Elevation files for $100M IPO to fund tumor-agnostic candidate

Nasdaq
Elevation believes the phase 2 may support a filing for FDA approval. (Nasdaq)

Elevation Oncology has filed to raise $100 million in an IPO. The money will support development of an anti-HER3 antibody that failed multiple trials at Merrimack Pharmaceuticals before being picked up by Elevation and repositioned as a treatment for solid tumors harboring an NRG1 fusion.

The antibody, seribantumab, failed multiple midphase trials, causing Sanofi to return the rights to the drug and ultimately leading to Merrimack offloading it to Elevation in 2019. Elevation picked up the molecule after identifying HER3 inhibition as an approach for tumors driven by an NRG1 fusion. In preclinical tests, HER3 inhibition led to reductions of growth for NRG1 fusion-driven tumors.

“We believe that direct inhibition of the NRG1 activation of HER3 with a monoclonal antibody approach may drive improved responses for these patients given its direct role in sustaining proliferation and survival of tumors harboring an NRG1 fusion,” Elevation wrote in its IPO paperwork.

Elevation raised almost $100 million across series A and B rounds from investors including Aisling Capital, venBio Partners and Cormorant Asset Management, giving it the means to start a phase 2 clinical trial. Now, the biotech is seeking public investment for further development of seribantumab.

If successful, Elevation believes the phase 2 may support a filing for FDA approval. The 55-subject pivotal cohort of the study is enrolling patients with a centrally confirmed NRG1 fusion who haven’t been previously treated with an EGFR-, HER2- or HER3-directed therapy. The primary endpoint is the overall response rate.

Elevation sees other ERBB or HER3 inhibitors in development at companies including Merus, Rain Therapeutics, Hummingbird Bioscience, GamaMabs Pharma and AVEO Oncology as the key rivals to seribantumab. Other companies such as Daiichi Sankyo, GlaxoSmithKline and Boehringer Ingelheim are working on similar drugs, but Elevation is unsure whether they are targeting NRG1 fusion tumors.