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The partnership is said to have a three-year financial commitment for which GSK has made an initial payment of $70m.

GSK has signed a three-year partnership agreement with Tempus to enhance clinical trial design, expedite subject enrolment and detect drug targets.

Under the collaboration, GSK will gain access to the artificial intelligence (AI)-enabled platform of Tempus, which includes a library of de-identified data from patients. 

The alliance will also leverage GSK’s Artificial Intelligence and Machine Learning (AI/ML) expertise, will add to the research and development (R&D) success rate of GSK and offer a tailored treatment for patients quickly. 

The new partnership is said to have a three-year financial commitment for which GSK made an initial payment of $70m. 

GSK also holds an option to expand the deal for another two years.

The latest deal is built on an existing collaboration between the firms that commenced in 2020 on clinical trial enrolment of individuals with certain cancer types. 

GSK chief scientific officer Tony Wood said: “This collaboration will provide GSK with unique insights to discover better medicines and transform drug discovery. 

“Tempus complements the work our team is already doing at the intersection of genomics and machine learning across both early discovery and clinical trials.”

At present, the companies are partnering on an open-label Phase II trial which uses a data-guided approach to expedite and simplify study timelines. 

This method comprises fast-tracking the protocol development and intelligent selection of sites in less than 60 days and enrolment of initial subjects within three months of launching the trial.

The latest development comes after GSK reported positive findings from the Phase II PERLA trial of Jemperli (dostarlimab) plus chemotherapy in patients with first-line, metastatic, non-squamous non-small cell lung cancer.

According to the ABPI report, some pharmaceutical firms are forced to conduct their trials in other countries.

The Association of the British Pharmaceutical Industry (ABPI) has reported that the number of industry clinical trials started in the UK each year dropped by 41% between 2017 and last year.

Titled ‘Rescuing Patient Access to Industry Clinical Trials in the UK’, the report stated that the trials for cancer were also in this margin.

Between 2017 and 2021, the number of Phase III industry trials started in the country dropped by 48%.

During the same time period, the global rankings for the UK fell from second to sixth in Phase II trials while it dropped to the tenth position, from fourth, in Phase III trials.

Access to industry trials on the National Institute for Health and Care Research Clinical Research Network (NIHR CRN) for patients declined to 28,193, from 50,112 between 2017-18 and 2021-22, indicating a decline of 44%.

ABPI noted that this data indicate a threat to the long-term future of industry clinical research in the UK and the advantages it offers to patients, the UK National Health Service (NHS), and the economy of the country.

According to the report, some pharmaceutical firms are forced to conduct their trials in other countries, owing to sluggish and variable trial set-up and recruitment timelines in the NHS.

As a result, UK patients and clinicians have reduced opportunities to obtain access to cutting-edge research. 

ABPI chief executive Richard Torbett said: “The Covid-19 pandemic has accelerated the decline in late-stage industry clinical research in the UK, compared to its global peers. 

“The time it takes to set up trials and recruit patients in the UK is out of line with our global competitors and is moving in the wrong direction. 

“As a result of this, and growing commercial pressures, pharmaceutical companies are increasingly looking elsewhere when choosing where to develop and launch new medicines and vaccines.”

Walmart is the latest US retail pharmacy giant to announce its intention of disrupting the clinical trials category, with the launch of a new institute that pledges to increase and diversify community access to healthcare research.

The Walmart Healthcare Research Institute (WHRI) won’t be running trials itself, but will spearhead Walmart’s efforts to connect patients who visit its massive, nationwide chain of health centres with organisations running clinical trials.

The move follows in the footsteps of both Walgreens and CVS, which have both launched clinical trial services businesses in the last year with the aim of matching patients with trial sponsors.

All three say their network of locations – which include socially vulnerable areas, will help to improve recruitment of under-represented groups, including African-American, Asian, Hispanic, and Latino people in clinical studies.

WHRI will be focused on therapies that can make a difference in populations including older adults, rural residents, women, and minority populations, said Walgreens in a statement, and will focus particularly on chronic healthcare conditions.

