On behalf of our team who is leading some of the most innovative science within the field of cancer immunotherapy, I would like to thank you for your continued support of OncoSec’s programs and business strategy. We are committed to providing timely updates and communication on our business including recent achievements and upcoming milestones. You can engage with OncoSec directly on our quarterly conference calls and other avenues of communication.
Over this past quarter and our fiscal year 2016 end, we have 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 on an ongoing basis. 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
Overall, in the fourth quarter of our fiscal year 2016, we continued to advance the development of our lead clinical program, ImmunoPulse® IL-12, focused on the anti-PD1 non-responsive patient population in melanoma. The development of ImmunoPulse® IL-12 in combination with an anti-PD1, checkpoint inhibitor represents a potential immunotherapy product for melanoma patients that are progressing on anti-PD1 therapy. In fact, we have enrolled over 20 patients in our Phase II combination clinical study of ImmunoPulse® IL-12 with Merck’s KEYTRUDA® (pembrolizumab) in melanoma patients that are considered non-responders to anti-PD1, and we remain on track to announce interim data from approximately 15 of these patients at a three-month follow-up at the 31st Annual Meeting and Associated Program of the Society for Immunotherapy of Cancer (“SITC 2016”).
We’re looking forward to sharing additional updates regarding our melanoma development strategy with you over the next few months.
We encourage you to join our inaugural Investor & Analyst day on November 17th starting at 8 am PST. This event will be held in San Diego at the Alexandria Auditorium, 10996 Torreyana Road, San Diego CA 92121. If you plan on attending in-person, please RSVP to email@example.com. The live webcast can be accessed here, and will be available for replay on our website. This event will provide a forum for OncoSec to share updates on its clinical development plan for melanoma, advancement of its intratumoral immunotherapy pipeline of DNA-based product candidates, and next generation device development.
NEW PRE-CLINICAL AND CLINICAL DATA
We continue to expand our research pipeline and broaden our engineering efforts relating to new devices that will be launched with our next clinical candidate with the goal of providing meaningful clinical benefit to patients and investment value for OncoSec’s shareholders.
We were one of a select number of companies that were chosen for an oral poster presentation at SITC 2016. Dr. Alain Algazi, Clinical Instructor, Department of Medicine (Hematology/Oncology) at the University of California San Francisco (UCSF), will present an oral poster presentation for Abstract #466 on November 11, 2016 at 12:50 PM (EST) in National Harbor, MD.
The title of the poster is “Phase II Study of Intratumoral Plasmid Interleukin 12 (pIL-12) with Electroporation in Combination with Pembrolizumab in Stage III/IV Melanoma Patients with Low Tumor Infiltrating Lymphocytes. Dr. Algazi, the Principal Investigator for the Phase II Investigator Sponsored Trial (IST) led by UCSF, will present new clinical data from patients treated with a combination of OncoSec’s investigational intratumoral therapy, ImmunoPulse® IL-12, and Merck’s KEYTRUDA® (pembrolizumab).
We look forward to sharing this new clinical data at our inaugural Investor and Analyst Day, and at upcoming conferences including the Stifel Healthcare Conference 2016 this November.
ADVANCEMENTS IN GENE ELECTRO-TRANSFER
We continue 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. 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. We plan to provide additional details on our devices at our inaugural Investor and Analyst Day on November 17, 2016.
Members from our discovery research team presented new study results in two poster presentations at the American Association of Cancer Research (“AACR”)’s Special Conference on Engineering and Physical Sciences in Oncology, in June. We also presented at the 13th International Bioelectrics Symposium in Rostok, Germany in September, 2016.
We presented new data related to our Tissue-based Real-time Adaptive Controlled Electroporation (TRACE™) technology and helical integrated applicator (Helix™), which showed that these technologies have the potential to reduce procedural frequency as well as enhance usability by physicians. The new TRACE™ and Helix™ technologies are a testament to the expertise of OncoSec’s engineering and research teams, and we believe that these novel technologies are a breakthrough in the field of electroporation therapy. As we look beyond the proof-of-concept stage for our intratumoral immunotherapy programs, these advancements are a major step forward in being able to consistently deliver more advanced therapeutic agents with the potential to target multiple facets of tumor immune subversion.
In closing, we would like to share upcoming milestones with our esteemed shareholders. In FY2017, we plan to accomplish the following:
- Advance enrollment in the Phase II melanoma combination study and present interim clinical data;
- Work in parallel to meet clinical and regulatory objectives for initiating a melanoma combination registration study;
- Announce a novel “multi-gene” combination ImmunoPulse® candidate which will be OncoSec’s planned next clinical candidate; we expect to advance this into the clinic with our new devices incorporating the TRACE™ technology;
- Continue enrollment and complete the triple negative breast cancer biomarker study as proof of concept in breast cancer, present interim data, and discuss the future development plan
To learn more about our recent achievements and our FY2016 Q4 and fiscal year end financial results, please access the following related materials: Earnings Conference Call, Press Release and Form 10-Q.
Clinical Development Plans
OncoSec in the News
Chance Collaboration Yields an Advance in Cancer Treatment http://www.wsj.com/articles/chance-collaboration-yields-an-advance-in-cancer-treatment-1471297059
I have terminal cancer and I know my friends want to ask, ‘Aren’t you dead yet?’ http://www.latimes.com/opinion/op-ed/la-oe-welsh-cancer-immunotherapy-20160717-snap-story.html
Immune-Cell Population Predicts Immunotherapy Response in Melanoma https://www.ucsf.edu/news/2016/08/403831/immune-cell-population-predicts-immunotherapy-response-melanoma
About OncoSec Medical Incorporated
OncoSec is a biotechnology company developing DNA-based intratumoral immunotherapies with an investigational technology, ImmunoPulse®, for the treatment of cancer. ImmunoPulse® is designed to enhance the local delivery and uptake of DNA-based immune-targeting agents, such as IL-12. 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 as well as the potential to initiate a systemic immune response. OncoSec’s lead program, ImmunoPulse® IL-12, is currently in clinical development for several indications, including metastatic melanoma, head and neck cancer, and triple-negative breast cancer. The program’s current focus is on the significant unmet medical need in patients with melanoma who are refractory or non-responsive to anti-PD-1/PD-L1 therapies. 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 press release 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.