On April 23, 2025 Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, reported the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application of VS-7375, an oral KRAS G12D (ON/OFF) inhibitor for clinical evaluation (Press release, Verastem, APR 23, 2025, View Source [SID1234652065]). The Company expects to initiate a Phase 1/2a study in mid-2025 with plans for multiple expansion cohorts, including combinations, in advanced solid tumors, such as pancreatic cancer, colorectal cancer, and non-small cell lung cancer.

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The Company also announced the acceptance of an abstract, by our partner GenFleet Therapeutics, for rapid oral presentation of the preliminary dose escalation phase of the Phase 1/2 study of VS-7375 (also known as GFH375) conducted by GenFleet at the upcoming 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held on May 30-June 3, 2025, in Chicago, IL. The abstract is under embargo until May 22, 2025, at 5:00 pm EDT, when additional data will be released.

"We’re excited to advance the clinical program for VS-7375 in the U.S. and build on the initial dose escalation work conducted by GenFleet in China that demonstrated oral bioavailability and no dose-limiting toxicities across six dose levels, with partial responses achieved among multiple patients with both pancreatic and advanced lung cancers," said Dan Paterson, president and chief executive officer of Verastem Oncology. "We believe there remains a significant opportunity to improve on the efficacy seen to date with other KRAS G12D-selective agents. VS-7375’s dual inhibition of both the ON/OFF states has the potential to drive deep and durable cancer responses and allow for better combinability with other agents. We look forward to our partner GenFleet’s oral presentation that will include updated safety and efficacy data from the Phase 1 study at the ASCO (Free ASCO Whitepaper) annual meeting."

The Phase 1/2a study will be conducted in the U.S., with the potential to expand globally, and will evaluate the safety and efficacy of VS-7375 in patients with advanced KRAS G12D mutant solid tumors. The starting dose for the Phase 1 study is based on an efficacious dose identified in the initial data from the GenFleet study to accelerate the trial’s progress. Verastem plans to dose escalate across levels where cancer responses were observed in GenFleet’s study and will assess in the Phase 2a portion the efficacy and safety of VS-7375, both as monotherapy and in combination, in patients with advanced solid tumors, such as pancreatic, colorectal, and non-small cell lung cancers.

ASCO 2025 Presentation Details:

The abstract is under embargo until May 22, 2025, at 5:00 pm EDT.

Title: A First-in-Human Phase I/II Study of GFH375, a Highly Selective and Potent Oral KRAS G12D Inhibitor in Patients with KRAS G12D Mutant Advanced Solid Tumors
Abstract Number: 3013
Session: Rapid Oral Abstract Sessions: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Session Date/Time: Monday, June 2, 2025, from 8:00 am to 9:30 am CDT
About KRAS G12D

KRAS G12D represents 26% of all KRAS mutations, making it the most prevalent KRAS mutation in human cancers. The KRAS G12D mutation occurs most commonly in pancreatic (37%), colorectal (12.5%), endometrial (8%), and non-small cell lung (5%) cancers. Currently, no therapies are approved by the U.S. Food and Drug Administration specifically targeting KRAS G12D mutations in cancer.

About VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor

VS-7375 is a potential best-in-class, potent, and selective oral KRAS G12D dual ON/OFF inhibitor. VS-7375 is the lead program from the Verastem Oncology discovery and development collaboration with GenFleet Therapeutics. Verastem announced in April 2025 that the U.S. Investigational New Drug (IND) application for VS-7375 was cleared and plans to initiate a Phase 1/2a clinical trial in mid-2025. GenFleet’s IND for VS-7375 (known as GFH375 in China) was approved in China in June 2024, and the first patient was dosed in a Phase 1/2 study in July 2024.

On April 23, 2025 Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology, reported three upcoming presentations at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 30 – June 3 in Chicago, Illinois (Press release, Agenus, APR 23, 2025, View Source [SID1234652064]). A poster presentation will highlight new translational data monitoring induced T-cell dynamics from the botensilimab and balstilimab (BOT/BAL) program in mismatch repair–proficient (pMMR)/microsatellite stable (MSS) metastatic colorectal cancer (mCRC). In addition, two trials-in-progress presentations will showcase the design and scientific rationale of ongoing clinical studies evaluating botensilimab-based combinations in advanced pancreatic cancer.

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Presentation Details:

Presentation Title: Monitoring botensilimab and balstilimab induced T cell dynamics in refractory mismatch repair proficient metastatic colorectal cancer.
Presenting Author: Dr. Gertjan Rasschaert
Poster Session: Gastrointestinal Cancer—Colorectal and Anal
Session Date and Time: May 31st, 2025; 9:00 AM-12:00 PM CDT
Abstract Number: 3527
Poster Number: 196

Presentation Title: A phase 2 study of botensilimab and AGEN1423, an anti-CD73-TGFβ-trap bifunctional antibody, with or without chemotherapy in subjects with advanced pancreatic cancer. (NCT05632328)
Presenting Author: Dr. Bruno Bockorny
Poster Session: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
Session Date and Time: May 31st, 2025; 9:00 AM-12:00 PM CDT
Abstract Number: TPS423
Poster Number: 506a

Presentation Title: An open-label, phase 1 trial with expansion cohort of botensilimab (AGEN1181) + balstilimab (AGEN2034) + nab-paclitaxel + gemcitabine + cisplatin + chloroquine + celecoxib in adult patients with previously untreated metastatic pancreatic cancer. (NCT06076837)
Presenting Author: Dr. Dan Van Hoff
Poster Session: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
Session Date and Time: May 31st, 2025; 9:00 AM-12:00 PM CDT
Abstract Number: 507b
Poster Number: TPS4234

About Botensilimab (BOT)

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.

