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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) presented data at the 2025 AACR:IO Conference showcasing their SON-1010 immunotherapy platform. The presentation highlighted their Fully Human Albumin Binding (FHAB®) technology, which enhances tumor targeting and extends the half-life of interleukin-12.
Key clinical findings revealed a 48% clinical benefit rate in advanced solid tumor patients, including a partial response at the highest dose in a clear cell sarcoma patient. The company is conducting multiple trials, including combinations with atezolizumab for platinum-resistant ovarian cancer and planned studies with NALIRIFOX for pancreatic cancer.
The FHAB platform addresses traditional cytokine therapy limitations by improving drug delivery to the tumor microenvironment (TME) and reducing toxicity risks. The technology demonstrates enhanced targeting through albumin binding to FcRn, GP60, and SPARC, resulting in increased activation of various immune cells and conversion of pro-tumor M2 MDSCs to inflammatory M1 APCs.
Sonnet BioTherapeutics (NASDAQ: SONN) announced the advancement of its proprietary Antibody Drug Conjugate (ADC) platform for drug discovery partnerships. The platform leverages the company's FHAB targeting domain and flexible docking peptides, offering controllable drug-antibody ratios (DAR).
Their initial proof-of-concept construct, SON-5010, demonstrated comparable performance to Kadcyla® and trastuzumab-MMAE in preclinical studies. SON-5010 comprises an anti-HER2-FHAB-anti-HER2 targeting scaffold linked to MMAE, showing similar tumor reduction activity at 10mg/kg in the BT-474 HER2+ carcinoma breast tumor mouse model.
The platform's key advantages include stable structural integrity, extended conjugation site flexibility, potential for enhanced tumor penetration, and the ability to select various payloads with different mechanisms of action for targeting cancer cells.
Sonnet BioTherapeutics (NASDAQ: SONN) announced that its abstract has been accepted for poster presentation at the 2025 American Association for Cancer Research (AACR) IO Conference. The conference will be held from February 23-26, 2025, at the JW Marriott in Los Angeles.
The presentation, scheduled for Tuesday, February 25, 2025 (1:45-4:45 PM PT), will focus on combination immunotherapy with an albumin-binding interleukin-12 fusion protein. The research explores how this protein extends cytokine half-life, targets the tumor microenvironment, and enhances therapeutic efficacy.
Sonnet BioTherapeutics (NASDAQ:SONN) has appointed Stephen J. McAndrew, Ph.D., as Chief Business Officer, effective February 17, 2025. Dr. McAndrew, who brings over 30 years of experience in biologics transactions, has been serving as Vice President and Senior Vice President of Business Development at Sonnet, managing partnering strategy, research partnerships, and the global IP portfolio.
The appointment aims to strengthen Sonnet's business development initiatives as their FHAB assets advance in clinical development. Dr. McAndrew's extensive experience includes senior roles at Oncobiologics (now Outlook Therapeutics) and Bristol-Myers Squibb, where he managed business development, licensing, and marketing functions.
Sonnet BioTherapeutics (NASDAQ: SONN) has reported key developments in its clinical programs and financial results for Q1 FY2025. The company completed the Phase 1 SB101 trial dose escalation for SON-1010, showing stable disease in 48% of evaluable monotherapy patients and one partial response with 45% tumor reduction. Clinical trials are progressing for SON-1010 combinations with Atezolizumab and trabectedin.
The company secured a licensing agreement with Alkem Laboratories for SON-080 in India and reported Q1 FY2025 financial results with a net loss of $3.2 million ($1.56 per share), compared to $1.2 million loss in Q1 FY2024. Cash position stands at $4.9 million as of December 31, 2024. The company recently raised $3.9 million through a registered direct offering.
Leadership changes include Stephen McAndrew's promotion to Chief Business Officer and Donald Griffith's appointment as new CFO, replacing Jay Cross.
Sonnet BioTherapeutics (NASDAQ: SONN) has secured European Patent No. EP3583125 B1 for its Fully Human Albumin Binding (FHAB®) technology, effective until February 20, 2038. The patent covers therapeutic fusion proteins utilizing FHAB for tumor targeting and extended pharmacokinetics.
The company's FHAB platform consists of a single, fully human construct with high affinity to bind to human albumin, providing an off-the-shelf solution for rapid therapeutic biologics development. This EU patent adds to Sonnet's existing global IP protection in China, Japan, Russia, and New Zealand.
Preclinical studies have demonstrated that FHAB-derived drug candidates show extended pharmacokinetics, enhanced tumor payload delivery, and improved efficacy compared to wild type cytokines. The platform enables both mono- and bi-functional mechanisms of action, potentially allowing for biological synergy between cytokines.
Sonnet BioTherapeutics (NASDAQ: SONN), a clinical-stage company focused on developing targeted immunotherapeutic drugs, has announced its participation in an upcoming healthcare investment webinar. Dr. Pankaj Mohan, the company's CEO, will present at the LIVE! with Webull Corporate Connect: Healthcare Investment Webinar on Wednesday, January 29th, 2025 at 2:40 PM ET.
The virtual biotech investment event provides an opportunity for investors to learn more about Sonnet's developments in the immunotherapeutics space. Interested participants can access the presentation through the provided registration link.
Sonnet BioTherapeutics (NASDAQ:SONN) announced the expansion of its Phase 1 SB101 clinical study of SON-1010 to evaluate its combination with trabectedin in soft-tissue sarcoma patients. The expansion follows successful monotherapy dose escalation and will explore SON-1010's immune-oncology impact at the maximum tolerated dose of 1200 ng/kg.
The study will enroll up to 18 patients with unresectable, metastatic liposarcoma or leiomyosarcoma. Enrollment is expected to complete in H1 2025, with topline safety data anticipated in H2 2025. The trial's primary outcomes include safety, tolerability, pharmacokinetics, and pharmacodynamics of SON-1010.
SON-1010, Sonnet's proprietary version of IL-12, is configured using the FHAB platform to extend half-life and bioactivity. The company believes combining SON-1010 with trabectedin could enhance local immune response in the tumor microenvironment and potentially improve treatment outcomes for soft-tissue sarcoma patients.
Sonnet BioTherapeutics (NASDAQ: SONN) has released its latest CEO Corner segment featuring CEO Pankaj Mohan, Ph.D. The segment, published on the company's website, reviews key accomplishments for 2024 and outlines targeted value-driving milestones for 2025. The content will remain accessible on www.sonnetbio.com for 90 days.
Sonnet BioTherapeutics (NASDAQ: SONN) reported fiscal year 2024 results with significant operational improvements. The company achieved a 37% reduction in total operating expenses compared to fiscal year 2023, with 43% of expenses covered by non-dilutive funding. Key developments include progress in clinical trials for SON-1010 in solid tumors and Platinum-Resistant Ovarian Cancer, and a licensing agreement for SON-080 in Diabetic Peripheral Neuropathy.
Financial results show R&D expenses decreased to $5.7M from $11.8M, and G&A expenses reduced to $6.1M from $7.1M year-over-year. The company had $0.1M cash on hand as of September 30, 2024, but secured additional funding through stock sales and tax incentives, projecting operations funded through July 2025.
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