On August 29, 2025 Genor Biopharma reported interim report 2025 (Presentation, Genor Biopharma, AUG 29, 2025, View Source [SID1234656306]).

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On August 29, 2025 Jacobio Pharma (1167.HK) reported its interim results for the six months ended June 30, 2025 (Press release, Jacobio Pharmaceuticals, AUG 29, 2025, View Source [SID1234655592]).

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During the reporting period, the Company achieved revenue of RMB45.7 million, representing a 100% increase compared with the same period in 2024. Research and development (R&D) expenses amounted to RMB93.2 million. The net loss for the first half of 2025 was RMB59.0 million, narrowing by 65.1% compared with the same period in 2024. As of June 30, 2025, Jacobio maintained cash and bank balances, and investments in capital protected structure deposits, totaling RMB1,07billion, along with RMB270 million bank credit available which provides sufficient and stable liquidity to support our R&D activities.

Dr. Yinxiang Wang, Chairman and Chief Executive Officer of Jacobio, said: "In the first half of 2025, we reached an important milestone with the approval and launch of Glecirasib in China. Through our collaboration with business partners, we significantly alleviated the pressure of R&D investment, enabling the Company to focus resources on advancing our pan-KRAS inhibitor and ADC pipeline. Looking forward, we remain committed to a transformative innovation strategy, working hand in hand with global partners to accelerate the development of breakthrough therapies and deliver benefits to more cancer patients."

Accelerated Progress in Core Programs

JAB-23E73 (pan-KRAS inhibitor):

The dose-escalation portion of the phase I trials are onging in China and the U.S, respectively.
Safety profile: low incidence of skin toxicity (rash observed in 10%, all Grade 1) no Grade ≥3 liver toxicity reported to date.
Favorable PK with predicted exposure.
Multiple partial responses have been observed to date.
Preclinical data to be presented at the AACR (Free AACR Whitepaper)-NCI-EORTC International Conference in October 2025.
Phase I results readout expected in the first half of 2026.
JAB-BX600 (First-in-class EGFR-KRAS G12Di ADC):

This program uses a highly potent KRAS G12D inhibitor as the payload.
The candidate demonstrates picomolar (pM)-level cellular activity, compared with nanomolar (nM) typically achieved by oral small molecules.
Unlike oral small molecules usually achieve tumor drug concentrations 1–10x higher than plasma levels, the JAB-BX 600 delivers a KRAS G12D inhibitor at 1,000 x higher in tumor, resulting in a substantially wider therapeutic window.
The KRAS G12D inhibitor and EGFR antibody have synergistic effect and durable anti-tumor activity.
IND submission planned for the second half of 2026.
Glecirasib (JAB-21822, KRAS G12C inhibitor):

Approved by China’s NMPA in May 2025 for ≥2L KRAS G12C mutant NSCLC, successfully launched in China.
Triggered a RMB50 million milestone payment in addition to the RMB200 million upfront received in 2024.
The full second-line NSCLC dataset has been published in Nature Medicine (Impact Factor: 50).
Phase I/II data for the combination with SHP2 inhibitor has been accepted by a top-tier academic journal, with publication expected in H2 2025.
Sitneprotafib (JAB-3312, SHP2 inhibitor):

Ongoing Phase III registration trial in combination with Glecirasib as first-line NSCLC treatment in China.
Translational research published in Clinical Cancer Research (Impact Factor: 10.2), demonstrating significant synergy with Glecirasib.
JAB-BX467 (HER2-STING iADC):

A HER2-targeted ADC carrying a STING agonist, designed to convert "cold tumors" into "hot tumors" and address the 70% of patients unresponsive to PD-1 inhibitors.
Currently in IND-enabling stage, with IND filing planned for H2 2026.

On August 29, 2025 Foresight Diagnostics ("Foresight") reported that it has entered into a limited licensing agreement with Roche Molecular Systems and Roche Sequencing Systems (together, "Roche") related to Foresight’s patented PhasED-Seq technology (Press release, Hoffmann-La Roche, AUG 29, 2025, View Source [SID1234655591]). The agreement closes the litigation between the parties, with all claims against Foresight, its founders, and Stanford University dismissed with prejudice.

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Under the terms of the agreement, Foresight has granted Roche a limited royalty-bearing non-exclusive sublicense under certain patents for use of PhasED-Seq for the development of in vitro diagnostic (IVD) kits for Non-Hodgkin’s Lymphoma (NHL).

Intellectual property rights in the PhasED-Seq technology remain with Stanford University, with Foresight continuing to hold the exclusive license to the patents for all uses and geographies.

"We are pleased to have resolved our differences with Roche and to move forward with this licensing agreement, which provides Roche with tailored rights in the field of Non-Hodgkin’s Lymphoma," said Jake Chabon, PhD, Chief Executive Officer of Foresight Diagnostics. "This resolution allows Foresight to remain focused on our mission to advance cutting-edge diagnostics aimed at improving outcomes for cancer patients worldwide."

