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VYNE Therapeutics Announces Granting of Composition of Matter Patent for VYN202, a Novel BD2-Selective BET Inhibitor

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VYNE Therapeutics Inc. (Nasdaq: VYNE) has announced the granting of a composition of matter patent for VYN202, its novel BD2-selective BET inhibitor. The patent, GB Patent No. 2621505, was granted by the United Kingdom's Intellectual Property Office and covers the compound in VYNE's VYN202 program. The patent has a 20-year term expiring in June 2042.

David Domzalski, President and CEO of VYNE, emphasized the importance of this patent for the development of VYN202, which the company believes is the most potent and BD2-selective BET inhibitor in development. The patent is derived from Tay Therapeutics 's PCT application and is exclusively licensed to VYNE. This marks the first of the nationally filed applications to be granted, with VYNE seeking protection in additional jurisdictions as they progress their BET inhibitor pipeline.

Positive
  • Granted composition of matter patent for VYN202, enhancing intellectual property protection
  • Patent has a 20-year term, providing long-term exclusivity until June 2042
  • VYN202 believed to be the most potent and BD2-selective BET inhibitor in development
  • Exclusive license to the patent, derived from Tay Therapeutics' PCT application
Negative
  • None.

The recent patent granted to VYNE Therapeutics for their compound VYN202 represents a significant milestone in the pharmaceutical industry. Patents protect intellectual property, giving the holder exclusive rights to their innovation, which in turn can provide a competitive advantage. This patent ensures that VYNE has exclusive rights to develop, manufacture and commercialize VYN202 until June 2042 in the UK. This is particularly important in the highly competitive biopharmaceutical sector, where intellectual property can be a key differentiator.

For investors, the long-term protection offered by the patent de-risks the investment by potentially providing a clear market path free from generic competition for nearly two decades. This can enhance the company's valuation, especially if VYN202 proves to be as potent and selective as promised. Intellectual property is often a critical asset for biotech firms, impacting their ability to secure funding, partnerships and market share.

However, while the patent provides protection, the success of VYN202 will also depend on subsequent clinical trials, regulatory approvals and market adoption. Investors should be aware that the path from patent to market can be fraught with challenges, including potential development setbacks and regulatory hurdles.

From a financial standpoint, the granting of this patent could significantly bolster VYNE Therapeutics' valuation. Patents are often seen as valuable assets because they can lead to monopoly profits if the drug reaches commercial success. The 20-year term until 2042 offers a long window of potential market exclusivity, which is attractive to investors and can lead to favorable financing terms and potential partnerships or acquisitions.

Furthermore, the patent's coverage of a novel BD2-selective BET inhibitor—which may offer a new approach to treating inflammatory disorders, immune disorders and cancer—positions VYNE well within high-demand therapeutic areas. The unique selectivity of VYN202, if validated by clinical success, could command a premium pricing in the market, further increasing potential revenues.

However, investors should also consider the costs associated with continued R&D, clinical trials and eventual commercialization. The stock price might react positively in the short term due to this news, but long-term gains will depend on the successful execution of the development plan and market acceptance.

BRIDGEWATER, N.J., July 16, 2024 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a clinical-stage biopharmaceutical company developing proprietary, innovative and differentiated therapies for the treatment of immuno-inflammatory conditions, today announced GB Patent No. 2621505 entitled “Pyrrolopyridone derivatives useful in the treatment of inflammatory disorders, immune disorders and cancer” has been granted by the United Kingdom’s Intellectual Property Office. This granted patent covers the compound in VYNE’s VYN202 program and has a 20-year term that will expire in June 2042.

“The granting of this composition of matter patent is key to the development of VYN202, which we believe is the most potent and BD2-selective BET inhibitor in development,” said David Domzalski, President and Chief Executive Officer of VYNE. “Obtaining intellectual property protection is an important value driver for VYNE and we will continue to seek protection in additional jurisdictions as we progress our BET inhibitor pipeline.”

This newly issued patent is derived from Tay Therapeutics Limited’s Patent Cooperation Treaty (PCT) application No. WO 2023/275542 A1, which was filed nationally in multiple jurisdictions, and is exclusively licensed to VYNE. This patent is the first of the national filed applications to be granted.

