Now in phase 1 and 2 clinical trials, demonstrating both safety and efficacy. Is that not beyond generation of pharmacodynamic data?
"As previously reported, a subset of patients that completed a single cycle of TAVO in this study, were sequentially treated with an anti-PD-1 checkpoint therapy (nivolumab). Importantly, some of these patients, one with prior disease progression on anti-PD-L1 antibody monotherapy, experienced robust clinical responses beyond the TAVO treated lesions. One of these patients continues to be treated with TAVO under a compassionate use protocol.
Based on these findings, OncoSec and Merck initiated a second TAVO Phase 2 study in TNBC, KEYNOTE-890, to evaluate the combination of TAVO with Merck's anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in approximately 25 patients with treatment-refractory, inoperable or metastatic triple negative breast cancer (NCT03567720).
Since KEYNOTE-890 opened in October, investigators have already enrolled five patients into the trial. The KEYNOTE-890 study is testing the combination in patients with inoperable locally advanced or metastatic TNBC who have progressed on more than one line of prior therapy. Patients will be treated with the combination of TAVO with pembrolizumab. The primary endpoint is to assess efficacy as measured by objective response rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
About OncoSec Medical Incorporated
OncoSec is a biotechnology company developing DNA-based intratumoral immunotherapies with an investigational technology, ImmunoPulse®, for the treatment of cancer. ImmunoPulse is designed to enhance the local delivery and uptake of DNA-based immune-targeting agents, such as plasmid encoded IL-12 (tavokinogene telseplasmid or "tavo"). In Phase 1 and 2 clinical trials, ImmunoPulse® IL-12 has demonstrated a favorable safety profile, evidence of anti-tumor activity in the treatment of various solid tumors, and the potential to reach beyond the site of local treatment to initiate a systemic immune response. OncoSec's lead program, ImmunoPulse IL-12, is currently in clinical development for metastatic melanoma and triple-negative breast cancer. The program's current focus is on the significant unmet medical need in patients with melanoma who are refractory or have relapsed on anti-PD-1 therapies. In addition to tavo, the Company is also identifying and developing new immune-targeting agents for use with the ImmunoPulse platform. For more information, please visit www.oncosec.com.
