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Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) is a clinical-stage biotechnology company based in Cranbury, New Jersey. The firm is pioneering the development of targeted immunotherapeutic drugs primarily aimed at treating cancers. Sonnet employs its proprietary FHAB (Fully Human Albumin Binding) technology, which utilizes a single-chain antibody fragment that binds to human serum albumin for targeted delivery to tumor and lymphatic tissues. This innovative platform enhances drug efficacy and safety by extending the half-life of therapeutic agents and concentrating them in the tumor microenvironment (TME).
Sonnet’s mission focuses on generating immuno-oncology candidates and advancing them to Phase II clinical assets. The company's current pipeline includes several promising products:
- SON-080 - A low-dose IL-6 aimed at treating chemotherapy-induced peripheral neuropathy (CIPN).
- SON-1210 - Combines IL-12 and IL-15 with Sonnet's FHAB for robust immune response targeting tumors.
- SON-1010 - Consists of a single-chain IL-12 linked with the albumin-binding domain for enhanced targeting and efficacy in cancer treatment.
Recent achievements include the publication of preclinical data demonstrating the efficacy of SON-1210 in reducing tumor growth in melanoma models. Additionally, the company reported positive safety and tolerability results from Phase 1 studies of SON-1010 in healthy volunteers and cancer patients.
Sonnet's collaboration with Genentech for the combination study of SON-1010 and atezolizumab (Tecentriq) in platinum-resistant ovarian cancer is a significant milestone. Financially, the company has successfully leveraged tax credits and managed its cash runway effectively, projecting operations funding into the latter part of 2024.
The company is also actively exploring strategic alternatives to maximize stockholder value, having engaged Chardan Capital Markets to assist in evaluating potential business development, partnerships, acquisitions, or mergers.
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
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.
Sonnet BioTherapeutics Holdings, (NASDAQ:SONN) announced significant preclinical data for its bispecific interleukin candidates, SON-1010, SON-1210, and SON-1410, during the AACR Annual Meeting 2022. The studies demonstrated effective tumor growth reduction in a B16-F10 melanoma model, with 67% reduction for SON-1210 and 76% for SON-1410 at a 5µg dose. The company plans to initiate the first patient dosing for SON-1010, paving the way for further development of its bispecific candidates.
Sonnet BioTherapeutics Holdings (NASDAQ:SONN) has received FDA clearance for its Investigational New Drug (IND) application for SON-1010, a proprietary version of Interleukin 12 (IL-12), marking the company's first IND clearance. This enables the initiation of a Phase 1 trial aimed at evaluating the safety and efficacy of SON-1010 in adult oncology patients, expected to begin in Q2 2022. The trial will focus on safety, tolerability, and pharmacokinetics, utilizing a standard 3+3 oncology design to establish dosing parameters.
Sonnet BioTherapeutics Holdings (NASDAQ:SONN) announced that its preclinical data on Fully Human Albumin Binding candidates (SON-1010, SON-1210, SON-1410) will be presented at the AACR Annual Meeting 2022 from April 8-13 in New Orleans. The presentation will showcase an innovative platform for targeted delivery of bispecific interleukins to tumors. The session is scheduled for April 13, 2022, from 9:00 AM to 12:30 PM EDT. The company focuses on developing biologic drugs that improve therapeutic efficiency and safety.
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