Category Archives: R&D

Shire’s von Willebrand disease therapy Veyvondi approved in EU

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

The European Commission has approved Shire’s Veyvondi for treatment of the bleeding disorder von Willebrand disease (VWD).

VWD is the most common inherited bleeding disorder, affecting up to 1% of the global population, and is caused by deficiency or dysfunction in the protein known as von Willebrand factor (VWF).

The commission granted a marketing authorisation for Veyvondi (vonicog alfa, recombinant von Willebrand factor) for bleeding events and treatment or prevention of surgical bleeding in adults with VWD when desmopression treatment alone is ineffective or not indicated.

Veyvondi is the first recombinant treatment for VWD that addresses primary deficiency or dysfunction of VWF while also allowing the body to restore and maintain adequate Factor VIII plasma levels.

Approval is based on outcomes from three clinical trials of a total of 80 patients with VWD exposed to Veyvondi.

These include a phase 1 multicentre, controlled, randomised, single-blind, dose-escalation study of the safety, tolerability and pharmacokinectics  in subjects 18 to 60 years of age with severe VWD.

Also in the dossier was a phase 3 multicentre, open-label study to assess the pharmacokinetics, safety and efficacy of the Veyvondi and recombinant factor VIII and Veyvondi alone in the treatment of bleeding episodes in adult subjects with severe VWD.

There was also a phase 3, prospective, open-label, uncontrolled, non-randomised, international multicentre study to assess the haemostatic efficacy and safety of rVWF with or without recombinant factor VIII in 15 adult subjects with severe VWD undergoing major, minor, or oral elective surgical procedures.

Andreas Busch, head of R&D and chief scientific officer at Shire, said: “The approval in Europe for Veyvondi marks a key milestone in our efforts to tackle unmet medical needs for those living with von Willebrand disease.

“We are excited to take the next steps in ensuring that Veyvondi is widely available across Europe to address the individual needs of those affected by the condition and in need of factor replacement.”

SOURCE: www.pharmaphorum.com/news

New C.diff drug to be tested on patients for first time

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

A new drug aimed at treating potentially deadly Clostridium difficile (C. diff) infections is set to be tested on patients for the first time.

Glasgow-based life sciences firm MGB Biopharma (MGB) said it was preparing to launch a Phase II clinical trial of its anti-bacterial agent MGB-BP-3.

The trial is expected to involve 30 patients based in North America.

All have been diagnosed with C.diff-associated disease (CDAD).

C.diff infections can cause diarrhoea and fever.

They have been a major problem in hospitals around the world, with thousands of deaths in the US alone linked to the bug each year.

The bacteria are able to take over the gut when a course of antibiotics kills off the bugs that normally live there.

MGB’s announcement came after it raised £1.3m from investors for trials of the new drug, which was invented at the University of Strathclyde.

The funding round was led by Edinburgh-based Archangels, with co-funding from a range of sources, including the Scottish Investment Bank, Barwell and Melrose-based Tri Capital.

The cash supplements a £2.7m grant awarded earlier this year by Innovate UK.

MGB said its trial would “evaluate safety and tolerability, efficacy and in particular look for improvement in global (or sustained) cure rates”.

Chief executive Dr Miroslav Ravic said: “We are already witnessing renewed interest in our new anti-bacterial agent and its trial in key medical centres in North America where CDAD is particularly prevalent.

“This offers opportunities both to progress the study rapidly and to attract increased attention to the results for this important trial.”

The company said it was aiming to start the trials in areas of the US and Canada with a high incidence of CDAD early next year.

SOURCE: www.bbc.co.uk/news/

From molecule to medicine, the importance of persistence

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

Here, Dr Sheuli Porkess, deputy chief scientific officer, Association of the British Pharmaceutical Industry (ABPI), outlines how the pharmaceutical industry takes a substance from molecule to medicine and how the process requires persistence.

A report last week from the Office of Health Economics (OHE) shows the amazing impact medicines have had on the NHS and more widely. The antipsychotic chlorpromazine, first used in the NHS in 1954, paved the way for deinstitutionalisation and community-based care for people with mental illness. In 1948, there were almost 400,000 cases of measles in England and Wales, and 327 people died. By 2015 the number of cases of measles in England and Wales had fallen below 1,200.

These medicines, and others, had a variety of benefits including better clinical outcomes, saving lives, improving quality of life, greater health service efficiency and wider societal impacts. But making medicines is a complicated and costly business. It costs billions of pounds and can take decades. Successes can change the world; failures are an inevitable part of the discovery and development process. But when medicines get through the development process, they can clearly change millions of lives.

