Kiromic Biopharma Has Received Authorization from The FDA To Commence A Phase 1 Clinical Trial to Evaluate Deltacel In the Treatment of Non-Small Cell Lung Cancer
In order to create cell therapies with a focus on immuno-oncology, Kiromic Bio Pharma, today announced that the U.S. Food and Drug Administration (FDA) has approved the company’s Investigational New Drug (IND) application to launch a Phase 1 clinical trial to assess Deltacel.
The company’s allogeneic, non-engineered, over-the-counter Gamma Delta T-cell (GDT) therapy is called Deltacel. Notably, unlike many other cell therapies, Deltacel does not require the use of a viral vector, which, among other benefits, enables lower manufacturing costs. Kiromic is using cell therapy to treat solid tumors in an effort to fill a huge unmet need.
“We can now push our GDT therapeutic candidate into the clinic with FDA’s approval to deliver Deltacel to patients. We anticipate the chance for Deltacel to meaningfully affect the hundreds of thousands of patients with non-small cell lung cancer and other solid cancers as a potentially well tolerated and effective treatment, said Pietro Bersani, Chief Executive Officer of Kiromic Bio pharma.
Kiromic Bio Pharma, based out of Texas, USA, is a biotherapeutics company focusing on the clinical stage, with a primary goal of using its proprietary DIAMOND® artificial intelligence (AI) 2.0 target discovery engine to develop and bring to market cell therapies for immuno-oncology. Its current focus is on a multi-indication allogeneic cell therapy platform that harnesses the natural potency of Gamma Delta T-cells to target solid tumors.