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Sapient enables discovery of circulating biomarkers at unprecedented speed & scale, providing a deeper understanding of human biology to align patients & drug therapies.
Aura Biosciences is a clinical-stage biotechnology company developing virus-like drug conjugates (VDC), a novel class of therapies, for the treatment of multiple oncology indications. At Aura, our mission is to deliver meaningful therapeutic benefit to a range of cancer indications with high unmet need in which we believe we can establish a new standard of care. We are driven by our passion and commitment to science and the patients battling cancer who are relying on us to pioneer these new therapies. We are focusing the initial development of our VDC technology platform to treat tumors of high unmet need in ocular and urologic oncology. Belzupacap sarotalocan (bel-sar), our first VDC candidate, is being developed for the first-line treatment of early-stage choroidal melanoma, a rare disease with no drugs approved. Beyond early-stage choroidal melanoma, we are developing bel-sar in additional ocular oncology indications, including choroidal metastasis. Leveraging our VDCs` broad tumor targeting capabilities, we have also initiated a clinical program in non-muscle invasive bladder cancer, or NMIBC, our first non-ocular solid tumor indication.
Clario is a leading healthcare research and technology company that generates the richest clinical evidence in the industry for our pharmaceutical, biotech and medical device partners. Across decentralized, hybrid and site-based trials, our deep scientific expertise, global scale and the broadest endpoint technology platform in the industry allows our partners to transform lives. Clario has the only technology platform that combines eCOA, cardiac safety, medical imaging, precision motion, and respiratory endpoints. Clario`s global team of science, technology and operational experts have helped deliver more than 27,000 trials and contributed to over 500 FDA and EMEA new drug approvals involving more than seven million participants in over 100 countries. Our innovation has been transforming clinical trials for 50 years.
MEI Pharma (Nasdaq: MEIP) is a San Diego-based pharmaceutical company focused on leveraging its extensive development and oncology expertise to identify and advance new therapies for cancer. Our approach to building our pipeline is to license promising cancer agents and create value in programs through development and commercialization, or strategic partnerships, as appropriate. Our portfolio contains four clinical-stage drug candidates, including one candidate in an ongoing global registration trial and another candidate that is anticipated to advance into a registration trial this year. Our drug candidate pipeline includes: Pracinostat, an oral HDAC inhibitor that is in a Phase 3 pivotal study in combination with azacitidine for the treatment of acute myeloid leukemia. Pracinostat is also being evaluated in a clinical study in patients with myelodysplastic syndrome. Pracinostat is licensed to Helsinn Healthcare SA, a Swiss pharmaceutical corporation. ME-401, a selective oral inhibitor of phosphatidylinositol 3-kinase (“PI3K”) delta. ME-401 is anticipated to progress into a single-agent registration study in 2018 for the treatment of adults with relapsed or refractory follicular lymphoma. Voruciclib, an orally administered and selective cyclin-dependent kinase (“CDK”) inhibitor differentiated by its potent in vitro inhibition of CDK9 in addition to CDK6, 4 and 1. Initiation of a Phase I dose-escalation study in patients with relapsed and/or refractory B-cell malignancies after failure of prior standard therapies is scheduled to being in the second calendar quarter of 2018. ME-344, a novel and tumor selective, isoflavone-derived mitochondrial inhibitor drug candidate, has demonstrated evidence of single-agent activity against refractory solid tumors in a Phase I study. In preclinical studies, tumor cells treated with ME-344 resulted in a rapid loss of ATP and cancer cell death. It is currently being evaluated in an investigator-initiated study in combination with the VEGF inhibitor bevacizumab (marketed as Avastin®) in patients with HER2 negative breast cancer.
i-FACTOR Peptide Enhanced Bone Graft is a drug/device combination that creates a new category of bone graft technology. Take a moment to review our introduction to i-FACTOR, our Level-1 IDE study and comparative performance sections given below.