On January 31, 2023 Istari Oncology, Inc., a clinical-stage biotechnology company focused on development of the novel immune activator lerapolturev for the treatment of solid tumors, reported the first patient has been dosed via intravesicular instillation in the non-muscle-invasive bladder cancer (NMIBC) cohort of the LUMINOS-103 basket trial (Press release, Istari Oncology, JAN 31, 2023, View Source [SID1234626689]). LUMINOS-103 is a dynamic phase 1/2 open-label basket trial evaluating the administration of lerapolturev with or without PD-1/L1 inhibitors in adult subjects with solid cancers.

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"We know that NMIBC tissue expresses the poliovirus receptor, CD155 and is responsive to immunotherapy, providing the rationale for intravesicular lerapolturev for patients with low to intermediate risk BCG-naïve NMIBC," said W. Garrett Nichols, MD, MS, Chief Medical Officer at Istari Oncology. "Approximately 60,000 patients with low to intermediate risk NIMBC are identified each year in the US alone; these patients could benefit from a well-tolerated immunotherapy such as lerapolturev as a replacement for repeat resections and intravesicular chemotherapy."

This substudy is designed to test the intravesical instillation of lerapolturev and its ability to infect tumor cells and infiltrating APCs within tumor tissue lining the bladder mucosa. To facilitate efficient enrollment, a heterogenous population of patients is being recruited (prior history of stage Ta, T1, or Tis urothelial carcinoma of the bladder; recurrent disease requiring TURBT or cystectomy). If successful, the planned patient population for phase 2 will be patients with low- to intermediate-risk BCG-naïve disease.

"We’re pleased to be the exclusive site for the NMIBC sub-study," said Dr. Neal Shore principal investigator and Director, Carolina Urologic Research Center. "This is a largely unaddressed population of NMIBC patients that, if we can identify and intervene early and effectively with a therapy like lerapolturev, can avoid progression and repeated surgeries or treatment with BCG, which has experienced severe shortages."

Recruiting for the NMIBC substudy is ongoing and is expected to reach full enrollment by mid-year.

For more information about Istari Oncology and their ongoing clinical trials, visit www.istarioncology.com.

About Lerapolturev

Lerapolturev is an investigational immunotherapy based on the live attenuated Sabin type 1 polio vaccine genetically modified for safety. Lerapolturev has a distinct target (the poliovirus receptor CD155), which is widely expressed in neoplastic cells of most solid tumors. Via CD155, Lerapolturev targets tumors with three key mechanisms: 1) engagement and activation of antigen presenting cells (APCs), leading to T cell priming and sustained, systemic anticancer immunity; 2) direct tumor cell killing and antigen release; and 3) amplification of the immune response via recall of polio vaccine-specific T cells. Lerapolturev has been granted Breakthrough Therapy and Orphan Drug Designation status by the U.S. Food and Drug Administration in recurrent glioblastoma, and Fast Track and Orphan Drug Designation status in refractory melanoma.

On January 31, 2023 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer, reported it granted inducement awards on January 31, 2023 (Press release, Adicet Bio, JAN 31, 2023, View Source [SID1234626688]).

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Six individuals hired by Adicet in January 2023 received, in the aggregate, non-qualified stock options to purchase 72,800 shares of Adicet’s common stock with an exercise price of $9.15 per share, the closing price of Adicet’s common stock as reported by Nasdaq on January 31, 2023. One-fourth of the shares underlying each employee’s option will vest on the one-year anniversary of each recipient’s start date and thereafter the remaining three-fourths of the shares underlying each employee’s option will vest in thirty-six substantially equal monthly installments, such that the shares underlying the option granted to each employee will be fully vested on the fourth anniversary of the recipient’s start date, in each case, subject to each such employee’s continued employment with Adicet on such vesting dates.

All of the above-described awards were granted outside of Adicet’s stockholder-approved equity incentive plans pursuant to Adicet’s 2022 Inducement Plan (the Inducement Plan), which was adopted by the board of directors in January 2022 and subsequently amended in January 2023. The awards were authorized by the compensation committee of the board of directors, which is comprised solely of independent directors, as a material inducement to the employees entering into employment with Adicet in accordance with Nasdaq Listing Rule 5635(c)(4).

On January 31, 2023 Ymmunobio AG, a preclinical stage biotech company specializing in the development of innovative treatments for cancer patients, reported that it has secured ownership to neuronal pentraxin receptor (NPTXR) antibodies, which have shown utility for developing therapeutics and for novel diagnostic tools in the treatment of several gastro-intestinal cancers, including gastric cancer (Press release, Ymmunobio, JAN 31, 2023, View Source [SID1234626687]). Ymmunobio signed the transfer ownership agreement in 2022 with Nagoya University for the license to NPTXR antibodies, which were invented by Professor Mitsuro Kanda, Department of Gastroenterological Surgery, Nagoya University, Japan.

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Ymmunobio has begun developing the lead, fully humanized and first-in-class NPTXR antibody, YB-800, which has demonstrated anti-tumor activity in vivo and in vitro for solid tumors, including several gastro-intestinal and breast cancers.

"Ymmunobio’s ownership of NPTXR represents a great leap forward for our company," said Ymmunobio Founder and CEO Katrin Rupalla. "Our lead antibody YB-800 targets directly various cancers overexpressing NPTXR and selectively kills cancer cells so that healthy tissue is not affected. This antibody is extending our innovative pipeline of first-in-class or novel antibodies. We’re optimistic that our ongoing preclinical development with NPTXR will enable us to start IND-enabling studies by the end of this year."

As indicated in Kanda’s study1, there is a pressing need to identify candidate therapeutic targets for the development of agents to control cancer metastasis through novel mechanisms. NPTXR plays an essential role in controlling the malignant behavior of gastric cancer cells in vitro and in vivo. NPTXR-targeting therapeutic antibodies (Abs) may have utility as novel diagnostic tools and/or treatment modalities for gastric cancer.1

The potential impact of NPTXR in developing antibodies to treat solid tumors is especially significant considering that 35% of colon cancer patients have a high expression of NPTXR, while 50% of gastric cancer patients have a high expression of NPTXR.

To learn more, visit Ymmunobio’s website.

ABOUT GI CANCERS
Colorectal cancer is the third leading cause of cancer death in the world and is estimated to make up 10% of all cancers.2 Gastric cancer (stomach cancer) was the fifth most common malignant tumor in the world in 2020 and the fourth leading cause of cancer death globally with approximately 800,000 deaths.3

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.