Elevation lifts HER3 ADC toward clinic with $368M Synaffix deal

Elevation Oncology has tapped Lonza’s Synaffix to support the expansion of its pipeline, agreeing to pay up to $368 million to access technology for use in its newly nominated HER3 antibody-drug conjugate (ADC).

Synaffix has become a go-to partner for drug developers seeking ADC technology. Last year, AmgenHummingbird BioscienceMacroGenics and Sotio struck deals valued at around $5 billion in biobucks to get their hands on the Lonza subsidiary’s technologies. Elevation joined the list of companies betting on the Synaffix technology this week.

The deal gives the biotech access to antibody conjugation and polar spacer technologies, plus the toxSYN linker-payload. Elevation has identified the technologies as differentiators that could enable it to make a splash in the HER3 ADC market.

The biotech will need its ADC to stand out given the head start it has ceded to rival assets. Merck & Co. and Daiichi Sankyo are advancing a HER3-directed ADC as part of their collaboration, which cost the U.S. drugmaker $4 billion upfront. BioNTech licensed MediLink Therapeutics’ prospect for $70 million upfront last year.

Merck and Daiichi reported a hit on the primary endpoint in a phase 3 trial of their HER3 candidate in September. BioNTech’s rival ADC is in phase 1. Elevation is yet to commit to a timeline for entering the clinic, but CEO Joseph Ferra has said a 12- to 18-month lag between candidate selection and an IND filing is typical. The timeline suggests it might be 2026 before the first human receives Elevation’s HER3 ADC.

Ferra discussed the timeline at a Piper Sandler event last week. The CEO said Daiichi has shown “HER3 certainly has legs” but Elevation sees “a further opportunity for a differentiated HER3 ADC.” The biotech shared preclinical proof-of-concept data on its attempt to realize the opportunity in April, showing how the choice of antibody, conjugation technology and payload could affect outcomes. The choices resulted in an ADC that had an “incredibly meaningful and differentiated” effect in preclinical models, Ferra said.

“We think there's an opportunity for driving a program like that forward,” the CEO said. “Most of the field is focused on topo as a payload. In that poster, we used [a] MMAE payload.”

At the Piper Sandler event, Ferra declined to answer an analyst’s question about whether the ADC uses site-specific conjugation. The deal clears up that question—Synaffix is providing its site-specific ADC technology—and provides an early look at why Elevation believes it can crash Merck and Daiichi’s party.