fiercebiotechSeptember 21, 2018
Tag: Inflammation , fibrosis , drug discovery
Corbus Pharmaceuticals Holdings has licensed worldwide rights to drug candidates from more than 600 compounds targeting the endocannabinoid system from Jenrin Discovery—which it says will fuel one to two new clinical programs in inflammatory and fibrotic diseases each year, starting in 2020.
Up first is CRB-4001—a CB1 inverse agonist aimed at multiple indications in liver, lung, heart and kidney fibrotic diseases, including NASH, pulmonary fibrosis and more—with plans for a phase 1 safety study in 2019, followed by an NIH-supported, phase 2 first-in-patient study.
The deal included a $250,000 upfront cash payment and up to $18.4 million in milestone payments for each compound developed, plus royalties. In return, Jenrin agreed to not research or develop any compounds intended to modulate any cannabinoid receptor for the next 10 years.
"Securing this extensive portfolio of endocannabinoid system-targeting compounds strongly complements our existing phase 3 lead drug lenabasum," said Corbus CEO Yuval Cohen, Ph.D., describing Corbus’ CB2 agonist aimed at immune cells in rare inflammatory diseases.
"Our now expanded pipeline is built on robust underlying science based on the endocannabinoid system as a master regulator of inflammation and fibrosis in the body," Cohen said. The system of neurotransmitters has been linked to the regulation of multiple physiological and cognitive processes.
CRB-4001 was developed in collaboration with the NIH, and was designed to avoid the psychological side effects seen in earlier generations of similar drugs, by making it unable to penetrate the blood-brain barrier. Other potential indications include primary biliary cholangitis, myocardial fibrosis following a heart attack and acute interstitial nephritis, among others.
To help shepherd CRB-4001 and the other compounds in the new endocannabinoid portfolio, Corbus brought on George Kunos, M.D., Ph.D., the scientific director of the NIH’s National Institute on Alcohol Abuse and Alcoholism, to serve on the company’s scientific advisory board as an uncompensated member.
Kunos led the work at the NIH to advance CRB-4001 to clinical testing, including studies in animal models of nonalcoholic fatty liver disease, Type 2 diabetes, diet-induced insulin resistance and Type 2 diabetic nephropathy. Corbus plans to provide more details on the clinical development path of CRB-4001 before the end of the year.
Lenabasum, meanwhile, is being studied in separate phase 3 trials of systemic sclerosis and dermatomyositis, as well as a large phase 2 study of pulmonary exacerbations in cystic fibrosis, funded in part by the Cystic Fibrosis Foundation. In addition, lenabasum, previously known as anabasum, is being evaluated in an NIH phase 2 study for the treatment of lupus.
Corbus estimates a potential annual market opportunity of between about $2 billion and over $5 billion, totaled for those first three indications, in addition to $2 billion to $3 billion in lupus alone.
One of the company’s main competitors could be a CB1-focused drug that Johnson & Johnson obtained last year from Bird Rock Bio, namacizumab, being studied in NASH, Cohen said in a conference call with investors.
"More and more big pharma companies are going to turn their attention to this completely untapped biological system," Cohen said. "The advantages we have as Corbus—our vision, our nimbleness and now, our patent portfolio—put us ahead of the pack."
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