On October 1, 2024 Kiromic BioPharma, Inc. (OTCQB: KRBP) ("Kiromic" or the "Company") reported good safety and favorable ongoing efficacy results from the 10-month follow-up visit of the first patient treated in its Deltacel-01 Phase 1 clinical trial (Press release, Kiromic, OCT 1, 2024, View Source [SID1234646980]). This trial is evaluating Deltacel (KB-GDT-01), the Company’s allogeneic, off-the-shelf, Gamma Delta T-cell (GDT) therapy, in patients with stage 4 metastatic non-small cell lung cancer (NSCLC) who have failed to respond to standard therapies.
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In this patient, the tumor size was reduced by approximately 27% compared with the pre-treatment size, and no new sites of disease were identified. As a result, the progression-free survival (PFS) has reached 10 months with no reported adverse events. These results follow an approximate 20% reduction in tumor size detected at eight months post-treatment and an approximate 13% reduction at six months post-treatment. This patient is being treated at the Beverly Hills Cancer Center (BHCC).
"As this patient is the most advanced in our ongoing Deltacel-01 clinical trial, we are particularly encouraged by these latest follow-up results that continue to validate the potential of Deltacel as a safe and effective treatment for patients with later-stage cancers," said Pietro Bersani, Chief Executive Officer of Kiromic BioPharma. "We believe these findings underscore the promise of our allogeneic GDT therapy in providing durable clinical benefit."
"The latest results from this patient are highly promising, particularly given the durable progression-free survival and tumor reduction we observed," said Afshin Eli Gabayan, M.D., Medical Oncologist, Medical Director and Deltacel-01 Principal Investigator at BHCC. "This patient’s response to Gama Delta T-Cell Treatment continues to provide optimism as we evaluate Deltacel’s therapeutic potential. Continued meaningful results could represent a significant breakthrough for these late-stage cancer patients with limited treatment options."
Kiromic expects to report additional follow-up results from the fourth patient enrolled in this study in October.
About Deltacel-01
In Kiromic’s open-label Phase 1 clinical trial, titled "Phase 1 Trial Evaluating the Safety and Tolerability of Gamma Delta T Cell Infusions in Combination With Low Dose Radiotherapy in Subjects With Stage 4 Metastatic Non-Small Cell Lung Cancer" (NCT06069570), 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.