On March 12, 2018 Selecta Biosciences, Inc. (Nasdaq:SELB), a clinical-stage biopharmaceutical company focused on unlocking the full potential of biologic therapies by avoiding unwanted immune responses, reported that the first patient has been dosed in a Phase 1 clinical trial of SEL-403, Selecta’s product candidate consisting of SVP-Rapamycin in combination with LMB-100 (Press release, Selecta Biosciences, MAR 12, 2018, View Source [SID1234524682]). The trial (ClinicalTrials.gov Identifier# NCT03436732 ), is enrolling patients with malignant pleural or peritoneal mesothelioma who have undergone at least one regimen of chemotherapy, and it is being conducted under a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), part of the National Institutes of Health.
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SVP-Rapamycin is Selecta’s proprietary, clinical-stage anti-drug antibody (ADA) prevention and immune tolerance technology. LMB-100 is a recombinant immunotoxin that targets mesothelin, a protein expressed in nearly all mesotheliomas and pancreatic adenocarcinomas, and a high percentage of other malignancies, including lung, breast and ovarian cancers. A paper co-authored by Selecta and researchers at the NCI discussing preclinical work completed with this combination therapy candidate was recently published in Proceedings of the National Academies of Sciences (PNAS, 2018 Jan 23;115(4): E733-E742).
"Mesothelioma remains one of the deadliest and most challenging-to-treat forms of cancer," stated Raffit Hassan, M.D., Senior Investigator, Thoracic and GI Oncology Branch in NCI’s Center for Cancer Research and Principal investigator of the trial. "Recombinant immunotoxins hold the potential to induce marked anti-tumor activity if anti-drug antibodies are prevented and sufficient cycles of therapy can be administered. We are pleased to get this clinical investigation underway to determine if patients may indeed benefit from a combination therapy consisting of LMB-100 and SVP-Rapamycin."
Patients in this open-label dose-escalation trial will receive up to four treatment cycles, each treatment cycle consisting of an initial dose of the combination of SVP-Rapamycin and LMB-100 on day 1 followed by two doses of LMB-100 alone on days 3 and 5. The study, which is expected to enroll up to 18 patients, is designed to evaluate the safety and tolerability of this treatment and provide data on pharmacokinetics, anti-drug antibody (ADA) levels, as well as an objective response rate assessment.
For Patients
Patients interested in enrolling please contact NCI’s toll-free number 1-800-4-Cancer (1-800-422-6237) (TTY: 1-800-332-8615) and/or the Web site: View Source
About Mesothelioma
Mesothelioma is a mesothelin-expressing cancer predominantly affecting the layer of tissue lining the lungs and chest wall. This type of cancer has been linked to asbestos exposure. According to the American Cancer Society, approximately 3,000 people are diagnosed with this disease each year in the United States. The prognosis for mesothelioma is very poor, with an average life expectancy of 12-18 months following diagnosis.