25 September 2019

Bayer invests in joint research lab for chronic lung diseases

Bayer has committed more than $30m over the next five years to support research projects on therapies for chronic lung diseases at a joint lab in the US.

Launch of the lab is in alliance with Brigham and Women’s Hospital (BWH) and Massachusetts General Hospital (MGH).

Located at Brigham and Women’s Hospital, the lab will house more than 20 people from all three partners. Scientists will leverage Bayer’s drug discovery and development capabilities.

Furthermore, the BWH and MGH’s clinical expertise will support the research, with awareness on disease mechanisms, data analysis expertise and insights from physician-scientists.

BWH Channing Division of Network Medicine chief Edwin Silverman, Bayer Lung Diseases preclinical research head Markus Koch, MGH Pulmonary and Critical Care chief Benjamin Medoff and BWH Pulmonary and Critical Care Medicine chief Bruce Levy will lead the research projects.

Chronic lung diseases are a group of diseases that target airways and other lung structures.

Currently, Bayer is researching multiple lung diseases, such as chronic obstructive pulmonary disease, interstitial lung disease, and obstructive sleep apnoea, as well as pulmonary arterial hypertension and persistent chronic cough.

The company’s lung franchise comprises products and compounds in different preclinical and clinical development stages.

Bayer research and development head Dr Joerg Moeller said: “This strategic collaboration complements our in-house research and will bring us closer to providing life-changing treatment options for patients living with chronic lung diseases.

“The joint lab concept continues to be an innovative model for collaboration between academia and industry, enabling novel approaches to drug discovery.”

The lab is set to boost Bayer’s existing footprint in the Boston region, where the company is planning to open lab and office space to bolster its research and development activities.

Bayer opened its first joint lab in Boston last year in partnership with the Broad Institute of MIT and Harvard, with focus on cardiovascular diseases.

24 September 2019

Omega Therapeutics launches with focus on epigenetic drugs

US-based Flagship Pioneering has launched a genomics medicine company, Omega Therapeutics, to develop drugs that will leverage the human genome to cure or treat various diseases.

The epigenetic drugs regulate genomic expression without impacting nucleic acid sequences.

Omega Therapeutics was originally founded in 2017, developing a platform to accurately control the human genome’s Insulated Genomic Domains (IGDs), the fundamental regulator, or GenomStats.

Based on the mechanism, the company will engineer genomic modulators, Omega Controllers, for precise tuning of genomic activity to desired therapeutic levels to tackle the biological cause of disease.

Flagship Pioneering general partner David Berry said: “Omega’s proprietary platform technology allows us to develop therapeutics for disease control and potentially impact the way we treat and manage a broad range of illnesses.

“In addition to our own capabilities for therapeutic development, our technology also presents the opportunity to partner and optimise other targeted in vivo and ex vivo therapeutics to enhance their ability to treat disease and further help a wide range of patient populations with significant unmet needs.”

Some diseases occur due to changes in gene expression or IGD structure. Omega Controllers regulate the GenomStat and in turn, single or multi-gene expressions to levels required for the treatment or cure of disease.

Omega Therapeutics also plans to optimise existing therapies across multiple therapeutic areas, such as rare genetic diseases, inflammation, metabolic diseases, immunology and oncology.

Currently, the company is working towards early-stage discovery programmes and will further boost its platform to address conditions related to genomic malfunction or dysregulation.

Macrolide Pharmaceuticals’ former president and CEO Mahesh Karande has been selected to serve as the company’s president, CEO and member of the board of directors.

23 September 2019

DRC to administer second vaccination to tackle Ebola outbreak

The World Health Organization (WHO) has announced that the health authorities of the Democratic Republic of Congo (DRC), which is currently tackling a serious Ebola epidemic, will be providing vaccination to at-risk populations with a second product in addition to the current use of Merck’s rVSV-ZEBOV-GP.

The vaccine chosen for the second vaccination is manufactured by Johnson & Johnson (J&J) and will be provided in two doses 56 days apart. It will administered to at-risk people in areas yet to see active Ebola transmission.

WHO director-general Dr Tedros Adhanom Ghebreyesus said: “The DRC authorities, in deciding to deploy the second experimental vaccine to extend protection against this deadly virus, have once again shown leadership and their determination to end this outbreak as soon as possible.”

The organisation’s regional director for Africa Dr Matshidiso Moeti commented: “The evaluation of the second Ebola vaccine will help ensure that we have potentially an additional tool to prevent the expansion of the outbreak and also a potential tool to protect populations before outbreaks hit areas at risk.”

Introducing a second experimental vaccine to attempt to tackle the outbreak is in line with recommendations made in May this year by the WHO’s Strategic Advisory Group of Experts on Immunization. The group suggested two options: J&J’s candidate Ad26.ZEBOV/MVA-BN and CanSino-Beijing Institute of Biotechnology Ad5-EBOV vaccine.

