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Sonnet BioTherapeutics Further Expands Global Intellectual Property Portfolio with Issuance of EU Patent for FHAB® Platform Technology

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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) ha ottenuto il Brevetto Europeo No. EP3583125 B1 per la sua tecnologia Fully Human Albumin Binding (FHAB®), valido fino al 20 febbraio 2038. Il brevetto copre le proteine fusione terapeutiche che utilizzano FHAB per il targeting dei tumori e una farmacocinetica prolungata.

La piattaforma FHAB dell'azienda consiste in una costruzione totalmente umana con alta affinità per legarsi all'albumina umana, offrendo una soluzione pronta all'uso per lo sviluppo rapido di biologici terapeutici. Questo brevetto dell'UE si aggiunge alla protezione della proprietà intellettuale globale già esistente di Sonnet in Cina, Giappone, Russia e Nuova Zelanda.

Gli studi preclinici hanno dimostrato che i candidati farmacologici derivati da FHAB mostrano una farmacocinetica prolungata, una migliore consegna del payload tumorale e un'efficacia migliorata rispetto ai citochine di tipo selvaggio. La piattaforma consente meccanismi d'azione sia monofunzionali che bifunzionali, potenzialmente permettendo sinergia biologica tra le citochine.

Sonnet BioTherapeutics (NASDAQ: SONN) ha obtenido la Patente Europea No. EP3583125 B1 para su tecnología Fully Human Albumin Binding (FHAB®), válida hasta el 20 de febrero de 2038. La patente cubre proteínas de fusión terapéuticas que utilizan FHAB para la localización de tumores y una farmacocinética prolongada.

La plataforma FHAB de la compañía consiste en una construcción completamente humana con alta afinidad para unirse a la albúmina humana, proporcionando una solución lista para usar para el desarrollo rápido de biológicos terapéuticos. Esta patente de la UE se suma a la protección existente de propiedad intelectual global de Sonnet en China, Japón, Rusia y Nueva Zelanda.

Los estudios preclínicos han demostrado que los candidatos a fármacos derivados de FHAB muestran farmacocinética prolongada, mejora en la entrega de carga tumoral y eficacia mejorada en comparación con citoquinas de tipo salvaje. La plataforma permite tanto mecanismos de acción mono como bifuncionales, permitiendo potencialmente sinergia biológica entre citoquinas.

Sonnet BioTherapeutics (NASDAQ: SONN)가 Fully Human Albumin Binding (FHAB®) 기술에 대해 유럽 특허 제 EP3583125 B1을 확보했습니다. 이는 2038년 2월 20일까지 유효합니다. 이 특허는 FHAB를 활용한 종양 표적 치료 융합 단백질과 약물의 약리학적 동작을 연장하는 데 적용됩니다.

회사의 FHAB 플랫폼은 인간 알부민에 높은 친화력을 가진 단일 완전 인간 구조로 이루어져 있어, 신속한 치료 생물학적 제제 개발을 위한 바로 사용할 수 있는 솔루션을 제공합니다. 이 EU 특허는 중국, 일본, 러시아 및 뉴질랜드에서 Sonnet의 기존 글로벌 지식 재산 보호를 추가하는 것입니다.

전임상 연구는 FHAB로부터 유래한 약물 후보가 약리학적 특성이 연장되고, 종양 배달 효율성이 향상되며, 일반형 사이토카인에 비해 효능이 개선된 것을 보여주었습니다. 이 플랫폼은 단일 및 이중 기능 작용 메커니즘을 모두 허용하여 사이토카인 간의 생물학적 시너지를 가능하게 합니다.

Sonnet BioTherapeutics (NASDAQ: SONN) a obtenu le brevet européen n° EP3583125 B1 pour sa technologie Fully Human Albumin Binding (FHAB®), valable jusqu'au 20 février 2038. Le brevet couvre des protéines de fusion thérapeutiques utilisant FHAB pour le ciblage des tumeurs et une pharmacocinétique prolongée.

La plateforme FHAB de l'entreprise se compose d'une construction humaine unique avec une forte affinité pour se lier à l'albumine humaine, fournissant une solution prête à l'emploi pour le développement rapide de biologiques thérapeutiques. Ce brevet de l'UE s'ajoute à la protection de propriété intellectuelle mondiale existante de Sonnet en Chine, au Japon, en Russie et en Nouvelle-Zélande.

Des études précliniques ont démontré que les candidats médicamenteux dérivés de FHAB présentent une pharmacocinétique prolongée, une livraison améliorée de la charge tumorale et une efficacité supérieure comparée aux cytokines de type sauvage. La plateforme permet des mécanismes d'action mono- et bifonctionnels, permettant potentiellement une synergie biologique entre les cytokines.

Sonnet BioTherapeutics (NASDAQ: SONN) hat sich das europäische Patent Nr. EP3583125 B1 für seine Fully Human Albumin Binding (FHAB®) Technologie gesichert, das bis zum 20. Februar 2038 gültig ist. Das Patent umfasst therapeutische Fusionsproteine, die FHAB für die Tumor-targeting und verlängerte Pharmakokinetik nutzen.

Die FHAB-Plattform des Unternehmens besteht aus einer einzigen, vollständig humanen Konstruktion mit hoher Affinität zur Bindung an menschliches Albumin, was eine sofort einsatzbereite Lösung für die schnelle Entwicklung therapeutischer Biologika bietet. Dieses EU-Patent ergänzt den bestehenden globalen IP-Schutz von Sonnet in China, Japan, Russland und Neuseeland.

