On October 6, 2022 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, reported 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 (Press release, Kiromic, OCT 6, 2022, View Source [SID1234621786]).
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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.
"We are delighted to receive this very productive feedback about Deltacel/KB-GDT from the FDA, confirming our development strategy for this therapeutic candidate," stated Pietro Bersani, Chief Executive Officer of Kiromic. "It was a strategic decision to focus on metastatic stage 4 lung cancer as our first indication in addressing solid malignancies, and we are very heartened to be continuing to fulfill our mission to address solid malignancies, which represent more than 90% of all cancers."
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. As part of that aligned strategy and following a thorough evaluation to maximize operational efficiencies, Kiromic’s management made the difficult yet necessary decision to eliminate 20 positions or approximately 29% of its workforce. The Company believes these key actions and overall strategy align with financing options it is actively pursuing.
"Deltacel is our most advanced therapeutic candidate, and its use of allogeneic, non-viral, non-engineered off-the-shelf Gamma Delta T-cells (GDT) is a next-generation solution for patients. As such, this prioritization also mitigates supply-chain challenges associated with a virus-based approach. We believe these advantages will allow us to efficiently establish the platform’s safety and tolerability and build upon Deltacel’s previously demonstrated preclinical efficacy across multiple indications. With the FDA guidance in hand, we believe we’ve further strengthened our case to align operations with Deltacel and deliver value sooner to our shareholders," commented Bersani.