Mabwell Announces NMPA Approval to Initiate Clinical Trial of novel B7-H3-targeting ADC for Advanced Solid Tumors in Combination with PD-1 Inhibitor

On April 2, 2025 Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, reported that its novel B7-H3-targeting ADC (R&D code: 7MW3711) has been approved by the NMPA to enter Phase Ib/II clinical trial in combination with a PD-1 Inhibitor, with or without antitumor therapies, for the treatment of advanced solid tumors (Press release, Mabwell Biotech, APR 2, 2025, View Source [SID1234651767]).

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7MW3711 is developed by Mabwell’s Interchain-Disulfide Drug Conjugate (IDDC) platform and is pharmaceutical characterized as stable structure, homogeneous composition, high purity, and it is suitable for industrial scale-up. The approved phase Ib/II clinical trial aims to evaluate the safety, tolerability, preliminary efficacy and pharmacokinetic profile of 7MW3711 in combination with a PD-1 inhibitor, with or without antitumor therapies, in patients with advanced solid tumors. Previously, 7MW3711 has been approved for clinical studies in advanced solid tumors by the NMPA and the FDA, respectively, and was granted orphan drug designation (ODD) by the FDA for the treatment of small cell lung cancer.

Enliven Therapeutics Announces Poster Presentations at the 2025 AACR Annual Meeting

On April 2, 2025 Enliven Therapeutics, Inc. (Enliven or the Company) (Nasdaq: ELVN), a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics, reported the Company will present five posters at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, taking place April 25-30, 2025, in Chicago, Illinois (Press release, Enliven Therapeutics, APR 2, 2025, View Source [SID1234651766]).

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Poster Presentation Details

Abstract 4712 – ELVN-002, a potent, selective HER2 inhibitor with a differentiated binding mode conferring the potential for enhanced efficacy in combination with HER2-targeting antibody-drug conjugates
Date/Time: Tuesday, April 29, 2025, 9:00 a.m. – 12:00 p.m. CDT
Session: Targeted Therapies and Combinations 2
Location: Poster Section 34

Abstract 4361 – Development and application of a mechanistic pharmacokinetic pharmacodynamic (PKPD) model to predict anti-chronic myeloid leukemia (CML) effects of tyrosine kinase inhibitors
Date/Time: Tuesday, April 29, 2025, 9:00 a.m. – 12:00 p.m. CDT
Session: Pharmacokinetics and Pharmacodynamics of Cancer Therapeutics
Location: Poster Section 20

Abstract LB295 – ELV-3111, a type 1 pan-RAF inhibitor, that safely combines with MEK inhibitors for enhanced anti-tumor activity in NRAS and BRAF mutant cancers including the most common mechanisms of BRAF inhibitor clinical resistance
Date/Time: Tuesday, April 29, 2025, 9:00 a.m. – 12:00 p.m. CDT
Session: Late-Breaking Research: Experimental and Molecular Therapeutics 3
Location: Poster Section 52

Abstract LB294 – Mechanism of tumor-selective inhibition of dimeric RAF by a Type 1 RAF inhibitor
Date/Time: Tuesday, April 29, 2025, 9:00 a.m. – 12:00 p.m. CDT
Session: Late-Breaking Research: Experimental and Molecular Therapeutics 3
Location: Poster Section 52

Abstract 5515 – ELVN-001, a highly selective ATP-competitive ABL1 tyrosine kinase inhibitor for the treatment of chronic myeloid leukemia alone or in combination with asciminib
Date/Time: Tuesday, April 29, 2025, 2:00 p.m. – 5:00 p.m. CDT
Session: Drug Resistance in Molecular Targeted Therapies 3
Location: Poster Section 17

First dose level cleared in IV combination arm of Phase 1 onCARlytics trial

On April 2, 2025 Imugene Limited (ASX: IMU), a clinical-stage immuno oncology company, reported it has received clearance from the Cohort Review Committee (CRC) to escalate the dose level in the intravenous (IV) combination arm of its Phase 1 onCARlytics trial (Press release, Imugene, APR 2, 2025, View Source [SID1234651765]).

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With the successful completion of the safety observation period the IV combination arm will progress to a higher dose level.

Known as OASIS, the Phase 1 dose escalation onCARlytics clinical trial is targeting adult patients with advanced or metastatic solid tumours. The trial aims to evaluate the safety and efficacy of two routes of administration, intratumoural (IT) injection and intravenous (IV) infusion of either onCARlytics (a CD19-expressing oncolytic virus) alone, or in combination with CD19 targeting bispecific monoclonal antibody blinatumomab (Blincyto), which is a cancer immunotherapy.

OASIS is being conducted at seven sites in the U.S. including City of Hope, University of Cincinnati, MD Anderson Cancer Center, Emory, Roswell Park, University of Pittsburgh, Northwestern and University of Nebraska, with the potential to open a total of 10 sites to recruit approximately 40-50 patients with advanced solid cancers that have spread.

Imugene’s Managing Director and Chief Executive Officer, Leslie Chong, said:

"CD19 is a very significant target for blood cancers, but solid cancers like breast, lung or gastric do not have a common target on their cell surface, and therefore the aim with onCARlytics is to make available a target for CD19 therapies to treat these solid cancers. As the trial continues to progress and dose escalation is executed, we are eager to learn of the potential impact our treatment is having for patients in need."

Syndax Announces Participation at the Stifel 2025 Virtual Targeted Oncology Forum

On April 2, 2025 Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported that Michael A. Metzger, Chief Executive Officer of Syndax, as well as members of the Syndax management team, will participate in a fireside chat at the Stifel 2025 Virtual Targeted Oncology Forum on Wednesday, April 9, 2025, at 10:30 a.m. ET (Press release, Syndax, APR 2, 2025, View Source [SID1234651764]).

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A live webcast of the fireside chat will be available in the Investor section of the Company’s website at www.syndax.com, where a replay will also be available for a limited time.

Sensei Biotherapeutics to Participate in the Canaccord Genuity Horizons in Oncology Virtual Conference

On April 2, 2025 Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical stage biotechnology company focused on the discovery and development of next-generation therapeutics for cancer patients, reported that John Celebi, President and Chief Executive Officer, will participate in the New Radiotherapy and Targeted Therapy Approaches panel at the Canaccord Genuity Horizons in Oncology Virtual Conference on Monday, April 7 at 2:00 p.m. ET (Press release, Sensei Biotherapeutics, APR 2, 2025, View Source [SID1234651763]).

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