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MBrace Therapeutics Launches Phase I/Ib Trial of EphA5-Targeted Antibody-Drug Conjugate

NEW YORK – MBrace Therapeutics on Tuesday said it began dosing patients with its EphA5-targeted antibody-drug conjugate (ADC) MBRC-101 in a Phase I/Ib trial.

In the study, MBrace researchers will evaluate the optimal biologically relevant doses, maximum-tolerated dose, safety profile, and anti-tumor activity of MBRC-101 in patients with advanced solid tumors refractory to standard treatments. Patients with histologic or cytologic diagnosis of a malignant solid tumor of any type will be eligible to enroll in the Phase I dose escalation portion of the trial. In the Phase Ib dose expansion portion, researchers will enroll patients with non-small cell lung cancer in cohort A; triple-negative or hormone receptor-positive, HER2-negative breast cancer in cohort B; and any type of solid tumor expressing EphA5 other than NSCLC and breast cancer in cohort C.

"We need novel efficacious therapies, including new ADCs, to benefit patients with advanced cancer resistant to prior treatments," Shiraj Sen, director of clinical research at NEXT Oncology-Dallas and an investigator in the trial, said in a statement.

In November, MBrace raised $85 million in a Series B financing round and said it would use the money to advance MBRC-101 into clinical studies. The company is also developing a diagnostic test to select patients for treatment and will conduct a retrospective analysis of treatment response according EphA5 expression on patients' tumors.

The San Diego-based firm developed MBRC-101 and another undisclosed ADC using its antibody discovery platform, dubbed Selection of Phage-displayed Accessible Recombinant Targeted Antibodies, or SPARTA.