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Tuesday, June 18, 2019

AstraZeneca Lynparza gets EU nod as 1st-line ovarian cancer maintenance med

British drugmaker AstraZeneca Plc on Tuesday said its cancer medicine Lynparza was approved as a first-line maintenance treatment for a type of advanced ovarian cancer by the European Commission, following a panel’s consent in April.

Lynparza, being jointly developed by AstraZeneca along with U.S. drugmaker Merck & Co, can now be used in patients who are in response following chemotherapy for advanced BRCA-mutated ovarian cancer in Europe, AstraZeneca said.
BRCA genes are responsible for producing proteins which repair damaged DNA, and if the genes are mutated, they can cause cancer growth.
Lynparza belongs to a class of drugs known as PARP inhibitors which keep cancer cells damaged by chemotherapy from repairing themselves. It became the first PARP drug to reach the market with a U.S. approval for ovarian cancer in late 2014.
AstraZeneca has been pushing to build its cancer drug portfolio and Lynparza is an important growth driver for the drugmaker, with analysts pegging the drug to hit $2.5 billion in sales in 2023, according to Refinitiv Eikon data.
Lynparza also helped patients with advanced pancreatic cancer who carry BRCA gene mutations go nearly twice as long without their disease worsening, late-stage clinical trial data from earlier this month showed.
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Medical device maker Ambu’s shares dive after new CEO cuts outlook

Shares in Danish medical device maker Ambu plunged 18% in early trade on Tuesday after its new chief executive announced cuts to the company’s growth prospects for this year and next.

The reduction in targets is Chief Executive Officer Juan-José Gonzalez’s first big announcement after the former Johnson & Johnson executive took over from Lars Marcher last month.
During more than a decade at the helm, Marcher presided over a roughly 5,000 percent rise in the company’s shares as he led the company’s successful expansion of diagnostic and life-support devices for hospitals, focusing on products such as single-use endoscopes.
Ambu’s shares have fallen more than 40% since Marcher’s unexpected exit when the company said it wanted a CEO with a strong international profile as it sought to expand globally.
On Tuesday, Ambu said that its lower growth outlook for the current fiscal year was partly due to discontinuation of one of its colonoscopes, called SC210, after it disappointed in tests in a U.S. hospital.
For the 2018/2019 financial year ending in September, it said it now expects organic revenue growth of 14-15% down from a previous guidance of 15-16% and an EBIT-margin before special items of around 22% compared to a previously stated 22-24%.
It also said it would invest 225 million Danish crowns (£27 million) in sales and marketing and more than double its global sales force and launch a number of new products.
“We will fulfil our aspiration to become one of the major European medical devices companies,” Gonzalez, an American, said.
In the 2019-2020 financial year Ambu now sees organic revenue growth of 16-19%, down from a previously forecasted 18-23%, and an EBIT margin of at least 20% compared to a previous estimate of 26-28%.
Free cash flows in 2019-2020 are now estimated to be around 9% of revenue compared to previously 18% of revenue.
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Sanofi and Google join forces to create ‘Innovation Lab’

Sanofi and Google are to create a virtual innovation lab, aiming to transform how future medicines and health services are delivered, using the power of data technology.
The French pharma appointed Ameet Nathwani as its first chief digital officer in February, and this is the first major initiative he has begun since taking the job.
Sanofi hopes the collaboration will change the way it develops new treatments, focusing on three key objectives.
These are to better understand patients and diseases, increase operational efficiency, and improve patient and customer experience.
In order to develop a more personalised approach to medicine, the companies will apply technology and analytics to Sanofi’s large real-world database to better understand what treatments work for patients.
This aims to result in an improved ability to offer personalised treatment advice, thus optimising patient care and reducing healthcare costs.
The companies also plan to use artificial intelligence (AI) to better forecast sales and inform marketing and supply chain efforts.
This will take into account real-time information as well as geographic, logistic and manufacturing constraints to improve accuracy of these activities.
Sanofi will also migrate some business solutions to Google Cloud Platform to modernise its infrastructure.
Using automation along with increases in data and analytic capabilities, Sanofi says it will accelerate and simplify management of older products.
It will also provide easy access to recent technologies and help its integration into business plans.
At the start of this month, Sanofi said it had appointed Paul Hudson to take over as its CEO, replacing Olivier Brandicourt who will retire in September.
Hudson will be tasked with rejuvenating a business that has been hit by cheaper competition for its top-selling insulin, Lantus.
However the company’s recently approved Dupixent (dupilumab) for asthma and eczema is tipped to become a blockbuster following a strong launch after it hit the market in 2017.
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Monday, June 17, 2019

