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.

On January 9, 2025 TheRas, Inc. d/b/a BridgeBio Oncology Therapeutics ("BBOT" or the "Company"), a clinical-stage biopharmaceutical company focused on RAS-pathway malignancies, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to BBO-8520, an investigational oral therapy for the treatment of adult patients with previously treated, KRASG12C-mutated metastatic non-small cell lung cancer (NSCLC) (Press release, BridgeBio, JAN 9, 2025, View Source [SID1234649558]).

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BBO-8520 is designed to inhibit the "ON and OFF" state to provide optimal target coverage and to address KRASG12C amplification and receptor tyrosine kinase activation – the two key mechanisms of adaptive resistance to current "OFF" state inhibitors. It drives substantial tumor growth inhibition in multiple preclinical models, even after emergence of resistance to sotorasib, an FDA approved "OFF" state inhibitor of KRASG12C.i The discovery of BBO-8520 was the result of a collaboration between the National Cancer Institute RAS Initiative at Frederick National Laboratory for Cancer Research, Lawrence Livermore National Laboratory, and BBOT.

"Receiving Fast Track designation for BBO-8520 is a significant milestone in our efforts to overcome the limitations of existing therapies for KRASG12C-mutant cancers," said Yong Ben, MD, Chief Medical and Development Officer of BBOT. "BBO-8520 represents a first-in-class approach with potential to address high unmet medical needs and shift the paradigm for cancer treatment. We will continue to work closely with the FDA to expedite the development of BBO-8520, which is currently being evaluated in a Phase 1 study (NCT06343402) of KRASG12C NSCLC patients pre-treated with first generation KRASG12C "OFF" inhibitors or with no prior KRASG12C targeted therapy experience."

Fast Track designation is intended to help rapidly advance the development and review process for promising therapeutic candidates for serious conditions that may fill an unmet medical need.

On January 9, 2025 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a leading clinical-stage precision oncology company, reported a re-alignment of resources and a re-prioritization of its clinical portfolio to focus on the continued advancement of its Phase 1 clinical programs, RP-1664 (PLK4 inhibitor) and RP-3467 (Polθ ATPase inhibitor) (Press release, Repare Therapeutics, JAN 9, 2025, View Source [SID1234649557]). Repare also announced its intention to seek partnering opportunities across its portfolio, including for lunresertib and camonsertib ("Lunre+Camo") prior to any start of pivotal development. The consequent savings of late-stage clinical funding combined with planned cost and headcount reductions are expected to extend Repare’s cash runway into mid-2027.

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"While Lunre+Camo demonstrated positive results from our Phase 1 clinical trial, after careful consideration we have decided to progress this program into pivotal trials contingent on securing a strategic partner to fund further development. We are focused on achieving near-term inflection points for our Phase 1 clinical assets, RP-1664 and RP-3467, both of which have the potential to address significant unmet patient needs and deliver important catalysts in 2025," said Lloyd M. Segal, President and Chief Executive Officer of Repare. "Combined with other initiatives, these changes, which we will implement later this quarter, provide the foundation for meaningful value creation."

Recent Pipeline Progress & Upcoming Milestones of Prioritized Clinical Programs:

RP-1664: First-in-class, highly selective, oral inhibitor of PLK4

Repare is evaluating RP-1664 as a monotherapy in the Phase 1 LIONS clinical trial in adult and adolescent patients with TRIM37-high solid tumors.

Upcoming Expected Milestones:

Q3 2025: Initiation of a Phase 1/2 expansion trial in pediatric neuroblastoma
Q4 2025: Initial topline safety, tolerability and early efficacy data from the LIONS trial
Mid-2026: Trial completion, final trial readout for proof-of-concept from the LIONS trial
RP-3467: Potential best-in-class Polθ ATPase inhibitor

Repare is dosing patients in the Phase 1 POLAR clinical trial evaluating RP-3467 alone and in combination with the poly-ADP ribose polymerase (PARP) inhibitor, olaparib. This trial is enrolling patients with locally advanced or metastatic epithelial ovarian cancer, metastatic breast cancer, metastatic castration-resistant prostate cancer, or pancreatic adenocarcinoma.

Upcoming Expected Milestones:

Q3 2025: Topline safety, tolerability and early efficacy data from the POLAR trial in monotherapy and in combination with olaparib.
Lunresertib and Camonsertib

Repare recently reported positive efficacy and safety data from the Phase 1 MYTHIC gynecologic expansion clinical trial evaluating the combination of lunresertib and camonsertib (Lunre+Camo) at the recommended Phase 2 dose (RP2D) in patients with endometrial cancer (EC) and platinum-resistant ovarian cancer (PROC). Nearly half of patients with gynecologic cancers maintained progression-free survival (PFS) at 24 weeks, comparing favorably to PFS for current standard of care. Repare intends to seek partnering opportunities for this program as a condition to advancing the program into planned and regulatory-supported pivotal development.

Repare is currently evaluating lunresertib in combination with Debio 0123, a highly selective, brain-penetrant, clinical WEE1 inhibitor, in patients with advanced solid tumors harboring CCNE1 amplification or FBXW7 or PPP2R1A deleterious alterations as part of an ongoing 50/50 cost sharing collaboration with Debiopharm.

The Company will not continue to develop lunresertib or camonsertib in other studies, including the ongoing camonsertib non-small cell lung cancer expansion study, absent securing a partnership with a development partner.

Upcoming Expected Milestone:

Q2 2025: Enrollment completion of MYTHIC trial evaluating lunresertib in combination with Debio 0123 (WEE1 inhibitor)
Cash Position and Financial Guidance:

Repare ended 2024 with approximately $153 million in cash, cash equivalents and marketable securities, which is anticipated with the implementation of the cost-saving measures announced above to fund the Company’s streamlined operations into mid-2027.