On behalf of our team, I would like to start our quarterly update thanking 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.
At about the halfway mark in 2017, our team remains focused to meet our corporate milestones that we believe will be transformative for the Company. In this quarter, we announced a clinical trial collaboration and supply agreement with one of the world’s leading cancer immuno-oncology companies, as well as Orphan Drug Designation from the Food and Drug Administration (FDA). We believe these third-party validating events, in combination with the Fast Track Designation that we received earlier this year, provides additional confidence in our strategic pathway. We intend to provide additional independent validating events in the future.
I hope you find these updates informative, and I look forward to sharing more information with you in the future. Thank you again for your ongoing confidence in OncoSec as we continue to advance our immuno-oncology pipeline.
President and CEO
In recent years, OncoSec has established clinical response data that supports a clinical strategy of combining ImmunoPulse® IL-12 with anti-PD-1 in melanoma patients who have failed anti-PD-I therapy alone. This has the potential to significantly address an unmet medical need for these patients, as there are no approved treatments for this difficult-to-target population.
Clinical data from our Phase II IST ongoing study in patients predicted not to respond to anti PD-I therapies, which we believe to be a similar population to those who will fail the anti PD-I therapies, has been presented at numerous conferences showing an excellent safety and tolerability profile and a 48% best overall response rate at 24 weeks.
These encouraging results, coupled with the granting of Fast Track Designation by the FDA, lead us to believe that the upcoming Phase II registration-directed clinical study, PISCES (Anti-PD-1 IL-12 Stage III/IV Combination Electroporation Study), will be truly significant.
OncoSec has laid out a clear and strategic direction for this study, as acknowledged by the FDA. We believe that the successful execution of the PISCES trial, potential accelerated approval, and subsequent commercialization of ImmunoPulse® IL-12 will generate value for our patients and shareholders. As such, we are continuing to validate our technology through clinical and regulatory milestones to advance product development.
We remain focused on advancing the registration-directed PISCES trial as we continue to deliver on our mission of addressing an unmet medical need in melanoma with ImmunoPulse® IL-12.
In May 2017, OncoSec entered into a collaboration and supply agreement with a leading cancer immuno-oncology Company to evaluate the combination of ImmunoPulse® IL-12 and their approved anti-PD-1 therapy in the PISCES clinical trial, signifying the completion of one of our major development milestones this year. This collaboration also provides OncoSec with pharma validation and millions of dollars in savings for the drug supply that we need for our registration-directed trial.
In the PISCES trial, a total of 48 eligible patients will be enrolled in the Simon 2-stage design with the primary endpoint of best overall response rate by an independent central review group based on RECIST version 1.1. Eligible patients will be those with stage III or IV metastatic melanoma who have been progressing or have progressed on one of the approved anti-PD-1 therapies (as either a monotherapy or as a combination therapy).
Initiating our pivotal study is an exciting phase for us. We been focused on getting the clinical systems on-line and selecting sites for the trial and still expect to meet our major objectives of patient enrollment for stage one this year.
In June 2017, the FDA granted Orphan Drug Designation for pIL-12, otherwise known as tavokinogene telsaplasmid or “tavo”, for the treatment of unresectable metastatic melanoma. Tavo is the active biologic agent in OncoSec’s lead product candidate, ImmunoPulse® IL-12. The Orphan Drug status will make OncoSec eligible for certain development incentives, including tax credits for clinical testing, exemption from a prescription drug user fee, and seven years of market exclusivity.
This represents an important regulatory milestone for OncoSec as we advance ImmunoPulse® IL-12 toward commercialization. The FDA grants Orphan Drug Designation status to products that treat rare diseases, providing incentives to sponsors developing drugs or biologics. The FDA defines rare diseases as those affecting fewer than 200,000 people in the U.S. at any given time. With Fast Track and Orphan Drug designations in-hand, this allows for potential priority review, as well as accelerated market approval.