$200M Adaptive Biotech IPO to fund next-gen kit, deals with Microsoft, Genentech

Ten years after spinning out from Fred Hutch, Adaptive Biotechnologies is planning a $200 million IPO to help power its diagnostic sequencing tests aimed at the body’s immune system and the scores of related therapies.
The Seattle-based company has proposed to list on the Nasdaq, under the symbol ADPT, by offering 12.5 million shares priced between $15 and $17 each. The midpoint of that range would allow Adaptive to claim a market value of $2.1 billion, according to Renaissance Capital.
The company currently offers two commercial product lines—its immunoSEQ kit and translational research service, and its clonoSEQ clinical diagnostic test to track minimal residual disease levels following cancer treatment. The latter received a de novo clearance from the FDA in September 2018 for monitoring bone marrow samples for signs of remaining cancer cells in patients with multiple myeloma and B cell acute lymphoblastic leukemia.

Meanwhile, in its prospectus, Adaptive said its immunoSEQ platform has been used by more than 125 biopharma companies and over 480 clinical trials since the company’s launch in 2009. According to Renaissance, Adaptive brought in $59 million in revenue in the 12 months before March 31 of this year.
Following the IPO, the company plans to begin development of a next-generation research kit capable of using a wide range of sample types, which it hopes will enable the global distribution of its products.

In addition, Adaptive is working with Microsoft to employ machine learning in the creation of an atlas mapping out the interactions between the immune system and multiple diseases, with the ultimate goal of developing a diagnostic blood test. The companies plan to confirm the test’s first indications by the end of this year before bringing it before the FDA for review in 2020.
Adaptive also inked a multibillion-dollar collaboration deal with Genentech at the top of the year to develop T-cell therapies for a broad range of tumors. Using Adaptive’s T-cell receptor discovery and immune system profiling platform, the two hope to create cell therapies tailored to each patient’s specific cancer.
Adaptive received a $300 million upfront payment in February, with Genentech on the hook for about $1.8 billion more if the project reaches successful milestones, plus royalties. Genentech retains control over future commercialization, and Adaptive is barred from developing T-cell receptor-based cell therapies in oncology on its own or with a third party.
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Anthem to reaffirm 2019 EPS guidance in investor meetings

Anthem (NYSE:ANTM) plans to reaffirm the company’s full-year 2019 adjusted EPS of greater than $19.20 during meetings with investors being held from June 18 to June 28, 2019.
The adjusted per-share figure excludes ~93 cents of net unfavorable items; including the items, Anthem expects 2019 net income of greater than $18.27 per share, consistent with prior guidance.
The average analyst estimate for 2019 adjusted EPS is $19.30.
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Repurposing existing drugs, combining therapies may aid in autoimmunities

