On May 16, 2024 Spanios, a firm that created and leverages its unique 3D tumoroid platforms to validate solid tumor therapies reported a partnership with Accelerated Biosciences, a company that licenses its commercial-grade human trophoblast stem cell (hTSC) platform for drug discovery, therapeutic development, biomanufacturing, and toxicology testing (Press release, Accelerated Biosciences, MAY 16, 2024, View Source [SID1234643413]).

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The partnership combines Spanios’ proprietary COMPASS platforms and patient-derived tumoroid models with AccelBio’s hTSC platform to advance therapeutic design across solid tumor cancers.

Accelerated Bio’s hTSC platform serves as the starting material for this collaboration. hTSCs are the earliest form of pluripotent stem cells that are ethically sourced. These cells are highly plastic and immune-privileged, making them ideal for numerous medical and biotechnological applications. Among many other functions that the hTSCs can perform, effector cells derived from the hTSCs have been shown to be successful against many cancer cells.

Spanios’ tumoroid research expertise enhanced by its ability to rapidly recapitulate preclinical therapeutic performance ex vivo will play a key role in generating clinically relevant data for the hTSCs. "We are excited about the preliminary data supporting the NK-like behaviors of these cells," said Vivek Ravi, Spanios CEO. "This opens a huge opportunity for cell-based therapies where other forms have struggled, especially for Ovarian, Colorectal and other challenging cancers, and is the driving force for the partnership."

"We are excited to collaborate with Spanios to advance the research and development of effector cells derived from hTSCs," said Yuta Lee, CEO of Accelerated Bio. "Together, we believe that we can further demonstrate the versatility of the hTSC platform for the development of the next-generation precision medicine therapies," said Ravi.

On May 16, 2024 Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, reported the online publication of a peer reviewed paper titled "PVRIG is expressed on stem-like T cells in dendritic cell-rich niches in tumors and its blockade may induce immune infiltration in non-inflamed tumors" link, in Cancer Immunology Research, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) (Press release, Compugen, MAY 16, 2024, View Source [SID1234643412]).

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"Increasingly, we are observing that an additional component is needed to optimize the anti-tumor response to a combination of an anti-TIGIT and anti-PD-(L)1," said Anat Cohen-Dayag, Ph.D., President, and Chief Executive Officer of Compugen. "Through our computational discovery work at Compugen we were the first to discover the novel immune checkpoint PVRIG and later presented preclinical data on the potential synergy in blocking PVRIG, TIGIT and PD-1 pathways. Subsequently, we showed in Phase 1 studies, that the triple blockade of PVRIG with our potential first-in-class antibody, COM701 in combination with an anti-TIGIT and anti-PD-1 demonstrated durable clinical responses with a favorable safety profile in indications typically not responding to immunotherapy. These responses were associated with the infiltration and proliferation of cancer-fighting T cells in the tumor microenvironment, atypical for less inflamed indications."

Eran Ophir, Ph.D., Chief Scientific Officer at Compugen added, "Our paper published online today in Cancer Immunology Research provides an advanced understanding of the unique biology of PVRIG and its role in cancer. Using single-cell RNA sequencing and spatial transcriptomic analysis, we showed the differentiated expression of PVRIG and its ligand PVRL2 on early differentiated stem like memory T cells and dendritic cells, respectively, the interaction of which plays an important role in inhibiting the recruitment and proliferation of cancer fighting T-cells in the tumor microenvironment. This unique biology of PVRIG may support a novel approach of potentially overcoming resistance to immunotherapy by sensitizing tumors to respond to other immune checkpoint inhibitors."

On May 16, 2024 Carisma Therapeutics Inc. (Nasdaq: CARM) ("Carisma" or the "Company"), a clinical stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, reported that the first patient was dosed in its Phase 1 clinical trial evaluating CT-0525, an ex vivo gene-modified autologous chimeric antigen receptor-monocyte (CAR-Monocyte) cellular therapy, for the treatment of patients with solid tumors that overexpress human epidermal growth factor receptor 2 (HER2) (Press release, Carisma Therapeutics, MAY 16, 2024, View Source [SID1234643411]).

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"Dosing of the first patient in the CT-0525 Phase 1 trial is a significant step in the development of engineered myeloid cells, marking the first time a CAR-Monocyte is tested in humans in the solid tumor setting," said Eugene P. Kennedy, M.D., Chief Medical Officer of Carisma. "Our pre-clinical data leads us to believe that this next-generation approach of our CAR-M platform has the potential to have a greater impact on patients than our initial CAR-Macrophage program, particularly through faster manufacturing, higher dosing, and increased potency, persistence, and tumor infiltration. We look forward to progressing this trial and expect to report initial data by the end of 2024."

