ELVN-001 / Enliven Therapeutics - LARVOL DELTA

ELVN-001, a highly selective ATP-competitive ABL1 tyrosine kinase inhibitor for the treatment of chronic myeloid leukemia alone or in combination with asciminib (AACR 2025) - "While the active-site TKI ponatinib is active against T315I, its poor kinome selectivity limits its clinical utility. Finally, ENU mutagenesis screens were conducted in a Ba/F3 BCR-ABL1 line with ELVN-001 and asciminib, alone and in combination. Results of these studies and their impact on the clinical utility of this combination will be discussed."

Combination therapy • Chronic Myeloid Leukemia • Hematological Malignancies • Leukemia • Oncology • ABL1 • BCR • FLT3 • KDR • KIT

Enliven Therapeutics Announces Poster Presentations at the 2025 AACR Annual Meeting (PRNewswire) - "Enliven Therapeutics...announced the Company will present five posters at the upcoming American Association for Cancer Research (AACR) Annual Meeting..."

Clinical data • Preclinical • Chronic Myeloid Leukemia • Solid Tumor

Enliven Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides a Business Update (PRNewswire) - "Recent Research and Development Highlights and Upcoming Milestones: ELVN-001...(i) The U.S. Food and Drug Administration (FDA) granted orphan drug designation to ELVN-001 for the treatment of chronic myeloid leukemia (CML); (ii) The first patient was dosed in the Phase 1 trial evaluating ELVN-001 in Japanese patients with CML (NCT06787144); (iii) The Company plans to report additional data from the ongoing Phase 1a/b trial in the middle of 2025."

Orphan drug • P1 data • Trial status • Chronic Myeloid Leukemia

CML: ELVN-001 for the Treatment of Chronic Myeloid Leukemia With and Without T315I Mutation in Japanese Participants (clinicaltrials.gov) - P1 | N=21 | Recruiting | Sponsor: Enliven Therapeutics

New P1 trial • Chronic Myeloid Leukemia • Hematological Malignancies • Leukemia • Oncology

Study to Assess the Safety, Tolerability and Pharmacokinetics Of ELVN-001 In Normal Healthy Participants (ANZCTR) - P1 | N=80 | Completed | Sponsor: Enliven Therapeutics, Inc. | Recruiting ➔ Completed

Trial completion • Chronic Myeloid Leukemia

Enliven Therapeutics Reports Third Quarter Financial Results and Provides a Business Update (PRNewswire) - "Pipeline Updates: (i) ELVN-001:...The Company plans to report additional Phase 1 data in 2025 and is expected to include between approximately 60-100 patients across various lines of therapy with significant follow-up; (ii) ELVN-002:...Enliven plans to report Phase 1 data from the ongoing trials in 2025."

P1 data • Chronic Myeloid Leukemia • Colorectal Cancer • HER2 Positive Breast Cancer

First safety and efficacy data for ELVN-001, a selective BCR::ABL1 inhibitor in CML (DGHO 2024) - P1 | "Median number of prior TKIs was 3 (range 1-9) with most patients having received ≥3 prior TKIs, including ponatinib and/or asciminib. ELVN-001 demonstrated a favorable safety profile to date and was well tolerated across dose levels. Despite the heavily pretreated patient population, encouraging preliminary efficacy was observed."

Clinical • Chronic Myeloid Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Neutropenia • Oncology • Pain • Pancreatitis • Thrombocytopenia • ABL1 • HCK • KDR

Enliven Therapeutics Announces Positive Data Update from Phase 1 Clinical Trial of ELVN-001 in Chronic Myeloid Leukemia (GlobeNewswire) - P1a/1b | N=180 | NCT05304377 | "Enliven Therapeutics...announced updated, positive data from the Phase 1 clinical trial evaluating ELVN-001...at the European Society of Hematology International Chronic Myeloid Leukemia Foundation (ESH-iCMLf) 26th Annual John Goldman Conference....The updated data presented today includes 39 patients across various dose levels, 18 of whom were evaluable for molecular response by 24 weeks....A cumulative major molecular response (MMR) rate of 44.4% (8/18) was observed by 24 weeks in response-evaluable CML patients....Among the 16 patients previously evaluated for efficacy, all 16 had stable or deepening responses between weeks 12 and 24. Among TKI-resistant patients, ELVN-001 achieved a cumulative MMR rate of 41.7% (5/12) by 24 weeks. Among post-asciminib patients, ELVN-001 achieved a cumulative MMR rate of 40.0% (4/10) by 24 weeks."

