Kiromic BioPharma Reports Consistent Favorable Safety, Tolerability, and Efficacy in Deltacel-01 Clinical Trial First Three Patients
Follow-up Scans Show Continued Stable Disease in First Patient Cohort
Company to Apply for FDA Fast Track Designation
Two months after completing treatment, Patients 2 and 3 continued to show stable disease. Imaging scans from Patient 2 also showed no brain metastases, confirming findings from that patient’s six-week follow-up visit.
Four months after completing treatment, the first patient continues to show stable disease compared with the two-month post-treatment scans, which showed a primary tumor size reduction of 6.6%. The four-month follow-up for the second and third patients on trial is scheduled for June.
A summary of all findings reported to date for the first cohort can be found in the table below.
In addition, the fourth patient in Deltacel-01 completed treatment on
Based on encouraging preliminary results from the first patient cohort, Kiromic intends to apply for Fast Track Designation (FTD) from the
"We are highly encouraged by the initial outcomes from the first three patients in our Deltacel-01 Phase 1 clinical trial. Consistency in safety, tolerability, and disease stability is of paramount importance at this stage of testing, and the data thus far bolster our confidence in Deltacel's potential as a transformative treatment," stated
"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 |
3 |
No dose-limiting toxicities |
Stable disease |
Stable disease |
Expected in |
"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.
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.
About the
As a private, academic, community-based cancer center, the
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Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. Kiromic makes such forward-looking statements pursuant to the safe harbor provisions of the United States Private Securities Litigation Reform Act, Section 21E of the Securities Exchange Act of 1934, as amended, and other federal securities laws. 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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Global Head, Corporate Communications
ldyson@kiromic.com
281-468-7683
LHA Investor Relations
tpatel@lhai.com
212-201-6614
Chief Strategy Officer
SN@BHCancerCenter.com
310-432-8925
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