Generex Signs Letter of Intent with Kiromic to Mer

Generex Signs Letter of Intent with Kiromic to Merge with NuGenerex Immuno-Oncology Forming a Multi-Platform Clinical Stage Immunotherapy Company
9:00 AM ET, 06/25/2019 - GlobeNewswire
MIRAMAR, Fla., June 25, 2019 (GLOBE NEWSWIRE) -- Generex Biotechnology Corporation (“Generex”) (www.generex.com) (OTCQB:GNBT) (http://www.otcmarkets.com/stock/GNBT/quote) today announced that Generex has signed a Letter of Intent (“LOI”) with Kiromic, Inc., a clinical stage immunotherapy company (“Kiromic”), to merge into a newly formed Generex entity, called NuGenerex Immuno-Oncology, in an all-stock transaction. With the merger, NuGenerex Immuno-Oncology will house both Kiromic and our subsidiary Antigen Express, Inc., which is developing AE37 in combination with check point inhibitors for the treatment of triple negative breast cancer. Together, the broad technology portfolio and deep pipeline opportunities provided in the merger position NuGenerex Immuno-Oncology on the forefront of cancer immunotherapy.

Kiromic, which is collaborating with MD Anderson Cancer Center, has multiple patented proprietary immuno-oncology platforms, including CAR-T, CAR NK, an oral vaccine delivery system, and DIAMOND AI, an artificial intelligence system with a multifaceted predictive algorithm that combines genomic sequencing, proteomic analysis, and clinical data to identify novel tumor mutations that can be targeted with immunotherapy. Kiromic has used the DIAMOND AI technology to identify and validate several cancer biomarkers, including SP17, which was granted an orphan indication for ovarian cancer, and is in early-stage clinical trials with the injectable formulation, and has filed an FDA IND for its oral formulation. In addition to advancing the ovarian cancer program, we plan to advance Kiromic’s proprietary CAR-T and CAR NK technologies into proof of concept clinical trials. We also have many exciting opportunities to implement the DIAMOND AI technology in cooperation with academic partners at leading cancer research institutions across the country to not only identify new cancer antigens, but also to build out the multifaceted database with genomic, proteomic, and clinical data to guide personalized treatment regimens based on a patient’s tumor profile. Kiromic is led by its founder, Dr. Maurizio Chiriva-Internati, who was previously a faculty member in the Department of Internal Medicine and Director of Basic/Translational Research Program at Texas Tech University Health Sciences Center, Lubbock, TX, USA, and an Associate Professor, (Adjunct) in the Department of Lymphoma and Multiple Myeloma at the University of Texas MD Anderson Cancer Center (MDACC), and who is currently a senior research scientist in the department of gastroenterology at MDACC.

“We are very fortunate to have Dr. Chiriva-Internati leading our research and clinical development efforts for NuGenerex Immuno-Oncology as we build a world-class immunotherapy company with three new platforms,” said Joe Moscato, CEO of Generex. “He is world-renowned in the oncology community through his research at Texas Tech and his clinical work at M.D. Anderson Cancer Center. His discoveries, including the DIAMOND AI artificial intelligence algorithms, CAR-T and CAR NK platforms, and oral vaccine technologies have shown proof-of-concept, and we look forward to great developments in the future.”

Dr. Chiriva-Internati added, “I am excited to join NuGenerex Immuno-Oncology as we build a world-class oncology company that integrates genomic, proteomic, and molecular data sets to identify and validate cancer biomarkers. The Ii-Key technology enables rapid product development and a clear regulatory path for immunotherapeutic peptides that have been proven safe and effective for eliciting immune responses for cancer therapy. The future is bright for advancing immunotherapy as the new standard of care for cancer treatment.”