OncoSec Medical Inc (NASDAQ:ONCS) shares blossomed Wednesday after the company announced it entered into a Clinical Trial Collaboration and Supply Agreement with Merck to evaluate the combination of OncoSec’s TAVO with Merck’s KEYTRUDA in a Phase 3 study.
The company, out of Pennington, New Jersey, reported Tuesday the planned clinical trial will evaluate the overall survival of patients treated with the TAVO™ in combination with KEYTRUDA ® versus standard of care in late-stage patients with metastatic melanoma who are refractory to immune checkpoint therapy.
TAVO™ has received Fast Track designation from the U.S. Food and Drug Administration (FDA), as a potentially first-in-class, intratumoral anti-cancer gene therapy that expresses IL-12 for the treatment of metastatic melanoma, following progression on KEYTRUDA ® or OPDIVO ® (nivolumab).
KEYNOTE-C87 is intended to support accelerated approval by the U.S. FDA and/or serve as a pivotal study to support a full licensure. Under the terms of the Agreement, Merck will provide KEYTRUDA ®, while OncoSec will provide the investigational drug, TAVO™.
Said Interim CEO Brian Leuther, “We are thrilled to enter into this collaboration and supply agreement with Merck – one of the world’s leading immuno-oncology companies – to help bring TAVO™ to patients with metastatic melanoma whose disease did not respond to initial checkpoint inhibitor therapy or who have developed progressive disease and therefore do not have additional treatment options available.”
ONCS shares leaped $1.34, or 48%, to $4.13.