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OncoSec Medical Incorporated (NASDAQ: ONCS) (the "Company" or "OncoSec") today announced new positive 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.
TAVO + KEYTRUDA led to a 30% ORR in the first 54 out of 100 planned patients. This interim investigator assessed ORR is much higher than the primary efficacy endpoint for the study, which is a 20% ORR determined by blinded independent review. The data were selected for a Poster Walk discussion and will be additionally presented in the virtual Poster Hall on Wednesday, November 11 and Friday November 13 and as part of a Company Symposium on November 11th at the Society for Immunotherapy of Cancer (SITC)'s 35th Anniversary Annual Meeting.
"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. 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," 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.
Key highlights of KEYNOTE-695 include:
- Of the first 54 out of 100 planned patients evaluated by investigator-assessed RECIST v1.1:
- ORR was 30% (95%CI [18.0%, 43.6%]) (16/54)
- Complete response rate was 6% (3/54)
- All responses were confirmed by scans taken no earlier than after 6 months on study
- 9% (5/54) patients had 100% reduction of target lesions
- ORR was 35% (n=6/17) in patients with Stage IV M1c/M1d disease
- ORR was 40% (n=6/15) in patients with prior exposure to ipilimumab
- Median duration of response (mDOR) is currently 12.2 months (95% CI, 5.6-NE)
- Median study follow-up was 13.5 months
- Excellent safety profile resulting from intramural treatment approach
- Only 5.4% Grade 3 treatment-related AEs
- No grade 4/5 treatment-related AEs
- This study enrolled rapidly progressing patients with a short interval of 1.2 months (median) between the last dose of anti-PD-1 and study treatment
Adil Daud, M.D., a Professor of Medicine at The University of California, San Francisco, Director of the Melanoma Clinical Research, and lead author of the study added, "the TAVO-electroporation (TAVO-EP) delivery system works by optimizing cellular uptake of DNA-based IL-12 in the tumor microenvironment, leading to local, sustained production of IL-12 in the tumor, where it matters, with negligible systemic exposure. This recruits and primes immune cancer-fighting cells in the tumor leading to systemic immune responses without systemic toxicity. The totality of the safety and efficacy data establishes TAVO-EP as a best-in-class intratumoral therapy."
Daniel O'Connor, Chief Executive Officer of OncoSec, added "Patients with recurrent metastatic melanoma are in great need of effective treatment options. We believe this data demonstrates not only strong levels of efficacy, but also very low treatment related adverse events with the TAVO + pembrolizumab combo. This, combined with its ease of administration to accessible lesions within minutes in an outpatient setting, plus TAVO's low-cost/simple manufacturing process and its off-the-shelf availability, build a strong case that the TAVO + pembrolizumab combination, in a real-world setting, could equip clinicians with more options for their patients."
OncoSec also announced pre-clinical data showing that CORVax12 triggers an immune response against the SARS-CoV-2 virus. CORVax12 combines OncoSec's novel DNA-encodable vaccine immuno-stimulant IL-12 expression platform, TAVO™ with the National Institute of Health (NIH)'s COVID-19 "spike" protein. On November 3, the Company announced FDA clearance of its Investigational New Drug (IND) application for a first-in-human Phase 1 trial to evaluate the safety and immunogenicity of CORVax12.
Mr. O'Connor continued, "Older adults or immuno-compromised patients, such as cancer patients, may not receive adequate protection from any one of the seven vaccine candidates currently being tested in humans in the U.S. The addition of our proprietary IL-12 delivery system may optimize the immune response to these vaccines and better protect these vulnerable populations. We believe that CORVAx12 represents a second-generation vaccine that has the potential to contribute to the eradication of COVID-19."
Additionally, the company presented preclinical data in murine models of triple negative breast cancer (TNBC) demonstrating that intratumoral injection of TAVO followed by electroporation prior to anti-PD-1 therapy led to complete tumor regression and long-term survival in a significant proportion of mice.
Additional details about the poster presentations, Symposium and Investor & Analyst Day are as follows:
Oral Poster Walk Presentation (by invitation only) and General Poster PresentationTitle: Durable responses and immune activation with intratumoral electroporation of pIL-12 plus pembrolizumab in actively progressing anti-PD-1 refractory advanced melanoma: KEYNOTE 695 interim dataPoster #: 799Date/Time: Wednesday, Nov. 11, from 5:15-5:45 p.m. EST and Friday, Nov. 13, from 4:40-5:10 p.m. EST. at the virtual Poster Hall.Presenter: Adil Daud, M.D., HS Clinical Professor, Department of Medicine (Hematology/Oncology), University of California, San Francisco (UCSF); Director, Melanoma Clinical Research, UCSF Helen Diller Family Comprehensive Cancer Center
Company SymposiumEvent Name: DNA Plasmid-Based IL-12 Delivered Intratumoral Electroporation: Achieving Meaningful Tumor Response while Avoiding Systemic ToxicitiesDate/Time: Thursday, Nov. 12, 2020 from 7:30 – 8:30 a.m. ETPresenters:
- Paulo Ascierto, M.D., Director Dept. of Melanoma, Cancer Immunotherapy, Development Therapeutics, Ist. Naz. Tumori IRCCS Pascale
- Deborah Charych, Ph.D., Founder and Chief Technology Officer at RayzeBio
- Richard Heller, Ph.D., Professor at University of South Florida
- Michael Pritchett, D.O. and M.P.H. ,Director of Thoracic Oncology; Director, Chest Center of the Carolinas; FirstHealth of the Carolinas; Pinehurst Medical Clinic Pulmonary & Critical Care Medicine
- Chris Twitty, Ph.D., Chief Scientific Officer (moderator)
OncoSec Live Investor & Analyst Day WebcastDate/Time: Wednesday, Nov.11, 2020 from 8:30-10:30 a.m. ETPresenters:
- Tara Mitchell, M.D., Penn Medicine
- Adil Daud, M.D., University of California San Francisco
- Alain Algazi, M.D., University of California, San Francisco
- Matteo Carlino, M.D., University of Sydney
- Rohit Joshi, M.D. Calvary Central Districts Hospital
- Bernard Fox, Ph.D., Earle A. Chiles Research Institute
Additional Poster Presentations
Title: Intratumoral plasmid IL-12 expands CD8+ T cells and induces a clinically validated CXCR3 signature in triple-negative breast cancerPoster #: 789Date/Time: Wednesday, November 11, 2020 from 5:15–5:45 p.m. ET and Friday, November 13 from 4:40–5:10 p.m. ETSession: Virtual Poster HallPresenter: Erika J. Crosby, Ph.D., Department of Surgery, Duke University Medical Center
Title: Preliminary evaluation of a novel coronavirus vaccine (CORVax) using electroporation of plasmid DNA encoding a stabilized prefusion SARS-CoV-2 spike protein alone or with transfection of plasmid IL-12Poster #: 480Date/Time: Thursday, November 12, 2020 from 4:50–5:20 p.m. EST and Saturday, November 14 from 1–1:30 p.m. ETSession: Virtual Poster HallPresenter: Shawn M. Jensen, Ph.D., Robert W. Franz Cancer Research Center, Earle A. Chiles Research Institute, Providence Portland Medical Center
Copies of the posters will be archived and available in the Investors section of the Company's website at www.oncosec.com. The live video webcast of the Investor & Analyst day call will be accessible under Events and Presentations in the Investors section of the Company's website. The archived audio webcast will be available on the OncoSec website following the call and will be available for 30 days.