After ERT hit by ransomware attack, trial company kicks out CEO

Clinical trial health tech firm eResearchTechnology (ERT) is getting a new CEO in the same week a report said its work on COVID-19 treatments was delayed due to a cyberattack.

The Philadelphia company, which sells software for clinical trials and works on tests, treatments and a vaccine for COVID-19, was hit by a so-called ransomware attack that  “has slowed some of those trials over the past two weeks.”

The attack had not been reported by the company (and is still not on its site), but according to the report began two weeks ago when “employees discovered that they were locked out of their data by ransomware, an attack that holds victims’ data hostage until they pay to unlock it.”

The company took its systems offline that day, called in outside cybersecurity experts and notified the FBI. It follows a string of ransomware attacks over the past few years in which attackers demand money to have a lock they’ve put on a system reopened.

ERT said clinical trial patients were never at risk, but customers said the attack “forced trial researchers to track their patients with pen and paper,” which caused minor delays to some of its work with partners on COVID-19.

These include IQVIA, the CRO working on AstraZeneca’s COVID-19 vaccine trial, and Bristol Myers Squibb, which is working on a rapid test for the virus.

Several days after the story broke, ERT said current CEO and President Jim Corrigan was stepping down, replaced immediately by Joe Eazor, most recently CEO of Conifer Health Solutions and previously leader of both Rackspace and Earthlink.

It’s not clear whether the two events are linked, or whether Corrigan was sacrificed for the attack after news of it surfaced. He will, however, “continue to support the company during a transition period,” according to a statement.

The company does not know who is behind the attack. Drew Bustos, ERT’s vice president of marketing, said: “Nobody feels great about these experiences, but this has been contained.”

https://www.fiercebiotech.com/cro/as-ert-hit-by-ransomware-attack-trial-company-kicks-out-old-chief-as-covid-work-delayed

BofA Likes Qiagen After Thermo Fisher Deal Fails

The COVID-19 environment may boost Qiagen's QGEN 1.97% new products, like QIA-STAT and NeuMoDx, according to BofA Securities.

The Qiagen Analyst: Derik de Bruin reinitiated coverage of with a Buy rating and a price target of $59.

The Qiagen Thesis: Although Thermo Fisher Scientific Inc. TMO 0.99% raised its offer to 43 euros per share, the deal to acquire Qiagen fell through as shareholders still considered the price too low, de Bruin said in the re-initiation note.

“We have been very critical of QGEN given their track record of uneven capital deployment, lack of transparency, and missed expectations,” the analyst wrote in a note.

He added that although execution risks remain, Qiagen’s new products may be boosted by COVID-19.

“With a new CEO in place and new products in the portfolio, QGEN has the opportunity to reinvent itself, especially when it comes to deploying capital, further reducing the cost structure, and delivering on expectations,” said de Bruin.

https://www.benzinga.com/analyst-ratings/analyst-color/20/10/17802128/bofa-likes-qiagen-after-thermo-fisher-deal-fails-to-get-shareholder-approval

Myokardia Analysts See Mavacamten As Blockbuster Opp For Bristol

Myokardia Inc MYOK 0.3% announced Monday a definitive agreement to be bought by Bristol-Myers Squibb Co BMY 2.5%.

The Myokardia Analysts: Wedbush analyst David Nierengarten downgraded Myokardia from Outperform to Neutral and raised the price target from $127 to $225.

Wells Fargo Securities analyst John Birchenough downgraded the stock from Overweight to Equal Weight and increased the price target from $133 to $225.

Wedbush Sees Long-Term Opportunity In Mavacamten: Given Bristol-Myers Squibb's strong presence in the cardiovascular space with Eliquis, the addition of Myokardia's first-in-class myosin ATPase inhibitor mavacamten is complementary to the former's portfolio, Nierengarten said in a Tuesday downgrade note.

The asset should provide a long-term opportunity, the analyst said. 

With an NDA for mavacamten in obstructive hypertrophic cardiomyopathy, or HCM, set for submission by the first quarter of 2021, a commercial launch is likely by the end of 2021 or early 2022, he said. 

