SAN DIEGO, CA, January 18, 2012 — OncoSec Medical Incorporated (OTCBB:ONCS), which is developing its advanced-stage OncoSec Medical System(OMS) ElectroOncology therapies to treat solid tumor cancers, presented its corporate strategy for 2012 and reported on progress since launch of the company lastyear at the Biotech Showcase and OneMedForum conferences held January 9-13 in San Francisco, CA.
“Despite a financially challenging year, 2011 was a pivotal and an exciting year for us, and our shareholders, as we laid the foundation for OncoSec’s success.” Said Punit Dhillon, President and CEO. “If we scored ourselves based on the milestones set forth by the OncoSec Board of Directors and management team, then 2011 was a resounding success. We now look forward to taking the next critical steps as a clinical development company with three cancer immunotherapy clinical studies beginning. It is our goal to address indications with substantial unmet medical needs and therefore allow patients with lethal skin cancers to evaluate eligibility in the pioneering OncoSec treatment. Unfortunately these are indications that have not seen new satisfactory options for patients in quite some time.”
ENROLMENT SOON TO BE INITIATED FOR OMS ELECTROIMMUNOTHERAPY CLINICAL PROGRAMS AT LEADING ACADEMIC CANCER INSTITUTES
The Company established a robust clinical development plan based on its novel, first-in-class OMS ElectroImmunotherapy treatment platform for the treatment of rare and deadly skin cancers, including (1) metastatic melanoma; (2) Merkel cell carcinoma; and (3) cutaneous T-cell lymphoma. OMS ElectroImmunotherapy employs electroporation to deliver, directly into the patient’s own cells, a gene which expresses interleukin-12 (DNA-based IL-12), a potent, naturally occurring protein that is central to the regulation of the bodies cellular anti-cancer immune responses. Preclinical and Phase I studies have shown that the therapy is safe, without toxic side effects, and has resulted in immuneresponses that produced both a local and systemic response against cancerous lesions. Positive clinical data of DNA-based IL-12, the first-ever to demonstrate electroporation-mediated delivery of a DNA plasmid designed to express a therapeutic protein in humans, were presented at the 2011 Annual Meeting of the American Society of Clinical Oncology. In the Phase I human study, 15% of patients demonstrated 100% clearance of distant, untreated metastatic melanoma tumors; in retrospect only 0.25% would be expected to spontaneous resolve on their own if left untreated. If OncoSec’s Phase II trials further validate this evidence, the DNA-based IL-12 electroimmunotherapy platform would represent an important advancement in the treatment of both local and metastatic cancers. All three Phase II studies will be physician-sponsored clinical trials.
“With initiation of these three Phase II open label, multi-center clinical trials, OncoSec will demonstrate its commitment to developing revolutionary therapies for rare skin cancers.” Said Mr. Dhillon. “Despite recent drug approvals for metastatic melanoma, there still remains a significant need for more durable and safer treatment alternatives. In the case of Merkel cell carcinoma and cutaneous T-cell lymphoma, little, if any, treatment options are available for this population of patients destined to die with their disease.”
Phase II Melanoma Trial (OMS-I100)
Over 9,000 people die from melanoma each year in the U.S. alone and it is estimated that the rate of growth for this deadly cancer will increase to over 150,000 new cases per year by 2020. OncoSec’s melanoma trial, entitled “Phase II trial of intratumoral pIL-12 electroporation in advanced stage cutaneous and in transit malignant melanoma,” will be an open-label, multicenter trial. The primary endpoint is objective response rate (local and distant) at six months. Secondary trial endpoints include time to objective response (complete and partial responses), duration of distant response and overall survival. Current outcomes for melanoma treated using standard chemotherapies alone, or new biologic and small molecule treatmentapproaches, have not proved encouraging because of low response rates, short duration, high toxicity, high refractory rates, and severe side effects, while only providing a modest improvement in survival.
