Indian pharmaceutical firm Glenmark Pharmaceuticals has obtained clearance from the US Food and Drug Administration (FDA) for its investigational new drug (IND) application to commence a Phase I clinical trial of GBR 1342 to treat patients with multiple myeloma.
Based on the firm’s bispecific engagement by antibodies based on the T-cell receptor (BEAT) technology platform, GBR 1342 is a humanised monoclonal antibody (bsAb) currently being developed to trigger and redirect immune cells towards tumours.
The two-part Phase I trial will recruit patients who have received prior therapies.
The dose escalation part of the trial will establish the drug's safety profile and maximum tolerable dose, while the expansion cohort will further determine its safety profile and preliminary efficacy when administered at the maximum tolerable dose.
Glenmark Pharmaceuticals president and chief scientific officer Kurt Stoeckli said: "This is an exciting time for Glenmark as our flagship biotechnology platform and antibody science are beginning to become a reality for patients, now that we have a second oncology candidate entering clinical trials.
"While there is still significant development ahead, these steps signify that Glenmark's investment in discovery and development of biologics is rapidly progressing."
The firm intends to further investigate GBR 1342 as a treatment option for other malignancies.
Glenmark also developed HER2xCD3 bsAb GBR 1302 and EGFRxCD3 bsAb GBR 1372 based on BEAT technology.
GBR 1302 is currently being evaluated for the treatment of HER2+ cancers, and GBR 1372 showed activity against EGFR expressing cells observed in the case of resistant and refractory tumours.