OncoSec to Present Encore Interim Data from the KEYNOTE-695 Phase 2b Clinical Trial at the 10th World Congress of Melanoma

Rhea-AI Summary

OncoSec Medical (NASDAQ: ONCS) announced it will present encore interim data from its KEYNOTE-695 Phase 2b trial for TAVO™ (tavokinogene telseplasmid) in combination with KEYTRUDA® at the 10th World Congress of Melanoma. The trial targets anti-PD-1 resistant metastatic melanoma patients. Results indicate a 30% overall response rate with no serious adverse events, suggesting significant therapeutic potential. TAVO has received Fast Track Designation from the FDA for use in metastatic melanoma, enhancing its clinical development prospects.

Positive

• 30% overall response rate in trial participants.
• No serious adverse events reported.
• TAVO received Fast Track Designation from the FDA.

Negative

• None.

PENNINGTON, N.J. and SAN DIEGO, April 15, 2021 /PRNewswire/ -- OncoSec Medical Incorporated (NASDAQ:ONCS) (the "Company" or "OncoSec"), a biotechnology company focused on cytokine-based intratumoral immunotherapies, today announced that it will be presenting encore interim data from its KEYNOTE-695 registration-enabled Phase 2b clinical trial evaluating TAVO™ (tavokinogene telseplasmid), a DNA plasmid-based interleukin-12 (IL-12), in combination with KEYTRUDA^® (pembrolizumab) in rigorously defined anti-PD1 checkpoint resistant metastatic melanoma patients at the 10^th World Congress of Melanoma. This is an encore presentation of data presented at The Society for Immunotherapy of Cancer's (SITC) 2020 Annual Meeting. Presenters will also discuss the therapeutic potential of OncoSec's DNA medicines platform to elicit robust anti-tumor immunity via intratumoral gene electrotransfer of TAVO plus CXCL9.

"Achieving an overall response rate of 30% with several complete responses and no serious adverse events is extremely encouraging for checkpoint resistant metastatic melanoma patients who currently rely on systemic administration of immune-stimulating drugs  associated with severe toxicity," said Paolo A. Ascierto, M.D., Director of the Unit of Melanoma, Cancer Immunotherapy and Innovative Therapy at the National Tumor Institute Fondazione G. Pascale in Naples, Italy. "The data reported, in addition to its ease of use, demonstrate the potential of TAVO in combination with pembrolizumab as a next-generation intratumoral IL-12 therapy that can induce regression of both locally treated and untreated distant and visceral lesions."

OncoSec's presentation is summarized below:

Introduction
Presenter: Christopher G. Twitty, Ph.D.
Session Date/Time: Saturday, April 17, 2021, 4:15 p.m. – 4:18 p.m. ET

OncoSec's KEYNOTE-695 interim data
Presenter: Paolo Ascierto, M.D.
Session Date/Time: Saturday, April 17, 2021, 4:18 p.m. – 4:28 p.m. ET

OncoSec's next generation therapies: amplification of the CRX3/CXCL9 axis via intratumoral electroporation of CXCL9 synergizes with IL-12 therapy (TAVO) to elicit robust anti-tumor immunity
Presenter: Christopher G. Twitty, Ph.D.
Session Date/Time: Saturday, April 17, 2021, 4:28 p.m. – 4:48 p.m. ET

Live Q&A
Presenters: Christopher G. Twitty, Ph.D., Paolo Ascierto, M.D.
Session Date/Time: Saturday, April 17, 4:48 p.m. – 5:15 p.m. ET

The conference will be held virtually from April 15 – 17, 2021. To access the conference virtual platform, visit: https://worldmelanoma2021.com/login-virtual-platform.

About KEYNOTE-695
KEYNOTE-695 is OncoSec's registration-directed Phase 2b trial (NCT#03132675) evaluating TAVO™ (tavokinogene telseplasmid), a DNA plasmid-based interleukin-12 (IL-12) + KEYTRUDA® (pembrolizumab) in patients with rigorously confirmed anti-PD-1 checkpoint resistant metastatic melanoma. The trial aims to enroll up to 100 patients with 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). TAVO™ has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for the treatment of metastatic melanoma following progression on KEYTRUDA or OPDIVO.

About TAVO™ 
OncoSec's gene therapy technology combines TAVO  (tavokinogene telseplasmid), a DNA plasmid-based interleukin-12 (IL-12), with an intra-tumoral electroporation gene delivery platform to achieve endogenous IL-12 production in the tumor microenvironment that enables the immune system to target and attack tumors throughout the body. TAVO  has demonstrated a local and systemic anti-tumor response in several clinical trials, including the pivotal Phase 2b trial KEYNOTE-695 for metastatic melanoma and the KEYNOTE-890 Phase 2 trial in triple negative breast cancer (TNBC). TAVO™ has received both Orphan Drug and Fast-Track Designation by the U.S.  Food & Drug Administration for the treatment of metastatic melanoma.

About OncoSec Medical Incorporated
OncoSec Medical Incorporated (the "Company," "OncoSec," "we" or "our") is a 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 along with an acceptable safety profile, warranting further development. In addition to TAVO™, OncoSec is identifying and developing new DNA-encoded therapeutic candidates and tumor indications for use with its new Visceral Lesion Applicator (VLA), to target deep visceral lesions, such as liver, lung or pancreatic lesions. For more information, please visit www.oncosec.com.

TAVO™ is a trademark of OncoSec Medical Incorporated.

Company Contact
Brian Leuthner
Chief Operating Officer 
investors@oncosec.com 

Media Contact
Patrick Bursey
LifeSci Communications
+1-646-970-4688
pbursey@lifescicomms.com 

 

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SOURCE OncoSec Medical Incorporated

FAQ

What are the results from the KEYNOTE-695 trial presented by OncoSec on April 17, 2021?

The results show a 30% overall response rate with no serious adverse events among anti-PD-1 resistant melanoma patients.

What is TAVO and its significance in cancer treatment?

TAVO is a DNA plasmid-based interleukin-12 therapy that aims to stimulate the immune system to attack tumors, showing promise in treating metastatic melanoma.

When will OncoSec present its clinical trial data?

OncoSec will present its KEYNOTE-695 interim data on April 17, 2021, from 4:18 p.m. to 4:28 p.m. ET.

What is the purpose of the KEYNOTE-695 trial?

The trial is designed to evaluate TAVO in combination with KEYTRUDA in patients with metastatic melanoma who are resistant to anti-PD-1 treatments.

How does TAVO work in combination with KEYTRUDA?

TAVO works by intratumoral delivery of interleukin-12 to enhance anti-tumor immunity, potentially increasing the effectiveness of KEYTRUDA.