Sonnet BioTherapeutics (NASDAQ: SONN) Reports Positive Safety Data in SON-1010 Monotherapy Dose Escalation Trial

Sonnet BioTherapeutics Holdings, Inc. filed a Form 8-K with the Securities and Exchange Commission on December 9, 2024, detailing the successful completion of the SON-1010 monotherapy dose escalation in the Phase 1 SB101 trial. The results indicated exciting developments for the company’s proprietary version of recombinant human interleukin-12 (rhIL-12), configured using genetic fusion to its Fully Human Albumin Binding (FHAB) platform.

Topline safety data from the SON-1010 trial revealed that the maximum tolerated dose (MTD) was set at 1200 ng/kg, with no dose-limiting toxicity or evidence of cytokine release syndrome at any dose level. Notably, stable disease (SD) at four months post-initiation of dosing was observed in 48% of evaluable monotherapy patients, with one patient dosed at the MTD showing a partial response. These results suggest potential clinical benefits associated with SON-1010 monotherapy administration.

The Safety Review Committee in the Phase 1 SB101 clinical trial formally evaluated the results of SON-1010, assessing safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) in adult patients with advanced solid tumors. The study enrolled 24 subjects to date, focusing on evaluating the safety and tolerability of SON-1010 and establishing the MTD.

Describing SON-1010, Sonnet’s Chief Medical Officer, Richard Kenney, M.D., highlighted the unique biodistribution and albumin binding profile of the drug, which contributes to its minimal toxicity at higher doses. The data indicated a promising antitumor effect with enhanced safety levels, potentially allowing the drug to target and induce responses within the tumor microenvironment.

The Phase 1 SB101 trial employed a desensitizing first dose and observed no dose-limiting toxicities or related serious adverse events so far, displaying a typical safety and toxicity profile for an oncology trial. Encouragingly, almost half of the evaluable patients showed clinical benefit, supporting the potential synergistic effects of SON-1010 in combination with other therapies.

Looking ahead, Sonnet is exploring partnership opportunities to support the later-stage development of SON-1010. The company remains committed to advancing its clinical programs, with ongoing trials evaluating SON-1010 for the treatment of solid tumors and platinum-resistant ovarian cancer.

This announcement marks a significant milestone in Sonnet BioTherapeutics’ clinical development efforts, signaling positive prospects for the future of its immunotherapeutic drug pipeline.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Sonnet BioTherapeutics’s 8K filing here.

Sonnet BioTherapeutics Company Profile

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Sonnet BioTherapeutics Holdings, Inc, a biotechnology company, owns a platform for biologic medicines of single or bifunctional action. The company develops fully human albumin binding technology, which utilizes human single chain antibodies fragment that binds to and hitch-hikes on human serum albumin for transport to target tissues.

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