OncoSec Quarterly Update: July 2016
July 14, 2016
WELCOME FROM THE CEO
As we work to develop new cancer treatments for patients, I would first like to thank you for your ongoing support of OncoSec’s programs and business strategy. We are committed to providing timely corporate updates, including recent achievements and upcoming milestones. We are pleased to provide brief recaps of our conference calls to further expand our avenues of communication. We hope these continued activities further enhance shareholder engagement.
Over this past quarter, we’ve announced positive pre-clinical and clinical data as well as significant advancements in the field of gene electro-transfer. I hope you find these updates informative, and I look forward to sharing more information with you throughout the year. Thank you again for your ongoing confidence in OncoSec as we continue to advance our immuno-oncology pipeline.
President and CEO
WHAT'S NEW AT ONCOSEC
RECENT QUARTERLY UPDATES
We believe that establishing clinical response data supporting the combination rationale of ImmunoPulse® IL-12 with anti-PD-1 in melanoma offers the greatest opportunity to generate value in the near term. The positive data that we have observed thus far and ongoing data from our current studies will help inform the next steps in clinical development and support a potential registration pathway.
From an R&D perspective, we believe the future of immuno-oncology is the combination of multiple agents that target several facets of tumor immune subversion. Therefore, we are leveraging the unique capabilities of our ImmunoPulse® platform to deliver potentially synergistic immune molecules to combat multiple facets of immune suppression and increase tumor immunity.
By continuing to validate our technology both pre-clinically and clinically, we expect to be in a stronger position to advance our product development towards commercialization and generate value for our shareholders.
New Pre-Clinical and Clinical Data
This past quarter, we presented pre-clinical and clinical data at the American Association for Cancer Research Annual Meeting in April. First, we presented preclinical results from our collaboration with Heat Biologics, which focused on evaluating the combination of Heat and OncoSec’s immunotherapy platforms. In brief, data showed that combining Heat’s ComPACT vaccine with our intratumoral DNA electroporation delivery platform stimulated an expansion of neoantigen-specific CD8+ T cells, leading to a regression in both treated and untreated cancer tumors in two mouse models. This marks the completion of one of our important milestones for the year, and we look forward to further exploring synergies between Heat and OncoSec’s platforms.
In a separate oral presentation, Dr. Alain Algazi from the University of California, San Francisco discussed follow-up data of patients who were treated with ImmunoPulse® IL-12 and later went on to receive an anti-PD-1/PD-L1 therapy. These new data were generated from a retrospective analysis of the Company’s Phase II monotherapy clinical study of ImmunoPulse® IL-12 in patients with advanced melanoma. After completing ImmunoPulse® IL-12 therapy, a subset of patients subsequently received an anti-PD-1/PD-L1 therapy either as their next line of treatment or a later line of treatment.
After treatment with ImmunoPulse® IL-12, the best overall response to anti-PD-1 or anti-PD-L1 therapy was 64% (9 of 14 patients). In a subset of eight (8) patients, who went straight from ImmunoPulse® IL-12 to treatment with anti-PD-1 with no intervening therapies, a best overall response of 75% (6 of 8 patients) was observed. Although this is a small subset of patients and a retrospective analysis, these observed response rates are much higher in these patients than the expected 30-40% seen with anti-PD-1 monotherapy.
These data provide promising evidence that ImmunoPulse® IL-12 can prime the immune system, thereby enhancing the response to anti-PD-1 therapies and potentially addressing a great unmet need in immuno-oncology. Based on this encouraging data in melanoma and under the leadership of our clinical and regulatory teams, we are working diligently to advance our melanoma development program and registration strategy for ImmunoPulse® IL-12 in combination with anti-PD1 in patients with advanced melanoma.