Präklinische Studien haben gezeigt, dass aus FHAB abgeleitete Arzneimittelkandidaten eine verlängerte Pharmakokinetik, verbesserte Tumorbeladung und eine höhere Wirksamkeit im Vergleich zu Wildtyp-Zytokinen aufweisen. Die Plattform ermöglicht sowohl mono- als auch bifunktionale Wirkmechanismen, die potenziell biologische Synergien zwischen Zytokinen ermöglichen.

Positive
  • Secured EU patent protection until 2038 for FHAB technology
  • Expanded global IP portfolio now includes EU, China, Japan, Russia, and New Zealand
  • Preclinical studies show improved efficacy and delivery compared to wild type cytokines
Negative
  • None.

Insights

The newly granted EU patent for Sonnet's FHAB platform technology marks a crucial milestone in their intellectual property strategy. This patent, extending to 2038, provides comprehensive protection in the lucrative European market for their innovative albumin-binding technology.

The strategic value of this patent lies in three key areas:

  • The extended patent protection until 2038 provides a significant commercialization window for their pipeline products
  • The global IP portfolio now covering major markets (EU, US, China, Japan, Russia, New Zealand) creates substantial barriers to entry for competitors
  • The FHAB platform's versatility as an 'off-the-shelf lock and load' system enables rapid development of multiple therapeutic candidates, potentially accelerating time-to-market

The technical advantages of their albumin-binding technology, particularly the enhanced pharmacokinetics and improved tumor targeting, could translate into superior drug efficacy and reduced dosing frequency. This differentiation from existing technologies strengthens Sonnet's competitive position and could make them an attractive partner for larger pharmaceutical companies seeking to improve their biologics delivery systems.

While this patent issuance doesn't directly generate revenue, it significantly enhances Sonnet's ability to protect future revenue streams and creates opportunities for potential licensing deals or strategic partnerships. The comprehensive IP protection across major markets positions Sonnet favorably for future commercialization efforts or potential M&A activities.

European Patent Office (EPO) grants EU Patent No. EP3583125 B1 covering the Company’s Fully Human Albumin Binding (FHAB®) domain fusion proteins

In addition to the U.S. and EU, Sonnet’s global IP coverage
now extends to China, Japan, Russia and New Zealand

Management releases “What This Means” segment discussing the newly granted EU patent; Access here

PRINCETON, NJ, Jan. 28, 2025 (GLOBE NEWSWIRE) -- Sonnet BioTherapeutics Holdings, Inc. (the “Company” or “Sonnet”) (NASDAQ: SONN), a clinical-stage company developing targeted immunotherapeutic drugs, today announced that the European Patent Office (EPO) has granted Patent No. EP3583125 B1, entitled ”Albumin Binding Domain Fusion Proteins,” which covers Sonnet’s Fully Human Albumin Binding (FHAB®) technology and includes therapeutic fusion proteins that utilize FHAB for tumor targeting and retention and provide extended pharmacokinetics (PK). The EU patent carries a term effective until February 20, 2038. Additionally, the Company announced the release of a “What This Means” segment to discuss the EU patent and its global IP estate, which is now available here.

“The granting of this EU patent represents another milestone that provides expanded global protection along with building our intellectual capital and differentiation from any existing or emerging competitive technologies that may leverage the beneficial characteristics of binding to human serum albumin,” commented Pankaj Mohan, Ph.D., Founder and CEO of Sonnet. “Further, this European patent issuance expands the global IP protection for our product pipeline beyond previous patents issued in China, Japan, Russia and New Zealand, which we believe provides further validation for our FHAB platform.”

Sonnet's FHAB platform consists of a single, fully human construct of a FHAB antibody fragment that has high affinity to bind to human albumin. The platform provides an off-the-shelf lock and load opportunity to rapidly develop numerous therapeutic biologics.

John Cini, Ph.D., Co-Founder and CSO of Sonnet commented, “The FHAB platform technology provides each of Sonnet’s pipeline drug candidates with either a mono- or bi-functional mechanism of action, thus allowing for the potential of biological synergy between cytokines. Preclinical comparative in vivo studies with wild type cytokines have shown that FHAB-derived drug candidates have reproducibly extended pharmacokinetics, enhanced payload delivery to the tumor and improved efficacy.”

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. 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 Section21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to 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


FAQ

What is the expiration date of Sonnet BioTherapeutics' (SONN) new EU patent?

The EU patent (EP3583125 B1) for Sonnet BioTherapeutics' FHAB technology is effective until February 20, 2038.

Which countries are covered by Sonnet BioTherapeutics' (SONN) FHAB patent protection?

Sonnet BioTherapeutics' FHAB technology is now patent-protected in the European Union, China, Japan, Russia, and New Zealand.

What advantages does Sonnet's (SONN) FHAB platform demonstrate in preclinical studies?

Preclinical studies show FHAB-derived drug candidates have extended pharmacokinetics, enhanced tumor payload delivery, and improved efficacy compared to wild type cytokines.

What is the mechanism of action of Sonnet's (SONN) FHAB platform technology?

The FHAB platform provides both mono- and bi-functional mechanisms of action, allowing for potential biological synergy between cytokines through high-affinity binding to human albumin.

Sonnet BioTherapeutics Holdings, Inc.

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