On September 23, 2025 NorthStar Medical Radioisotopes, LLC (NorthStar), a leading radiopharmaceutical company, reported the formation of a multi-faceted strategic partnership with the University of Wisconsin School of Medicine and Public Health, working closely with the school’s Initiative for Theranostics and Particle Therapy (ITPT) to advance research and support workforce development in the nuclear medicine sector (Press release, NorthStar Medical Radiostopes, SEP 23, 2025, View Source [SID1234656182]). This collaboration represents a significant advancement in efforts to create closer ties between industry and academia in order to foster innovation and further strengthen the nuclear medicine development in Wisconsin.

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The multi-year partnership will focus on opportunities for NorthStar and the UW School of Medicine and Public Health to conduct collaborative research, clinical and translational research, and contract research and drug development. The partnership also aims to provide academic and practical, real-world education opportunities to develop the workforce in the growing field of radiopharmaceuticals and particle therapy.

"We’re thrilled to partner with one of the nation’s leading academic institutions to drive sector innovation and help accelerate new therapies to market," said Dr. Frank Scholz, CEO at NorthStar. "This partnership underscores our commitment to staying at the forefront of the industry and developing the talent pool that will be required to support the significant growth expected in our industry."

Key goals of the partnership include:

Comprehensive radiopharmaceutical drug development services: Leverage the university’s advanced research infrastructure, scientific expertise and capabilities to expand the preclinical and early-stage development services that NorthStar offers
Joint research collaborations: Support clinical and translational drug discovery through the collaborative efforts of scientists and radiochemists from NorthStar and ITPT
Education and workforce development: Provide structured training opportunities at NorthStar to give students practical, career-building opportunities and help NorthStar and other Wisconsin nuclear medicine firms engage in talent development for the next generation of professionals
"The new collaboration with NorthStar will build on University of Wisconsin School of Medicine and Public Health’s strong leadership in radiopharmaceutical and theranostics R&D, yielding highly productive, impactful research and educational opportunities," said Nita Ahuja, MD, MBA, Dean of the school and Vice Chancellor for Medical Affairs at the University of Wisconsin–Madison. "This partnership aligns with our mission to advance health with innovative research that extends beyond the university, in alignment with the Wisconsin Idea."

The partnership officially launches in September, 2025, with several initiatives already underway.

On September 23, 2025 Healx, the AI-powered biotech company pioneering the next generation of drug discovery for rare diseases, reported it has entered into a strategic transaction with Vuja De Sciences, a US-based biotech company focused on addressing cancer recurrence and metastatic endurance (Press release, Healx, SEP 23, 2025, View Source [SID1234656181]).

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Healx’s proprietary AI platform has uncovered and prioritised therapeutic opportunities across rare diseases and is actively applied in rare and pediatric oncology. The platform is designed to generate and advance Healx’s own discovery programs, making it a natural fit with Vuja De Sciences, which brings both deep expertise in metastatic recurrence and a clinical-stage programme targeting cancer recurrence in osteosarcoma, which are highly complementary with Healx’s strategic focus and AI-driven approach. Together with Healx’s neurofibromatosis type 1 (NF1) program, this transaction reinforces the company’s established rare and pediatric oncology focus and further strengthens its growing therapeutic portfolio aimed at delivering innovative treatments for underserved patient communities.

This transaction underscores Healx’s mission-driven use of AI for good ─ applying cutting-edge technology to accelerate treatment discovery and bring meaningful options to rare disease patients. By combining Healx’s platform with Vuja De’s innovative program, the companies are advancing a promising therapy, HLX-4310, for preventing recurrence of metastatic osteosarcoma and deepening their shared commitment to rare and pediatric oncology. With the addition of this programme, Healx now advances two clinical-stage assets in this area.

"At Healx, we believe our AI platform can help solve humanity’s toughest health challenges ─ cancer recurrence," said Dr. Tim Guilliams, CEO and Co-founder of Healx. "By joining forces with Vuja De Sciences, we are combining our AI driven discovery capabilities with their science innovation to accelerate novel breakthrough cancer treatments – starting with a promising therapy entering clinical trials this year."

"This is a pivotal moment for Healx. By bringing together world-class science and cutting-edge AI, we are creating new opportunities to reshape the future of rare and pediatric cancers. I’m inspired by the path ahead and the impact we can make for patients," said Dr. Jonathan Milner, Healx Chairman.

