On behalf of our team, who are at the forefront of innovative science in 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 regarding our business, including recent achievements and upcoming milestones.
Thus far, 2017 has proven to be an inflection year for OncoSec. We remain on track to hit certain clinical development milestones that we believe will be transformative for the Company. In this quarter alone, we announced positive pre-clinical and clinical data, obtained Fast Track designation for our pivotal registration-directed program by the Food and Drug Administration (FDA), and initiated our first Technology Access Program (TAP) agreement – with additional validating events on the horizon.
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
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. As we move forward in the coming months, we plan to initiate a registration-directed clinical study in melanoma called PISCES, which stands for: Anti-PD-1 IL-12 Stage III/IV Combination Electroporation Study. We believe the data from this trial will have the potential for priority review with the FDA, as well as an accelerated approval, if the data is favorable.
Furthermore, we believe it has the potential to attract a strategic licensing partner that will be instrumental in commercializing our innovative therapy. The start-up activities related to the registration-directed study are underway as we plan to initiate a drug supply agreement from a collaborative partner, who is ready to assist in the advancement of this cutting-edge therapy.
By continuing to validate our technology both through clinical and regulatory milestones, we expect to be in a stronger position to advance our product development towards commercialization and generate value for our shareholders.
This past quarter, we presented both pre-clinical and clinical data at various prestigious scientific forums including, the American Society of Clinical Oncology and Society for Immunotherapy of Cancer (ASCO-SITC) Clinical Immuno-Oncology Symposium, the Keystone Symposium, and most recently, the American Association for Cancer Research (AACR) Annual Meeting.
At ASCO-SITC, Dr. Alain Algazi presented new clinical data from a Phase II trial combining our lead molecule, ImmunoPulse® IL-12, with Merck’s approved anti-PD-1, pembrolizumab, in a melanoma patient population predicted to not respond to anti-PD-1 therapy alone. These data showed an objective response rate of 43% and best overall response rate of 48% in 22 patients. This shows that nearly half of these patients – who are predicted to not respond to pembrolizumab alone – responded to combination therapy with our ImmunoPulse® IL-12.
Moreover, analysis of the biomarker data indicates that the combination of ImmunoPulse® IL-12 and pembrolizumab can convert “cold” tumors to “hot” tumors in the patients who responded to the combination treatment.
We are grateful for the investigators and patients who are participating in this study.
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 these compelling data, we believe that our ImmunoPulse® IL-12 has the potential to rescue patients that are clinically failing anti-PD-1 treatment by combining it with an approved PD-1 inhibitor. In other words, we believe that patients that fail (i.e., don’t respond to) Merck’s therapy could be helped with a combination of Merck’s and OncoSec’s immunotherapy treatment.
For information regarding our pre-clinical data please visit: http://oncosec.com/oncosec-technologies/publications/.
On February 27th, we announced that the FDA granted OncoSec Fast Track designation for our ImmunoPulse® IL-12 to treat patients with metastatic melanoma following disease progression on either pembrolizumab or nivolumab. This represents a significant milestone for OncoSec and an important third party validation of our technology and approach.
We believe our clinical development plan, which is focused initially on ImmunoPulse® IL-12 in the non-responder population, addresses a large underserved patient population in the immunotherapy treatment paradigm. By following this development path and meeting regulatory criteria set by the FDA, we believe our ImmunoPulse® IL-12 has the potential to eventually become a first-in-class therapy and an important agent in cancer immunotherapy to improve response rates to checkpoint inhibitor therapies, like pembrolizumab.
Of note, OncoSec is the first company to achieve Fast Track designation for the unmet medical need of nivolumab and pembrolizumab progressors in metastatic melanoma. This in turn, positions our ImmunoPulse® IL-12 as the first therapeutic with the potential for accelerated approval in the anti-PD-1 non-responder population, leading to a projected multi-billion-dollar market opportunity.
As previously stated, the initiation of PISCES will be the next step in advancing our clinical program. This will be a Phase II, open-label, multicenter study of ImmunoPulse® IL-12 in combination with pembrolizumab in patients with Stage III or IV melanoma.
The patients selected for this study will be true nonresponders who have progressed on either pembrolizumab or nivolumab treatment as a monotherapy or in combination with another approved checkpoint inhibitor. The core objectives of the trial are to assess the efficacy, safety, and tolerability up to 24 weeks of the combined treatment.
With the start-up activities related to the initiation of PISCES in motion, we look forward to working closely with the FDA at this important stage of our clinical program.
To learn more about our recent achievements and our FY2017 Q2 financial results, please access the following related materials:
OncoSec LIVE from the NYSE floor with Cheddar.com https://vimeo.com/212099893
Intratumoral therapy increases response to checkpoint inhibitor for melanoma http://www.healio.com/hematology-oncology/melanoma-skin-cancer/news/online/%7Bea4e1385-a40f-499e-841e-e1b71069e812%7D/intratumoral-therapy-increases-response-to-checkpoint-inhibitor-for-melanoma
Cancer immunotherapy has life-saving powers and limits http://www.pbs.org/newshour/bb/cancer-immunotherapy-life-saving-powers-limits/
Improving Anti-PD-1 Response Rate: The Potential Role of a Combination Therapy http://www.dddmag.com/article/2017/04/improving-anti-pd-1-response-rate-potential-role-combination-therapy#.WOew4kddu4c.facebook/
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.