Endeavor Raises $101M to Advance Taladegib, IPF Therapy Now in Trial

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by Marta Figueiredo, PhD |

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Endeavor BioMedicines has raised $101 million to advance its pipeline programs, including taladegib (ENV-101), an investigational oral treatment for idiopathic pulmonary fibrosis (IPF) now in a clinical trial, and for cancer linked to mutations in the PTCH1 gene.

The funding was the result of a series B financing round led by Ally Bridge Group and Avidity Partners, and featuring existing and new investors.

“Endeavor BioMedicines is developing precision medicines targeting the genetic culprits of cancer and fibrosis,” John Hood, PhD, Endeavor’s co-founder, CEO, and chairman, said in a press release.

“The capital raised from a committed, top-tier investor syndicate enables us to deliver the right drug to the right patients in order to get the best clinical outcome,” Hood added.

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Taladegib is an orally available small molecule that works by blocking the Hedgehog pathway, a signaling cascade involved in cell growth, blood vessel formation, and in the activation of myofibroblasts, the main cellular drivers of fibrosis, or lung scarring.

Hedgehog is overly active in the lungs of people with IPF and in cancer patients with mutations in the PTCH1 gene, a negative regulator of Hedgehog. Taladegib is expected to halt, and possibly reverse, lung fibrosis and promote the death of Hedgehog-associated cancer cells.

According to Endeavor, the therapy has shown a favorable safety profile and ability to effectively block the Hedgehog pathway and promote myofibroblast death in nearly 200 people who participated in six clinical trials.

Endeavor raised $62 million last year to support the launch of Phase 2 trials to test taladegib in IPF patients.

An ongoing Phase 2 trial (NCT04968574) is evaluating the therapy’s safety and effectiveness in up to 60 adults, ages 40 and older, with mild-to-moderate IPF who are being actively recruited in Australia and Malaysia.

The first patient was dosed in September 2021 and participants are being randomly assigned so that half will receive either an oral tablet of 200 mg of taladegib, or a placebo, once a day for 12 weeks.

Taladegib’s dose may change across the study.

Patients will not be allowed to use a standard IPF therapy, such as Ofev (nintedanib) and Esbriet (pirfenidone), two weeks before and during the trial.

The study’s main goals are to assess the frequency and severity of side effects and laboratory abnormalities along with changes in participants’ key vital signs. Secondary goals include changes in lung function and shortness of breath using validated measures.

Pending this trial’s outcomes — expected by year’s end — Endeavor may launch a second Phase 2 trial of taladegib in combination with standard IPF treatments.

Proceeds from the series B funding will also be used to advance ENV-201, a candidate for cancers associated with KRAS gene  mutations, into clinical trials. ENV-201. It works by suppressing the ULK1/2 pathway, which is overly active in tumors with KRAS mutations.

“Researchers have investigated Hedgehog and ULK1 signaling pathways over the last decade, but now we have the understanding and capability to identify the patients who will benefit most from them,” Hood said.

Omega Funds and Longitude Capital were existing investors in this series B round, while new investors include Perceptive Advisors, Piper Heartland Healthcare Capital, Revelation Partners, funds managed by Tekla Capital Management, and funds and accounts advised by T. Rowe Price Associates.

As part of the financing, Andrew Lam of the Ally Bridge Group, and Monal Mehta, PhD, of Avidity Partners were nominated to join Endeavor’s board of directors.

“We are proud to be supporting a great team that has advanced an exciting pipeline of precision medicines in a short amount of time to deliver disease-modifying therapies for patients,” Mehta said.

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