APG-157 Earns FDA Fast Track Designation for Head and Neck Cancer Treatment

Head and neck cancer: © CLIPAREA.com- stock.adobe.com

• The FDA has granted fast track designation to APG-157, a next-generation immuno-oncology drug, for the neoadjuvant treatment of head and neck cancer.
• Fast track designation is designed to facilitate the development and review of agents that fill serious unmet medical needs.
• A phase 2 study (NCT05312710) is investigating the safety and efficacy of the agent.

APG-157 has been granted fast track designation by the FDA for the neoadjuvant treatment of head and neck cancer.¹

“There is an urgent need for new treatments for [patients with] head and neck cancer, many of whom face poor survival odds and considerable morbidities following current standard-of-care treatments, including surgery, radiotherapy, and chemotherapy/targeted treatments. The rare grant of fast track designation for neoadjuvant treatment in head and neck cancer underscores the FDA’s recognition of the potential role of APG-157 in providing meaningful treatment benefits to these patients,” said Parag Mehta, PhD, chief executive officer of Aveta Biomic, in a press release.

Fast track designation is intended to expedite the development and review of agents that fill unmet medical needs for serious conditions. With this designation, Aveta Biomic, the sponsor, will be eligible for more frequent interactions with the FDA, rolling submissions for marketing applications, and potential accelerated approval.

APG-157 is a first-in-class agent that has a dual mechanism of inducing selective apoptosis and reprogramming the immune environment.¹ APG-157 is administered as an oral soft lozenge that dissolves in the mouth that is taken 3 times per day for 4 to 6 weeks before surgery.²

A phase 2 study is investigating the agent’s safety and efficacy in patients with head and neck cancer. An estimated 24 patients will be enrolled, and the study is still enrolling patients in Los Angeles, California, and Miami, Florida.

The primary end point is change in tumor size from baseline, and secondary end points include changes in immunohistochemistry, cytokine levels, and cell-free RNA biomarkers.

Patients with newly diagnosed, treatment-naive stage I to IV head and neck squamous cell carcinoma who are scheduled to receive curative intent surgery or palliative intent radiation or who refuse surgery or are unfit for local therapy are eligible for enrollment. Those for whom definitive, local treatment is available in less than 4 weeks from diagnosis or who have recurrent or metastatic disease, tooth abscesses, bleeding gums, cracked teeth, or other related diseases to the oral cavity or oropharynx are not eligible for participation.

The study has an estimated completion date of December 31, 2024.

REFERENCES:

1. FDA grants fast track designation to Aveta Biomics’ APG-157 for neoadjuvant treatment of head and neck cancer. News release. Aveta Biomics. August 22, 2024. Accessed August 23, 2024. https://tinyurl.com/34d98yup

2. Safety and efficacy of APG-157 in head and neck cancer. ClinicalTrials.gov. Updated August 14, 2024. Accessed August 23, 2024. https://clinicaltrials.gov/study/NCT05312710