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     105  0 Kommentare Kiromic BioPharma Provides Updates on its Deltacel-01 Clinical Trial

    Kiromic BioPharma, Inc. (OTCQB: KRBP) (“Kiromic” or the “Company”) reports follow-up results from the second, third and fourth patients enrolled in its Deltacel-01 Phase 1 clinical trial. 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.

    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.

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    Kiromic BioPharma Provides Updates on its Deltacel-01 Clinical Trial Kiromic BioPharma, Inc. (OTCQB: KRBP) (“Kiromic” or the “Company”) reports follow-up results from the second, third and fourth patients enrolled in its Deltacel-01 Phase 1 clinical trial. This trial is evaluating Deltacel (KB-GDT-01), the Company’s …