- Kiromic BioPharma Inc KRBP received validating written feedback from the FDA per their Type B Pre-IND Meeting Request regarding its Deltacel development strategy.
- Deltacel is the Company’s most advanced therapeutic candidate for use in allogeneic, non-viral, non-engineered commercial grade gamma delta T (GDT) cells.
- The request prior to the IND meeting was to align with Kiromic’s proposed development strategy regarding the chemistry, manufacturing and controls (CMC), non-clinical studies and clinical study plan for Deltacel/KB-GDT for non-small cell lungs Adjust Kiromic and obtain guidance from the FDA Cancer (NSCLC).
- Kiromic plans to start a clinical trial in the first quarter of 2023.
- To reaffirm management’s focus on executing the Deltacel-aligned development strategy, the Company has streamlined its operations and directed key resources to further develop its Deltacel product candidate while maintaining its other product candidates, Procel and Isocel.
- Kiromic has decided to cut 20 positions, or approximately 29% of its workforce, as part of this coordinated strategy.
- The company says the prioritization mitigates supply chain challenges associated with a virus-based approach.
- Price promotion: KRBP shares are up 54.5% to $0.42 on the latest check Thursday.
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