Sonnet BioTherapeutics Achieves Key Enrollment Milestone in SB101

Sonnet BioTherapeutics Completes Enrollment in Phase 1 Study

SON-1010 represents a groundbreaking approach to cancer treatment, using targeted immune activation therapy designed to convert 'cold' tumors into 'hot' ones.

Progress in Clinical Trials

Recently, Sonnet BioTherapeutics Holdings, Inc. (NASDAQ: SONN) announced the successful completion of enrollment and the initiation of dosing in its Phase 1 SB101 clinical trial for SON-1010 (IL12-FHAB). This study focuses on adult patients with advanced solid tumors and aims to gather comprehensive safety data.

Upcoming Safety Data Reports

Topline safety data from the SB101 trial are expected in the fourth quarter. CEO Pankaj Mohan emphasized the significance of this milestone in their development program, expressing hope for continued safety and tolerability.

Understanding SON-1010

SON-1010 is a unique version of recombinant human interleukin-12 (rhIL-12), enhanced through Sonnet’s Fully Human Albumin Binding (FHAB) platform. This technology increases the drug's half-life by binding to native albumin found in serum, enhancing its effectiveness in targeting the tumor microenvironment (TME).

Safety Review and Tolerability

The safety review process has been rigorous, with the Safety Review Committee monitoring the trial throughout the dose escalation. The design aims to minimize toxicity while maximizing treatment efficacy using a desensitizing approach for the first dose. So far, adverse events reported have been mild and transient, with no cases of cytokine release syndrome.

Clinical Observations and Outcomes

In an intriguing case, one patient with progressive endometrial sarcoma showed stable disease for nearly two years while receiving SON-1010 as a monotherapy. Although not classified as a partial response, this instance underlines the potential benefit of the treatment.

Pharmacodynamic Measurements

Cytokine analysis revealed a significant induction of interferon gamma (IFN?) post-treatment, indicating a robust immune response. The control of this immune activation and the absence of severe cytokine release syndrome signals promise for SON-1010 in oncology.

Future Prospects for SB101 Trial

The SB101 trial is designed as a first-in-human study primarily to evaluate safety. Conducted across multiple sites, it encompasses multiple ascending doses of SON-1010 in cancer patients. Primary endpoints will explore safety, while secondary endpoints will investigate pharmacokinetics, pharmacodynamics, and anti-tumor activity.

About Sonnet BioTherapeutics Holdings, Inc.

As an oncology-focused biotechnology company, Sonnet is committed to creating targeted biologic drugs with enhanced efficacy. Their proprietary FHAB technology leverages a fully human scaffold to facilitate drug targeting to lymphatic and tumor tissues, improving the safety and effectiveness of therapies.

Expanding Clinical Programs

In addition to SON-1010, Sonnet is advancing its second program, SON-1210, an innovative immunotherapeutic candidate for solid tumors. Collaborations, like those with Roche for the treatment of Platinum-Resistant Ovarian Cancer, underline Sonnet's commitment to innovative cancer solutions.

Investor Relations and Inquiries

For more details on their ongoing studies and corporate strategy, interested parties are encouraged to contact Sonnet BioTherapeutics Holdings, Inc.'s investor relations team. They are actively seeking partnerships to support their development programs.

Frequently Asked Questions

What is SON-1010?

SON-1010 is an innovative cancer therapy that aims to enhance immune responses against solid tumors by utilizing engineered interleukin-12.

What does the Phase 1 SB101 trial assess?

The trial primarily assesses the safety and tolerability of SON-1010 in advanced cancer patients, alongside pharmacokinetic and pharmacodynamic data.

When will results from the SB101 trial be available?

Topline safety data from the SB101 trial is expected to be reported in the fourth quarter.

How does SON-1010 work?

SON-1010 targets the tumor microenvironment by enhancing immune responses, specifically designed to bind to proteins crucial for tumor targeting.

What are the future plans for Sonnet BioTherapeutics?

Sonnet aims to expand its clinical programs, including SON-1210, and continues to seek partnerships to advance their innovative cancer therapies.

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