Endeavor Biomedicines wants to best the two idiopathic pulmonary fibrosis (IPF) drugs on the market by going after the so-called Hedgehog pathway—what it calls the "root cause" of the disease—and now it has $101 million in new funding to test its candidate and potentially add to its pipeline.
At the helm is John Hood, Ph.D., who sold his previous biotech, Impact Biomedicines, to Celgene for $1.1 billion upfront in January 2018. That deal led to Bristol Myers Squibb securing an FDA nod for Inrebic, a JAK inhibitor for myelofibrosis, in 2019.
Hood's 15-person biotech is going after a different form of fibrosis this time. The biotech's small-molecule inhibitor, dubbed taladegib or ENV-101, is in an international phase 2 study in IPF patients. Enrollment should wrap up by year-end, and the trial is slated to read out within 18 months, Hood said in an interview.
The most common form of pulmonary fibrosis, IPF is marked by scarring and stiffness in the lungs that leads to difficulty breathing.
"By going after Hedgehog, we’re really going after the root cause of the disease, the cellular cause of the disease, which is a cell type called myofibroblast, or fibroblast with muscle-like characteristics," Hood said. The pathway is implicated in certain cancers in addition to IPF.
Patients with IPF are "pretty poorly served," Hood said, noting that existing meds slow the decline in lung function but don't halt the deterioration. Boehringer Ingelheim and Roche both secured FDA approval in 2014 for their rival meds, Ofev and Esbriet, respectively.
Boehringer recorded net sales of about $1.37 billion for Ofev in the first half of 2021. The drug is approved for IPF in more than 80 countries and other chronic lung diseases in more than 60 countries. Esbriet generated (PDF) about $1.1 billion in full-year 2021 sales, Roche reported Feb. 2. The drug is approved for IPF in more than 60 countries.
In the IPF world, Avalyn Pharma is attempting to turn Roche's oral med into an inhaled formulation. The lung-scarring disease has caused road bumps for drug developers, though, as Belgian biotech Galapagos ditched a phase 3 asset in February 2021.
Endeavor's series B proceeds will also bankroll a midstage study of taladegib in patients with activating mutations of the Hedgehog pathway, which are found in about 5% of all cancers, Hood said. The open-label phase 2 trial should have data this year, the CEO said.
Beyond those two trials, Endeavor aims to begin a phase 1 study of its next candidate, ENV-201, within 18 months. The biotech said it plans to test the small molecule in patients with RAS and/or STK-11-driven cancers. Endeavor obtained exclusive worldwide rights to the orally available med from the Salk Institute for Biological Studies and Sanford Burnham Prebys in September 2021.
With the $101 million—plus a $62 million series A from January 2021—Endeavor also has its eyes out for additional molecules to in-license, Hood said. The biotech is focused on high unmet need indications and isn't looking to be the "19th rheumatoid arthritis drug," the CEO added.
“With the market meltdown, there may be those opportunities out there for assets that other companies just don’t simply have the bandwidth or capital to develop," Hood said.
Speaking of market meltdown, Hood said if biotech's public market woes are resolved by the end of this year, Endeavor would be ready to debut on Wall Street at that time, "if we so desire."
Ally Bridge Group and Avidity Partners led the round. Existing investors Omega Funds and Longitude Capital participated and were joined by new backers Perceptive Advisors, Piper Heartland Healthcare Capital, Revelation Partners, Tekla Capital and T. Rowe Prices.