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Don’t invest unless you’re prepared to lose all the money you invest. This is a high-risk investment and you are unlikely to be protected if something goes wrong. Take 2 mins to learn more

o2h Ventures backed In4Derm enters into an exclusive license agreement with VYNE Therapeutics
o2h Ventures backed In4Derm enters into an exclusive license agreement with VYNE Therapeutics
Aug 13 2021

 

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
646-889-1200
jallaire@lifesciadvisors.com

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

 

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Please refer to the relevant fund’s full risk warnings contained in their Information Memorandums.
Your capital is at risk. Investing in early stage businesses involves risks, including illiquidity, lack of dividends, loss of investment and dilution, and it should be done only as part of a diversified portfolio. o2h Ventures’ funds are targeted exclusively at sophisticated or high net worth investors who understand these risks and make their own investment decisions. Tax relief depends on an individual’s circumstances and may change in the future. In addition, the availability of tax relief depends on the company invested in maintaining its qualifying status. Past performance is not a reliable indicator of future performance. You should not rely on any past performance as a guarantee of future investment performance.
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Risk Information

Due to the potential for losses, the Financial Conduct Authority (FCA) considers this investment to be high risk

What are the key risks?

1 – You could lose all the money you invest

• If the business you invest in fails, you are likely to lose 100% of the money you invest. Most start-up businesses fail.

2 – You are unlikely to be protected if something goes wrong

• Protection from the Financial Services Compensation Scheme (FSCS), in relation to claims against failed regulated firms, does not cover poor investment performance. Try the FSCS investment protection checker here. (https://www.fscs.org.uk/check/investment-protection-checker)

• Protection from the Financial Ombudsman Service (FOS) does not cover poor investment performance. If you have a complaint against an FCA-regulated firm, FOS may be able to consider it. Learn more about FOS protection here. (https://www.financial-ombudsman.org.uk/consumers)

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• Even if the business you invest in is successful, it may take several years to get your money back. You are unlikely to be able to sell your investment early.

• The most likely way to get your money back is if the business is bought by another business or lists its shares on an exchange such as the London Stock Exchange. These events are not common.

• If you are investing in a start-up business, you should not expect to get your money back through dividends. Start-up businesses rarely pay these.

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• Putting all your money into a single business or type of investment for example, is risky. Spreading your money across different investments makes you less dependent on any one to do well.

• A good rule of thumb is not to invest more than 10% of your money in high-risk investments (https://www.fca.org.uk/investsmart/5-questions-ask-you-invest)

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• The percentage of the business that you own will decrease if the business issues more shares. This could mean that the value of your investment reduces, depending on how much the business grows. Most start-up businesses issue multiple rounds of shares.

• These new shares could have addition rights that your shares don’t have, such as the right to receive a fixed dividend, which could further reduce your chances of getting a return on your investment.

If you are interested in learning more about how to protect yourself, visit the FCA’s website here (https://www.fca.org.uk/investsmart)