• Company’s vision is to become the leader in the treatment of inflammatory and fibrotic diseases by targeting the endocannabinoid system
• Lenabasum in late-stage clinical studies in three orphan indications with combined 350,000 patients in the US, EU and Japan
• Issuance of composition of matter patent combined with recently issued patents on method of use further strengthens the IP portfolio for lenabasum and enhances strategic optionality

Norwood, MA, Dec. 18, 2018 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), a clinical stage drug development company with the industry’s leading pipeline focused on treating inflammatory and fibrotic diseases by targeting the endocannabinoid system, announced today that the U.S. Patent and Trademark Office (“USPTO”) issued Patent No. 10,154,986 to the Company which claims pharmaceutical compositions of lenabasum through 2034. The patent is entitled: “Ultrapure Tetrahydrocannabinol-11-oic acids.” The issuance of this new patent follows the previously issued U.S. Patent Nos. 10,085,964, 9,801,849 and 9,820,964 covering uses of lenabasum in multiple inflammatory and fibrotic diseases, including scleroderma, dermatomyositis, cystic fibrosis and systemic lupus erythematosus as well as multiple sclerosis, rheumatoid arthritis, psoriasis and other fibrotic and inflammatory diseases.

Lenabasum is a synthetic oral drug candidate designed to resolve chronic inflammation and fibrosis through the activation of the CB2 pathway to stimulate production of specialized pro-resolving mediators, inhibition of pro-inflammatory mediators and tissue infiltration with inflammatory cells as well as cessation of fibrogenic processes.

“We are pleased to receive this new patent issuance related to lenabasum which reflects the novelty and uniqueness of the composition. The issuance of this patent reinforces the lenabasum composition’s unique properties and combined with the prior issued patents provides exclusivity for the use of lenabasum for the treatment of multiple inflammatory and fibrotic diseases that have limited therapeutic options. We remain dedicated to pursuing the expansion of our lenabasum product portfolio as we strive to become leaders in the field,” said Mark Tepper, Ph.D., President and Chief Scientific Officer of Corbus.

About Lenabasum

Lenabasum is a rationally-designed, oral, small molecule that selectively binds as an agonist to the cannabinoid receptor type 2 (CB2). CB2 is preferentially expressed on activated immune cells, fibroblasts, muscle cells, and endothelial cells. In both animal and human studies conducted to-date, lenabasum has induced the production of Specialized Pro-resolving lipid Mediators (“SPMs”) that activate endogenous pathways which resolve inflammation and speed bacterial clearance without immunosuppression. Lenabasum is also believed to have a direct effect on fibroblasts to limit production of fibrogenic growth factors and extracellular connective tissue that lead to tissue fibrosis (scarring). Data from animal models and human clinical studies suggest that lenabasum can reduce expression of genes and proteins involved in inflammation and fibrosis. Lenabasum has demonstrated promising activity in animal models of skin and lung inflammation and fibrosis in systemic sclerosis (SSc). Lenabasum is also active in animal models of lung infection and inflammation in cystic fibrosis and joint inflammation and scarring in rheumatoid arthritis.

Lenabasum has demonstrated favorable safety and tolerability profiles in clinical studies to date. Lenabasum improved multiple physician-assessed and patient-reported efficacy outcomes in Phase 2 studies in patients with diffuse cutaneous SSc and skin-predominant dermatomyositis. Lenabasum also reduced pulmonary exacerbations in a Phase 2 cystic fibrosis study. Additional clinical studies are being conducted and/or planned to confirm these results and support applications for regulatory approval.

About Corbus

Corbus Pharmaceuticals Holdings, Inc. is a Phase 3 clinical-stage pharmaceutical company focused on the development and commercialization of novel therapeutics to treat inflammatory and fibrotic diseases by leveraging its pipeline of endocannabinoid system-targeting synthetic drug candidates. The Company's lead product candidate, lenabasum, is a novel, synthetic, oral, selective cannabinoid receptor type 2 (CB2) agonist designed to resolve chronic inflammation and fibrotic processes. Lenabasum is currently being evaluated in systemic sclerosis, cystic fibrosis, dermatomyositis, and systemic lupus erythematosus.

Corbus licensed the exclusive worldwide rights to develop, manufacture and market drug candidates from more than 600 novel compounds targeting the endocannabinoid system from Jenrin Discovery LLC. The pipeline includes CRB-4001, a 2^nd generation, peripherally-restricted, selective cannabinoid receptor type 1 (CB1) inverse agonist designed to eliminate blood-brain barrier penetration and subsequent brain CB1 receptor occupancy that mediates the neuropsychiatric adverse events associated with first-generation CB1 inverse agonists. Potential indications for CRB-4001 include NASH, primary biliary cholangitis, idiopathic pulmonary fibrosis, radiation-induced pulmonary fibrosis, myocardial fibrosis after myocardial infarction and acute interstitial nephritis, among others. Corbus plans to enter a Phase 1 study of CRB-4001 in 2019, intended to be followed by a National Institutes of Health (NIH)-funded proof-of-concept Phase 2 study.

For more information, please visit www.CorbusPharma.com and connect with the Company on Twitter, LinkedIn, and Facebook.

Forward-Looking Statements

This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company's product development, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statement that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management's current beliefs and assumptions.

These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential, "predict," "project," "should," "would" and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company's filings with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

Investor Contacts:

Institutional Investor Inquiries
Ted Jenkins, Senior Director, Investor Relations and Communications
Corbus Pharmaceuticals, Inc.
Phone: +1 (617) 415-7745
Email: ir@corbuspharma.com

All Other Investor Inquiries
Jenene Thomas
Jenene Thomas Communications, LLC
Phone: +1 (833) 475-8247
Email: crbp@jtcir.com

Media Contact

Lindsey Smith
Phone: +1 (617) 415-7749
Email: mediainfo@corbuspharma.com

Source: Corbus Pharmaceuticals Holdings, Inc.

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Released December 18, 2018