Phase I

Ipsen SA and Les Laboratoires Servier SAS, both of Paris

Onivyde (liposomal irinotecan)

Topoisomerase inhibitor

Metastatic pancreas cancer

Among patients with previously untreated metastatic pancreatic ductal adenocarcinoma cancer, combination of Onivyde with 5- fluorouracil/leucovorin and oxaliplatin led to treatment-emergent adverse events of grade 3 or higher in 20 of 32 patients from the 50/60 dose pooled patient analysis; none reported grade 3 or higher fatigue or peripheral neuropathy

Neurovive Pharmaceutical AB, of Lund, Sweden

KL-1333

Quinone reductase-1 modulator; NAD kinase modulator

Mitochondrial disease

Initiated repeated dosing of healthy volunteers in second part of its phase Ia/b study

Phase II

Gamamabs PharmaSA, of Paris

Murlentamab (GM-102)

Glycoengineered (low-fucose)monoclonal antibody targeting AMHRII

Metastatic colorectal cancer

In combination with Lonsurf (trifluridine/tipiracil), progression-free survival was longer than expected (40% and 31% at 4 and 6 months, respectively)

Puma Biotechnology Inc., of Los Angeles

Neratinib

Irreversible pan-HER tyrosine kinase inhibitor

Biliary cancer

Interim results in patients with efficacy of neratinib in HER2-mutated cancers showed confirmed overall response rate was 10% and clinical benefit rate was 30%

Tyme Technologies Inc., of New York

Racemetyrosine (SM-88)

Cocktail of 3 established low-dose noncancer treatments

Metastatic pancreatic cancer

Demonstrated median overall survival of 6.4 months as of April 25 in Tyme-88-Panc trial; plans to initiate randomized pivotal trial in patients with pancreatic cancer in third quarter of 2019

Valbiotis SA, of Perigny, France

Valedia (TOTUM-63)

Combination of 5 plant extracts

Prediabetes

Top-line phase IIa data showed significantly reduced fasting and postprandial blood glucose levels, the 2 main risk factors for type 2 diabetes; compound also significantly reduced body weight and waist circumference

Phase III

Infant Bacterial Therapeutics AB, of Stockholm

IBP-9414

Contains active compound Lactobacillus reuteri

Prevention of necrotizing enterocolitis

Recruited first patient in pivotal Connection study testing safety and efficacy in preventing necrotizing enterocolitis and other aspects of feeding preterm babies

Notes

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