On November 4, 2025 Grit Biotherapeutics Co., Ltd. ("Grit Bio"), a leading clinical-stage biopharmaceutical company pioneering next-generation immunotherapies, reported that its groundbreaking GT801 in vivo CAR-T program has been selected for an oral presentation at the upcoming 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, to be held December 6–9, 2025, in Orlando, Florida, USA.

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The abstract, titled "Precision In Vivo CAR-T Generation via CLAMP-Enabled mRNA Delivery: Toward Scalable and Translatable Cell Therapy," was accepted in the CAR-T Cell Therapies: Basic and Translational session. The presentation will be delivered by Professor Pin Wang, Chief Scientific Officer of Grit Biotherapeutics, on Saturday, December 6, 9:30–9:45 AM (local time) at the OCCC – Sunburst Room (W340).

GT801 is an innovative anti-CD19 in vivo CAR-T candidate developed using T-cell-targeted lipid nanoparticles (T-LNPs) encapsulating optimized mRNA. Grit Bio leveraged the proprietary CLAMP (Controllable Ligand Attachment Modification and Purification) technology to achieve site-specific antibody conjugation and precise ligand density control. This approach allows selective T-cell targeting, minimal off-target uptake, and robust, durable CAR expression following systemic administration.

In preclinical studies, GT801 demonstrated:

>95% B-cell clearance in humanized PBMC mouse models at doses as low as 0.01 mg/kg;

>80% CAR expression across tissue-resident T cells with <1% off-target delivery to myeloid and hepatic cells;

>30-fold in vivo expansion of CAR-T cells with minimal cytokine release (IL-6, TNF-α), supporting the safety and feasibility of repeat dosing.
Preliminary clinical data further validate efficient CAR expression, deep B-cell depletion, and repeat-dose tolerability, highlighting GT801’s strong potential as a scalable, off-the-shelf immunotherapy candidate.

"The invitation to present at ASH (Free ASH Whitepaper) 2025 highlights international recognition of Grit Bio’s leadership in advancing in vivo CAR-T innovation," said Dr. Yarong Liu, Chairman and CEO of Grit Biotherapeutics. "Our GT801 platform represents a paradigm shift in cell therapy—transforming complex ex vivo manufacturing into a simple, repeatable, and scalable in vivo process. We are eager to share our latest clinical data and explore global partnerships that accelerate the translation of this breakthrough technology to patients worldwide."

(Press release, Grit Bio, NOV 4, 2025, View Source [SID1234659395])

On November 4, 2025 BullFrog AI Holdings, Inc. (NASDAQ: BFRG; BFRGW) ("BullFrog AI" or the "Company"), a technology-enabled drug development company using artificial intelligence ("AI") and machine learning to enable the successful development of pharmaceuticals and biologics, reported that an abstract submitted in collaboration with Eleison Pharmaceuticals has been accepted for presentation at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO GI), to be held January 8–10, 2026, in San Francisco, California.

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The abstract, titled "Data-driven subtyping and differential glufosfamide benefit in pancreatic adenocarcinoma," will be featured in Poster Session B on January 9. It will also be published in the ASCO (Free ASCO Whitepaper) GI 2026 online proceedings and subsequently appear in the Journal of Clinical Oncology (JCO) supplement corresponding to the symposium.

Co-authored by Richard Kim, MD, Service Chief of Medical Gastrointestinal Oncology and Senior Member in the Gastrointestinal Oncology Department at Moffitt Cancer Center, Nikolas Naleid, MD, PharmD, Hematology/Oncology Fellow at Moffitt Cancer Center, Eleison Pharmaceuticals and BullFrog AI, the study explores data-driven precision-oncology approaches to identify patient subtypes that may demonstrate enhanced response to glufosfamide, an investigational chemotherapeutic agent for pancreatic cancer. The research leverages BullFrog AI’s bfLEAP and bfPREP platforms to analyze complex clinical datasets and uncover biologically meaningful patient clusters.

"This acceptance by ASCO (Free ASCO Whitepaper) underscores the growing recognition of AI’s ability to transform oncology research," said Vin Singh, CEO of BullFrog AI. "Our collaboration with Eleison Pharmaceuticals clearly demonstrates how causal AI can help reveal critical insights that guide more precise, effective treatment strategies for difficult cancers like pancreatic adenocarcinoma."

Results from the study will be presented during the poster session, and in accordance with ASCO (Free ASCO Whitepaper)’s embargo policy, no additional data will be publicly disclosed until the official embargo lifts prior to the presentation.

