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Friday, July 10, 2020

Karyopharm up on uncertainty with advisory committee nod for Glaxo drug

Karyopharm Therapeutics (KPTI +5.2%) perks up, albeit on below-average volume, in apparent response to the release of a briefing document for Tuesday’s FDA advisory committee meeting on GlaxoSmithKline’s (GSK -1.0%marketing application seeking accelerated approval of antibody-drug conjugate (ADC) belantamab mafodotin for the treatment of multiple myeloma (MM) patients who have received at least four prior lines of therapy.
The review team appears concerned with the ADC’s safety profile, specifically ocular toxicity, and is unconvinced that the company’s proposed actions to mitigate the risk will be adequate.
Karyopharm’s Xpovio (selinexor) is the only FDA-approved drug for “last-line” treatment of patients with relapsed/refractory MM, receiving the regulatory nod a year ago.

China’s Zhifei starts Phase II trial of COVID-19 vaccine

A coronavirus vaccine candidate developed by a unit of China’s Chongqing Zhifei Biological Products has moved into Phase II human trials, the company said on Friday, less than three weeks after it launched clinical trials.
The firm did not provide details of the trial design or results of the Phase I test of the experimental vaccine, being co-developed by Anhui Zhifei Longcom Biopharmaceutical and the Institute of Microbiology of the Chinese Academy of Sciences.
Earlier, the company had estimated Phase I trials would be completed on July 21, with the study results expected on Sept 20.
Shares in Zhifei rose 3.5% on Friday in a flat market.
The vaccine candidate is one of eight treatments Chinese researchers and companies are testing in humans. Nearly 20 vaccines are in different stages of clinical trials globally against the virus that has caused more than half a million deaths.
However, none of them have yet passed large-scale, late-stage phase III clinical trials, a necessary hurdle for entry to the consumer market.

FDA unclear if benefits of Glaxo multiple myeloma drug outweigh risks

The U.S. Food and Drug Administration said on Friday it was unclear whether the benefits of GlaxoSmithKline’s experimental treatment for a common form of blood cancer outweigh the risks ahead of a review of a side-effect which affects the eyes.
Approval for belantamab mafodotin as a treatment for multiple myeloma, a rival to Johnson & Johnson and Genmab’s Darzalex treatment, is seen as important for GSK’s growing oncology portfolio.
In submissions ahead of a meeting of the Oncologic Drugs Advisory Committee (ODAC) on July 14, the FDA said it had concerns about how belantamab mafodotin can cause deposits to gather on the cornea, known as keratopathy.
The FDA highlighted the frequency of the side effect, its severity, the lack of clear mitigation strategies and incomplete data on whether it is reversible.
GSK is confident in the benefit/risk profile of the drug, and proposes it should be managed through modifying or interrupting the course of treatment.
“There is uncertainty whether the proposed dose modification strategy is sufficient to mitigate the risks,” a briefing document published on the FDA’s website said.
“It is not clear whether the benefit outweighs the risks of ocular toxicity.”
Broker Jefferies said that while it was usual for the document to flag contentious issues, “our confidence is dented by FDA’s remarks”.
In its mid-stage study DREAMM-2, nearly 100 patients were given the belantamab mafodotin at the dosage for which GSK has submitted for approval.
Of those patients, 27% experienced medically severe keratopathy. One patient discontinued treatment due to the side effect but no patients experienced life threatening symptoms.
The trial was testing the drug, also known as GSK2857916, in patients who had received four to seven prior other treatments, including Darzalex.
GSK has other trials planned aimed at showing its benefits in earlier stages of treatment.

