Hornet Therapeutics is on a mission to prevent and treat conditions related to the Epstein-Barr virus (EBV) with the help of a drug candidate shelved by Kyowa Kirin.
With $5 million in seed funding from 4BIO Capital, the UK biotech is advancing its lead asset for EBV-driven post-transplantation lymphoproliferative diseases (PTLD). The condition develops when lymphocytes grow out of control and can lead to lymphoma.
Hornet’s program initially belonged to Kyowa Kirin and the “whole preclinical package” went through regulatory bodies in the US and EU for cancer before the Japanese pharma hit pause on development, Hornet CEO Fraser Gray told Endpoints News in an interview. The biotech named the asset HTX-201 after licensing it from Kyowa Kirin in a deal with undisclosed financials.
Hornet plans to start a Phase 1/2 study in solid organ transplant patients in 12 to 18 months. “We’re still in the process of fine-tuning the actual design [of the Phase 1/2] but it’s probably going to be in the region of around 50-odd patients with a focus on two specific cohorts,” Gray said.
Both cohorts will recruit kidney transplant patients, with the first cohort not infected with EBV and the second recruiting ones who are EBV positive.
Up to 30% of high-risk solid organ transplant recipients will develop lymphoma as a result of unchecked EBV, according to Hornet CSO Christoph Hess. HTX-201 could thus “massively impact the lives of solid transplant recipients, specifically during the most vulnerable period of their post-transplant career, which is the first year after transplant,” Hess said in the joint interview.
The biotech’s chairman Dima Kuzmin declined to comment on its cash runway, but said it is planning to raise a Series A round later this year.
As an inhibitor of the enzyme IDO-1, Kuzmin said HTX-201 belongs to a drug class that was once considered a failure because of its lack of success in immuno-oncology. In 2018, a combination of Incyte’s IDO-1 inhibitor epacadostat plus Merck’s Keytruda flunked a Phase 3 trial in advanced melanoma. Not long after, Bristol Myers Squibb halted several studies testing its own IDO-1 inhibitor, dubbed BMS-986205.
“It’s important to underscore that the mechanism of action [in EBV] is completely different from what people tried to achieve in the cancer space — we are drugging the same enzyme but for a completely different reason,” Kuzmin said.
HTX-201 is unique because it targets the way the virus hijacks cell metabolism to its benefit rather than targeting the virus itself, Hess said.