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Savara Inc. is an orphan lung disease company. Savara`s pipeline comprises: Molgradex, an inhaled granulocyte-macrophage colony-stimulating factor, or GM-CSF, in Phase 3 development for PAP, and in Phase 2a development for NTM lung infection; and AeroVanc, a Phase 3 stage inhaled vancomycin for treatment of MRSA infection in cystic fibrosis. Savara`s strategy involves expanding its pipeline of potentially best-in-class products through indication expansion, strategic development partnerships and product acquisitions, with the goal of becoming a leading company in its field. Savara`s management team has significant experience in orphan drug development and pulmonary medicine, in identifying unmet needs, developing and acquiring new product candidates, and effectively advancing them to approvals and commercialization.
Unum is a Cambridge, MA-based cellular therapeutics company ushering in a new wave of innovation in cancer immunotherapy. Unum has built an antibody-coupled T-cell receptor (ACTR) platform that, when combined with tumor-specific antibodies, directs an individual’s cytotoxic T-lymphocytes (CTLs) to kill tumor cells. In contrast to other approaches that hit a single target and treat a narrow set of tumors, Unum’s approach is not restricted by antigens and may have applications for treating many types of cancers. Our lead program based on ACTR technology is expected to enter Phase I clinical testing soon to assess safety and efficacy in certain forms of leukemia and lymphoma. In parallel, we are actively seeking partners interested in using the ACTR technology to arm novel proprietary antibodies with a T-cell to improve their therapeutic potential. Working initially to pre-clinically validate antibody-ACTR combinations with partners, we expect to rapidly advance multiple proprietary combinations into clinical testing within the next few years.
Cebert Pharmaceuticals is a Birmingham, AL-based company in the Healthcare, Pharmaceuticals, and Biotech sector.
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Madrigal Pharmaceuticals is a clinical-stage biopharmaceutical company pursuing novel therapeutics that target a specific thyroid hormone receptor pathway in the liver, which is a key regulatory mechanism common to a spectrum of cardio-metabolic and fatty liver diseases with high unmet medical need. The Company has advanced its lead candidate, resmetirom, also known as MGL-3196, a first-in-class, orally administered, small-molecule, liver-directed, thyroid hormone receptor (THR) β-selective agonist, through Phase 2 clinical trials in NASH. Primary and key secondary endpoints were achieved including reduction of liver fat on a sensitive non-invasive imaging test, lowering of multiple atherogenic lipids including LDL-cholesterol and triglycerides, and resolution of NASH on liver biopsy. Based on evidence of broad activity and a favorable safety profile, Madrigal has initiated a Phase 3 clinical study in NASH patients with advanced liver fibrosis, MAESTRO-NASH, in which the primary endpoint after one year of dosing is resolution of NASH and key secondary endpoints include LDL-cholesterol lowering and reduction in liver fibrosis. Clinical benefit in reducing progression to more advanced liver disease, including cirrhosis, is a long-term goal of this trial. A second Phase 3 clinical study, MAESTRO-NAFLD-1, has also been initiated. This 52-week non-invasive study in a broader segment of NASH patients will provide additional safety information to support the NASH indication and will include key efficacy endpoints: LDL-cholesterol lowering, triglyceride lowering, reduction of liver fat as determined by MRI-PDFF, as well as reduction of elevated liver enzymes and reduction in fibrosis biomarkers. This is a non-biopsy study in people with NASH, as documented using non-invasive techniques or historical liver biopsy.