On February 20, 2025 Signet Therapeutics, a clinical-stage biotech company leveraging organoid- and AI-driven cancer drug discovery, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for SIGX1094, the world’s first potential targeted therapy for diffuse gastric cancer (DGC) (Press release, Signet Therapeutics, FEB 20, 2025, View Source [SID1234650436]). This designation is designed to accelerate the development and regulatory review of therapies addressing serious diseases with unmet medical needs, bringing promising new treatments to patients more quickly. In November 2024, SIGX1094 was also granted Orphan Drug Designation (ODD) from the FDA.

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"Receiving Fast Track Designation for SIGX1094 underscores the FDA’s recognition of both the serious, life-threatening nature of diffuse gastric cancer and the potential of SIGX1094 to address this critical medical need," said Dr. Haisheng Zhang, founder and CEO of Signet Therapeutics. "This milestone highlights our commitment to rapidly advancing innovative cancer treatments through our organoid and AI platform, bringing us closer to offering a breakthrough solution for patients with diffuse gastric cancer."

SIGX1094 is an innovative targeted therapy developed using Signet’s proprietary organoid + AI drug discovery platform. Based on a novel therapeutic target independently identified by Signet, SIGX1094 was discovered and optimized in collaboration with XtalPi (2228.HK), a leading drug discovery platform integrating quantum physics, AI, and robotics. As the world’s first drug developed through the integration of organoid models and AI, SIGX1094 represents a major advance in the treatment of DGC, a highly aggressive cancer with no approved targeted therapies. The drug is currently being evaluated in a Phase I clinical trial at Beijing Cancer Hospital in China.

With Fast Track Designation, Signet Therapeutics will benefit from more frequent interactions with the FDA throughout the drug development process, early regulatory guidance, and potential eligibility for accelerated approval, priority review, and rolling review—all aimed at expediting SIGX1094’s path to market and addressing the urgent need for effective DGC treatments. SIGX1094 received Orphan Drug Designation (ODD) from the U.S. FDA in November 2024. The FDA grants ODD to therapies for rare diseases affecting fewer than 200,000 people in the U.S.

Signet Therapeutics is at the forefront of integrating organoid models with AI to revolutionize drug discovery. By combining AI-driven molecular screening with its proprietary organoid platform, Signet accelerates the identification, evaluation, and optimization of novel therapeutics. This innovative approach significantly enhances drug development efficiency and clinical success rates, representing a paradigm shift in the convergence of AI and biotechnology for precision oncology.

On February 20, 2025 Incyte (Nasdaq:INCY) and Genesis Therapeutics, Inc. reported that the companies have entered into a strategic collaboration focused on the research, discovery and development of novel small molecule medicines, with an initial focus on collaboration targets selected by Incyte (Press release, Incyte, FEB 20, 2025, View Source [SID1234650435]).

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Genesis is pioneering generative and predictive artificial intelligence (AI) technologies to help create therapeutics for challenging targets. Utilizing Genesis’ proprietary AI platform, GEMS (Genesis Exploration of Molecular Space), the partnership will pursue the discovery and optimization of small molecule compounds for the collaboration targets. Incyte is granted exclusive rights for potential clinical development and commercialization of collaboration products.

"As a leader in pharmaceutical innovation, Incyte is continually seeking new technologies that can transform how new medicines are discovered and developed," said Pablo J. Cagnoni, M.D., President and Head of Research and Development at Incyte. "Partnering with Genesis Therapeutics presents a unique opportunity to leverage their AI technologies to accelerate the discovery of breakthrough small molecules for high-impact targets in our pipeline."

"AI has the potential to redefine how we discover small molecule medicines, and our team is at the forefront of this revolution," said Evan Feinberg, Ph.D., Founder and Chief Executive Officer of Genesis. "We are pleased to establish this world-class partnership to combine our GEMS AI platform with Incyte’s deep expertise and track record in drug discovery and development, with the shared goal of advancing critical treatments for patients with severe diseases."

Terms of the Agreement

Under the terms of the agreement, Genesis will receive an upfront payment of $30 million. Genesis and Incyte have agreed to collaborate on two initial targets, and Incyte will have the option to nominate an additional target for a predetermined fee. If all milestones are achieved, Genesis is eligible to receive up to $295 million in development, regulatory and commercial milestone payments per target. Genesis is also eligible to receive tiered royalties on sales of any collaboration products, once approved.

On February 20, 2025 OS Therapies, Inc. (NYSE-A: OSTX), a clinical-stage biotechnology company advancing immunotherapies and targeted drug conjugates for cancer treatment, reported that it received a Notice of Allowance from the United States Patent & Trademark Office (USPTO) that a patent will be issued covering the manufacturing methods required for the OST-HER2 commercial product (Press release, OS Therapies, FEB 20, 2025, View Source [SID1234650434]). The USPTO granted a Patent Term Adjustment of 572 days, providing market exclusivity for the OST-HER2 commercial drug product into 2040. OS Therapies is preparing to initiate discussions with the United States Food & Drug Administration (FDA) following the successful treatment phase of its Phase 2b clinical trial in the prevention of recurrent, resected, lung metastatic osteosarcoma with a view towards submitting a Biologics Licensing Application (BLA) and gaining conditional or accelerated FDA approval in 2025. The Company recently completed a $7.1 million financing in January 2025 and has sufficient capital into mid-2026.

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OST-HER2 has already received rare pediatric disease (RPDD), fast-track (FTD) and orphan drug (ODD) designations from the US FDA for osteosarcoma. The Company intends to (1) focus on gaining FDA BLA approval for OST-HER2 in osteosarcoma in late 2025, (2) sell the Priority Review Voucher (PRV) it would receive from the FDA BLA approval prior to the September 30, 2026 PRV deadline to a larger pharmaceutical company at prevailing market prices (most recent PRV sale transaction was $150 million), (3) commercialize OST-HER2 in osteosarcoma and (4) then expand the clinical development of OST-HER2 into breast cancer and other larger solid tumor indications for additional revenue potential.

OST-HER2 has successfully completed a Phase 1 trial in adult patients with HER2 overexpressing cancers, primarily breast cancer patients. Preclinical breast cancer results with OST-HER2 showed:

78% reduction in tumor size (3mm for OST-HER2 treated vs. 14mm for control arm) in FVB/N HER2 transgenic mouse model of breast cancer treatment at day 75
33% prevention of breast cancer in OST-HER2 treated mice vs. 0% prevention of breast cancer in FVB/N HER2 transgenic model of breast cancer prevention at week 50
20% reduction of tumor size for OST-HER2 plus HER2-targeted antibody vs. HER2-targeted antibody alone Tg tumor regression model of breast cancer at day 42
65% reduction cellular concentration of metastatic cells for OST-HER2-treated mice compared with controls in brain metastasis model of primary breast cancer
The osteosarcoma treatment market was estimated at $1.2 billion in 2022 according to Data Bridge Market Research. The Company believes the market opportunity for OST-HER2 in the prevention of lung metastases in osteosarcoma is over $500 million. The breast cancer treatment market was estimated at $29.2 billion in 2023 and expected to grow to $53.7 billion by 2030 according to Grandview Research. The Company believes the market opportunity for OST-HER2 in the treatment of breast cancer exceeds $1 billion.

On February 20, 2025 Myris Therapeutics emerged from stealth reported its strategic focus (Press release, Myris Therapeutics, FEB 20, 2025, View Source [SID1234650430]). Myris, formerly known as BioHybrid Solutions, has built on its history in enzyme bioconjugate development to emerge as a new Antibody Drug Conjugate (ADC) therapeutics company focused on the discovery and development of ultra-high Drug Antibody Ratio (DAR) ADCs. The first public release of Myris’ ADC capabilities will be presented at AACR (Free AACR Whitepaper) in Chicago, April 25-30, 2025.

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Myris Therapeutics has a novel pipeline of ultra-high DAR ADC oncology medicines, developed using the company’s deep expertise in polymer chemistry and cancer biologics. Myris’ technology enables the development of ADCs with DAR50-300, meaning Myris can put 50-300 copies of the drug payload per antibody which is 10-100x higher than current standards. "This dramatically expands the range of possible payloads and precision therapy opportunities. Moreover, there are many clinically-validated small molecules that have previously not been amenable to use in ADCs because of their pharmacology or therapeutic index," said Laura Benjamin, PhD, CEO of Myris Therapeutics. "We are advancing promising clinical candidates by utilizing innovative, yet proven, antibodies and payloads. Our emerging preclinical data suggest that we will see the expected improvement in efficacy and tolerability that the field so desperately needs."

Laura Benjamin, PhD, joined Myris’ Board in 2023 and stepped in as CEO in 2024 to lead the company’s shift to oncology. Prior to Myris, Laura was the CEO at OncXerna, where she raised >$100 million USD to advance clinical development of two oncology programs. Earlier positions included VP/CSO in oncology at Eli Lilly, Associate Professor in Pathology at Harvard Medical School, and Co-director of the Center for Vascular Biology at the Beth Israel Deaconess Medical School. Laura received her BA in Biology from Barnard College, Columbia University and her PhD in Molecular Biology from the University of Pennsylvania.

Myris Therapeutic’s predecessor company, BioHybrid Solutions, was founded to use sophisticated polymer chemistry to improve the druggability of therapeutic enzymes. The polymer technology remains central to Myris’ ultra-high DAR ADC capabilities and the company’s founders continue to play a leading role in Myris. Co-founder Krzysztof Matyjaszewski, PhD, from CMU is one of the leading figures in polymer chemistry world-wide and is a Director of Myris and active scientific advisor, co-founder Tonia Simakova, PhD, leads discovery research at Myris, and co-founder Alan Russell, PhD, currently VP of Large Molecule Discovery and Research Data Science at Amgen, is Chair of Myris’ Scientific Advisory Board. The company’s legacy programs are partnered and continue to advance rapidly towards the clinic. Pipeline success has allowed Myris to develop the technical capabilities needed to support the shift in focus to ultra-high DAR ADCs. Most notably, the lead program has been fully funded by the Department of Defense and has led to the successful nomination of a development candidate.

Under Laura Benjamin’s leadership, the team has been expanded to support the successful development of the ADC pipeline. Key advisors include biotech veteran Patrick Zweidler-McKay, MD, an experienced oncologist with over 11 years at MD Anderson, who spent 8 years developing ADCs at Immunogen before its acquisition by AbbVie, and decorated oncologist Pasi Janne, MD, currently Director for the Lowe Center for Thoracic Oncology at Dana-Farber Cancer Institute and Professor of Medicine at Harvard. In addition, the internal team has been strengthened by the addition of Becky Wolfe, a proven business and program leader in biopharma, as COO; Jeffrey S. Humphrey, MD, a seasoned industry oncologist, as CMO; and Bryant McLaughlin, PhD, an accomplished CMC scientist, as Head of CMC.

On February 20, 2025 Harbour BioMed (HKEX: 02142, the "Company"), a global biopharmaceutical company committed to the discovery, development and commercialization of novel antibody therapeutics focusing on immunology and oncology, and Insilico Medicine ("Insilico"), a clinical stage generative artificial intelligence (AI)-driven biotechnology company, reported a strategic collaboration to accelerate the discovery and development of innovative therapeutic antibodies, leveraging their respective technological strengths in antibody discovery and artificial intelligence (Press release, Harbour BioMed, FEB 20, 2025, View Source [SID1234650433]).

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Under the collaboration agreement, the parties will combine Harbour BioMed’s industry-leading technology platform, proprietary dataset and extensive expertise in antibody development with Insilico’s advanced capabilities in designing integrated AI-driven drug discovery and development platforms to jointly develop the next-generation AI-powered antibody application. Additionally, the two companies will collaborate on early-stage drug discovery programs targeting novel, specific antibodies, leveraging Insilico’s AI expertise and Harbour BioMed’s wet lab capabilities. These efforts aim to deliver innovative therapeutic solutions for the unmet medical needs of immunology, oncology, and neuroscience.

Harbour BioMed has built a strong foundation in antibody discovery and development, underpinned by its advanced technology platform, proprietary dataset, and deep expertise. The Company’s proprietary Harbour Mice platform enables the generation of fully human monoclonal antibodies in both conventional (H2L2) and heavy chain-only (HCAb) formats, eliminating the need for additional engineering or humanization. The HCAb technology, in particular, produces unique, fully human heavy chain-only antibodies that are approximately half the size of conventional IgGs, offering significant advantages for next-generation antibody therapies. With a clinically validated and globally recognized platform, Harbour BioMed has applied its technology in more than 250 drug discovery programs across various therapeutic areas, establishing itself as a leader in the field of biotherapeutics.

Insilico has previously showcased the capability of its proprietary AI platform to significantly reduce cost and improve efficiency in the early stages of small molecule drug discovery and development. Since 2021, the company has established a wholly-owned pipeline of 30 assets powered by its Pharma.AI platform, 10 of which have received IND clearance, setting a benchmark for AI-driven drug discovery and development. In July 2024, Insilico introduced Generative Biologics, an AI-powered tool for de novo protein engineering, designed to accelerate the development of next-generation biologics. Moving forward, the company plans to leverage real-world case studies to further refine and advance the application through ongoing enhancements and iterative improvements.

"We are excited to collaborate with Insilico, a pioneer and leading advocate in AI-driven drug discovery and development, to integrate AI technologies with our industry-leading technology platform and proven expertise in antibody discovery and development," said Jingsong Wang, MD, PhD, Founder, Chairman, and CEO of Harbour BioMed. "By combining our validated Harbour Mice platform with advanced generative AI approaches, we aim to further streamline antibody discovery, enhance candidate selection, and ultimately bring innovative therapies to patients more efficiently."

"By combining advanced machine learning models with biological expertise, AI platforms are transforming antibody discovery and engineering – enabling the prediction of antibody structures, identification of binding sites, and design of candidates with enhanced specificity, efficacy, and safety," said Feng Ren, PhD, Co-CEO and Chief Scientific Officer of Insilico Medicine. "High-quality dataset and wet-lab validation are critical components in this process, and we are thrilled to collaborate with Harbour BioMed who excel in these areas. Together, we aim to build the next generation AI-driven antibody platforms and deliver breakthrough antibody therapies to address critical healthcare needs."