Kiromic BioPharma, Inc. (NASDAQ: KRBP) Receives FDA Validating Written Input on Its DeltacelTM Development Strategy


A clinical-stage fully-integrated biotherapeutics company, Kiromic BioPharma, Inc. (NASDAQ: KRBP) plunged over 15.88% in early trading session on Friday as It announces that the FDA provided validating written input on its DeltacelTM development strategy on October 4, 2022, in response to its Type B Pre-IND meeting request.

The purpose of the Pre-IND meeting request was to seek alignment with and obtain FDA guidance on Kiromic’s proposed development strategy for Deltacel /KB-GDT for treating subjects with Non-Small Cell Lung Cancer, including chemistry, manufacturing, and controls (CMC), nonclinical studies, and clinical study plan (NSCLC). Kiromic will incorporate the FDA Pre-IND written confirmatory input and suggestions into a comprehensive IND filing package for a clinical study scheduled to begin in Q1 2023.

Chief Executive Officer of Kiromic, Pietro Bersani stated that they are pleased to have received such positive FDA input on DeltacelTM/KB-GDT, validating their development plan for this therapeutic candidate. It was a strategic decision to focus on metastatic stage 4 lung cancers as their initial indication in treating solid malignancies, and they are extremely encouraged to be able to continue their goal to target solid malignancies, which account for more than 90% of all cancers.

To reinforce Management’s commitment to executing the Deltacel-aligned development plan, the Company has simplified its operations and aligned key resources to advance its DeltacelTM product candidate while preserving its other product candidates, ProcelTM and IsocelTM. Kiromic’s management took the painful but necessary choice to remove 20 roles, or around 29% of its personnel, as part of that aligned plan and following a comprehensive examination to enhance operational savings. The Company believes that these major measures and overall strategy are consistent with the funding options it is actively exploring.


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