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.
相关临床试验
11
4 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
N/A
进行中（未招募）
2
18.2%
尚未招募
2
18.2%
招募中
5
45.5%
终止
1
9.1%
撤回
1
9.1%
暂无批准数据
- Enliven Therapeutics plans to launch the pivotal Phase 3 ENABLE-2 trial for ELVN-001 in chronic myeloid leukemia in the second half of 2026. - Updated positive data from the Phase 1 ENABLE clinical trial evaluating ELVN-001 were announced earlier in June 2026. - CEO Rick Fair stated ELVN-001 has the potential to become a best-in-class therapy, citing a remaining unmet need in the CML market. - The company closed an upsized public offering generating approximately $460 million in gross proceeds, with cash runway expected into the first half of 2029.
- Enliven Therapeutics announced encouraging Phase 1b ENABLE trial data for ELVN-001 in chronic myeloid leukemia patients who are relapsed, refractory, or intolerant to available tyrosine kinase inhibitors. - The trial demonstrated major molecular response rates of 38% in the 80 mg cohort and 53% in randomized 60-120 mg cohorts, with deep molecular response rates of 16% and 35% respectively. - ELVN-001 showed a favorable safety profile with no maximum tolerated dose identified and no new safety signals across all evaluated doses. - The company plans to initiate the ENABLE-2 Phase 3 trial in the second half of 2026 based on these positive results.
- Enliven Therapeutics has appointed Rick Fair as CEO, bringing over 25 years of experience in oncology and hematology product development and commercialization. - The leadership transition positions the company for a pivotal Phase 3 trial of ELVN-001 in chronic myeloid leukemia patients, planned to initiate in 2026. - Co-founder Sam Kintz will transition to Head of Pipeline to focus on advancing the company's early-stage research programs and discovery efforts. - ELVN-001 is positioned as a potential best-in-class ATP-competitive inhibitor that could offer improved efficacy, tolerability and convenience compared to current CML treatments.
- The chronic myelogenous leukemia treatment market is expected to experience significant growth through 2032, driven by increasing disease prevalence and multiple recent FDA approvals. - Recent regulatory milestones include FDA approvals for Cipla's nilotinib capsules, Marks Shorla's oral liquid imatinib formulation, and Novartis's accelerated approval for Scemblix in newly diagnosed patients. - The market features a robust pipeline of emerging therapies from companies including Enliven Therapeutics, Terns Pharmaceuticals, and Ascentage Pharma targeting unmet needs in resistant cases. - Current epidemiological data shows approximately 9,280 new CML diagnoses expected in the US in 2024, with 85-90% of patients diagnosed during the chronic phase.
• 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 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.
