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.
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
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.
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.
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:
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.
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
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.
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.
Immunotherapy is changing the way we perceive and treat cancer. Advances in science and technology have brought about a new wave of promising cancer immunotherapies, which harness the power of the immune system to fight disease. We are witnessing the emergence of a new vision within the cancer treatment landscape – one that is having an immediate and powerful impact on cancer patients everywhere.
During this year’s State of the Union address, President Barack Obama announced Cancer Moonshot 2020: a new initiative aimed at eliminating cancer as we know it. Cancer Moonshot 2020 plans to break down barriers and enable progress by enhancing data access, facilitating collaborations, and investing in the development of new technologies and treatments. We applaud this initiative not only for its emphasis on eliminating the burden of cancer, but also for its practical approaches and acknowledgement of the complexities of this mission.
On behalf of the OncoSec team, we’re thrilled to announce the first patient enrolled in the Phase II Investigator Sponsored Trial led by the University of California, San Francisco (UCSF) to assess the safety and efficacy of the combination of our investigational therapy, ImmunoPulse™ IL-12, and Merck’s approved anti-PD-1 agent, KEYTRUDA® (pembrolizumab), in patients with unresectable metastatic melanoma.
We were thrilled to participate in the Nasdaq Opening Bell Ceremony to celebrate our recent listing to The Nasdaq Capital Market. This marks an exciting and significant milestone for our company as we continue to build on our success and advance our technologies to one day benefit patients everywhere.