OncoSec's KOL Symposium Sheds New Light on the Importance of IL-12 Use Via OncoSec's Technology and Provides Updates on TAVO's Clinical Progress

- KEYNOTE-695, a Clinical Study of TAVO™ with KEYTRUDA® in Advanced Melanoma is Now 40% Enrolled

- Tumor Responses are Being Observed in The First Patients of KEYNOTE-890, a Combination Study of TAVO™ and KEYTRUDA® in Metastatic Triple Negative Breast Cancer

SAN DIEGO and PENNINGTON, N.J., April 8, 2019 /PRNewswire/ -- OncoSec Medical Incorporated (OncoSec) (NASDAQ: ONCS), a company developing intratumoral cancer immunotherapies, provided an update on recent pipeline and regulatory progress during a Key Opinion Leader (KOL) Symposium focused on the potential of TAVO™ (IL-12 / tavokinogene telseplasmid) on Friday, April 5, 2019 in New York City.  The KOL Symposium featured presentations from Adil Daud, M.D. and H. Kim Lyerly, M.D.  

Dr. Daud is the lead U.S. investigator for KEYNOTE-695, Clinical Professor of Medicine and Dermatology at University of California, San Francisco (UCSF), and Director of Melanoma Clinical Research at the UCSF Helen Diller Family Comprehensive Cancer Center.  Dr. Lyerly is the George Barth Geller Professor for Research in Cancer at Duke University Medical Center and Director of the Duke Comprehensive Cancer Center.  Both Dr. Daud and Dr. Lyerly have worked extensively with IL-12 for the past 20 years.  Each presentation provided key insights on the importance of IL-12.  Dr. Daud also provided his observations regarding TAVO's two ongoing KEYNOTE clinical trials and Dr. Lyerly highlighted his upcoming work combining TAVO™ with HER2 in breast cancers.

Discussing KEYNOTE-695, Dr. Daud noted the following: 

  • A key differentiating factor with KEYNOTE-695 relative to other studies which have published data regarding checkpoint non-responder is that KEYNOTE-695 is enrolling only those patients who have definitively progressed on anti-PD-1 therapy by RECIST v1.1.  The expected response rate to anti-PD-1 therapy in the KEYNOTE-695 patient population is approximately 6% and therefore the responses having been observed thus far on the study are encouraging.  Dr. Daud commented, "There are checkpoint non-responders and then there are other checkpoint non-responders and I just want to highlight the rigor of the patients that are being enrolled here [in KEYNOTE-695]. We are talking about patients who have had RECIST progression on PD-1 treatment and then go on our trial where they have PD-1 plus TAVO™, and then have a RECIST response, so it's just a different kind of population."
  • Responding patients on KEYNOTE-695 had extensive progressive disease prior to TAVO™+ KEYTRUDA® treatment and responses have been observed in both treated and untreated lesions.  The duration of response is consistent with an immunologic response.  Dr. Daud stated, "So what we've seen so far and what's been publicly disclosed has been pretty encouraging. … These are patients with extensive progressive disease and we've seen responses both in treated and in untreated lesions on them. And the duration of response is consistent with an immunologic response, not an ablative response to treatments."
  • TAVO'S safety profile continues to be encouraging and there are no apparent systemic side effects.  Dr. Daud commented, "Our safety profile continues to be excellent. One of the impressive things about TAVO™ treatment is that, remember I told you that cytokine treatment is toxic and systemic cytokine treatment is pretty toxic. What is interesting about TAVO™ is that patients can have TAVO™ treatment and basically 30 minutes later go back to work. There isn't any nausea, there are no systemic side effects to speak of.  There can be some grade 1 lesion pain or lesion discomfort, some bleeding, some local redness and irritation, but that is pretty much it in terms of side effect profile. So you could imagine that it's combinable."
  • KEYNOTE-695 is approximately 40% enrolled and on track to complete enrollment by year-end.

Dr. Daud also commented on KEYNOTE-890, OncoSec's Phase 2 clinical trial for the treatment of late-stage triple negative breast cancer (TNBC) with TAVO™ in combination with Merck's KEYTRUDA® (pembrolizumab).  Dr. Daud stated, "So just to give you a highlight on another trial that's ongoing, that's the KEYNOTE-890, which is a breast cancer trial combining TAVO™ plus KEYTRUDA®, and patients with breast cancer.  And again, these seem – without going too far into details about patients, so these are patients who have visceral disease, who have also had skin disease.  And also have accessible treatable lesions. And we've just seen some amazing responses in this trial and will be presenting these as the year goes on."