There are broadly three stages to creating a new medicine: research, development and approval. Here’s how it works:

Drug discovery and development

The process usually starts with chemical compounds or biological molecules. With advances in technology over the last few years, we can screen compounds that have the potential to become treatments faster than ever before. AstraZeneca — a British pharmaceutical company — launched a new screening robot in 2016 called ‘NiCoLA-B’ which is able to test 300,000 compounds a day. Its job is to find those chemicals that show the slightest potential of being useful as a medicine.

The research stage benefits hugely from collaborative partnerships between the pharmaceutical industry, charities and universities, all working together to find a potential medicine. This stage can take four to five years and takes about 22% of the total budget it takes to find a treatment. Each compound has a less than 0.01% chance of success.

Preclinical research

From a batch of about 10,000 compounds screened in the drug discovery phase, only about 10–20 go into the pre-clinical phase, where scientists determine how safe a medicine might be through testing in cells and animals as well as using computational models.

Clinical research

If any of those 10-20 compounds show real potential of being turned into something useful, they’re developed in to a medicine that will move into clinical trial stage. There are three steps: Phase I involves about 20 to 100 volunteers. If medicines are successful here, they will move onto Phase II where they are tested in people with the disease.

Phase III can include up to 5,000 patients. Going through the three phases can take six or seven years. Over half, or about 65%, of the money it takes to make a medicine is spent in the development stage.

Phase IV clinical trials are after the medicine has a licence and are there to help monitor the medicine’s safety and help clinicians better understand how the medicine works in everyday life, not just in clinical trials.

Approval

The final stage is when regulators review the medicine and it can get ‘market authorisation’ — which shows the medicine is safe and effective. By this point, the manufacturing of the medicine has been scaled up. Only one medicine of 5,000–10,000 compounds discovered will make it to this stage.

The approval processes last anywhere from six months to two years. The medicine is continually monitored once it starts being prescribed for patients.

Researching and developing medicines takes a lot of time and work along the way; there is no guarantee that any particular medicine will make it through the various stages of this highly regulated process. The process is fascinating and once medicines get through this system, their impact can be huge.

Of course, the pharmaceutical industry is pioneering new ways to find treatments. The future looks exciting and how we detect, diagnose and treat disease is set to change significantly.

Advances in medical technology and the miniaturisation of diagnostics, wearables and devices will have a huge impact on our lives and could help people with chronic diseases to remain out of hospital.

Advances in understanding how cells monitor and repair damaged DNA enables us to develop game-changing treatments for cancer. Progress in immuno-oncology sees patients own immune cells used to attack cancer cells, and stem cell therapy is treating rare sight conditions.

We see AI and synthetic biology used for treating malaria, HIV and hepatitis. Gene-editing technology is happening in labs right now, identifying new disease targets, accelerating the discovery of novel treatments.

Passionate pioneers, such as those who invented the groundbreaking treatments in the report, have always been at the heart of our industry and it’s exciting to imagine what their successors could achieve in the next 70 years.

SOURCE: www.epmmagazine.com/opinion

A majority of Americans support using biotechnology to grow human organs in animals for transplants

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

Almost six-in-ten Americans (57%) consider it an appropriate use of technology to genetically engineer animals to grow organs or tissues that could be used for humans needing a transplant, while 41% say this would be going too far, according to a new survey by Pew Research Center.

The findings are part of a larger pattern that reveals Americans are more likely to support the bioengineering of animals if it benefits human health.

Demand for transplantable organs and tissues continues to grow in the United States. Last year saw the most organ transplants ever performed in the country. Organs were recovered from more than 10,000 donors – an increase of more than 25% over the past 10 years. Health experts attribute this increase, in part, to breakthroughs in medical technology that have made it possible to recover organs that previously would have been unsuitable for transplants. But, despite these advances, the U.S. Department of Health and Human Services reports that the gap between supply and demand remains wide.

Researchers are hoping to close that gap through the development of new medical technologies. One such approach is 3D organ printing– a process that uses “bio-ink” to print layers of cells that grow to form transplantable tissue.

Another method under development uses genetic engineering to grow human organs and tissues in animals. There was a breakthrough with this technique earlier this year, when scientists used gene editing to create hybrid embryos containing both human and sheep cells.

When the survey – conducted April 23-May 6 – asked the 41% of respondents who opposed this application of genetic engineering to explain, in their own words, the main reason behind their view, the objections included concerns about the use of animals in this way for human benefit (21% of those asked) and the potential risks for human health (16% of those asked).

