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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On May 16, 2024 Traws Pharma, Inc. ("Traws" or "Traws Pharma"), a clinical stage biopharmaceutical company developing oral small molecules for respiratory viral diseases and cancer, reported financial results for the first quarter of 2024, and provided a business update (Press release, Traws Pharma, MAY 16, 2024, View Source [SID1234643406]).

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"2024 has already been a transformative year for Traws Pharma to advance our portfolio of novel treatments for serious respiratory infections and oncology programs. We completed the acquisition of Trawsfynydd and concluded a concurrent $14 million private placement financing. In addition, we initiated first-in-human dosing for our COVID 19 product candidate, including completion of the first cohort dosing group. Furthermore, we completed the last dose escalation cohort for our CDK4+ inhibitor, narazaciclib." stated Werner Cautreels, Ph.D., Chief Executive Officer of Traws Pharma. "We believe that we are poised to make even more meaningful progress in the second half of 2024, as we advance our influenza treatment and ritonavir-free protease inhibitor for COVID 19 into expanded Phase 1 dose escalation studies and begin Phase 2 development."

"Based on the preclinical profile and early clinical data from our infectious disease candidates and narazaciclib, I am optimistic about the outlook for Traws’ portfolio and look forward to updating our investors with our progress through the year," concluded Dr. Cautreels.

Traws Proprietary Portfolio Highlights:

TRX100 (tivoxavir marboxil): a cap-dependent endonuclease inhibitor for influenza: Phase 1

· Targets the cap-dependent endonuclease of influenza and is a potent inhibitor of influenza virus replication including A and B strains

· First Phase 1 study demonstrated safety and tolerability in healthy volunteers with pharmacokinetics and pharmacodynamics (PK/PD) data to support the potential use of a single oral dose for treatment or prophylaxis

· We plan to initiate Phase 1 dose extension to evaluate one additional, higher dose prior to the initiation of Phase 2 studies in H2 2024. Topline data from the Phase 2 study are expected in H1 2025

TRX01 (ratutrelvir): a ritonavir-free Mpro protease inhibitor for COVID19: Phase 1

· Potent oral inhibitor of SARS-CoV-2 Mpro (3CL protease), effective against the original, delta, and omicron variants of SARS-CoV-2, that does not require co-administration with ritonavir, reducing the risk of drug-drug interactions. Preclinical data support once-daily dosing for 10days which could overcome viral rebound seen with other agents.

· We are in the process of conducting a Phase 1 first-in-human single ascending dose/multiple ascending dose (SAD/MAD) study in normal volunteers. The second dosing cohort is underway and topline data are expected H2 2024. A Phase 2 study is also planned to begin in H2 2024 in patients with moderate to severe COVID19. Topline data are expected H1 2025

Narazaciclib: CDK 4+ to treat solid tumors: Phase 1/2

· Available preclinical and clinical data suggest that narazaciclib is active in numerous tumor types, inhibiting CDK 2/4/6, CSF1R and ARK 5/NUAK1. Preclinical studies also showed reduced neutropenia, as compared to palbociclib, and inhibition of palbociclib resistant cancer cells.

· A dose escalation study to define the recommended Phase 2 dose (RP2D) recently enrolled the last cohort. A review of the clinical and PK/PD data is underway. We intend to utilize these data to define the clinical strategy, including selection of a lead indication and next steps in its development.

First Quarter 2024 Financial Results

Cash and cash equivalents as of March 31, 2024, were $16.4 million, compared with $20.8 million as of December 31, 2023.

In April 2024, the Company raised gross proceeds of $14 million from the sale of common and preferred stock to TPAV, LLC, an affiliate of Torrey Pines, and OrbiMed Private Investments VIII, LP, an affiliate of OrbiMed Advisors.

The Company believes that its cash and cash equivalents will be sufficient to fund ongoing clinical trials and business operations into the fourth quarter of 2024.

Revenue was fifty-six thousand dollars for the first quarter of 2024, consistent with the same period in 2023.

General and administrative (G&A) expenses were $3.4 million for the first quarter of 2024, compared with $2.1 million for the same period in 2023. The increase in G&A expenses was caused by higher legal and professional fees related to the Trawsfynydd acquisition on April 1, 2024, partially offset by lower bonus accrual as well as lower insurance, meeting, and public company expenses.

Research and development (R&D) expenses were $1.9 million for the first quarter of 2024, compared with $4.1 million for the same period in 2023. The decrease was primarily caused by lower costs related to narazaciclib drug substance and drug product manufacturing, a reduction in clinical development and consulting costs and lower personnel expenses due to lower bonus accrual.

Net loss for the first quarter of 2024 was $5.0 million, or $0.24 per share on 20.8 million weighted average shares outstanding, compared with a net loss of $5.8 million, or $0.28 per share for the same period in 2023, based on 20.8 million weighted average shares outstanding.