(Press release, Bullfrog AI, NOV 4, 2025, View Source [SID1234659346])

On November 4, 2025 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported that the company, through a subsidiary (Prometheus BioSciences), has reached an agreement with Dr. Falk Pharma GmbH (Falk) to discontinue an existing contract concerning co-development and co-commercialization rights in certain territories for MK-8690 (formerly PRA-052), and for Merck to assume full responsibility for the development program going forward. MK-8690 is an investigational anti-CD30 ligand monoclonal antibody being evaluated by Merck in an early-stage clinical trial.

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Under the terms of the agreement, Prometheus BioSciences (Prometheus) and Falk have discontinued their collaboration based on their existing co-development contract resulting in Prometheus having secured global rights to MK-8690. In exchange, Falk will receive a $150 million upfront payment and is eligible to receive a payment associated with a development milestone as well as royalties on sales in certain territories. The original contract between Falk and Prometheus was signed in 2020. Merck subsequently acquired Prometheus in 2023.

As a result of the transaction with Falk, Merck will record a pre-tax charge to research and development expenses of $150 million, or approximately $0.05 per share, in both its GAAP and non-GAAP fourth quarter results.

(Press release, Merck & Co, NOV 4, 2025, View Source [SID1234659362])

On November 4, 2025 Werewolf Therapeutics, Inc. (the "Company" or "Werewolf") (Nasdaq: HOWL), an innovative biopharmaceutical company pioneering the development of conditionally activated therapeutics engineered to stimulate the body’s immune system for the treatment of cancer and other immune-mediated conditions, reported a business update and announced financial results for the third quarter ended September 30, 2025.

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"Werewolf is delivering on the promise of its proprietary PREDATOR platform of conditionally activated immune therapeutics, marked by significant progress for our lead INDUKINETM clinical programs, WTX-124 and WTX-330, and our first INDUCER T-cell engager candidate, WTX-1011," said Daniel J. Hicklin, Ph.D., President and Chief Executive Officer of Werewolf. "For WTX-124, which received Fast Track Designation last month, we plan to provide an update later in the fourth quarter of 2025 on the path to a registration-enabling trial based on interim Phase 1/1b clinical trial data and feedback from an End of Phase 1 meeting with the FDA. At the same time, we plan to provide an update on the current Phase 1b/2 clinical trial of WTX-330 and a potential development plan for this program. Finally, we continue to make progress in IND-enabling studies for WTX-1011, our first INDUCER T cell Engager development candidate, and plan to nominate a differentiated target candidate by year-end."

Recent Highlights and Upcoming Milestones
Clinical-Stage INDUKINE Molecules:
•WTX-124: a systemically delivered, conditionally activated Interleukin-2 (IL-2) INDUKINE molecule being developed as monotherapy and in combination with pembrolizumab in multiple solid tumor types.
◦Fast Track Designation received from the US FDA for the use of WTX-124 for the potential treatment of patients with locally advanced or metastatic cutaneous melanoma after standard of care immunotherapy. Fast Track Designation is intended to expedite the development of drugs to address a serious unmet medical need and provide opportunities for frequent FDA interactions.
◦All expansion arms are either actively enrolling patients or fully enrolled in the ongoing Phase 1/1b clinical trial at a recommended dose of 18 mg administered intravenously every two weeks (IV Q2W). Enrollment is expected to be completed in all arms by the first quarter of 2026.
◦In the fourth quarter of 2025, Werewolf plans to release interim data from the monotherapy and combination expansion arms and to provide feedback from the Company’s End of Phase 1 meeting with the FDA. These inputs are expected to provide insight into potential registrational pathways for WTX-124 in advanced or metastatic cutaneous melanoma.
◦At the 2025 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 40th Annual Meeting, the Company will present a poster entitled: "Pharmacokinetic insight into the IL-2 INDUKINE prodrug WTX-124: real-time assessment of tumor-specific activation and immune modulation."