According to the FDA, in 2020 around three quarters of clinical trial participants in the US were white, while just 11% were Hispanic, 8% were Black, and 6% were Asian. Moreover, less than 4% of Americans participate in clinical trials, and around a third of those that do so drop out before the study is completed, with the loss of important data.

“We know our customers are interested in participating in healthcare research, but many have not had access until now,” said Dr John Wigneswaran, Walmart’s chief medical officer, adding that Walmart’s existing activities in this area are already achieving a threefold improvement in referrals compared to industry benchmarks.

He also pointed out that around 90% of Americans live within 10 miles of a Walmart outlet, giving it enormous reach across the country.

“We are already making an impact for our customers and for medical research, by raising patient trust and engagement in their care,” he continued, pointing to ongoing relationships with a wide range of study partners, including clinical research organisations, pharma companies, and academic medical centres.

Walmart is accompanying the formation of the WHRI with the launch of a digital tool called MyHealthJourney, which will help patients take control of their own data by providing some medical records and insurance information in one place.

The app will provide reminders for appointments and other healthcare services, and also serve as a conduit to enable participation in research studies.

Swedish digital health company Alex Therapeutics has reported encouraging results in a trial of a digital therapeutic (DTx) for anxiety in patients with the respiratory disease idiopathic pulmonary fibrosis (IPF).

The cognitive behavioural therapy-based DTx – called Almee (formerly VP04) – is being developed in collaboration with Swedish drugmaker Vicore Pharma to see if it can reduce the psychological symptom burden in adults diagnosed with IPF, a debilitating and progressive disease with no curative treatment.

Patients with IPF have an average life expectancy of just three to five years, during which time symptoms like cough, fatigue, and shortness of breath get worse, and around two thirds of them report moderate to severe anxiety.

The pilot study found that patients with IPF who used a truncated version of Almee saw a 49% reduction in anxiety score – measured using the GAD-7 scale – over the course of four weeks’ follow-up.

It was open-label and conducted in just 10 subjects, so was not powered to give a robust indication of efficacy. Rather, it was designed to test the safety of the DTx and gauge how easy it was for patients to use.

Those primary objectives were found to be positive and, coupled with the positive effect on GAD-7 scores, have encouraged the two partners to start the pivotal phase of the study – which will enrol around 270 subjects using the full Almee programme – before the end of the year.

If positive, the study – called COMPANION – could be used to support regulatory filings for Almee under software as a medical device (SaMD) pathways.

Alex Therapeutics said in a statement that the DTx was associated with a 4.2-point reduction on the GAD-7 scale, well ahead of the threshold of 2 points or more that, according to the company, is considered “clinically meaningful.”

John Drakenberg, chief executive and co-founder of Alex Therapeutics, acknowledged that the data is preliminary.

“Even though the patient population is small, it’s a positive indication heading into the next phase of the clinical trial,” he said. “Digital therapeutics have tremendous potential for treating depressive and anxiety symptoms in somatic diseases and we look forward to continuing our work in the space.”

Vicore – a specialist in respiratory disease therapies – joined forces with Alex last year to develop the DTx, securing all rights to the therapy in exchange for an upfront payment of around $1 million plus potential milestones and royalties.

MatchMiner can be used by a clinician or an oncologist to look up trial options for a patient.

Dana-Farber Cancer Institute designers have reported in a new study that its computer platform makes the patient matching process easier, as well as faster.

With the new MatchMiner platform, clinicians and clinical researchers will be able to find potential matches between subjects and targeted treatment trials based on genetic alterations in their tumours.

The study authors found that MatchMiner, which has been developed by the Knowledge Systems Group at Dana-Farber, expedited the patient enrolling process in the trials by over 20%.

Tali Mazor is the co-lead author of the paper, with Dana-Farber colleague Harry Klein.

Mazor said: “Profiling patient tumours for genomic alterations has become a widespread part of cancer care, especially as new drugs targeting those alterations go into clinical trials or are approved as cancer therapies.