On August 29, 2025 IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a leading precision medicine oncology company, reported that an abstract with data from the company’s single-arm, Phase 1/2 trial of darovasertib in combination with crizotinib in first-line metastatic uveal melanoma (mUM) was accepted for an oral presentation at the 2025 Society for Melanoma Research Congress (SMR), taking place on October 25-28 in Amsterdam (Press release, Ideaya Biosciences, AUG 29, 2025, View Source;crizotinib-combination-in-metastatic-uveal-melanoma-at-the-2025-society-for-melanoma-research-congress-302542236.html [SID1234655590]). The presentation will include data from over 40 patients in the trial, including the first reported median overall survival (OS) data for the combination of darovasertib and crizotinib in mUM. A detailed summary of the data from the abstract will be shared at a later date.

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Details of the Presentation are as follows:

Title (Abstract #209): First reported overall survival results from a phase 1/2 study of darovasertib (OptimUM-01) plus crizotinib as first-line treatment for metastatic uveal melanoma

Presenter: Dr. Meredith McKean, MD, MPH; Director, Melanoma and Skin Cancer Research at Sarah Cannon Research Institute

On August 29, 2025 BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, reported positive topline results from a Phase 1/2 study (BGB-11417-201) of sonrotoclax, a next-generation and potentially best-in-class investigational BCL2 inhibitor, in adult patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL), following treatment with a Bruton’s tyrosine kinase inhibitor (BTKi) and anti-CD20 therapy (Press release, BeOne Medicines, AUG 29, 2025, View Source [SID1234655589]). BeOne plans to present the full data at an upcoming medical meeting.

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"For people with relapsed or refractory mantle cell lymphoma, the disease is aggressive, the treatment landscape fragmented, and the outcomes unacceptably poor. These topline results for sonrotoclax underscore its potential to deliver meaningful and durable responses and offer the first BCL2 inhibitor for patients with R/R MCL, if approved," said Lai Wang, PhD, Global Head of R&D, BeOne Medicines. "These data add to the remarkable progress we’ve seen over the past five years in treating B-cell malignancies, and I’m proud that BeOne has played an impactful role in that transformation with our leading BTK inhibitor."

The BGB-11417-201 (NCT05471843) study is a global, multicenter, single-arm, open-label, Phase 1/2 study, which enrolled 125 adult patients with R/R MCL post-treatment with anti-CD20 therapy and a BTK inhibitor. In Part 1, 22 patients received daily treatment with either 160 mg or 320 mg of sonrotoclax to assess the safety and tolerability of sonrotoclax and identify the recommended dose for Part 2. In Part 2, 103 patients were enrolled to receive the recommended daily dose of sonrotoclax (320 mg), following ramp-up, to assess the efficacy and safety of sonrotoclax.

The study met its primary endpoint of overall response rate (ORR) as assessed by an independent review committee (IRC), demonstrating that treatment with sonrotoclax elicited clinically meaningful responses in this heavily pretreated population. The study also showed promising results across several secondary efficacy endpoints, including complete response (CR) rate, duration of response (DOR) and progression-free survival (PFS). The safety profile was generally well-tolerated, and the toxicities were manageable. These findings represent another important milestone in BeOne’s hematology franchise, which now includes three foundational medicines designed to address the ongoing and evolving needs of patients across B-cell malignancies.

BeOne plans to submit these data to the U.S. Food and Drug Administration (FDA) and other global regulatory bodies for the potential approval of sonrotoclax in R/R MCL. New drug applications for sonrotoclax for the treatment of R/R MCL and R/R CLL/SLL have also been accepted and are under review by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) for potential accelerated approval. The Phase 3 confirmatory CELESTIAL-RR MCL study (BGB-11417-302; NCT06742996) is underway, with the first patient enrolled earlier this year. The U.S. FDA previously granted sonrotoclax Orphan Drug Designation for the treatment of patients with MCL.

About Mantle Cell Lymphoma
Mantle cell lymphoma (MCL) is a rare subtype of aggressive B-cell non-Hodgkin lymphoma (NHL)1 that develops in B-cells located in the mantle zone of the lymph nodes. MCL accounts for approximately 5% of all NHL cases globally2, affecting an estimated 28,000 people3. MCL is often diagnosed at advanced stages4 and nearly all MCL patients will eventually develop refractory or relapsed (R/R) disease.5 The five-year survival rate for MCL is approximately 50%, reflecting the urgent need for new therapeutic options.6

About Sonrotoclax (BGB-11417)
Sonrotoclax is a next-generation and potential best-in-class investigational inhibitor of B-cell lymphoma 2 (BCL2), which is one of several proteins that help cancer cells survive. It is part of a group of drugs called BH3 mimetics, which mimic natural cell death signals. Studies in the lab and during early drug development have shown that sonrotoclax is a highly potent and specific inhibitor of BCL2 with a short half-life and no drug accumulation. Sonrotoclax has shown promising clinical activity across a range of B-cell malignancies, and nearly 2,000 patients have been enrolled to date across the broad global development program. The U.S. Food and Drug Administration (FDA) granted sonrotoclax Fast Track Designation for the treatment of adult patients with mantle cell lymphoma (MCL) and Waldenström macroglobulinemia (WM).