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PRINCETON, N.J. - Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN), a clinical-stage biotechnology company with a market capitalization of $3.89 million, has announced positive safety results for its drug SON-1010, used in combination with atezolizumab in a clinical trial involving patients with platinum-resistant ovarian cancer (PROC). The trial, known as SB221, has successfully identified the maximum tolerated dose (MTD) of SON-1010 at 1200 ng/kg without any dose-limiting toxicity or cytokine release syndrome observed. According to InvestingPro data, the company maintains a strong liquidity position with more cash than debt on its balance sheet.
The study’s interim data revealed that out of 15 evaluable patients, five maintained stable disease four months after treatment initiation, with four continuing beyond six months. Additionally, one patient treated at the MTD exhibited a partial response (PR) with a 44% reduction in tumor size and a significant decrease in the CA 125 ovarian cancer biomarker.
This Phase 1b/2a trial, designed to assess the safety and preliminary efficacy of SON-1010 in combination with atezolizumab, an immune checkpoint inhibitor, has now moved to the expansion phase. This phase will further investigate the drug’s effect before proceeding to a randomized comparison with the standard of care.
Lead Principal Investigator, Dr. Robert Wenham from Moffitt Cancer Center, expressed optimism regarding the efficacy of the combination therapy, especially considering the historically low response rates to current treatments for PROC. He highlighted the significance of the observed tumor reduction and the potential to enter the next stage of the trial.
SON-1010 utilizes Sonnet’s proprietary Fully Human Albumin Binding (FHAB®) platform, which aims to improve the delivery and efficacy of cytokines like interleukin-12 (IL-12). The drug is designed to target the tumor microenvironment (TME), potentially turning immunologically ’cold’ tumors ’hot’ and enhancing the immune system’s ability to fight cancer.
Sonnet’s Chief Medical Officer, Dr. Richard Kenney, remarked on the encouraging safety data and the partial response seen in the ovarian cancer patient. The company is excited about the possibility of realizing the antitumor effects of IL-12 that have been demonstrated in preclinical models.
The SB221 trial has shown a typical safety and toxicity profile for a Phase 1 oncology trial, with most adverse events being mild and transient. With the establishment of the MTD for the combination with an immune checkpoint inhibitor, the trial will continue to monitor patients for long-term safety and tumor responses.
Sonnet is actively seeking partnership opportunities to support the later stage development of SON-1010. While the company’s stock has experienced significant pressure, trading near its 52-week low of $1.22 compared to a high of $16.80, InvestingPro analysis suggests the stock is currently undervalued. Despite challenging market conditions, analysts project revenue growth of 52.69% for the current fiscal year. For more information on the SB221 study, interested parties can visit www.clinicaltrials.com using the identifier NCT05756907.Investors seeking deeper insights into Sonnet’s financial health and growth prospects can access 12 additional exclusive ProTips and comprehensive financial metrics through InvestingPro’s advanced analytics platform.
This report is based on a press release statement from Sonnet BioTherapeutics Holdings, Inc. and enhanced with financial data from InvestingPro.
In other recent news, Sonnet BioTherapeutics Holdings, Inc. has made significant changes in its leadership following the passing of its founder and CEO, Pankaj Mohan. The company appointed Raghu Rao as the interim Chief Executive Officer and promoted Stephen McAndrew, Ph.D., to President and Chief Business Officer. Sonnet also reported promising early safety data from its ongoing Phase 1 SB101 clinical trial for its drug SON-1010, which is being tested in combination with trabectedin for treating certain sarcomas. The Safety Review Committee found no unexpected toxicities among the first seven patients treated at the maximum tolerated dose. Additionally, Sonnet received a Notice of Allowance from the USPTO for a new patent related to its IL-18 variant protein, IL-18BPR, which could enhance its efficacy in cancer treatments. The company announced plans to further develop its Antibody Drug Conjugate (ADC) platform, with initial proof-of-concept showing promising results. Sonnet’s lead program, SON-1010, is also in development for advanced solid tumors, highlighting the company’s ongoing commitment to advancing its therapeutic programs. These developments underscore Sonnet’s strategic initiatives and its focus on expanding its oncology-focused pipeline.
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