Sonnet BioTherapeutics develops a modified IL-18 variant, receiving a patent that enhances its therapeutic potential for oncology.
Quiver AI Summary
Sonnet BioTherapeutics Holdings, Inc. announced that the United States Patent and Trademark Office has issued a Notice of Allowance for a new patent related to its modified form of Interleukin-18, known as IL-18Binding Protein Resistant (IL-18BPR), which has been engineered to bind effectively to the IL-18 receptor while avoiding interaction with the inhibitory IL-18 Binding Protein. This patent covers various amino acid substitutions in the IL-18BPR sequence, enhancing the company's intellectual property and opening potential licensing opportunities. The company is pursuing the development of two drug candidates, SON-1411 and SON-1400, which utilize this variant IL-18BPR with Sonnet's proprietary Fully Human Albumin Binding (FHAB) platform to improve cancer therapy. SON-1411 is designed as a bifunctional fusion protein that combines IL-18BPR with IL-12, aiming to activate immune responses against tumors. Sonnet is positioning itself to advance its clinical programs, leveraging this new patent to potentially enhance treatment options for various cancers.
Potential Positives
- The company received a Notice of Allowance from the USPTO for a novel patent related to its variant human IL-18BPR, strengthening its intellectual property portfolio in the competitive immunotherapy landscape.
- The allowed patent potentially opens up licensing opportunities for the IL-18BPR, which could generate additional revenue streams for the company independent of its existing platform.
- The press release highlights significant advancements in the company's pipeline with the development of SON-1411, a proprietary bifunctional fusion protein combining IL-18BPR and IL-12, which may enhance therapeutic efficacy for cancer patients.
- Management’s communication about the allowed patent and new developments demonstrates transparency, which could improve investor confidence and engagement.
Potential Negatives
- Potential concerns over the efficacy of the IL-18BPR variant proteins, as the press release emphasizes the inhibitory challenges previously faced with IL-18 therapies, indicating that overcoming these obstacles remains critical.
- The announcement contains a significant reliance on forward-looking statements, which may lead to investor caution due to inherent uncertainties regarding future clinical outcomes and product development timelines.
- The company has not provided detailed information about clinical trial results or potential risks associated with the new candidates, which may raise red flags regarding transparency and confidence in their development pipeline.
FAQ
What is IL-18BPR?
IL-18BPR is a modified version of Interleukin-18 that exhibits effective binding to the IL-18 receptor while avoiding inhibitory interactions.
What are the advantages of Sonnet's IL-18BPR patent?
This patent strengthens Sonnet’s intellectual property rights, enabling independent licensing opportunities and enhancing therapeutic potential in oncology.
How does Sonnet's FHAB platform work?
The FHAB platform allows biologic drugs to bind to human serum albumin, improving their delivery and efficacy in targeted therapies.
What are the goals of the SON-1411 candidate?
SON-1411 aims to enhance immune responses against tumors and improve treatment outcomes by combining IL-18BPR with IL-12.
How does Sonnet's research focus on cancer therapy?
Sonnet is focused on developing targeted immunotherapeutic drugs for various cancers, utilizing innovative approaches to enhance treatment efficacy.
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.
$SONN Hedge Fund Activity
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Full Release
Company advancing development of its modified version of Interleukin-18 (IL-18
Binding Protein Resistant
or IL-18
BPR
) that exhibits wild-type binding to the IL-18 receptor (IL-18Rc), coupled with undetectable binding to the inhibitory IL-18 Binding Protein (IL-18BP)
thus making IL-18
BPR
more effective in vitro
Sonnet’s variant human IL-18
BPR
is a key cytokine which comprises substitutions at the following amino acid positions: Y1, M51, M60, S105 and D110, relative to human wildtype IL-18
Patent opens up potential licensing opportunities for rights to IL-18
BPR
independent of Sonnet’s F
H
AB platform patent estate
Management releases “What This Means” segment discussing the allowed patent;
Access here
PRINCETON, N.J., March 19, 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 United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance to the Company for a second patent in the IL-18 variant protein field which discloses the amino acid sequence of its variant human IL-18
BPR
protein. The allowed patent claims cover variant human IL-18 (hIL-18) proteins, including but not limited to hIL-18 proteins having amino acid substitutions at the following positions: Y1W, Y1K, M51Y, M51S, M60W, S105E, and D110Y, relative to human wildtype IL-18. Additionally, the Company announced the release of a
Virtual Investor “What This Means” segment
to discuss the allowed patent, which is now available
here
.
