On January 31, 2023 Coeptis Therapeutics Holdings, Inc. (NASDAQ: COEP) ("Coeptis" or "the Company"), a biopharmaceutical company developing innovative cell therapy platforms for cancer, reported a sponsored research agreement with the University of Pittsburgh to advance pre-clinical development of SNAP-CAR T cells targeting HER2 as well as identify opportunities to expand the applicability of SNAP-CAR in oncology (Press release, Coeptis Therapeutics, JAN 31, 2023, View Source [SID1234626686]). SNAP-CAR, which Coeptis licensed from the University of Pittsburgh, is a multi-antigen chimeric antigen receptor T cell (CAR T) technology that can be adapted to different cancer indications, including hematologic and solid tumors.

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Under the terms of the sponsor research agreement, the University of Pittsburgh will conduct pre-clinical research on the SNAP-CAR technology necessary to enable the filing of an Investigational New Drug (IND) application for clinical trials involving SNAP-CAR T cells targeting HER2-positive cancers. Specifically, researchers at the University of Pittsburgh, led by principal investigator, Jason Lohmueller, Ph.D., Assistant Professor of Surgery and Immunology in the Division of Surgical Oncology Research, and Alexander Deiters, Ph.D., Professor of Chemistry, will work in coordination with Coeptis’ CRO partner, IQVIA, to develop a treatment strategy for ovarian cancer (or other solid tumors) in animals and identify a lead candidate for first-in-human clinical development. HER2 is a tumor-associated antigen (TAA) that is overexpressed in approximately 28%1 of ovarian cancer tissues and 25% of patients with breast cancer2.

"We are very excited to continue our work with the University of Pittsburgh to advance the development of SNAP-CAR towards a potential first indication: HER2-expressing ovarian cancer," said Dave Mehalick, President and CEO of Coeptis Therapeutics Holdings. "If successful, this could represent a potential breakthrough in the treatment of HER2-positive cancers and the applicability of CAR T to treat a range of solid tumors, including ovarian and breast cancer, as well as hematologic cancers. We look forward to working with Dr. Lohmueller, Dr. Deiters, and the research team at the University of Pittsburgh, as well as IQVIA, to prioritize the initial target indication for advancing SNAP-CAR through the IND process and into the clinic."

"Current CAR T therapies are designed to target specific tumor antigens that correspond to a specific cancer indication. This approach has proven effective in certain cancer types but limits the applicability of those CAR T therapies," said Dr. Lohmueller. "SNAP-CAR has been designed as a ‘universal’ CAR T cell therapy platform that can be adapted to different tumor antigens and cancer indications. We are eager to work with the teams at Coeptis and IQVIA to begin the pre-clinical development of a potential lead candidate targeting HER2-positive ovarian cancer, as well as optimizing the platform to increase its value potential."

About SNAP-CAR
SNAP-CAR, which Coeptis Therapeutics licensed from the University of Pittsburgh, is designed to be a "universal" CAR T cell therapy platform that can be adapted to different cancer indications. Instead of directly binding to a target on the tumor cell, CAR T cells are co-administered with one or more antibody adaptors that bind to the tumor cells and are fitted with a chemical group that irreversibly connects them to the SNAP-CAR on the therapeutic cells via a covalent bond. Pre-clinical studies in mice have demonstrated that by targeting tumors via antibody adaptor molecules, the SNAP-CAR therapy provides a highly programmable therapeutic platform.

On January 31, 2023 CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative therapies for the treatment of hematologic malignancies and solid tumors, has reported CARsgen’s execution of a collaboration agreement with F. Hoffmann-La Roche Ltd ("Roche") to evaluate CARsgen’s investigational drug AB011, the first humanized monoclonal antibody against Claudin18.2 (CLDN18.2) that received IND clearance globally, in combination with atezolizumab, Roche’s PD-L1 checkpoint inhibitor, along with standard-of-care chemotherapy in patients with gastric or gastroesophageal junction carcinoma (Press release, Carsgen Therapeutics, JAN 31, 2023, View Source [SID1234626685]). Under the terms of the agreement, Roche will be responsible for operation and conduct of the trial while both companies co-share the costs of the AB011 treatment arms in the study. As part of the clinical collaboration, CARsgen’s proprietary CLDN18.2 IHC test kit, which has showed excellent specificity and sensitivity profiles, will be applied to evaluate CLDN18.2 expression in the gastric cancer patients.

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The co-funded study of AB011 in combination with atezolizumab will be conducted as part of Roche’s Morpheus Platform. The Morpheus Platform is a collection of Phase Ib/II clinical trials in multiple cancers with high unmet clinical needs including gastrointestinal cancer, designed to assess the safety and early efficacy to enable more rapid and efficient development of novel cancer treatment combinations.