Bristol-Myers Squibb will also find additional opportunities with mavacamten in non-obstructive HCM and targeted heart failure with preserved ejection fraction, Nierengarten said.

"We expect the deal to go forward and do not see competing bids or regulatory hurdles as likely to occur." 

Analyst Says Mavacamten Worth $3B: Myokardia is focused on developing precision medicines for genetic heart disease, with its lead myosin modulator mavacamten awaiting regulatory filing in obstructive HCM and also being evaluated in non-obstructive HCM, and HFpEF, Birchenough said in a Monday downgrade note. 

Another Phase 2 asset — danicamtiv — is being evaluated for dilated cardiomyopathy and broader heart failure with reduced ejection fraction, the analyst said.

Wells Fargo's peak sales estimate for mavacamten in obstructive HCM and non-obstructive HCM combined is $3 billion, he said. 

"With our estimate of $3B in peak sales for lead cardiac drug mavacamten, we view valuation at >4x peak sales as compelling and unlikely to be exceeded."

https://www.benzinga.com/analyst-ratings/analyst-color/20/10/17805990/myokardia-analysts-see-mavacamten-as-blockbuster-opportunity-for-bristol-myers-squi

Iovance delayed TIL when?

The sellside was quick today to shrug off a delay to Iovance’s lead project, lifileucel, in metastatic melanoma. But the fact the company cannot agree with the FDA on the potency assays needed for its BLA submission highlights yet another potential stumbling block for the real-world use of tumour-infiltrating lymphocytes (TILs). As Iovance’s TILs are simply extracted from a person’s tumour and expanded before being reinfused, therapy will vary from patient to patient – and the active targets are also likely to differ, Stifel analysts noted, unlike with CAR-T, for example. This will make standardising TIL therapy tricky, and the FDA is obviously keen to cut down on variability as much as possible. Iovance seems confident that it can “refine” its potency assay data and file lifileucel in 2021; it had previously expected to submit by the end of this year. Both Stifel and Mizuho analysts remain hopeful of approval in 2022, based on the data released so far. But the potency issue comes on top of questions around whether TILs are patentable or economically viable, and Iovance stock opened down 12% this morning. Other TIL players take note.

Selected TIL players
Company	Lead TIL project	Status
Iovance Biotherapeutics	Lifileucel	Melanoma filing delayed until 2021
Achilles Therapeutics	ATL001	Ph1/2 in melanoma (NCT03997474) & NSCLC (NCT04032847)
Immatics	ACTolog	Ph1, NCT02876510
Tilt Biotherapeutics	TILT-123 + TILs	Ph1, NCT04217473
Source: EvaluatePharma, clinicaltrials.gov.2 https://www.evaluate.com/vantage/articles/news/snippets/iovance-delayed-til-when

Vax plan head Slaoui sees Pfizer, Moderna data readouts November-December

The chief adviser for the U.S. government’s Operation Warp Speed COVID-19 vaccine program, Moncef Slaoui, on Tuesday said efficacy data readouts are expected from Pfizer Inc and Moderna Inc between next month and December.

Speaking at a symposium conducted by the Johns Hopkins University and the University of Washington, Slaoui said data readouts from leading vaccine developers are expected to come in three waves over the next several months.

The first wave would be coming from Pfizer and Moderna, both of which are developing mRNA-based vaccines for the coronavirus, he said.

Slaoui said efficacy data on one or two vaccines will be available within the next month or two, for which there will be enough doses to immunize 30 million people between November and December.

Commenting on AstraZeneca’s vaccine program, Slaoui said while the company’s U.S. study remains on hold, data readouts on the vaccine’s effectiveness may be expected somewhere in late October or November from ongoing studies in the UK, Brazil and South Africa.

“At that time, we will have very few doses to be able to, if the decision was to approve the vaccine, immunize,” he said, adding that efforts are in place to scale up manufacturing and stockpiling of the vaccine.

https://www.reuters.com/article/us-health-coronavirus-usa-vaccine/u-s-vaccine-program-head-slaoui-expects-pfizer-moderna-vaccine-data-readouts-in-november-december-idUSKBN26R3FE