“The combination of this growing body of genomic data and increasing number of precision medicine trials has created a kind of disconnect: finding the right trial for each patient can be a difficult task. MatchMiner helps bridge that gap.”

Launched in 2016, the platform draws on the institutes’ programmes in genomic analysis and clinical research.

MatchMiner can be used by a clinician or an oncologist to look up trial options for a patient, or by a trial team for identifying potential participants.

Investigators analysed patient enrollment data for precision medicine trials at Dana-Farber in the new study for determining whether MatchMiner expedited the process of finding an appropriate trial for patients whose tumours had been profiled genomically.

In this process, 166 instances were found in which the platform identified a potential match between a patient and a trial.

MatchMiner considers the molecular features of the patient’s tumour, its type, and age to link patients to trials and ignores other trial criteria such as the stage of the tumour, previous treatment, and a patient’s overall health.

Alcanza is changing the model for research access to underrepresented people to enhance inclusion in clinical trials.

Middle market healthcare fund Martis Capital has invested in Alcanza Clinical Research in order to meet the pressing requirements of equitable healthcare.

Established in December last year, Alcanza is a clinical research site network platform focused on developing a sustainable and comprehensive clinical trial environment for everyone.

With patient advocacy organisations, research stakeholders, and regulators pushing sponsors to enhance inclusion in clinical trials, Alcanza is changing the model for research access to underrepresented people across various races, genders, ethnicities, sexual orientations, and disability statuses, among others. 

Martis Capital managing partner Mario Moreno said: “This partnership is a unique opportunity to drive sustainable improvements in the highly fragmented clinical trial space by focusing on improving disparities in clinical research.”

Alcanza has taken over five well-performing clinical research firms as an initial step. 

These comprise Boston Clinical Trials, Coastal Carolina Research Center, ActivMed and Allcutis Research, Quest Research Institute, and Charlottesville Medical Research.

They operate in eight regions in Massachusetts, Michigan, New Hampshire, South Carolina, and Virginia, US. 

They also offer complementary treatment specialisation in neurology, psychiatry, vaccines, and infectious disease, among other areas. 

Alcanza will work on extending its national site network in order to offer complete Phase I-IV expertise in various therapeutic regions while preserving a diverse client base of blue-chip biopharmaceutical firms and contract research organisations.

Alcanza Clinical Research CEO Carlos Orantes said: “We are excited to collaborate with Martis Capital to develop the next-generation site model that combines education, community engagement, and exceptional patient care for truly inclusive research. 

“Our leadership team looks forward to expanding the reach of clinical research for all.”

Zelpultide alfa has received Orphan Drug Designation from the European Medicines Agency and the US FDA.

Airway Therapeutics has dosed the first subject in its Phase Ib clinical trial of zelpultide alfa (rhSP-D) in Spain for preventative usage in very preterm infants who are at bronchopulmonary dysplasia (BPD) risk. 

The trial is already underway at ten sites in the US.

The company plans to further extend the trial in Europe to include up to ten sites in Spain by end of the third quarter, and up to three sites in Italy by the end of this year.

A new recombinant form of the endogenous human protein hSP-D, zelpultide alfa is being developed for BPD prevention, as well as for treating Covid-19 in seriously-ill individuals.

hSP-D lowers the body’s inflammation and infection, and regulates the immune response for breaking the injury and inflammation cycle. 

Zelpultide alfa has received Orphan Drug Designation from the European Medicines Agency and the US Food and Drug Administration (FDA).

The anti-inflammatory and anti-infective properties of the product could make it a potential therapy to treat various respiratory ailments such as respiratory syncytial virus, inflammatory diseases outside the lung, and influenza. 

“In Spain, we received approval for the expansion of the Phase Ib trial for zelpultide alfa to patients outside the United States. 

“This is an integral step toward understanding the potential of zelpultide alfa in very preterm infants, with the goal of making our novel therapy accessible globally.”

