The designation was granted for KB-GDT-01 in combination with low-dose radiation for patients with metastatic non-small cell lung cancer.

RT’s Three Key Takeaways:

  1. Fast Track Designation: The FDA has granted Fast Track designation to a new Gamma Delta T-cell therapy combined with low-dose radiation, aimed at treating patients with metastatic non-small cell lung cancer (NSCLC) who have not responded to at least two lines of standard therapies.
  2. Purpose of Fast Track: This designation is intended to expedite the development and review process of the therapy, providing more frequent communication with the FDA, potential priority review, and rolling submissions.
  3. Current Clinical Evaluation: The therapy is currently being tested in a phase 1 clinical trial involving stage 4 NSCLC patients, focusing on evaluating its safety and preliminary efficacy, with the goal of improving progression-free survival and overall survival rates.

Kiromic BioPharma Inc, announced that the US Food and Drug Administration (FDA) has granted Fast Track designation to Deltacel (KB-GDT-01), the company’s allogeneic, off-the-shelf, Gamma Delta T-cell (GDT) therapy. 

The designation was awarded for KB-GDT-01 in combination with low-dose radiation therapy for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) who have progressed on at least two lines of standard of care therapy including platinum-based chemotherapy, immune checkpoint inhibitors, and targeted therapy to improve progression-free survival and overall survival. 

Deltacel is currently being evaluated in the Deltacel-01 phase 1 study in patients with stage 4 NSCLC who have failed to respond to standard therapies.

Facilitating Development

Fast Track designation is designed to facilitate the development and expedite the review of drugs intended to treat serious conditions and fill an unmet medical need. The designation allows for more frequent communication with the FDA, potential priority review, and a rolling submission of Biologics License Application or New Drug Application.

“Receipt of Fast Track designation is a significant milestone for Kiromic and underscores the potential of Deltacel to address the urgent needs of patients with advanced solid tumors,” says Pietro Bersani, chief executive officer of Kiromic BioPharma, in a release. “We are encouraged by the FDA’s recognition of our innovative approach and are committed to the clinical development of Deltacel. Fast Track designation will enable us to work more closely with the FDA as we complete Deltacel-01 and advance this promising therapy into later-stage studies.”

The Fast Track designation follows recent positive data from the ongoing Deltacel-01 clinical trial, in which Deltacel has demonstrated a favorable safety profile and preliminary clinical efficacy in NSCLC patients. Kiromic expects to activate a fifth clinical trial site on Aug 30.

Deltacel-01

In Kiromic’s open-label phase 1 clinical trial, patients with stage 4 NSCLC will receive two intravenous infusions of Deltacel with four courses of low-dose, localized radiation over a 10-day period. 

The primary objective of the Deltacel-01 trial is to evaluate safety, while secondary measurements include objective response, progression-free survival, overall survival, time to progression, time to treatment response, and disease control rates.

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