Company Product Description Indication Status
Aclaris Therapeutics Inc., of Wayne, Pa. ATI-450 MK2 inhibitor Hospitalized patients with COVID-19 FDA cleared the IND for a phase IIa study with the primary endpoint of proportion of patients who are free from respiratory failure by day 14
Curevac AG, of Tubingen, Germany SARS-CoV-2 vaccine mRNA vaccine COVID-19 prophylaxis German Health Authority Paul-Ehrlich-Institute and the Belgian Federal Agency for Medicines and Health Products approved the dose-escalation phase I trial in 168 subjects
Hookipa Pharma Inc., of New York HB-202 Arenavirus expressing E7/E6 fusion protein derived from HPV16 Human papillomavirus 16-positive cancers FDA cleared the IND, which will allow the company to add an arm testing HB-202 plus HB-201 to the phase I/II study of HB-201
Ipsen SA, of Paris  Onivyde (liposomal irinotecan)  Topoisomerase I inhibitor  Previously untreated, unresectable, locally advanced and metastatic pancreatic ductal adenocarcinoma FDA granted fast track designation for the drug in combination with 5-fluorouracil/leucovorin and oxaliplatin
Kamada Ltd., of Rehovot, Israel Plasma-derived IgG product  Plasma-derived IgG product  COVID-19 Proposed protocol for a phase I/II trial submitted to the Israeli Ministry of Health; company expects to initiate the study during the third quarter of 2020
Merck & Co. Inc., of Kenilworth, N.J. Keytruda (pembrolizumab) Monoclonal antibody targeting PD-1 Unresectable or metastatic, mutational burden-high solid tumors FDA approved the expanded indication regardless of tumor type; FDA also approved the Foundationone Cdx (Foundation Medicine Inc.) as a companion diagnostic for Keytruda in patients with mutational burden-high tumors
Nanobiotix SA, of Paris NBTXR-3 Designed to destroy tumors when activated by radiotherapy Head and neck cancer Received feedback from FDA to advanced phase III study design and CMC development plan for NDA; 500-patient Nanoray-312 study set to start after company makes protocol refinements and secures requisite financing 
Novartis AG, of Basel, Switzerland Cosentyx (secukinumab) Monoclonal antibody targeting interleukin-17A Active non-radiographic axial spondyloarthritis FDA approved the expanded indication
Novartis AG, of Basel, Switzerland Ilaris (canakinumab) Monoclonal antibody targeting interleukin-1beta Active Still’s disease FDA approved the expanded indication
PTC Therapeutics Inc., of South Plainfield, N.J. PTC-299  Dihydroorotate dehydrogenase inhibitor COVID-19 FDA authorized starting the phase II/III study; CTA submitted in Spain; plans to file in Europe, Brazil and Australia
Reneuron Group plc, of London hRPC stem cell therapy Retinal progenitor cells Retinitis pigmentosa FDA approved the expansion of the phase IIa study to add an additional 9 patients at higher doses; U.K.'s Medicines and Healthcare products Regulatory Agency approved opening a clinical site for the study; plans to seek regulatory approval in the second half of 2021
TG Therapeutics Inc., of New York Umbralisib Inhibitor of PI3K-delta and CK1-epsilon Previously treated marginal zone lymphoma and follicular lymphoma Completed rolling submission of the NDA

Notes

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

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