SAN DIEGO, Nov. 8, 2017 /PRNewswire/ -- OncoSec Medical
Incorporated ("OncoSec" or "Company") (NASDAQ:ONCS), a company
developing DNA-based intratumoral cancer immunotherapies, today
announced positive updated long-term follow-up data from its Phase
2 OMS I-102 combination study of ImmunoPulse®
IL-12 and pembrolizumab in patients unlikely to respond to
anti-PD-1 therapy. The updated data will be presented in an oral
poster presentation (P524) by Dr. Alain
Alagzi at the Society for Immunotherapy of Cancer (SITC)
Annual Meeting in National Harbor, MD on November 10th, 2017 at 12:45 p.m. EST.
The updated clinical and correlative immune-focused biomarker
data demonstrated a 57% progression free survival (PFS) rate at 15
months with 100% (11/11) duration of response and median PFS not
yet reached. Building upon previously reported data of a best
overall response rate (BORR) of 50% (41% complete response [CR]
rate), the updated data further demonstrate that the combination of
these therapies can prime a coordinated innate and adaptive immune
response, and strongly suggests a synergistic relationship with
anti-PD-1. The latest findings further demonstrate that this
combination approach can reshape the tumor microenvironment,
yielding a robust intratumoral and systemic anti-tumor response
converting "cold" tumors to "hot," potentially improving clinical
outcomes in patients predicted to not respond to anti-PD-1
therapy.
"Overall, the Phase 2 trial results, including progression free
survival beyond two years in multiple patients, duration of
response, best overall response rate, and tolerability of the
combination, provide a strong and consistent theme across multiple
endpoints, underscoring the promise of ImmunoPulse IL-12 plus
pembrolizumab as a viable treatment option for patients diagnosed
with metastatic melanoma," said Dr. Alain
Algazi, Lead Trial Investigator, Associate Professor,
Department of Medicine (Hematology/Oncology), at the University of California San Francisco (UCSF) Helen
Diller Family Comprehensive Cancer Center.
Dan O'Connor, CEO of OncoSec
noted: "The robust PFS benefit and tolerability observed with
ImmunoPulse IL-12 plus pembrolizumab is the first demonstrating
efficacy in a predicted PD-1 non-responder population and shows
that the combination represents a potentially important addition to
the treatment landscape for metastatic melanoma patients who have
progressed or are progressing on anti-PD-1 therapy."
The full abstract is available and can be viewed on the STIC
website at www.sitcancer.org. The poster is available in the
Publications section of OncoSec's website.
Analyst Event in National Harbor, MD
OncoSec will host an analyst and investor event with clinical
investigators on Friday, November 10,
2017 at 7:00 a.m. EST in
National Harbor, MD during the 2017 Society of Immunotherapy for
Cancer Annual Meeting. The event will include a presentation and
discussion of updated clinical data for the company's ImmunoPulse
IL-12 program, highlighting the global, registration-directed
PISCES/KEYNOTE-695 trial. The event will be held in-person
and via live webcast.
Investors and analysts are invited to listen to a live audio
webcast of the presentation. To access the audio broadcast, please
dial (877) 731-1960 and enter the conference ID number 4938639. To
join via webcast, please use the following link:
https://edge.media-server.com/m6/p/aj3vpts5. An archived version of
the presentation will be available for 90 days on the "Investors"
section of OncoSec's website:
http://ir.oncosec.com/events-presentations.
For those interested in attending this event in person, please
contact media@oncosec.com. Please RSVP in advance as seating is
limited.
Peer-Reviewed Publication
The findings published in Immunotherapy provide an
overview of OncoSec's preclinical and Phase 1 clinical data
demonstrating that ImmunoPulse IL-12 plus electroporation is safe
and well-tolerated by patients. Many patients do not respond to
anti-PD-1 therapies alone, representing a significant unmet medical
need. ImmunoPulse IL-12 has shown to increase intratumoral
lymphocyte infiltration, pro-inflammatory cytokines and TH1 immune
responses, potentially boosting the activity of PD-1 antibodies
without significant systemic toxicity.
For the full-article please visit,
https://www.ncbi.nlm.nih.gov/pubmed/29064334.
About the SITC Annual Meeting
The Society for Immunotherapy of Cancer (SITC) is a non-profit
medical professional society of influential scientists,
academicians, researchers, clinicians, government representatives,
and industry leaders from around the world dedicated to improving
cancer patient outcomes by advancing the science and application of
cancer immunotherapy. Currently, SITC has nearly 1,600
members representing 17 medical specialties and are engaged in
research and treatment of at least a dozen types of cancer. The
32nd SITC Annual Meeting & Associated Programs will take place
November 8-12, 2017 at the Gaylord
National Hotel & Convention Center in National Harbor, MD. For
more information, please go to http://www.sitcancer.org/2017.
About PISCES/KEYNOTE-695
PISCES/KEYNOTE-695 is a global, multicenter phase 2b, open-label
trial of intratumoral plasma encoded IL-12 (tavokinogene
telseplasmid or "tavo") delivered by electroporation in combination
with intravenous pembrolizumab in patients with stage III/IV
melanoma who have progressed or are progressing on either
pembrolizumab or nivolumab treatment. The Simon 2-stage study of
intratumoral tavo plus electroporation in combination with
pembrolizumab will enroll approximately 48 patients with
histological diagnosis of melanoma with progressive locally
advanced or metastatic disease defined as Stage III or Stage IV.
The primary endpoint will be the Best Overall Response Rate
(BORR).
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 (tavokinogene telseplasmid
[pIL-12] or "tavo"). In Phase 1 and 2 clinical trials, ImmunoPulse®
IL-12 has demonstrated a favorable safety profile, evidence of
anti-tumor activity in the treatment of various solid tumors, and
the potential to reach beyond the site of local treatment to
initiate a systemic immune response. OncoSec's lead program,
ImmunoPulse IL-12, is currently in clinical development for
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 have relapsed on
anti-PD-1 therapies. In addition to tavo, 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.
University of California
Disclaimer
The information stated above was prepared by OncoSec Inc. and
reflects solely the opinion of the corporation. Nothing in this
statement shall be construed to imply any support or endorsement of
OncoSec, or any of its products, by The Regents of the University of California, its officers, agents and
employees.
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, including statements about OncoSec's business strategies,
including advancement of its lead melanoma program and its broader
clinical portfolio and plans to pursue collaborations with industry
partners, as well as the potential contributions and impact of new
directors on these strategies. In some cases, you can identify
forward-looking statements by terminology such as "may", "should",
"expects", "plans", "anticipates", "believes", "estimates",
"predicts", "potential" or "continue" or the negative of these
terms or other comparable terminology.
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 OncoSec's 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: the status, progress and results of clinical programs;
ability to obtain regulatory approvals for, and the level of market
opportunity for, OncoSec's product candidates; OncoSec's business
plans, strategies and objectives, including plans to pursue
collaboration, licensing or other similar arrangements or
transactions; expectations regarding OncoSec's liquidity and
performance, including expense levels, sources of capital and
ability to maintain operations as a going concern; the competitive
landscape of OncoSec's industry; and general market, economic and
political conditions; and the other factors discussed in OncoSec's
filings with the Securities and Exchange Commission, including its
annual report on Form 10-K for the year ended July 31, 2017.
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.
CONTACT:
Investor Relations:
OncoSec Medical Incorporated
Phone: 855-662-6732
investors@oncosec.com
Media Relations:
OncoSec Medical Incorporated
Phone: 855-662-6732
media@oncosec.com
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