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PRINCETON, NJ - Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN), a clinical-stage biotech company with a market capitalization of $4.63 million, has expanded its Phase 1 SB101 clinical trial to include a new cohort that combines its immunotherapeutic drug SON-1010 with trabectedin, a chemotherapeutic agent, for treating advanced soft-tissue sarcoma (STS). The trial aims to explore the potential enhancement of trabectedin's therapeutic effects by leveraging the immune-oncology properties of SON-1010. According to InvestingPro analysis, the company currently maintains a weak financial health score of 1.46, reflecting significant operational challenges typical of early-stage biotech firms.
Patients with unresectable, metastatic liposarcoma or leiomyosarcoma are the focus of this open-label, single-arm expansion cohort. The combination therapy will be administered in standard 21-day cycles, with a target enrollment of up to 18 patients. The primary outcome measures include safety, tolerability, pharmacokinetics, and pharmacodynamics, with the maximum tolerated dose (MTD) set at 1200 ng/kg. Enrollment is currently underway and is expected to be completed in the first half of 2025, with topline safety data anticipated in the second half of the same year.
Dr. Sant Chawla of the Sarcoma Oncology Center, the Principal Investigator for the study, expressed optimism about the combination's potential to meet a significant unmet need in STS treatment. The synergy between trabectedin's ability to activate pro-inflammatory tumor macrophages and SON-1010's stimulation of NK and T cells to secrete interferon-gamma may improve anti-tumor control.
SON-1010 is a proprietary version of recombinant human interleukin-12 (rhIL-12) fused with Sonnet's Fully Human Albumin Binding (FHAB®) platform, designed to extend the half-life and bioactivity of IL-12. This technology aims to target the tumor microenvironment (TME) and potentially transform 'cold' tumors into 'hot' ones, thereby stimulating a more robust immune response.
The success of this cohort could position SON-1010 for a larger Phase 2 study and potentially establish the combination as an improved treatment for STS. Additionally, SON-1010 is being evaluated in a Phase 1b/2a dose-escalation and proof-of-concept study in combination with atezolizumab for platinum-resistant ovarian cancer, with an update on safety at the MTD expected in the first quarter of 2025. With the stock trading at $1.54 and showing a year-to-date return of 5.48%, investors should note that InvestingPro has identified 14 additional key investment factors for SONN, including detailed financial health metrics and growth projections. The company's next earnings report is scheduled for February 13, 2025.
This expansion of the Phase 1 SB101 trial is based on a press release statement from Sonnet BioTherapeutics Holdings, Inc. For more details on the trial, reference identifier NCT05352750 can be found at www.clinicaltrials.gov.
In other recent news, Sonnet BioTherapeutics has been making significant progress in its various endeavors. The clinical-stage biopharmaceutical company recently completed a dose escalation in the Phase 1 SB101 trial for its drug SON-1010, designed for patients with advanced solid tumors. The trial found the maximum tolerated dose of SON-1010 to be 1200 ng/kg, with no observed toxicity.
Sonnet also reported that 48% of patients maintained stable disease four months after beginning treatment with SON-1010. The company has also secured a patent for its novel immunotherapeutic proteins, SON-1411 and SON-1400, which could potentially enhance cancer treatment.
In financial news, 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.
Sonnet continues to seek partnership opportunities to support the later-stage development of SON-1010. It has also entered into a licensing agreement with Alkem Laboratories for the development and commercialization of SON-080 in India. These are among the recent developments for Sonnet BioTherapeutics.
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