firstwordpharmaJune 25, 2021
Tag: OncoSec , TAVO™ , immunotherapy
OncoSec Medical Incorporated (NASDAQ:ONCS) (the "Company" or "OncoSec") today announced that Daniel O'Connor has resigned and that Brian Leuthner, formerly Chief Operating Officer, has been appointed Interim Chief Executive Officer, effective June 25, 2021. Mr. O' Connor is also stepping down from his seat on the Board of Directors.
"Under Dan's leadership over the past four years, OncoSec has transformed itself into the leading intra-tumoral cancer immunotherapy Company," said Margaret Dalesandro, Ph.D., Chair of the Board of Directors at OncoSec. "Dan operationally drove several value-creating clinical programs with the Company's lead product candidate, TAVO™, including the now fully enrolled pivotal study in anti-PD-1 checkpoint refractory metastatic melanoma patients, KEYNOTE-695, as well as a phase 2 program in metastatic triple negative breast cancer. Under his leadership, OncoSec is well-capitalized to meet important inflection points and has established a string of strategic partnerships with large pharma companies and top research institutions. On behalf of the Board, I want to thank Dan for his tireless work ethic and leadership in delivering to our shareholders a Company that is now extremely well-positioned for success."
Dr. Dalesandro continued, "Brian Leuthner, a former public company CEO with decades of experience, will now step into the CEO role bringing fresh energy and his own brand of leadership, which we are confident will enhance the Company's upward trajectory and further exploit the potential of our platform for the benefit of both cancer patients and our shareholders. In parallel, I, along with the Board, will evaluate and potentially identify a new CEO candidate who will work to ensure that we reach the next evolution as the leading intra-tumoral cancer immunotherapy company."
Mr. Leuthner joined OncoSec in February 2021. Over the course of his 32-year career in biological pharma, Mr. Leuthner has held several leadership positions, including several public and private CEO positions. For a decade, Mr. Leuthner was co-founder, President, and CEO of Edge Therapeutics, Inc., an orphan disease-focused company.
Mr. Leuthner added, "I came to OncoSec because I saw it as a well-established company with valuable technology that I believed I could further enhance. As OncoSec's Interim Chief Executive Officer, I look forward to adding to the momentum Dan built as we strive to improve the long-term outcomes to patients living with cancer"
OncoSec's gene therapy technology combines TAVO (tavokinogene telseplasmid), a DNA plasmid-based interleukin-12 (IL-12), with an intra-tumoral electroporation gene delivery platform to achieve endogenous IL-12 production in the tumor microenvironment that enables the immune system to target and attack tumors throughout the body. TAVO has demonstrated a local and systemic anti-tumor response in several clinical trials, including the pivotal Phase 2b trial KEYNOTE-695 for metastatic melanoma and the KEYNOTE-890 Phase 2 trial in triple negative breast cancer (TNBC). TAVO has received both Orphan Drug and Fast-Track Designation by the U.S. Food & Drug Administration for the treatment of metastatic melanoma.
OncoSec Medical Incorporated (the "Company," "OncoSec," "we" or "our") is a biotechnology company focused on developing cytokine-based intratumoral immunotherapies to stimulate the body's immune system to target and attack cancer. OncoSec's lead immunotherapy investigational product candidate - TAVO™ (tavokinogene telseplasmid) - enables the intratumoral delivery of DNA-based interleukin-12 (IL-12), a naturally occurring protein with immune-stimulating functions. The technology, which employs electroporation, is designed to produce a controlled, localized expression of IL-12 in the tumor microenvironment, enabling the immune system to target and attack tumors throughout the body. OncoSec has built a deep and diverse clinical pipeline utilizing TAVO™ as a potential treatment for multiple cancer indications either as a monotherapy or in combination with leading checkpoint inhibitors; with the latter potentially enabling OncoSec to address a great unmet medical need in oncology: anti-PD-1 non-responders. Results from recently completed clinical studies of TAVO™ have demonstrated a local immune response, and subsequently, a systemic effect as either a monotherapy or combination treatment approach along with an acceptable safety profile, warranting further development. In addition to TAVO™, OncoSec is identifying and developing new DNA-encoded therapeutic candidates and tumor indications for use with its new Visceral Lesion Applicator (VLA), to target deep visceral lesions, such as liver, lung or pancreatic lesions.
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