Kiromic BioPharma is a biotechnology company focused on developing the next generation of cancer immunotherapies. The company was founded in 2012 and has obtained an IND for both solid and hematological malignancies. Kiromic’s product candidate pipeline is built on a foundation of proprietary cancer-specific targets and novel delivery technologies that will change the way cancer is treated.
Immunotherapy has the potential to provide the cure for cancer, however, current therapies in development have experienced poor response rates, high toxicity, and negative side effects – issues similar to conventional cancer treatments. The immunotherapies are also costly to produce and are parenterally administered due to the usage of “living” active ingredients (such as cells). The immunotherapies also often have low patient eligibility and high toxicity because the active ingredients target uncommon cancer-associated biomarkers expressed on both healthy and tumor cells, which leads to poor efficacy and on-target off-tumor related toxicities.
To address the current limitations for immunotherapy, Kiromic developed BSK02, the first synthetic, orally-administered cancer immunotherapy with the potential to treat patients with solid and hematological malignancies. Using over eighteen years of research on five cancer-associated biomarkers, Kiromic designed BSK02 to use these five immunostimulants capable of educating the immune system to selectively seek out tumors expressing any of the five related biomarkers. These five immunostimulants are delivered to the immune system using Kiromic’s “protective packaging”: a proprietary synthetic, biodegradable microparticle system that protects the immunostimulants from harsh conditions in the GI tract and precisely delivers them to immune cells capable of initiating an anti-tumor attack. The microparticle system addresses many of the major issues associated with the first generation of immunotherapies, as it can be stored at room temperature, is orally administered, and is cheaper to produce and distribute compared to other immunotherapies in development.
Each BSK02 pill contains immunostimulants that are tumor-tailored, i.e. the five immunostimulants can be mixed-and- matched to produce multiple pill combinations so that physicians may prescribe the optimal therapy that best matches each patient’s tumor. This “tumor-tailoring” results in reduced toxicities associated with the therapy and, therefore, less side-effects for patients. Plus the thirty-one different “off-the-shelf” pill combinations widen BSK02’s potential market impact.
The BLADE™-SMART platforms are key elements of Kiromic’s parenteral (BSK01) and first-in-class oral (BSK02) therapies. A phase I/II trial of parenteral BSK01 is in the final stages of preparation to initiate in Q3 2017 at the MD Anderson Cancer Center (Houston, TX) in patients with Acute Myeloid Leukemia. The follow-on development of the Oral Delivery Platform (ODP) will be used to further validate the parenteral development program, which in June 2016 was granted an orphan-drug designation (ODD) by the FDA for BSK02 for the treatment of ovarian cancer. Both programs will employ a customized patient and tumor–specific combination of cancer-specific immunotargets, immune-stimulatory compounds, and for the oral program, lymphatic system targeting moieties. Both approaches will be developed with the objective of safely and effectively eliciting a powerful, highly selective, and durable programmed immunogenic response against cancer cells throughout the patient’s body.
Kiromic’s mission is to create the next generation of immunotherapy products that will safely and precisely reprogram a patient’s immune system.