Sonnet reports positive early results in sarcoma drug trial

PRINCETON, N.J. - Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN), a clinical-stage biopharmaceutical company with a market capitalization of $4.17 million, has announced promising safety data from the first review of its ongoing Phase 1 SB101 clinical trial. According to InvestingPro data, the company maintains a strong liquidity position with more cash than debt on its balance sheet. The trial is examining the safety and efficacy of SON-1010, a proprietary immunotherapeutic drug, in combination with the FDA-approved sarcoma treatment trabectedin (Yondelis®).

The recent review by the Safety Review Committee (SRC) found no unexpected toxicities in the first seven patients treated with SON-1010 at the maximum tolerated dose (MTD). These patients are part of a cohort that is testing the combination therapy for advanced leiomyosarcoma (LMS) and liposarcoma (LPS), two challenging forms of cancer. While the clinical progress appears promising, InvestingPro analysis reveals the company’s current financial health score stands at 1.67, labeled as ’WEAK’, with 10 additional key insights available to subscribers.

In the trial, adverse events related to either drug were mild or moderate, and the combination did not appear to adversely impact each other. The review included all 30 patients dosed to date, with common adverse events including fatigue, fever, chills, and myalgia. One patient progressed, while the other six are tolerating the treatment after an average of slightly over two months.

The annual review also showed that 83% of patients in the high-dose monotherapy group exhibited stable disease at four months, and four continue on trial at six months with no new safety concerns. Moreover, 13 of the 24 patients studied during SON-1010 dose escalation had evidence of clinical benefit, including a partial response in one patient.

Dr. Sant Chawla, Principal Investigator at the Sarcoma Oncology Center, expressed optimism about the potential of SON-1010 to improve therapeutic effectiveness when combined with trabectedin. The trial’s primary outcome measures include safety, tolerability, pharmacokinetics, and pharmacodynamics of SON-1010, as well as establishing the MTD.

Sonnet expects to enroll up to 18 patients in the open-label, single-arm expansion cohort, with treatments alternating between SON-1010 and standard 21-day trabectedin cycles. The goal is to evaluate the combination therapy’s potential to activate immune responses in tumors, potentially improving the efficacy of trabectedin.

Pankaj Mohan, Ph.D., Sonnet Founder and CEO, highlighted the $2.1 billion global market opportunity for trabectedin and the significant unmet medical need in sarcoma treatment. The company believes that the results of this trial may position SON-1010 for a larger Phase 2 study and potential partnerships. Trading near its 52-week low of $1.30, SONN’s current valuation appears attractive according to InvestingPro Fair Value metrics, though investors should note the company is not yet profitable and analysts expect sales to decline in the current year.

This news is based on a press release statement from Sonnet BioTherapeutics Holdings, Inc.

In other recent news, Sonnet BioTherapeutics Holdings, Inc. has announced the receipt of a Notice of Allowance from the United States Patent and Trademark Office for a new patent related to its IL-18 variant protein, IL-18BPR. This patent is expected to enhance the therapeutic potential of IL-18BPR in cancer treatments and further solidify Sonnet’s intellectual property position. The company is also advancing its Antibody Drug Conjugate (ADC) platform, which aims to address technical challenges in ADCs and offers a flexible payload capacity. The initial proof-of-concept ADC construct, SON-5010, showed promising results in preclinical studies with similar tumor reduction activity and no detectable toxicity compared to existing treatments.

Additionally, Sonnet BioTherapeutics has appointed Stephen J. McAndrew, Ph.D., as its new Chief Business Officer. With over three decades of experience in the biopharmaceutical industry, McAndrew is expected to enhance the company’s business development and licensing strategies. In clinical developments, Sonnet has expanded its Phase 1 SB101 clinical trial to include a new cohort combining its drug SON-1010 with trabectedin for treating advanced soft-tissue sarcoma. This trial aims to evaluate the safety and potential therapeutic benefits of the combination therapy.

These recent developments reflect Sonnet’s ongoing efforts to innovate and expand its oncology-focused pipeline. The company’s lead program, SON-1010, is currently under evaluation for multiple cancer treatments, including a combination study with atezolizumab for platinum-resistant ovarian cancer. Investors are advised to consider the inherent risks and uncertainties associated with these forward-looking statements.

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