Kiromic: FDA Feedback in Pre-IND Meeting Confirms Development Strategy

Company Reiterates Deltacel is Next Clinical Trial Candidate, with Projected Clinical Trial Launch Expected in Q1 2023

Company is Streamlining Operations to Execute Deltacel-Aligned Development Strategy

Kiromic BioPharma, Inc. (NASDAQ: KRBP) ("Kiromic" or the "Company"), a clinical-stage fully-integrated biotherapeutics company using its proprietary DIAMOND® artificial intelligence and data mining platform to develop cell and gene therapies with a focus on immuno-oncology, announces it received validating written feedback on October 4, 2022 from the FDA pursuant to its Type B Pre-IND meeting request regarding its Deltacel™ development strategy.

The purpose of the Pre-IND meeting request was to seek alignment with and to obtain FDA guidance on Kiromic’s proposed development strategy about the chemistry, manufacturing, and controls (CMC), nonclinical studies, and clinical study plan for Deltacel™/KB-GDT for treating subjects with Non-Small Cell Lung Cancer (NSCLC). Kiromic will leverage this FDA Pre-IND written confirmatory feedback and recommendations into a robust IND submission package for a projected clinical trial launch in Q1 2023.

https://finance.yahoo.com/news/kiromic-biopharma-announces-fda-feedback-120800678.html