Botensilimab alone, or in combination with Agenus’ investigational PD-1 antibody, balstilimab, has shown clinical responses across nine metastatic, late-line cancers. Approximately 1,100 patients have been treated across the botensilimab/balstilimab program in phase 1 and phase 2 clinical trials. For more information about botensilimab trials, visit www.clinicaltrials.gov.

About Balstilimab (BAL)

Balstilimab is a novel, fully human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1 (programmed cell death protein 1) from interacting with its ligands PD-L1 and PD-L2. It has been evaluated in >900 patients to date and has demonstrated clinical activity and a favorable tolerability profile in several tumor types.

On April 23, 2025 Bio-Techne Corporation (NASDAQ: TECH) reported it will showcase its latest advancements in cancer research tools at the 2025 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, taking place April 25-30 at McCormick Place Convention Center in Chicago, IL (Press release, Bio-Techne, APR 23, 2025, View Source [SID1234652063]). Bio-Techne’s booths will feature its oncology research portfolio spanning early discovery, translational research, and cell and gene therapy development.

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AACR is recognized as one of the world’s most influential cancer research conferences, convening global experts to exchange groundbreaking discoveries and innovations in cancer science and medicine. Bio-Techne will engage with these researchers and industry professionals to highlight its cutting-edge solutions that empower scientific progress across the oncology landscape.

At booth #3049, Bio-Techne will feature its comprehensive portfolio, including high-performance proteins, antibodies, small molecules, cell culture reagents, immunoassays, automated proteomic analysis platforms, and spatial multiomic solutions. These technologies are designed to drive advancements in oncology research, accelerate immune cell therapy development, and support the creation of next-generation diagnostic tools. Advanced Cell Diagnostics (ACD), a Bio-Techne brand, will feature its complete solution for accelerating spatial multiomic research, including its protease-free workflows across the RNAscope spatial portfolio. To support the expanded capabilities for multiomic detection on the Leica Bond RX, we will showcase scientific posters and an evening reception on April 27th co-hosted by ACD, Leica Biosystems and Indica Labs.

At booth #3249, Lunaphore, one of Bio-Techne’s spatial biology brands, will present its enhanced end-to-end portfolio that offers high-value spatial biology solutions for the translational research community. Lunaphore’s latest advancements include the launch of the fully-automated, same-section multiomics application for fixed-frozen tissue. Additionally, Lunaphore will bring together the spatial biology community at an exclusive dinner reception on April 28, held in affiliation with AACR (Free AACR Whitepaper), providing a unique opportunity to connect with leaders in the field of multiomics, and explore Lunaphore’s upcoming releases, including innovative tools for HORIZON image analysis software.

"As cancer research advances at an unprecedented pace, Bio-Techne remains committed to providing scientists with the tools they need to drive discovery and innovation," said Kim Kelderman, Bio-Techne’s President and Chief Executive Officer. "Our solutions empower researchers at every stage—from fundamental science to translational applications—helping to shape the future of precision medicine and next-generation cancer therapies. We are excited to connect with the scientific community at AACR (Free AACR Whitepaper) to explore new possibilities in the fight against cancer."

Bio-Techne Presentations and Poster Presentations:

Protein Quantitation for Characterization of Potential Cancer Therapeutics in Early Discovery and Mechanism of Action Insights in Translational Studies
Tuesday, April 29 | 10:00 – 11:00 AM
Exhibit Hall, Spotlight Theater A

Evaluation of IDH1, EGFR, IGF1R, and Ki67 Biomarkers in Glioblastoma Using Lunaphore COMET Platform
Monday, April 28 | 9:00 AM – 12:00 PM
Poster Board 29 | Abstract 2093
Presenter: Jennifer Jones, Sr. Product Marketing Specialist

Multiomic Co-Detection of Proteins, mRNA and Protein-Protein Interactions Reveal PD1-PDL1 Interactions in the Tumor Microenvironment of Bladder Cancer Patients Treated with anti-PD-L1
Monday, April 28 | 9:00 AM – 12:00 PM
Poster Board 3 | Abstract 2179
Presenter: Ge-Ah Kim, Sr. Scientist

Multiomic Fluorescent Co-Detection of Biomarkers in the Tumor Microenvironment Using a New RNAscope Assay on Roche DISCOVERY ULTRA
Monday, April 28 | 9:00 AM – 12:00 PM
Poster Board 28 | Abstract 2092
Presenter: Anushka Dikshit, Sr. Applications Manager

