Sonnet BioTherapeutics Announces Publication Detailing the Discovery and Development of SON-1010, an Albumin-Binding IL-12 Fusion Protein, Demonstrating Its Mechanism of Action
Sonnet BioTherapeutics (NASDAQ: SONN) announced the publication of discovery and development data for SON-1010, their lead drug candidate, in Frontiers in Immunology. The research details their albumin-binding (FHAB®) technology combined with IL-12 for improved cancer treatment delivery.
The publication highlights the identification of molecules that bind to serum albumin across multiple species and pH ranges, leading to extended half-life and improved tumor targeting. Patents for FHAB and SON-1010 have been issued in major markets including the US, China, and Japan, expiring between 2038-2039.
The company is currently conducting a Phase 1 clinical trial of SON-1010 for advanced solid tumors, with safety data expected in Q4 2024. Additionally, SON-1010 is being evaluated in a Phase 1/2a study in combination with Roche's atezolizumab for Platinum-Resistant Ovarian Cancer.
Sonnet BioTherapeutics (NASDAQ: SONN) ha annunciato la pubblicazione di dati di scoperta e sviluppo per SON-1010, il loro principale candidato farmaceutico, su Frontiers in Immunology. La ricerca descrive la loro tecnologia di legame all'albumina (FHAB®) combinata con IL-12 per una migliore somministrazione dei trattamenti oncologici.
La pubblicazione mette in evidenza l'identificazione di molecole che si legano all'albumina sierica attraverso diverse specie e intervalli di pH, con conseguente prolungamento della emivita e miglioramento del targeting tumorale. I brevetti per FHAB e SON-1010 sono stati rilasciati nei principali mercati, tra cui USA, Cina e Giappone, con scadenza tra il 2038 e il 2039.
L'azienda sta attualmente conducendo un trial clinico di Fase 1 di SON-1010 per tumori solidi avanzati, con dati sulla sicurezza previsti per il quarto trimestre del 2024. Inoltre, SON-1010 è in fase di valutazione in uno studio di Fase 1/2a in combinazione con l'atezolizumab di Roche per il carcinoma ovarico resistente al platino.
Sonnet BioTherapeutics (NASDAQ: SONN) anunció la publicación de datos de descubrimiento y desarrollo para SON-1010, su principal candidato a fármaco, en Frontiers in Immunology. La investigación detalla su tecnología de unión a la albúmina (FHAB®) combinada con IL-12 para una mejor entrega de tratamientos contra el cáncer.
La publicación destaca la identificación de moléculas que se unen a la albúmina sérica en múltiples especies y rangos de pH, lo que lleva a una mayor vida media y mejor focalización de los tumores. Se han emitido patentes para FHAB y SON-1010 en los principales mercados, incluidos EE. UU., China y Japón, con vencimientos entre 2038 y 2039.
La compañía está llevando a cabo actualmente un ensayo clínico de Fase 1 de SON-1010 para tumores sólidos avanzados, con datos de seguridad esperados para el cuarto trimestre de 2024. Además, SON-1010 se está evaluando en un estudio de Fase 1/2a en combinación con el atezolizumab de Roche para el cáncer de ovario resistente al platino.
Sonnet BioTherapeutics (NASDAQ: SONN)는 SON-1010, 그들의 주요 약물 후보의 발견 및 개발 데이터가 Frontiers in Immunology에 발표되었다고 발표했습니다. 이 연구는 암 치료를 개선하기 위해 IL-12와 결합된 그들의 알부민 결합(FHAB®) 기술을 자세히 설명합니다.
이 출판물은 여러 종과 pH 범위에서 혈청 알부민에 결합하는 분자의 식별을 강조하여 반감기를 연장하고 종양 표적화를 향상시킵니다. FHAB 및 SON-1010에 대한 특허는 미국, 중국 및 일본을 포함한 주요 시장에서 발급되었으며, 2038-2039년 사이에 만료됩니다.
회사는 현재 고급 고형종양에 대한 SON-1010의 1상 임상 시험을 진행 중이며, 안전성 데이터는 2024년 4분기에 예상됩니다. 또한 SON-1010은 Roche의 아테졸리주맙과 함께 백금 내성 난소암을 위한 1/2a상 연구에서 평가되고 있습니다.
Sonnet BioTherapeutics (NASDAQ: SONN) a annoncé la publication de données sur la découverte et le développement pour SON-1010, leur principal candidat médicament, dans Frontiers in Immunology. La recherche détaille leur technologie de liaison à l’albumine (FHAB®) combinée avec IL-12 pour améliorer l’administration des traitements contre le cancer.
