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December 4, 2020

Woodbridge biotech gets FDA ‘orphan’ status for anti-tumor drug

PHOTO: Contributed  Uday Khire
By Natalie Missakian

Federal regulators have deemed a Woodbridge biotechnology company’s tumor-fighting therapy an ‘orphan’ drug, making it eligible for financial incentives.

AlloMek Therapeutics earned the Food and Drug Administration designation for CIP-137401, its experimental treatment for neurofibromatosis-1 (NF-1). 

The inherited condition causes benign tumors to develop on the skin or along nerves. It affects about one in 3,000 people worldwide, according to the Children’s Tumor Foundation. 

The company expects to begin human testing on the drug in 2021.

The ‘orphan’ designation makes AlloMek eligible for tax credits, a new drug application fee waiver, and a period of market exclusivity after the drug is approved.

The FDA reserves the designation for potential new drugs targeting diseases affecting fewer than 200,000 people in the United States, or for those not expected to recoup the cost of bringing the drug to market.

AlloMek specializes in macrocycles, which are molecules containing at least one ring of eight or more atoms, according to the company’s website. The molecules have drug-like properties and can be used as therapeutics, the website says.

AlloMek’s drug is a macrocyclic MEK kinase inhibitor that has been shown in preclinical studies to dramatically reduce the number and size of benign nerve tumors known as plexiform neurofibromas, according to AlloMek. 

AlloMek said the potential to administer the drug once a day makes it an excellent candidate to combine with complementary therapeutics. The drug was well-tolerated with limited side effects in animal testing, the company said.

Founder and CEO Uday Khire, a former Bayer chemist, launched AlloMek in 2011 to develop drugs discovered by Cheminpharma LLC, also founded by Khire.

In addition to developing CIP-137401 to treat NF-1 and other rare diseases, AlloMek said it is seeking partnerships to test the drug as a cancer therapy.

Contact Natalie Missakian at news@newhavenbiz.com

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