Pandemic-proofing: Insurance may never be the same

Insurers are creating products for a world where virus outbreaks could become the new normal after many businesses were left out in the cold during the COVID-19 crisis.
While new pandemic-proof policies might not be cheap, they offer businesses from restaurants to film production companies to e-commerce retailers ways of insuring against disruptions and losses if another virus strikes.
The providers include big insurers and brokers adding new products to existing coverage, as well as niche players that see an opportunity in filling the void left by mainstream firms that categorise virus outbreaks like wars or nuclear explosions.
Tech firm Machine Cover, for example, aims to offer policies next year that would give relief during lockdowns. Using apps and other data sources, the Boston-based company measures traffic levels around businesses such as restaurants, department stores, hairdressers and car dealers.
If traffic drops below a certain level, it pays out, whatever the reason.
“This is the type of coverage which … businesses thought they had paid for when they bought their current business interruption policies before the coronavirus pandemic,” the company’s founder Inder-Jeet Gujral told Reuters.
“I believe this will be a major opportunity because post-COVID, it would be as irresponsible to not buy insurance against pandemics as it would be to not buy insurance against fire.”
The company is backed by insurer Hiscox and individual investors, mostly from the insurance and private equity world.
Restaurants in Florida’s Miami-Dade County, where Mayor Carlos Gimenez on Monday ordered dining to shut down soon after reopening, are now reeling, said Andrew Giambarba, a broker for Insurance Office of America in Doral, Florida.
“It’s been like they made it to the ninth round of the fight and were holding on when this punch came out of nowhere,” said Giambarba, whose clients include restaurants that did not get payouts under their business interruption coverage.
“Every niche that is dealing with insurance that is affected by business interruption needs every new product they can have.”
FILLING THE VOID
Pandemic exemptions have helped some insurers emerge relatively unscathed and the sector has largely resisted pressure to provide more virus cover. Indeed, some insurers that paid out for event cancellations and other losses have removed pandemics from their coverage.
British risk managers association Airmic said last week that the pandemic had contributed to a lack of adequate insurance at an affordable price and most of its members were looking at other ways to reduce risk.
To help fill the void in a locked-down world, Lloyd’s of London insurer Beazley Plc, started selling a contingency policy last month to insure organisers of streamed music, cultural and business events against technical glitches.
“These events are completely reliant on the technology working and a failure can be financially crippling,” said Mark Symons, contingency underwriter at Beazley.
Marsh, the world’s biggest insurance broker, has teamed up with AXA XL, part of France’s AXA, and data firm Arity, which is part of Allstate, to help businesses such as U.S. supermarket chains, restaurants and e-commerce retailers cope with the challenges of social distancing.
With home deliveries surging, firms have hired individual drivers to meet demand, but commercial auto liability insurance for “gig” contractors with their own vehicles is hard to find.
Marsh and its partners devised a policy based on usage with a price-by-mile insurance, which can be cheaper than typical commercial auto cover as delivering a pizza doesn’t have the same risks as driving people around.
“Even when the pandemic is over, we believe last-mile delivery will continue to grow,” said Robert Bauer, head of Marsh’s U.S. sharing economy and mobility practice.
A report by consultants Capgemini showed that demand for usage-based insurance has skyrocketed since COVID-19 first broke out and more than 50% of the customers it surveyed wanted it.
However, only half of the insurers interviewed by Capgemini for its World Insurance Report said they offered it.
BESPOKE COVER
Since businesses are only now learning how outbreaks can affect them, some new products are effectively custom-made.
Elite Risk Insurance in Newport Beach, California, has been offering “COVID outbreak relapse coverage” since May for businesses forced to shut down a second time, its founder Jeff Kleid said.
The policies are crafted around specific businesses and only pay out when certain conditions are met, Kleid said.
For film and television production companies that could be when a cast member contracts the virus, forcing them to stop shooting. Another client, which raises livestock for restaurants, is covered for a scenario in which it would be impossible to get animal feed.
Such policies do not come cheap. A $1 million policy could cost between about $80,000 (£63,543) to $100,000 (£79,428) depending on the terms.
“The insurance … is costly because it covers a risk that does not have a historical basis for calculating the price,” Kleid says.
And in March, when COVID-19 ravaged northern Italy, Generali’s Europ Assistance offered medical help, financial support and teleconsultations for sufferers when discharged from hospital, on top of regular health insurance.
It sold 1.5 million policies in just two weeks and now has 3 million customers in Europe and United States.
Some insurers are also working on changes to employee compensation and health insurance schemes. With millions of workers not expected to return to offices anytime soon, some large insurers in Asia are preparing coverage to account for that, according to people familiar with those efforts.
At least one Japanese insurer has started work on a product to cover employees for injury while working at home, they said.
“Working from home will be the new normal for years to come. That would make the scope of the employee compensation scheme meaningless if a person suffers an injury while at home,” said a Hong Kong-based senior executive at a European insurer.

DBV Tech’s Viaskin Peanut shows benefit in long-term extension study

DBV Technologies (DBVT) announces results from a three-year open-label extension, PEOPLE, of the Phase 3 PEPITES study evaluating Viaskin Peanut in children with peanut allergy. The data were just published in The Journal of Allergy and Clinical Immunology. 
Participants experienced sustained clinical benefit with an additional two years’ treatment with Viaskin Peanut.
75.9% (n=107/141) showed an improvement in eliciting dose (ED) from baseline at month 36.
51.8% (n=73/141) achieved an ED of at least 1,000 mg at month 36.
Mean cumulative reactive dose was 1,768.8 mg (median: 944 mg) at month 36 compared to 223.8 mg (median: 144 mg) at baseline.
The treatment effect was observed across a range of baseline activity, including the most sensitive patients.
77.8% (n=14/18) of a subset of patients were able to maintain desensitization for a two-month period while off therapy and without peanut consumption.
The company’s U.S. marketing application is currently under FDA review with an action date of August 5, although about four months ago the company reported that the review team identified “questions” concerning efficacy and canceled the scheduled advisory committee meeting. It said that it was “communicating” with the agency about additional information on patch-site adhesion and data from the extension study.

Nkarta prices IPO at $18

Nkarta (NKTX) has priced its IPO of 14M common shares at $18.00/share, for expected gross proceeds of ~$252M.
Underwriters’ over-allotment is an additional 2.1M shares.
Trading kicks off today.
Closing date is July 14.

Gilead’s remdesivir cut mortality risk 62% in COVID-19 study

Gilead Sciences (NASDAQ:GILD) reports additional data on remdesivir that includes a comparative analysis of the Phase 3 SIMPLE-Severe study and a real-world retrospective cohort of severely ill COVID-19 patients. The results are being presented virtually at the 23rd International AIDS Conference.
Treatment with remdesivir was associated with a 62% reduction in mortality compared to standard-of-care (SOC) treatment. 74.4% of treated patients recovered by day 14 versus 59.0% of those receiving SOC. Remdesivir demonstrated its superiority to SOC in terms of mortality rate, 7.6% at day 14 versus 12.5% in patients not receiving the antiviral.
The study assessed five-day and 10-day dosing regimens of remdesivir administered intravenously.
Patients who received hydroxychloroquine in addition to remdesivir experienced lower recovery rates (57% vs. 69%) compared to those who received remdesivir without the malaria drug. Concomitant use of hydroxychloroquine was not associated with a higher mortality rate in the 14-days analysis window.
Results from its remdesivir compassionate use program showed that 83% of pediatric patients and 92% of pregnant and postpartum women with a broad spectrum of COVID-19 severity recovered by day 28.