Identifying Immune Cell Phenotypes and Their Function by Using High Throughput Spatial Multiomics
Tuesday, April 29 | 2:00 PM – 5:00 PM
Poster Board 24 | Abstract 5318
Presenter: Anushka Dikshit, Sr. Applications Manager

Profiling the Tumor-Immune Landscape with a Same-Section Multiomics Assay
Tuesday, April 29 | 2:00 PM – 5:00 PM
Poster Board 10 | Abstract 5304
Presenter: Jacqueline Giliberti, PhD, Product Manager

Spatial Multiomics Reveals T-cell Activation and Exhaustion States in the Tumor Microenvironment
Wednesday, April 30 | 9:00 AM – 12:00 PM
Poster Board 12 | Abstract 6471
Presenter: Anushka Dikshit, Sr. Applications Manager

Poster Presentation In Collaboration
A Novel Protease-Free Workflow for Spatial Multiomics Analysis of the Tumor Microenvironment in Breast Cancer
Poster Board 21 | Abstract 170
Presenter: Dr. Tanni Rahman, HistoWiz

Dissecting the Immune Landscape in EBV+ Classical Hodgkin Lymphoma Following IL-23 Inhibition Using Single-Cell Hyperplex Immunofluorescence Analysis: A Case Report
Wednesday, April 30 | 9:00 AM – 12:00 PM
Poster Board 9 | Abstract 6468
Presenter: Dr. Janusz Franco-Barraza, Fox Chase Cancer Center

Translating clinically Validated Antibodies into a Multiplexed Immunofluorescent Panel for the Spatial Profiling of Lymphoid Malignancies
Monday, April 28 | 2:00 PM – 5:00 PM
Poster Board 4 | Abstract 2525
Presenter: Dr. Tania Pannellini, European Institute of Oncology (EIO)

For more information about Bio-Techne’s presence at AACR (Free AACR Whitepaper) 2025, visit View Source

On April 23, 2025 ImCheck Therapeutics reported an oral presentation at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2025, taking place from May 30 to June 3, in Chicago, Illinois, USA (Press release, ImCheck Therapeutics, APR 23, 2025, View Source [SID1234652062]). The presentation will focus on results from its ongoing open-label, randomized Phase I/II study EVICTION, including updated efficacy, safety and dose-selection data on the company’s lead γ9δ2 T-cell activator, ICT01, in combination with azacitidine and venetoclax for the treatment of older or unfit patients with newly diagnosed acute myeloid leukemia (AML).

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Details of the oral presentation at ASCO (Free ASCO Whitepaper) 2025 are:

Abstract Title: "γ9δ2 T-cell activation with ICT01 combined with azacitidine-venetoclax for older/unfit adults with newly diagnosed AML: Preliminary efficacy and dose selection in phase 1/2 study EVICTION"

Session: Oral Abstract Session S100a – Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes, and Allotransplant

Date: Monday, June 2, 2025

Time: 5:12 p.m.- 5:24 p.m. Central Time

The ASCO (Free ASCO Whitepaper) presentation will be available on ImCheck’s corporate website after the presentation has been held.

On April 23, 2025 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, reported that it will be delivering a rapid oral presentation of randomized Phase I trial data of individualized neoantigen therapeutic cancer vaccine TG4050 in head and neck cancer at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (Press release, Transgene, APR 23, 2025, View Source [SID1234652061]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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A rapid oral presentation is part of a formal session, with a six-minute oral presentation format. It aims at sharing clinical data that stood out among many submissions.

The company will also present a poster on randomized Phase II data of TG4001 in combination with avelumab in the cervical cancer subgroup.

The 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), annual meeting will take place in Chicago from May 30 to June 3, 2025.

TG4050— Rapid oral presentation details:

Title: "Randomized Phase I trial of adjuvant personalized cancer vaccine TG4050 in resected locally advanced head and neck squamous cell carcinoma (HNSCC) patients."

· Session title: Rapid Oral Abstract Session

· Date and Time: Sunday, June 1, 12:06 p.m. CDT

· First Author: Prof. C. Le Tourneau

· Abstract Number: 6016

TG4050 is an individualized neoantigen therapeutic cancer vaccine being developed for solid tumors which is based on Transgene’s myvac technology and powered by NEC’s longstanding artificial intelligence and machine learning expertise. TG4050 is being evaluated in a randomized multicenter Phase I/II clinical trial as a single agent in the adjuvant treatment of HPV-negative head and neck cancers (NCT04183166). Transgene intends to present 24-month follow-up data from patients enrolled in the Phase I part of the trial. Patients are currently being enrolled in the Phase II part of this trial.

TG4001— Poster presentation details:

Title: "Randomized Phase II trial evaluating the combination of TG4001, an HPV16 therapeutic cancer vaccine and avelumab in patients with immunotherapy-naïve recurrent and/or metastatic (R/M) HPV16-positive cervical or anogenital cancer."

· Session title: Developmental Therapeutics ̶ Immunotherapy

· Date and Time: Monday, June 2, 1:30 p.m. CDT

· First author: Prof. C. Le Tourneau

· Abstract number: 2638

The abstracts will be available on the ASCO (Free ASCO Whitepaper) website on May 22, 2025, at 5 p.m. ET.