Major pharma companies including Novartis and Merck build federated learning platform for drug discovery

Venturebeat | September 17, 2020

Major pharma companies including Novartis and Merck build federated learning platform for drug discovery
Last June, 10 major pharmaceutical companies — Amgen, Astellas, AstraZeneca, Bayer, Boehringer Ingelheim, GSK, Institut De Recherches Servier, Janssen, Merck, and Novartis — inked an agreement to build a shared platform called MELLODDY (Machine Learning Ledger Orchestration for Drug Discovery). In partnership with Nvidia, Owkin, and other tech partners, the group sought to leverage techniques like federated learning to collectively train AI on datasets without having to share any proprietary data.

Spotlight

A Prescription for the NHS: Recognising the value of clinical pharmacology and therapeutics was developed by the British Pharmacological Society because of increasing demand on the NHS and well-documented evidence that CPT is able to meet these challenges, despite being a little-known specialty outside the medical establishment.

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RESEARCH

DarwinHealth Announces Scientific Collaboration with Prelude Therapeutics in Oncology

Prelude Therapeutics | October 13, 2021

DarwinHealth, Inc. today announced a scientific research collaboration that uses its Biomarker Enrichment Strategies for Assays (BEST platform ) to elucidate novel biomarkers that guide translational trajectories of multiple cancer molecules being developed by Prelude Therapeutics. Under the collaboration, DarwinHealth will use its proprietary, quantitative, systems biology-based algorithms, CLIA-approved technologies, and validated approaches focused on Protein Master Regulator (MR) and tumor checkpoints to identify novel protein-based biomarkers that will add a significant precision a Selection of patient cohorts for clinical trials to be conducted at Prelude's discretion in hematological and solid tumors. The goal of this biomarker-focused collaboration, is to assess and characterize the general and tumor-specific mechanisms of action of molecules in the Prelude pipeline in an attempt to identify new biomarkers that can align these agents with responding patient cohorts. In addition, the The collaboration will mechanically characterize potential therapeutic opportunities for Prelude pipeline molecules that target various oncogenic pathways through multiple hematologic malignancies and solid tumor subtypes, as selected by Prelude Therapeutics.The study will leverage the VIPER algorithm to characterize the activity of these various compounds against key Master Regulator (MR) protein modules (tumor checkpoints) required for subtype-specific tumor viability. - Professor Andrea Califano , Professor and Director of Clyde and Helen Wu , Department of Systems Biology, Columbia Universityand co-founder of DarwinHealth "The BEST initiative will provide accurate and actionable tumor- and compound-specific information to assess the potential of Prelude's pipeline molecules to reverse the activity of subtype-specific tumor checkpoints," explained Dr. Mariano Alvarez , Chief Scientific Officer of DarwinHealth. "The purpose of such studies is to generate a range of validated compound / tumor subtype / biomarker alignments that represent evidence-based roadmaps and mechanisms for biomarker development and patient selection to potentially accelerate clinical studies." As part of the BEST initiative, DarwinHealth will provide a comprehensive reading of the potential clinical value of selected Prelude molecules in a spectrum of tumor types. Using quantitative modeling and biomarker-focused translation pathways, DarwinHealth will also assist in the design of in vivo validation studies to exploit key opportunities that may not be apparent with conventional technologies. "The BEST collaboration addresses one of the critical unmet needs of the biotech and biopharmaceutical spaces focused on cancer drug discovery, that is, the development of highly predictive biomarkers of clinical response to compounds whose ultimate efficacy may be the result of an incompletely decipherable range of both in - and multi-target off-target drug effects of regulatory programs underlying cancer dependencies, These uncertainties lend themselves to extending the concept of biomarkers beyond the primary target (ie, high affinity) of a drug, to multiple protein classifiers identified by our experimental and computational integrative methodologies." - Dr. Gideon Bosker, CEO and Co-Founder of DarwinHealth. These technologies are ideal for identifying mechanical alignments between drug candidates and cancer patients based on the ability of drugs to inactivate patient-specific MR proteins that are necessary for maintenance of tumor status. Importantly, these discoveries can rapidly mature into precision biomarker-driven human clinical trials and commercial development. About DarwinHealth, Inc. DarwinHealth: Precision Therapeutics for Cancer Medicine is a cancer frontier biotechnology-focused company, co-founded by CEO Gideon Bosker, MD, and Professor Andrea Califano, Clyde and Helen Wu Professor of Chemical Systems Biology and Chair of the Department of Systems Biology from Columbia University. The company's technology was developed by Califano's laboratory over the past 14 years and is exclusively licensed by Columbia University. DarwinHealth technology has been developed to identify mechanistic and biomarker-driven, processable and often unforeseen alignments at the proteomic level between small molecules and specific tumor subtypes / patient cohorts and is therefore positioned to accelerate the development of oncology pipelines. About Prelude Therapeutics Prelude Therapeutics is a precision clinical-stage oncology company developing innovative drug candidates that target critical pathways in cancer cells. The company's main candidate products are designed to be potent and selective oral inhibitors of PRMT5. Prelude's first clinical candidate, PRT543, is in phase 1 development for advanced solid tumors and selected myeloid cancers. Prelude also advances PRT811, a second PRMT5 inhibitor optimized for high brain exposure, in a phase 1 clinical trial that includes glioblastoma multiforme (GBM). The company's portfolio also includes its third clinical candidate, PRT1419,

