Qilu Pharmaceutical Submits IND Application for CEND-1, a $235M In-Licensed First-in-Class Oncology Candidate

Source: Pharma Insights

According to a public notice from the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA), Qilu Pharmaceutical submitted a clinical trial application for CEND-1 for injection, which was accepted on May 27. Public records indicate that CEND-1 is a potential "first-in-class" anticancer therapy developed by Cend Therapeutics. In February 2021, Qilu Pharmaceutical secured exclusive rights to this candidate drug in the Greater China region through a collaboration agreement valued at up to $235 million.

Screenshot source: CDE Official Website

CEND-1, also known as iRGD, is a peptide capable of binding to neuropilin-1. Neuropilin-1 is one of the proteins highly expressed on pancreatic cancer cells. Upon binding with iRGD, it mediates cellular endocytosis and the formation of delivery vesicles. These vesicles transport anticancer drugs co-administered with iRGD from the bloodstream into the tumor tissue, thereby enhancing the cytotoxic efficacy of the anticancer drugs.

On February 16, Cend Therapeutics and Qilu Pharmaceutical announced that they have entered into a collaboration agreement. Under the terms of the agreement, Qilu Pharmaceutical has obtained exclusive development and commercialization rights for CEND-1 in the Greater China region (including mainland China, Hong Kong, Macau, and Taiwan), while Cend Therapeutics will retain all rights to the drug candidate outside of Greater China. Additionally, Cend Therapeutics will receive a $10 million upfront payment and will be eligible for up to $225 million in milestone payments, as well as corresponding royalties.

According to Cend's official website, CEND-1 is being developed for the treatment of pancreatic cancer, triple-negative breast cancer, and other indications. Data presented at the 2020 ESMO Congress indicated that in a Phase I clinical trial, a triplet regimen comprising CEND-1, gemcitabine, and nab-paclitaxel achieved an overall response rate (ORR) of 59% and a disease control rate (DCR) of 83% in patients with metastatic pancreatic cancer. Currently, Cend is planning a registrational clinical trial of CEND-1 for pancreatic cancer and will explore combination therapy studies with other treatment modalities.

Note: The original text has been abridged.

References:

[1] Center for Drug Evaluation, National Medical Products Administration. Retrieved May 27, 2021, from http://www.cde.org.cn/news.do?method=changePage&pageName=service&frameStr=3

[2]Cend Therapeutics and Qilu Pharmaceutical Announce Partnership. Retrieved Feb 16, 2021, from https://cendrx.com/media/#press-releases

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