On September 25, 2025 TAE Life Sciences (TLS), a global leader in advancing next-generation boron neutron capture therapy (BNCT), and the University of Wisconsin–Madison (UW) reported to have signed a memorandum of understanding (MOU) announcing the intention to launch the first accelerator-based BNCT center in the United States (Press release, TAE Life Sciences, SEP 25, 2025, View Source [SID1234656249]). As part of this collaboration, UW would install the Alphabeam compact accelerator-based BNCT system developed by TAE Life Sciences. This significant milestone has the potential to pave the way for the adoption of BNCT in the United States.

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As part of this proposal, UW and TAE Life Sciences will collaborate on research and development of Alphabeam and novel boron-10 drugs through pre-clinical and clinical studies on several cancer indications with high unmet need, including brain and head and neck cancers. Available in Japan, and currently being evaluated in clinical trials in several other countries, BNCT is a cutting-edge cancer treatment that selectively targets cancer cells while minimizing harm to healthy tissue. TAE Life Sciences, with its compact accelerator-based neutron source and novel targeted boron-10 drug development, is the only company to have a comprehensive BNCT solution that replaces earlier challenges with nuclear reactor-based BNCT and has the potential to establish accelerator-based BNCT as a mainstay cancer treatment in the United States. This announcement further builds upon the success TAE Life Sciences has had deploying its technology globally. To date, the company has installed its neutron beam system in China’s Xiamen Humanity Hospital, which is currently running human clinical trials, and its Alphabeam will soon be installed at Italy’s National Center of Oncological Hadrontherapy (CNAO).

"Our collaboration with the esteemed University of Wisconsin–Madison underscores the growing momentum and recognition of BNCT as a transformative cancer therapy," stated Robert Hill, Chief Executive Officer of TAE Life Sciences. "By working closely with UW and the University of Wisconsin Carbone Cancer Center, a leading cancer center renowned for its commitment to innovation, we aim to revolutionize the landscape for cancer treatment, and make even the most challenging cancers treatable with minimal side effects."

Alphabeam is a patented neutron source developed for clinical BNCT that offers a breakthrough approach to cancer treatment. This combinational therapy utilizes targeted boron-10 drugs and low-energy neutrons to destroy tumors with no damage to healthy tissues. With this system, patients can undergo a short, minimally invasive treatment in just one or two sessions, providing a streamlined alternative to traditional cancer therapies.

"Today marks a significant milestone in the field of oncology in the United States," said Dr. Zachary Morris, Chair and Paul Harari Professor of Human Oncology at the University of Wisconsin School of Medicine and Public Health. "Our collaboration with TAE Life Sciences brings together our expertise in clinical radiation medicine, translational research, and theranostics with the accelerator-based BNCT system, enabling us to harness the full potential of this advanced cancer treatment. Together, we aim to accelerate the development and clinical implementation of this therapy, ultimately providing patients with what we hope will be a markedly improved cancer treatment option that is currently not available anywhere else in North America."

The Alphabeam BNCT system and novel boron-10 drugs are for research purposes and not available for sale.

About BNCT

BNCT is a combination treatment based on the reaction that occurs when a non-toxic compound containing boron-10 is irradiated with a low-energy neutron beam. BNCT differs radically from other radiation therapy and shows promise in becoming the next-generation cancer treatment. Research has shown BNCT has the capability of killing cancer cells that are resistant to traditional radiation therapy with limited harm to healthy tissue. Current advances in both neutron radiation technology and medicinal boron drug targeting are enabling BNCT’s potential to improve patient care while also improving treatment economics. To date, approximately 2,000 patients have been treated with BNCT at research sites worldwide.

On September 25, 2025 Verismo Therapeutics, a clinical-stage CAR T company developing a novel KIR-CAR platform technology, reported the successful manufacture of its first clinical cell product using lentiviral vector supplied by Miltenyi Bioindustry, a dedicated CDMO division of Miltenyi Biotec (Press release, Verismo Therapeutics, SEP 25, 2025, View Source [SID1234656248]). The batch was produced for STAR-101, a Phase 1 clinical trial evaluating Verismo’s lead pipeline SynKIR-110 targeting mesothelin. This marks a major milestone in the clinical trial and lays the groundwork for later-stage development of SynKIR-110 for the treatment of solid tumors.

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This collaboration ensures a reliable supply chain and is an important step in preparation for Phase 2 and beyond, including use in commercial applications. Miltenyi Bioindustry is a leader in translating gene-edited cell therapy products into the clinic, including design, construction, and production of lentiviral vectors, from research through GMP manufacturing.