J&J’s candidate has shown a robust and durable immune response, as well as being well tolerated in clinical trials to date.

Merck’s vaccine, which was developed during the 2014-6 Ebola outbreak in West Africa, will continue to be administered through a ring strategy to those who have come into contact with someone with a confirmed case of Ebola.

Dr Tedros added: “The Merck vaccine is highly efficacious, and we’ll soon have a second vaccine to increase the number of those being protected against the virus”.

“But vaccine and therapeutics are only some of the tools — the key to ending the outbreak is community ownership. With the communities fully engaged, and with all partners stepping up and rallying behind our common goal, we can and will end this outbreak.”

23 September 2019

Two suppliers of antidepressant admit to illegal data sharing in UK

King Pharmaceuticals and Alissa Healthcare Research, suppliers of antidepressant drug Nortriptyline, have admitted to illegally sharing information to maintain high prices across the UK market.

The move comes after the UK Competition and Markets Authority (CMA)’s probe, which also includes a third firm, Lexon.

Prescribed by the country’s National Health Service (NHS), Nortriptyline provides relief from symptoms in depression sufferers. The drug cost the NHS £38m in 2015 when its spending peaked.

In June, the CMA accused that King, Alissa and Lexon illegally exchanged information on prices, volumes and entry plans in a bid to maintain high prices for Nortriptyline.

According to the competition watchdog, Auden Mckenzie agreed in 2014 to supply only 10mg tablets, while King would supply only 25mg tablets of the drug.

Accusations state that the two companies also fixed the supply quantities and prices.

In a Statement of Objections, CMA director of antitrust Geoff Steadman said: “If pharmaceutical companies get together to restrict competition for the supply of a drug, this can lead to the NHS and ultimately the UK taxpayer, paying over the odds for what are often essential medical treatments.

“We expect drug suppliers to abide by competition law so that the NHS is not denied the opportunity of benefitting from lower prices for medicines.”

In the latest development, King and Alissa have admitted to sharing commercially sensitive information with each another and with Lexon from 2015-2017.

Lexon has denied any participation in the alleged activities; the CMA is now investigating the firm.

Alissa and King are expected to face a fine for breaking competition law after the CMA completes its investigation.

In May, CMA alleged that Lexon, along with Alliance Pharmaceuticals, Focus and Medreich engaged in anti-competitive behaviour for anti-nausea drug, prochlorperazine.

20 September 2019

Researchers use three-drug combination to treat lung cancer

A study by the Francis Crick Institute and The Institute of Cancer Research, London has tested the combination of a G12C KRAS inhibitor with mTOR and IGF1R inhibitors for the treatment of lung cancer.

The drug acts on a specific mutation in the KRAS gene, which can lead to uncontrollable multiplication of cells, allowing fast growth of cancers.

The mutations are characteristic of 14% of the most common type of lung cancer, lung adenocarcinomas. Most of these cancers lack effective therapies and eight out of ten patients are known to die within five years.

According to researchers, G12C KRAS mutation is responsible for lung cancers of nearly 2,800 individuals in the UK each year.

In clinical trials performed in the US, G12C KRAS inhibitors demonstrate promising anti-tumour activity and few adverse effects. However, additional research is required to determine the duration response before resistance occurs.

The latest study revealed significant shrinkage of lung tumours in mice and human cancer cells treated with the three-drug combination, where the tumours remained small.

However, tumours treated with only the G12C KRAS inhibitor shrank initially but grew within a few weeks.

Study lead researcher Julian Downward said: “It’s likely that tumours will develop resistance to the new drugs, so we need to stay one step ahead. Our results suggest that it would be worth trying this combination in human trials in the coming years, to prevent or at least delay drug resistance.”

mTOR, as well as IGF1R inhibitors, have been studied in cancer patients. mTOR inhibitors are available in the market, while IGF1R inhibitors are in the trial stage.

To develop the combination, researchers obtained tumour cells from patients with the G12C KRAS mutation, editing them to block the activity of 16,019 different genes.

Compounds that address the KRAS mutant cancers were then used to treat the cells.

20 September 2019

FDA grants RMAT designation to SanBio’s cell therapy

The US Food and Drug Administration (FDA) has granted regenerative medicine advanced therapy (RMAT) designation to SanBio Group’s cell therapy, SB623, to treat chronic neurological motor deficits secondary to traumatic brain injury (TBI).

SB623 is an investigational cell therapy using modified and cultured mesenchymal stem cells from adult bone marrow after temporary genetic modification.

Implantation of these cells into injured nerve tissue in the brain allows restoration of lost motor functions by stimulating the organ’s natural regenerative ability.

RMAT granted designation due to SB623’s clinical data, including the Phase II STEMTRA trial conducted over 12 months to assess the safety and efficacy of the cell therapy.

