Trogarzo (ibalizumab; Theratechnologies/TaiMed Biologics) is a recombinant humanized monoclonal antibody approved for the treatment of HIV-1 infection. It targets the HIV-1 post-attachment process by binding one of the domains of the CD-4 protein, which inhibits a conformational change in CD-4 that is necessary to allow entry of HIV into T-cells.
Symtuza ([darunavir + cobicistat + emtricitabine + tenofovir alafenamide (TAF)]; Johnson & Johnson) is a once-daily single-tablet regimen (STR) combination of the protease inhibitor (PI) Prezista, the two nucleos(t)ide reverse transcriptase inhibitors (NRTIs), Emtriva (emtricitabine; Gilead) and TAF (Gilead), and the boosting agent Tybost (cobicistat; Gilead). Symtuza is the first STR containing a PI.
Odefsey ([rilpivirine + emtricitabine + tenofovir alafenamide (TAF)]; Gilead/Johnson & Johnson) is a single-tablet regimen approved in the US and five major EU markets (France, Germany, Italy, Spain, and the UK) for the treatment of HIV-1 infection. Odefsey contains Gilead’s nucleos(t)ide reverse transcriptase inhibitors (NRTIs) TAF and Emtriva (emtricitabine), and Johnson & Johnson’s non-nucleoside reverse transcriptase inhibitor Edurant (rilpivirine; Johnson & Johnson).
Juluca ([dolutegravir + rilpivirine]; ViiV Healthcare/Johnson & Johnson) is a single-tablet regimen approved in the US for the treatment of patients infected with HIV-1 who have achieved viral suppression.
Descovy ([emtricitabine + tenofovir alafenamide (TAF)]; Gilead/Japan Tobacco) is a fixed-dose combination of two of Gilead’s nucleos(t)ide reverse transcriptase inhibitors, Emtriva (emtricitabine) and Vemlidy (tenofovir alafenamide [TAF]). The combination is currently approved in the US, Japan, and EU.
Biktarvy ([bictegravir + emtricitabine + tenofovir alafenamide (TAF)]; Gilead) is an single-tablet regimen (STR) approved for the treatment of HIV-1 infection. It is a co-formulation of Gilead’s novel integrase strand transfer inhibitor (INSTI) bictegravir, and the marketed drug Descovy, which is a fixed-dose combination (FDC) of the nucleoside reverse transcriptase inhibitors (NRTIs) emtricitabine and TAF.
Delstrigo ([doravirine + lamivudine + tenofovir disoproxil fumarate (TDF)]; Merck & Co) is a single-tablet regimen being developed for the treatment of HIV-1 infection. The drug is a co-formulation of the non-nucleoside reverse transcriptase inhibitor (NNRTI) doravirine and the two nucleos(t)ide reverse transcriptase inhibitors (NRTIs), lamivudine and TDF.
Dovato ([dolutegravir + lamivudine]; ViiV Healthcare) is a single-tablet regimen approved in the US for the treatment of HIV-1 infection in patients who are treatment-naïve. It is also being developed in the EU for the treatment of HIV-1 infection in patients who are treatment-naïve (with an approval decision expected by Q3 2019), as well as for patients who are virologically suppressed (US/Japan/EU).
Tislelizumab (BeiGene) is a humanized monoclonal antibody that was designed to bind to the PD-1 receptor and prevent binding of PD-L1. In addition, tislelizumab was designed to minimize binding to Fc-gamma-receptors (FcyR) on macrophages.
Tymlos (abaloparatide; Radius Health) is a synthetic peptide analog of human parathyroid hormone-related protein (PTHrP), which binds to the same receptor as parathyroid hormone (PTH).
Onzeald (etirinotecan pegol; Nektar Therapeutics) is a polyethylene glycol (PEG) conjugate of irinotecan, a prodrug that is metabolized via enzymatic cleavage into the biologically active metabolite 10-hydroxy-7-ethyl camptothecin, also known as SN-38. SN-38 inhibits DNA topoisomerase 1 during the S-phase of the mitotic cycle.
Enhertu (trastuzumab deruxtecan; Daiichi Sankyo/AstraZeneca) is an antibody-drug conjugate composed of a monoclonal antibody that targets human epidermal growth factor receptor 2 (HER2), an enzymatically cleavable peptide-linker, and a topoisomerase 1 inhibitor derived from exatecan. The drug-to-antibody ratio of Enhertu is 8:1.
Capivasertib (AstraZeneca) is an orally active, highly selective Akt inhibitor that preferentially targets Akt isoforms 1–3. Akt is a key enzyme in the PI3K/Akt/mTOR tumor cell survival pathway and is dysregulated in a number of malignancies through loss of tumor suppressor phosphatase and tensin homolog (PTEN), acquisition of activating mutations in phosphatidylinositol-4,5-bisphosphate 3- kinase catalytic subunit alpha (PIK3CA) or AKT1, as well as amplification of PI3K.
Balixafortide (Polyphor) is a synthetic cyclopeptide derived from polyphemusin that inhibits C-X-C motif chemokine receptor 4 (CXCR4), a G-protein coupled receptor that exclusively binds to its ligand, stromal cell-derived factor-1 (SDF-1).
Adagloxad simolenin (OBI Pharma) is a carbohydrate-based vaccine comprised of Globo-H conjugated to keyhole limpet hemocyanin. Upon exposure to the synthetic Globo-H vaccine and an immunological adjuvant, the immune system mounts IgM and IgG responses against Globo-H hexasaccharide.
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