La publication met en évidence l’identification de molécules se liant à l’albumine sérique à travers plusieurs espèces et plages de pH, permettant ainsi une demi-vie prolongée et un meilleur ciblage des tumeurs. Des brevets pour FHAB et SON-1010 ont été délivrés dans les principaux marchés comme les États-Unis, la Chine et le Japon, expirant entre 2038 et 2039.
L’entreprise mène actuellement un essai clinique de Phase 1 de SON-1010 pour des tumeurs solides avancées, avec des données de sécurité attendues pour le quatrième trimestre 2024. De plus, SON-1010 est en cours d’évaluation dans une étude de Phase 1/2a en combinaison avec l’atezolizumab de Roche pour le cancer de l’ovaire résistant au platine.
Sonnet BioTherapeutics (NASDAQ: SONN) gab die Veröffentlichung von Entdeckungs- und Entwicklungsdaten für SON-1010, ihren Hauptkandidaten, in Frontiers in Immunology bekannt. Die Forschung beschreibt ihre albuminbindende Technologie (FHAB®) in Kombination mit IL-12 für eine verbesserte Krebsbehandlung.
Die Veröffentlichung hebt die Identifizierung von Molekülen hervor, die über verschiedene Spezies und pH-Bereiche an Serumalbumin binden, was zu einer verlängerten Halbwertszeit und einer verbesserten Tumoransprache führt. Patente für FHAB und SON-1010 wurden in wichtigen Märkten, darunter die USA, China und Japan, erteilt und laufen zwischen 2038 und 2039 aus.
Das Unternehmen führt derzeit eine Phase 1- klinische Studie zu SON-1010 für fortgeschrittene solide Tumore durch, wobei Sicherheitsdaten im vierten Quartal 2024 erwartet werden. Darüber hinaus wird SON-1010 in einer Phase 1/2a-Studie in Kombination mit Roche's Atezolizumab für platinresistenten Ovarialkrebs evaluiert.
- Patent protection secured in major markets until 2038-2039
- Ongoing Phase 1 clinical trial for solid tumors
- Partnership with Roche for combination therapy study
- Improved drug delivery system with extended half-life
- Safety data not yet available
- Additional funding needed for new compound development
Insights
This peer-reviewed publication in Frontiers in Immunology marks a significant scientific validation of Sonnet's FHAB platform technology and SON-1010 drug candidate. The research demonstrates several critical advantages: extended half-life, improved tumor targeting and reduced toxicity compared to standard IL-12 therapy. The strong patent protection through 2038-2039 in major markets provides substantial intellectual property value.
The technology addresses key limitations of traditional IL-12 therapeutics through albumin binding, potentially enabling more effective cancer treatment with fewer side effects. The ongoing Phase 1 trial with expected safety data in Q4 2024 and the Roche partnership for combination therapy in ovarian cancer represent important clinical validation opportunities. However, investors should note that as a
The patent portfolio for SON-1010 is particularly robust, with composition of matter claims secured in critical markets including the US, China, Japan, Russia and New Zealand. The patent protection extending to 2038-2039 provides a substantial exclusivity window for commercialization. The detailed mechanism of action and manufacturing process documentation strengthens the IP position.
The FHAB platform technology's novel approach to improving cytokine delivery could enable multiple follow-on drug candidates, creating potential for an extensive patent family. However, the company's ability to defend and expand this IP portfolio may be constrained by its financial resources.
Pankaj Mohan, CEO of Sonnet discusses what this publication means in a Virtual Investor “What This Means” segment; access here
PRINCETON, NJ, Dec. 04, 2024 (GLOBE NEWSWIRE) -- Sonnet BioTherapeutics Holdings, Inc. (the "Company" or "Sonnet”) (NASDAQ: SONN), a clinical-stage company developing innovative targeted immunotherapeutic drugs, today announced the publication of extensive discovery, development and preclinical data on SON-1010 demonstrating its mechanism of action in Frontiers in Immunology. SON-1010, Sonnet’s lead proprietary drug candidate, combines the Company’s fully human albumin-binding (FHAB®) construct with a native single-chain IL-12 sequence to simplify delivery of the cytokine systemically. The paper entitled, “SON-1010: An Albumin-binding IL-12 Fusion Protein with Improved Cytokine Half-life Targets Tumors and Enhances Therapeutic Efficacy,” details the identification of single-chain variable fragments (scFv) from a human phage display library that bound human, mouse, and cynomolgus macaque serum albumin, both at physiologic and acidic conditions. The composition of matter patent claims on the FHAB domain and SON-1010 fusion protein have been issued in a number of major markets, including but not limited to the U.S., China, Japan, Russia and New Zealand, and expire between 2038 and 2039. Additionally, the Company announced the release of a “What This Means” segment to discuss the publication which is now available here.
