22 APRIL 2020

SOM Biotech identifies three Covid-19 drug candidates

SOM Biotech has completed in-vitro analyses and identified three drug candidates that can be potentially used to treat Covid-19.

The three candidates inhibit the main protease of SARS-CoV-2, which causes Covid-19, in turn targeting the virus’ replication.

SOM Biotech partnered with Ewha Woman’s University in South Korea for Covid-19 research.

The company’s artificial intelligence (AI)-based screening technology, SOMAIPRO, was used to discover the inhibitors of 3CL proteases of SARS-CoV-2, SARS-CoV and MERS-CoV. These inhibitors were intended to offer potential Covid-19 treatments.

Ewha Woman’s University professor Dong-Hae Shin said: “We are very proud about working on promising Covid-19 treatments and contributing to finding effective, safe and fast solutions due to the importance of the current pandemic situation.

“We decided to start working with SOM Biotech as we are committed to tackling this Covid-19 pandemic leveraging on partners with innovative technologies and excellent know-how.”

Of the three in-vitro validated candidates, Eravacycline is an approved drug while Prexasertib is currently in clinical development and Cynarine is a natural compound used as a dietary supplement.

All three drug candidates can be repurposed to treat Covid-19, said the company.

The company also filed a patent application for method-of-use protection for the three compounds globally.

SOM Biotech CEO and founder Raul Insa said: “We have joined forces with professor Dong-Hae Shin from Ewha Woman’s University to combine our scientific and medical expertise to find new therapies for the treatment of Covid-19.

“Thanks to our capabilities in screening molecules with our AI-based technology, we have validated active anti-coronavirus compounds. Thus, we look forward to the rapid development of these drugs to be able to provide patients with an effective and safe treatment against the Covid-19 as soon as possible.”

The company said that clinical studies of these drug candidates can be launched immediately.

21 APRIL 2020

FDA and EMA agree to review shorter infusion time of Roche’s Ocrevus

The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have agreed to review Roche’s applications for a shorter infusion time of Ocrevus to treat relapsing or primary progressive multiple sclerosis (MS).

Ocrevus is a humanised monoclonal antibody that acts on CD20-positive B-cells, linked to myelin and nerve cell damage, which can cause disability in MS patients.

It is said to be the first drug to receive approval for relapsing-remitting MS (RRMS) and active, or relapsing, secondary progressive MS, and primary progressive MS (PPMS).

Ocrevus is formulated for an intravenous infusion every six months. The initial dose is administered as two 300mg infusions given two weeks apart and the following doses are administered as single 600mg infusions.

The company is now seeking approval for a two-hour infusion time and the drug will be dosed twice yearly.

Roche chief medical officer and Global Product Development head Levi Garraway said: “With more than 150,000 people treated with Ocrevus, the twice-yearly dosing schedule has benefited many MS patients and their physicians, as indicated by more than 90% of patients continuing with treatment through one year.

“We hope a shorter infusion time will further improve the experience for people living with MS while also increasing capacity in healthcare systems.”

The new applications submitted to the FDA and EMA are supported by data from the randomised, double-blind ENSEMBLE PLUS study.

Results demonstrated comparable infusion-related reactions (IRRs) frequency and severity for a two-hour infusion time compared to the approved 3.5-hour time in RRMS patients.

The first dose was given according to the approved dosing schedule and the subsequent doses were given over the shorter, two-hour time.

The primary endpoint was the proportion of patients with IRRs after the first randomised 600mg infusion. Investigators did not report any IRR-related study discontinuations or new safety signals.

20 APRIL 2020

Novartis expands ophthalmology pipeline with Amblyotech acquisition

Novartis has acquired US-based software startup Amblyotech, which is developing a digital treatment for amblyopia (lazy eye) that leads to vision loss in children and young adults.

Financial details of the transaction are yet to be divulged by either company.

Amblyopia impacts approximately 3% of the population worldwide. Some of these patients could be eligible for Amblyotech’s therapy, if approved, said Novartis.

Existing treatment options, including patching and atropine, have low compliance and low success rates. In addition, adults have limited approved therapies.

Amblyotech leverages active gaming and passive video technology, along with 3D glasses, to train the eyes to work together for viewing an image completely. Technology-based therapy improves compliance.

Its software uses a visual presentation, dichoptic display, which presents each eye with different images via a proprietary algorithm.

Early clinical studies showed that Amblyotech’s software could improve vision in children, as well as adults with faster onset when compared to standard of care treatment.

Novartis expects the software to expand the refractive disorder pipeline in ophthalmology therapeutic area.

Novartis Ophthalmology global business franchise head Nikos Tripodis said: “By offering a noninvasive solution that has the potential to be significantly faster than current standards of care such as patching for children and adults impacted by lazy eye, Amblyotech’s software is a great example of how we can reimagine medicine using digital technology.