Dr. Lyerly discussed the importance of IL-12 and OncoSec's technology:

  • Dendritic cells are the critical cells necessary for transferring antigens and stimulating antigen specific T cells again, which is the basis for cancer immunotherapy.  The key cytokine for activated and fully matured dendritic cells is IL-12 production.  Systemic use of IL-12 generated systemic toxicities, which seemed to preclude its use, requiring a technical solution to exquisite delivery.  OncoSec's technology affords a potential solution to the problem of systemic use of IL-12.
  • A variety of IL-12 delivery mechanisms, including viruses and other strategies for direct gene transfer have been explored; however, OncoSec's plasmid delivery system directs IL-12 expression to the tumor microenvironment which has advantages over these other mechanisms. 
  • In his independent research, he has previously demonstrated the power of IL-12 as a therapeutic against breast cancer and could be foundational, even as primary treatment in early stages of cancer. 

"Imagine if you will that if you had the opportunity to deliver IL-12, stimulate systemic antitumor immunity that would provide lifetime benefit to you," said Dr. Lyerly, "Would you not include that in your initial treatment regime?  So rather than simply thinking about the treatment of end-stage cancers, we began to explore the potential of IL-12 delivery and really developing systemic antitumor immunity to prevent recurrences and attack these cancers and again this is ongoing work with one of the reasons we were excited about the potential for the OncoSec technical solution."

For a full transcript of the KOL Symposium, please visit www.oncosec.com.  An archived replay of the webcast is available in the Investor Relations section of OncoSec's website at ir.oncosec.com.

About OncoSec Medical Incorporated and TAVO
OncoSec is a clinical-stage biotechnology company focused on developing cytokine-based intratumoral immunotherapies to stimulate the body's immune system to target and attack cancer.  OncoSec's lead immunotherapy investigational product candidate – TAVO™ (tavokinogene telseplasmid) – enables the intratumoral delivery of DNA-based interleukin-12 (IL-12), a naturally occurring protein with immune-stimulating functions.  The technology, which employs electroporation, is designed to produce a controlled, localized expression of IL-12 in the tumor microenvironment, enabling the immune system to target and attack tumors throughout the body.  OncoSec has built a deep and diverse clinical pipeline utilizing TAVO™ as a potential treatment for multiple cancer indications either as a monotherapy or in combination with leading checkpoint inhibitors; with the latter potentially enabling OncoSec to address a great unmet medical need in oncology: anti-PD-1 non-responders.  Results from recently completed clinical studies of TAVO™ have demonstrated a local immune response, and subsequently, a systemic effect as either a monotherapy or combination treatment approach. In addition to TAVO™, OncoSec is identifying and developing new DNA-encoded therapeutic candidates and tumor indications for use with its ImmunoPulse® platform.  For more information, please visit www.oncosec.com.

KEYNOTE-695 is a global, multicenter, registration-directed Phase 2b open-label trial of intratumoral delivery of TAVO™ with intravenous KEYTRUDA® in patients with unresectable, advanced melanoma.  Eligible patients had refractory, locally advanced or metastatic disease defined as unresectable Stage III/IV metastatic melanoma that had definitively progressed on a full-course of anti-PD-1 treatment with KEYTRUDA® (pembrolizumab) or OPDIVO® (nivolumab). KEYNOTE-695 is expected to complete in 2019 and based on the outcome of the study, OncoSec intends to file for accelerated approval in 2020.

KEYNOTE-890 is a Phase 2 study testing the combination of TAVO™ with pembrolizumab in patients with inoperable locally advanced or metastatic TNBC who have progressed on more than one line of prior therapy. The primary endpoint is to assess efficacy as measured by objective response rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

OPDIVO® is a registered trademark of Bristol-Myers Squibb.

ImmunoPulse® is a registered trademark of OncoSec Medical Incorporated.

TAVO™ trademark of OncoSec Medical Incorporated.

Investor Relations:
Will O'Connor
Stern Investor Relations 
(212) 362-1200

Media Relations:
Katie Dodge
JPA Health Communications
(617) 657-1304

OncoSec Medical Incorporated logo (PRNewsfoto/OncoSec Medical Incorporated)


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