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 [SID1234649544]). 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 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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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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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 Oxford Vacmedix (OVM), the UK-based biopharma company developing vaccines to treat cancer, reported the grant of a prestigious Investor Partnership award from Innovate UK for the clinical development of its lead cancer vaccine OVM-200 (Press release, Oxford Vacmedix, JAN 9, 2025, View Source;utm_medium=rss&utm_campaign=innovate-uk-award-to-ovm-for-clinical-development-of-ovm-200 [SID1234649545]). The award is made as part of the SME Round 6 programme and will contribute to the project costs for Phase 1b for OVM-200. This phase of the trial will enroll a cohort of cancer patients to be treated with an extended dosing protocol newly approved by the UK MHRA (Medicines and Healthcare products Regulatory Agency). The award underpins OVM in attracting inward investment from outside the UK. As previously announced, this has now been achieved with the lead Series B investment from major shareholder Dx&Vx from South Korea, and with additional funding from Prostate Cancer Research. OVM will receive the award over the duration of the project.

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OVM-200 targets survivin, a protein overexpressed by cancer cells that allow unregulated growth, which stimulates an immune response. The vaccine is in a Phase 1 trial in the UK which is both the first time OVM-200 has been used in people and also the first time any ROP (Recombinant Overlapping Peptide) based vaccine has been tested in the clinic. The ongoing trial is focused on safety and on establishing an immune response in advanced cancer patients in three cancer indications: non-small-cell lung cancer (NSCLC), prostate cancer, and ovarian cancer. Initial results from Phase 1a, the dose escalation part of the trial, have shown very good safety and a strong immune response.

Partnership
OVM has a long partnership with Innovate UK and excellent track record of grants, both directly and as part of collaborations. This latest award adds to the support from Innovate UK to develop OVM’s novel groundbreaking ROP technology.

William Finch, CEO of OVM said:

This non-dilutive award from Innovate UK is hugely helpful to fund the ongoing clinical development of OVM-200 and demonstrates real confidence in our ROP technology. We are very pleased with the initial results from Phase 1a and look forward to the completion of this trial to help patients with advanced cancers.

Dr Anthony Coombs, Chairman added:

We are delighted to have this support from Innovate UK for the development of OVM-200 and to be able to incentivise inward investment into the company. The strength of UK technology is regonised worldwide and the recombinant overlapping peptides we are developing have real potential to help patients with cancer, both alone and in combination.

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 PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to changing the lives of patients with devastating diseases, reported that the U.S. Food and Drug Administration ("FDA") has granted Fast Track designation to LYT-200, a first-in-class anti-galectin-9 monoclonal antibody, for the treatment of acute myeloid leukemia ("AML") (Press release, PureTech Health, JAN 9, 2025, View Source [SID1234649546]). Fast Track designation is a process designed to streamline the development and accelerate the assessment of drugs that target serious conditions with unmet medical need.

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"Fast Track designation from the FDA reinforces our belief in the potential for LYT-200 to address the urgent needs of AML patients," said Luba Greenwood, J.D., Entrepreneur-in-Residence at PureTech who is leading the Gallop Oncology work. "This milestone builds on the FDA’s recognition of LYT-200’s promise, including Orphan Drug designation for AML and a second Fast Track designation for head and neck cancers, both of which were granted last year. By targeting galectin-9, a key driver of cancer proliferation and immune suppression, LYT-200 represents a novel and promising approach for patients in need, and we look forward to the continued development of this program."

LYT-200 exerts its therapeutic effects in AML by killing cancer cells directly via apoptosis and DNA damage as well as reactivating central anti-cancer effectors of the immune system. LYT-200 is the most advanced clinical program against galectin-9 and is being evaluated in two ongoing clinical trials, including:

1. Phase 1/2 clinical trial evaluating LYT-200 as a monotherapy and in combination with venetoclax and hypomethylating agents in hematological malignancies, including AML and high-risk myelodysplastic syndrome (MDS). In this trial, LYT-200 has demonstrated a favorable safety and tolerability profile as well as early signals of clinical activity as single agent and in combination.

2. Phase 1/2 trial in advanced/metastatic solid tumors, including head and neck

cancers. In this trial, LYT-200 is being evaluated as a monotherapy and in combination with tislelizumab, an anti-PD-1 antibody developed by BeiGene. To date, LYT-200 has demonstrated a favorable safety profile in all cohorts, including the monotherapy and combination arms with BeiGene’s tislelizumab, and shown disease control and suggestions of initial anti-tumor activity.

The FDA has also granted orphan drug designation to LYT-200 for the treatment of AML as well as a separate Fast Track designation for the treatment of recurrent/metastatic head and neck squamous cell carcinomas ("head and neck cancers"), in combination with anti-PD1 therapy. PureTech previously announced that it intends to advance LYT-200 via its Founded Entity, Gallop Oncology.

About LYT-200

LYT-200 is a fully human IgG4 monoclonal antibody targeting a foundational oncogenic and immunosuppressive protein, galectin-9, for the potential treatment of hematological malignancies and locally advanced metastatic solid tumors, including head and neck cancers, with otherwise poor survival rates. A wide variety of preclinical data support the potential clinical efficacy of LYT-200 and the importance of galectin-9 as a target and suggest a potential opportunity for biomarker development. PureTech has presented data demonstrating high expression of galectin-9 across various solid tumor types and blood cancers and has found that, in several cancers, galectin-9 levels correlate with shorter time to disease relapse and poor survival. Preclinical work also demonstrates single mechanistic and anti-tumor efficacy of LYT-200 in multiple animal and patient-derived tumor cell models. For example, LYT-200 outperforms anti-PD-1 in solid tumor models models as a single agent. LYT-200 also synergizes with anti-PD-1 in activating CD4 and CD8 T cells in in vivo cancer models. LYT-200 is currently being evaluated in two ongoing Phase 1/2 adaptive design trials for the potential treatment of AML/MDS and head and neck cancers.