Company Product Description Indication Status
Ascentage Pharma Group International, of Suzhou, China HQP-1351 BCR-ABL inhibitor Chronic myeloid leukemia FDA granted fast track designation for use in patients with certain genetic mutations who have failed to respond to treatments with existing tyrosine kinase inhibitors
Bexion Pharmaceuticals Inc., of Covington, Ky. BXQ-350 Composed of lysosomal activator protein Saposin C and phosphatidylserine Malignant glioma FDA granted orphan designation, including for use in diffuse intrinsic pontine glioma
Canbridge Pharmaceuticals Inc., of Beijing and Shanghai Nerlynx (neratinib) Kinase inhibitor binding to HER2, HER4 and EGFR Breast cancer China’s NMPA granted marketing approval for use in adults with early stage HER2-positive disease following adjuvant trastuzumab-based therapy
Daiichi Sankyo Co. Ltd., of Tokyo Trastuzumab deruxtecan (DS-8201) HER2-directed antibody-drug conjugate Metastatic gastric cancer Submitted supplemental NDA to Japan’s Ministry of Health, Labour and Welfare seeking approval for treatment of patients with HER2-positive disease
Evelo Biosciences Inc., of Cambridge, Mass. EDP-1815 Anti-inflammatory agent  Hospitalized COVID-19 patients Submitted IND to the FDA for a study of 60 patients; primary endpoint is reduced requirements for oxygen therapy; secondary endpoints include symptom duration, progression along the WHO scale of disease severity and mortality; data expected in second half of 2020
Genelux Corp., of San Diego Olvi-Vec (olvimulogene nanivacirepvec) Oncolytic virus Ovarian cancer Type C meeting with FDA provided guidance for phase III registrational trial in patients with platinum-refractory/resistant disease; company plans to meet with FDA after lock of phase II Viro-15 study in the fourth quarter of 2020, with plans to start phase III in 2021
Gilead Sciences Inc., of Foster City, Calif. Remdesivir Nucleotide analogue COVID-19 Japan’s Ministry of Health, Labour and Welfare granted regulatory approval of drug, branded Veklury, under exceptional approval pathway
Immunicum AB, of Stockholm Ilixadencel Cell-based, off-the-shelf immune primer Renal cell carcinoma FDA granted regenerative medicine advanced therapy designation
Nanobiotix SA, of Paris NBTXR-3 Designed to destroy tumors when activated by radiotherapy Pancreatic cancer FDA deems phase I trial safe to proceed
Novartis AG, of Basel, Switzerland Tabrecta (capmatinib, INC-280) Oral MET inhibitor Metastatic non-small-cell lung cancer Approved by FDA for use in patients whose tumors have a mutation that leads to MET exon 14 skipping as detected by an FDA-approved test; approval granted under accelerated pathway based on overall response rate and duration of response
Sapience Therapeutics Inc., of Harrison, N.Y. ST-101 Peptide therapy Solid tumors U.K.’s Medicines and Healthcare products Regulatory Agency accepted the CTA for phase I/II study in adults with unresectable and metastatic disease who are not eligible for other therapies or have progressed on prior therapies
Twi Biotechnology Inc., of Taipei, Taiwan AC-1101 Topical JAK inhibitor Vitiligo Received CTA approval from Health Canada for a phase I trial in healthy volunteers

Notes

For more information about individual companies and/or products, see Cortellis.

No Comments