VYNE Therapeutics Announces Licensing of BET Inhibitor Platform for Immuno-Inflammatory Conditions with In4Derm Limited

  • VYNE will have exclusive access to a library of new chemical entities
  • VYNE will prioritize initial development efforts on rare skin diseases and major immunology and inflammatory conditions with high unmet needs
  • VYNE expects to enter VYN201 and VYN202 into the clinic in 2022

BRIDGEWATER, N.J., August 12, 2021 — VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”) today announced that it has entered into an exclusive license agreement (the “License Agreement”) with In4Derm Limited (“In4Derm”), a spin-out of the University of Dundee’s School of Life Sciences focused on the discovery and development of proprietary Bromodomain and Extra-Terminal Domain inhibitors (“BET inhibitor” or “BETi”) for the treatment of immunology and oncology conditions. The University of Dundee is one of the foremost integrated university hospitals and biotechnology research institutes in Europe.

“We are extremely excited to announce this potentially transformational transaction and to partner with In4Derm, a company devoted to developing small molecule drugs for anti-inflammatory and orphan indications,” said David Domzalski, President and CEO of VYNE. “This partnership provides us access to a novel BETi platform for both topical and oral treatments for immuno-inflammatory diseases of high unmet medical need. Initially, we will advance a topical BETi program for the treatment of rare skin diseases into the clinic in 2022. We believe this collaboration will create numerous opportunities to drive value and look forward to providing further updates on our progress.”

Topical BETi program: VYN201 is a first-in-class topical pan-BD BET inhibitor that is designed to mitigate systemic drug exposure and will be developed for topical applications. VYNE intends to progress VYN201 in rare, neutrophilic, dermatological indications where there is a significant unmet need due to a lack of indicated treatment options.  This program is expected to enter the clinic in 2022.

Oral BETi program: VYNE expects to exercise its exclusive option with In4Derm to develop oral BET inhibitors following the selection of a lead candidate for the program. VYN202 is an orally delivered, first-in-class BET inhibitor that is highly selective for Bromodomain 2 (“BD2”). By selectively inhibiting BD2, the Company believes VYN202 could have a more targeted anti-inflammatory effect with an improved benefit/risk profile and views VYN202 as having significant potential as a novel, oral treatment for major immuno-inflammatory indications. Upon final candidate selection and exercise of its option, the Company intends to commence an IND-enabling non-clinical safety program and enter the clinic next year.

There is substantial interest in BET inhibitors as therapeutic targets for a wide range of diseases. To date, much of the clinical research has been focused on oncology. The Company believes there is also compelling science to show that BET inhibition may play an important role in effectively treating immuno-inflammatory diseases.

In4Derm’s CEO Dr. Tim Sparey commented, “We are delighted to announce this strategic partnership with VYNE Therapeutics. Together, both companies share a vision to develop new therapeutics to treat high unmet needs in inflammation and rare diseases, where millions of patients suffer from no adequate treatment options.  This partnership validates In4Derm’s ability to deliver high-quality drug candidates in important markets and brings a partner with the necessary expertise to accelerate clinical development. We look forward to shared success with VYNE.”

The parties previously entered into an Evaluation and Option Agreement (the “Option Agreement”) pursuant to which In4Derm granted the Company an exclusive option to obtain exclusive worldwide rights to research, develop and commercialize products containing In4Derm’s BETi compounds, which are new chemical entities (NCEs), in both topical (the “Topical BETi Option”) and oral (the “Oral BETi Option”) treatments in all fields for any disease, disorder or condition in humans.

On August 6, 2021, the Company exercised the Topical BETi Option and the parties entered into a License Agreement granting the Company a worldwide, exclusive license that is sublicensable through multiple tiers to exploit certain of In4Derm’s BETi compounds identified to be suitable for topical administration in all fields. The Company paid a $1.0 million cash payment to In4Derm upon the execution of the Option Agreement and $0.5 million in connection with the exercise of the Topical BETi Option. Pursuant to the License Agreement, the Company has agreed to make cash payments to In4Derm upon the achievement of specified clinical development and regulatory approval milestones with respect to each licensed topical product in the U.S. of up to $15.75 million. In addition, the Company expects to exercise the Oral BETi Option following the selection of a lead candidate for the program. Upon exercise of the exclusive Oral BETi Option, the parties will sign a license agreement (the “Oral License Agreement”) and the Company will pay In4Derm a $4.0 million cash payment. The Oral License Agreement will include cash payments of up to $43.75 million payable to In4Derm upon the achievement of specified clinical development and regulatory approval milestones with respect to each licensed oral product in the U.S. The license agreements also provide for tiered royalty payments of up to 10% of net annual sales across licensed BETi products by the Company. In4Derm is entitled to additional milestone payments upon the achievement of regulatory approvals in certain jurisdictions outside the U.S.

About Bromodomain and Extra-Terminal Domain Inhibitors

BET proteins are key components of transcriptional processing for a wide range of proinflammatory and immunoregulatory genes.1 Inactivation of BET proteins such as BRD4 directly perturbs the biosynthesis of pro-inflammatory proteins that are implicated in a wide variety of immune-inflammatory/fibrotic and myeloproliferative neoplastic disorders. A topically applied BETi product has the possibility to positively impact diseases involving multiple, diverse inflammatory cell signaling pathways that are active in rare neutrophilic dermatoses. Furthermore, bromodomain 2 selective oral BET inhibitors may present as convenient, non-biologic treatment options for both acute control and chronic management of immuno-inflammatory indications, where the damaging effects of unrestricted inflammatory signaling activity are common.
Wang N, Wu R, Tang D, and Kang R, Signal Transduct. Target Ther.2021 Jan 19;6(1):23

Conference Call Details:

Thursday, August 12th @ 8:30 am Eastern Time
Toll-Free:                      877-256-3294
International:                212-231-2918
Conference ID:             21995997
Webcast:                      http://public.viavid.com/index.php?id=145705
A replay of the call will be archived on the Company’s website at www.vynetherapeutics.com after the conference call.

About VYNE Therapeutics Inc.

VYNE’s mission is to improve the lives of patients by developing proprietary, innovative and differentiated therapies in dermatology and beyond.
With expertise in topical medicine innovation as a springboard, VYNE is working to develop and commercialize a variety of solutions and has received FDA approval for AMZEEQ® (minocycline) topical foam, 4%, the world’s first topical minocycline, and for ZILXI® (minocycline) topical foam, 1.5%, the first minocycline product of any kind to be approved by the FDA for use in rosacea. For more information about our approved products, please see AMZEEQ’s Full Prescribing Information at AMZEEQ.com and ZILXI’s Full Prescribing Information at ZILXI.com.
For more information about VYNE Therapeutics Inc. or its investigational products, visit www.vynetherapeutics.com or follow VYNE on Twitter. 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, public conference calls, and webcasts.

About In4Derm

In4Derm is a biotech that develops new small molecule drugs for anti-inflammatory and orphan indications.
In4Derm is a spin-out from the world-leading University of Dundee’s School of Life Sciences and has laboratory facilities in Dundee, Scotland. In4Derm is seeking to discover first-in-class medicines that provide meaningful benefits for patients. In4Derm is supported by o2h Ventures, Meltwind, Wren Capital, Scottish Enterprise, and The University of Dundee.
For more information, please visit www.In4Derm.com or contact Tim Sparey Ph.D. (CEO) tim@in4derm.com (+44 (0) 7718864561).

Investor Relations:

Joyce Allaire
LifeSci Advisors, LLC

Tyler Zeronda
VYNE Therapeutics Inc.