Sonnet BioTherapeutics Holdings, Inc. (NASDAQ: SONN) is making significant strides in its clinical programs and strategic partnerships, according to recent business updates. The company is focused on advancing its lead program, SON-1010, and expanding its pipeline across the solid tumor market.
SON-1010 Clinical Trial Progress
Sonnet BioTherapeutics has reported encouraging data from its Phase 1 SB101 trial of SON-1010 (IL12-FHAB) as a monotherapy. The trial, designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple ascending doses of SON-1010 in patients with advanced solid tumors, has shown promising results. Stable disease (SD) was observed in 48% of evaluable monotherapy patients at four months post-initiation of dosing. Notably, one patient dosed at the maximum tolerated dose (MTD) achieved a partial response (PR), with a 45% reduction in tumor size based on RECIST criteria.
Pankaj Mohan, Ph.D., Founder and CEO of Sonnet, commented on the progress, stating, "This encouraging data with SON-1010 excites us with the ongoing combination trials with Atezolizumab and with the initiation of recruitment for the combination with trabectedin (Yondelis®)."
Combination Trials and Upcoming Milestones
Sonnet is actively pursuing clinical trials evaluating SON-1010 in combination with Atezolizumab for Platinum-Resistant Ovarian Cancer (PROC) and with trabectedin for advanced soft-tissue sarcomas (STS). These trials aim to assess the safety, tolerability, PK, PD, and efficacy of SON-1010 in combination with these agents.
The company anticipates several key milestones in the near future:
- H1 2025: Topline efficacy data from the Phase 1 SB101 trial (monotherapy).
- Q1 2025: Additional safety data from the Phase 1b/2a trial of SON-1010 in combination with Atezolizumab for PROC.
- H2 2025: Recommended Phase 2 dose (RP2D) and topline efficacy data from the Phase 1b/2a trial for PROC.
SON-1210 Development
Sonnet is also advancing its SON-1210 program, a bifunctional version of human Interleukins 12 (IL-12) and 15 (IL-15) configured using the company's Fully Human Albumin Binding (FHAB®) platform. SON-1210 is being developed in combination with chemotherapy for the treatment of advanced solid tumors and metastatic pancreatic cancer.
The company has successfully completed two IND-enabling toxicology studies of SON-1210 in non-human primates (NHPs), demonstrating no overt toxicity. A significant increase in interferon gamma (IFNγ) was observed, a key pharmacodynamic biomarker for anti-tumor efficacy.
In August 2024, Sonnet entered into a Master Clinical Collaboration Agreement with the Sarcoma Oncology Center to conduct an investigator-initiated Phase 1/2a clinical study evaluating SON-1210 in combination with chemotherapeutic agents, including NALIRIFOX, for metastatic pancreatic cancer.
Upcoming milestones for SON-1210 include:
- Q1 2025: IND submission.
- H1 2025: First patient dosed in the investigator-initiated Phase 1/2a study.
SON-080 Licensing Agreement
In October 2024, Sonnet entered into a licensing agreement with Alkem Laboratories Limited for the research, development, manufacturing, marketing, and commercialization of its SON-080 molecule for the treatment of Diabetic Peripheral Neuropathy (DPN) in India. Alkem will conduct clinical trials to obtain regulatory approval in India for SON-080 in DPN.
Financial Update
Sonnet BioTherapeutics reported a reduction in total annual operating expenses by approximately 37% compared to fiscal year 2023. The company believes it has sufficient funds for projected operations into July 2025, based on current cash on hand and recent funding activities.
