Patient A, is a 78-year-old female with a diagnosi

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Patient A, is a 78-year-old female with a diagnosis of metastatic breast cancer, stage IV. The subject previously received Taxotere/Herceptin/Pertuzumab as frontline therapy for metastatic HER2 positive breast cancer. She had partial response for her systemic disease, but then developed diffuse brain metastases

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[0134] Approximately two months following the initial treatment, no new metastasis was detectable in the brain after treatment with leronlimab being the only treatment the subject was receiving to treat brain metastasis. Prior to enrolling in the trial, the patient had 18 identifiable tumor spots in the brain. At approximately two months following the start of weekly 700 mg doses of leronlimab, only three lesions were identifiable, as detected by Mill. Furthermore, the treatment resulted in a 56% reduction in tumor volume of the largest brain tumor identified in the subject's brain at the initiation of treatment.

[0135] Approximately ten weeks following the initiation of treatment, the subject's CTC and EMT counts were measured, and zero CTCs and zero EMTs were identified.

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Leronlimab for Treatment of Solid Tumors

[0136] A Phase 2 protocol for a basket trial with the U.S. Food and Drug Administration (FDA) as an Investigational New Drug (IND) Application for the treatment of cancer is ongoing. At least 22 solid tumor cancer types are being treated under this protocol, including, but not limited to, melanoma, brain (glioblastoma) , throat, lung, stomach, colon, colon carcinoma, breast, testicular, ovarian, uterine, pancreas, bladder, esophageal, appendix, and prostate cancers, among other indications. The basket trial is a Phase 2 study with 30 patients with CCR5+ locally advanced or metastatic solid tumors. Leronlimab will be administered subcutaneously as a weekly dose of 350 mg. Subjects participating in this study will be allowed to receive and continue the standard-of-care chemotherapy as determined by the treating physician.

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