The responses included:

“In manufacturing organs, the existence of these animals would be miserable … I can’t ethically say that I would agree with such a practice.”

“Factory farming already as an industry unethically treats animals. I imagine organ growing wouldn’t treat the animals any differently.”

“When you mix human and non-human genetics I believe that will cause extreme problems down the road.”

“Even human-to-human organ transplants often reject, so I can only imagine the bad side effects that an animal-to-human transplant would cause. Keep things simple and the way nature intended.”

Majority supports bioengineering animals to grow human organs

SOURCE: www.pewresearch.org/fact-tank

JSM could lead to improved arthritis treatment

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

An algorithm to monitor the joints of patients with arthritis, which could change the way that the severity of the condition is assessed.

An algorithm to monitor the joints of patients with arthritis, which could change the way that the severity of the condition is assessed, has been developed by a team of engineers, physicians and radiologists led by the University of Cambridge.

The technique, which detects tiny changes in arthritic joints, could enable greater understanding of how osteoarthritis develops and allow the effectiveness of new treatments to be assessed more accurately, without the need for invasive tissue sampling.

Osteoarthritis is the most common form of arthritis in the UK. It develops when the articular cartilage that coats the ends of bones and allows them to glide smoothly over each other at joints, is worn down, resulting in painful, immobile joints. Currently, there is no recognised cure and the only definitive treatment is surgery for artificial joint replacement.

Osteoarthritis is normally identified on an x-ray by a narrowing of the space between the bones of the joint due to a loss of cartilage. However, x-rays do not have enough sensitivity to detect subtle changes in the joint over time.

Joint space in hip, knee and ankle joints as analyzed by the JSM algorithm. – Tom Turmezei

 

“In addition to their lack of sensitivity, two-dimensional x-rays rely on humans to interpret them,” said lead author Dr Tom Turmezei from Cambridge’s Department of Engineering. “Our ability to detect structural changes to identify disease early, monitor progression and predict treatment response is frustratingly limited by this.”

The technique developed by Dr Turmezei and his colleagues uses images from a standard computerised tomography (CT) scan, which isn’t normally used to monitor joints but produces detailed images in three dimensions.

The semi-automated technique, called joint space mapping (JSM), analyses the CT images to identify changes in the space between the bones of the joint in question, a recognised surrogate marker for osteoarthritis. After developing the algorithm with tests on human hip joints from bodies that had been donated for medical research, they found that it exceeded the current ‘gold standard’ of joint imaging with x-rays in terms of sensitivity, showing that it was at least twice as good at detecting small structural changes. Colour-coded images produced using the JSM algorithm illustrate the parts of the joint where the space between bones is wider or narrower.

“Using this technique, we’ll hopefully be able to identify osteoarthritis earlier, and look at potential treatments before it becomes debilitating,” said Dr Turmezei, who is now a consultant at the Norfolk and Norwich University Hospital’s Department of Radiology. “It could be used to screen at-risk populations, such as those with known arthritis, previous joint injury, or elite athletes who are at risk of developing arthritis due to the continued strain placed on their joints.”

While CT scanning is regularly used in the clinic to diagnose and monitor a range of health conditions, CT of joints has not yet been approved for use in research trials. According to the researchers, the success of the JSM algorithm demonstrates that 3D imaging techniques have the potential to be more effective than 2D imaging. In addition, CT can now be used with very low doses of radiation, meaning that it can be safely used more frequently for the purposes of ongoing monitoring.

“We’ve shown that this technique could be a valuable tool for the analysis of arthritis, in both clinical and research settings,” said Dr Turmezei. “When combined with 3D statistical analysis, it could be also be used to speed up the development of new treatments.”

The results are published in the journal Scientific Reports.

SOURCE: www.europeanpharmaceuticalreview.com/news/76547

Seven million euros for research into chronic inflammatory bowel conditions

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

A new collaborative research centre/Transregio 241 ‘Immune-epithelial communication in inflammatory bowel diseases’ is due to commence its research at Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU) in July 2018.

In conjunction with the Charité hospital in Berlin, doctors and biotechnologists at FAU will be conducting research in order to better understand the interaction between cells in mucous membranes and immune cells in the bowel and to develop more effective therapy methods for chronic inflammation. The German Research Foundation (DFG) is providing funding worth 11.5 million euros for the first funding period until 2022, and FAU has been allocated nearly 7 million euros of this amount.

