Biospecimen M&A: Discovery acquires Albert Li's hepatocyte project; PhIII trial on Bayer's Nubeqa reached primary endpoint
Discovery Life Sciences has acquired what claims to be the Maryland-based host of the world’s largest hepatocyte inventory, known as IVAL, to help researchers select more effective and safer drug candidates in the future.
The combined companies will now serve a wider range of drug research and development scientists, according to Albert Li, who founded IVAL in 2004 and is set to join the Discovery leadership team as the CSO of pharmacology and toxicology.
Li has spent his career with IVAL supporting the submissions and approvals of several breakthrough therapies, carving out a specialty in the isolation, cryopreservation, and culturing of human hepatocytes and the application of human hepatocytes to evaluate drug metabolism, drug-drug interactions, and drug toxicity.
“I am grateful to my IVAL team members who have entrusted me with their careers and are instrumental to our achievements. I look forward to be part of the wonderful and talented DLS family,” Li said in a LinkedIn post.
The companies did not offer a dollar figure on the acquisition.
The acquisition is Discovery’s ninth in less than four years. In May, it acquired Targos Molecular Pathology GmbH out of Germany, to up its global tissue biomarker services. Before that, it picked up Santa Barbara, CA-based QualTek, an immunohistochemistry provider. In March 2020, it announced a significant expansion of its cell biology and immunology services laboratory to speed up the development of cell therapies and immunotherapies. — Josh Sullivan
Nubeqa reaches primary endpoint in PhIII trial on new indication for prostate cancer
Bayer’s prostate cancer drug Nubeqa reached its primary endpoint in a Phase III trial on a type of prostate cancer, the company announced early this morning.
The Phase III Arasens trial, investigating what is also known as darolutamide on metastatic hormone-sensitive prostate cancer (mHSPC), showed that the drug in combination with chemotherapy docetaxel and androgen deprivation therapy (ADT) significantly increased overall survival rate, compared to docetaxel and ADT by themselves.
Nubeqa is currently indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC).
“We are especially grateful to the patients and investigators for participating in this important trial and look forward to presenting the full results at an upcoming meeting,” said Bayer SVP and head pharmaceutical oncology development Scott Fields.
In a statement, Bayer said they plan to discuss the data from the trial with health authorities regarding the submission of Nubeqa for marketing authorization in this indication. No timeline was given. — Paul Schloesser
BeiGene and partner get Sylvant approved for multicentric Castleman disease (MCD) in China
BeiGene and collaborator EUSA Pharma announced last night that China’s NMPA approved monoclonal antibody treatment Sylvant to treat adult patients with multicentric Castleman disease (MCD) who are both HIV-negative and negative for herpes — which is also known as idiopathic MCD (iMCD).
This follows previous approval in the US and the EU.
“Today’s approval provides a new treatment for patients in China with this rare systemic disorder,” commented Xiaobin Wu, president, COO, and general manager of China at BeiGene. “This approval is our second product in our collaboration with EUSA. We look forward to launching siltuximab in 2022 and to helping patients with iMCD in China.”
The approval of siltuximab for the treatment of iMCD was supported by clinical results from a multinational, randomized, double blind and placebo-controlled Phase II trial conducted in 79 patients from 19 countries and regions. — Paul Schloesser