Pipeline

BCR-ABL Program: ELVN-001

ELVN-001, is a potent, highly selective, small molecule kinase inhibitor designed to specifically target the BCR-ABL gene fusion, the oncogenic driver for patients with chronic myeloid leukemia (CML).

Although the approval of BCR-ABL tyrosine kinase inhibitors (TKIs) has improved the life expectancy of patients with CML significantly, tolerability, safety, resistance and patient convenience concerns have become more prominent as patients can now expect to live on therapy for decades. These issues can result in the loss of molecular response and disease progression for many patients and drive approximately 20% of patients to switch therapy within the first year of therapy and approximately 40% to switch in the first five years of therapy. 

As a highly selective active site inhibitor, ELVN-001 has a unique mechanism of action, and therefore potentially represents a complementary option to allosteric BCR-ABL inhibitors, which may play an increasingly important role in the standard of care.

ELVN-001 was also designed to have activity against the T315I mutation, the most common BCR-ABL mutation, which confers resistance to nearly all approved TKIs as well as activity against mutations known to confer resistance to allosteric BCR-ABL inhibitors. Importantly, ELVN-001 was designed to be a more attractive option for patients with comorbidities, on concomitant medications or desiring more freedom from stringent administration requirements.

ELVN-001 is currently being evaluated in a Phase 1 clinical trial in adults with CML. Positive proof of concept data from the study were recently announced and can be found on the Program Presentations & Publications section of the website. To learn more about the ongoing Phase 1 study, visit clinicaltrials.gov. (NCT05304377).

HER2 Program: ELVN-002

ELVN-002, is a potent, highly selective, central nervous system (CNS) penetrant and irreversible HER2 inhibitor with activity against wild type HER2 and various HER2 mutations. The overexpression, amplification or mutation of HER2 is highly associated with aggressive forms of solid cancers, including breast cancer (BRC), non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and several others.

ELVN-002 is designed to inhibit wild-type HER2 and key mutations of HER2, while sparing wild-type EGFR and avoiding EGFR-related toxicities. We believe that if ELVN-002 achieves this profile, it will be able to achieve an improved therapeutic index compared to current approved and investigational TKIs as well as provide a meaningful therapeutic option to patients with brain metastases, a key mechanism of resistance to current therapies in patients with NSCLC, BRC and other HER2 driven cancers. Additionally, ELVN-002 was specifically designed to enable rational combination therapies, which we believe will be important for the treatment of patients with metastatic HER2 overexpressing and amplified cancers. 

Due to the recent approvals and success of antibody drug conjugates (ADC) targeting HER2 expressing cancers, the HER2-altered cancer treatment paradigm is shifting. Because of this and the fact that a standard of care regimen has not been established for patients that progress or are intolerant to this new treatment modality, we believe there is a significant patient need in the post-ADC setting. Based on established clinical precedent, we believe dual HER2-targeting may represent an important treatment option for patients with HER2+ cancers, especially for those who progress or are intolerant to previously approved treatments. 

Our focus for this program is NSCLC, BRC and CRC as a single agent and/or in combination with standard of care.

ELVN-002 is currently being evaluated in a Phase 1 clinical trial in people with cancers harboring an abnormal HER2 gene. To learn more, please visit www.clinicaltrials.gov (NCT05650879).

ELVN-002 is also being evaluated in combination with trastuzumab with or without prior chemotherapy in people with HER2+ MBC and CRC. To learn more about the upcoming Phase 1 study, please visit www.clinicaltrials.gov (NCT06328738).

Additional Programs

In addition to our two parallel lead programs, we are currently pursuing several additional research stage opportunities that align with our development approach, for which we have established target product profiles. This approach led to the nomination of our third product candidate in the second quarter of 2023.

We believe that the collective experience of our team, along with the insights we develop from our initial programs, will enable us to efficiently test our preclinical hypothesis and continue to design high quality program candidates for at least one of these opportunities.