Enliven Therapeutics and Imara will merge in an all-stock deal to form a precision oncology company, the companies announced Friday. The combined company plans to raise about $165 million in private financing co-led by new investors.
The new entity will operate under the name Enliven Therapeutics and trade on the Nasdaq under the ELVN ticker symbol.
In a conference call, Rahul Ballal, Ph.D., co-founder and CEO of Imara, called the deal “a compelling option for our stockholders.”
Once the deal and the raise are complete, Ballal said Enliven will have “a strong balance sheet with $300 million in cash and runway into early 2026.”
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The merged company will have “two parallel lead programs currently in development” which “offer multiple near-term milestones,” Ballal said.
The programs include ELVN-001, a highly selective small molecule BCR-ABL inhibitor, which the company hopes will be competitive with currently available ATP tyrosine kinase inhibitors (TKI) for chronic myeloid leukemia (CML). The second is ELVN-002, a potent, selective and irreversible HER2 and pan-HER2 mutant kinase inhibitor for the treatment of HER2 mutant lung cancer. It also has potential in other HER2-driven cancer types.
Sam Kintz, co-founder and CEO of Enliven, introduced the merged company’s management team and laid out the strengths of the two concurrent programs. Enliven’s current C-suite is led by Kintz, co-founder and CEO, Joe Lyssikatos, Ph.D., co-founder and CSO, Anish Patel, PharmD, co-founder and COO, Helen Collins, MD, CMO and Ben Hohl, CFO.
The new board of directors will include nine members, eight existing Enliven directors and one existing Imara director. The overall focus will be on advancing Enliven’s programs.
Kintz noted the company “recently initiated a Phase I trial for ELVN-001 and hope[s] for early data in early 2023.”
The focus for ELVN-001 is on CML, with “77% of healthcare providers indicating a need for more effective safe and tolerable therapies,” Kintz said. “The CML population is growing due to improved survival” but there is a continuing need for differentiated treatments.
In the United States and Europe, the majority of CML patients switch across lines of therapy, and with TKIs, this is driven by intolerance or a lack of initial molecular response. This opens up the market for another drug that could be used in this treatment paradigm, particularly if it has lower toxicity and tolerability issues.
“We believe ELVN-001 is a meaningful commercial opportunity,” Kintz said, with the drug having “the potential for significantly greater therapeutic index than the existing competitive TKIs.”
The chronic nature of CML lets doctors switch between therapies with limited negative consequences.
“New drugs with better tolerability and efficacy profiles drive increased switching rates and gain rapid adoption, similar to the HIV market,” Kintz said.
He also spoke to the market potential of ELVN-002, saying, “We believe that ELVN-002 has the ability to be comparable to and complementary to Enhertu.”
Most approved drugs in this area are dual EGFR/HER2 inhibitors that have dose limitations due to EGFR-driven toxicity. And currently, they all have too many toxicity issues to be used to treat brain metastases.
Enliven’s initial focus for ELVN-002 will be on non-small cell lung cancer patients harboring HER2 mutations. There are no approved TKIs for that patient population.
Kintz noted ELVN-002 “may be useful to patients with brain metastases.” He called the drug a “fast-to-market opportunity” due to the high unmet need in NSCLC. The company noted it also has the potential to be developed for other HER2 indications, including breast cancer.
Enliven expects to file an Investigational New Drug application for ELVN-002 by the end of this year.
Source: Biospace
