On January 21, 2021 Merck KGaA reported that it will discontinue a Phase III clinical trial studying its cancer drug hopeful bintrafusp alfa (Press release, Merck KGaA, JAN 21, 2021, View Source [SID1234574230]). The decision was made based on an Independent Data Monitoring Committee recommendation which indicated the study was unlikely to meet its specified primary efficacy endpoint of progression-free survival.

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Bintrafusp alfa (anti-PD-L1/TGF-beta trap) is an investigational bifunctional immunotherapy co-designed with GlaxoSmithKline (GSK) to manage hard-to-treat cancers. Merck KGaA was studying the therapy in the ongoing INTR@PID Lung 037 clinical trial as a first-line therapy for patients with stage IV non-small cell lung cancer (NSCLC) and high expression of PD-L1.

"We have pioneered the science behind bintrafusp alfa, and now through a strategic alliance, multiple non-correlated parallel hypotheses are being evaluated across numerous indications in our extensive INTR@PID clinical program," said Merck KGaA’s Global Head of Development for the Healthcare business Danny Bar-Zohar, M.D., in a statement. "We remain committed to further evaluation of bintrafusp alfa, and these data from INTR@PID Lung 037 will provide important insights that may be applied to future studies."

The discontinuation of the trial threatens the cancer drug development goals of GSK, which is developing bintrafusp alfa with Merck under a 2019 collaboration agreement. The partnership agreement held the potential of paying the German company up to $4.5 billion.

Following the news of the trial’s failure, American depositary receipts (ADRs) in Merck KGaA fell 1.7%, while ADRs in GSK fell 1.6%. Merck shares remained unchanged at $83.19.

Despite this setback, Merck KGaA is still investigating the utility of bintrafusp alfa in other clinical trials for other indications. The therapy is being investigating in biliary tract cancer in the INTR@PID BTC 047 study as well as another planned Phase II/III study. In addition, the company is investigating the efficacy of bintrafusp alfa in a Phase II study focused on cervical cancer and two studies focused on non-small cell lung cancer (INTR@PID LUNG 005 and INTR@PID LUNG 024).

Meanwhile, Merck KGaA recently announced it had acquired Hamburg-based AmpTec, a deal that Merck says will increase its ability to produce mRNA for vaccines, diagnostics and treatments focused on COVID-19, among other diseases. This may place Merck in the running toward developing another mRNA-based COVID-19 vaccine, aside from approved vaccines from Pfizer/BioNTech and Moderna.

"By combining AmpTec’s PCR-based mRNA technology with Merck’s extensive expertise in lipids manufacturing, we are able to provide a truly differentiated and integrated offering across the mRNA value chain, which will significantly decrease supply chain complexity and enhance speed-to-market," said CEO Stefan Oschmann. "This transaction is another important step to support the constant growth of our Life Science business through tailored, small-scale acquisitions with high impact."

AmpTec offers Merck a differentiated PCR-based technology for mRNA manufacturing. The company suggests its technology has significant advantages over technologies from other companies, boasting benefits such as greater purity and flexibility, increased quality and higher performance.

Last month, Merck also announced a partnership with Artios to produce several precision cancer drugs over a three-year period. Under terms of the collaboration deal, Artios will receive an upfront $30 million payout and will be eligible for future payments of $860 million per treatment target.