“I believe that Sonnet has become of one of the few companies that hold proprietary rights to IL-18
BPR
which could be a highly valuable cytokine for cancer patients. This patent covers the composition of matter of the amino acid sequence of our human IL-18
BPR
variant protein which bolsters our intellectual property position and provides further validation to our approach that when IL-18
BPR
is synergistically combined with IL-12, we believe we will have the potential to develop an important therapeutic asset for oncology and cell-based therapy. Additionally, we feel that this patent enables us to explore opportunities for IL-18
BPR
to be licensed independent of our F
H
AB platform. We continue to believe that novel bifunctional molecules such as SON-1411, when combined with our proprietary F
H
AB platform, have the potential to demonstrate improved tumor targeting, extended half-life and an enhanced therapeutic window,” said Pankaj Mohan, Ph.D., Sonnet Founder and Chief Executive Officer.
Sonnet previously reported the generation of two novel drug candidates, SON-1411 (IL18
BPR
-F
H
AB-IL12) and SON-1400 (IL18
BPR
-F
H
AB), each containing a variant version of recombinant human interleukin-18 (IL-18
BPR
). SON-1411 is a proprietary bifunctional fusion protein consisting of IL-18
BPR
combined with single-chain wild-type IL-12, linked to Sonnet's Fully Human Albumin Binding (F
H
AB
®
) platform while SON-1400 is a monofunctional fusion protein comprising the same IL-18
BPR
domain linked to the F
H
AB. F
H
AB extends the half-life and biological activity of linked molecules by binding native albumin in the serum and targets the tumor microenvironment (TME) through high affinity binding to glycoprotein 60 (gp60) and the Secreted Protein Acidic and Rich in Cysteine (SPARC).
“SON-1411 (IL18
BPR
-F
H
AB-IL12) is a bifunctional combination of IL-12 and the F
H
AB domain with a human variant of human interleukin-18 (“IL-18
BPR
”), which was modified to resist an inhibitory interaction with IL-18 binding protein (IL-18BP). IL-18 is involved in activating both innate and adaptive immune responses; however, IL-18 clinical therapies have been hampered by a lack of efficacy due to the inhibitory activity of the IL-18BP,” commented John Cini, Ph.D., Sonnet Chief Scientific Officer.
About SON-1411
SON-1411 is a candidate immunotherapeutic recombinant drug that is closely related to and will replace SON-1410, which links an unmodified single-chain human IL18 and an unmodified IL-12 with the albumin-binding domain of the single-chain antibody fragment A10m3. The only difference between SON-1410 and SON-1411 is that in the latter, the IL-18 domain has been modified via mutagenesis to retain wildtype binding to the IL-18 receptor (IL-18 Rc) while inhibiting or abolishing binding to the IL-18 binding protein (IL-18 BP). The A10m3 scFv was selected to bind both at normal pH, as well as at the acidic pH that is typically found in the TME. The F
H
AB technology targets tumor and lymphatic tissue, providing a mechanism for dose sparing and an opportunity to improve the safety and efficacy profile of IL-18 and IL-12, as well as a variety of potent immunomodulators that can be added using the platform. Interleukin-12 can orchestrate a robust immune response to many cancers and pathogens. Given the types of proteins induced in the TME, such as SPARC and gp60, several types of cancer such as non-small cell lung cancer, melanoma, head and neck cancer, sarcoma, and some gynecological cancers are particularly relevant for this approach. SON-1411 is designed to deliver IL-18
BPR
and IL-12 to local tumor tissue, turning ‘cold’ tumors ‘hot’ by stimulating IFNγ, which activates innate and adaptive immune cell responses and increases the production of Programed Death Ligand 1 (PD-L1) on tumor cells.
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 F
H
AB 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 advanced solid tumors, certain types of sarcoma, and platinum-resistant ovarian cancer (PROC). SON-1010 is being evaluated in an ongoing Phase 1/2a study through a Master Clinical Trial and Supply Agreement with Roche in combination with atezolizumab (Tecentriq
®
) for the treatment of PROC. The Company is also evaluating its second product candidate, SON-1210, an IL12-F
H
AB-IL15 bifunctional for solid tumors, in collaboration with the Innovative Immuno-Oncology Consortium (IIOC), and plans to commence an investigator-initiated and funded Phase 1/2a study for the treatment of locally-advanced or metastatic pancreatic ductal adenocarcinoma (PDAC).
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 a 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 in India.
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 impact of the second patent in the IL-18 variant protein field, 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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