Number of patients with IBD is increasing

Severe diarrhoea, stomach pain, cramps – these are the most common symptoms of inflammatory bowel disease (IBD) such as Morbus Crohn or Colitis ulcerosa. Around 40,000 people in Germany suffer from IBD and this number continues to rise. Patients of IBD often suffer from flare-ups of their condition, which severely affects their quality of life and physical capabilities. ‘Despite the use of strong medication, chronic inflammatory bowel conditions remain difficult to treat’, says Prof. Dr. Christoph Becker, lead researcher at the Department of Medicine 1 at FAU’s Universitätsklinikum Erlangen and spokesperson of the collaborative research centre. ‘Acute flare-ups are often treated with corticosteroids that ease symptoms only in some cases. Many patients have to take several immunosuppressive substances.’ In addition, their symptoms are often accompanied by other conditions such as arthritis, acute inflammation of fatty tissue and chronic inflammation of the biliary tract in the liver.

Little research to date on molecular and cellular mechanisms

IBD is difficult to treat because the interactions between various cell populations in the bowel are not yet fully understood. ‘Newer findings show that the intestinal mucosa cannot be regarded as merely a physical barrier. In fact, it is highly-dynamic tissue that reacts to a large number of environmental stimuli including intestinal flora and local or systemic signals,’ explains Christoph Becker. ‘The immune system in the intestine regulates the barrier function of the intestinal wall and the composition of intestinal flora and vice versa as the intestinal barrier influences the immune system.’ However, there is a lack of knowledge of how the interactions between the epithelium and immune cells influence the long-term cellular reactions that contribute to controlling chronic inflammation processes.

New concept for new therapies

This is the starting point for the researchers from Erlangen and Berlin. During the next few years, they aim to integrate findings about the regulation and function of the immune system in the bowel and current data about anti-microbial defence on the mucous membrane barrier into a new concept. The individual projects will focus in particular on the role of misdirected communication between epithelium and immune cells during the pathogenesis of IBD. The researchers’ long-term aim is to develop medication that targets the causes of bowel inflammation while retaining the ability of the immune system to fight infections and cancer cells. In addition, they hope to find diagnostic methods that predict patients’ response to therapies – a goal that not only serves to relieve symptoms quickly, but should also contribute to lowering treatment costs.

Researchers from Erlangen involved in 14 projects

The scientific programme of CRC/TRR 241 is divided into three research areas: Area A ‘Immune regulation of intestinal barrier functions’, comprises projects focusing on the effects of acute and chronic inflammation on epithelial cells, in particular on their cell homeostasis and barrier-forming functions. Area B ‘The epithelium as a regulator of immunity and inflammation in the bowel’ examines the effects of disruptions to the barrier function and antigen translocation on the mucosal immune system. The objective of research area C ‘Diagnosis and therapeutic intervention of IBD’ is to develop innovative therapeutic and diagnostic approaches and evaluate them in a clinical setting. CRC/TRR 241 comprises a total of 22 projects, 14 of which are either based in Erlangen or involve researchers from Erlangen. The Department of Medicine 1 – Gastroenterology, Pneumology and Endocrinology, Department of Medicine 3 – Rheumatology and Immunology, the Department of Surgery and the Department of Dermatology and the Institute for Medical Biotechnology are all involved. 23 jobs and 9 scholarships are being funded during the next four years with the nearly 7 million euros allocated to the FAU.

SOURCE: www.eurekalert.org/pub_releases

AbbVie trial backs chemo-free Imbruvica combo regimen

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

The pairing of of AbbVie’s Imbruvica and Roche’s Gazyva has hit the mark in a chronic lymphocytic leukaemia trial – raising the prospect of a new chemotherapy-free combination regimen for previously untreated CLL patients.

The iLLUMINATE trial showed that oral BTK inhibitor Imbruvica (ibrutinib) plus anti-CD20 injection Gazyva (obinutuzumab) was more effective than Gazyva plus chemo (chlorambucil) in treatment-naïve, older patents (aged 65 or more) with either CLL or small lymphocytic leukaemia (SLL) – a different form of the same disease.

The top-line data isn’t being made available just yet, but in a statement AbbVie said the duo extended progression-free survival (PFS) compared to the active control arm, adding that it will be sharing the data with regulators, in the hope of bringing “the first chemotherapy-free CD20 combination in first-line CLL treatment” to market.

The trial ties in with AbbVie’s strategy of expanding use of Imbruvica as a first-line CLL treatment and, while Gazyva has been something of a slow burner for Roche since its launch in that setting in 2014, it has started to gain momentum with sales rising 41% to CHF 278m last year.

