Windtree Strengthens Global Intellectual Property Portfolio with New Japanese Patent For the Company’s Oncology Pipeline

Rhea-AI Summary

Windtree Therapeutics (NASDAQ: WINT) has secured a new Japanese patent (No. 7603605) for its oncology pipeline, specifically for inhibitors of atypical protein kinase C (aPKCi) in treating hedgehog pathway-dependent cancers. The patent will expire in 2040.

The company's aPKCi inhibitor platform represents a novel, high-potency drug candidate targeting various cancers, including basal cell carcinoma, medulloblastoma, rhabdomyosarcoma, and small cell lung cancer. The platform features both topical and oral formulations, developed in collaboration with Cancer Research UK and academic research centers. The patent claims also cover combination therapies using hedgehog pathway inhibitors with HDAC inhibitors for enhanced anti-cancer efficacy.

Positive

• Secured new Japanese patent protection until 2040
• Platform includes both topical and oral formulation options
• Partnership with Cancer Research UK enhances development credibility

Negative

• Product still in preclinical stage
• Significant development and commercialization timeline ahead

Insights

Biotech Patent Expert

The issuance of this Japanese patent for Windtree's aPKCi inhibitor platform represents a moderate strategic development, though its immediate commercial impact is The patent, extending to 2040, provides 17 years of market exclusivity in Japan for both topical and oral formulations targeting hedgehog pathway-dependent cancers.

The platform's dual formulation approach and combination therapy claims with HDAC inhibitors demonstrate technical sophistication. However, being in preclinical stage, significant development milestones remain before potential commercialization. The Japanese market, while substantial for oncology treatments, is just one piece of a necessary global IP strategy.

For a micro-cap company ($2.2M market cap), securing international patent protection is important but insufficient alone to drive significant value creation. The patent's scope covering multiple cancer types (basal cell carcinoma, medulloblastoma, small cell lung cancer) suggests broad potential applications, yet substantial capital investment will be required to advance these programs clinically.

Oncology Research Analyst

The scientific significance of targeting aPKCi in hedgehog pathway-dependent cancers warrants attention, but must be viewed through a pragmatic lens. This novel mechanism represents a first-in-class approach, potentially offering new treatment options for difficult-to-treat cancers like medulloblastoma and small cell lung cancer.

The collaboration with Cancer Research UK adds credibility to the research program. However, the preclinical status means the path to proof-of-concept in humans remains lengthy and uncertain. The combination strategy with HDAC inhibitors is scientifically sound, as these epigenetic modifiers have shown promise in various cancers.

In simple terms, think of this as designing a new key (the drug) that fits a specific lock (aPKCi) controlling cancer growth. While the design looks promising on paper, it still needs to be manufactured and tested extensively before we know if it works in actual patients.

The Company’s oncology aPKCi inhibitor is a novel, first in class drug candidate

WARRINGTON, Pa., Jan. 15, 2025 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a biotechnology company focused on advancing early and late-stage innovative therapies for critical conditions and diseases, today announced the issuance of a patent in Japan for “Inhibitors of atypical protein kinase C (aPKCi) and their use in treating hedgehog pathway-dependent cancers.” The patent number is 7603605 and expires in 2040.

The aPKCi inhibitor platform is a novel, potential high-potency, specific, drug candidate with applications in oncology, particularly in hedgehog pathway-dependent cancers. Such cancers include basal cell carcinoma, medulloblastoma, rhabdomyosarcoma, small cell lung cancer and other malignant diseases. The asset platform includes two formulations (topical and oral) that have been in development in partnership with Cancer Research UK and top academic research centers. The claims also include combination therapies comprising use of the hedgehog pathway inhibitors along with an HDAC inhibitors enhancing anti-cancer efficacy.

“Issuance of the new patent for our oncology preclinical aPKCi inhibitor pipeline is an important part of our development strategy,” said Jed Latkin, CEO of Windtree Therapeutics. “We will continue with our intellectual property work to expand our patent portfolio in key markets throughout the world.”

About aPKCi inhibitor
The drug candidate is a novel, potential high-potency, specific, azaquinazoline ATP-competitive atypical PKC iota (aPKCi) inhibitor efficacy for the treatment of skin cancer and other rare malignant diseases. The asset platform includes two formulations (topical and oral) of the aPKCi inhibitor. Windtree Therapeutics also has an additional pending PCT application directed to crystalline forms of these inhibitors, also for use in cancer treatment.

