After the release of encouraging topline safety results from the Phase 1 SB101 clinical study of SON-1010, shares of Sonnet BioTherapeutics Holdings, Inc. (NASDAQ: SONN) saw a notable increase on the US stock charts today. As of the last check during current session, SONN stock was surging 49.33% to $3.14.
Promoting Results in Advanced Solid Tumor Research
In significant Phase-1 research, Sonnet evaluated SON-1010 (IL12-FHAB), its proprietary recombinant human interleukin-12 (rhIL-12) fusion protein, in adult patients with advanced solid tumors. The trial, which has so far included 24 participants, aims to assess the drug’s safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD). Minimal toxicity was verified by the Safety Review Committee’s review at the highest dose, which is encouraging considering the past difficulties with rhIL-12.
SON-1010 targets the tumor microenvironment (TME) and improves its half-life and bioactivity by utilizing Sonnet’s Fully Human Albumin Binding (FHAB) technology. This innovative design facilitates binding to gp60 and Secreted Protein Acidic and Rich in Cysteine (SPARC), ensuring effective delivery to tumor sites.
Advancing Toward Therapeutic Potential
The trial results indicate that SON-1010 achieves robust yet controlled IFNγ responses, critical for antitumor activity, with a sustained return to baseline levels. Notably, a partial response (PR) observed at the highest dose highlights the drug’s potential to synergize with checkpoint inhibitors or chemotherapy. Nearly half of the evaluable patients demonstrated clinical benefits, marking a significant step toward realizing rhIL-12’s long-anticipated therapeutic promise.
Strategic Plans for Future Development
With dose escalation successfully completed, Sonnet has established the maximum tolerated dose (MTD) for SON-1010. The company continues to monitor treated patients for long-term safety and tumor responses while actively seeking partnerships to advance the drug into later-stage development.
Together with atezolizumab, SON-1010 is being assessed in a Phase 1b/2a dose-escalation and proof-of-concept study (SB221) for platinum-resistant ovarian cancer (PROC) in partnership with Genentech, a Roche Group member. An update on safety at the MTD in that trial is anticipated in Q1 2025, and enrollment is still open.
This achievement represents a pivotal moment for Sonnet BioTherapeutics, affirming its commitment to transforming cancer treatment through innovative biotechnology.