Apart from BPD, zelpultide alfa is currently being assessed in a Phase Ib trial for Covid-19 in the US.

Satisfai and Virgo will merge expertise with Alimentiv to attain AI-driven precision imaging’s full potential in a GI trial space.

Satisfai Health and Virgo Surgical Video Solutions have entered a strategic collaboration with Alimentiv to leverage artificial intelligence (AI)-powered technology to boost clinical trials in inflammatory bowel disease (IBD) and other gastrointestinal (GI) diseases.

The partnership will transform central reading, capturing of data, decision support, and the recruitment of patients in the clinical trial domain for IBD and associated GI ailments. 

Satisfai is an artificial intelligence solutions developer for the gastroenterology sector while Virgo focuses on endoscopy video capture technology. Alimentiv is a contract research organisation (CRO) in gastroenterology. 

The alliance will offer special access to the SmartScore Central Reading tool of Satisfai and a completely integrated, Cloud-based, hands-free, high-definition video-capture fleet of Virgo to Alimentiv to continue its leadership in GI trials.

The partnership will also offer pharmaceutical and biotech sponsors access to the continuing development of new endpoints, scalable solutions, and scoring methodologies to bring new treatments to the market rapidly.

Alimentiv CEO Jeff Smith said: “This synergy of Satisfai and Virgo with Alimentiv is a positive development for patients with IBD and the drug development space. 

“Clinical trials have many pain points, and this strategic partnership will enable advances in improving the efficiency of clinical trials and make some significant changes to how trials are run.”

Olympus EU-ME3 Ultrasound Processor Delivers Higher Resolution Images for Endoscopic Ultrasound

~ To Support More Accurate Diagnosis and Treatment of Pancreaticobiliary and Lung Diseases ~

TOKYO & HAMBURG, Oct 7, 2022 – (JCN Newswire) – Olympus Corporation (Olympus), a global medtech company committed to making people’s lives healthier, safer and more fulfilling, today announced the launch of EU-ME3, a new Endoscopic Ultrasound Processor*, which addresses the needs of healthcare professionals for high-quality clear images when conducting the endoscopic ultrasound procedure. EU-ME3 will be launched in Europe, the Middle East, Africa, parts of Asia, and Oceania within this fiscal year. EU-ME3 will be exhibited during The 30th United European Gastroenterology Week (UEG Week) from October 8 to 11.

As a pioneer in endoscopic ultrasound technology, Olympus aims to leverage its expertise to enhance the care pathway in gastrointestinal and respiratory disease management. The technology is used for endoscopic ultrasonography (EUS) imaging to support the diagnosis of lesions in the pancreas, the bile ducts, or lesions that are located deep inside the body and are not visible with gastrointestinal endoscopes. In addition, the technology enhances the detailed examination of pancreatitis, pancreatic cancer, and the diagnosis of cancer invasion in the stomach and the esophagus. Endoscopic ultrasound also plays a key role in facilitating the visualization of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) for early, minimally invasive diagnosis and lung cancer staging.

“It is said that pancreatic cancer is difficult to be detected in its early stages, and that lung cancer has the highest mortality rate among all cancers. With the launch of the EU-ME3, Olympus aims to enhance the standard of care including these diseases and to further improve the quality of life of patients,” said Hironobu Kawano, Head of Endoscopic Solutions Division at Olympus.

Advancing the dimensions of Endosonography

With the needs of healthcare professionals and patient outcomes at the core, EU-ME3 is tailored to improve a variety of procedures.

Enhanced visualization and usability

EU-ME3 provides outstanding image quality and functionality – the image quality has been substantially enhanced compared to the prior generation model (EU-ME2), providing enhanced visualization, and therefore supporting more reliable diagnosis and treatment. Shear Wave Quantification, a newly equipped feature for EU-ME3, also contributes to accurate diagnosis by providing quantitative information on the stiffness of tumor and inflamed lesions, which is an important factor when diagnosing a degree of pancreatitis and malignancy of pancreatic cancer during endoscopic ultrasonography.