•WTX-330: a systemically delivered, conditionally activated Interleukin-12 (IL-12) INDUKINE molecule being developed in advanced or metastatic solid tumors.
◦Actively enrolling in a Phase 1b/2 clinical trial (WTX-330×2102) in locally advanced or metastatic solid tumors. An update on the clinical trial is expected to be released in the fourth quarter of 2025, with guidance on potential further development plans.
◦At the 2025 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 40th Annual Meeting, the Company will present a poster entitled: "Sequential administration of WTX-124 and mWTX-330, IL-2 and IL-12 INDUKINE molecules, enhanced anti-tumor activity in mice bearing poorly immunogenic EMT6 tumors without systemic toxicity."
Preclinical-Stage INDUCER Molecules:
•WTX-1011: a potential first-in-class conditionally activated anti-STEAP1 T-cell engager to provide an improved therapeutic index.
◦STEAP1 is a promising prostate cancer target with limited expression in normal tissues, but notable toxicities are associated with existing anti-STEAP1 T-cell engager therapy.
◦Preclinical data demonstrated that PREDATOR masking technology successfully silenced peripheral activity and prevented cytokine release.
•Utilizing a novel and highly effective anti-CD3 masking strategy, Werewolf expects to nominate a differentiated target candidate in the fourth quarter of 2025.
•At the 2025 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 40th Annual Meeting, the Company will present a poster entitled: "Development of conditional T cell engagers (INDUCERTM molecules) with a highly effective masking approach to reduce dose-limiting cytokine release and off-target peripheral toxicity."
Preclinical-Stage INDUKINE Partnering Opportunities:
•Werewolf’s previously announced development candidates available for partnering include: WTX-712, its Interleukin-21 (IL-21) INDUKINE molecule, and WTX-518, its binding protein resistant Interleukin-18 (IL-18) INDUKINE molecule, each for the treatment of cancer, and WTX-921, a first-of-its-kind Interleukin-10 (IL-10) INDUKINE molecule for the treatment of inflammatory bowel disease (IBD) and potentially other inflammatory diseases.
Financial Results for the Third Quarter of 2025:
•Cash position: As of September 30, 2025, cash and cash equivalents were $65.7 million, compared to $77.6 million as of June 30, 2025. The Company believes its cash and cash equivalents as of September 30, 2025, will be sufficient to fund operational expenses and capital expenditure requirements into the fourth quarter of 2026.
•Research and development expenses: Research and development expenses were $11.6 million for the third quarter of 2025, compared to $12.5 million for the same period in 2024.
•General and administrative expenses: General and administrative expenses were $4.1 million for the third quarter of 2025, compared to $4.6 million for the same period in 2024.
•Net loss: Net loss was $16.4 million for the third quarter of 2025, compared to $16.7 million for the same period in 2024.

(Press release, Werewolf Therapeutics, NOV 4, 2025, View Source [SID1234659378])

On November 4, 2025 Inhibrx Biosciences, Inc. (Nasdaq: INBX) ("Inhibrx" or the "Company"), a clinical-stage biopharmaceutical company with a pipeline of novel biologic therapeutic candidates, reported it will be presenting at the following upcoming scientific conferences:

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21st Annual Industry/Academia Precision Oncology & Radmed Symposium
November 5th, 2025 – La Jolla, California

Title: DR5 Agonist Clinical Data in Chondrosarcoma, Colorectal Cancer and Ewings Sarcoma
Format: Presentation
Presenters: Josep Garcia, PhD, Executive Vice President, Chief Clinical Development Officer, Inhibrx; Katelyn Willis, PhD, Director, Biotherapeutics, Inhibrx
Date: Wednesday, November 5th, 2025
Time: 4:45 PM Eastern Standard Time
Location: The Alexandria at Torrey Pines, La Jolla, California

Connective Tissue Oncology Society (CTOS) 2025 Annual Meeting
November 12th – 15th, 2025 – Boca Raton, Florida

Title: The Tetravalent Death Receptor 5 (DR5) Agonist ozekibart (INBRX-109) in Conventional Chondrosarcoma: Results from the Randomized, Registrational, Phase 2 ChonDRAgon Study
Lead Author: Robin L. Jones, MD – Medical Oncology, The Royal Marsden and Institute of Cancer Research
Format: Presentation
Date: Friday, November 14th, 2025
Time: 8:30 AM – 10:00 AM Eastern Standard Time
Location: The Boca Raton, Boca Raton, Florida

Society for NeuroOncology (SNO) 2025 Annual Meeting
November 19th – 23rd, 2025 – Honolulu, Hawaii

Title: The Tetravalent Death Receptor 5 (DR5) agonist ozekibart (INBRX-109) exhibits anti-tumor activity in GBM models as a monotherapy and in combination with TMZ
Format: Poster Presentation
Date: Saturday, November 22nd, 2025
Time: 4:45 pm – 6:00 PM Eastern Standard Time
Location: Hawaii Convention Center, Honolulu, Hawaii; Kamehameha Exhibit Hall II & III

The presentation and poster will be accessible through a link on the investors’ section of Inhibrx’s website at View Source upon commencement of each event.

(Press release, Inhibrx, NOV 4, 2025, View Source [SID1234659396])