Phase II Merkel Cell Carcinoma Trial (OMS-I110)
Merkel cell carcinoma is a lethal but rare form of skin cancer affecting approximately 1,500 people in the U.S. each year. Current outcomes to chemotherapy treatment have demonstrated short-lived responses with no clear impact on overall survival due to the 33% mortality rate inherent with Merkel cell cancer. OncoSec’s clinical trial, entitled “A Phase II study of intratumoral injection of interleukin-12 plasmid and in vivo electroporation in patientswith Merkel cell carcinoma,” is a single dose, open-label, multicenter trial. The study’s endpoint is DNA-based IL-12 gene expression in tumor tissue at three to four weeks post-treatment. Secondary endpoints will evaluate objective response rates, time to relapse or progression and overall survival. This study will evaluate the safety and tolerability of DNA-based IL-12 as a treatment for Merkel cell carcinoma and aims to further validate the findings of the previously referenced Phase I trial in metastatic melanoma patients. The recent discovery of a Merkel cell polyomavirus, coupled with strong evidence suggesting that patients with Merkel cell carcinoma carry significant immune dysfunction in the tumor microenvironment suggests that an immunotherapy, such as DNA-based IL-12, may be effective at treating this disease.
Phase II Cutaneous T-Cell Lymphoma (OMS-I120)
OncoSec’s electroimmunotherapy is a potential new treatment for patients suffering from cutaneous T-cell lymphoma, or CTCL. This cancer affects approximately 3,000people in the U.S. each year. Today’s systemically delivered treatment methods typically result in toxicities that preclude their long-term use for this chronic life-altering disease. Some immunotherapies have shown promising therapeutic benefit. For example, recombinant human IL-12 (rhIL-12) has been shown to have greater than 40% response rate in Phase I and II clinical trials. However, side effects of this systemically delivered therapy proved to be intolerable for most patients, and chronic use of rhIL-12 resulted in drug resistance. OncoSec’s OMS ElectroImmunotherapy will locally deliver low-dose DNA-based IL-12 into the cancerous lesion with the goal of inducing a systemic immune response capable of destroying cancerous cells while avoiding toxicities and any chance of resistance.
Strategic goals for OncoSec’s OMS ElectroImmunotherapy program in 2012:
- Initiate and enroll (OMS-I100) Phase II melanoma study led by the University of California at San Francisco along with other cancer centers across the US.
- Initiate and enroll (OMS-I110) Phase II Merkel Cell Carcinoma study led by the University of Washington (Fred Hutchinson Cancer Center) and University of California at San Francisco.
- Initiate and enroll (OMS-I120) Phase II Cutaneous T-Cell Lymphoma (CTCL) led by the University of California at San Francisco along with multiple centers across the US.
- Complete and report interim analysis of clinical data from each of the clinical studies.
- Finalize sponsor IND based on positive Phase II clinical results in consultation with regulatory authorities.
OMS ELECTROCHEMOTHERAPY CONTINUES TO SHOW IMPRESSIVE DATA AND NEAR TERM COMMERCIALIZATION THROUGH POTENTIAL REGIONAL PARTNERSHIPS AND/OR A GLOBAL PARTNER
This past year also demonstrated the Company’s ability to continue to create value from its advanced-stage OMS ElectroChemotherapyprogram for the treatment of primary and recurrent localized solid tumors. Since the acquisition of a clinical data set of over 400 patients, OncoSec has compiled, reviewed, and analyzed the data and presented preliminary resultsfrom it’s Phase IV European head & neck cancer trials and Phase I/II breast cancer trial. The preliminary data sets from the completed Phase III recurrent head and neck cancer studies carried out in the U.S. are now being analyzed, and the Company expects to share this information with potential partners for the continued development of this program.
“With positive results presented from the completed Phase I/II breast cancer and preliminary Phase IV skin and head and neck cancer studies in 2011, OMS ElectroChemotherapy has demonstrated the clinical benefit for patients with quite manageable side effects,” said Mr. Dhillon. “We strongly believe in the clinical relevance of our therapeutic approach and believe these results demonstrate tolerability and efficacy and point to the combinability of this novel treatment approach with current available therapies for the management of local tumors. Clinical experience from these programs supports the uniqueness of OMS ElectroChemotherapy in its ability to achieve selective destruction of cancerous tumors while sparing healthy normal tissue including highly vascularized and innervated surrounding structures, providing physicians with an important flexible treatment alternative.”