P1 data • Chronic Myeloid Leukemia

Preliminary safety and efficacy of ELVN-001, a selective active site inhibitor of BCR::ABL1 in CML (ESH-CML 2024) - No abstract available

Clinical • Chronic Myeloid Leukemia • ABL1

Enliven Therapeutics Announces Details Regarding the Presentation of Updated ELVN-001 Phase 1a Data at the ESH-iCMLf 26th Annual John Goldman Conference on CML (GlobeNewswire) - "Enliven Therapeutics, Inc...announced details for the updated ELVN-001 Phase 1a data, which was selected for an oral presentation at the upcoming European Society of Hematology International Chronic Myeloid Leukemia Foundation (ESH-iCMLf) 26th Annual John Goldman Conference taking place September 27-29 in Prague, Czech Republic."

P1 data • Chronic Myeloid Leukemia • Hematological Malignancies • Leukemia • Oncology

Enliven Therapeutics director sells over $31k in company stock (Investing.com) - "In a recent transaction, Enliven Therapeutics, Inc...director Richard A. Heyman sold shares of the company's common stock, with the total sale amount exceeding $31,000...This transaction was publicly disclosed as required by the Securities and Exchange Commission (SEC) regulations, which mandate company insiders to report their trading activities...Meanwhile, Baird initiated coverage on Enliven Therapeutics, assigning an Outperform rating and a price target of $32. The firm highlighted Enliven's robust chemistry team and promising results from their lead assets, ELVN-001 and ELVN-002....These developments come as Enliven Therapeutics secured approximately $90 million in private investment in public equity (PIPE) financing, projected to extend the company's cash runway into late 2026. This funding will cover several key clinical milestones for its lead programs, ELVN-001 and ELVN-002."

Financing • Stock price • Breast Cancer • Chronic Myeloid Leukemia • CNS Disorders • Colorectal Cancer • Gastrointestinal Cancer • Hematological Malignancies • HER2 Breast Cancer • HER2 Positive Breast Cancer • Leukemia • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Enliven Therapeutics Reports First Quarter Financial Results and Provides a Business Update (GlobeNewswire) - "ELVN-001: Phase 1b data is expected in 2025 and is expected to include between approximately 60-100 patients across various lines of therapy with significant follow-up."

P1 data • Chronic Myeloid Leukemia • Oncology

Enliven Therapeutics Announces Positive Proof of Concept Data from Phase 1 Clinical Trial of ELVN-001 in Chronic Myeloid Leukemia (GlobeNewswire) - P1a/1b | N=180 | NCT05304377 | Sponsor: Enliven Therapeutics | "Enliven Therapeutics, Inc...announced positive proof of concept data from the Phase 1 clinical trial evaluating ELVN-001 in patients with chronic myeloid leukemia (CML) who are relapsed, refractory, or intolerant to available tyrosine kinase inhibitors (TKIs) (NCT05304377)...ELVN-001 achieved a cumulative major molecular response (MMR) rate of 44% (7/16) by 12 weeks and demonstrated responses in patients with prior exposure to asciminib and/or who were TKI-resistant: Among post-asciminib patients, ELVN-001 achieved a cumulative MMR rate of 44% (4/9) by 12 weeks; Among TKI-resistant patients, ELVN-001 achieved a cumulative MMR rate of 40% (4/10) by 12 weeks....The discussion will cover details of ELVN-001’s Phase 1 initial proof of concept data, the evolving treatment paradigm in CML, and how ELVN-001 could fit into the CML landscape."