According to Data Monitor, there are projected to be 239,000 cases of melanoma in the US in 2019. While there are two biopharmaceutical companies with FDA-approved checkpoint therapies (also known as anti-PD-1), for the treatment of late stage metastatic melanoma, the majority of patients (60%) do not respond to this type of immunotherapy, representing a huge unmet need in oncology.
We believe that OncoSec is uniquely positioned to address this unmet need. We anticipate approximately 12,000 melanoma patient cases will fail or progress on checkpoint inhibitors (either as a monotherapy or dual) each year, and many of these can potentially be addressed with ImmunoPulse® IL-12, based on internal estimates.
Beyond the melanoma market, there is potential to expand ImmunoPulse® IL-12 in the non-responder population using the same regulatory pathway to other cancer indications as well, such as squamous cell carcinoma of the head and neck.
OncoSec is positioned to be the first company to bring an approved therapy to market for the anti-PD1 non-responder population in melanoma – with the potential to expand into other indications. Our work is important and we will continue to seek cost effective ways to achieve our goals while maximizing efficiency and prudent spending of our current cash resources. We are actively pursuing various activities that would allow us to fund operations through the completion of our registration directed study, PISCES, and beyond.
We will be required to raise additional capital. As stated in our Q3’17 earnings call, we are conscious of equity dilution and it is our preference to raise additional capital in a non-dilutive (or less dilutive) manner, such as a possible development partnership. We continue to pursue those options and opportunities. We also continue to be diligent in managing our cash burn rate to maximize value for our investors and we believe it to be prudent to continue to explore all financing options.
On July 25, 2017, OncoSec filed a Form 424B5 prospectus supplement for the sale of up to $8.4 million of our common stock through an “at-the-market” or “ATM” equity offering program. Our common stock will be offered over a period of time and from time-to-time through or to Oppenheimer & Co. Inc. (“Oppenheimer”), acting as our sales agent or principal, in accordance with the terms of the Equity Distribution Agreement that we have entered into with Oppenheimer, which is filed as Exhibit 1.1 to our Form 8-K.
We intend to utilize our ATM facility to raise capital when appropriate, and strategically, to maximize value and minimize dilution for our shareholders, as much as possible. The capital raised will help to finance our immediate clinical needs including general working capital. The ATM is the first step in a broader strategic financing plan to raise the additional capital required for the continued development of our technology and the completion of our registration directed trial. We will remain opportunistic in our efforts to raise the working capital necessary to continue our development and clinical activities, mainly related to the execution of our PISCES program through equity and non-equity based capital with the ultimate goal of increasing value for our shareholders.
For more information on the our prospectus supplement and accompanying prospectus relating to the ATM offering (without charge), please visit our website (www.oncosec.com and go to /investors/secfilings/all sec filing and see the filings on July 25, 2017) or visit the SEC’s website at www.sec.gov.
To learn more about our recent achievements and our FY2017 Q3 financial results, please access the following related materials:
OncoSec’s Metastatic Melanoma Therapy Candidate ImmunoPulse IL-12 Wins FDA Orphan Drug Status https://immuno-oncologynews.com/2017/06/13/oncosecs-metastatic-melanoma-therapy-candidate-pil-12-granted-fda-orphan-drug-status/
OncoSec Medical (ONCS) at LD Micro: Arming the Immune System to Fight Cancer https://www.equities.com/news/oncosec-medical-oncs-at-ld-micro-today-arming-the-immune-system-to-fight-cancer
OncoSec, Merck to Collaborate on Trial of ImmunoPulse IL-12, Pembrolizumab in Metastatic Melanoma https://www.healio.com/hematology-oncology/melanoma-skin-cancer/news/online/%7Bacf7dcc9-d471-43fb-95c6-af3e671cf469%7D/oncosec-merck-to-collaborate-on-trial-of-immunopulse-il-12-pembrolizumab-in-metastatic-melanoma
Improving Anti-PD-1 Response Rate: The Potential Role of a Combination Therapy https://www.dddmag.com/article/2017/04/improving-anti-pd-1-response-rate-potential-role-combination-therapy
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.