Research led by the University of Birmingham has found re-purposing already existing drugs or combining therapies could be used to treat patients who have difficult to treat autoimmune diseases.
Funded by Versus Arthitis, the research was led by the University of Birmingham’s Institute of Inflammation and Ageing and Institute of Cardiovascular Sciences and was published today (June 17th) in Proceedings of the National Academy of Sciences.
The research, a collaboration with the University of Oxford, University of Cambridge, University of York, Université Rennes in France, and the University of Lausanne in Switzerland, was supported by the National Institute for Health Research Birmingham Biomedical Research Centre.
Dr. Saba Nayar, of the University of Birmingham, explained: “In this study, we found for the first time that fibroblasts— that play a critical role in healing—also play a key role in the process of the formation of tertiary lymphoid structures, which are small clusters of blood and tissue cells found at the sites of chronic inflammation.
“Inflammation is the body’s process of fighting against things that harm it, such as infections, injuries, and toxins, in an attempt to heal itself. When something damages cells, our bodies releases chemicals that trigger a response from our immune system.
“This response usually lasts for a few hours or days in the case of acute inflammation, however in  the response lingers, leaving your body in a constant state of alert. Chronic  occurs in a range of conditions from cancer to arthritis and autoimmune conditions—illnesses or disorders that occur when  get destroyed by the body’s own immune system.”
Dr. Joana Campos, also of the University of Birmingham, added: “Tertiary lymphoid structures are believed to play a key role in the progression of autoimmune conditions such as Sjögren’s Syndrome—a condition that affects parts of the body that produce fluids like tears and spit.
“Previously research has not identified the role fibroblasts play in the formation and maintenance of tertiary lymphoid structures.
“We proved that fibroblasts expand and acquire immunological features in a process that is dependent on two cytokines—substances which are secreted by cells including fibroblasts in the .”
Dr. Francesca Barone, also of the University of Birmingham, said: “Our research has led us to conclude that, by re-purposing already existing drugs or combining therapies, we could use these medications to directly target immune cells and fibroblasts to attack these cytokines in patients who have difficult to treat  in which the formation of tertiary lymphoid structures plays a critical role.
“Our findings were surprising and unexpected and have addressed functional questions that the science community has been trying to address since tertiary lymphoid structures were first discovered.”
Explore further
More information: Saba Nayar el al., “Immunofibroblasts are pivotal drivers of tertiary lymphoid structure formation and local pathology,” PNAS(2019). www.pnas.org/cgi/doi/10.1073/pnas.1905301116
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Clinical Trials in Plain English: TrialAssure Translates for Patients

Software is playing a growing role in clinical trials, and over the years it’s been introduced as a tool to help enroll patients, collect data, and analyze results. But one aspect of clinical trial record-keeping has been stubbornly stuck on paper—the reporting of data to the patients who volunteer for the studies.
TrialAssure, a Canton, MI-based company developing software tools to increase the transparency of clinical trials, has launched a new website called TrialResults that enables the companies that conduct these studies to share plain-language trial summaries with the participating patients.
Zach Weingarden, TrialAssure’s product solutions manager, says the online portal allows clinical trial participants to read lay summaries of the trial’s results in English, or whatever their native language is. It replaces the typical process of mailing paper copies of summaries to patients, he adds. Some of the larger trial sponsors—the biotech and pharmaceutical companies that are running the studies to test their drugs–will post summaries of results on their own websites, but he maintains that small and mid-size companies often don’t have the resources to do that in-house.
“That’s where TrialResults fits an unmet need,” Weingarden says, noting that some clinical studies take years to complete, making it harder to track patients down when it’s time to deliver a summary. “Trial participants put their health on the line to contribute to science. Having one document uploaded for everybody to read makes the logistical challenge easier.”
Sponsors pay TrialAssure a subscription fee to post summaries, but patients can access them free of charge. Weingarden says contract research organizations, pharma companies, and other sponsors upload plain-language trial summaries onto the portal. Participants enter an already-provided unique trial identifier to access the information. Sponsors can also send participants a link to the URL containing the summary. In addition to the data of an individual patient, the summaries often include broader, anonymized data about the overall study.
The company says only 2 percent of clinical trial sponsors have issued lay summaries to participants in the past few years, according to a report by Applied Clinical Trials. Trying to parse dozens of pages of jargon-filled summaries posted on government registries can be a challenge for many patients, Weingarden says. At TrialResults, they’ll find that information distilled into a few pages written at an eighth-grade level and often containing graphics.
Weingarden says that TrialAssure was born out of a partnership with MMS, a Canton contract research organization, about a decade ago. The 30-person software-as-a-service company provides a suite of tools that anonymize trial participant data so it can be shared publicly or with other researchers, and help to manage trial compliance and disclosure.
TrialAssure’s ultimate goal, Weingarden continues, is to create a collaborative platform and rich repository of information that people can search by condition, date, geography, or other parameters. “If they can find it all in one place, it could be a powerful tool for patients,” he says.
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