Clinical • P1 data • Chronic Myeloid Leukemia • Hematological Malignancies • Leukemia • Oncology

Enliven Therapeutics to Share Initial Proof of Concept Data from Phase 1 Clinical Trial of ELVN-001 and Host Virtual Key Opinion Leader Event on April 11, 2024 (GlobeNewswire) - "Enliven Therapeutics...announced it will host a webcast on Thursday, April 11, 2024, at 8:00 a.m. ET to discuss initial proof of concept data on ELVN-001 and the evolving chronic myeloid leukemia (CML) landscape."

P1 data • Chronic Myeloid Leukemia

ELVN-001-101: A Phase 1a/1b Study of ELVN-001 for the Treatment Chronic Myeloid Leukemia (clinicaltrials.gov) - P1 | N=180 | Recruiting | Sponsor: Enliven Therapeutics | N=120 ➔ 180

Enrollment change • Chronic Myeloid Leukemia • Hematological Malignancies • Leukemia • Oncology

Enliven Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides a Business Update (GlobeNewswire) - "ELVN-001: The first clinical data disclosure is expected in the second quarter of 2024; ELVN-002: The Company’s Investigational New Drug (IND) application to evaluate ELVN-002 in combination with trastuzumab +/- chemotherapeutic agents in adults with HER2+ metastatic breast cancer (MBC) and colorectal cancer (CRC) received U.S. Food and Drug Administration (FDA) clearance. Dosing of the first patient is expected by mid-2024...The ongoing Phase 1a dose escalation...is nearly complete...The initial data disclosure for ELVN-002 is expected in 2024."

P1 data • Breast Cancer • Chronic Myeloid Leukemia • Colorectal Cancer • Gastrointestinal Cancer • Hematological Malignancies • Leukemia • Oncology • Solid Tumor

Enliven Therapeutics Announces $90 Million Private Placement Financing and Provides Pipeline Updates (GlobeNewswire) - "Enliven Therapeutics, Inc...announced that it has entered into a securities purchase agreement for a private investment in public equity (PIPE) financing that is expected to result in gross proceeds of approximately $90 million, before deducting offering expenses...'The additional funding further strengthens our balance sheet and enables us to achieve critical, longer-term clinical milestones as we advance our parallel lead programs, ELVN-001 and ELVN-002.'...More detailed ELVN-001 data will be presented at the April 11^th KOL event....ELVN-001: In 2025, Phase 1b data including between approximately 60-100 patients across various lines of therapy with significant follow-up; By the end of 2025, initial regulatory interactions with the aim of achieving regulatory path clarity regarding the first head-to-head pivotal trial."

Financing • P1 data • Regulatory • Breast Cancer • Chronic Myeloid Leukemia • Colorectal Cancer • Gastrointestinal Cancer • Hematological Malignancies • HER2 Breast Cancer • HER2 Positive Breast Cancer • Leukemia • Oncology • Solid Tumor

A study to evaluate safety, tolerability and pharmacokinetics of ELVN-001 in Normal Healthy Participants- Part A (ANZCTR) - P1 | N=15 | Not yet recruiting | Sponsor: Enliven Therapeutics, Inc.

New P1 trial • Chronic Myeloid Leukemia • CNS Disorders • Hematological Malignancies • Leukemia • Movement Disorders • Oncology • Parkinson's Disease

A study to evaluate safety, tolerability and pharmacokinetics of ELVN-001 in Normal Healthy Participants- Part B (ANZCTR) - P1 | N=15 | Not yet recruiting | Sponsor: Enliven Therapeutics, Inc.

