On January 09, 2025 Light Horse Therapeutics Inc., a developer of first-in-class small molecule therapeutics, announced a multi-target collaboration with Novartis to identify and develop potentially first-in-class therapeutics using the biotech’s platform (Press release, Light Horse Therapeutics, JAN 9, 2025, View Source [SID1234649563]). Under the terms of the agreement, Light Horse will receive a $25 million upfront payment. The company is also eligible for $1 billion in further research, development and sales milestones, in addition to royalties on licensed therapeutics. Further details are undisclosed.

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"Light Horse’s high-caliber team has built a cutting-edge discovery platform that rapidly enables the exploration of core biological areas of interest, the identification of novel targets and the functionalization of high-value targets," said John Tallarico, Head of Discovery Sciences at Novartis. "This collaboration has the potential to create first-in-class therapeutics capable of driving meaningful benefit for patients."

"The Novartis collaboration presents an extraordinary opportunity to leverage our unbiased genetic screening platform and proprietary chemical libraries to address novel, high-value targets previously considered hard to drug," said Light Horse CEO Markus Renschler, MD. "We are excited to work with the Novartis team to potentially accelerate the development of innovative cancer treatments over the coming years."

On January 9, 2025 A2 Biotherapeutics, Inc. (A2 Bio), a clinical-stage cell therapy company developing first-in-class logic-gated cell therapies to selectively target tumor cells and protect normal cells, reported the closing of its $80 million Series C financing round, supported by a syndicate of investors that includes The Column Group and Samsara BioCapital (Press release, A2 Biotherapeutics, JAN 9, 2025, View Source [SID1234649562]). Proceeds will fund the company’s three clinical development programs and advancement of its pipeline of CAR-T cell therapies based on its proprietary Tmod platform technology.

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"We are excited by the initial clinical data from our lead programs, which we believe validates our proprietary logic-gate technology approach to solid tumor cancers," said Jim Robinson, chief executive officer of A2 Bio. "This funding will enable us to continue ongoing clinical development of our CAR-T cell therapies as well as fund the potential next phase of development."

A2 Bio is currently conducting two seamless phase 1/2 clinical studies: EVEREST-1 studying A2B530 for pancreatic, lung and colorectal cancers by targeting carcinoembryonic antigen (CEA); and EVEREST-2 studying A2B694 for pancreatic, ovarian, lung, colorectal and mesothelioma cancers by targeting mesothelin (MSLN). Patients are enrolled in EVEREST-1 and EVEREST-2 through the BASECAMP-1 prescreening study. BASECAMP-1 utilizes artificial intelligence (AI)-enabled precision diagnostics, as a cost-effective, high-yield approach to identify eligible patients for all A2 Bio clinical studies.1

A2 Biotherapeutics, established in 2018, is a fully integrated discovery, development and manufacturing company based in Agoura Hills, Calif. A2 Bio plans to direct the Series C funds to support the company’s three clinical studies, as well as to advance preclinical programs using its Tmod platform for potential clinical targets representing significant unmet needs in cancer and beyond.

About the Tmod Platform

A2 Bio has pioneered a precision-targeting cellular system – the Tmod platform – that incorporates two receptors, an activator and a blocker, to aim the powerful armaments of immune cells directly at tumors to unequivocally differentiate tumors from normal tissues. The activator recognizes antigens on tumor cells that trigger their destruction, while the blocker recognizes antigens on normal cells that protect them. This novel blocker technology enables precise, personalized and effective T cell targeting. The blocker component equips Tmod cells with the capacity to identify tumors as distinct from normal cells.

On January 9, 2025 Nimbus Therapeutics, LLC ("Nimbus Therapeutics" or "Nimbus"), a biotechnology company that designs and develops breakthrough medicines for patients through its powerful computational drug discovery engine, reported the advancement of its clinical oncology therapeutic pipeline, and the appointment of Peter J. Tummino, Ph.D., to President of Research and Development (Press release, Nimbus Therapeutics, JAN 9, 2025, View Source [SID1234649561]). Dr. Tummino will be responsible for advancing the company’s product portfolio through all phases of discovery and clinical development.

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The company announced the completion of an investigational new drug (IND) application submission for NDI-219216, a novel Werner syndrome helicase (WRN) inhibitor in development for the treatment of microsatellite instability high (MSI-H) tumors. Nimbus plans to initiate the first clinical trial of NDI-219216 in the first half of 2025 under the leadership of Anita Scheuber, M.D., Ph.D., Senior Vice President, Therapeutic Area Head, Oncology.

"We are encouraged by the building momentum in our oncology portfolio including important advances in our non-covalent WRN inhibitor program, with data indicating NDI-219216 has the potential to be a best-in-class agent," said Dr. Tummino.

"NDI-219216 has demonstrated compelling preclinical data, including significant tumor regression and complete responses at low oral doses across tumor types. The preclinical safety studies suggest a promising benefit-risk profile as we prepare to evaluate this compound in patients. We are excited to advance NDI-219216 into a first-in-human clinical trial later this year," said Dr. Scheuber.

The company recently completed its Phase 1/2 clinical study of NDI-101150, a highly selective and potent hematopoietic progenitor kinase 1 (HPK1) inhibitor, for the treatment of advanced solid tumors. Clinical data presented in November 2024 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 39th Annual Meeting demonstrated monotherapy efficacy with a favorable safety profile that supports potential combination therapy approaches. The company is actively evaluating opportunities to maximize the therapeutic potential of this program.

Nimbus continues to progress drug discovery efforts across metabolic and autoimmune targets as well, including the development of novel therapies that activate AMP-activated protein kinase (AMPK) to treat metabolic disorders as part of an ongoing research collaboration and exclusive worldwide license agreement with Eli Lilly and Company. Nimbus has also expanded its pipeline with the addition of new undisclosed therapeutic targets leveraging its novel computational and structure-based drug design approach.