“We look forward to using our deep clinical development expertise in ophthalmology to accelerate this platform toward regulatory approval and our global commercial footprint to maximise access for patients who need it.”

Novartis will collaborate with Ubisoft and McGill University to speed-up the digital treatment’s development.

The aim is to develop a series of engaging games for the therapy, proof-of-concept studies planned for later this year.

In November, Novartis signed a definitive agreement to acquire US-based The Medicines Company for $9.7bn.

17 APRIL 2020

Sobi releases new haemophilia treatment report

Biopharmaceutical firm Sobi has released the 2020 Haemophilia Index, a report that analyses the quality of life of patients treated for haemophilia in Europe.

The release of the report marks the 30th World Haemophilia Day, observed on 17 April.

European haematologists report high treatment satisfaction and physical activity levels among severe haemophilia patients to indicate that access to appropriate treatment enables active lives in this patient population.

The index revealed the highest levels of physical activity among severe haemophilia patients in Italy, while Germany reports the highest quality of life in Europe.

Meanwhile, Switzerland and Sweden report the highest patient satisfaction levels.

Sobi noted that 50% of global countries in the study entirely depend on the World Federation of Hemophilia (WFH) Humanitarian Aid Program for haemophilia medication.

The Haemophilia Index is a two-part study of a survey reviewing quality of life for severe haemophilia patients in Europe and a global index that tracks the far-reaching effects of humanitarian aid.

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Together, the two parts of the index could provide insights into the differences in opportunities available for haemophilia patients globally.

Sobi haematology head Philip Wood said: “Just like anybody else, people living with haemophilia should have the right to pursue the opportunities they desire in life no matter where they live.

“At Sobi, we are proud to be working with the community to help patients reach for the many possibilities that advances in care have allowed.”

With donations by Sobi and Sanofi Genzyme, the WFH Humanitarian Aid Program could deliver treatment for approximately 17,223 patients over the last five years.

According to Sobi, around 1,400 haemophilia patients have started prophylactic treatment, including 441 below four years of age.

Wood added: “As 2020 marks the 30th anniversary of World Haemophilia Day, it is our hope that this study can illustrate the progress that has been made in managing the condition so far, while also drawing attention to areas we can work to improve as a community.”

17 APRIL 2020

University of Waterloo to develop nasal vaccine for Covid-19

University of Waterloo researchers in Canada are developing a DNA-based vaccine candidate that can be given via nasal route to protect from Covid-19 infection.

The vaccine will use bacteriophage-based approach, which will allow it to replicate within bacteria already present in the body, formulated to act on tissues in the nasal cavity and lower respiratory tract.

The aim is to deliver the vaccine to cells in targeted tissues and trigger the production of a virus-like particle (VLP) that will induce an immune response.

While the VLP will look similar to the SARS-CoV-2 structure, it is harmless, said the researchers. This similarity will stimulate the body’s natural immune response against viral infections similar to the VLP, including the novel coronavirus.

The VLP will attach to receptors that the coronavirus would bind to, limiting potential sites for transmission.

Through these changes in the body, the vaccine will be able to develop immunity against Covid-19 and also mitigate the severity of progressing infections. This indicates that the product can act as a vaccine, as well as a therapeutic.

University of Waterloo School of Pharmacy professor Roderick Slavcev said: “When complete, our DNA-based vaccine will be administered non-invasively as a nasal spray that delivers nanomedicine engineered to immunise and decrease Covid-19 infections.

“This research combines the expertise of many and leverages existing technology developed by my team, which we’re reconfiguring for a Covid-19 application.”

To design the vaccine, Slavcev partnered with another School of Pharmacy professor, Emmanuel Ho and a chemical engineering professor, Marc Aucoin.

A team led by Ho is designing the nanomedication, delivered by the nasal spray. The testing process for this is underway.

Meanwhile, Aucoin’s lab is constructing and purifying the VLP and working to enhance immunity after the initial administration of the vaccine.

Slavcev’s research team completed the bacteriophage delivery system design and is now altering the system for Covid-19 application. Additional design and testing will be performed later this year.

A Natural Sciences and Engineering Research Council of Canada grant are supporting the research components.

16 APRIL 2020

SMC accepts Janssen’s ulcerative colitis drug Stelara for NHS use

Scottish Medicines Consortium (SMC) has accepted Janssen Pharmaceutical’s Stelara (ustekinumab) for use on the National Health Service (NHS) Scotland to treat moderately to severely active ulcerative colitis (UC) in adults.

The drug can be given to patients who did not experience an adequate response with, lost response to or have an intolerance to standard therapy or a biologic.