"We are delighted to join forces with Healx and share a deep commitment to addressing rare diseases," said Dr. David Warshawsky, Founder & CEO of Vuja De Sciences. "Metastatic osteosarcoma is a devastating cancer affecting mostly young patients, with a five-year survival rate of less than 20%. Our innovative therapeutic strategy aims to prevent recurrence and transform outcomes. Pairing our science with Healx’s AI platform broadens our reach and accelerates our mission to change the trajectory of rare cancers."

Dr. Warshawsky will continue to lead the osteosarcoma program and will be joining the Healx executive team as Global Head of Metastatic Prevention.

The FDA has cleared the Investigational New Drug (IND) application for HLX-4310, demonstrating readiness to advance into clinical trials. The program is progressing with the National Pediatric Cancer Foundation’s flagship research program – the Sunshine Project – for the upcoming Phase 1/2 clinical trial.

This transaction exemplifies Healx’s clinical-stage portfolio and strengthens its scientific footprint in rare oncology. It reinforces Healx’s position at the intersection of AI and drug development, committed to harnessing technology for good to develop breakthrough therapies for patients in need and to build a future where every rare condition can be treated.

Financial terms of the transaction are not disclosed.

On September 23, 2025 Foundation Medicine, Inc., a precision medicine company transforming lives in cancer care and beyond, reported the addition of a tissue-informed whole genome sequencing molecular residual disease (Tissue-informed WGS MRD) test to its portfolio of high-quality testing solutions (Press release, Foundation Medicine, SEP 23, 2025, View Source [SID1234656180]). The test is currently available for research use in retrospective clinical trials.

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Foundation Medicine’s FlexOMx Lab now offers highly sensitive Tissue-informed WGS MRD test results for early and late-stage cancer research studies. The test monitors hundreds to thousands of tumor-specific variants, enabling accurate quantification of circulating tumor DNA (ctDNA) in patients with cancer for a more complete picture after treatment. Foundation Medicine’s method offers high sensitivity and specificity in detecting potential cancer recurrence, even in samples with low tumor burden where other methods might misinterpret the signal as noise. In a feasibility study, Foundation Medicine’s test was able to find tumor DNA at low levels, down to 1 part per 100,000 (10ppm, 0.001%).

"Foundation Medicine is setting a new standard for how our biopharmaceutical partners can monitor and understand cancer," said Troy Schurr, chief biopharma business officer at Foundation Medicine. "Our new Tissue-informed WGS MRD test gives partners a new tool for exploratory analysis in early to late-stage cancers, that offers highly specific and deep insights into a patient’s response and resistance to therapy."

Foundation Medicine’s Tissue-informed WGS MRD test allows biopharmaceutical partners to unlock rich multi-omics insights with an expanded monitoring portfolio that includes FoundationOneMonitor for research use, a tissue-free treatment monitoring test.

For an even deeper look, biopharmaceutical partners can leverage Foundation Medicine’s Tissue-informed WGS MRD test with the clinical trial assays based on FoundationOneCDx or FoundationOneLiquid CDx for comprehensive genomic profiling and identification of resistance mutations.

On September 23, 2025 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech", HKEX: 6990) reported it will present results from multiple clinical studies at the 2025 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress will take place in Berlin, Germany, from October 17 to 21, including data from its TROP2 ADC sacituzumab tirumotecan (sac-TMT), HER2 ADC A166 (trastuzumab botidotin), and CLDN18.2 ADC SKB315 (Press release, Kelun, SEP 23, 2025, View Source [SID1234656179]). Among these, two Phase III clinical studies of sac-TMT were selected for the Latest Breakthrough Abstracts (LBA) and presented as oral reports, including one featured in the Presidential Symposium; one Phase III clinical study of A166 was selected for LBA and presented as oral report.

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Abstract titles of these studies have been published on the official website of ESMO (Free ESMO Whitepaper). The study results to be presented include:

Title: Sacituzumab tirumotecan (sac-TMT) vs platinum-based chemotherapy in EGFR-mutated (EGFRm) non-small cell lung cancer (NSCLC) following progression on EGFR-TKIs: results from the randomized, multi-center phase 3 OptiTROP-Lung04 study
Presentation Type: Presidential Symposium
Presentation #: LBA5
Date and Lecture Time: October 19, 4：52 PM to 5:04 PM local time

Title: Sacituzumab tirumotecan (sac-TMT) vs investigator’s choice of chemotherapy (ICC) in previously treated locally advanced or metastatic hormone receptor-positive, HER2-negative (HR+/HER2-) breast cancer (BC): results from the randomized, multi-center phase 3 OptiTROP-Breast02 study
Presentation Type: Proffered Paper
presentation #: LBA23
Date and Lecture Time: October 18, 10:45 AM to 10:55 AM local time

Title: Trastuzumab botidotin vs trastuzumab emtansine (T-DM1) in HER2-positive unresectable or metastatic breast cancer: results from a randomized phase 3 study
Presentation Type: Proffered Paper
presentation #: LBA24
Date and Lecture Time: October 18, 10:55 AM to 11:05AM local time

Title: SKB315, a novel Claudin 18.2 (CLDN18.2) antibody-drug conjugate (ADC), in patients (pts) with advanced solid tumors including gastric/ gastroesophageal junction cancer (GC/GEJC): a phase 1 study
Presentation Type: Poster
Presentation #: 2139P
Date and Session Time: October 19, 9:00 AM to 5:00 PM local time

Title: Sacituzumab tirumotecan (sac-TMT) in Participants (pts) with Previously Treated, Advanced KRAS-Mutant NSCLC: Results from Cohort 5d of the SKB264-II-08 Study
Presentation Type: Poster
Presentation #: 1945P
Date and Session Time: October 18, 9:00 AM to 5:00 PM local time

Title: Sacituzumab tirumotecan (sac-TMT) + pembrolizumab[1] (pembro) for treatment-naïve advanced PD-L1 positive NSCLC: results from the Phase 2 MK-2870-003/SKB264-II-04 study
Presentation Type: Poster
Presentation #: 1949P
Date and Session Time: October 18, 9:00 AM to 5:00 PM local time

Title: Sacituzumab tirumotecan (sac-TMT) + Pembrolizumab in Metastatic Castration-Resistant Prostate Cancer (mCRPC): Results from Phase 2 MK-2870-002/SKB264-II-06 Study
Presentation Type: Poster
Presentation #: 2421P
Date and Session Time: October 18, 9:00 AM to 5:00 PM local time

Title: Sacituzumab tirumotecan (Sac-TMT) Monotherapy in Advanced/Metastatic Endometrial Carcinoma (EC): Results from a Phase 1/2 Study (MK-2870-001/KL264-01)
Presentation Type: Poster
Presentation #: 1111P
Date and Session Time: October 18, 9:00 AM to 5:00 PM local time

Title: Efficacy and Safety of sacituzumab tirumotecan (Sac-TMT) Monotherapy in Advanced/Metastatic Cervical Cancer: Results from a Phase 1/2 Study (MK-2870-001/KL264-01)
Presentation Type: Poster
Presentation #: 1168P
Date and Session Time: October 18, 9:00 AM to 5:00 PM local time

About sac-TMT

Sac-TMT, a core product of the Company, is a novel human TROP2 ADC in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as NSCLC, BC, gastric cancer (GC), gynecological tumors, among others. Sac-TMT is developed with a novel linker to conjugate the payload, a belotecan-derivative topoisomerase I inhibitor with a drug-to-antibody-ratio (DAR) of 7.4. Sac-TMT specifically recognizes TROP2 on the surface of tumor cells by recombinant anti-TROP2 humanized monoclonal antibodies, which is then endocytosed by tumor cells and releases the payload KL610023 intracellularly. KL610023, as a topoisomerase I inhibitor, induces DNA damage to tumor cells, which in turn leads to cell-cycle arrest and apoptosis. In addition, it also releases KL610023 in the tumor microenvironment. Given that KL610023 is membrane permeable, it can enable a bystander effect, or in other words kill adjacent tumor cells.

In May 2022, the Company licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc., Rahway, NJ, USA) to develop, use, manufacture and commercialize sac-TMT in all territories outside of Greater China (includes Mainland China, Hong Kong, Macau, and Taiwan).

