News

FDA granted Orphan Drug Designation to Extend Biosciences’ EXT608 for the treatment of hypoparathyroidism.

Kate Didio, RN MBA, has joined Extend Biosciences as Clinical Program Lead, and will be responsible for all of the clinical operations and monitoring for the Phase 1 trial of EXT608. Ms. Didio has over 25 years of experience in clinical operations for biotech and pharmaceutical companies in multiple therapeutic areas, including pulmonary and metabolic diseases as well as orphan indications.

Extend Biosciences’ EXT608 for hypoparathyroidism receives additional support from MassVentures’ START program, which helps growing Massachusetts-based companies convert research developed under SBIR and STTR contracts into businesses and jobs in Massachusetts.

Read about the START program here ->

NIDDK continues to fund Extend Biosciences’ long-acting PTH for hypoparathyroidism with a Phase IIB grant for the conduct of a Phase 1 trial in healthy volunteers.

Poul Strange, MD PhD, has joined the clinical team at Extend Biosciences to spearhead the Phase 1 trial of EXT608 in healthy volunteers. Dr. Strange is the Founder and serves as the Medical Director and President of Integrated Medical Development, a US full service clinical CRO focused assisting companies with their medical product development. IMD will be responsible for data management of the trial.

A Phase 1 SBIR was awarded to advance the development of a long duration, novel opioid medical countermeasure for use by Department of Defense Service Members in far-forward deployed settings.

Dr. Soliman was selected by the National Cancer Institute for their Investor Initiatives program, a once-yearly competitive program that connects SBIR-funded companies with potential investors and strategic partners to continue the commercialization efforts initially funded by NCI. He received executive coaching on his presentation, EXT418 for the Treatment of Cancer Cachexia, in preparation for pitching at the Emerging Company Showcase at the Life Sciences Summit held in New York City. Extend Biosciences also received financial assistance from NCI to cover the presentation and registration costs for the conference.

See the agenda here->

The grant will be used to fund proof-of-concept work and efficacy studies on a long-acting ghrelin for the treatment of peripheral neuropathy.

The company received an Administrative Supplement award from NCI to further the development of the long-acting ghrelin asset for the treatment of cancer cachexia.

Extend Biosciences’ trademark registration has been issued for the name of their platform technology, D-VITylation.