Enliven Therapeutics
🇺🇸United States
- Country
- 🇺🇸United States
- Ownership
- Public
- Employees
- 46
- Market Cap
- $1B
- Introduction
Enliven Therapeutics, Inc. operates as a clinical stage precision oncology company. It is focused on the discovery and development of next-generation small molecule kinase inhibitors and advancing Enliven's pipeline of precision oncology product candidates. The company was founded by Sam S. Kintz, Joe P. Lyssikatos, and Anish Patel in June 2019 and is headquartered in Boulder, CO.
Leap Therapeutics Halves Workforce and Refocuses Cancer Drug Development Amid Market Challenges
• Leap Therapeutics has announced a significant restructuring, reducing its workforce by approximately 50% and narrowing the development focus of its lead cancer drug candidate in response to challenging market conditions.
• The strategic pivot aims to extend the company's cash runway while concentrating resources on the most promising clinical applications of its lead oncology asset, potentially improving its chances for regulatory success.
• This move follows similar restructuring trends across the biotech sector, with companies like Arcturus, NGM Bio, and Erasca all recently announcing staff reductions and pipeline reprioritizations to navigate the difficult funding environment.
Arvinas Advances Vepdegestrant into Phase 3 Trials for Breast Cancer and Updates Pipeline Milestones
• Arvinas plans to initiate two Phase 3 trials in 2025 for vepdegestrant in ER+/HER2- metastatic breast cancer, one in the first-line setting with atirmociclib and another in the second-line setting with a CDK4/6 inhibitor.
• Topline data from the Phase 3 VERITAC-2 monotherapy trial of vepdegestrant in second-line-plus ER+/HER2- metastatic breast cancer is anticipated in the first quarter of 2025.
• Arvinas is set to present initial data from the Phase 1 trial of ARV-393 in B-cell lymphomas and file an IND application for a novel PROTAC KRAS G12D degrader in 2025.
• Phase 1 trial with PROTAC LRRK2 degrader ARV-102 in patients with Parkinson’s disease has been initiated, with data expected to be presented in the first half of 2025.
FDA Approves New Cancer Treatments Amidst Rising Global Cancer Rates
• The FDA issued 16 oncology approvals between July and September 2024, addressing the global surge in cancer cases, particularly among individuals under 50.
• Oncolytics Biotech is advancing pelareorep, with plans to submit a clinical trial for HR+/HER2- breast cancer to the FDA in early 2025, following positive BRACELET-1 trial results.
• AbbVie has submitted a BLA for telisotuzumab vedotin for previously treated non-small cell lung cancer (NSCLC) with c-Met protein overexpression.
• HUTCHMED's partner, Takeda, received approval in Japan for FRUZAQLA (fruquintinib) for previously treated metastatic colorectal cancer (CRC).
Enliven Therapeutics' ELVN-001 Shows Promising Phase 1 Data in Chronic Myeloid Leukemia
• Enliven Therapeutics announced updated Phase 1 data for ELVN-001, presented at the ESH-iCMLf conference, showing clinical benefit in heavily pretreated CML patients.
• The trial reported a cumulative major molecular response (MMR) rate of 44.4% by 24 weeks in response-evaluable CML patients treated with ELVN-001.
• ELVN-001 continues to exhibit a favorable safety profile, with no dose reductions reported and a median treatment duration of 20 weeks across 39 patients.
• These results suggest ELVN-001's potential to address limitations of current active-site TKIs, particularly for patients who have failed allosteric inhibitors.
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