About Windtree Therapeutics, Inc.
Windtree Therapeutics, Inc. is a biotechnology company focused on advancing early and late-stage innovative therapies for critical conditions and diseases. Windtree’s portfolio of product candidates includes istaroxime, a Phase 2 candidate with SERCA2a activating properties for acute heart failure and associated cardiogenic shock, preclinical SERCA2a activators for heart failure and preclinical precision aPKCi inhibitors that are being developed for potential in rare and broad oncology applications. Windtree also has a licensing business model with partnership out-licenses currently in place.

Forward Looking Statements
This press release contains statements related to the potential clinical effects of istaroxime; the potential benefits and safety of istaroxime; the clinical development of istaroxime; and our research and development program for treating patients in early cardiogenic shock due to heart failure. Such statements constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. The Company may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are based on information available to the Company as of the date of this press release and are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from the Company’s current expectations. Examples of such risks and uncertainties include, among other things: the Company’s ability to acquire revenue generating subsidiaries; the market’s reaction to potential acquisitions by the Company; the Company’s ability to secure significant additional capital as and when needed; the Company’s ability to achieve the intended benefits of the aPKCi asset acquisition with Varian Biopharmaceuticals, Inc.; the Company’s risks and uncertainties associated with the success and advancement of the clinical development programs for istaroxime and the Company’s other product candidates, including preclinical oncology candidates; the Company’s ability to access the debt or equity markets; the Company’s ability to manage costs and execute on its operational and budget plans; the results, cost and timing of the Company’s clinical development programs, including any delays to such clinical trials relating to enrollment or site initiation; risks related to technology transfers to contract manufacturers and manufacturing development activities; delays encountered by the Company, contract manufacturers or suppliers in manufacturing drug products, drug substances, and other materials on a timely basis and in sufficient amounts; risks relating to rigorous regulatory requirements, including that: (i) the U.S. Food and Drug Administration or other regulatory authorities may not agree with the Company on matters raised during regulatory reviews, may require significant additional activities, or may not accept or may withhold or delay consideration of applications, or may not approve or may limit approval of the Company’s product candidates, and (ii) changes in the national or international political and regulatory environment may make it more difficult to gain regulatory approvals and risks related to the Company’s efforts to maintain and protect the patents and licenses related to its product candidates; risks that the Company may never realize the value of its intangible assets and have to incur future impairment charges; risks related to the size and growth potential of the markets for the Company’s product candidates, and the Company’s ability to service those markets; the Company’s ability to develop sales and marketing capabilities, whether alone or with potential future collaborators; the rate and degree of market acceptance of the Company’s product candidates, if approved; the economic and social consequences of the COVID-19 pandemic and the impacts of political unrest, including as a result of geopolitical tension, including the conflict between Russia and Ukraine, the People’s Republic of China and the Republic of China (Taiwan), and the evolving events in the Middle East, and any sanctions, export controls or other restrictive actions that may be imposed by the United States and/or other countries which could have an adverse impact on the Company’s operations, including through disruption in supply chain or access to potential international clinical trial sites, and through disruption, instability and volatility in the global markets, which could have an adverse impact on the Company’s ability to access the capital markets. These and other risks are described in the Company’s periodic reports, including its Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, filed with or furnished to the Securities and Exchange Commission and available at www.sec.gov. Any forward-looking statements that the Company makes in this press release speak only as of the date of this press release. The Company assumes no obligation to update forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

Contact Information:
Eric Curtis
ecurtis@windtreetx.com

FAQ

What is the expiration date of Windtree's (WINT) new Japanese patent?

Windtree's new Japanese patent (No. 7603605) for its aPKCi inhibitor platform expires in 2040.

What types of cancer does Windtree's (WINT) aPKCi inhibitor target?

The aPKCi inhibitor targets hedgehog pathway-dependent cancers, including basal cell carcinoma, medulloblastoma, rhabdomyosarcoma, small cell lung cancer, and other malignant diseases.

What formulations are available for Windtree's (WINT) aPKCi inhibitor?

The aPKCi inhibitor platform includes both topical and oral formulations.

Who is Windtree (WINT) partnering with for the development of its aPKCi inhibitor?

Windtree is developing the aPKCi inhibitor in partnership with Cancer Research UK and top academic research centers.

What combination therapy is covered in Windtree's (WINT) new patent?

The patent claims include combination therapies using hedgehog pathway inhibitors along with HDAC inhibitors to enhance anti-cancer efficacy.