OncoSec Announces Exclusive License Agreement for Cliniporator® Gene Electrotransfer Platform Developed by IGEA Clinical Biophysics
-- Agreement accelerates OncoSec's plan to treat visceral lesions in clinical trials with VLA --
-- Favorable licensing terms with broad field of use for gene delivery in oncology --
-- Cliniporator cleared for use in Phase 1 clinical trial investigating CORVax12 by FDA --
PENNINGTON, N.J. and SAN DIEGO, Nov. 24, 2020 /PRNewswire/ -- OncoSec Medical Incorporated (NASDAQ:ONCS) (the "Company" or "OncoSec"), a late-stage biotechnology company developing intra-tumoral cancer immunotherapies, today announced that it has licensed the exclusive rights to the Cliniporator® electroporation or gene electrotransfer platform from IGEA Clinical Biophysics ("IGEA"). The license encompasses a broad field of use for gene delivery in oncology, including use as part of OncoSec's visceral lesion applicator (VLA) program. Additionally, the U.S. Food and Drug Administration (FDA) has cleared the Cliniporator platform for use in the upcoming Phase 1 trial to be held at Providence Health investigating CORVax12, the Company's DNA-encodable vaccine candidate for COVID-19. CORVax12 combines TAVO™ (tavokinogene telseplasmid), a DNA plasmid-based interleukin-12 (IL-12), with the National Institute of Health (NIH)'s SARS-CoV-2 virus "spike" protein.
"Based on our recently presented data at SITC and the current competitive landscape, we are confident that our gene electrotransfer technology will emerge as a preferred choice for therapeutic gene delivery in patients with advanced cancer for whom currently available treatment options have little or no effect," said Daniel O'Connor, Chief Executive Officer of OncoSec. "The efficiency at which gene electrotransfer delivers therapy, along with a highly favorable safety profile and ease of use, make it an ideal choice for drug delivery. While our own current gene electrotransfer technology platform remains in development for low voltage applications, the exclusive rights we obtained under the IGEA Agreement provides OncoSec with the opportunity to bring low voltage technology to the clinic sooner, which potentially allows us to accelerate our VLA program. Low voltage application is also favorable for the delivery of DNA vaccines, and we will be testing Cliniporator in U.S. clinics as part of the Phase 1 clinical trial investigating CORVax12. Our unique approach with CORVax12 aims to produce stronger, longer-lasting immune responses and better protection against COVID-19 and other viruses, which is of particular importance for patient populations at risk of mounting an inadequate immune response, such as the elderly or immunocompromised individuals."
The Cliniporator® is CE marked and can be used in most countries outside the United States and is routinely used for electrochemotherapy in and outside of Europe in over 200 major oncological centers to treat cutaneous metastatic cancer nodules, including melanoma. IGEA has clinical experience with gene therapy as well, which OncoSec will build on. This pioneering technology will strengthen OncoSec's current product candidate portfolio and potentially provide an important accelerator to the Company's upcoming clinical trials.
Ruggero Cadossi, M.D., IGEA President, added, "We are proud to collaborate with OncoSec, a company committed to delivering innovative therapies to cancer patients. The culture of knowledge, honesty, moral commitment and the focus on solutions for patients diagnosed with cancer and other life-threatening diseases were and will continue to be the guiding light of IGEA."
OncoSec's gene therapy technology combines TAVOTM (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-895 Phase 2 trial in triple negative breast cancer (TNBC). TAVO™ has received Orphan Drug and Fast-Track Designation by the U.S. Food & Drug Administration (FDA) for the treatment of metastatic melanoma following progression on KEYTRUDA® or OPDIVO®.
About Visceral Lesion Applicator (VLA) Program
OncoSec's investigational visceral lesion applicator (VLA) technology is designed to treat non-cutaneous, internal tumors through direct delivery of OncoSec's lead product candidate, TAVO™, or other immunologically relevant genes and immunotherapies. Lesions located within organs of the gastrointestinal tract, lung, liver, pancreas and bone can often be difficult to treat successfully with conventional therapies. This investigational, next-generation intratumoral delivery platform will be comprised of novel access applicators, both rigid and flexible catheter-based, as well as reversible, low-voltage electroporation generators, including Cliniporator ® and Oncosec's technology in development, APOLLO.
CORVax12 is the only DNA vaccine that uses an immune stimulant to promote an immune response against the SARS-CoV-2 virus. The CORVax12 vaccine approach combines the co-administration of TAVO™ (plasmid IL-12) with a DNA-encodable version of the SARS-CoV-2 spike or "S" glycoprotein to enhance immunogenicity of the component developed by scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center. CORVax12 is designed to drive a coordinated vaccine response, capable of drawing upon the innate and adaptive humoral and cellular arms. This multi-pronged innate, adaptive and cellular immune response has the potential to generate a robust anti-viral response.
About OncoSec Medical Incorporated
OncoSec Medical Incorporated (the "Company," "OncoSec," "we" or "our") is a late-stage 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. For more information, please visit www.oncosec.com. TAVO™ is a trademark of OncoSec Medical Incorporated.
TAVO™ is a trademark of OncoSec Medical Incorporated.
Risk Factors and Forward-Looking Statements
This release, as well as other information provided from time to time by the Company or its employees, may contain forward-looking statements that involve a number of risks and uncertainties that could cause actual results to differ materially from those anticipated in the forward-looking statements. Forward-looking statements provide the Company's current beliefs, expectations and intentions regarding future events and involve risks, uncertainties (some of which are beyond the Company's control) and assumptions. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. You can identify forward-looking statements by the fact that they do not relate strictly to historical or current facts. These statements may include words such as "anticipate," "believe," "could," "estimate," "expect," "intend," "may," "plan," "potential," "should," "will" and "would" and similar expressions (including the negative of these terms). Although we believe that expectations reflected in the forward- looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. The Company intends these forward-looking statements to speak only at the time they are published on or as otherwise specified, and does not undertake to update or revise these statements as more information becomes available, except as required under federal securities laws and the rules and regulations of the Securities Exchange Commission ("SEC"). In particular, you should be aware that the success and timing of our clinical trials, including safety and efficacy of our product candidates, patient accrual, unexpected or expected safety events, the impact of COVID-19 on the supply of our candidates or the initiation or completion of clinical trials and the usability of data generated from our trials may differ and may not meet our estimated timelines. Please refer to the risk factors and other cautionary statements provided in the Company's Annual Report on Form 10-K for the fiscal year ended July 31, 2020 and subsequent periodic and current reports filed with the SEC (each of which can be found at the SEC's website www.sec.gov), as well as other factors described from time to time in the Company's filings with the SEC.
Vice President, Corporate Development
Monica Rouco Molina, Ph.D.
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SOURCE OncoSec Medical Incorporated
Released November 24, 2020