Sonnet BioTherapeutics Secures European Patent for Fully Human Albumin Binding Technology, Expanding Global IP Coverage

EPO grants Sonnet EU Patent No. EP3583125 B1 for Fully Human Albumin Binding (FHAB®) domain fusion proteins, expanding global IP protection.

Quiver AI Summary

Sonnet BioTherapeutics Holdings, Inc. announced that the European Patent Office has granted EU Patent No. EP3583125 B1 for its Fully Human Albumin Binding (FHAB®) technology, which enhances therapeutic fusion proteins for tumor targeting and retention, extending their pharmacokinetics. This patent, effective until February 20, 2038, strengthens Sonnet's global intellectual property protection, now covering multiple countries, including the U.S., China, Japan, Russia, and New Zealand. The company's leadership emphasized the patent's significance in enhancing their competitive position within the biotechnology field. Sonnet's FHAB platform enables rapid development of targeted biologic drugs, with ongoing clinical programs aimed at treating various cancers and conditions.

Potential Positives

• Granting of EU Patent No. EP3583125 B1 enhances Sonnet's intellectual property portfolio, providing significant global protection until February 20, 2038.
• Expansion of global IP coverage to key markets including China, Japan, Russia, and New Zealand, validating the company's Fully Human Albumin Binding (FHAB®) technology.
• The FHAB platform's unique mechanism, which enhances pharmacokinetics and therapeutic efficacy, differentiates Sonnet from competitors in the biotechnology field.
• Ongoing Phase 1/2a clinical trials for lead programs indicate active progress in developing innovative treatments for solid tumors, potentially increasing investor confidence and market interest.

Potential Negatives

• While the granting of the EU patent is a milestone, the fact that the company is still in the clinical-stage raises concerns about the timeline and regulatory hurdles needed to bring their therapies to market.
• The press release primarily focuses on the patent approval and does not provide any updates on clinical trial progress or results, which may indicate a lack of substantive advancements in their product pipeline.
• The mention of "forward-looking statements" suggests uncertainty surrounding the company's future performance and market position, reflecting potential risks associated with their ongoing projects and strategies.

FAQ

What is the significance of the EU Patent No. EP3583125 B1?

The EU patent covers Sonnet's Fully Human Albumin Binding (FHAB®) domain fusion proteins, enhancing its global intellectual property protection.

Which countries are included in Sonnet's global IP coverage?

Sonnet's IP coverage extends to the U.S., EU, China, Japan, Russia, and New Zealand.

What is the purpose of Sonnet's FHAB platform?

The FHAB platform is designed to develop targeted biologics for optimized tumor targeting and improved pharmacokinetics.

What are the main drug candidates in Sonnet's pipeline?

Sonnet's lead drug candidates include SON-1010 for solid tumors and SON-080 for chemotherapy-induced peripheral neuropathy.

Where can I find more information about the recent patent grant?

More details about the EU patent and its implications can be found in the “What This Means” segment released by Sonnet.

Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.

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Full Release

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

(F

_H

AB

^®

)

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 (F

_H

AB

^®

) technology and includes therapeutic fusion proteins that utilize F

_H

AB 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 F

_H

AB platform.”

Sonnet's F

_H

AB platform consists of a single, fully human construct of a F

_H

AB 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 F

_H

AB 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 F

_H

AB-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 F

_H

AB (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. F

_H

AB 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-F

_H

AB, 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-F

_H

AB-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

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.