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PHARMA TECH

Gannex Received U.S. FDA Fast Track Designation for Its NASH Drug Candidate ASC42,an FXR Agonist

Gannex | December 14, 2020

Gannex, an entirely claimed organization of Ascletis Pharma Inc. (HKEX:1672) and completely committed to the R&D and commercialization of new medications in the field of NASH, reported today that it got Fast Track assignment from the U.S. Food and Drug Administration (FDA) for its non-alcoholic steatohepatitis (NASH) drug applicant ASC42. The U.S. FDA's Fast Track advancement program is intended to encourage the turn of events and speed up the survey of medications that have capacity to treat genuine or perilous infections or conditions and exhibit the possibility to address neglected clinical necessities with extra clinical advantages to patients. There are no FDA affirmed drugs for NASH sign yet. This Fast Track assignment speaks to FDA's acknowledgment of ASC42's potential in tending to these neglected clinical requirements for NASH patients. Gannex got the investigational new medication application (IND) endorsement for ASC42 from the U.S. FDA in October this year. ASC42 is an in-house developed,novel non-steroidal, specific, intense Farnesoid X Receptor (FXR) agonist with top tier potential. In two NASH creature models, ASC42 showed critical enhancements in liver steatosis, aggravation and fibrosis. The oral tablet plan of ASC42 has been created with the in-house restrictive innovation and is steady at room temperature. "We are excited that the FDA allowed Fast Track assignment for our FXR agonist ASC42 which is found and created by our in-house skilled R&D group," said Dr. Jinzi J. Wu, "This basic acknowledgment by FDA will quicken worldwide advancement of ASC42, a potential top tier FXR agonist."

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PRACTICE MANAGEMENT

Infant Bacterial Therapeutics today announces new patent protection approvals in Brazil and in Hong Kong

Infant Bacterial Therapeutics | December 28, 2021

Infant Bacterial Therapeutics AB announces that the Patent Offices of Brazil and Hong Kong have approved a patent of Lactobacillus reuteri covering IBP-9414. IBT is currently developing its drug candidate IBP-9414 in Phase III for the prevention of necrotizing colitis and improvement of feeding tolerance in preterm infants. The patent covers a novel way to activate the bacteria. Corresponding patent applications are currently pending across several important future markets. This patent reinforces the existing protection of IBT’s drug candidate IBP-9414. Additional market protection, beyond patent exclusivity, is also anticipated in the form of Orphan Drug Exclusivity and biological data protection in the US and EU. The patent provides coverage until 2036. IBP-9414 is intended to be marketed in Brazil and Hong Kong upon marketing authorization. “We are pleased to have strengthened our intellectual property protection for IBP-9414 through the approved patents in Brazil and Hong Kong. Brazil is in particular a substantial market with about 215 million inhabitants, which makes it a very interesting commercial opportunity for our future product", CEO Staffan Strömberg, IBT About Infant Bacterial Therapeutics AB Infant Bacterial Therapeutics AB is a public company domiciled in Stockholm. The company’s Class B shares are listed on Nasdaq Stockholm, Mid-cap. Infant Bacterial Therapeutics AB is a pharmaceutical company with a product in clinical phase III with a vision to develop drugs influencing the infant microbiome, and thereby prevent or treat rare diseases affecting infants. IBT is currently developing the drug candidate IBP-9414. The ambition for IBP-9414 is to become the world’s first approved probiotical drug with the goal to prevent life threatening diseases in premature infants including NEC and sepsis by promoting healthy stomach-and bowel development in premature infants. IBP-9414 contains the active compound Lactobacillus reuteri, which is a human bacterial strain naturally present in breast milk. The product portfolio also includes another project, IBP-1016, for the treatment of gastroschisis, a severe and rare disease affecting infants. By developing these drugs, IBT has the potential to fulfill unmet needs for diseases where there are currently no prevention or treatment therapies available.

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Spotlight

A Prescription for the NHS: Recognising the value of clinical pharmacology and therapeutics was developed by the British Pharmacological Society because of increasing demand on the NHS and well-documented evidence that CPT is able to meet these challenges, despite being a little-known specialty outside the medical establishment.