In a bid to push Merrimack’s dropout drug seribantumab through Phase 2, Elevation Oncology has raised $65 M in a Series B financing round, led by new investors venBio Partners and Cormorant Asset Management. The funds will help the Phase 2 CRESTONE study complete its enrollment of patients along with “other corporate development activities.”
Founded by Shawn Leland in July 2019 with $32.5 M in Series A funds from Aisling Capital, Elevation Oncology aims to provide precision medicines for genomically defined cancers. Leland, who was Elevation’s former Chief Business Officer and a member of the Board of Directors, was announced as the new CEO on November 18th, taking over from Steve Elms, who served as the interim CEO up until now.
“Shawn has been instrumental in the founding and success of Elevation Oncology to date,” said Mr. Elms. “On behalf of the entire Board of Directors, I express our great confidence in the future of Elevation Oncology under Shawn’s leadership. The proceeds raised with the Series B positions the Company well to deliver on our mission of developing precision therapeutics for patients with genomically defined cancers.”
Elevation Oncology’s lead clinical candidate, seribantumab, was once Merrimack’s high-profile drug until it flunked a Phase 2 trial for the treatment of NSCLC in combination with docetaxel. Seribantumab failed to show efficacy as a combinatorial therapy compared with docetaxel alone and failed to improve disease-free survival. Therefore, Merrimack pharma decided to cut its losses and drop the drug.
Seribantumab is a HER3 monoclonal antibody that blocks the binding of NRG1 protein to the HER3 receptor. The NRG1 gene fusion is a rare oncogenic driver (0.2 percent of solid tumors) that combines NRG1 with another partner protein to create chimeric NRG1 “fusion proteins.” The NRG1 fusion is often also able to activate the HER3 pathway and may be essential for developing tumors in multiple cancers.
By acquiring the biologic for up to $85 M and deploying a simple change in the strategy by focusing on NRG1 fusion driven tumors rather than HER3 amplifications, Elevation hopes to turn around an accelerated approval for seribantumab with results from their CRESTONE trial.
“There is this unique ability to go out and get a license or acquire a HER3 monoclonal antibody and repurpose it for this genetically defined patient population, where a HER3 monoclonal antibody approach was very much tailored to the disease biology,” Leland said.
Elevation plans to expand its pipeline and prioritize targeted therapy approaches in tumor types defined by genomic driver alterations.
The Phase 2 CRESTONE trial aims to determine the efficacy and safety of seribantumab in patients with any solid tumor with an NRG1 fusion. Since NRG1 fusions are rare genetic events that drive several tumor types, Elevation’s CRESTONE is a “basket trial” evaluating the tumor agnostic seribantumab in multiple solid tumor types. CRESTONE is currently enrolling and plans to enroll a total of 75 participants across three cohorts and is estimated for completion around June 2022.
By Sangeeta Chakraborty, Ph.D.
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