On September 24, 2025 Sapu Nano, developer of Deciparticle, reported that it has received approval from Australia’s Human Research Ethics Committee (HREC) to begin enrolling patients in a Phase 1 human clinical trial of Sapu003-an injectable form of Everolimus-for the treatment of breast cancer (Press release, Sapu Bioscience, SEP 24, 2025, View Source [SID1234656203]). Sapu Nano is part of the Sapu family of companies, formed through GMP Biotechnology Limited, a joint venture between Oncotelic Therapeutics, Inc. (OTCQB: OTLC) and Dragon Overseas Capital Limited.

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Everolimus is already an FDA-approved drug (sold under the brand name Afinitor) for various cancers, including advanced breast cancer, kidney cancer, and certain rare tumors. However, in oral pill form, only about 10% of the drug is absorbed by the body, which limits how effective it can be. Using Sapu Nano’s proprietary Deciparticle technology, Sapu003 is delivered intravenously (by injection), which allows 100% of the drug to reach the bloodstream. Preclinical studies suggest this approach could be more effective than the current oral version.

"We are extremely pleased to receive approval from the HREC to proceed with human clinical trials," said Sapu Nano Chief Executive Officer Dr. Vuong Trieu. "Despite advances in treatment, there remains a critical unmet need for next generation mTOR inhibitors. Current therapies often extend progression-free survival for less than one year and rarely deliver long-term disease control. This Phase 1 trial will allow us to determine the best dose for future studies, including a Phase 3 trial."

Dr. Sud Agarwal, Chief Executive Officer of Ingenu, added: "The approval of Sapu003 to enter human trials is a landmark moment. By enabling full drug absorption through intravenous delivery, this program has the potential to achieve meaningful tumor shrinkage where oral formulations have been limited. We are proud to support Sapu Nano in advancing this therapy, which may ultimately give breast cancer patients better outcomes and improved quality of life."

What This Means for Patients
Put simply, Sapu003 is a new way of giving an existing cancer drug so it works better. The pill form doesn’t get fully absorbed, only about 10% makes it into the body. By delivering it as an injection, researchers can deliver the medicine at full strength, which could make it more effective at shrinking tumors. This first trial is the starting point to see if this improved version can give breast cancer patients longer-lasting benefits and new hope.

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 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 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 Manas AI, a full-stack, AI native drug discovery and development company, reported the closing of a $26M Seed Extension and the addition of its new Co-Founder and Chief Technology Officer, Ujjwal Singh (Press release, Manas AI, SEP 23, 2025, View Source [SID1234656927]).

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Manas AI was founded to overcome the critical inefficiencies of traditional drug development. By uniting world-class biomedical expertise and next generation AI capabilities, the company is pioneering a new paradigm of faster, cheaper, and more precise medicines.

Manas AI will utilize the new funding to accelerate the development of its drug discovery foundational models and advance its current therapeutic campaigns. Manas AI will also utilize funds to continue to expand its team of premier interdisciplinary individuals, with new additions headed by Ujjwal Singh.

Singh joins Manas AI having most recently served as Chief Technology and Product Officer at Multiverse. He previously held the role of Head of Workplace at Meta, following a distinguished tenure at Google where he drove significant product innovation. At Google, Singh was a Partner at the internal incubator, Area 120, and as Senior Director of Engineering, he founded and launched Google Hangouts. He also spearheaded the engineering efforts that expanded YouTube into dedicated platforms like YouTube Kids, Music, and Gaming.

"We are incredibly excited to welcome Ujjwal Singh as both a Co-Founder and Chief Technology Officer", said Dr. Siddhartha Mukherjee, CEO and Co-Founder of Manas AI. "Ujjwal’s extensive AI and productization background perfectly complement the AI-native, scalable design of Manas’ vision. Ujjwal will not only make an impact on our cutting-edge AI capabilities but also as an experienced and visionary leader in the Co-Founder role."

"Manas AI’s mission to usher in a new era of medicine—one defined by accelerated discovery and highly targeted therapies—deeply resonates with me," said Singh. "Together with Reid Hoffman, Dr. Siddhartha Mukherjee, and the rest of the remarkable leadership team, I believe we can build a truly meaningful company that harnesses and deploys the most impactful aspects of the AI revolution we are witnessing."

"It is excellent to work with Ujjwal again. Ujjwal is an amazing technologist, who brings the experience of many scale AI projects to Manas’ mission to transform the drug discovery process," said Reid Hoffman, Co-Founder of Manas AI, Inflection AI, and LinkedIn.

Manas AI’s Seed Extension follows a $24.6M Seed Round announced in January of this year led by General Catalyst and Reid Hoffman. The seed extension also includes The General Partnership, Wisdom Ventures, Blitzscaling Ventures, Westbound Equity Partners, Mosaic Ventures, and a number of individuals.