SAN DIEGO and PENNINGTON, N.J., May 29, 2019 /PRNewswire/ -- OncoSec Medical Incorporated (OncoSec) (NASDAQ: ONCS), a company developing intratumoral cancer immunotherapies, and Emerge Health Pty (Emerge), the leading Australian company providing full registration, reimbursement, sales, marketing and distribution services of therapeutic products in Australia and New Zealand, have entered into a collaboration agreement commercializing OncoSec's proprietary TAVO (enhanced IL-12 DNA-plasmid) and making it available under Australia's Special Access Scheme (SAS) in 2019. As a specialized Australian pharmaceutical company focused on the marketing and sales of high quality medicines to the hospital sector, Emerge has previously made numerous other products successfully available under Australia's SAS.
This collaboration will allow OncoSec to begin generating revenue, potentially as early as the fourth quarter of 2019. The ability to begin this process in Australia with TAVO sets OncoSec apart from other clinical-stage companies developing therapies for the treatment of refractory metastatic melanoma. TAVO will be the only drug available under the SAS program for melanoma patients who have failed checkpoint inhibitor or targeted therapy.
The SAS was introduced by Australia's Therapeutics Goods Administrations (TGA) in recognition that there are circumstances where patients need access to therapeutic products that are not on the Australian Register of Therapeutic Goods (ARTG). Australia's SAS allows physicians to prescribe and treat patients with drugs not yet approved in Australia provided those patients have a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment. 1
In 2019, it is estimated that 15,229 new cases of melanoma skin cancer will be diagnosed in Australia (8,899 males and 6,330 females) and that it will become the ninth most common cause of death from cancer in 2019. TAVO, to be used for melanoma patients who have failed either checkpoint inhibitors or targeted therapy, could treat up to 1,000 Australian patients. 2
Chris Rossidis, Co-Founder and Head of Emerge's Commercial Operations stated, "Australia has a very high melanoma rate with medical experts estimating that one Australian is affected by melanoma every five minutes because of the high intensity of the sun in this part of the world. Similar to our other successful collaborations with other companies, this new collaboration with OncoSec will help us achieve Emerge's underlying purpose of distributing products in selected therapeutic specialty areas and working to ensure all patients have access to these important and potentially life-saving medicines."
"TAVO fits perfectly into the SAS program. As with other parts of the world, Australia has a very high prevalence of melanoma patients and a considerable number who fail all treatments, including checkpoint inhibitors and targeted therapies. This leaves a patient population in great need for an effective 'rescue' treatment. Based on the continued efficacy we are seeing in TAVO's clinical trials in metastatic melanoma, we appreciate the very important role that Emerge can play to potentially help these patients access TAVO treatment under the SAS program," said Daniel J. O'Connor, President and CEO of OncoSec.
About Emerge Health Pty
Emerge Health Pty Ltd is an innovative, specialised Australian pharmaceutical company focused on the marketing and sales of niche, high quality medicines to the hospital sector. Emerge Health is dedicated to providing exceptional products and support to ensure we meet our customers' and partners' needs and priorities.
About OncoSec Medical Incorporated
OncoSec is a clinical-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. 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™ trademark of OncoSec Medical Incorporated.
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