HER2 Biomarkers

The Quantum Leap-sponsored I-SPY 2 trial will evaluate Byondis' antibody-drug conjugate SYD985 against standard of care for HER2-low, early-stage breast cancer.

Enhertu, or trastuzumab deruxtecan, will also receive accelerated assessment by the European Medicines Agency's Committee for Medicinal Products for Human Use.

Bolt's lead candidate, BDC-1001, is an immune-stimulating antibody conjugate currently being studied in a Phase I clinical trial in HER2-expressing solid tumors.

Healthcare professionals can inject the regimen, containing Perjeta, Herceptin, and hyaluronidase, in patients' homes after intravenous chemotherapy.

The new drug developer's current pipeline consists of CAR-NK cell drugs targeting HER2-positive tumors and CD19-positive B-cell malignancies, as well as a universal NK cell therapy.

In the study, pelareorep will be combined with paclitaxel and the PD-L1 inhibitor Bavencio in patients with HR-positive, HER2-negative breast cancer.

The company will initiate a Phase I/II clinical trial in patients with HER2-positive solid tumors later this year.

The firms will jointly study the combination, and Sanofi will have an exclusivity period to negotiate the in-licensing of KN026, contingent on certain milestones.

The company will start Phase I/II trials to evaluate the safety and anti-tumor activity of its natural killer cells in combination with Herceptin or Erbitux in the third quarter of 2020.