During the Phase II study, researchers compared SB623 with surgery in 61 patients with stable chronic neurological motor deficits secondary to TBI at 13 surgical and 18 assessment sites across the US, Japan and Ukraine.

Researchers implanted the cells around the brain injury site. The primary endpoint was mean change from baseline in Fugl-Meyer Motor Scale (FMMS) score, a measure of motor impairment changes at six months.

SB623 met the primary endpoint, demonstrating an average of 8.3 point improvement in the FMMS from baseline, compared to 2.3 in the control group, at 24 weeks.

Of all participants who received cell therapy, 18 achieved a ten or more point FMMS improvement versus one control.

The study did not reveal any new safety signals and the most common adverse effect was headaches.

SanBio chief medical officer and research head Bijan Nejadnik said: “The RMAT designation for SB623 is an important regulatory milestone for SanBio as we investigate it as a treatment option for patients with chronic neurological motor deficits resulting from a traumatic brain injury.

“TBIs are one of the most common health conditions worldwide that often cause long-term complications or death. We look forward to working with the FDA on a potentially accelerated clinical development programme to address this serious unmet medical need.”

The therapy also secured the Sakigake designation from the Japanese Ministry of Health, Labour and Welfare.

20 September 2019

Takeda and Lundbeck’s Trintellix approved in Japan for depression

Takeda has announced that its drug Trintellix (vortioxetine) has been approved by the Japanese Ministry of Health, Labour and Welfare for the treatment of depression and depressed state.

Danish company Lundbeck discovered Trintellix, but since 2017 Lundbeck and Takeda have been collaborating on the development of the drug in Japan. The two companies extended the agreement in 2018 to include co-commercialisation of the drug in Japan following its approval.

This approval was based upon a randomised, placebo-controlled, double-blind Phase III trial of 493 adult patients in Japan with recurrent depression.

In the study, Trintellix demonstrated statistical significant improvement in overall symptoms of depression in adults, compared to placebo. This was the primary endpoint after week eight of administration and as measured by the Montgomery-Åsberg Depression Rating Scale. These results were supported by three other studies: one global and two carried out in Japan.

Takeda Development Centre Japan head Naoyoshi Hirota said: “Major depressive disorder (MDD) remains a serious and complicated disease and I firmly believe that Trintellix will be an important new treatment option for patients in Japan, and health care professionals.”

Lundbeck executive vice-president of commercial operations Jacob Tolstrup said: “I am pleased that individuals suffering from depression in Japan now also have access to this important treatment option.

“Today’s approval of Trintellix, furthermore, represents a new chapter in Lundbeck’s commercial expansion as we will have our own commercial organization behind the launch of Trintellix in Japan in collaboration with our partner Takeda.”

Trintellix has already been approved for MDD in 83 countries, including the US, EU and Canada. It was first marketed in the US in September 2013.

The drug is an inhibitor of serotonin reuptake and a regulatory action on serotonin receptors 3, 7 and 1D. It is believed its mechanism of action is regulating neurotransmission through several systems, including serotonin, norepinephrine, dopamine, acetylcholine and histamine.

19 September 2019

Roche receives FDA breakthrough status for lupus nephritis drug

Roche has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for its Gazyva (obinutuzumab) to treat lupus nephritis in adults.

Lupus nephritis is a potentially fatal complication of systemic lupus erythematosus, which develops due to inflammation of the kidneys and can lead to end-stage renal disease or death.

Gazyva is an engineered monoclonal antibody that binds to the CD20 protein present on certain types of B-cells. The drug is thought to attack targeted cells directly and also in conjunction with the body’s immune system.

In the US, Roche subsidiary Genentech is developing the drug as part of an alliance with Biogen.

Roche global product development head and chief medical officer Sandra Horning said: “New treatment options are needed for lupus nephritis, a potentially life-threatening inflammation of the kidneys that most commonly affects women.

“We are committed to developing Gazyva as a potential new therapy for lupus nephritis and plan to begin enrolling patients in a Phase III trial next year.”

The FDA decision to grant breakthrough status for Gazyva is due to the drug’s results from the Phase II NOBILITY clinical trial, which enrolled 126 adults with proliferative lupus nephritis.

During the trial, a combination of the drug with a standard of care, comprising mycophenolate mofetil or mycophenolic acid and corticosteroids, was compared with placebo plus standard of care.

Patients received treatment on days 1, 15, 168 and 182. The primary endpoint was the proportion of participants with a protocol-defined complete renal response (CRR) at week 52.

According to study data, the drug combination had better efficacy in demonstrating complete renal response at one year, compared to the placebo combination.

The drug also led to an improved complete and partial renal response, as well as serologic markers of disease activity. Also, the trial did not reveal any new safety signals with Gazyva.

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