Amgen and The University of Texas MD Anderson Cancer Center said they have launched two collaborations of undisclosed value that are intended to speed up development of the biotech giant’s early-stage oncology therapies.
The therapies—which are either nearing or just beginning clinical development—have been generated by Amgen's bispecific T-cell engager (BiTE®), chimeric antigen receptor (CAR) T-cell, and small-molecule programs. The collaborations will combine candidates from both programs with the cancer center’s translational medicine capabilities, Amgen and MD Anderson said.
One collaboration agreement will consist of a five-year effort that will begin with Phase I clinical studies for BiTE antibody constructs and CAR T-cell therapies for multiple myeloma and small-cell lung cancer. The second agreement spans four years and will study BiTE® antibody constructs and CAR-T and small-molecule treatments in leukemia and MDS.
“The collaboration allows MD Anderson to study up to 16 different oncology treatments, which we hope will lead to rapid development and advancement of important therapies into clinical practice,” Patrick Hwu, M.D., division head of Cancer Medicine at MD Anderson, said in a statement. “The field of immuno-oncology is rapidly evolving and combining resources from both organizations could be important in answering key scientific questions.”
The collaborations include multi-institutional preclinical and clinical trials, some of which will be led by MD Anderson, and may offer the potential for identifying new biomarkers, Amgen and the cancer center added.
“These agreements build on a long history of collaboration between Amgen and MD Anderson, including a number of different efforts that helped to enable the advancement and regulatory approval of Amgen's first bispecific T-cell engager,” added David M. Reese, M.D., Amgen SVP of Translational Sciences and Oncology. “We are pleased to work with MD Anderson to accelerate the translation of several of our early-stage oncology programs from the laboratory to the clinic.”
Partners Launching Phase I Trial
The two collaborations are the latest in a series of cancer drug-development alliances between the partners.
On May 17, Amgen won institutional review board approval for a Phase I, up-to-41 patient study at MD Anderson designed to evaluate the safety, tolerability, and efficacy of the company’s CAR-T treatment AMG 119 in patients with relapsed or refractory small-cell lung cancer, then determine an appropriate cell dose for future clinical studies (NCT03392064).
In January 2015, Amgen and MD Anderson launched a research partnership focused on identifying targets for BiTE in MDS.
That partnership emerged a month after the FDA approved a marketed drug based on BiTE technology—Blincyto® (blinatumomab), a bispecific CD19-directed CD3 T-cell engager approved by the FDA in 2014 and indicated for Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
On March 29, the FDA granted accelerated approval to Blincyto for a new indication of treating adults and children with B-cell precursor ALL who are in remission but still have minimal residual disease (MRD).