On June 20, 2024 Kiromic BioPharma, Inc. (OTCQB: KRBP) ("Kiromic" or the "Company") reported follow-up results from the second, third and fourth patients enrolled in its Deltacel-01 Phase 1 clinical trial (Press release, Kiromic, JUN 20, 2024, View Source [SID1234644452]). 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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The third and fourth patients showed stable disease at their four- and two-month follow-up visits, respectively. Both patients are doing well, and neither showed any dose-limiting toxicities. Patients three and four are being treated at the Beverly Hills Cancer Center (BHCC).
The second patient, also being treated at the BHCC, previously had stable disease and showed a complete response in their brain metastasis. At the four-month follow-up visit, while stable disease of previously treated sites and a clean brain MRI were confirmed, a new site of disease, a sub-cutaneous metastasis, was detected by CT and PET scans. This patient is in generally good condition and tolerated their initial treatment well. As such, the Institutional Review Board (IRB) and the U.S. Food and Drug Administration (FDA) approved a single-use, single-patient protocol, and on June 19, the patient started a new course of treatment with low-dose radiation and gamma-delta T cells under a single patient IND.
"We are optimistic the latest targeted treatment with Deltacel will control the second patient’s new lesion, which is suspected to have originated from a micro-metastasis not detected and therefore not targeted with radiation during the first course of treatment. This new protocol might be applied to all patients who received or will receive the Deltacel treatment and could be instrumental in controlling any new tumor lesions or progressing lesions," said Pietro Bersani, CEO of Kiromic BioPharma.
Kiromic BioPharma also reports submitting a request for Fast Track designation for Deltacel to the FDA. Fast Track designation facilitates and expedites the development and review of drugs that treat serious conditions and address unmet medical needs. For further information on Fast Track designation, please visit the FDA’s website.
"We continue to be encouraged by the favorable results of the Deltacel-01 trial, which reinforce our confidence in the potential of Deltacel to provide meaningful clinical benefits to patients in need. This confidence underscores the recent open-market purchases of common stock by several Kiromic directors and executive officers, as reported on Form 4 filings," noted Mr. Bersani.
"Proceeding with a single-use, single-patient protocol of Deltacel supports our commitment to advancing innovative therapies that address unmet clinical needs in unique ways, which include the possibility for retreatment," he added. "We are also excited about the potential of expediting Deltacel clinical development through Fast Track designation."
The fifth patient in the trial completed their 30-day safety visit at the BHCC with no toxicities reported, and the sixth patient is expected to be enrolled in July.
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.