"Patients battling HER2-overexpressing solid tumors face an urgent need for new therapeutic options, as disease progression is a common challenge," commented Davendra Sohal, M.D., M.P.H., Professor of Medicine at the University of Cincinnati Cancer Center. "CT-0525 introduces a differentiated approach to potentially address this shortcoming, offering hope for HER2-positive cancer patients. We are proud to be the first site to treat a patient with CT-0525 and look forward to continuing to collaborate with Carisma and other cancer centers to rapidly enroll patients in the Phase 1 trial."

The Phase 1 clinical trial for CT-0525 is an open-label study designed to assess the safety, tolerability, and manufacturing feasibility of CT-0525. This trial will enroll participants with locally advanced (unresectable) or metastatic solid tumors overexpressing HER2 whose disease has progressed on standard approved therapies. The study will consist of two dose escalation cohorts. Further details of the trial can be found at www.clinicaltrials.gov under NCT identifier: NCT06254807.

Carisma will present a Trial in Progress poster outlining the design of the CT-0525 Phase 1 trial at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2024 Annual Meeting, scheduled to take place from May 31 to June 4, 2024, in Chicago, IL.

About CT-0525

CT-0525 is a first-in-class, ex vivo gene-modified autologous chimeric antigen receptor-monocyte (CAR-Monocyte) cellular therapy intended to treat solid tumors that overexpress human epidermal growth factor receptor 2 (HER2). It is being studied in a multi-center, open label, Phase 1 clinical trial for patients with advanced/metastatic HER2-overexpressing solid tumors that have progressed on available therapies. The CAR-Monocyte approach has the potential to address some of the challenges of treating solid tumors with cell therapies, including tumor infiltration, immunosuppression within the tumor microenvironment, and antigen heterogeneity. CT-0525 has the potential to enable significant dose escalation, enhance tumor infiltration, increase persistence, and reduce manufacturing time compared to macrophage therapy.

On May 16, 2024 Agenus Inc. ("Agenus") (Nasdaq: AGEN), a leader in discovering and developing novel immunological agents to treat various cancers, reported it will conduct a Type B End-of-Phase 2 (EOP2) meeting in July with the U.S. Food and Drug Administration (FDA) to discuss the botensilimab plus balstilimab (BOT/BAL) combination therapy studies in patients with relapsed/refractory metastatic colorectal cancer that is not MSI-high or dMMR (r/r MSS mCRC), as well as the critical elements of the program to support a future biologics license application (BLA) submission (Press release, Agenus, MAY 16, 2024, View Source [SID1234643410]).

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The meeting is scheduled as part of Agenus’ ongoing efforts to expedite the development of this promising therapeutic option in CRC, considered to be one of the most challenging types of cancer due to its high incidence and mortality rates. It is also one of the fastest-growing cancer types in the U.S., particularly noted for its increasing prevalence among younger adults. Agenus aims to collaborate closely with the FDA to outline the path forward, including the Phase 3 study design and other elements needed to support a BLA filing under the FDA’s accelerated approval pathway. The FDA granted BOT/BAL fast track designation in April 2023.

"Our upcoming End of Phase 2 meeting with the FDA represents a significant milestone in the ongoing development of BOT/BAL for patients diagnosed with metastatic MSS CRC who do not have active liver metastases," stated Steven O’Day, M.D., Chief Medical Officer of Agenus. "The results from our Phase 1 and Phase 2 studies contribute valuable insights into the potential of this therapy for managing a specific and challenging subgroup of colorectal cancer. We remain dedicated to further exploring innovative immunotherapeutic strategies."

The Phase 2 data will be submitted to a major medical conference later this year. In addition to advancing BOT/BAL in colorectal cancer, Agenus remains committed to exploring the potential of this combination therapy in other cancer indications and is preparing to present further data at upcoming medical conferences.

About Botensilimab

Botensilimab is a human Fc enhanced CTLA-4 blocking antibody designed to boost both innate and adaptive anti-tumor immune responses. Its novel design leverages mechanisms of action to extend immunotherapy benefits to "cold" tumors which generally respond poorly to standard of care or are refractory to conventional PD-1/CTLA-4 therapies and investigational therapies. Botensilimab augments immune responses across a wide range of tumor types by priming and activating T cells, downregulating intratumoral regulatory T cells, activating myeloid cells and inducing long-term memory responses.

Approximately 900 patients have been treated with botensilimab in phase 1 and phase 2 clinical trials. Botensilimab alone, or in combination with Agenus’ investigational PD-1 antibody, balstilimab, has shown clinical responses across nine metastatic, late-line cancers. For more information about botensilimab trials, visit www.clinicaltrials.gov with the identifiers NCT03860272, NCT05608044, NCT05630183, and NCT05529316.

On May 16, 2024 Erasca presented its corporate presentation (Presentation, Erasca, MAY 16, 2024, View Source [SID1234643408]).

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