On behalf of our team, who are 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.
In the last quarter, we announced positive pre-clinical and clinical data as well as participated in significant investor conferences, including the 9th Annual Biotech Showcase, which was held in San Francisco during one of the industry’s largest annual healthcare investor conferences.
As we advance our programs, I would like to thank you again for your ongoing confidence in OncoSec. I hope you find these updates informative, and I look forward to sharing more information with you throughout the year.
President and CEO
Based on our current cash runway, we are positioned to meet our value-driving clinical and regulatory milestones into calendar 2018 and have a clear strategy to expand our therapeutic platform.
Our primary focus for the next year is to initiate a melanoma registration-directed clinical study. We believe we will generate meaningful data in 2017 and 2018 to support the discussions with the FDA and a future biologics license application (BLA) to attract a partner, who is ready to advance this innovative therapy.
We believe ImmunoPulse IL-12 has pathways for potential licensing and partnering. First, in the US, a partnership with Big Pharma in melanoma, as well as other indications., Second, ex-US partnerships involving indications that are prevalent in certain geographic areas, such as head and neck cancers and esophageal cancers in Asia.
In addition, on October 7, 2016, OncoSec Medical Australia Pty, Ltd. (“OncoSec Australia”) was created as a wholly-owned subsidiary of OncoSec Medical Incorporated to facilitate the enrollment for our clinical trials principally in Australia where there is a high rate of melanoma cases. We believe our clinical investment dollars in Australia provide more data at a lower per patient c
We are determined to advance our lead program – ImmunoPulse® IL-12 in anti-PD-1 non-responder advanced melanoma patients.
As you know, we have an on-going Investigator Sponsored Trial (IST) being conducted at the University of California San Francisco (UCSF) and at the Huntsmann Cancer Institute at the University of Utah with Principal Investigator, Dr. Alain Algazi, Clinical Instructor at UCSF. For this IST, we have been assessing the combination of our ImmunoPulse® IL-12, and Merck’s KEYTRUDA® in melanoma patients who are predicted to not respond to anti-PD-1 monotherapy.
We were pleased to report that interim data was accepted for an oral poster presentation at last year’s Annual Meeting for the Society for the Immunotherapy of Cancer (SITC). This provided an early look at clinical response data for the first 15 patients enrolled and treated in the clinical trial, as well as, preliminary translational biology data.
In brief, using a unique biomarker profile, the combination of ImmunoPulse® IL-12 with KEYTRUDA® in melanoma patients, who were predicted to not respond to anti-PD-1 monotherapy, was associated with a 40% overall response rate based on Response Evaluation Criteria In Solid Tumors (or “RECIST”). In other words, 40% of the patients predicted as KEYTRUDA® non-responders, showed some type of response to our combination therapy.
These results provided compelling support for our therapeutic hypothesis that ImmunoPulse® IL-12 improves response rates in advanced melanoma in combination with anti-PD-1 checkpoint inhibitor therapies.
We are grateful for the investigators and patients for their continued participation in this study, and are working diligently to advance this agent toward registration-directed clinical programs.
We look forward to sharing new clinical data at upcoming conferences, including the 2017 ASCO-SITC Clinical Immuno-Oncology Symposium on February 23, 2017.
As presented at our November 17th Investor and Analyst Day event, there is precedent at the FDA, to support early adoption of a novel therapy, if it can be shown that the new therapy provides a benefit to patients with a significant unmet medical need.
Thus, by focusing our next registration-directed clinical trial on anti-PD-1 non-responders, we can take advantage of all regulatory pathways available to us, including those that may result in early regulatory approval.
We are anticipating that by Q2 of 2017, we will have approval for our registration study and our first patient enrolled.
Within the population of patients treated with anti-PD-1 therapy, approximately 65% of them are anticipated to be non-responders, representing more than 10,000 patients with advanced melanoma that could be eligible for ImmunoPulse® IL-12. We are providing a potential “rescue” option for patients that do not have any other remaining treatment options after failing checkpoint therapy. This is an attractive place to start for an initial approval of ImmunoPulse® IL-12. We further anticipate that ImmunoPulse® IL-12 could expand to other non-responder populations, and perhaps be offered as an earlier line of treatment in advanced melanoma.
As you can see, the melanoma opportunity alone for ImmunoPulse® IL-12 is quite significant.
In closing, we would like to share upcoming milestones with our stakeholders. In FY2017, we plan to accomplish the following:
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 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.
To the extent statements contained in this newsletter are not descriptions of historical facts regarding OncoSec Medical Incorporated, they may be considered forward looking statements, as described in the Private Securities Litigation Reform Act of 1995, reflecting management’s current beliefs and expectations. Forward looking statements speak only as of the date they are made, and they are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels of activity, performance or achievements to be materially different from those anticipated by such statements. You can identify forward-looking statements by words such as “aimed at,” “anticipate,” “believe,” “can,” “could,” “estimate,” “expect,” “focus,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would,” or the negative of those terms, and similar expressions that convey uncertainty of future events or outcomes. Forward looking statements contained in this newsletter include, but are not limited to, statements regarding: (i) the success and timing of our product development activities and clinical trials; (ii) our ability to develop and commercialize our product candidates; (iii) our plans to research, discover, evaluate and develop additional potential product, technology and business candidates and opportunities; (iv) our and our partners’ ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process; (v) the size and growth potential of the markets for our product candidates, and our ability to serve those markets; (vi) the rate and degree of acceptance of our product candidates; (vii) our ability to attract and retain key scientific or management personnel; (viii) the anticipated timing of clinical data availability; (ix) the anticipated timing of commercial launch of ImmunoPulse® IL-12; (x) our ability to meet our milestones; (xi) our expectations regarding our ability to obtain and maintain intellectual property protection; (xii) the level of our corporate expenditures; (xiii) the assessment of our technology by potential corporate partners; and, (xiv) the impact of capital market conditions on our Company. Undue reliance should not be placed on forward looking statements. Such statements are subject to factors, risks and uncertainties, such as those described in our periodic filings with the Securities and Exchange Commission, including without limitation our Quarterly Reports on Form 10-Q, our annual reports on Form 10-K and other filings. Various factors may cause actual results to differ materially from those expressed or implied by such forward looking statements. We undertake no obligation to publicly update any forward-looking statements. OncoSec’s investigational drug and device products have not been approved or cleared by the FDA.