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Angel Pharmaceuticals Announces IND Acceptance for Clinical Trial of ITK Inhibitor CPI-818 in China

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.

Quest Diagnostics Declares Quarterly Cash Dividend

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]).

Immunicom Continues Successful Immunopheresis® Clinical Trial in Advanced, Non-Small Cell Lung Cancer Treatment with Acibadem University

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.

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.

McKesson to Host Investor Day on December 8, 2021

On August 16, 2021 McKesson Corporation (NYSE:MCK) reported that the Company will host an Investor Day on December 8, 2021 in New York City (Press release, McKesson, AUG 16, 2021, View Source [SID1234586652]).

A live audio webcast and presentation slides will be available on McKesson’s Investor Relations website at View Source Further details will be provided at a later date.

ADDING MULTIMEDIA Calidi Biotherapeutics Announces Exclusive License Agreement with City of Hope and the University of Chicago for Novel Oncolytic Virotherapy Technology

On August 16, 2021 Calidi Biotherapeutics, Inc., a clinical-stage biotechnology company with novel allogeneic stem cell platforms for delivery of oncolytic viruses, together with the University of Chicago and City of Hope, a world renowned NCI-Designated Comprehensive Cancer Center, based in Duarte, California, reported that it have entered into an exclusive worldwide licensing agreement for patents covering cutting edge therapies using an oncolytic adenovirus in combination with a clinical grade allogeneic neural stem cell line (Press release, Calidi Biotherapeutics, AUG 16, 2021, View Source [SID1234586651]).

City of Hope (COH) scientists, led by Dr. Karen Aboody in collaboration with Dr. Maciej Lesniak’s team at University of Chicago, and later Northwestern University, have used COH’s exclusive GMP grade immortalized, clonal human neural stem cell line, to selectively deliver an oncolytic adenovirus to tumor sites. Dr. Aboody and Dr. Lesniak, together with Dr. Rachael Mooney at COH, have spent 13 years in a passionate effort to translate promising pre-clinical results into the clinic, attaining FDA approval for commencing a first-in-human Phase-1 trial in recurrent glioma patients.

"We are very excited about the partnership and collaboration with Calidi Biotherapeutics. Their deep understanding and expertise using allogeneic stem cells as a delivery platform to protect, deliver, amplify, and potentiate oncolytic virotherapy, can potentially result in a significantly more effective treatment for cancer patients with invasive tumors," commented Dr. Karen Aboody, Professor, Department of Developmental and Stem Cell Biology, City of Hope National Medical Center & Beckman Research Institute.

"The first wave of Oncolytic Viruses were novel, but lacked the ability to efficiently deliver the virus to tumor sites, due to the human complement immune system inactivating the viruses, usually within one hour of patient injection, thus resulting in a lack of efficacy," stated Allan Camaisa, Co-Founder, Chairman and CEO of Calidi Biotherapeutics. "We believe this collaboration with City of Hope will allow us to implement Calidi’s proprietary techniques together with City of Hope’s novel approach to glioblastoma and other malignant tumors, using neural stem cells combined with an oncolytic adenovirus. This FDA approved Investigational New Drug (IND), planned for patient trials in the first quarter of 2022, increases Calidi’s drug pipeline and gives our company a tumor-tropic stem cell line to use for oncolytic virus delivery in cancer patients."

This exclusive license agreement, which was executed by the University of Chicago’s Polsky Center for Entrepeneurship and Innovation, transferred the COH/University of Chicago IND to Calidi for the commercial development of a licensed product. The agreement grants to Calidi commercial exclusivity in using neural stem cells with the adenovirus known as CRAd-pk-S-7 for oncolytic virotherapy.

"Calidi’s scientific and medical teams are very excited to contribute in the development of this promising technology that has significant potential to help many patients with advanced tumors," said Boris Minev, MD, President, Medical and Scientific Affairs at Calidi Biotherapeutics. "We are delighted to collaborate with the outstanding researchers and clinicians who developed this novel oncolytic virotherapy approach."