On October 8, 2024 Kiromic BioPharma, Inc. (OTCQB: KRBP) ("Kiromic" or the "Company") reported favorable ongoing efficacy results from follow-up visits for Patient 4 and Patient 6 in its Deltacel-01 Phase 1 clinical trial (Press release, Kiromic, OCT 8, 2024, View Source [SID1234647086]). 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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At the six-month follow-up visit, Patient 4 maintained stable disease with a 5.3% reduction in tumor size compared to the pre-treatment size. At the two-month follow-up visit, Patient 6 demonstrated stable disease with no new lesions detected and no signs of disease progression. Both of these patients are being treated at the Beverly Hills Cancer Center.
As a result of these updates, the median progression-free survival (PFS) across the trial has now increased to 6 months, highlighting the potential of Deltacel-01 to delay disease progression in advanced lung cancer patients. The median follow-up duration for all patients in the trial is now 7.7 months.
"We are encouraged by the consistency in disease stabilization seen across the patients enrolled in this study as well as the emerging signs of tumor reduction, which further support the potential clinical benefits of Deltacel," said Pietro Bersani, Chief Executive Officer of Kiromic BioPharma. "These latest results continue to validate the therapeutic potential of gamma-delta T cells and their ability to provide meaningful outcomes for patients with advanced cancer."
"The follow-up results we are seeing in the Deltacel-01 trial are encouraging, especially for patients with limited treatment options. The stabilization of disease, combined with early signs of tumor reduction in some cases, speaks to the potential of this therapy to make an impact in the treatment of advanced solid tumors. We are hopeful that continued follow-up will support the promising outcomes we’ve seen to date," added Afshin Eli Gabayan, M.D., Medical Oncologist, Medical Director and Deltacel-01 Principal Investigator at the Beverly Hills Cancer Center.
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.
About Deltacel
Deltacel (KB-GDT-01) is an investigational gamma delta T-cell (GDT) therapy currently in the Deltacel-01 Phase 1 trial for the treatment of stage 4 metastatic NSCLC. An allogeneic product consisting of unmodified, donor-derived gamma delta T cells, Deltacel is the leading candidate in Kiromic’s GDT platform. Deltacel is designed to exploit the natural potency of GDT cells to target solid cancers, with an initial clinical focus on NSCLC, which represents about 80% to 85% of all lung cancer cases. Data from two preclinical studies demonstrated Deltacel’s favorable safety and efficacy profile when it was combined with low-dose radiation.