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.
The radiopharma field has garnered increasing attention in recent years due to big-ticket deals like Bayer AG's $2.9 billion acquisition of Algeta ASA and Novartis AG's nearly $6 billion spent on buying Advanced Accelerator Applications SA and Endocyte Inc. As a result, competition is ratcheting up and pipelines are exploding with new combinations of different drugs. The global radiopharmaceuticals market was estimated to be valued at $6.7 billion in 2020, a number expected to reach $11.5 billion by 2027, according to a 2022 William Blair report.
The possibilities of cures for cancer and other tough-to-treat diseases and the ability to further personalize medicine are creating a lot of excitement about the future of radiopharmaceuticals as both therapy and diagnostics. To reach that future, industry and researchers will have to overcome a lot of challenges, not the least of which stem from the multiple government agencies involved in regulating the source material, development, distribution and use of radioactive drugs and devices.
Radiopharmaceuticals require sophisticated infrastructure, with just-in-time radioactives delivered to patients who must isolate while receiving the therapy. Quality control and numerous layers of regulation makes for a daunting space to enter.
Supply issues are a “major concern for the whole industry and for the medical community as well, because they see targeted radiotherapy as a very promising field with very interesting results in the clinic, but they are concerned that drugs may not be available for a large number of patients, and it is a legitimate concern,” Orano Med SAS CEO Julien Dodet said.