Advancements in Gene-Electro Transfer
We intend to develop a new ImmunoPulse® combination product, which will deliver multiple DNA-encoded immuno-modulatory agents directly into tumors, targeting multiple facets of tumor immune subversion; and therefore, mount an orchestrated attack to increase tumor immunity. We have made significant advancements in establishing a new ImmunoPulse® product that includes several preclinical multigene plasmid candidates. All preclinical plasmid candidates incorporate encoded IL-12 as a backbone and may encode up to six (6) genes, including known potent co-stimulatory molecules.
Our new ImmunoPulse® product will also leverage our latest advancements in electroporation which we believe will position OncoSec as a leader in gene electro-transfer technologies in cancer immunotherapy. Members from our discovery research team presented new study results in two poster presentations at AACR’s Special Conference on Engineering and Physical Sciences in Oncology, in June. We believe these findings represent an unprecedented advancement in gene electro-transfer technology and its use in immuno-oncology.
New data related to OncoSec’s Tissue-based Real-time Adaptive Controlled Electroporation (TRACE™) technology and helical integrated applicator (Helix™) showed that these technologies have the potential to reduce procedural frequency as well as enhance usability by physicians. Together, these novel technologies may improve a patient’s gene electro-transfer experience and therapeutic outcomes, which we believe will help broaden the adoption of gene-electro transfer technologies in immunotherapy. The TRACE™ and Helix™ technologies also have the potential to improve delivery of new therapeutic agents and access a variety of new tumor types and locations.
A GROWING SECTOR
MARKET OPPORTUNITY FOR ONCOSEC
ONCOSEC IN THE NEWS
Not Just Science Fiction How Technology Will Shape the Future of Cancer Treatments http://www.huffingtonpost.com/aj-agrawal/not-just-science-fiction_b_10715988.html
These Startups Are Disrupting the Healthcare Industry With Targeted Cancer Treatments https://www.entrepreneur.com/article/277349
OncoSec, TIL Kingdom Comes? Data with OncoSec’s Approach Lifting Hope in Melanoma http://www.bioworld.com/content/til-kingdom-comes-data-oncosecs-approach-lifting-hope-melanoma
OncoSec Medical’s ImmunoPulse® IL-12 Primes Patients for an Enhanced Response to PD-1 Blockade http://adcreview.com/news/oncosec-medicals-immunopulse-il-12-primes-patients-for-an-enhanced-response-to-pd-1-blockade/
About OncoSec Medical Incorporated
OncoSec is a biotechnology company developing DNA-based intratumoral immunotherapies with an investigational technology, ImmunoPulse®, for the treatment of cancer. The ImmunoPulse® platform is designed to enhance the local delivery and uptake of DNA-based immune-targeting agents such as IL-12. OncoSec’s lead program, ImmunoPulse® IL-12, is currently in clinical development for indications that include metastatic melanoma and triple-negative breast cancer. The program’s current focus is on the significant unmet medical need in refractory and non-responders to anti-PD-1/PD-L1 therapies in melanoma. In Phase I and II clinical trials, ImmunoPulse® IL-12 has demonstrated a favorable safety profile and evidence of anti-tumor activity in the treatment of various solid tumors and has shown the potential to reach beyond the site of local treatment to initiate a systemic immune response. In addition to ImmunoPulse® IL-12, the Company is also identifying and developing new immune-targeting agents for use with the ImmunoPulse® platform. For more information, please visit www.oncosec.com.
Cautionary Note Regarding Forward Looking Statements
This post contains “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as “expect,” “may,” “will,” “believe,” “intend,” “can,” and similar references to future periods.
Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on management’s current preliminary expectations and are subject to risks and uncertainties, which may cause our results to differ materially and adversely from the statements contained herein. Potential risks and uncertainties that could cause actual results to differ from those predicted include, among others, the following: uncertainties inherent in pre-clinical studies and clinical trials, such as the ability to enroll patients in clinical trials and the risk of adverse events; unexpected new data, safety and technical issues; our ability to raise additional funding necessary to fund continued operations; and the other factors discussed 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.