Company |
Product |
Description |
Indication |
Status |
Phase I | ||||
Beigene Ltd., of Beijing |
Tislelizumab |
Anti-PD-1 antibody |
Solid tumor |
Preliminary data from patients with microsatellite instability-high or mismatch repair-deficient solid tumors found objective response rate of 29% in 4 patients out of 25-patient cohort; median duration of response still maturing |
Cardurion Pharmaceuticals Inc., of Cambridge, Mass. |
CRD-733 |
PDE9 inhibitor |
Heart failure |
FDA accepted the IND, and a study in healthy volunteers was initiated |
Cell Medica Ltd., of London |
CMD-501 |
Autologous CAR-NKT therapy |
Neuroblastoma |
Dosed first patient in GINAKIT2, a first-in-human, dose-escalation evaluation in children with relapsed or refractory high-risk neuroblastoma |
Exicure Inc., of Skokie, Ill. |
AST-008 |
Spherical nucleic acid |
Carcinoma |
Doses up to 20 µg/kg found safe and well-tolerated; treatment-related AEs were short-lived, reversible and consistent with TLR9 activation; elicited high levels of certain cytokines and activation of important effector cells; preliminary data from phase Ib trial expected in late 2019 |
Galectin Therapeutics Inc., of Norcross, Ga. |
GR-MD-02 |
Galectin-3-targeting polysaccharide |
Melanoma |
Investigator-initiated trial with Providence Cancer Institute found GR-MD-02 + Keytruda (pembrolizumab, Merck & Co. Inc.) yielded objective response rate and duration of response rate higher than expected with Keytruda alone |
Nanobiotix SA, of Paris |
NBTXR-3 |
Hafnium oxide crystal nanoparticles |
Metastatic head and neck cancer |
Strengthening of NBTXR-3 data showing the potential impact on survival in elderly and frail patients with locally advanced head and neck cancers; biomarker analysis and new preclinical data support NBTXR-3 mechanism of action in immune-oncology and use in combination with immune checkpoint inhibitors |
Oxurion NV, of Leuven, Belgium |
THR-687 |
Pan-RGD integrin antagonist |
Diabetic macular edema |
Enrolled the first patient; open-label, dose-escalation study will test single intravitreal injection; up to 18 patients to be enrolled |
Phase II | ||||
Aivita Biomedical Inc., of Irvine, Calif. |
Root of cancer |
Patient-specific treatment consisting of autologous dendritic cells loaded with autologous antigens from patient's tumor-initiating cells |
Advanced ovarian cancer |
Dosed the first 10 patients in the 99-patient trial; treatment is administered via series of injections along with standard of care |
Amygdala Neurosciences Inc., of San Francisco |
ANS-6637 |
Selective ALDH2 inhibitor |
Opioid use disorder |
SEARCH studies, sponsored by the National Institute of Allergy and Infection Diseases with $12.4 million in funding, will test safety, efficacy and underlying mechanisms of craving reduction as a strategy to prevent opioid misuse, dependence and relapse, and improve the morbidity and reduce mortality |
Cocrystal Pharma Inc., of Atlanta |
CC-31244 |
Oral, non-nucleoside inhibitor |
Hepatitis C virus |
Completed patient enrollment in the phase IIa study for ultra-short treatment of HCV patients |
ISR Immune System Regulation Holding AB, of Stockholm |
ISR-048 |
GnRH agonist |
HIV |
Enrolled first patient in phase IIa study testing ISR-048 plus antiretroviral therapy (ART) vs. ART alone |
Oxurion NV, of Leuven, Belgium |
THR-317 |
Anti-PIGF antibody |
Macular telangiectasia type 1 |
Enrolled the first patient in the study testing efficacy and safety of intravitreally administered drug, assessed via functional and anatomic endpoints |
Phase III | ||||
Astellas Pharma Inc., of Tokyo |
Roxadustat |
Inhibits HIF prolyl hydroxylase activity |
Chronic kidney disease with anemia |
ALPS study met primary endpoints, showing superiority vs. placebo in both hemoglobin response rate in the first 24 weeks and Hb change from baseline at weeks 28 to 52 |
Erytech Pharma SA, of Paris |
Eryaspase |
L-asparaginase encapsulated inside donor-derived red blood cells |
Second-line metastatic pancreatic cancer |
First 3 patients enrolled in the pivotal TRYbeCA1 trial; 500-patient trial is testing eryaspase in combination with chemotherapy vs. chemotherapy alone; primary endpoint is overall survival |
Innovent Biologics Inc., of Suzhou, China |
Sintilimab |
Fully human anti-PD-1 antibody |
First-line nonsquamous non-small-cell lung cancer |
Data from cohort D in combination with pemetrexed and cisplatin showed an objective response rate of 68.4% based on 19 patients with at least 1 radiological assessment among 21 patients total; as of data cut-off, median duration of response, progression-free survival and overall survival have not been reached |
Mesoblast Ltd., of Melbourne, Australia |
Remestemcel-L |
Allogeneic mesenchymal stem cell candidate |
Steroid-refractory acute graft-vs.-host disease |
Pediatric study met the primary endpoint of day 28 overall survival, with 69% of patients achieving that endpoint vs. protocol-defined historical control rate of 45% (p=0.0003); in patients with positive overall response at day 28, survival was 87% at day 100; day 180 survival for those patients was 79% |
Novo Nordisk A/S, of Bagsvaerd, Denmark |
Oral semaglutide |
GLP-1 analogue |
Type 2 diabetes |
Headline results from phase IIIa PIONEER 10 study in Japanese patients achieved primary objective, showing comparable number of adverse events with oral semaglutide vs. 0.75-mg dulaglutide |
Notes For more information about individual companies and/or products, see Cortellis. |