(RTTNews) - Biopharmaceutical company BioLineRx Ltd. (BLRX) announced Monday that it has entered into a collaboration agreement with China-based peer GenFleet Therapeutics to advance Motixafortide through a randomized Phase 2b clinical trial in pancreatic ductal adenocarcinoma, or PDAC.
Under the terms of the agreement, GenFleet will fully fund, design and execute a randomized Phase 2b clinical trial that will enroll approximately 200 first-line metastatic PDAC patients in China. This randomized controlled study will aim to evaluate the superiority of Motixafortide in combination with an anti-PD-1 and chemotherapy compared to chemotherapy alone, the current standard of care.
As part of the collaboration, BioLineRx will supply Motixafortide, while GenFleet will supply the other study drugs for the trial. Trial oversight will be administered by a Joint Development Committee.
GenFleet will be eligible to receive low-to-mid-single digit tiered percentage royalties on future Motixafortide sales, if approved.
This collaboration is based on the highly encouraging results from BioLineRx's Phase 2a COMBAT/KEYNOTE-202 study of Motixafortide in combination with an anti-PD-1 and chemotherapy.
BioLineRx said it remains on track to submit its New Drug Application (NDA) for Motixafortide in stem cell mobilization in the U.S. in the next few months. It is continuing the pre-launch activities in anticipation of potential FDA approval in 2023.
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