Kiromic BioPharma Reports Consistent Favorable Safety, Tolerability, and Efficacy in Deltacel-01 Clinical Trial First Three Patients - Seite 2

"These early results establish the foundation of our planned FDA application for Fast Track Designation. Achieving this designation could significantly accelerate the process to bring Deltacel to patients versus traditional timelines. We also have the potential to apply for Breakthrough Therapy Designation, enabling more guidance due to demonstrating a substantial improvement over current standard of care. We look forward to sharing more updates, including the results from additional patients, as Deltacel-01 progresses."

Patient

Safety

Six Weeks

Post-treatment

Two Months

Post-treatment

Four Months

Post-treatment

1

No dose-limiting toxicities

Stable disease

Tumor size reduction of 6.6%

Stable disease compared with two-month follow-up

2

No dose-limiting toxicities

Stable disease

 

Complete resolution of brain lesions

Stable disease

 

Confirmed clean brain scan

 

No new brain lesions

Expected in June 2024

3

No dose-limiting toxicities

Stable disease

Stable disease

Expected in June 2024

"We are very pleased with the initial safety and efficacy results seen in the first cohort of patients treated with Deltacel as part of the Phase 1 clinical trial at our cancer center. The consistency we have observed so far in disease control and lack of dose limiting toxicities is encouraging," said Dr. Afshin Eli Gabayan, Medical Oncologist, Medical Director and Principal Investigator at BHCC. "As one of the pioneers of immuno-oncology clinical research, we strive to help advance promising treatments like Deltacel, through our expertise and partnerships with leaders in cellular therapy innovation. Seeing signs of early response and tolerability gives hope for patients facing late-stage cancer. We will continue supporting efforts to better understand and potentially transform outcomes for lung cancer patients."