On October 31, 2023 Sonnet BioTherapeutics Holdings, Inc., (NASDAQ:SONN) a clinical-stage company developing targeted immunotherapeutic drugs for cancer, reported a fiscal year 2023 business overview (Press release, Sonnet BioTherapeutics, OCT 31, 2023, View Source [SID1234636554]).
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"As has been our objective since the company’s founding, we are committed to innovating next generation cancer treatments of significant potential utility for patients and caregivers, alike," commented Pankaj Mohan, Ph.D., Founder and CEO of Sonnet. "I am excited by the progress of our therapeutic pipeline, and we remain acutely focused on our business development initiatives. We continue to believe this represents a compelling value proposition for investors in the company."
Overview of Corporate Developments
In October, Sonnet completed an underwritten public offering led by existing investors for total gross proceeds of approximately $4.55 million. The company anticipates using the net proceeds from the offering for research and development, including clinical trials, working capital and general corporate purposes. After undertaking significant cost reductions designed to fund assets with the highest estimated business development potential, cash runway is projected into the calendar year third quarter of 2024.
In August, the FDA accepted Sonnet’s IND for the SB221, the Phase 1b/2a US clinical trial of SON-1010 (IL12-FHAB) in combination with Roche’s anti-PD-L1 checkpoint inhibitor, atezolizumab. The study has been launched with several patients currently being dosed. The trial consists of a modified 3+3 dose-escalation design in Part 1 to establish the maximum tolerated dose (MTD) of SON-1010 with a fixed dose of atezolizumab. Clinical benefit in PROC will be confirmed in an expansion group to establish the recommended Phase 2 dose. Part 2 of the study will then investigate SON-1010 monotherapy, its use in combination with atezolizumab, or the standard of care (SOC) for PROC in a randomized comparison to show proof-of-concept (POC).
Sonnet is working to complete enrollment in the SON-080 trial in chemotherapy-induced peripheral neuropathy (CIPN) and continues to expect early safety data prior to the 2023 calendar year end.
The evaluation of SON-1010, SON-1210 and SON-1410 in combination with certain of Janssen’s proprietary cell therapy assets remains underway.