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Hoth Therapeutics Enters into Commercial Licensing Agreement with University of Maryland, Baltimore and Isoprene Pharmaceuticals Inc.

Wednesday, March 13, 2019

  • Hoth secures exclusive rights to develop and commercialize therapeutic compounds for dermatological treatments
  • Lead compounds show potent in vivo anti-cancer activity
  • Lead compounds show promise in vitro for treating dermatology conditions
  • Good oral bioavailability and safety profile

NEW YORKMarch 13, 2019 /PRNewswire/ -- Hoth Therapeutics, Inc.(NASDAQ: HOTH), a development-stage biopharmaceutical company focused on unique targeted therapeutics for patients suffering from indications such as atopic dermatitis–also known as eczema–as well as dermatological and chronic wound disorders, today announced that Hoth Therapeutics, Inc. (Hoth) has entered into a Commercial Evaluation Sublicense and Option Agreement with the University of Maryland, Baltimore (UMB) and Isoprene Pharmaceuticals Inc.

The agreement grants Hoth complete evaluation and option rights in the Dermatology Evaluation Field to develop and commercialize therapeutic compounds for the treatment of dermatological conditions in humans. The licensing agreement stems from results reported by UMB relating to the effect Retinoic acid metabolism blocking agents (RAMBAs) offer in treating cancer and dermatology related issues. To view the published results of the research, please click here.

Mr. Robb Knie, Chief Executive Officer of Hoth, commented, "We are excited about the opportunity to evaluate these novel retinamides (Retinoic acid metabolism blocking agents or RAMBAs) for the treatment of dermatological diseases. The initial work done by the University of Maryland, Baltimore and Isoprene Pharmaceuticals has shown promising therapeutic results, and we look forward to working with these respected institutions as we continue to progress through the trial phase." 

"The partnership between UMB, Isoprene Pharmaceuticals, and Hoth Therapeutics is an example of how early-stage technology investment by UM Ventures, Baltimore can enhance the commercial viability of important new medical innovations emerging from academic research," said Rana Quraishi, PhD, Director of new ventures at UMB. 

"The collaboration between Hoth Therapeutics, University of Maryland, Baltimore, and Isoprene Pharmaceuticals is critical for the development of UMB's unique novel retinamide small molecules as potential new therapeutics for a variety of dermatological diseases," said Vincent C.O. Njar, PhD, lead scientific inventor and professor in the University of Maryland School of Medicine.

University of Maryland, Baltimore Findings
Researchers at UMB discovered novel retinamide RAMBAs and validated their therapeutic utility in animal models of breast and prostate cancer. RAMBAs inhibit the cellular enzyme that metabolizes all-trans retinoic acid (ATRA), which actively directs cells to mature in a controlled manner to ensure normal growth. In addition to enhancing the beneficial effects of ATRA, the mechanism of action for these RAMBAs has been shown to involve degradation of Mnk 1/2 and suppression of the oncogenic eIF4E pathway. For potential use in treating dermatological conditions, UMB researchers obtained promising early results demonstrating that lead retinamide RAMBAs have equal or superior effects over approved retinoids (ATRA and 13-CRA) to inhibit proliferation of normal human adult keratinocytes and sebocytes, and antikeratinizing effects in reconstructed human epidermis. Initial toxicity profiles for a panel of RAMBAs [Njar et al., 2006] also showed good indications for safe therapeutic use.

These novel RAMBAs block the normal metabolism of endogenous ATRA in cells, increasing the beneficial effects of ATRA. They provide a unique approach to achieve the therapeutic benefit of retinoid therapy while potentially circumventing the adverse events associated with it, a very important property for application to dermatology therapy. ATRA deficiencies are associated with dermatological diseases (acne and psoriasis), and retinoid derivatives have been one of the mainstay therapies for acne. Liarozole is in clinical use for the treatment of psoriasis and ichthyosis. Dermatological retinoid deficiencies are characterized by hyperkeratinization and desquamation and include diseases such as acne, eczema, psoriasis, cold sores, wounds, burns, sunburn, ichthyosis, skin cancer, and Kaposi's Sarcoma, all of which are plausible targets for retinamide RAMBA therapy.

