5, 2021 (Press release, Quest Diagnostics, AUG 16, 2021, View Source [SID1234586654]).

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On August 16, 2021 Immunicom, Inc., a clinical stage biotech pioneering non-pharmaceutical immunotherapies, reported that progresses with its cancer clinical trial to evaluate the clinical effectiveness of Immunopheresis in partnership with Acibadem University conducted in Acibadem Healthcare Group hospitals (Press release, Immunicom, AUG 16, 2021, View Source [SID1234586653]). This multi-arm study has been recruiting patients since October 2020 and evaluates Immunicom’s oncology platform for non-small cell lung cancer (NSCLC) in combination with Roche’s pharmaceutical checkpoint inhibitor, Tecentriq (atezolizumab). This is Immunicom’s third clinical trial assessing Immunopheresis for solid cancers.

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The Immunopheresis therapy employs Immunicom’s lead product, the proprietary LW-02 subtractive column, to remove targeted immune-suppressive cytokines that block the natural immune response to attack malignant tumors. Immunopheresis is intended to treat cancer while avoiding the typical side-effects, toxicity, and negative impacts on quality of life that are frequently associated with other cancer treatments.

Immunicom’s LW-02 column has received U.S. FDA Breakthrough Device designation for stage IV metastatic cancer and has received European regulatory clearance (CE Mark certification) for use in adults with advanced, refractory, triple negative breast cancer (TNBC).

"Lung cancer is one of the most common cancers in the world and the most prevalent cancer in Turkey. Currently available therapies for lung cancer are commonly associated with serious side-effects and often patient’s tumors become resistant to even the newer immunotherapies. Moreover, the presently available immunotherapies are prohibitively expensive which precludes this option for many patients," said Ahmet Şahin, MD., Prof., Chairman of the Medical Executive Board of Acibadem Healthcare Group. "We are highly optimistic that Immunicom’s Immunopheresis therapy will provide physicians with a novel breakthrough cancer immunotherapy that should be markedly better tolerated, improve patient’s quality of life, and its cost-effectiveness will make it widely available to many patients who might otherwise not be able to benefit from an immunotherapy."

The multicenter, multi-arm clinical study led by Gökhan Demir, MD, Prof., Acibadem University School of Medicine, Department of Internal Diseases Medical Oncology who serves as the Principal Investigator, and conducted by Mustafa Bozkurt, MD tests the clinical effectiveness of the LW-02 Immunopheresis column to treat stage IIIB/IV non-small cell lung cancer patients whose disease has progressed after at least one first-line chemotherapy round of treatment. The clinical study is divided into three treatment arms, each with the LW-02 column; the first in combination with Tecentriq (atezolizumab), the second in combination with Taxol (paclitaxel), and the third with Immunopheresis as a monotherapy for patients who have disease progression after a second-line of chemotherapy treatment.

"With this clinical trial, Immunicom and Acibadem are centered on demonstrating the effectiveness of Immunicom’s Immunopheresis therapy for treating patients facing a highly aggressive form of non-small cell lung cancer. This important study assesses Immunopheresis in combination with both Roche’s Tecentriq, one of the world’s leading PD-L1 checkpoint inhibitor immunotherapy drugs, and with paclitaxel, a very commonly used chemotherapy agent," said Amir Jafri, Founder and CEO of Immunicom, Inc.

"We have developed Immunopheresis intending that it could be used with many different oncology regimens and the growing array of promising immunotherapy drugs, while keeping in the forefront our mission of preserving patients’ quality of life to ensure that they can fight cancer in a compassionate and dignified way. We are confident that our breakthrough Immunopheresis technology will provide patients the benefits associated with upregulation of their immune system to attack resistant cancers. Immunicom’s motto of ‘Healing Reimagined,’ reflects our mission to improve quality-of-life for all patients in a meaningful way and expedite their path to a healthy recovery," continued Mr. Jafri.

For an overview of how this breakthrough technology works, visit View Source Immunopheresis is an investigational therapy that has not yet been approved for use by the FDA.