Immune-Cell Numbers Predict Response to Combination Immunotherapy in Melanoma

Immune-Cell Numbers Predict Response to Combination Immunotherapy in Melanoma

According to a new study conducted by researchers and clinicians at the University of California, San Francisco (UCSF), an abundance of certain white blood cells present in tumors could be the answer to predicting a patient’s response to immunotherapy.

The study, published on July 20, 2017 in the Journal of Clinical Investigation (JCI) Insights, evaluated tumor samples from 102 patients with melanoma and measured the percentage of a specific subset of immune cells that had infiltrated tumors. Study results showed that patients with lower levels of a type of immune cell called “partially exhausted cytotoxic T lymphocytes” (peCTLs) in their tumors benefited the most from a combination of two immunotherapies.

The findings from this study build upon a previous publication, also led by UCSF researchers, demonstrating that a novel predictive biomarker could identify patients likely to respond to anti-PD-1 checkpoint inhibitor therapies, whereby a high frequency of tumor-infiltrating T cells expressing both CTLA-4 and PD-1 proteins on their cell surface, correlated with patient responses. In the new report, researchers continued to study this peCTL population in pre- treatment tumor biopsies and found that patients with high levels of peCTLs in their tumors still benefitted from the anti-PD-1 monotherapy treatment. By comparison, patients with low levels of peCTLs in their tumors benefitted from an immunotherapy combination.

Improving Response Rates with OncoSec’s ImmunoPulse® IL-12

Data from the JCI Insights study shows that only 5.6% of patients with low peCTL responded to anti-PD-1 alone. In combination with anti-CTLA-4, the response rate improved to 35%. “At OncoSec, we believe that our lead product candidate, ImmunoPulse® IL-12, may improve this response rate even further, said OncoSec President and CEO, Punit Dhillon.

In preliminary studies, OncoSec has shown that ImmunoPulse® IL-12, in combination with anti- PD-1, can yield objective responses in patients with low frequencies of peCTL. Interim data from a phase II study, led by UCSF Principal Investigator Dr. Alain Algazi, showed a 48% best overall response rate from the combination of ImmunoPulse® IL-12 with pembrolizumab in the low peCTL population.

“We believe this combination melanoma trial is the first clinical trial to use this T cell biomarker to evaluate the clinical response of patients with low frequency of peCTL. To date, 48% of the patients evaluable in the interim data of our study showed partial or complete response to the combination”, continued Mr. Dhillon. “These results continue to provide evidence that ImmunoPulse® IL-12, in combination with anti-PD-1 therapies, can improve response rates in advanced melanoma. We believe that these new results reinforce the relevance of the clinical data we presented in this difficult-to-target population, namely those unlikely to respond to anti-PD-1 monotherapy. The data from this study also further validates the approach we have taken in our upcoming PISCES trial; to treat patients that fail to respond to anti-PD-1 therapy alone.”

For the full article please visit: https://insight.jci.org/articles/view/93433.

OncoSec Quarterly Update: August 2017

Dear Stakeholders,

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.

Sincerely,

signature

 

 

 

Punit Dhillon

President and CEO

 

WHAT’S NEW AT ONCOSEC

RECENT QUARTERLY UPDATES

CORPORATE STRATEGY

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.

 

PISCES PROGRAM

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.

 

ORPHAN DRUG DESIGNATION

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.

 

MARKET OPPORTUNITY

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.

RAISING CAPITAL

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:

 

IN CASE YOU MISSED IT

Summer-Newsletter-Image-1

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/
Summer-Newsletter-Image-2

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
Summer-Newsletter-Image-3

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
Summer-Newsletter-Image-4

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

 

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 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

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.

OncoSec Quarterly Update: April 2017

Dear Stakeholders,

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.

Sincerely,

signature

 

 

 

Punit Dhillon

President and CEO

 

WHAT’S NEW AT ONCOSEC

RECENT QUARTERLY UPDATES

CORPORATE STRATEGY

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.

