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Sonnet BioTherapeutics Holdings Inc. develops immunotherapeutic biologic drugs for oncology using its FHAB Fully Human Albumin-Binding platform. The platform uses a fully human single-chain antibody fragment designed to bind human serum albumin and transport large-molecule therapies toward tumor and lymphatic tissue, supporting constructs that include cytokines, peptides, antibodies and vaccines.
Company news centers on clinical and regulatory updates for targeted oncology programs, including SON-1010 or IL-12-FHAB in solid tumors and platinum-resistant ovarian cancer, as well as scientific conference presentations, shareholder voting matters, financing activity, capital-structure disclosures and governance developments.
Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) has appointed Lori McNeill to its Board of Directors, also making her the Chairperson of the newly established Business Advisory Committee (BAC). With over 20 years in healthcare and a background at Pfizer, McNeill is expected to enhance Sonnet's strategic collaborations and communication efforts, particularly regarding government initiatives like the Cancer Moonshot. The BAC will guide the company on external partnerships and elevate its profile in immune oncology, coinciding with upcoming clinical trial data releases.
On September 21, 2022, Sonnet BioTherapeutics Holdings announced progress in their Phase 1 clinical trials for SON-1010 (IL-12-FHAB), having dosed 19 subjects so far. The initial safety review has cleared the way for continued dose escalation. SB101 focuses on advanced solid tumors, while SB102 involves healthy volunteers. No dose-limiting toxicities have been reported. Upcoming data on safety and cytokine-specific responses is expected in Q4 2022. This development marks a significant milestone in immunotherapy, with SON-1010 aiming to enhance safety and efficacy in cancer treatment.
Sonnet BioTherapeutics Holdings (NASDAQ:SONN) announced a 1-for-14 reverse stock split effective September 19, 2022. The split aims to elevate the share price above the $1.00 minimum for continued Nasdaq listing. Post-split, shares will decrease from approximately 69.6 million to 5.0 million. The initiative was approved by stockholders on September 15, 2022, and will also impact outstanding warrants and options. No fractional shares will be issued; cash payments will be provided instead for fractional interests. The par value remains at $0.0001 per share.
Sonnet BioTherapeutics (NASDAQ:SONN) announced the initiation of clinical trials for SON-1010 and SON-080, targeting advanced solid tumors and chemotherapy-induced peripheral neuropathy, respectively. Positive preclinical data supports SON-1010’s combination with anti-PD1 therapy.
Financially, Sonnet reported $5.2 million cash on hand, with R&D expenses rising to $5.6 million. Additionally, the company launched a $6.1 million at-the-market offering and completed a private placement raising $2.25 million.
Sonnet BioTherapeutics announced the initiation of a Phase 1b/2a clinical trial for SON-080, a treatment targeting persistent chemotherapy-induced peripheral neuropathy (CIPN). The trial, authorized for multiple sites in Australia, aims to assess safety, pharmacokinetics (PK), and pharmacodynamics (PD), with dosing expected soon. SON-080 is a proprietary form of recombinant human interleukin-6 (rhIL-6), anticipated to promote nerve regrowth and alleviate CIPN symptoms. Successful results may lead to further development for diabetic peripheral neuropathy.
Sonnet BioTherapeutics announced the initiation of a second Phase 1 clinical trial for SON-1010 (IL12-FHAB) after successfully starting its first trial. This new study will provide important pharmacokinetic (PK) and pharmacodynamic (PD) data, focusing on safety and tolerability in healthy volunteers in Australia. SON-1010 utilizes the F technology to enhance delivery to tumors. The trial aims to inform further potential applications of SON-1010 while expanding on its foundational bispecific molecule research.
Sonnet BioTherapeutics (NASDAQ:SONN) reported promising preclinical data indicating that SON-1010 (IL12-FHAB) combined with a commercially available anti-PD1 antibody led to significant tumor growth inhibition in a melanoma model. The combination resulted in a 79.1% inhibition rate compared to a placebo group and improved survival rates, with seven out of nine mice surviving the combination treatment. These results highlight the potential of SON-1010 in enhancing checkpoint inhibitor efficacy, aiding future study designs.
Sonnet BioTherapeutics Holdings (NASDAQ:SONN) announced the adjournment of its 2022 Annual Meeting due to lack of quorum. The meeting, originally held on June 2, 2022, will reconvene on June 23, 2022, at 9:00 a.m. ET. Only 46% of outstanding shares entitled to vote were represented. Stockholders of record as of April 4, 2022, are encouraged to vote by June 22, 2022. The company aims to finalize voting on proposals outlined in its proxy statement filed on April 12, 2022. The Board recommends voting in favor of all proposals.
Sonnet BioTherapeutics Holdings announced the clearance of IND for its lead asset, SON-1010, and the initiation of its first clinical trial for advanced solid tumors. The company aims to advance SON-080 into clinical studies by mid-2022 and plans non-human primate toxicity studies for SON-1210 soon. Financially, Sonnet reported $13.6 million in cash with R&D expenses rising to $6.4 million in Q2 2022, driven by increased operational activities. The decrease in general and administrative expenses to $1.9 million indicates ongoing cost management efforts.
Sonnet BioTherapeutics Holdings (NASDAQ:SONN) announced the initiation of a Phase 1 clinical trial for SON-1010 (IL12-FHAB) in adult patients with advanced solid tumors. This trial aims to evaluate the safety, tolerability, and pharmacokinetics of SON-1010. The FHB technology targets tumors, potentially enhancing the efficacy and safety of immunotherapy. The trial, employing a 3+3 design, seeks to establish the maximum tolerated and recommended doses. Dr. Richard Kenney expressed optimism about the potential of SON-1010 to improve cytokine immunotherapy outcomes.