Pharmaceutical Business review

LSK BioPharma, HCI enter license agreement for HCI-1401 to treat B-cell malignancies

As part of the deal, HCI awarded LSKB global rights in all therapeutic indications of HCI-1401.

Developed by HCI’s Center for investigational therapeutics, HCI-1401 was selectively designed to have excellent oral bioavailability while inhibiting the BTK enzyme, a mediator of several pro-survival mechanisms in B-cell cancers.

HCI Clinical Research and Division chief of Oncology and senior director Sunil Sharma said: "BTK inhibitors are an exciting class of drugs not only because of their proven efficacy in B-cell cancers but because of their potential in other disease areas as well.

"With recent clinical findings highlighting the emergence of resistance mutations against the BTK inhibitor ibrutinib, there is an acute need for new compounds that maintain their activity in cancers that acquire these mutations."

Apart from showing high potency inhibiting normal BTK, HCI-1401 was designed to maintain its activity against the commonly mutated form of BTK that gives resistance to other BTK inhibitors such as ibrutinib.

Data from preclinical in vitro studies shows that HCI-1401 is several times more potent in inhibiting BTK than other competitive inhibitors.

Both the parties expect HCI-1401 to enter into clinical trials next year and to have clinical utility in fighting certain B-cell mediated malignancies as well as in autoimmune and inflammatory diseases including rheumatoid arthritis and systemic lupus erythematosus.

LSKB president Dr Sung Chul Kim said: "Huntsman Cancer Institute has made significant progress in the research and development of HCI-1401, and we look forward to bringing this molecule closer to application in cancer and autoimmune disorders."