Kiromic BioPharma Reports 32% Decrease in Tumor Volume Eight Months Post-Treatment in Fourth Patient Enrolled in Deltacel-01
KRBP 12.12.2024
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- 01.21.2025 - Kiromic BioPharma Reports Tumor Volume Decrease in Two Patients Enrolled in Deltacel-01
- 12.12.2024 - Kiromic BioPharma Reports 32% Decrease in Tumor Volume Eight Months Post-Treatment in Fourth Patient Enrolled in Deltacel-01
- 12.03.2024 - Kiromic BioPharma Announces Settlement of Previously Disclosed SEC Investigation
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8-Month Follow-Up for Patient #4: Partial Response with Tumor Reduction of 32%
Preliminary results from the eight-month follow-up visit for the fourth patient enrolled in Deltacel-01 revealed an approximately 32% decrease in tumor volume compared with the pre-treatment size. This patient continues to experience clinical benefit without adverse events.
11-Month Follow-Up for Patient #1: Stable Disease Maintained
The first patient enrolled in the Deltacel-01 trial has maintained stable disease with no evidence of disease progression or new sites of malignancy. Kiromic last reported that 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 PFS has reached 11 months with no reported adverse events. This patient's final follow-up visit is scheduled for the end of December.
Patient #7 Completes Treatment
The seventh patient successfully completed the Deltacel-01 treatment regimen and is tolerating therapy well. Initial efficacy results for this patient are expected in early
Patient #8 Enrolled
The eighth patient in the Deltacel-01 clinical study was enrolled this week at the Clinical Research Advisors Koreatown, a satellite location of the
“The magnitude of the tumor reduction observed in Patient #4 is significant and highly encouraging. We look forward to reporting results from the first and seventh patients in January, and expect to enroll additional patients through the beginning of 2025,” said
"The remarkable 32% tumor reduction seen in the fourth patient treated with Deltacel is truly exciting and holds great promise for improving outcomes for patients with advanced lung cancer. As a leading cancer center focused on delivering the most innovative and effective therapies, we are proud to partner with Kiromic on this important clinical trial. The early safety and tolerability data, coupled with these signs of robust antitumor activity, suggest Deltacel’s promise as a transformative new treatment option. We look forward to continued enrollment and results that could change the standard of care for these patients who have exhausted other options," said Dr.
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 DeltacelTMwith four courses of low-dose, localized radiation over a 10-day period. The primary objective of Deltacel-01 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 DeltacelTM
DeltacelTM(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, DeltacelTMis the leading candidate in Kiromic’s GDT platform. DeltacelTMis 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 DeltacelTM’s favorable safety and efficacy profile when it was combined with low-dose radiation.
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Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements other than statements of historical facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as: “will,” “potential,” “could,” “can,” “believe,” “intends,” “continue,” “plans,” “expects,” “anticipates,” “estimates,” “may,” or the negative of these terms or other comparable terminology. These forward-looking statements include, but are not limited to, statements regarding: Kiromic’s ability to achieve its objectives and Kiromic’s financing strategy and availability of funds. These forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties discussed in our Annual Report on Form 10-K for the year ended
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