In the latest deal from the burgeoning antibody-drug conjugate (ADC) space, Eisai Co. Ltd. and privately held Bliss Biopharmaceutical (Hangzhou) Co. Ltd. reached a development and commercialization agreement that could be worth up to $2 billion. The massive collaboration is the eighth largest so far this year and one of three that involve ADCs in the year’s top 10 deals.
Roche AG acquired global rights to Zion Pharma Ltd.’s lead program, ZN-A-1041, an orally administered selective tyrosine kinase inhibitor that is designed to penetrate the blood-brain barrier and can prevent and treat brain metastases in HER2-positive metastatic breast cancer patients.
Albatroz Therapeutics Pte Ltd. has secured $3 million in seed funding to develop therapeutic antibodies against a new target that degrades the extracellular matrix, a key contributor to cancer and arthritis.
Shanghai Junshi Biosciences Co. Ltd.’s anti-PD-1 monoclonal antibody toripalimab showed positive interim event-free survival (EFS) results in a phase III study to treat patients with resectable non-small-cell lung cancer (NSCLC). This is the world’s first phase III trial that shows perioperative treatment with an anti-PD-1 monoclonal antibody significantly extends EFS of patients with resectable NSCLC, according to Shanghai-based Junshi Biosciences.
Daiichi Sankyo Co Ltd. has experienced yet another setback with its quizartinib NDA submission, as the U.S. FDA has now extended the review period by three months to July 24, 2023, to allow additional time to review requested updates to the proposed Risk Evaluation and Mitigation Strategies.
Junshi Biosciences Co. Ltd.’s PARP inhibitor, senaparib (JS-109/IMP4297), met the primary endpoint of progression-free survival in a phase III ovarian cancer study, according to a prespecified interim analysis.
Pyramid Biosciences Inc. has in-licensed Genequantum Healthcare Co. Ltd.’s preclinical trophoblast cell surface antigen 2 (TROP2)-targeting antibody-drug conjugate (ADC), GQ-1010, in a deal worth up to $1 billion in potential milestones. Under the terms, Pyramid gains exclusive rights to develop and commercialize GQ-1010 globally, excluding greater China (mainland China, Hong Kong, Macau and Taiwan).
During what has become one of the slowest IPO years in recent memory, cancer immunotherapy company Cytomed Therapeutics Ltd. debuted on Nasdaq, raising $9.65 million, while inflammatory disease firm Acelyrin Inc. filed to list its stock for a potential $100 million. Up to this point, there were only six biopharma IPOs completed this year – the fewest since 2013. Cytomed, which priced 2.4 million shares at $4 apiece, is now the seventh for 2023, and the fifth on Nasdaq. Two other IPOs have closed on Chinese markets.
Noxopharm Pty Ltd.’s stock plummeted nearly 40% on the morning of April 6 after the company announced it was quitting development of its lead program, Veyonda (idronoxil/formerly OX-66), shuttering its DARRT-2 and CEP-2 oncology clinical trials and disbanding its clinical trial team to contain costs.
In the string of successes and frustrations generated by their five-year collaboration, Merck & Co. Inc. and Eisai Inc. can now add a few more frustrations. The companies are discontinuing the phase III LEAP-003 study of Keytruda (pembrolizumab) plus Lenvima (lenvatinib) for first-line treatment of unresectable or metastatic melanoma because it did not improve overall survival (OS) vs. Keytruda as a monotherapy. Also, the phase III LEAP-017 trial evaluating the combination in unresectable and metastatic colorectal cancer did not meet its primary endpoint of OS.
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