PRINCETON, NJ - Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN), a clinical-stage biopharmaceutical company with a market capitalization of $1.76 million, has announced the completion of dose escalation in the Phase 1 SB101 clinical trial of its drug SON-1010 for patients with advanced solid tumors. According to InvestingPro analysis, the company's stock is currently trading below its Fair Value, despite facing significant market challenges with an 84% decline year-to-date. The trial has determined the maximum tolerated dose (MTD) of SON-1010 to be 1200 ng/kg, with no dose-limiting toxicity or cytokine release syndrome observed at any level.
The company reports that 10 out of 21 evaluable patients, or 48%, maintained stable disease four months after beginning treatment with SON-1010 as a monotherapy. Notably, one patient treated at the MTD experienced a partial response with a 45% reduction in tumor size, according to RESIST criteria. The company maintains a healthy balance sheet with more cash than debt, which could support continued clinical development. InvestingPro subscribers have access to detailed financial health metrics and 13 additional ProTips about SONN's market position.
SON-1010 is a proprietary version of recombinant human interleukin-12 (rhIL-12), which is designed to target the tumor microenvironment. The drug leverages Sonnet's Fully Human Albumin Binding (FHAB®) platform to extend its half-life and bioactivity.
The SB101 study, which enrolled 24 subjects, primarily aimed to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of SON-1010. According to Dr. Richard Kenney, Sonnet's Chief Medical (TASE:PMCN) Officer, the positive safety profile and partial response observed at the highest dose suggest potential for SON-1010 in combination with other treatments such as checkpoint inhibitors and chemotherapy.
Sonnet's CEO, Pankaj Mohan, Ph.D., expressed satisfaction with the trial's progress and noted the clinical benefit observed in almost half of the evaluable patients. The company is actively seeking partnership opportunities to support the later-stage development of SON-1010.
In addition to the SB101 trial, SON-1010 is also being evaluated in a Phase 1b/2a study in combination with atezolizumab for the treatment of platinum-resistant ovarian cancer, with safety updates expected in the first quarter of 2025. Investors should note that the company's next earnings report is scheduled for December 13, 2024, where analysts maintain a Strong Buy consensus recommendation despite current financial challenges.
This announcement is based on a press release statement by Sonnet BioTherapeutics and does not constitute an endorsement of the company or its products. The Phase 1 SB101 trial is registered under the identifier NCT05352750 at www.clinicaltrials.com.
In other recent news, Sonnet BioTherapeutics has made significant strides in drug development and financial growth. The clinical-stage biotech firm has reported advances in its lead cancer immunotherapy drug, SON-1010, with preclinical data demonstrating significant tumor growth inhibition and minimal toxicity. Furthermore, Sonnet has secured a patent for its novel immunotherapeutic proteins, SON-1411 and SON-1400, which could potentially enhance cancer treatment.
In addition to its research developments, Sonnet has successfully raised funds through a $5 million public offering and the sale of New Jersey State net operating losses and research and development tax credits, potentially raising up to $0.795 million. The firm has also regained compliance with Nasdaq's minimum bid price rule, ensuring its continued listing on the Nasdaq Capital Market.
Sonnet has also forged strategic partnerships, such as a licensing agreement with Alkem Laboratories for the development and commercialization of SON-080, a neuropathy treatment, in India. These developments reflect Sonnet's ongoing efforts to advance its drug portfolio and strengthen its financial position.
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