"Nimbus made significant progress in 2024 in our discovery and development programs across oncology, immunology, and metabolism, bringing us one step closer to our ultimate goal of delivering transformative medicines to patients," said Jeb Keiper, M.S., M.B.A., Chief Executive Officer of Nimbus. "Peter’s appointment to President of R&D reflects his exceptional leadership and deep expertise in drug discovery and development, and his expanded role will be instrumental in advancing our innovative pipeline. We continue to broaden our drug discovery engine to unlock new difficult-to-drug targets with compelling biology through deep computational expertise, a breadth of internal drug discovery expertise, and key partnerships. We look forward to multiple key milestones in the coming year."

Mr. Keiper will provide an overview of the company’s progress, pipeline, and anticipated milestones for 2025 and beyond at the 43rd Annual J.P. Morgan Healthcare Conference on Monday, January 13, 2025 at 7:30 a.m. PT.

On January 9, 2025 Biocytogen (HKEX: 02315), a global biotech company dedicated to discovering and developing novel antibody therapeutics, reported the licensing of its fully human antibodies to SOTIO Biotech, a clinical-stage biopharmaceutical company owned by PPF Group (Press release, Biocytogen, JAN 9, 2025, View Source [SID1234649560]). The licensing agreement will advance the development of an innovative antibody-drug conjugate (ADC) targeting a novel tumor antigen, under the option and license agreement established between the companies. Biocytogen’s fully human antibody will support the development of SOT109, SOTIO’s new ADC candidate aimed at the treatment of colorectal cancer and other gastrointestinal (GI) cancers.

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Biocytogen’s innovative RenMice platform offers an extensive library of fully human antibodies targeting over 1,000 antigens, with over 400,000 off-the-shelf antibody sequences. The RenMab platform is specifically engineered to generate high-quality monoclonal antibodies characterized by strong immune responses, high affinity, and high specificity, without the need for additional in vitro humanization, leading to substantial time and cost savings in downstream development, expediting the development and translation of cutting-edge bispecific, multispecific antibodies, and ADC therapies.

"We are thrilled to see the remarkable progress achieved through our collaboration with SOTIO," said Yuelei Shen, Ph.D., president and chief executive officer of Biocytogen. "The fully human monoclonal antibodies developed using our RenMab platform exhibit exceptional binding and internalization capabilities, along with excellent developability. By utilizing Synaffix’s platform and combining it with SOTIO’s extensive experience in ADC development, SOT109 has been developed as a highly promising candidate, offering new hope for the treatment of colorectal and other GI cancers."

"SOT109 holds tremendous promise as a transformative treatment for colorectal cancer and other GI cancers, marking the next milestone from our innovative ADC platform. Our collaboration with Biocytogen has been instrumental in identifying a fully human and selective mAb candidate that demonstrates excellent cross-species reactivity, binding affinity, and internalization properties," said Martin Steegmaier, Ph.D., chief scientific officer of SOTIO. "We are now in the final stages of clinical candidate selection for the program, and plan to commence IND-enabling studies this month."

Under the terms of the agreement, SOTIO will pay Biocytogen an option exercise fee at license execution. Biocytogen will also be eligible to receive success-dependent development and regulatory milestone payments, commercial milestone payments, and low single-digit royalties on net sales.

On January 9, 2025 TriSalus Life Sciences, Inc. ("TriSalus" or the "Company") (Nasdaq: TLSI), TriSalus Life Sciences seeks to transform outcomes for patients with solid tumors by integrating our innovative delivery technology with standard-of-care therapies and our investigational immunotherapy, reported the publication of research titled, "Pressure Enabled Drug Delivery (PEDD) Significantly Increases Intraarterial Delivery of Embolic Microspheres to Liver Tumors in a Porcine Model," in the peer-reviewed Journal of Vascular and Interventional Radiology (Press release, TriSalus Life Sciences, JAN 9, 2025, View Source [SID1234649559]). The study, conducted in a transgenic tumor model, highlights the superior performance of the TriNav Infusion System in delivering Embospheres into liver tumors when compared to delivery with a traditional microcatheter.

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Key Findings:

Improved Tumor Penetration: PEDD achieved a 227 % increase (p=0.029) in the concentration of fluorescently labeled Embospheres within tumor tissue compared to a traditional microcatheter.
Improved Tumor Selectivity: The tumor-to-normal (T:N) ratio rose from 2.7 for a traditional microcatheter to 4.2 when delivered by PEDD, indicating more precise tumor targeting and reduced off-target delivery.
Increased Peritumoral Delivery: Delivery to peritumoral regions increased by 209% (p=0.045), demonstrating PEDD’s ability to overcome challenging tumor associated microenvironments.
"This study further validates the potential of TriNav using the PEDD approach to transform the treatment of liver tumors," said Bryan F. Cox, Ph.D., Chief of Research for TriSalus. "By significantly enhancing therapeutic delivery and sparing healthy tissue, PEDD offers a promising advancement for patients whose outcomes may be limited by conventional delivery methods."

The study was conducted using a transgenic porcine (Oncopig) liver tumor model, employing fluorescent imaging and advanced deep-learning algorithms to quantify therapeutic delivery with millimeter-scale resolution. Results showed the TriNav Infusion System using the PEDD approach markedly outperforms traditional microcatheters in delivering embolic microspheres into liver tumors.

These findings add to the growing body of clinical and real-world evidence supporting PEDD’s ability to improve the delivery of therapeutic agents for patients with primary and metastatic liver cancers.