GOLDEN, Colo.–PharmaJet®, a company that engineers precision delivery systems that overcome the challenges of vaccine and pharmaceutical companies, today announced that their partner Immunomic Therapeutics received FDA fast track designation (FTD) for the clinical study of their plasmid DNA vaccine ITI-3000 in patients with Merkel cell carcinoma (MCC), a rare but aggressive form of skin cancer. Enrollment is in progress for the phase 1 study that exclusively uses the PharmaJet Stratis Needle-free Injection System (NFIS).
“We are pleased that our partner Immunomic Therapeutics has received fast track designation for this important DNA therapeutic for aggressive skin cancer”
“The FDA’s decision to grant FTD underscores the potential for the ITI-3000 program to address a serious unmet need and serve as a meaningful therapeutic option for patients with Merkel cell carcinoma,” stated Dr. William Hearl, Chief Executive Officer of ITI. “We are committed to unlocking the full potential of ITI-3000 in patients with this aggressive form of skin cancer. We expect to report top-line data from our ongoing phase 1 trial of ITI-3000 in MCC patients next year and look forward to working closely with the FDA on a potential next phase clinical study design, while simultaneously continuing dialogue with possible partners.” The PharmaJet Stratis® NFIS was chosen due to its ability to precisely deliver the vaccine to the intramuscular tissue layer.
“We are pleased that our partner Immunomic Therapeutics has received fast track designation for this important DNA therapeutic for aggressive skin cancer,” said Chris Cappello, President and CEO, PharmaJet. “The PharmaJet NFIS have been used successfully in administration of therapeutics for the prevention or treatment of lymphoma, advanced solid tumors, HPV and other oncology applications.”
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PharmaJet’s vision is to enable greater access to life-saving vaccines and pharmaceuticals globally. We are committed to helping our partners realize their research and commercialization goals while making an impact on public health. PharmaJet Needle-free Systems provide increased vaccine effectiveness, a preferred patient and caregiver experience, and a proven path to commercialization. They are also safe, fast, and easy-to-use. The Stratis® System has U.S. FDA 510(k) marketing clearance, CE Mark, and WHO PQS certification to deliver medications and vaccines either intramuscularly or subcutaneously. The Tropis® System has CE Mark and WHO PQS certification for intradermal injections. For more information visit https://pharmajet.com. Follow us on LinkedIn.
About Immunomic Therapeutics, Inc.
Immunomic Therapeutics, Inc. (ITI) is a privately held, clinical-stage biotechnology company pioneering the development of vaccines through its proprietary technology platform UNITE, which is designed to utilize the body’s natural biochemistry to develop vaccines that generate broad immune responses. ITI is primarily focused on applying the UNITE platform to oncology indications, where it could potentially have broad applications, including development of antigen-derived antibodies as biologics in a number of cancers. The company has built a pipeline leveraging UNITE with programs in oncology, animal health, infectious disease, and allergy. ITI maintains its headquarters in Rockville, Maryland. For more information, please visit www.immunomix.com.
About Fast Track Designation
Fast Track Designation is designed to facilitate the development and expedite the FDA review of drugs to treat serious conditions and fulfill unmet medical needs, enabling drugs to reach patients earlier. Clinical programs with Fast Track Designation benefit from early and frequent communication with the FDA throughout the regulatory review process. These clinical programs may also be eligible to apply for accelerated approval and breakthrough designation review by the FDA if relevant criteria are met.