Lead compounds show potent 
in vivo anti-cancer activity
Lead compounds show promise 
in vitro for treating dermatology conditions
Good oral bioavailability and safety profile

Stage of Development
Oncology: Lead retinamide RAMBA compounds demonstrate potent tumor inhibition in mouse xenograft models of human triple-negative breast cancer and castration-resistant prostate cancer [see Refs 2014 - 2015].

Dermatology: Lead retinamide RAMBAs demonstrate antikeratinization and sebosuppressive effects in vitro and in reconstructed human epidermis, with equal or superior effects to currently marketed retinoids, 13-CRA and ATRA [unpublished data].

Mbatia HW et al. (2015) J Med Chem. 58:1900-1914
Ramamurthy VP et al. (2015) Oncotarget. 6(5):3195-3210
Ramalingam S et al. (2014) Oncotarget. 5(2):530-543.
Njar VCO et al. (2006) Bioorg & Med Chem. 14:4323-4340.

Patent Status 
US Patent 9,156,792 (issued 10/13/2015)
WO 2016/081589 (published 5/26/2016)
Other patents pending

About Hoth Therapeutics, Inc.
Hoth Therapeutics, Inc., a Nevada corporation, is a development-stage biopharmaceutical company focused on unique targeted therapeutics for patients suffering from indications such as atopic dermatitis, also known as eczema. Hoth has exclusive worldwide rights to the BioLexa Platform. Hoth intends to use the BioLexa Platform to develop two different topical cream products: (i) a product to treat eczema and (ii) a product that reduces post-procedure infections, accelerates healing, and improves clinical outcomes for patients undergoing aesthetic dermatology procedures. Hoth's initial focus will be on the development of the BioLexa Platform for the treatment of eczema. Eczema is a disease that results in inflammation of the skin and is characterized by rash, red skin, and itchiness. Eczema is also referred to as atopic dermatitis.

About the University of Maryland, Baltimore
The University of Maryland, Baltimore (UMB) and its biomedical research park are commercializing breakthrough therapies, diagnostics, and devices, fueling the creation of innovative start-up companies, and attracting industry leaders and entrepreneurs to its thriving campus. Founded in 1807 as the first public medical school in the nation, UMB is a fast-growing biomedical research center with nationally ranked professional schools of dentistry, law, medicine, nursing, pharmacy, and social work, as well as an interdisciplinary graduate school. The School of Medicine is ranked eighth (among publics) for total grants and research expenditures. In Fiscal Year 2018 UMB was awarded over $667 million in grants and contracts.

About Isoprene Pharmaceuticals Inc.
Isoprene Pharmaceuticals Inc. is a cancer therapeutic company developing novel small molecules for the treatment of cancer. It is a UMB New Ventures Initiative start-up founded by the lead scientific inventor, Vincent C.O. Njar, PhD, professor of medicinal chemistry and pharmacology in the University of Maryland School of Medicine Department of Pharmacology and head of the Medicinal Chemistry Section, Center for Biomolecular Therapeutics (CBT), Institute for Bioscience and Biotechnology Research (IBBR), and the UMB New Ventures Initiative Management Team (see listing of members below).

Isoprene's lead molecules degrade the mitogen-activated protein kinase-interacting kinases (Mnk 1/2). Mnk 1/2 regulate the cancer-promoting activities of eIF4E via phosphorylation of serine 209 on eIF4E. However, Mnk-mediated phosphorylation of eIF4E is not required for normal eIF4E function. Therefore, preventing phosphorylation of eIF4E by Mnks represents an ideal therapeutic target. Isoprene's approach is to disrupt Mnk-induced eIF4E phosphorylation by degrading Mnks.

UMB New Ventures Initiative Management Team
Rana Quraishi, PhD, Director, New Ventures
Darryl L. Carter, MD, Venture Advisor and Scientific Advisor to Isoprene
Mark Lafferty, PhD, Associate Director, New Ventures
Adam Kronk, MS, MBA, Venture Associate

Forward Looking Statements
Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend" or similar expressions, or statements regarding intent, belief, or current expectations are forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in the Company's filings with the Securities and Exchange Commission (the "SEC"), not limited to Risk Factors relating to its patent business contained therein. Thus, actual results could be materially different. The Company expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.

Investor Relations Contact:
Phone: (646) 756-2997
[email protected]

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SOURCE Hoth Therapeutics, Inc.

Company Codes: NASDAQ-NMS:HOTH