"Our collaboration with Miltenyi Bioindustry plays a key role as we scale our programs," said Dr. Bryan Kim, CEO of Verismo Therapeutics. "This partnership reflects Verismo’s commitment to ensuring manufacturing continuity and Phase 2 clinical readiness."

Stefan Miltenyi, founder and CEO at Miltenyi Biotec, added: "We’re proud to continue supporting Verismo’s efforts with our viral vector platform. Their work in next-generation CAR T therapies reflects the innovation we strive to enable."

On September 25, 2025 Jacobio Pharmaceuticals (1167.HK) reported that its Chairman and Chief Executive Officer, Dr. Yinxiang Wang, together with concerted parties, have recently increased their shareholding in the Company by 11.06 million shares, representing a total investment of approximately HK$96.34 million (Press release, Jacobio Pharmaceuticals, SEP 25, 2025, View Source [SID1234656247]). This action underscores their strong confidence in the Company’s long-term growth prospects.

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In addition, the Company’s share repurchase plan with an upper limit of HK$100 million, which was approved by the Board in July 2025, has already led to the repurchase of 326,400 shares, with a cumulative payment of HK$2.67 million. The Company will continue to implement the repurchase plan based on market conditions.

In the interim results for 2025 released earlier, Jacobio reported multiple encouraging R&D achievements. The Company continues to focus on two major R&D pillars – KRAS and iADC – with core programs making steady progress, further demonstrating Jacobio’s competitiveness and growth potential in the global biopharmaceutical sector.

Within the KRAS pathway, Jacobio has established a comprehensive development strategy. In May 2025, the Company’s KRAS G12C inhibitor, Glecirasib, was approved by the National Medical Products Administration (NMPA) for second-line monotherapy in KRAS G12C mutant non-small cell lung cancer (NSCLC) and successfully launched in China. This milestone not only marked Jacobio’s first commercial entry into the Chinese market but also triggered a milestone payment of RMB 50 million from its partner Allist. At the same time, Glecirasib is being evaluated in combination with the SHP2 inhibitor sitneprotafib for first-line NSCLC.

Beyond its marketed product, Jacobio’s pan-KRAS inhibitor JAB-23E73 has shown important progress. In the dose-escalation phase of its Phase I clinical trial, multiple confirmed partial responses (PRs) have been observed, with favorable safety and pharmacokinetic (PK) profiles consistent with expectations. Full Phase I data are expected to be released in the first half of 2026, which will mark a critical milestone for the global pan-KRAS landscape. Meanwhile, the Company is actively advancing next-generation KRAS inhibitors. The EGFR-KRAS G12D tADC project, which utilizes EGFR as the targeting antibody and KRAS G12D as the payload to enable precise and efficient treatment, is expected to submit an IND application in the second half of 2026.

In its other R&D pillar, iADC, Jacobio also maintains a leading position. The Company is developing JAB-BX467, a HER2-STING iADC candidate. By using a STING agonist as the payload, this innovative program is designed to convert "cold tumors" into "hot tumors," offering a novel treatment option for solid tumors where PD-1 monotherapy has limited efficacy. The program is currently at the preclinical stage, with IND submission planned for the second half of 2026.

As an innovation-driven biotechnology company, Jacobio is already positioned among the global leaders in KRAS and iADC research, with a clear development roadmap and significant commercial potential. The Company believes that its current share price does not fully reflect the value of its pipeline or its long-term growth potential. The decision by the Chairman and concerted parties to increase their shareholding by nearly HK$100 million not only demonstrates the strong alignment of interests between management and shareholders but also underscores their unwavering confidence in the Company’s long-term value creation.

On September 25, 2025 Biostar Pharma, Inc., the US wholly-owned subsidiary of Beijing Biostar Biopharmaceutical Co., Ltd. ("Biostar," stock code: 2563.HK) which is a synthetic biology driven biopharma company focusing on the discovery, development and commercialization of innovative oncology drugs, reported that its core pipeline product Utidelone has once again been granted as Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA), for the treatment of pancreatic cancer (Press release, Biostar, SEP 25, 2025, View Source [SID1234656246]). This marks the third ODD granted to Utidelone by the FDA, following prior designations for breast cancer brain metastases and gastric cancer.

