Published on 6 Oct 2022 on Benzinga via Yahoo Finance
Kiromic BioPharma Inc (NASDAQ: KRBP) received validating written feedback from the FDA pursuant to its Type B Pre-IND meeting request regarding its Deltacel development strategy.Deltacel is the company's most advanced therapeutic candidate, applying in allogeneic, non-viral, non-engineered off-the-shelf Gamma Delta T-cells (GDT).The Pre-IND meeting request was to align with and 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 Non-Small Cell Lung Cancer (NSCLC).Kiromic projects a clinical trial launch in Q1 2023.Further reiterating Management's focus on executing the Deltacel-aligned development strategy, the company has streamlined its operations and aligned key resources to advance its Deltacel product candidate while maintaining its other product candidates, Procel and Isocel.Kiromic has decided to eliminate 20 positions, or approximately 29% of its workforce, as part of that aligned strategy.The company says the prioritization mitigates supply-chain challenges associated with a virus-based approach.Price Action: KRBP shares are up 54.5% at $0.42 on the last check Thursday.
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