ChemoCentryx gets new PDUFA date after major amendment; Nimium launches with eye on obesity
Following talks with the FDA, ChemoCentryx on Monday filed an amendment to its application for avacopan as a treatment of anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis, resulting in a new PDUFA goal date of Oct. 7.
While the company did not explain what was contained in the amendment filing, its stock spiked by more than 10% on the news. How the agency will ultimately decide on the drug remains a mystery. The agency’s Arthritis Advisory Committee in May voted 9-9 on whether the efficacy data from a small Phase III trial support approval of avacopan, 10-8 in favor of the drug’s safety profile, and 10-8 that the benefit-risk profile is adequate to support approval.
There was a contentious debate at the meeting over whether the Phase III trial was enough to support the approval as the FDA raised concerns about the statistical analyses of the data in the trial and what effect the use of glucocorticoids on top of cyclophosphamide or rituximab in both treatment arms had on the efficacy of avacopan.
“We appreciate the opportunity to put additional data and information before the Agency, information which we believe addresses many of the issues raised at the Advisory Committee meeting,” ChemoCentryx CEO Thomas Schall said in a statement. — Zachary Brennan
Biotech upstart launches with an eye on ‘excess caloric intake’
A new biotech focused on obesity has launched in Montreal.
The upstart is focused on the work of Marc Prentki, the principal scientist at the Centre de recherche du Centre Hospitalier de l’Université de Montréal. He’s credited with discovering that “an enzyme, glycerol-3-phosphate phosphatase (G3PP), plays a key role in sugar, fat and energy metabolism.”
The company, dubbed Nimium, has licensed IP covering agents that activate the human G3PP enzyme.
Philippe Walker, an AstraZeneca vet, is leading the startup. He notes: “From obesity to type 2 diabetes, and other diseases such as chronic kidney disease and non-alcoholic fatty liver disease, there is a global epidemic related to the toxic effects of overnutrition. Through Nimium, we aim to address this health crisis by developing a new therapeutic approach that will reduce the effects of excess caloric intake, and that should promote healthy aging.” — John Carroll
Mimetas and Roche partner for human disease models
Roche has entered into a collaboration with Netherlands-based Mimetas to develop human disease models for inflammatory bowel disease and hepatitis B virus infections, the companies said in a release Tuesday.
Mimetas will develop tissue-based models in OrganoPlate, its organ-on-chip platform that increases the predictability of biomarkers and reduces animal use in testing. Roche, in return, will get access to the technology, disease models and results, as well as an option to exclusively license models and assays for drug discovery. Mimetas is eligible for both upfront and milestone payments from Roche.
“The collaboration with Roche leverages our ongoing focus on developing predictive, phenotypic models, preceded by numerous successful projects over the last eight years,” Mimetas CEO Jos Joore said in a press release. “We will leverage our disease modeling expertise in our world-leading OrganoPlate platform to gain novel insights in IBD and HBV.” — Josh Sullivan
Sosei enlists InveniAI in AI-powered and GPCR-focused drug discovery collaboration
Sosei Group is partnering with InveniAI to develop new therapeutic product concepts for immune diseases where an AI- and ML-based approach can be used to generate compelling evidence for the role of G-protein coupled receptors (GPCRs) in relevant immunomodulatory pathways. The goal is to use these targets as a basis for structure-based drug design to generate novel compounds that could improve responses to existing immunotherapies.
“GPCRs represent an important class of pharmaceutical targets, and it is estimated that about 30% of known drugs have their mode of action through a relatively small number of GPCRs,” Sosei Heptares CSO Miles Congreve said in a statement. “This leaves a significant number of remaining GPCR targets that could be attractive for therapeutic intervention. InveniAI’s AlphaMeld platform will deconvolute the biology of disease and industrialize target discovery by rapidly unravelling connections between GPCR targets and diseases with high unmet need.” — Zachary Brennan
Leo Pharma gets new data partner after April CRL
Looking to rebound from an April CRL, Leo Pharma has enlisted a new partner to help it continue pursuing dermatology-related diseases.
The Danish biotech has enlisted Waltham, MA-based X-Chem in a partnership that will apply the latter’s platform to help identify potential new targets. Leo will retain the option for exclusive global rights for any medicine that comes out of the agreement, as well as all rights to commercialization.
Leo will be further responsible for all preclinical and clinical R&D. Financial terms of the deal were not disclosed.
“X-Chem’s DEL platform technology is a powerful approach giving us increased capabilities to feed our innovative project portfolio,” Leo head of early R&D Thorsten Thormann said in a statement. — Max Gelman