"We are glad to work with Roche, a global leader in oncology, to explore the potential of AB011 in combination with atezolizumab and chemotherapy for the treatment of gastric cancer," said Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen, "Gastric cancer is one of the most common cancer types worldwide and the treatment options for gastric cancer patients are still very limited. CLDN18.2 is a promising therapeutic target for the treatment of CLDN18.2 positive solid tumors, including gastric cancer, pancreatic cancer, etc. Since 2014, CARsgen team has developed several innovative medicines against CLDN18.2 in the pipeline including CAR T-cell therapies and AB011. AB011 is an important asset in the CLDN18.2 franchise of CARsgen and is the first monoclonal antibody against CLDN18.2 that received IND clearance in China. Through this collaboration, we are excited to evaluate the combination of AB011 and atezolizumab which can potentially bring greater clinical benefits to gastric cancer patients."

About AB011

AB011 is a humanized Claudin18.2 monoclonal antibody (mAb) product that has received an investigational new drug (IND) approval from the National Medical Products Administration (NMPA) for the treatment of Claudin18.2 positive solid tumors. CARsgen is conducting a Phase I clinical trial of AB011 for the treatment of Claudin18.2 positive solid tumors in China to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of AB011 infusion.

On January 31, 2023 Myeloid Therapeutics, Inc. ("Myeloid"), a clinical stage mRNA-immunotherapy company, reported that management will present at the Guggenheim Healthcare Talks 2023 Oncology Day, being held February 8-9, 2023, in New York, NY (Press release, Myeloid Therapeutics, JAN 31, 2023, View Source [SID1234626684]).

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Daniel Getts, Ph.D., CEO of Myeloid, will present a company overview on Wednesday, February 8, 2023, at 1:35 pm ET. Company management will also participate in one-on-one meetings with investors during the conference.

On January 31, 2023 Aethlon Medical, Inc. (Nasdaq: AEMD), a company developing medical technology to treat cancer and life-threatening infectious disease, reported that it will be presenting virtually at the upcoming Sequire Biotechnology Conference on Thursday, February 2nd, at 10:00 AM ET (Press release, Aethlon Medical, JAN 31, 2023, View Source [SID1234626683]). Steven LaRosa, M.D., Chief Medical Officer and Chief Scientific Officer of Aethlon Medical, will be giving the presentation.

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Event: Aethlon Medical, Inc. Presentation at the Sequire Biotechnology Conference
Date: Thursday, February 2nd, 2023
Time: 10:00 am ET

On January 31, 2023 Lunit (KRX:328130.KQ), in partnership with leading precision oncology company Guardant Health, reported the integration of its AI-based PD-L1 scoring algorithm into Guardant’s testing workflow to enhance biomarker detection in the Guardant360 TissueNextTM PD-L1 test for non-small cell lung cancer (NSCLC) (Press release, Guardant Health, JAN 31, 2023, View Source [SID1234626682]).

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The newly integrated algorithm will enable Guardant to offer augmented biomarker assessment for NSCLC patients through AI-based quantification of tissue samples using a scoring system generated by Lunit SCOPE PD-L1. The enhanced Guardant test is designed to support pathologists in diagnosing PD-L1 status with higher accuracy and efficiency. Through the AI software, the test showed improved detection of PD-L1 by more than 20 percent compared to manual pathologist interpretation in the most challenging cases in NSCLC1.

Lunit SCOPE PD-L1 is a CE-marked AI solution for detecting and analyzing PD-L1, a cancer biomarker. The solution may assist pathologists by minimizing interpretation discrepancy and allowing better prediction of treatment outcomes for non-small cell lung cancer (NSCLC) patients, as demonstrated in study findings published in the European Journal of Cancer.

Lunit SCOPE PD-L1’s integration with the Guardant360 TissueNext PD-L1 test is the first application in Guardant Galaxy, Guardant Health’s suite of technology applications developed internally and through outside partnerships to enhance the performance and utility of its portfolio of cancer tests.

The two companies have been in partnership since 2021, following a strategic investment from Guardant Health to Lunit.

"We are honored to partner with Guardant Health in leveraging the power of AI and digital pathology to enhance the capabilities of their comprehensive genomic profiling tests for cancer patients," said Brandon Suh, CEO of Lunit. "The development of the AI-supported scoring algorithm for the Guardant360 TissueNext PD-L1 test is a great example of using advanced medical image analytics to enhance precision diagnostics in lung cancer and help doctors find the right treatment for the right patients."

"With Guardant Galaxy, we are now accessing the most advanced AI techniques and the latest complementary technologies from leading companies in cancer diagnostics to enhance the capabilities of our tests and provide oncologists and researchers with precise and actionable information," said Helmy Eltoukhy, co-CEO of Guardant Health. "The digital pathology solution from Lunit has already demonstrated the power of AI to help improve detection of PD-L1 in certain cases of non-small cell lung cancer. We believe it has the potential to contribute much more broadly to advances in identifying cancer biomarkers and informing treatment decisions."