ELVN-002 / Enliven Therapeutics - LARVOL DELTA

ELVN-002; a potent, selective HER2 inhibitor with a differentiated binding mode conferring the potential for enhanced efficacy in combination with HER2-targeting antibody-drug conjugates (AACR 2025) - "While trastuzumab deruxtecan (T-DXd), a HER2-targeting antibody-drug conjugate (ADC) recently approved for HER2 altered cancer types, has resulted in improved outcomes there remains a substantial unmet need for patients who either progress on T-DXd or discontinue treatment due to adverse events. In contrast, treatment with other HER2 inhibitors results in increased cell surface HER2 retention and decreased internalization suggesting a decrease in cytotoxic payload deposition if combined with an ADC. The differentiated profile and mechanism of ELVN-002 has the potential to be a superior treatment in HER2 expressing cancers in combination with ADCs, other modalities, and as a single agent."

Clinical • Combination therapy • Breast Cancer • Gastric Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

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-002:...(i) Enliven continued to enroll patients in its Phase 1 trial evaluating ELVN-002 as a monotherapy agent in patients with HER2+ and HER2 mutant tumors and its exploratory cohort in combination with Kadcyla (an approved HER2 antibody drug conjugate) in patients with HER2+ metastatic breast cancer (MBC) (NCT05650879); (ii) Additionally, the Company continued to enroll patients in its Phase 1 trial evaluating ELVN-002 in combination with trastuzumab +/- chemotherapeutic agents in patients with HER2+ MBC and colorectal cancer (CRC) and began dosing patients in the Phase 1b trial specifically evaluating patients with CRC (NCT06328738); (iii) Enliven plans to report data from the ongoing Phase 1 trials in the second half of 2025."

P1 data • Trial status • Colorectal Cancer • HER2 Positive Breast Cancer

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

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-002: Following U.S. Food and Drug Administration approval of its Investigational New Drug application, the Company activated the first site to evaluate ELVN-002 in combination with trastuzumab +/- chemotherapeutic agents in HER2+ metastatic breast cancer (MBC) and colorectal cancer (CRC). First patient dosing for the combination trial is expected in Q2 2024; Phase 1 monotherapy data, Phase 1a/b Herceptin combination data in HER2+ CRC, and initial Phase 1a combination data in HER2+ MBC are expected in 2025."

P1 data • Trial status • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Solid Tumor

A Study of ELVN-002 in Healthy Adult Volunteers: Part A (ANZCTR) - P1 | N=48 | Terminated | Sponsor: Enliven Therapeutics, Inc. | Not yet recruiting ➔ Terminated

Trial termination • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study of ELVN-002 in Healthy Adult Volunteers: Part B (ANZCTR) - P1 | N=6 | Withdrawn | Sponsor: Enliven Therapeutics, Inc. | Not yet recruiting ➔ Withdrawn

Trial withdrawal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

ELVN-002 With Trastuzumab +/- Chemotherapy in HER2+ Solid Tumors, Colorectal and Breast Cancer (clinicaltrials.gov) - P1 | N=255 | Recruiting | Sponsor: Enliven Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Breast Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

ELVN-002 With Trastuzumab +/- Chemotherapy in HER2+ Solid Tumors, Colorectal and Breast Cancer (clinicaltrials.gov) - P1 | N=255 | Not yet recruiting | Sponsor: Enliven Therapeutics

Metastases • New P1 trial • Breast Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Enliven Therapeutics Announces $90 Million Private Placement Financing and Provides Pipeline Updates (GlobeNewswire) - "Recent Research and Development Updates and Upcoming Milestones...Following the U.S. Food and Drug Administration’s approval of its Investigational New Drug (IND) application, the Company recently activated its first site to evaluate ELVN-002 in combination with trastuzumab +/- chemotherapeutic agents in adults with HER2+ metastatic breast cancer (MBC) and colorectal cancer (CRC). Dosing of the first patient in the combination study is expected in Q2 2024....In 2025, Phase 1 monotherapy data, Phase 1a/b Herceptin combination data in HER2+ CRC, and initial Phase 1a combination data in HER2+ MBC."

IND • New P1 trial • P1 data • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HER-2

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

ELVN-002 in HER2 Mutant Non-Small Cell Lung Cancer (clinicaltrials.gov) - P1 | N=178 | Recruiting | Sponsor: Enliven Therapeutics | Phase classification: P1a/1b ➔ P1

Phase classification • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • BRAF • ROS1

Trials in Progress: Phase 1a/b study of ELVN-002, in Solid Tumors with HER2 Mutations, Amplification or Overexpression (IASLC-WCLC 2023) - "Additionally, ELVN-002 in combination with ado-trastuzumab emtansine (T-DM1) or trastuzumab deruxtecan (T-DXd) exhibited increased anti-tumor activity in vivo compared to either drug alone.Non-clinical data suggests ELVN-002 has a favorable pharmacokinetic (PK) profile and low risk of QTc prolongation. The trial opened for enrollment in February 2023.Study sponsor: Enliven Therapeutics. NCT0565087"

IO biomarker • P1 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • HER-2

A Study of ELVN-002 in Healthy Adult Volunteers: Part A (ANZCTR) - P1 | N=48 | Not yet recruiting | Sponsor: Enliven Therapeutics, Inc.

New P1 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study of ELVN-002 in Healthy Adult Volunteers: Part B (ANZCTR) - P1 | N=6 | Not yet recruiting | Sponsor: Enliven Therapeutics, Inc.

New P1 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study of ELVN-002 in Healthy Adult Volunteers: Part C (ANZCTR) - P1 | N=24 | Recruiting | Sponsor: Enliven Therapeutics, Inc. | Initiation date: May 2000 ➔ May 2023

Trial initiation date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Phase 1a/b Study of ELVN-002, In Solid Tumors with HER2 Mutations, Amplification or Overexpression (IASLC-WCLC 2023) - "Additionally, ELVN-002 in combination with ado-trastuzumab emtansine (T-DM1) or trastuzumab deruxtecan (T-DXd) exhibited increased anti-tumor activity in vivo compared to either drug alone.Non-clinical data suggests ELVN-002 has a favorable pharmacokinetic (PK) profile and low risk of QTc prolongation. Sponsor: Enliven Therapeutics. NCT0565087"

IO biomarker • P1 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • HER-2

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

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

Preclinical Activity of ELVN-002: A Potent, Selective, Irreversible and CNS Penetrant HER2 and pan-HER2 Mutant Small-Molecule Inhibitor for the Treatment of HER2-Driven Malignancies (AACR 2023) - "Enhertu (T-DXd), a HER2-specific antibody-drug conjugate was recently approved as an important therapy for this patient population...Currently, tucatinib is the only HER2-selective small molecule inhibitor approved for metastatic breast cancer in combination with trastuzumab and capecitabine...Additionally, ELVN-002 could provide a meaningful therapeutic option for patients with CNS metastases. ELVN-002 has been selected for clinical development."

Preclinical • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HER-2

ELVN-002 in HER2 Mutant Non-Small Cell Lung Cancer (clinicaltrials.gov) - P1a/1b | N=178 | Recruiting | Sponsor: Enliven Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • BRAF • ROS1

ELVN-002 in HER2 Mutant Non-Small Cell Lung Cancer (clinicaltrials.gov) - P1a/1b | N=178 | Not yet recruiting | Sponsor: Enliven Therapeutics

New P1 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • BRAF • ROS1