On January 7, 2025 Alloy Therapeutics Inc. ("Alloy"), a biotechnology ecosystem company dedicated to democratizing access to cutting edge drug discovery technologies, reported a target specific collaboration and license agreement for the use of their novel and proprietary AntiClastic Antisense Platform with Sanofi for a central nervous system (CNS) target (Press release, Alloy Therapeutics, JAN 7, 2025, View Source [SID1234649456]). In return, Sanofi will provide Alloy with upfront license fees and near-term preclinical milestone payments up to $27.5 million. Alloy will also be eligible to receive discovery, development, and commercial milestone payments of over $400 million, as well as tiered royalties on sales of any products resulting from the collaboration. This collaboration underscores a shared commitment to advancing innovative therapeutics in the CNS space.

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Alloy’s AntiClastic Antisense platform allows drug developers to realize the true potential of antisense therapeutics by reaching intracellular disease targets at the RNA level. The platform addresses limitations of current antisense chemistries relating to therapeutic index. This technology platform was launched by Alloy in 2023 after exclusively licensing its underlying intellectual property which implements a novel spatial conformation of the oligonucleotide developed by Sudhir Agrawal of Arnay Sciences.

"At Alloy Therapeutics, we’re transforming RNA therapeutics by bridging foundational insights with modern innovation," said Vinod Vathipadiekal, Chief Scientific Officer, Genetic Medicines at Alloy Therapeutics. "Our work on the AntiClastic Antisense platform and the data generated is pushing the technology beyond current standards and driving innovation that has the potential to redefine what’s possible in RNA therapeutics. With the capabilities we have built and validated, we are excited to work with Sanofi, and we look forward to continuing to deliver on Alloy’s commitment to open collaboration and accessible technologies to ensure these breakthroughs can drive the development of superior RNA-based therapies for patients."

Through the collaboration, Sanofi will leverage their neuroscience expertise and collaborate with Alloy to use the AntiClastic Antisense platform for delivery of therapeutics to the brain, aiming to develop a novel class of genetic medicine capable of crossing the blood-brain barrier.

"We’re excited to partner with Sanofi, a global leader in healthcare innovation, on this landmark licensing agreement for our AntiClastic Antisense platform," said Errik Anderson, Alloy Therapeutics CEO and Founder. "When we began working with Dr. Agrawal, a renowned leader in antisense therapeutics, to integrate his groundbreaking work into Alloy’s genetic medicines platform, we were confident in its potential to revolutionize antisense drug development and reshape the broader drug discovery landscape. This collaboration exemplifies Alloy’s adaptable, multi-modality approach, providing our partners with a comprehensive suite of discovery solutions and access to novel platforms to accelerate the development of the most effective therapies for patients in need."

Join the Alloy Therapeutics community by visiting alloytx.com and following Alloy on LinkedIn.

About the Alloy Therapeutics Genetic Medicines AntiClastic Antisense Platform
AntiClastic Antisense Platform, an offering under Alloy’s Genetic Medicines business unit, is a novel therapeutic format—exclusively available through Alloy Therapeutics collaborations—that is designed to overcome potency and therapeutic index challenges that have historically limited the promise of antisense drugs. Sudhir Agrawal invented the core technology, which combines improvements in the primary sequence with a novel spatial conformation of nucleic acid drugs to promote the delivery of antisense to target RNA, mitigate the inflammatory response, and improve a drug’s therapeutic index. The resultant drug candidates have shown a significant increase in potency compared to gapmer antisense formats. Partners can apply this format to existing antisense sequences or partner to discover new AntiClastic Antisense molecules against their intended target. Learn more at www.alloytx.com/genetic-medicines.

On January 7, 2025 Alloy Therapeutics Inc. ("Alloy"), a biotechnology ecosystem company dedicated to democratizing access to cutting edge drug discovery technologies, reported a target specific collaboration and license agreement for the use of their novel and proprietary AntiClastic Antisense Platform with Sanofi for a central nervous system (CNS) target (Press release, Alloy Therapeutics, JAN 7, 2025, View Source [SID1234649453]). In return, Sanofi will provide Alloy with upfront license fees and near-term preclinical milestone payments up to $27.5 million. Alloy will also be eligible to receive discovery, development, and commercial milestone payments of over $400 million, as well as tiered royalties on sales of any products resulting from the collaboration. This collaboration underscores a shared commitment to advancing innovative therapeutics in the CNS space.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Alloy’s AntiClastic Antisense platform allows drug developers to realize the true potential of antisense therapeutics by reaching intracellular disease targets at the RNA level. The platform addresses limitations of current antisense chemistries relating to therapeutic index. This technology platform was launched by Alloy in 2023 after exclusively licensing its underlying intellectual property which implements a novel spatial conformation of the oligonucleotide developed by Sudhir Agrawal of Arnay Sciences.

"At Alloy Therapeutics, we’re transforming RNA therapeutics by bridging foundational insights with modern innovation," said Vinod Vathipadiekal, Chief Scientific Officer, Genetic Medicines at Alloy Therapeutics. "Our work on the AntiClastic Antisense platform and the data generated is pushing the technology beyond current standards and driving innovation that has the potential to redefine what’s possible in RNA therapeutics. With the capabilities we have built and validated, we are excited to work with Sanofi, and we look forward to continuing to deliver on Alloy’s commitment to open collaboration and accessible technologies to ensure these breakthroughs can drive the development of superior RNA-based therapies for patients."

Through the collaboration, Sanofi will leverage their neuroscience expertise and collaborate with Alloy to use the AntiClastic Antisense platform for delivery of therapeutics to the brain, aiming to develop a novel class of genetic medicine capable of crossing the blood-brain barrier.

"We’re excited to partner with Sanofi, a global leader in healthcare innovation, on this landmark licensing agreement for our AntiClastic Antisense platform," said Errik Anderson, Alloy Therapeutics CEO and Founder. "When we began working with Dr. Agrawal, a renowned leader in antisense therapeutics, to integrate his groundbreaking work into Alloy’s genetic medicines platform, we were confident in its potential to revolutionize antisense drug development and reshape the broader drug discovery landscape. This collaboration exemplifies Alloy’s adaptable, multi-modality approach, providing our partners with a comprehensive suite of discovery solutions and access to novel platforms to accelerate the development of the most effective therapies for patients in need."

On January 7, 2025 Alivexis, Inc. (Headquartered in Minato-ku, Tokyo; CEO S. Roy Kimura, "Alivexis") a preclinical-stage computation-driven drug discovery firm, reported the first closing of its Series D round in the amount of 800M JPY (approximately $5.1M USD) (Press release, Alivexis, JAN 7, 2025, View Source [SID1234649452]). Investors participating in the first closing include funds managed by JIC Venture Growth Investments Co., Ltd., DBJ Capital Co., Ltd., and Fast Track Initiative, Inc. Alivexis has raised a total of 6.66B JPY (approximately $42.3M USD) to date.

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Alivexis will use the proceeds to further research and development programs utilizing its cutting-edge computational science-based drug discovery platform "ModBindTM", in addition to accelerating over 10 in-house R&D programs. Alivexis will expand key business strategies in early out-licensing and drug discovery collaboration, with the aim of further increasing its corporate value.

Comment from S. Roy Kimura, Ph.D., Co-founder and CEO:
"We are excited to announce the first closing of our latest funding round led by the JIC Venture Growth Investments Co., Ltd. with follow-on investments from existing shareholders. Since our last fund-raise, we have successfully licensed our cathepsin C inhibitor program and are currently working together with our partner toward IND submission. We also published a scientific article on the first version of our ModBindTM simulation platform, based on a unique theoretical approach that enables accurate absolute ligand efficacy predictions at ~2000x speeds relative to existing methods. In the next several months, we expect to sign additional licensing partnerships from our portfolio of immunology and oncology R&D programs, as well as additional ModBindTM-related alliances and collaborations. We look forward to continuing our mission with our shareholders and partners to accelerate discovery of new medicines for patients and their families in need."

Comment from Hanae Suzuki, JIC Venture Growth Investments Co., Ltd.:
"We are thrilled to announce our recent investment in Alivexis and are honored to collaborate with their exceptional team, renowned for its extensive expertise in the pharmaceutical a industries and its globally integrated operations. In this era of rapid innovation in AI and semiconductor technologies, we recognize the significant potential of Alivexis’s cutting-edge computational chemistry-based simulation platform.
Our firm is deeply committed to supporting Alivexis in driving its continued growth and innovation. We are confident that this investment will not only accelerate the development of groundbreaking medicines for patients and their families but also play a pivotal role in advancing Japan’s drug discovery ecosystem"

On January 7, 2025 BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing the novel, selective AXL kinase inhibitor bemcentinib for lung cancer reported that the first patient has been included in a clinical trial sponsored by the Mays Cancer Center at The University of Texas Health Science Center at San Antonio (UT Health San Antonio) (Press release, BerGenBio, JAN 7, 2025, View Source [SID1234649446]). The study is led by Josephine A. Taverna, MD, a thoracic oncologist at the Mays Cancer Center and Associate Professor in the Division of Hematology and Oncology at UT Health San Antonio.

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"Dr. Taverna’s research has shown that AXL and JAK-STAT3 work in tandem to transmit signals promoting tumor growth and metastasis in advanced lung cancer. We are pleased to see this research advancing into clinical application and believe this study aligns closely with BerGenBio’s strategic focus on addressing the significant unmet needs of lung cancer patients, including first-line Non-Small Cell Lung Cancer patients with mutations in the STK11 gene," said Olav Hellebø, Chief Executive Officer of BerGenBio.

The trial is designed to study BerGenBio’s bemcentinib in combination with pacritinib, which is a JAK2 inhibitor indicated for treatment of the bone marrow disorder myelofibrosis in patients with platelet counts below 50 x 109/L. It works by blocking certain growth factors and cytokines. Pacritinib is marketed in the United States as VONJO and owned by Swedish Orphan Biovitrum AB (Sobi) (STO: SOBI), a specialized international biopharmaceutical company. Bemcentinib is a first-in-class, selective, oral once-a-day inhibitor of AXL receptor tyrosine kinase, a promising therapeutic target for serious diseases.

The study will include patients with lung adenocarcinoma, the most common type of lung cancer in the United States, accounting for approximately 40% of all lung cancers. The study is funded by a grant from the National Cancer Institute (NCI) of the National Institutes of Health (NIH).

On January 7, 2025 4SC AG (4SC, FSE Prime Standard: VSC), a biotech company improving the lives of patients suffering with advanced-stage cutaneous T-cell lymphoma (CTCL), reported that it had submitted its responses to the Day-120 List of Questions from the European Medicines Agency (EMA) in December 2024 as planned, following 4SC’s initial Marketing Authorisation Application (MAA) filing for resminostat (Kinselby) in March 2024 (Press release, 4SC, JAN 7, 2025, View Source [SID1234649444]). The EMA has notified 4SC that examination of the Company’s MAA shall continue according to schedule.

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The Day-120 List of Questions were issued by the Committee for Medicinal Products for Human Use (CHMP) as part of the centralized review process for resminostat (Kinselby), an orally available treatment for Cutaneous T-cell Lymphoma (CTCL).

Subject to the EMA’s decision, marketing authorisation approval is expected around mid-2025. This filing moves resminostat (Kinselby) another step closer to market following Orphan Drug Designation from the EMA in 2023 and from the Swiss Agency for Therapeutic Products (SwissMedic) in September 2024.

Jason Loveridge, Ph.D., CEO of 4SC, commented: "This filing marks a significant step forward for resminostat (Kinselby) as we progress ever closer to marketing authorisation approval, which is expected in mid-2025. We remain committed to bringing this much needed treatment to patients as soon as possible, and preparations for market launch are ongoing, as well as actively engaging with potential partners interested in commercializing the drug."