Strategic goals for OMS ElectroChemotherapy in 2012:
- Finalize and present data analysis of completed Phase III recurrent head and neck cancer study.
- Finalize and present data analysis of completed Phase IV recurrent and primary head and neck cancer study.
- Finalize and present data analysis of completed Phase IV recurrent and primary skin cancer study.
- Establish regulatory path with the FDA for clinical development of advanced stage skin cancer and other solid tumor targets in the US to achieve licensure.
- Consider out-licensing opportunities through potential regional partnerships or a global partner to maximize near term commercialization opportunities in Europe, Asia and potentially other emerging markets.
FORMATION PHASE COMPLETE; CONTINUED COMMITMENT ON EFFICIENT OPERATIONS
The formation of OncoSec in 2011 occurred through the acquisition of certain non-DNA vaccine technology and intellectual propertyrelating to the Company’s OMS ElectroOncology therapies for treating solid tumor cancers. With seed capital secured, the Company moved quickly to attract and acquire an experienced and respected management team and scientific advisory board. The Company then established a clinical development plan based on its novel, first-in-class OMS ElectroImmunotherapy treatment platform for the treatment of deadly skin cancers, including metastatic melanoma, Merkelcell carcinoma and cutaneous T-cell lymphoma.
The Company will continue to build product value throughnext generation devices and drugs and generate additional intellectual property organically or through other in-licensing opportunities. In 2011, OncoSec completed its in-house capabilities to build, maintain and develop its own devices. In 2012, the Company expects to continue to boost its capabilities by meeting additional stringent quality assurance standards and increasing manufacturing capabilities for its ongoing and future clinical trials through additional efficiencies and ability to scale up production as needed to support potential partners.
“I am pleased that we have been able to leverage a large amount of existing investment into the OMS ElectroOncology platform to operate not only efficiently but resourcefully, I fully expect the Company to stay lean and agile while having the flexibility to outsource specific activities, where and when required, thereby allowing the Company to hold control over its operating expenditures.” said Mr. Dhillon.
Strategic goals for organizational efficiencies in 2012:
- Complete ISO13485 qualification and certification
- Acquire CE Mark of OncoSec Medical System
- Complete additional in-licensing opportunities
- Make additional hires in manufacturing, R&D, and administration to reflect program and business requirements
About OncoSec Medical Inc.
OncoSec Medical Incorporated (OTCBB: ONCS) develops novel OMS ElectroOncology therapies that combine its proprietary electroporation delivery technology with a chemotherapeutic or novel DNA-based immunotherapeutics. Targeted local delivery of these agents is designed to achieve selective destruction of cancerous tumors while sparing healthy normal tissue, resulting in improved functional, cosmetic and quality of life outcomes. These therapieshave achieved validating safety and efficacy data in early and late stage clinical studies of over 400 cancer patients. OncoSec’s clinical programs include three Phase II clinical trials for OMS ElectroImmunotherapy. More information is available at www.oncosec.com. Additional information may also be found at OncoSec’s Facebook , Twitter, and LinkedIn sites.
* * *
This press release contains forward looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this release that are not historical facts may be considered such “forward looking statements.” Forward looking statements are based on management’s current preliminary expectations and are subject to risks and uncertainties which may cause ourresults to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ from those predicted include our ability to raise additional funding, our ability to acquire, develop or commercialize new products, uncertainties inherent in pre-clinical studies and clinical trials, unexpected new data, safety and technical issues, competition and market conditions. These and additional risks and uncertainties are more fully described in OncoSec’s filings with the Securities and Exchange Commission. Undue reliance should not be placed on forward looking statements which speak only as of the date they are made. OncoSec disclaims any obligation to update any forward looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.