VerImmune Announces Positive Pre-IND Meeting with FDA
Favorable feedback and clear development path for VERI-101, a novel Immunotherapy
WASHINGTON, May 22, 2023 /PRNewswire/ -- VerImmune Inc ("VerImmune"), an early-stage biotechnology company specializing in the development of innovative products based on a novel Virus-inspired Particle (ViP™) technology platform, today announced the successful completion of a Type B pre-IND meeting with the US Food and Drug Administration (FDA) for its groundbreaking VERI-101 immuno-oncology lead product for the treatment of multiple solid tumors.
The primary objective of the pre-IND meeting was to seek FDA concurrence on VerImmune's manufacturing, control strategies and development plans, the design of non-clinical IND-enabling studies, and guidance on the proposed first-in-human clinical trial in cancer patients for VERI-101. The FDA provided clear and constructive feedback in the form of written responses to the Pre-IND package and questions submitted by VerImmune. This feedback from the FDA on the overall development strategy empowers VerImmune to advance towards the IND preparation and submission of VERI-101.
Joshua Wang, Ph.D., Founder and CEO of VerImmune Inc., commented, "This milestone for our startup is of paramount importance as it provides regulatory clarity, paving the way for our new ViP-based modality as well as our highly novel immunotherapy approach to advance to clinical trials. We are thrilled by the positive and valuable feedback received from the FDA, which enables us to efficiently execute the necessary steps for IND approval. I want to express my gratitude to our exceptional team and dedicated advisors who have worked tirelessly to reach this stage."
VerImmune's primary focus lies in the field of Oncology, wherein the ViP technology enables a pioneering first-in-class cancer immunotherapy approach known as Anti-tumor Immune Redirection (AIR). This innovative method harnesses the body's pre-existing immune system, specifically by leveraging the immune memory from past infections or childhood vaccination to combat cancer. By taking a highly orthogonal approach, VerImmune's technology holds immense potential to revolutionize the Immuno-Oncology market, offering new treatment possibilities for patients facing limited options or resistance to current cancer therapies.
About VerImmune
VerImmune is at the forefront of innovation, dedicated to the development of a groundbreaking first-in-class cancer immunotherapy called Anti-tumor Immune Redirection (AIR). This unique strategy leverages a proprietary virus-inspired particle (ViP) technology platform to redirect pre-existing pathogenic or childhood vaccine immune memory toward tumors. VerImmune's lead immuno-oncology product candidate, VERI-101, utilizes the ViP platform to harnesses the cellular immune memory responses from prior cytomegalovirus (CMV) infection to fight cancer. Such a mechanism of action not only differentiates VerImmune within the competitive Immuno-Oncology market but also has the potential to redefine the treatment paradigm, as a stand-alone product or in combination with other immunotherapies, for patients with untreatable cancers or resistance to existing therapies. For more information, please visit http://www.verimmune.com.