After receiving validation feedback, Kiromic BioPharma Inc. (Nasdaq: KRBP) stock gained 29.05% to $0.35 in current market conditions on the last check Thursday following its $0.27 closing price on Wednesday.
How has KRBP been validated?
In response to its Type B Pre-IND meeting request, Kiromic (KRBP) announced on October 4, 2022, that it received validating written feedback from the FDA regarding its Deltacel development strategy.
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- Pre-IND meetings were requested to obtain FDA guidance on Kiromic’s proposed development strategy for Deltacel/KB-GDT for treating non-small cell lung cancer (NSCLC), including chemistry, manufacturing, and controls (CMC), nonclinical studies, and clinical study plans.
- For the launch of a clinical trial scheduled for Q1 2023, KRBP will leverage FDA Pre-IND written confirmation feedback and recommendations and submit a robust IND submission package based on this feedback and recommendations.
- This FDA feedback about Deltacel/KB-GDT confirms Kiromic’s development strategy for this therapeutic candidate and is very productive for them.
- In order to address solid malignancies, KRBP has focused on metastatic stage-4 lung cancer as its first indication, and Kiromic will continue to fulfill its mission by addressing solid malignancies, which account for more than 90% of all cancers.
- Management has reiterated its focus on executing the Deltacel-aligned development strategy by streamlining its operations and aligning key resources to advance Deltacel while maintaining its other product candidates Procel and Isocel.
- After a thorough evaluation of maximizing operational efficiency, KRBP’s management made the difficult but necessary decision to eliminate 20 positions, or approximately 29% of the company’s workforce in accordance with that aligned strategy.
- As part of Kiromic’s financing strategy, Kiromic believes these key actions align with its overall strategy.
How will KRBP proceed?
The most advanced KRBP treatment candidate is Deltacel, which utilizes non-viral, non-engineered off-the-shelf Gamma Delta T-cells (GDT) to provide patients with a next-generation treatment. In addition to mitigating supply-chain challenges associated with virus-based approaches, this prioritization also mitigates supply-chain concerns. With these advantages in hand, Kiromic (KRBP) will be able to efficiently establish the platform’s safety and tolerability and build on Deltacel’s already demonstrated preclinical efficacy. Having received FDA guidance, KRBP is positioned to deliver value to its shareholders earlier by aligning operations with Deltacel.