To date, 2 indications for sac-TMT have been approved and marketed in China for the treatment of adult patients with unresectable locally advanced or metastatic triple negative breast cancer (TNBC) who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting), EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy. In addition, two new indication applications for sac-TMT for the treatment of adult patients with EGFR-mutant locally advanced or metastatic NSCLC who progressed after treatment with EGFR-TKI therapy and with unresectable locally advanced, metastatic hormone receptor positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) BC who have received prior endocrine therapy and other systemic treatments in the advanced or metastatic setting were accepted by the Center for Drug Evaluation of NMPA, and were included in the priority review and approval process. As of today, the Company has initiated 9 registrational clinical studies in China. MSD has initiated 14 ongoing Phase 3 global clinical studies of sac-TMT as a monotherapy or with pembrolizumab or other anti-cancer agents for several types of cancer. These studies are sponsored and led by MSD.

About Trastuzumab Botidotin (A166)

Trastuzumab botidotin is a differentiated HER2 ADC in new drug application (NDA) registration stage to treat advanced HER2+ solid tumors. As an innovative HER2 ADC developed by the Company, it conjugates a novel, MMAF derivative (a highly cytotoxic tubulin inhibitor, Duo-5) via a stable, enzyme-cleavable linker to a HER2 monoclonal antibody with a DAR of 2. Trastuzumab botidotin specifically binds to HER2 on the surface of tumor cells and is internalized by tumor cells, releasing the toxin molecule Duo-5 inside the cell. Duo-5 induces tumor cell cycle arrest in the G2/M phase, leading to tumor cell apoptosis. After targeting HER2, trastuzumab botidotin can also inhibit the HER2 signaling pathway; it has antibody-dependent cell-mediated cytotoxicity (ADCC) activity.

Based on the results of a randomized, controlled, open-label Phase III study, the New Drug Application (NDA) for trastuzumab botidotin was accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in January 2025 for the treatment of adult patients with HER2+ unresectable or metastatic BC who have received at least one prior anti-HER2 therapy was accepted by the CDE of the NMPA. At a pre-specified interim analysis, trastuzumab botidotin monotherapy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS) as assessed by the Blinded Independent Central Review (BICR) compared with T-DM1.

Currently, Kelun-Biotech has initiated an open, multi-center Phase II clinical study of trastuzumab botidotin in the treatment of HER2+ unresectable or metastatic BC that previously received a topoisomerase inhibitor ADC.

About SKB315

SKB315 is a novel CLDN18.2 ADC targeting advanced solid tumors configured with a proprietary, in-house developed humanized CLDN18.2 mAb and a differentiated payload-linker design. Currently, Kelun-Biotech has initiated the exploration in combination with immunotherapy for gastric/gastroesophageal junction cancer (GC/GEJC) while advancing monotherapy studies for tumors expressing CLDN18.2, such as GC/GEJC and pancreatic cancer.

On September 23, 2025 TegMine Therapeutics, Inc., ("TegMine"), a biotechnology company focused on redefining precision oncology by targeting the glycoproteins that drive cancer, reported a strategic research and development collaboration with Boehringer Ingelheim (Press release, Tegmine Therapeutics, SEP 23, 2025, View Source [SID1234656178]). The partnership will leverage TegMine’s proprietary 2-Factor Antibody System to develop more selective and better-tolerated ADC therapeutics.

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The collaboration is centered on an initial program targeting a clinically validated antigen, with the potential to expand to two additional targets. Powered by its proprietary TegMiner platform, TegMine discovers novel, tumor-specific glycan epitopes that are invisible to conventional approaches. The company’s 2-Factor Antibody System delivers a new level of therapeutic precision, requiring dual glycan/protein-based recognition to achieve unprecedented specificity and enhanced efficacy, with a goal to reduce on-target, off-tumor toxicity for the benefit of patient safety.

"At TegMine, we are exploiting the unique biology of tumor-associated glycans, molecular signatures that are highly prevalent in aggressive solid tumors yet largely absent in healthy tissues," said Jeff Bernstein, Ph.D., CEO of TegMine. "This collaboration endorses our approach, and specifically our 2-Factor Antibody System, which unlocks specific tumor-associated antigens and targets that were previously inaccessible with other technologies. We are excited to translate this approach into potentially meaningful therapies for patients alongside a world-class partner in Boehringer Ingelheim."

Under the terms of the agreement, TegMine will receive an upfront payment and research funding per target as well as a target option fee for each selected additional target. The company is also eligible to receive preclinical, clinical, regulatory, and commercial milestones, along with royalties on net sales for any potential products developed under the collaboration. Exact financial terms are undisclosed. Boehringer Ingelheim has global development and commercial rights for each target generated during the collaboration.