On October 4, 2022 OncoSec Medical Incorporated (NASDAQ: ONCS) (the "Company" or "OncoSec"), a clinical-stage biotechnology company focused on developing intratumoral immunotherapies to stimulate the patient’s own immune system to target and eradicate cancer, reported a corporate restructuring intended to prioritize development of its lead clinical candidate TAVO (TAVO-EP) a plasmid encoding interleukin 12 (IL-12) delivered by intratumoral electroporation, and extend the Company’s cash runway (Press release, OncoSec Medical, OCT 4, 2022, View Source [SID1234621681]).
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Oncosec is reducing its staff by approximately 45% and prioritizing clinical pipeline activities to reduce operating expenses. The Company and remaining employees will focus clinical activities in melanoma to advance TAVO-EP toward near-term data milestones of the KEYNOTE-695 clinical trial. OncoSec will provide more detail on the financial implications of the restructuring in the Form 10-K due in October.
Updated guidance on the pivotal Phase 2b KEYNOTE-695 trial in metastatic melanoma, is as follows.
Top-line results of the secondary endpoint, Objective Response Rate (ORR) by investigator assessment based on RECIST v1.1, is expected to be announced in the fourth quarter of 2022.
Top-line results of the primary endpoint, Overall Response Rate (ORR) by blinded independent central review (BICR) based on RECIST v1.1, is expected to be announced in the first quarter of 2023.
"Since joining as CEO my focus has been on reviewing all aspects of our technology and pipeline. This led to the conclusion that an operational restructuring and strategic pipeline refocus is the best course of action to accelerate advancing TAVO-EP and preparing for the completion and data readout of our KEYNOTE-695 trial," said Robert H. Arch, Ph.D., OncoSec’s Chief Executive Officer. "It is very unfortunate because this necessary step affects a very talented group of employees that have contributed to our efforts and helped build the company. We are grateful for their contributions."