It is also indicated for patients with medical contraindications to such therapies.

Ustekinumab acts on interleukin (IL)-12 and IL-23 cytokines, which is linked to inflammatory and immune responses.

Speaking of SMC acceptance, Janssen-Cilag EMEA immunology therapy area market access lead Jennifer Lee said: “We are pleased with the SMC’s decision to accept ustekinumab for use within NHS Scotland for eligible patients living with ulcerative colitis.

“We have a long-standing commitment to developing innovative therapies to improve the lives of those living with immune-mediated inflammatory diseases.

“The advice from the SMC reflects the true need for new treatment options for patients living with moderately to severely active ulcerative colitis.”

The SMC decision supports results from the Phase III UNIFI trial programme, which studied the safety and efficacy of the drug in adult patients.

UNIFI involved an eight-week, initial Induction study (UNIFI-I), followed by a 44-week maintenance study (UNIFI-M).

All UNIFI-M participants were induction responders to intravenous ustekinumab.

Data showed that a significantly greater percentage of patients receiving subcutaneous ustekinumab had clinical remission at week 44 compared to initial responders on placebo.

In addition, Ustekinumab also demonstrated a safety profile in UC and trials data revealed that the drug is generally well tolerated. The overall safety of the drug in this indication was consistent with its known profile in Crohn’s disease.

Previously, Stelara failed to receive a recommendation in the UK from the National Institute for Health and Care Excellence (NICE) over cost-effectiveness concerns.

16 APRIL 2020

TScan and Novartis partner to develop cancer therapies

Biopharmaceutical firm TScan Therapeutics has signed an agreement with Novartis to discover and develop therapies for the treatment of cancer.

The companies aim to work on TCR-engineered T-cell therapies for solid tumours. TScan’s platform will identify cancer antigens that could be targeted by TCR-based treatments.

As part of the deal, TScan will find and characterise TCRs while Novartis will hold an option to licence and develop TCRs for up to three new targets.

Furthermore, Novartis will have rights of first negotiation for more targets and TCRs resulting from the alliance. TScan may develop TCRs that act on targets not licensed by Novartis.

TScan Therapeutics president and CEO David Southwell said: “As one of the only companies able to efficiently discover novel cancer antigens that can be targeted with TCR-based therapies, we are delighted to be collaborating with Novartis to develop important TCR treatments.

“We see expansive potential for our platform and this collaboration gives us the opportunity to work with Novartis to develop novel TCR therapies, while at the same time preserving our ability to develop our own proprietary pipeline in both liquid and solid tumours.”

Under the agreement, Novartis will pay an upfront technology access fee and research funding of $30m to TScan.

TScan is also eligible for clinical, regulatory and sales milestone payments, as well as royalties on net sales for each product.

Earlier this month, Novartis entered an agreement with Aurobindo Pharma USA to terminate their deal covering the Sandoz US generic oral solids and dermatology businesses.

The deal was subject to closing conditions and the decision on termination comes after failing to secure the US Federal Trade Commission approval within timelines.

15 APRIL 2020

Insilico and Boehringer to use AI for drug targets discovery

Insilico Medicine has partnered with Boehringer Ingelheim to leverage artificial intelligence (AI) technology to identify potential therapeutic targets.

Under the collaboration, Insilico’s generative machine learning technology and Pandomics Discovery Platform will be used to discover drug targets across various disease areas.

Boehringer Ingelheim Greater China External Innovation Hub head Dr Weiyi Zhang said: “We believe that Insilico’s exclusive Pandomics platform will provide huge boost to our ability to explore and identify drug targets.

“We look forward to using AI to significantly improve the drug discovery process and contribute to human health.”

Founded in 2014, Insilico utilises generative models, reinforcement learning and other machine learning approaches to generate molecular structures, synthetic biological data, identify targets and predict clinical trial outcomes.

The company created a drug discovery engine that analyses numerous samples and data types to identify disease signatures.

It can also detect the most promising targets for molecules that exist or can be produced de novo with the required parameters.

To date, Insilico raised more than $52m, including $37m last September.

Commenting on the alliance with Boehringer, Insilico Medicine founder and CEO Alex Zhavoronkov said: “Insilico Medicine is very impressed with the Research Beyond Borders group at Boehringer Ingelheim capabilities in the search of potential drug targets.

“In this collaboration, Insilico will provide additional AI capabilities to discover novel targets for a variety of diseases to benefit the patients worldwide. We are very happy to partner with such an advanced group.”

In December, Boehringer partnered with UK-based drug technology firm Healx to use AI for identifying approaches to treat rare neurological disorders.

The partners agreed to advance Boehringer’s drug discovery programme using Healx’s AI technologies and expertise in rare diseases and pharmacology.

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