On February 7, 2022 Endeavor BioMedicines, a clinical-stage biotechnology company targeting the core drivers of terminal diseases including oncology and fibrosis, reported the completion of a $101 million Series B financing, led by Ally Bridge Group and Avidity Partners (Press release, Endeavor BioMedicines, FEB 7, 2022, View Source [SID1234607788]). New investors participating in the round include Perceptive Advisors, Piper Heartland Healthcare Capital, Revelation Partners, funds managed by Tekla Capital Management LLC, and funds and accounts advised by T. Rowe Price Associates, Inc. Existing investors Omega Funds and Longitude Capital also participated. Proceeds will support the advancement of Endeavor’s pipeline programs, including ENV-101 (taladegib), a small molecule inhibitor of the PTCH1 receptor in the Hedgehog signaling pathway for the treatment of cancer and idiopathic pulmonary fibrosis (IPF), as well as ENV-201, a potentially best-in-class small molecule inhibitor of ULK1/2 for the treatment of KRAS-driven cancers.
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"Endeavor BioMedicines is developing precision medicines targeting the genetic culprits of cancer and fibrosis," said John Hood, Ph.D., Co-Founder, CEO and Chairman of Endeavor BioMedicines."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. 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."
ENV-101: Targeting the Hedgehog Signaling Pathway in Oncology and Pulmonary Disease
ENV-101 (taladegib), an orally available small molecule inhibitor of the Hedgehog signaling pathway, has already demonstrated impressive clinical efficacy and safety in nearly 200 subjects enrolled across six completed studies. Initially targeted for a broad group of patients with basal cell carcinoma (BCC), Endeavor is now investigating precision therapy approaches for ENV-101 in multiple types of cancers driven by the oncogenic driver mutation PTCH1, as well as in IPF.
PTCH1, an oncogenic driver mutation in the Hedgehog signaling pathway is found in approximately 2% of all cancers. Because of its prevalence across multiple types of cancer Endeavor plans to enroll patients in a tumor agnostic study that includes any patient with oncogenic hedgehog mutations irrespective of tissue of origin. Endeavor is currently enrolling patients in an open label Phase 2 clinical trial in oncology (www.clinicaltrials.gov identifier NCT05199584).
In IPF, myofibroblasts (the repair cells activated by the Hedgehog pathway) become dysregulated and relentlessly remodel lung tissue, forming fibrotic scars and contracting the lung. Selectively inhibiting this pathway in lung tissue effectively inactivates the myofibroblasts responsible for the disorder and forces them to undergo apoptosis, thereby eliminating the key cellular driver of IPF. A Phase 2 clinical trial designed to assess the efficacy and safety of taladegib as a monotherapy in subjects with mild to moderate IPF is currently enrolling (www.clinicaltrials.gov identifier NCT04968574).
ENV-201: Targeting Autophagy and ULK1/2 Inhibition
ENV-201 is an orally available small molecule inhibitor of ULK1/2, a critical enzyme in a cellular recycling process called autophagy that is often linked to drug resistance in KRAS- and STK11-mutated cancers. Tumor cells harness this recycling process to supply much-needed nutrients and metabolites when there are not enough in the available blood supply. Tumors, such as those with KRAS mutations, with high levels of autophagy are resistant to standard therapies, and those patients generally have a very poor prognosis. Researchers have also found that specific genetic mutations frequently found in lung, colorectal and pancreatic cancers cause those tumors to be highly dependent on this recycling pathway.
The combined research supports a precision approach targeting ULK1/2 to inhibit autophagy in genetically defined cancers alone or in combination with existing chemo-, targeted- and immuno-therapeutics. Endeavor plans to complete IND-enabling studies and advance the program into the clinic in the next year.
Appointments to the Board of Directors
As part of the financing, Andrew Lam, Pharm.D. (Ally Bridge Group) and Monal Mehta, Ph.D. (Avidity Partners) will join John Hood, Ph.D. (Board Chair), Bernard Davitian (Omega Funds), and Patrick Enright (Longitude Capital), on the board.
"Endeavor is led by a proven and experienced management team with a track record of value creation of underappreciated assets," said Andrew Lam.
"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," said Monal Mehta.