The combination of Gazyva and chlorambucil is now recommended as a first-line therapy for CLL by the US National Comprehensive Cancer Network, which deems it a category 1 treatment, ie one with a high level of evidence backing its use, so outperforming it is a big win for the combination.

“This chemotherapy-free combination represents a potential new treatment option for patients with CLL,” said John Gribben of Barts Cancer Institute in the UK, the lead investigator for the iLLUMINATE study.

“It’s exciting to see the blood cancer treatment paradigm continue to evolve – each advance moves us one step closer to a better standard of care for these patients,” he added.

Imbruvica is already approved for all lines of therapy in CLL, and beating out chlorambucil is not a big surprise as AbbVie’s drug comprehensively outperformed the chemotherapy as a monotherapy in the head-to-head RESONATE-2 trial.

The trial was the basis of Imbruvica’s approval in 2016 as a chemo alternative in treatment-naïve CLL, and the disease accounts for the lion’s share of the drug’s sales, which grew almost 39% to $762m in the first quarter of this year, topping estimates. AbbVie is predicting sales of $3.3bn this year, well on course for its peak sales target of $6bn-$7bn.

AbbVie’s head of R&D Michael Severino said on the company’s first-quarter results call that the strategy is to build a “body of evidence” for Imbruvica – both as a monotherapy and in combination – across different CLL segments “including young and fit patients and the watch-and-wait population”.

SOURCE: www.pmlive.com/pharma_news

ABPI expert urges to find new ‘blockbuster treatments’ for brain tumors

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

With the Government set to invest an additional £20 million into the research, diagnosis and development of treatments for brain tumours, we need to talk more about how we are going to find the next blockbuster treatments for these devastating diseases.

Nearly 11,500 people are diagnosed with a brain tumour every year in the UK with fewer than 15% surviving beyond 10 years. This week’s announcement from the from the Department of Health and Social Care – following the death of Dame Tessa Jowell – that they would be doubling investment for brain cancer research to £40 million is a welcome commitment to helping achieve a goal our industry shares: finding innovative new treatments and cures for these diseases.

The science is advancing in laboratories here in the UK and around the world, funded and supported by charities, universities and the pharmaceutical industry, collectively we are working to fight back against this terrible disease.

Among the 7,000 medicines currently being developed by the global pharmaceutical industry, there are 58 medicines in the pipeline for brain tumours, including gliomas. Companies are actively working to find better ways to speed up medicines development to get treatments to patients sooner.

In her speech to the House of Lords in January, Dame Tessa Jowell talked candidly about her glioblastoma diagnosis and called for greater collaboration in the fight against cancer. She also talked about the speeding up of drug trials by testing more than one at a time, saying: “I am not afraid, but I am fearful that this new and important approach may be put into the ‘too difficult’ box.”

The type of clinical trials Tessa Jowell talked about have many different names: adaptive randomisation, drop-the-loser, adaptive dose-finding, adaptive seamless and the list goes on.

The one thing they all have in common is flexibility. In trials like this – that we call adaptive design clinical trials – researchers can see how patients are responding to treatments and then change or stop parts of the trial in real time.

When used appropriately, trials like this may improve efficiency, reduce cost, maximize information gained and minimize risk to the patients and sponsors. Ultimately, drug development can be accelerated so that the right treatments can be delivered rapidly to the right patients. The UK is seen as a pioneer of innovative clinical trials and this involves collaboration between academia, the NHS, industry and medical research charities –  we must ensure we keep it that way in the future.

The issue is that these clinical trial types are not easy to design, plan or execute. An adaptive design will not rescue a poorly planned trial or ineffective treatment.

We need to make sure the regulatory authorities in the UK are not seen as a barrier to innovation; the MHRA and HRA are open to discussion and we need to encourage researchers and pharmaceutical companies to start conversations with them early in the process of planning an innovative clinical trial.

We think that adaptive design clinical trials could be the solution to speeding up the research and development of not only brain tumor treatments, but for all sorts of diseases. Research into small or rare patient populations could really benefit from these trials since they help us quickly rule out the drugs or drug combinations that aren’t working and give more patients the option to contribute to research and clinical trials.

We’re not alone. In February, the Department of Health and Social Care published their brain tumor research report which stated that, because brain tumors are one of the areas that have small patient populations, we need to think differently about how we conduct clinical trials and incorporate innovative trial designs.