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Pancreatic cancer is a highly malignant tumor known as the "king of cancers" due to its insidious early symptoms, difficulty in diagnosis, rapid progression, strong invasiveness, and poor prognosis. The five-year survival rate is only approximately 10%, far lower than that of other common cancers, making it the lowest among all malignant tumors. Currently, there is no clearly effective treatment for pancreatic cancer. Combination regimens based on gemcitabine remain the main clinical treatment, but due to the high tendency of pancreatic cancer cells to develop resistance to gemcitabine, treatment outcomes are often unsatisfactory.

The potential of Utidelone in treating pancreatic cancer has been well validated in both non-clinical and clinical studies. Preclinical data show that Utidelone can significantly inhibit the proliferation and colony-forming ability of pancreatic cancer cells and exhibits strong anti-tumor activity in pancreatic cancer models. When combined with gemcitabine, Utidelone markedly reduces the IC50 value of gemcitabine without compromising its anti-tumor effect, and the combination demonstrates stronger anti-tumor activity compared with the traditional paclitaxel plus gemcitabine regimen. At the 2024 CSCO Annual Meeting, Biostar presented preliminary results from a multicenter, single-arm Phase II clinical study evaluating Utidelone combined with gemcitabine as first-line treatment for unresectable advanced pancreatic cancer. As of the report date, 20 advanced pancreatic cancer patients which were unresectable and ineligible for local treatment had been enrolled, with 11 completing their first efficacy evaluation. Among them, 3 patients achieved partial response (PR), and 5 achieved stable disease (SD); the objective response rate (ORR) was 27.27%, while the disease control rate (DCR) reached 72.72%. The median overall survival (mOS) was 9.57 months.

About Orphan Drug

An orphan drug is used to treat a rare disease that affects fewer than 200,000 patients in the US. Orphan drug development presents several major challenges including difficulties in patient recruitment, small market size and low return for the pharmaceutical companies. To encourage drug development for the benefit of rare disease patients, an ODD granted by the FDA provides many incentives such as tax relief on clinical trial costs, opportunity to apply for grants to support clinical trials, waiver of new drug application fee, acceleration for regulatory pathway, and the potential to receive 7 years of marketing exclusivity in the US market upon product approval.

About Utidelone

Utidelone is a new-generation genetically engineered microtubule inhibitor, and has similar mechanism of action with that of taxanes while demonstrating multiple advantages, including better anti-tumor activity, broader anti-tumor spectrum, better safety profile with very low hematologic toxicity, effective against multidrug-resistant tumors, less prone to developing drug resistance, capability of crossing the blood-brain barrier to prevent and treat brain tumors, and high oral bioavailability. Biostar has developed two formulations of Utidelone: injection (UTD1) and capsule (UTD2). UTD1 has been launched in China in 2021 for the treatment of metastatic breast cancer (MBC), who have progressed after at least one anthracycline- or taxane-containing chemotherapy regimen. The phase III study data showed that UTD1 plus capecitabine achieved both PFS and OS benefits versus capecitabine for heavily pretreated MBC patients, and the results were orally presented twice at ASCO (Free ASCO Whitepaper) annual meetings and published in prestigious journals.

On September 25, 2025 Leap Therapeutics, Inc. (Nasdaq: LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported it will present the final clinical results from Part B of the DeFianCe study (NCT05480306), a Phase 2 study of sirexatamab (DKN-01), an anti-DKK1 monoclonal antibody, in combination with bevacizumab and chemotherapy (Sirexatamab Arm) compared to bevacizumab and chemotherapy (Control Arm) in patients with advanced microsatellite stable (MSS) colorectal cancer (CRC) who have received one prior systemic therapy for advanced disease (Press release, Leap Therapeutics, SEP 25, 2025, View Source [SID1234656244]). The final results will be presented in a Mini Oral Session at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025, taking place October 17-21 in Berlin, Germany.

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Mini Oral Session Details:

Title: DeFianCe Trial: A randomized phase 2 trial of sirexatamab (DKN-01) plus bevacizumab and chemotherapy versus bevacizumab and chemotherapy as second-line therapy in advanced microsatellite stable (MSS) colorectal cancer (CRC)
Presenter: Zev A. Wainberg, M.D., Professor of Medicine and Co-Director of the GI Oncology Program at UCLA
Session Type: Mini Oral Session
Session Category: GI Tumours, Lower Digestive
Date and Time: Sunday, October 19, 2025, 4:05 p.m. CEST
Location: Cologne Auditorium – CityCube A
Abstract Number: LBA34