Raven biotechnologies Files First Investigational New Drug Application (IND)
Tuesday November 16, 7:31 am ET
Filing Follows Data Presented on RAV12 at Recent EORTC-NCI-AACR Symposium
[Forgetting for a moment the Hu in HuMAB. Any ideas why they are going forward with a chimeric antibody? I thought that would more or less represent an invitation for disaster to strike].
SOUTH SAN FRANCISCO, Calif., Nov. 16 /PRNewswire/ -- Raven biotechnologies, inc. announced today the submission of an Investigational New Drug Application (IND), seeking permission from the U.S. Food and Drug Administration (FDA) to initiate a Phase 1 clinical trial for RAV12, a therapeutic monoclonal antibody (MAb), in patients with advanced stage adenocarcinoma.
"Our first IND filing is a major milestone for Raven and brings us closer to meeting a seriously unmet medical need for patients suffering from GI cancers," said Jennie Mather, Ph.D., President and CEO of Raven. "Raven is exclusively focused on finding therapeutic antibodies for cancer. This IND also validates the power of our discovery platform and demonstrates our ability to efficiently bring drug candidates from our own internal research program to the clinic."
The Phase 1, open-label, dose-escalation clinical trial for RAV12 in patients with adenocarcinomas is planned to begin enrolling patients after IND activation by the FDA. This multicenter U.S. trial will include patients with colon, stomach or pancreatic cancer, or other target antigen positive adenocarcinomas, including breast, lung and prostate. The trial is designed to measure the safety and tolerability of RAV12. Patient enrollment will not commence until review of the IND application by the FDA is complete.
About RAV12 - Therapeutic Antibody for Cancer
RAV12 is a high affinity IgG1 chimeric antibody recognizing a primate restricted N-linked carbohydrate epitope expressed on a number of human carcinomas, especially adenocarcinomas. Preclinical studies have reported that RAV12 is directly cytotoxic against human colon cell lines in vitro. The mechanism of action of RAV12 appears to involve the induction of oncotic cell death, characterized by cell and organelle swelling and loss of membrane integrity. RAV12 is highly efficacious in colon, gastric and pancreatic tumor xenograft models in vivo and has been found to be well tolerated in repeat dose toxicology studies. |
