Monday, August 08, 2016 8:23:23 AM
The FDA and European Medicines Agency provided an affirmative path toward an indication for VGX-3100 to treat HPV-16/18-related high grade cervical dysplasia in a pivotal phase III registration study. We completed major commercial device design and manufacturing process development efforts, and are in the final stage of testing. Completion of this extensive work will enable us to then submit our final package to the FDA in order to start the phase III in 4Q 2016.
Received approval from the FDA to initiate a phase I human trial to evaluate Inovio’s Zika DNA vaccine (GLS-5700). This phase I, open-label, dose-ranging study with 40 healthy subjects is evaluating the safety, tolerability and immunogenicity of GLS-5700. Subsequent to the quarter Inovio announced the dosing of the first subject in this study. We expect to report interim immune response and safety data in 4Q 2016.
Inovio will continue to develop its hepatitis B DNA immunotherapy (INO-1800) independently following Roche’s notice that it will discontinue its collaboration with Inovio and its development of INO-1800. INO-1800 was licensed to Roche from Inovio in 2013. All of Roche's rights to INO-1800, including the right to license the product to other parties, will be returned. Inovio will continue to advance its current phase I study of INO-1800, which is enrolling as planned in 30 clinical sites in the U.S. and Asia-Pacific regions. Inovio anticipates completing enrollment in the first half of 2017 and expects results in the second half of 2017. The study has completed interim safety reviews with a favorable safety profile to date. Immunology analyses are planned after completion of enrollment.
Partnered with the National Cancer Institute and Mayo Clinic to initiate a phase I trial of our immunotherapy for hepatitis C (INO-8000). The dose escalation study will enroll patients in the early stages of chronic HCV infection to determine the therapy’s ability to decrease and potentially eliminate HCV viral load, measure HCV specific immune responses and durability of these immune responses, and evaluate safety and tolerability.
Completed enrollment of 94 subjects in the phase I study of our PENNVAX®-GP HIV immunotherapy. After completing extensive immunogenicity analyses, we expect to report data in 1H 2017.
Completed enrollment of 22 subjects in the phase I study of our HPV-driven cancer immunotherapy, INO-3112, in head & neck cancer patients. We expect to report additional immune response and safety data in 4Q 2016. (own addition: Keytruda just got approved in H&N, would be great combo)
Completed enrollment of 62 subjects in the phase I study of our INO-5150 prostate cancer immunotherapy. We expect to report interim immune response and safety data in 4Q 2016.
Completed enrollment of 75 subjects in the phase I study of our GLS-5300 MERS vaccine. We expect to report interim immune response and safety data in 4Q 2016.
Recent INO News
- INOVIO to Present at Upcoming Scientific Conference • PR Newswire (US) • 09/17/2024 08:30:00 PM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 08/13/2024 10:22:02 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/13/2024 10:06:54 AM
- INOVIO Reports Second Quarter 2024 Financial Results and Recent Business Highlights • PR Newswire (US) • 08/08/2024 08:05:00 PM
- INOVIO Reports Inducement Grant Under Inducement Plan • PR Newswire (US) • 08/01/2024 08:05:00 PM
- Inovio Receives Advanced Therapy Medicinal Product Certificate from European Medicines Agency for Quality and Non-Clinical Data for Lead Candidate INO-3107 • PR Newswire (US) • 07/25/2024 08:05:00 PM
- INOVIO to Report Second Quarter 2024 Financial Results on August 8, 2024 • PR Newswire (US) • 07/25/2024 12:00:00 PM
- INO-3107 Awarded the Innovation Passport Designation Under U.K. Government's Innovative Licensing and Access Pathway • PR Newswire (US) • 07/11/2024 12:00:00 PM
- INOVIO Announces Appointment of Steven Egge as Chief Commercial Officer • PR Newswire (US) • 07/02/2024 08:05:00 PM
- INOVIO Reports Inducement Grant Under Inducement Plan • PR Newswire (US) • 07/01/2024 08:00:00 PM
- INOVIO Added to Russell 2000® Index Effective July 1, 2024 • PR Newswire (US) • 07/01/2024 12:00:00 PM
- INOVIO to Participate in Virtual Fireside Chat Hosted by Stephens Inc. • PR Newswire (US) • 06/04/2024 12:00:00 PM
- INOVIO Reports Inducement Grants Under Inducement Plan • PR Newswire (US) • 05/31/2024 08:48:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/28/2024 08:01:02 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/22/2024 08:51:58 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/22/2024 08:51:38 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/22/2024 08:51:16 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/22/2024 08:51:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/22/2024 08:50:34 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/22/2024 08:50:11 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/22/2024 08:49:53 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/16/2024 09:13:02 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/16/2024 09:12:10 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/16/2024 09:11:09 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/16/2024 09:10:00 PM
Maybacks Global Entertainment and Lingerie Fighting Championships Enter Into Broadcast And Revenue Sharing Agreement • AHRO • Sep 26, 2024 8:30 AM
North Bay Resources Commences Operations at Bishop Gold Mill, Inyo County, California; Engages Sabean Group Management Consulting • NBRI • Sep 25, 2024 9:15 AM
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Cannabix Technologies and Omega Laboratories Inc. Advance Marijuana Breathalyzer Technology - Dr. Bruce Goldberger to Present at Society of Forensic Toxicologists Conference • BLOZF • Sep 24, 2024 8:50 AM
Integrated Ventures, Inc Announces Strategic Partnership For GLP-1 (Semaglutide) Procurement Through MedWell USA, LLC. • INTV • Sep 24, 2024 8:45 AM
Avant Technologies Accelerates Creation of AI-Powered Platform to Revolutionize Patient Care • AVAI • Sep 24, 2024 8:00 AM