Focus on the procedure with tailored technology

The Endoscopic ultrasound procedure typically utilizes a variety of observation modes dependent on procedure type or clinical area. Subsequently, in addition to the basic observation mode, EU-ME3 offers multiple software options for individual clinical needs, aiming to stay flexible in the selection of functions and tailor EU-ME3 depending on specialty. Smart and customizable user settings make it easy to fulfil needs for multiple specialties and personal requirements. The backlit keyboard includes a simple, easy-to-use large touch panel and trackpad, designed to support better operability and easier cleaning.

With EU-ME3, the aim is to provide seamless workflow integration for our partners while advancing the dimensions of endosonography for better overall patient outcome.

About Olympus

In its Endoscopic Solutions business, Olympus uses innovative capabilities in medical technology, therapeutic intervention and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic and minimally invasive procedures to improve clinical outcomes, reduce overall costs and enhance the quality of life for patients. Starting with the world’s first gastrocamera in 1950, Olympus’ Endoscopic Solutions portfolio has grown to include endoscopes, laparoscopes, and video imaging systems, digital and integrated customer solutions, as well as solutions for infection prevention. For more information, visit www.olympus-global.com and follow our global Twitter account: @Olympus_Corp.

Media Contacts
Nao Tsukamoto – Global-Public_Relations@olympus.com
Jessica Lee – Jessica.yy.lee@fleishman.com

* Registered name: EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME3. EU-ME3 is manufactured by Olympus Medical Systems Corporation.
* Note: Products or devices presented include future technology which may be pending regional regulatory approval and are not available for sale in all regions.

Olympus Corp [TYO: 7733] [ADR: OCPNY] [GDR: OLYs] https://www.olympus-global.com

AstraZeneca’s rare disease firm Alexion is set to expand its genomic medicine portfolio with the acquisition of gene editing specialist LogicBio Therapeutics, in a deal worth approximately $68 million.

US-based LogicBio is a clinical-stage genetic medicine company focused on genome editing and gene delivery platforms to address rare and serious diseases from infancy through adulthood. Instead of traditional CRISPR- based gene therapy, the company uses homologous recombination as the basis of its genome editing platform, ‘GeneRide’. It is also developing an adeno-associated virus (AAV) capsid engineering platform, dubbed ‘sAAVy’, which the company claims can optimise gene delivery for treatments in a broad range of indications and tissues.

Through Alexion, which AstraZeneca acquired in 2021, the company will gain access to LogicBio’s technology platforms for the delivery and insertion of genes to address genetic diseases, as well as a platform designed to improve viral vector manufacturing processes.

As per the agreement, Alexion will initiate a cash tender offer through a subsidiary to acquire all outstanding shares of LogicBio for $2.07 per share, a rare 660% premiumon LogicBio’s share price.

Following public announcement of the deal, LogicBio’s shares, previously traded below $1, soared by 637% on NASDAQ to reach $2 before the closing bell rang on Monday 3 October.

“The proposed acquisition of LogicBio is a significant development for our growing research in genomic medicine,” said Marc Dunoyer, chief executive officer at Alexion, AstraZeneca Rare Disease.

“LogicBio’s people, experience and platforms provide new scientific capabilities by adding best-in-class technology and expertise to our genomic medicine strategy. The scientific collaboration between Alexion and AstraZeneca has been a substantial area of focus since last year’s acquisition and the addition of LogicBio will expand this foundational work,” Dunoyer said.

The LogicBio deal is the latest in a string of acquisitions for AstraZeneca. In July, the company snapped up TeneoTwo and its T-cell engaging bispecific antibody drug candidate for $100 million, followed closely by the acquisition of Caelum BioSciences, a rare-disease company, for $500 million in September.

Alexion plans to close the deal in four to six weeks, subject to the tender of at least a majority of the outstanding shares of LogicBio common stock and satisfaction of other closing conditions It also intends on retaining LogicBio employees at their current location.