 

NEW PRE-CLINICAL AND CLINICAL DATA

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/.

 

FDA FAST TRACK DESIGNATION

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.

 

MELANOMA DEVELOPMENT PROGRAM

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:

 

COMPANY MILESTONES

Company Milestones

 

IN CASE YOU MISSED IT

cheddar logo

OncoSec LIVE from the NYSE floor with Cheddar.com https://vimeo.com/212099893
healio

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
PBS

Cancer immunotherapy has life-saving powers and limits http://www.pbs.org/newshour/bb/cancer-immunotherapy-life-saving-powers-limits/
DDD Mag

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/

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 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

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.

OncoSec Quarterly Update: January 2017

Dear Stakeholders,

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.

Sincerely,

signature

 

 

 

Punit Dhillon

President and CEO

 

WHAT’S NEW AT ONCOSEC

RECENT QUARTERLY UPDATES

CORPORATE STRATEGY

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.

 

NEW PRE-CLINICAL AND CLINICAL DATA

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.

 

MELANOMA DEVELOPMENT STRATEGY

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.

 

COMPANY MILESTONES

In closing, we would like to share upcoming milestones with our stakeholders. In FY2017, we plan to accomplish the following:

  • Move into a registration directed clinical trial of our ImmunoPulse® IL-12 technology (with the ultimate goal of becoming the first approved therapy for patients who do not respond to anti-PD-1).
  • Advance our gene transfer and construct innovations. Over the longer term, this includes:
    • Implementing our Tissue-based Real-time Adaptive Controlled Electroporation (or TRACETM) technology;
    • Gaining access to a variety of new tumor types and locations; and
    • Developing a multi-gene plasmids
  • Expand the distribution of our technology through technology access programs, strategic partnerships, and research collaborations with key opinion leaders in the field.

To learn more about our recent achievements and our FY2017 Q1 financial results, please access the following related materials: Earnings Conference Call, Press Release and Form 10-Q

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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 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

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.

OncoSec Quarterly Update: November 2016

Dear Stakeholders,

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.

Sincerely,

signature

Punit Dhillon

President and CEO

 

What’s New at OncoSec
Recent Quarterly Updates

CORPORATE STRATEGY

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 events@oncosec.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.

 

COMPANY MILESTONES

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

 

ONCOSEC’S
Clinical Development Plans 

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OncoSec in the News

wsjq2Chance Collaboration Yields an Advance in Cancer Treatment http://www.wsj.com/articles/chance-collaboration-yields-an-advance-in-cancer-treatment-1471297059

 

 

lat2I 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

 

 

 

ucsf_logoImmune-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.

 

A Patient’s Perspective

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.

Melanoma Spotlight
Melanoma is the deadliest form of skin cancer, accounting for the majority of skin cancer deaths worldwide. 

While melanoma rates have been rising over the last 30 years, advancements in treatment and early detection are providing new hope for patients everywhere. In this edition of Guided By Science, we explore melanoma prevention, early detection, and new treatments that are changing the way we treat this deadly disease.

Cancer Vaccines: Activating the Immune System
Vaccines are designed to boost our immune system’s natural ability to protect against disease. This rationale extends to cancer therapy, where researchers are developing new treatments that direct the immune system to fight cancer.

As combination therapies become the new standard in cancer care, experts believe cancer vaccines will be a critical component of the new treatment landscape. In this edition of Guided By Science, we explore the world of cancer vaccines and highlight anew approach to fight cancer with the natural power of our immune system.

How Does Cancer Escape the Immune System?
Researchers have long questioned how tumors can grow in a healthy immune system. This question is even more important today, as immune-targeted therapies are fundamentally changing what it means to treat cancer. 

New evidence suggests that tumor development is heavily influenced by our immune system. This theory, termed “cancer immuno-editing,” can be broken down into three phases: elimination, equilibrium, and escape. In this edition of Guided By Science, we explore the three phases of cancer immuno-editing to understand the battle between cancer and the immune system.


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