Dec 2019 - Jan 2020

Global Pharma

AI-based drug discovery platform

Artificial intelligence (AI) based drug discovery platform, Healnet from UK-based drug technology firm Healx, analyses rare disease data to predict and link therapies to rare diseases.

Founded in 2014, Healx aims to develop treatments for patients suffering from rare diseases.

Previously, Healnet identified eight repurposing drug candidates with the potential to treat fragile X syndrome. Many of the identified candidates showed efficacy in-vivo, while one candidate is being advanced toward a Phase IIa clinical trial.

The AI-based drug discovery platform was also used in another project with the Pitt Hopkins Research Foundation to evaluate, predict and advance therapies for Pitt-Hopkins syndrome, a rare neurodevelopmental condition.

In October, Healx raised $56m in a Series B funding round to support the development of rare disease treatments identified using Healnet. Healx plans to utilise the funds to bolster its pipeline, including fragile X syndrome therapies.

To discover drugs based on cellular behaviors

Flagship Pioneering has launched a new company, Cellarity, to discover drugs based on insights from research of cellular behaviours.

The company was established in 2017, developing a platform that uses single-cell technologies and machine learning to analyse cell behaviour

After digitising and quantifying cell behaviours, the platform understands the dynamics associated with those behaviours, using the information to develop therapies that can direct them.

Cellarity builds on the concept that several diseases occur due to abnormal cell behaviours in a tissue.

The company leverages this concept to quantita-tively define changes in cellular behaviours related to disease and identify therapies that can restore their normal state.

The information on cellular behaviours enables discovery of drugs that can concurrently act on molecular, cellular, phenotypic, organismal and clinical factors of a disease, instead of only a single target protein or pathway.

The Cellarity platform features a combination of the company’s physical laboratory and its digital technology, Cellarium.

To digitally transform manufacturing and supply chain

Novartis has collaborated with Amazon Web Services (AWS) to digitally transform the manufacturing, supply chain and delivery of its medicines using cloud services.

Under the multi-year partnership, Novartis will leverage AWS artificial intelligence (AI) and machine learning (ML) services for innovation and cost efficiencies of its business processes and systems worldwide.

The companies will work together to develop Novartis Insight Centers, which will enable realtime visibility across the pharmaceutical company’s manufacturing processes and distribution centres.

Novartis will also use the Cloud service to capture inventory, quality and production data. The company can apply internet of things (IoT), analytics and ML for better visibility and efficiencies.

Moreover, data scientists at the pharmaceutical company can explore new optimisation models to bolster the production of complex, personalised therapies.

IoT services will be used for visual inspections of Novartis’ manufacturing sites by creating images, which can be reviewed with computer vision algorithms to help track manufacturing risks.

This real-time data is expected to facilitate informed decisions for efficient production and distribution of drugs in 155 countries.

Blockbuster drugs become cheaper in China

China’s National Healthcare Security Administration (NHSA) has announced it has agreed an average 61% cut in prices of 70 topselling drugs with large pharma manufacturers in exchange for inclusion on a state-run insurance scheme list.

According to the South China Morning Post, the 70 drugs include Roche’s Perjeta, Novartis’ Xolair and the top selling drug in the world AbbVie’s Humira, as well as Eli Lilly and China-based Innovent Biologics’ Tyvyt.

State-owned news organisation Xinhua noted that 22 anti-cancer drugs, seven drugs for rare diseases, 14 for chronic diseases, four for paediatric indications and three for hepatitis were reduced in price by 87%.

The NHSA claims this makes the prices of these drugs the lowest in the world. Also, this agreements means big pharma and their drugs will have greater access to the world’s second largest pharma market because more Chinese citizens in smaller, more remote cities will be able to afford the drugs through their state medical insurance system.

NDA for drug indicated for multidrug resistant HIV

ViiV Healthcare has submitted a new drug application (NDA) to the USFDA for its first-inclass human immunodeficiency virus (HIV) drug fostemsavir

This is based upon data from the pivotal Phase III BRIGHTE study, which tested the effects of combining fostemsavir with an anti-retroviral in a group of heavily treatment-experienced adults with multi-drug resistant HIV-1 infection. This combination demonstrated superiority to placebo at 96 weeks, according to results presented at the International AIDS Society conference in Mexico City earlier this year.

Multi-drug resistance is a common issue in HIV treatment because the virus constantly mutates, and there are issues with tolerability and drug-todrug interactions in combination therapies for this condition.

Fostemsavir has a novel mechanism of action; it binds directly to the glycoprotein 120 subunit on the surface of the virus, which blocks HIV from attaching to CDR+ T cells and other immune cells, so they cannot infect them and multiply. There has been no demonstrated resistance to this mechanism, which ViiV believes is why this treatment works in multi-drug resistant strains of HIV.

ViiV has already received fast track and breakthrough therapy designation from the FDA for this drug, and are planning to submit applications to other regulators, including the European Medicines Agency, in early 2020.

Consortium to launch centre for regenerative therapies

A consortium of academic, biotech, biopharmaceutical and healthcare partners in the US is set to create a centre to manufacture and engineer regenerative cancer therapies.

Harvard University, Massachusetts Institute of Technology (MIT), GE Healthcare Life Sciences, Fujifilm Diosynth Biotechnologies and Alexandria Real Estate Equities will lead the consortium.

MilliporeSigma, Boston Children’s Hospital, Dana-Farber Cancer Institute, Brigham and Women’s Hospital, Beth Israel Deaconess Medical Center, Massachusetts General Hospital and the Commonwealth of Massachusetts will also contribute.

The $50m Center for Advanced Biological Innovation and Manufacturing is expected to be launched next year as an independent, non-profit entity.

It will focus on cell and gene therapies, biologic discovery and manufacturing, immunotherapy, cell therapies and gene editing.

The consortium aims to cut the time between research and clinical application.