The report provided practical recommendations for how we can work collaboratively to make quicker progress in this area. The next steps are to build on the UK’s existing strengths, ensure we have access to researchers with the right skills, and make sure that the right infrastructure is in place for us to make really make progress in this area.

Alongside their funding announcement, we welcome the Government’s commitment this week to accelerate the use of adaptive design trials. When used appropriately, drug development can be accelerated so that the right treatments can be delivered rapidly to the right patients – and that’s where the real benefit lies.

As we look to the future of cutting-edge research and development for blockbuster treatments, we know we need to make the case for innovative clinical trial design, talk more about the amazing science our researchers, companies and NHS are pioneering and encourage them to have open conversations with the UK regulators to ensure that innovative clinical research is safe and effective.

Together, we won’t rest until devastating brain tumours are a thing of the past.

SOURCE: www.news-medical.net/news

Pfizer eyes AI-powered drug discovery and development software

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

Pfizer has partnered with a ‘computation-driven’ pharmaceutical technology company to develop a drug discovery platform powered by artificial intelligence (AI).

Its collaboration with Cambridge, Massachusetts-based XtalPi will see the firms work on molecular modelling software that can be applied to drug-like small molecules.

Charlotte Allerton, Pfizer’s head of medicine design, said: “The XtalPi collaboration is an opportunity to enhance our computational modelling capabilities.

“We are looking forward to potentially utilising new tools to increase our effectiveness in small molecule drug discovery and development.”

In addition to supporting its own efforts, Pfizer plans to make available to the wider academic community some of the molecular mechanics parameters it will generate with public-domain compounds.

The new software platform will combine quantum mechanics, machine learning algorithms and cloud computing architecture to help Pfizer predict pharmaceutical properties that would be relevant for drug discovery and development.

Shuhao Wen, XtalPi’s co-founder and chairman of the board, said: “The collaboration allows us to apply our expertise in molecular modelling, AI, and cloud computing towards improving existing computational methods while exploring new algorithms to address a wide range of drug design challenges.

“We look forward to helping expedite research into novel therapeutics as our intelligent digital drug discovery and development platform continues to expand and succeed.”

The deal builds on XtalPi’s existing work with Pfizer on crystal structure prediction (CSP), with that project aiming to advance the partners’ capabilities in computation-based rational drug design and solid-form selection.

Founded in 2014 by a group of quantum physicists from MIT, XtalPi’s team combines expertise in physics, chemistry, pharmaceutical R&D, and algorithm design.

The company, which counts Google and Chinese internet conglomerate Tencent among its investors, is one of a swathe of AI players looking to innovate drug discovery and development processes.

These include BenevolentAI, Hitachi and Scotland’s Exscientia, with the latter working with the likes of GlaxoSmithKline, Sanofi and Evotec.

At stake is a share in market for healthcare AI applications that’s predicted to be worth more than $10 billion by 2024, driven by the rise in precision medicine and the need to reduce healthcare costs.

SOURCE: www.pharmaphorum.com/news

Scientists discover mutation that causes PARP inhibitor resistance

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

Scientists have made a major discovery having identified a mutation that gives cancer cells resistance to AstraZeneca’s Lynparza and other PARP inhibitors.

The findings could help predict which patients are likely to develop resistance to treatment with PARP inhibitors and thus allow doctors to tailor treatment at the earliest opportunity.

Using a gene editing technique a team at the Institute of Cancer Research, London, were able to identify a specific mutation in the PARP1 protein that stops PARP inhibitors from working.

The authors note that testing for this mutation could deepen personalisation to an already targeted treatment, not only helping to shape decisions on whether to initiate treatment with PARP inhibitors but also when to switch patients to alternative options.

“The evolution of cancers into drug resistant forms is a major challenge we face in getting cancer treatments to work,” noted study leader Professor Chris Lord, Professor of Cancer Genomics at The ICR.

“We hope our research will help doctors use the best drug right from the outset, respond quickly to early signs of resistance, and work out the best ways to combine treatments to overcome drug resistance.”

“This important finding could in future allow clinicians to determine who would benefit most from these drugs, or to track when they are becoming less effective and when a change of treatment might be appropriate,” said Baroness Delyth Morgan, chief executive at Breast Cancer Now.

“Studies like this, which build on the development of PARP inhibitors as a brand new treatment option for some women with breast cancer, could help take us a step closer to an even more personalised approach to treating the disease.”

The research was funded by Cancer Research UK and Breast Cancer Now, and published in the journal Nature Communications.

SOURCE: www.pharmatimes.com/news