The extensive discovery program included putting the scFv domains through a series of steps to identify strongly binding molecules that bind tightly over a 5.8 to 7.2 pH range and do not interfere with the normal physiology of albumin to bind the neonatal Fc receptor (FcRn). This resulted in having prolonged half-life in serum and binding to SPARC/GP60, which allows albumin to target the tumor microenvironment (TME). A final molecule was selected and a single mutation was introduced that minimizes the potential for immunogenicity. This FHAB domain was characterized, and manufacturing processes were developed to prepare Sonnet’s first drug candidate for the clinic. Once identified, the murine form of mIL12-FHAB was shown to be much more efficient at blocking tumor growth compared to murine IL-12, while stimulating significant and prolonged IFNγ production with minimal toxicity. Biodistribution studies in mice confirmed tumor delivery and toxicological studies in non-human primates allowed the initiation of the clinical trials.
“We are pleased to share these findings, which is the first time we have fully described the extensive research that was required to discover and develop our signature FHAB platform,” said Pankaj Mohan, Ph.D., Founder and CEO of Sonnet. “This work lays the foundation for all of the products on our platform that are designed to safely extend the half-life of cytokines and deliver them to the tumor, where they can convert the immunological response from ‘cold’ to ‘hot’ and potentially realize the promise of immunotherapy.”
“IL-12 and related compounds have been extensively studied in cancer and immunotherapy indications. However, recombinant interleukins have had limited clinical success owing to their short circulating half-life, inefficient TME targeting, and requirement for frequent dosing, often leading to substantial systemic toxicities,” added John Cini, Ph.D. Co-Founder and CSO of Sonnet. “We believe we have addressed these issues with our discovered platform, having utilized a molecule that can be applied in any solid tumor type that concentrates albumin, such as sarcoma, gynecologic, and gastrointestinal cancers. We intend to explore new compounds as well, as funds become available.”
The Company is currently conducting a Phase 1 clinical trial of SON-1010 (IL12-FHAB) as a monotherapy in adult patients with advanced solid tumors (SB101; NCT05352750). The Company expects to report safety data from this study in Q4 2024. SON-1010 is being evaluated in an ongoing Phase 1/2a study through a Master Clinical Trial and Supply Agreement, along with ancillary Quality and Safety Agreements, with Roche in combination with atezolizumab (Tecentriq®) for the treatment of Platinum-Resistant Ovarian Cancer (PROC).
About Sonnet BioTherapeutics Holdings, Inc.
Sonnet is an oncology-focused biotechnology company with a proprietary platform for developing targeted biologic drugs with single or bifunctional action. Known as FHAB (Fully Human Albumin-Binding), the technology utilizes a fully human single chain antibody fragment (scFv) that binds to and "hitch-hikes" on human serum albumin (HSA) for transport to target tissues. Sonnet's FHAB was designed to specifically target tumor and lymphatic tissue, with an improved therapeutic window for optimizing the safety and efficacy of immune modulating biologic drugs. FHAB platform is the foundation of a modular, plug-and-play construct for potentiating a range of large molecule therapeutic classes, including cytokines, peptides, antibodies and vaccines.
Sonnet’s lead program, SON-1010, or IL-12-FHAB, is in development for the treatment of solid tumors and ovarian cancer. SON-1010 is being evaluated in an ongoing Phase 1/2a study through a Master Clinical Trial and Supply Agreement, along with ancillary Quality and Safety Agreements, with Roche in combination with atezolizumab (Tecentriq®) for the treatment of Platinum-Resistant Ovarian Cancer (PROC). The Company is also evaluating its second program, SON-1210, an IL12-FHAB-IL15 for solid tumors, in collaboration with the Sarcoma Oncology Center to commence an investigator-initiated and funded Phase 1/2a study for the treatment of pancreatic cancer.
The Company’s SON-080 program is a low dose of rhIL-6 in development for Chemotherapy-Induced Peripheral Neuropathy (CIPN) and Diabetic Peripheral Neuropathy (DPN). SON-080 demonstrated encouraging results in a Phase 1b/2a clinical trial, being well tolerated with no evidence of a pro-inflammatory cytokine response. Sonnet is currently seeking partnership opportunities to support a Phase 2 trial. In October 2024, Sonnet announced an India license agreement with Alkem Laboratories, Inc. who will assume responsibility for advancing development of the SON-080 program into a Phase 2 study in DPN.
Forward-Looking Statements
This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the outcome of the Company’s clinical trials, the Company's cash runway, the Company's product development, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management's current beliefs and assumptions.
These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential," "predict," "project," "should," "would" and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company's filings with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.
Investor Relations Contact:
JTC Team, LLC
Jenene Thomas
908-824-0775
SONN@jtcir.com
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