Deal worth nearly $1B gets GSK potential best-in-class PH treatment
Global biopharma acquires 35Pharma, rights to drug now in clinical testing
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GSK (formerly called GlaxoSmithKline) has acquired rights to HS235, an experimental treatment for pulmonary hypertension (PH), now in early clinical testing, that the buyer hopes will become a new standard of care for PH.
The therapy’s developer 35Pharma announced that it’s being acquired by GSK for $950 million, which the pharma giant will pay in cash once the deal closes, pursuant to customary regulatory conditions.
“Pulmonary hypertension affects millions of people worldwide, yet patients are underserved. We’re delighted to add HS235 to our pipeline, a potential best-in-class medicine with a differentiated profile to reduce risk of bleeding and provide potential metabolic benefits clinically relevant to PH patients,” Tony Wood, PhD, GSK’s chief scientific officer, said in a press release from 35Pharma announcing the deal.
Ilia Tikhomirov, CEO of 35Pharma, commented: “In recent years, we witnessed a revolution in our understanding of pulmonary hypertension and how this life-threatening disease could be reversed. We are pleased to be combining our efforts with GSK, a leader in respiratory and inflammatory drivers of disease, who shares our vision of HS235’s potential to transform the treatment of this debilitating condition.”
PH is marked by elevated pressure in the vessels that carry blood from the heart through the lungs. Many forms of PH are characterized by abnormal cell growth in these blood vessels.
HS235 is designed to block the activin signaling pathway, a cellular signaling pathway that plays a central role in the abnormal cell growth and structural alterations of blood vessels that drive pulmonary hypertension.
This is the same signaling pathway targeted by Winrevair (sotatercept-csrk), an approved treatment for pulmonary arterial hypertension (PAH) from Merck.
HS235 designed to treat PH with fewer side effects
According to 35Pharma, HS235 has been engineered to specifically target certain parts of the activin pathway and not others, with the aim of minimizing abnormal bleeding — a side effect that can occur with other activin inhibitors such as Winrevair. The company states on its website that HS235 has been designed to have “exceptional selectivity, potency, and extended half-life,” which means a longer-lasting biological activity in the body.
“HS235 is a unique and potentially best-in-class agent that we designed guided by the most recent advances in the field,” said Maureen O’Connor, PhD, chief scientific officer at 35Pharma.
35Pharma has already completed Phase 1 clinical trials, which showed that HS235 had an acceptable safety profile in healthy volunteers. The company has also made plans for two further Phase 1 trials to test HS235 in certain types of PH.
Specifically, one study (NCT07143448) will test the therapy in people with PAH, and the other study (NCT07123779) will test it in people with pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF; when the heart doesn’t fill correctly in between pumps).
35Pharma said the trials are scheduled to start imminently, now with collaboration from GSK.
“This acquisition reflects the exceptional work of our team in building the scientific and clinical capabilities to discover and advance HS235 through clinical proof of biology in healthy volunteers,” O’Connor said. “We are proud to collaborate with GSK to accelerate development of this medicine which could help millions of patients affected by pulmonary hypertension, a life-threatening group of diseases.”