About VYN202
VYN202 is an innovative, oral small molecule BET inhibitor that has potential class-leading selectivity and potency (BD2 vs. BD1). By maximizing BD2 selectivity, VYNE believes VYN202 has the potential to be a more conveniently administered non-biologic treatment option for both acute control and chronic management of immuno-inflammatory indications, in which the damaging effects of unrestricted inflammatory signaling activity is common. VYN202 is structurally distinct from VYNE’s pan-BET inhibitor (VYN201) and covered by distinct PCT and provisional composition of matter patent applications directed to new chemical entities and their uses.

About BET Inhibitors
BET proteins play a key role in regulating gene transcription via epigenetic interactions (“reading”), and recent research has identified a key role for these proteins in regulating B cell and T cell activation and subsequent inflammatory processes. As epigenetic readers, BET proteins regulate the recruitment of transcriptional factors that are key to the production of several pro-inflammatory cytokines. BET inhibitors have the potential to treat a range of immuno-inflammatory and fibrotic diseases by blocking pro-inflammatory cytokine transcription with additional potential in myeloproliferative neoplastic disorders.

About VYNE Therapeutics Inc.
VYNE’s mission is to improve the lives of patients by developing proprietary, innovative and differentiated therapies for the treatment of immuno-inflammatory conditions. The Company’s unique and proprietary bromodomain & extra-terminal (BET) domain inhibitors, which comprise its InhiBET™ platform, include a locally administered pan-BD BET inhibitor (VYN201) and an orally available BD2-selective BET inhibitor (VYN202) that were licensed from Tay Therapeutics Limited. 

For more information about VYNE Therapeutics Inc. or its product candidates, visit www.vynetherapeutics.com. VYNE may use its website to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor VYNE’s website in addition to following its press releases, filings with the U.S. Securities and Exchange Commission (“SEC”), public conference calls, and webcasts.

Cautionary Statement Regarding Forward-Looking Statements
This release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements related to VYNE’s ability to obtain additional granted patents related to its BET inhibitor programs and the potential benefits of VYN202 as a therapy for a broad range of immune-mediated diseases. All statements in this press release which are not historical facts are forward-looking statements. Any forward-looking statements are based on VYNE’s current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions that could cause actual results to differ materially and adversely from those set forth or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: VYNE’s ability to enroll patients in its clinical trials and successfully develop its product candidates; VYNE’s ability to complete and receive favorable results from clinical trials of its product candidates; VYNE’s ability to obtain additional funding, either through equity or debt financing transactions or collaboration arrangements; and VYNE’s ability to comply with various regulations applicable to its business. For a discussion of other risks and uncertainties, and other important factors, any of which could cause VYNE’s actual results to differ from those contained in the forward-looking statements, see the section titled “Risk Factors” in VYNE’s Annual Report on Form 10-K for the year ended December 31, 2023 and VYNE’s other filings from time to time with the SEC. Although VYNE believes these forward-looking statements are reasonable, they speak only as of the date of this announcement and VYNE undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law. Given these risks and uncertainties, you should not rely upon forward-looking statements as predictions of future events.

Investor Relations:
John Fraunces
LifeSci Advisors, LLC
917-355-2395
jfraunces@lifesciadvisors.com

Tyler Zeronda
VYNE Therapeutics Inc.
908-458-9106
Tyler.Zeronda@vynetx.com

Media Relations:
Mike Beyer
Sam Brown Inc.
312-961-2502
mikebeyer@sambrown.com


FAQ

What patent did VYNE Therapeutics (VYNE) recently receive for VYN202?

VYNE Therapeutics received GB Patent No. 2621505, a composition of matter patent for VYN202, their novel BD2-selective BET inhibitor, granted by the United Kingdom's Intellectual Property Office.

How long is the term of VYNE Therapeutics' (VYNE) new patent for VYN202?

The patent for VYN202 has a 20-year term that will expire in June 2042.

What is significant about VYN202 according to VYNE Therapeutics (VYNE)?

VYNE Therapeutics believes VYN202 is the most potent and BD2-selective BET inhibitor currently in development.

Where did VYNE Therapeutics' (VYNE) new patent for VYN202 originate from?

The patent is derived from Tay Therapeutics 's Patent Cooperation Treaty (PCT) application No. WO 2023/275542 A1, which is exclusively licensed to VYNE Therapeutics.

VYNE Therapeutics Inc.

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