Sonnet BioTherapeutics Expands Phase 1 SB101 Trial to Evaluate Combination of SON-1010 with Trabectedin in Certain Sarcomas

Sonnet BioTherapeutics Holdings, Inc. filed a Form 8-K on January 21, 2025, with the Securities and Exchange Commission announcing the expansion of its Phase 1 SB101 trial. The company’s trial aims to evaluate the combination of SON-1010 with trabectedin in specific sarcomas.

The Phase 1 SB101 trial expansion follows the successful completion of monotherapy dose escalation for SON-1010. This expansion seeks to assess the immune-oncology impact of SON-1010 at the maximum tolerated dose of 1200 ng/kg in combination with trabectedin, an approved chemotherapeutic drug for certain advanced soft-tissue sarcomas (STS). The collaboration aims to potentially enhance the local immune response in the tumor microenvironment for patients with STS.

Sonnet BioTherapeutics plans to enroll up to 18 patients with unresectable, metastatic liposarcoma or leiomyosarcoma in an open-label, single-arm expansion cohort. The patients will receive treatment involving SON-1010 along with standard 21-day trabectedin cycles. This combination study is designed to explore the safety, tolerability, pharmacokinetics, and pharmacodynamics of SON-1010 in conjunction with trabectedin and establish the maximum tolerated dose.

SON-1010, a proprietary drug of Sonnet BioTherapeutics, is built on recombinant human interleukin-12 (rhIL-12), fused with the Company’s Fully Human Albumin Binding (FHAB) platform. Trabectedin, on the other hand, is an alkylating DNA-binding agent approved for certain sarcomas in early 2024. The company believes that the combination of SON-1010 and trabectedin has the potential to enhance the therapeutic effect by activating immune cells in the tumor microenvironment.

The Company anticipates the results of this expansion cohort could set the stage for a larger Phase 2 study focusing on evaluating the combination of SON-1010 and trabectedin as an improved treatment option for STS. Sonnet aims to leverage the synergy between SON-1010 and trabectedin to enhance the response and progress in the treatment of soft-tissue sarcomas.

The Company’s forward-looking statements emphasize the potential outcomes of the clinical trials and the strategic development of their product portfolio. Sonnet BioTherapeutics continues to engage in promising research and development endeavors to address unmet needs in cancer treatment.

Investors interested in more details about the Phase 1 SB101 trial and related studies can visit clinicaltrials.gov and reference identifier NCT05352750, where additional information is available.

This press release may contain forward-looking statements, reflecting the expectations, estimates, and projections regarding the industry, market, and management’s perspectives on potential growth opportunities. Prospective investors should consider the risks and uncertainties mentioned in the Company’s filings with the Securities and Exchange Commission. The Company pledges to provide updates on forward-looking statements as needed, aligning with its commitment to transparency and timely disclosure of information.

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.

About Sonnet BioTherapeutics

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.