Complete stage 1 enrollment of PISCES/KEYNOTE-695 clinical trial of ImmunoPulse® IL-12 in combination with KEYTRUDA® (pembrolizumab)
Present preliminary data from PISCES/KEYNOTE-695 at a medical meeting
Seek preliminary FDA feedback on accelerated approval pathway
Apply for advanced-therapy medicinal product (ATMP) classification in EU
OncoSec Medical Incorporated (“OncoSec” or the “Company”) (ONCS), a company developing intratumoral cancer immunotherapies, announced its anticipated operational milestones for 2018 and a review of business highlights for year-end 2017.
“The momentum we achieved in late 2017 provides the foundation for a transformational year in 2018,” said Daniel J. O’Connor, Chief Executive Officer of OncoSec. “The year ahead is critical for OncoSec with preliminary data expected in key clinical programs; preliminary feedback from regulators on an accelerated approval pathway for ImmunoPulse® IL-12 in unresectable metastatic melanoma patients who have progressed or are progressing on an anti-PD-1 therapy; and advances in our intratumoral delivery platform.”
He continued, “Operational execution will dominate 2018, with a focus on laying the groundwork for future BLA and IND filings. We plan to conduct a second clinical trial in triple negative breast cancer (TNBC), as well as two investigator sponsored trials in squamous cell carcinoma of the head and neck (SCCHN) and in the melanoma neoadjuvant setting. These trials will be in combination with anti-PD-1 therapy. We look forward to sharing progress toward our vision throughout the year: to have multiple products that will make a dramatic patient impact and an innovative pipeline driven by a sustainable product engine.”
2018 OPERATIONAL MILESTONES
OncoSec anticipates the following operational milestones in 2018:
ImmunoPulse IL-12 Melanoma
- Complete stage 1 enrollment of PISCES/KEYNOTE-695; a Phase 2b registration-directed clinical trial of ImmunoPulse IL-12 (intratumoral pIL-12 [tavokinogene telseplasmid or "tavo"] with electroporation), in combination with KEYTRUDA®(pembrolizumab) for patients with unresectable metastatic melanoma who have progressed or are progressing on an anti-PD-1 therapy
- Present preliminary data from PISCES/KEYNOTE-695 at a medical meeting
- Seek preliminary FDA feedback on an accelerated approval pathway for ImmunoPulse IL-12 Biologics License Application (BLA) in patients with unresectable metastatic melanoma who have progressed or are progressing on an approved anti-PD-1 therapy
- Apply for classification as an Advanced-Therapy Medicinal Product (ATMP) for the treatment of unresectable metastatic melanoma who have progressed or are progressing on an approved anti-PD-1 therapy by the European Medicines Agency’s Committee for Advanced Therapies (CAT)
- Prepare to commercially launch ImmuoPulse IL-12 in the U.S.
- Initiate a Phase 2 investigator-sponsored clinical trial in combination with an anti-PD-1 therapy in the neoadjuvant setting
ImmunoPulse IL-12 Triple Negative Brest Cancer (TNBC)
- Provide update of preliminary clinical observations for OMS-I140 TNBC pilot study conducted in collaboration with the Stanford University Medical Center
- Present preliminary data for OMS-I140 TNBC study at a medical meeting
- Initiate a Phase 2 clinical trial in combination with an anti-PD-1 therapy in the recurrent and/or metastatic setting
ImmunoPulse IL-12 Squamous Cell Carcinoma of the Head and Neck (SCCHN)
- Initiate a Phase 2 investigator-sponsored clinical study in combination with two other immunotherapies in the recurrent and/or metastatic setting
- Seek partner for the development, registration and commercialization of ImmunoPulse IL-12 in metastatic melanoma in the U.S. and EU, as well as in other important regions
- Pursue multiple partnerships and collaborations for cancer immunotherapy platform to enable additional research in combination with other cancer therapies and novel immunotherapies
Expanding Clinical Pipeline
- Prepare an IND for a second product candidate utilizing our proprietary, multi-gene expression Polycistronic Interleukin-12 Immune Modulator (PIIM) platform technology
Enhanced Platform Engineering and Manufacturing
- Advance second-generation proprietary GENESIS™ generator to be ready for introduction into the clinic
- Advance proprietary applicators in cancer indications beyond cutaneous and subcutaneous tumors
- Undertake technology transfers with partners and install new innovative technologies to improve the overall supply chain
2017 OPERATIONAL MILESTONE REVIEW
OncoSec achieved several important clinical, regulatory, business and operational milestones during 2017.
ImmunoPulse IL-12 Metastatic Melanoma
- Presented updated positive long-term follow-up data from our Phase 2 trial of ImmunoPulse IL-12 in combination with KEYTRUDA (pembrolizumab) at the 2017 Society for Immunotherapy of Cancer Annual Meeting
- Presented preclinical data demonstrating multigene platform for delivery of multiple cancer immunotherapies at the 2017 Society for Immunotherapy of Cancer Annual Meeting
- Announced the initiation of global, multi-center, registration-directed open-label PISCES/KEYNOTE-695 Phase 2b clinical trial, evaluating the combination of ImmunoPulse IL-12 and pembrolizumab in patients with unresectable metastatic melanoma who have progressed or are progressing on an approved anti-PD-1 therapy
- Granted Orphan Drug Designation for ImmunoPulse IL-12 for the treatment of unresectable metastatic melanoma from U.S. Food and Drug Administration (FDA)
- Granted Fast Track designation from the FDA for ImmunoPulse IL-12 in combination with pembrolizumab for stage III/IV melanoma patients who are progressing or who have progressed on either pembrolizumab or nivolumab treatment
Technology Access Program
- Established the OncoSec Technology Access Program (TAP) using OncoSec’s proprietary GENESIS™ research generator, which was developed specifically for gene electro-transfer and features customizable electroporation parameters for construct-specific optimization of expression. It is the only in vivo electroporation device enabled with TRACE™ Technology (Tissue-Based, Real-Time Adaptive Control Electroporation)
- Appointed Daniel J. O’Connor, JD, as Chief Executive Officer and Director
- Expanded intellectual property estate for ImmunoPulse Platform
- Completed two successful public offerings of common stock and warrant exercise, raising net proceeds of $17.5 million
- Promoted Christopher G. Twitty, Ph.D. to Chief Scientific Officer
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
ImmunoPulse® is a registered trademark of OncoSec Medical Incorporated, San Diego, CA, USA.
About Metastatic Melanoma
Melanoma is a type of skin cancer that begins in skin cells called melanocytes. As the cancer progresses and begins to spreads beyond the skin, such as to the lymphatic system (metastatic disease), melanoma becomes more difficult to treat. Given its occurrence in young individuals, the potential years of life lost to melanoma can be higher when compared with other cancers. Although melanoma is a rare form of skin cancer, it accounts for over 75% of skin cancer deaths. The American Cancer Society estimates that approximately 87,000 new melanoma cases and 10,000 deaths from the disease will have occurred in the United States in 2017. Additionally, the World Health Organization estimates that approximately 132,000 new cases of melanoma are diagnosed around the world every year.
About PISCES (Anti-PD-1 IL-12 Stage III/IV Combination Electroporation Study)/KEYNOTE-695
PISCES/KEYNOTE-695 is a global, multicenter phase 2b, open-label trial of intratumoral plasmid-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).
To learn more about the trial, visit http://www.piscesclinicaltrial.com. Additional details can also be found at www.clinicaltrials.gov via NCT03132675.