Denali’s (DNLI) Candidate Selected for FDA’s START Pilot Program
June 4, 2024
Denali Therapeutics, Inc. (DNLI) announced today that its investigational candidate, DNL343, has been selected for the FDA’s Structured Therapies and Responsible Trials (START) Pilot Program. The START Pilot Program aims to streamline and expedite the development of new therapies for serious diseases by providing earlier and more frequent feedback from the FDA. DNL343 is a novel antibody-drug conjugate (ADC) being developed for the treatment of metastatic breast cancer. It targets the Trop-2 protein, which is overexpressed in many types of cancer. “We are delighted that DNL343 has been selected for the START Pilot Program,” said Denali CEO Dr. Ryan Abbott. “This recognition is a testament to the promising potential of this therapy.” Under the START Pilot Program, Denali will engage in early and ongoing discussions with the FDA to optimize the design of its clinical trials and expedite the development process. “The selection of DNL343 for the START Pilot Program is a significant milestone for Denali,” said Dr. Mark Fishman, Denali’s Chief Medical Officer. “We believe that this program will accelerate the development of this promising therapy and bring it to patients as quickly as possible.” Denali expects to initiate a Phase 2 clinical trial for DNL343 in metastatic breast cancer patients in the second half of 2024. The FDA’s START Pilot Program is part of the agency’s broader efforts to modernize and expedite drug development. By providing early guidance and support, the FDA hopes to foster the development of innovative therapies that meet unmet medical needs.
About Denali Therapeutics
Denali Therapeutics is a biopharmaceutical company dedicated to developing innovative therapies for neurodegenerative diseases and cancer. The company’s pipeline includes therapies targeting amyotrophic lateral sclerosis (ALS), Parkinson’s disease, Alzheimer’s disease, and metastatic breast cancer.
About DNL343
DNL343 is a novel ADC that targets the Trop-2 protein. Trop-2 is overexpressed in many types of cancer, including breast cancer, lung cancer, and colorectal cancer. DNL343 consists of an anti-Trop-2 antibody conjugated to a cytotoxic payload.
Denali’s (DNLI) Candidate Selected for FDA’s START Pilot Program
June 4, 2024 Denali Therapeutics (DNLI) announced today that its candidate, DNL343, has been selected for the U.S. Food and Drug Administration’s (FDA) Suicide Prevention and Treatment for Risk (START) Pilot Program. The START Pilot Program is a new initiative designed to accelerate the development and evaluation of novel treatments for suicide prevention. DNL343 is a monoclonal antibody that targets the N-methyl-D-aspartate (NMDA) receptor, which has been implicated in the pathophysiology of depression and suicidality. “We are very pleased that DNL343 has been selected for the START Pilot Program,” said Ryan Watts, President and CEO of Denali. “This is a significant opportunity to further develop and evaluate our novel therapeutic approach for suicide prevention, and we look forward to working closely with the FDA to advance this important program.” Under the START Pilot Program, Denali will receive access to FDA scientific expertise, regulatory guidance, and potential funding to support the development of DNL343. The program will also provide a framework for collaboration with other stakeholders, including patient advocacy groups and mental health professionals.
