BioSpace Global Roundup, Aug. 6

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Lumicks – LUMICKS entered into a collaboration with Glycostem Therapeutics, to improve immunotherapeutic drug development. Netherlands-based Glycostem exploits the predictiveness of avidity in finding the best NK-cell population for cellular therapy. In this collaboration, Glycostem will assess their NK cells using LUMICKS’ z-Movi to gain new insights into the cell avidity and functional properties of their cells. Avidity is a new parameter that is crucial to understand immune cells better and choose the most potent ones for immunotherapy.

Enterome – France-based Enterome SA published a new study in Nature Biotechnology describing the creation of the most comprehensive and unified catalog to-date of genomic and proteomic data from the human gut microbiome. These reference catalogs build on previous global projects aimed at characterizing the human gut microbiome, such as the Human Microbiome Project. The goal of this research is to enable a better understanding of the functions and interactions of bacterial species in the gut microbiome and link to their roles in human health – linking genotype to phenotype within specific clinical contexts, such as during inflammatory diseases, metabolic diseases and cancer.

Biophytis – Age-related disease-focused Biophytis, based in France, has received approval from the Brazilian Health Regulatory Agency, ANVISA (Agencia Nacional de Vigilancia Sanitaria), to start its clinical development program COVA in Brazil, where the Coronavirus SARS-CoV-2 is still very active with high transmission rates of the virus. The COVA Phase II/III clinical program is designed to evaluate the efficacy and safety of Sarconeos (BIO101) as a treatment of the respiratory deterioration in COVID-19 patients with respiratory failure.

Centogene – Germany’s Centogene NV has expanded its ongoing development cooperation with the Ministry of Health and Social Protection of the Population of Tajikistan to now include SARS-CoV-2 testing. The project will enable Tajikistan to increase their testing capacities – helping the country to identify and quarantine patients with a SARS-CoV-2 infection and hence, control infection chains to minimize the outbreak of COVID-19.

Horizon Discovery Group – Cambridge, U.K.-based Horizon Discovery Group announced the addition of single-cell RNAseq-linked pooled CRISPR screening to its CRISPR screening services portfolio. The platform offers high-quality screening data and biological insight to address critical gaps in target identification and validation. The biological insight gained from Horizon’s single-cell RNAseq-linked CRISPR screening platform could help researchers to gain further understanding into complex biological models and speed up the time from discovery to validation by integrating the effect of gene editing with complex gene expression mapping.

MODAG – Germany-based MODA, which is focused on the development of disease-modifying small molecule therapeutics for neurodegenerative diseases, completes its first clinical trial of anle 138b. The candidate showed excellent safety and tolerability profiles at all dose levels and reached significantly higher plasma levels in humans than those required for full therapeutic efficacy in animal models. Anle138b was initially developed for the treatment of Multiple System Atrophy (MSA) and has the potential to be applied to other synucleinopathies, such as Parkinson's disease. Anle138b is a small molecule that specifically binds to toxic oligomeric structures of alpha-synuclein, the core aggregating protein in Parkinson's disease. That prevents the formation of new oligomers and thereby blocks the disease-specific aggregation process from advancing. Following the announcement, MODAG received $1.4 million from The Michael J. Fox Foundation for Parkinson's Research to support its development. Following the first-in-patient study, MODAG plans to conduct long-term clinical trials investigating the efficacy of anle138b in MSA and Parkinson’s disease patients. These studies are anticipated to begin at the end of 2021.

GENFIT – GENFIT, based in France, announced that pivotal data describing the derivation and validation of NIS4 has been accepted for publication by The Lancet Gastroenterology & Hepatology. NIS4 is GENFIT’s novel non-invasive, blood-based diagnostic technology, developed to identify patients with non-alcoholic steatohepatitis (NASH) and significant to advanced fibrosis (F>2), also referred to as at-risk NASH in the published study.

PanThera – Panthera’s oncology test sites in the United Kingdom are up and running after being temporarily halted due to the COVID-19 pandemic. Panthera has a network of seven clinical trial sites in the UK with several more in development. These include sites where specialist trials for oncology, vaccines and neurology can be carried out by experienced GCP trained staff. Panthera also undertakes research in conditions usually treated in primary care including cardiac disease, osteoarthritis, osteoporosis, diabetes, allergies and migraine.

Pfizer Canada – Pharma giant Pfizer’s Canadian operations, along with its development partner BioNTech, struck an agreement with the Canadian government to supply their BNT162 mRNA-based vaccine candidate against SARS-CoV-2, subject to clinical success and Health Canada approval. Financial details of the agreement were not disclosed. Deliveries of the vaccine candidate are planned for over the course of 2021. In July, Pfizer and BioNTech announced that following extensive review of preclinical and clinical data from Phase I/II clinical trials, the companies selected the BNT162b2 vaccine candidate to move forward into a Phase II/III study. BNT162b2 encodes an optimized SARS-CoV-2 full-length spike glycoprotein (S), which is the target of virus-neutralizing antibodiesBNT162b2 has received Fast Track designation from the U.S. FDA. Recently, two of the companies’ four investigational vaccine candidates – BNT162b1 and BNT162b2 – received Fast Track designation from the U.S. Food and Drug Administration (FDA). This designation was granted based on preliminary data from Phase I/II studies that are currently ongoing in the United States and Germany as well as animal immunogenicity studies. Assuming clinical success, Pfizer and BioNTech are on track to seek regulatory review for BNT162b2 as early as October 2020 and, if regulatory authorization or approval is obtained, plan to supply up to 100 million doses worldwide by the end of 2020 and approximately 1.3 billion doses by the end of 2021.

Revive Therapeutics – Toronto-based Revive Therapeutics received the green light from the FDA to begin a Phase III study to evaluate the safety and efficacy of rheumatoid arthritis drug Bucillamine in patients with mild-moderate COVID-19. The primary objective is to compare the frequency of hospitalization or death in patients with mild-moderate COVID-19 receiving Bucillamine therapy with those receiving placebo. The primary endpoint is the proportion of patients meeting a composite endpoint of hospitalization or death from the time of the first dose through Day 28 following randomization.

Variation Biotechnologies – Ontario-based Variation Biotechnologies, a subsidiary of VBI Vaccines, has been awarded up to a $56 million (Canadian) contribution from the Strategic Innovation Fund of the Government of Canada to support the development of the company’s coronavirus program, VBI-2900, through Phase II clinical studies. VBI expects to select the optimal vaccine candidates in the third quarter of 2020 to enable the start of clinical studies by the end of 2020.

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