Building IP: BMY Patent Application Re "TREATMENT OF PD-L1-POSITIVE MELANOMA USING AN ANTI-PD-1 ANTI

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8. The capsule of claim 6, wherein the excipient is polyvinylacetate phthalate polymer. 31. The capsule of claim 23, wherein the capsule comprises about 1.0% magnesium stearate by weight. 42. The capsule of claim 34, wherein the capsule comprises about 1.0% magnesium stearate by weight. 9. The capsule of claim 6, wherein the excipient is vinylpyrrolidone-vinyl acetate copolymer. 7. The capsule of claim 6, wherein the excipient is hydroxypropyl methylcellulose. 4. The capsule of claim 3, wherein the hydroxypropyl methylcellulose is present in an amount of about 53% by weight. 3. The capsule of claim 1, wherein the excipient is hydroxypropyl methylcellulose. 60. The tablet of claim 54, wherein the total weight of the tablet is about 250 mg. 58. The tablet of claim 54, wherein the tablet comprises about 4% of croscarmellose sodium by weight. 16. The capsule of claim 13, wherein the excipient is vinylpyrrolidone-vinyl acetate copolymer. 15. The capsule of claim 13, wherein the excipient is polyvinylacetate phthalate polymer. 50. The capsule of claim 45, wherein the capsule comprises about 5.0% fumaric acid by weight.



12. The capsule of claim 6, wherein the capsule comprises about 10% tocophersolan by weight. 30. The capsule of claim 23, wherein the capsule comprises about 0.6% fumed silica by weight. FIG. 36 shows a dissolution comparison across the PVA-P formulations (Capsule B, Capsule E, and Capsule H). 1-methylcyclohexane-1-carboxamide, alternatively named (1s,4s)-4-(2-(((3S,4R)-3-fluorotetrahydro-2H-pyran-4-yl)amino)-8-((2,4,6-- trichlorophenyl)amino)-9H-purin-9-yl)-1-methylcyclohexane-1-carboxamide, or a pharmaceutically acceptable salt, tautomer, solvate, hydrate, co-crystal, clathrate, or polymorph thereof, as well as such formulations for use in treating, preventing or managing cancer. 1-methylcyclohexane-1-carboxamide), or a pharmaceutically acceptable salt, tautomer, solvate, hydrate, co-crystal, clathrate, free online sex video chat (https://camarasexlive.com) or polymorph thereof by weight, and 45-55% of an excipient by weight. 23. The capsule of claim 21, wherein the capsule further comprises 10-30% microcrystalline cellulose by weight, 55-75% mannitol by weight, 2-8% fumaric acid by weight, 1-7% crospovidone by weight, 0.2-1% fumed silica by weight, and 0.5-3% magnesium stearate by weight. 34. The capsule of claim 32, wherein the capsule further comprises 10-30% microcrystalline cellulose by weight, 50-70% mannitol by weight, 2-8% fumaric acid by weight, 1-7% crospovidone by weight, 0.2-1% fumed silica by weight, and 0.5-3% magnesium stearate by weight.



10. The nucleic acid of claim 9, wherein the nucleic acid encodes a heavy chain and a light chain consisting essentially of the amino acid sequences of SEQ ID NOs: 7 and 8, respectively. The anti-huICOS antibodies described herein may include amino acid residues not encoded by human germline immunoglobulin sequences (e.g., because of mutations introduced by random or site-specific mutagenesis in vitro or by somatic mutation in vivo). 28. The capsule of claim 23, wherein the capsule comprises about 5.0% fumaric acid by weight. 45. The capsule of claim 43, wherein the capsule further comprises 10-30% microcrystalline cellulose by weight, 50-70% mannitol by weight, 2-8% fumaric acid by weight, 1-7% crospovidone by weight, 0.2-1% fumed silica by weight, and 0.5-3% magnesium stearate by weight. Edge et al., "Polysaccharide engineering: Silicified microcrystalline cellulose as a novel high-functionality pharmaceutical material", in: Polysaccharide Applications: Cosmetics and Pharmaceuticals, American Chemical Society Symposium Series 737, Chapter 7, pp.



Bollag et al., "Vemurafenib: the first drug approved for BRAF-mutant cancer," Nat. Pat. No. 4,475,196, which discloses an osmotic drug delivery system. 1-methylcyclohexane-1-carboxamide), or a pharmaceutically acceptable salt, tautomer, solvate, hydrate, co-crystal, clathrate, or polymorph thereof by weight, three way sex 20-30% of an excipient by weight, and 5-15% of tocophersolan by weight. 1-methylcyclohexane-1-carboxamide or a pharmaceutically acceptable salt, tautomer, solvate, hydrate, co-crystal, clathrate, or polymorph thereof for the treatment of cancer. Therasse et al., "New guidelines to evaluate the response to treatment in solid tumors," J. Natl. Penichet et al., "Antibody-cytokine fusion proteins for the therapy of cancer," J. Immunol. Alcorn et al., "c-Jun N-Terminal Kinase 1 is Required for the Development of Pulmonary Fibrosis," Am. Lee et al., "Bleomycin induces alveolar epithelial cell death through JNK-dependent activation of the mitochondrial death pathway," Am. Eisenhauer et al., "New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1)," Eur. 2016/0096841April 2016Alexander et al. 9512124December 2016Alexander et al. 27. The capsule of claim 23, wherein the capsule comprises about 1.0% sodium lauryl sulfate by weight.



53. The capsule of claim 45, wherein the capsule comprises about 1.0% magnesium stearate by weight. FIG. 23 shows high variability in dissolution of enhanced formulation (F27-15, Table 27) with HPMC capsule shells (25 mg strength) at neutral pH. FIG. 25 shows high variability in dissolution of enhanced formulation (F27-15, Table 27) with HPMC capsule shells (25 mg strength) at neutral pH in the dissolution media with 0.5% SLS. FIG. 26 shows that no variability was observed in dissolution of enhanced formulation (F27-15, Table 27) with gelatin capsule shells (25 mg strength) at neutral pH in the dissolution media with 0.5% SLS. FIG. 21 shows the dissolution profiles of the 25 mg enhanced formulation (F27-15, Table 27) with apparatus I at 100 RPM in 0.1N HCl, pH 4.5 acetate buffer and pH 6.8 phosphate buffer. FIG. 22 shows the dissolution profiles of a conventional formulation (F4-1 in Table 11) with apparatus I at 100 RPM in 0.1N HCl, pH 4.5 acetate buffer and pH 6.8 phosphate buffer.