New P1 trial • Chronic Myeloid Leukemia • CNS Disorders • Hematological Malignancies • Leukemia • Movement Disorders • Oncology • Parkinson's Disease

ELVN-001-101: A Phase 1a/1b Study of ELVN-001 for the Treatment Chronic Myeloid Leukemia (clinicaltrials.gov) - P1 | N=120 | Recruiting | Sponsor: Enliven Therapeutics | Phase classification: P1a/1b ➔ P1

Phase classification • Chronic Myeloid Leukemia • Hematological Malignancies • Leukemia • Oncology

Study to Assess the Safety, Tolerability and Pharmacokinetics Of ELVN-001 In Normal Healthy Participants (ANZCTR) - P1 | N=80 | Recruiting | Sponsor: Enliven Therapeutics, Inc.

New P1 trial • Chronic Myeloid Leukemia

First‑in‑Human Phase I Study of ELVN‑001, an Oral, Selective BCR::ABL1 Tyrosine Kinase Inhibitor, in Patients With Chronic Myeloid Leukemia Who Failed Prior Tyrosine Kinase Inhibitors (SOHO 2023) - P1a/1b | "Secondary endpoints are PK and molecular response, and for phase Ib, duration of molecular response, BCR::ABL1 transcript levels, and complete hematologic response. Ongoing analyses will determine the RDE of ELVN-001 and evaluate its safety and PK profile while assessing preliminary efficacy."

Clinical • P1 data • Breast Cancer • Chronic Myeloid Leukemia • Hematological Malignancies • Leukemia • Oncology • Solid Tumor • ABL1

Enliven Therapeutics Reports Second Quarter 2023 Financial Results and Highlights Recent Company Progress (GlobeNewswire) - "Patient enrollment and dose escalation continue to progress in the Phase 1 clinical trial evaluating ELVN-001 in adults with chronic myeloid leukemia (CML) (NCT05304377) and the Phase 1 clinical trial evaluating ELVN-002 in patients with solid tumors with HER2 alterations (NCT05650879). Initial safety and efficacy data from the Phase 1a trials are expected to be reported in 2024."

P1 data • Trial status • Chronic Myeloid Leukemia • Hematological Malignancies • Leukemia • Oncology • Solid Tumor

TRIALS IN PROGRESS: FIRST-IN-HUMAN STUDY OF ELVN-001, A SELECTIVE BCR::ABL1 TYROSINE KINASE INHIBITOR, IN PATIENTS WITH CHRONIC MYELOID LEUKEMIA WHO FAILED PREVIOUS TYROSINE KINASE INHIBITOR THERAPIES (EHA 2023) - P1a/1b | "Ba/F3 cells expressing a range of the most prevalent on-target BCR::ABL1 resistance mutants indicated that with the exception of certain P-loop mutations and F317L, ELVN-001 maintained potency, including for the myristoyl pocket mutations A344P and P465S and was active against the M244V mutation, an ATP pocket mutation known to confer resistance to asciminib. This FIH study will evaluate dosing, safety, tolerability, PK profile, and preliminary efficacy of ELVN-001 in CP-CML with and without T315I mutation. Study sponsor: Enliven Therapeutics. NCT05304377 BCR::ABL, Chronic myeloid leukemia, Tyrosine kinase inhibitor, Phase I"

Clinical • P1 data • Bone Marrow Transplantation • Chronic Myeloid Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Oncology • Transplantation • ABL1 • KDR • LYN

Enliven Therapeutics Highlights Business Achievements and Reports First Quarter 2023 Financial Results (Yahoo News) - "ELVN-002: Dosed the first patient in the Phase 1 clinical trial evaluating ELVN-002 in people with cancers harboring an abnormal HER2 gene....The Company expects to share initial safety and efficacy data from the Phase 1a study in 2024. ELVN-001: Continued progress in the dose escalation portion of the Phase 1 clinical trial evaluating ELVN-001 in adults with CML....The Company expects to share initial safety and efficacy data from the Phase 1a study in 2024."

P1 data • Trial status • Breast Cancer • Chronic Myeloid Leukemia • Hematological Malignancies • HER2 Breast Cancer • HER2 Positive Breast Cancer • Leukemia • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer