More than 2 years af­ter the ug­ly ro­ci de­ba­cle, Clo­vis says that the SEC is prep­ping civ­il charges

The hot wa­ter that Clo­vis $CLVS has been in with the SEC for the past two years is be­gin­ning to boil.

Clo­vis CEO Patrick Ma­haffy

The biotech to­day alert­ed in­vestors that the SEC has filed a Wells No­tice, sig­nal­ing its in­ten­tion to bring civ­il ac­tions against cur­rent and for­mer ex­ecs at the can­cer drug biotech. The SEC fil­ing did not spec­i­fy what ac­tions it will face, but Clo­vis did say it plans to con­test any charges.

Clo­vis’ 10-K has spot­light­ed an on­go­ing in­ves­ti­ga­tion by the SEC and the Jus­tice De­part­ment in­to an ug­ly in­ci­dent in late 2015 cen­tered on their now de­funct lung can­cer drug rocile­tinib, say­ing it was co­op­er­at­ing with the feds on their probe.

Here’s what hap­pened:

With shares pumped to about $100, Clo­vis stunned in­vestors in late 2015 when it sud­den­ly slashed the re­sponse rate on rocile­tinib for non-small cell lung can­cer to 34% for the 625-mg dose arm, and 28% for the 500-mg dose arm, a plunge of more than 20 points. The news put the drug—un­til then po­si­tioned as a promis­ing ri­val to Tagris­so (AZD9291) backed with peak sales pro­jec­tions of $3 bil­lion—at a dis­tinct dis­ad­van­tage, and the sub­se­quent rout evis­cer­at­ed the biotech’s share price.

Set­backs hap­pen in biotech. But some of the ex­perts who watched this drug say this was not the usu­al kind of clin­i­cal re­ver­sal that can eas­i­ly oc­cur in a risky field like drug de­vel­op­ment.

Clo­vis, run by well-known CEO Patrick Ma­haffy, had been pur­pose­ly mis­lead­ing in­vestors with a false por­trait of the da­ta, they claimed. 

“I feel that the ef­fi­ca­cy da­ta have, con­sis­tent­ly and re­peat­ed­ly, over many years, been mis­rep­re­sent­ed,” R&D ex­pert Kapil Dhin­gra told me months lat­er af­ter he wrote an analy­sis of the da­ta for An­nals of On­col­o­gy. “This is not sim­ply a case of gray zones, this is black and white un­true pre­sen­ta­tion of the da­ta. And it is not just a mi­nor mis­rep­re­sen­ta­tion (such as pho­to­shop­ping a west­ern blot im­age etc that can get a ba­sic sci­en­tist in trou­ble); the true ef­fi­ca­cy is about half of what they rep­re­sent­ed.”

The FDA made short work of Clo­vis’ ap­pli­ca­tion, re­ject­ing the mar­ket­ing bid af­ter a pan­el of ex­perts shook their heads over a risky safe­ty pro­file and a poor­ly de­fined pro­file of ef­fi­ca­cy da­ta. Clo­vis then dumped the drug rather than try to mount a new study, and turned their at­ten­tion to a late-stage PARP ther­a­py, win­ning an OK for Rubra­ca. Just yes­ter­day it won an ex­pand­ed OK to sell the drug as a main­te­nance ther­a­py.

Reg­u­la­tors, though, have a rep for be­ing slow and steady on the en­force­ment front. And they’ve ev­i­dent­ly stayed fo­cused on Clo­vis.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

#ES­MO20: Push­ing in­to front­line, Mer­ck and Bris­tol My­ers duke it out with new slate of GI can­cer da­ta

Having worked in parallel for years to move their respective PD-1 inhibitors up to the first-line treatment of gastrointestinal cancers, Merck and Bristol Myers Squibb finally have the data at ESMO for a showdown.

Comparing KEYNOTE-590 and CheckMate-649, of course, comes with the usual caveats. But a side-by-side look at the overall survival numbers also offer some perspective on a new frontier for the reigning checkpoint rivals, both of whom are claiming to have achieved a first.

Can a mag­net­ic cell ther­a­py re­place corneal trans­plan­ta­tion? As eight-year jour­ney leads to the clin­ic, two broth­ers un­veil bold vi­sion

Jeff Goldberg was getting acquainted with a brand new way to do corneal transplants when an even newer, even bolder idea hit him.

It was almost 10 years ago, and Goldberg was in his first faculty position at Bascom Palmer Eye Institute at the University of Miami. Scientists had developed a new way to do cornea transplants where instead of sewing a whole donor cornea — a decades-old practice — they were just engrafting the inner layer of cells.

News brief­ing: Tiny Vac­cinex's drug flops in PhII Hunt­ing­ton's tri­al, stock craters; Siol­ta nabs $30M Se­ries B to de­vel­op mi­cro­bio­me drug

Siolta Therapeutics, a microbiome company targeting allergic diseases, raked in a $30 million Series B to develop its lead candidate, STMC-103H. The drug, which has been FDA fast-tracked, is headed for proof-of-concept trials, according to the company. Its various indications include allergic asthma, food allergies, atopic dermatitis, allergic rhinitis, and allergy prevention.

The news comes just after the California-based biotech added a prominent biopharma veteran as an advisor: 20-year Gilead CEO John Martin. The biotech also gained Richard Shames as CMO, who came by way of Protagonist Therapeutics.

Samit Hirawat (Bristol Myers Squibb)

Af­ter bruis­ing re­jec­tion, blue­bird and Bris­tol My­ers Squibb land ide-cel pri­or­i­ty re­view. But will it mat­ter for the CVR?

With the clock all but up, the FDA accepted and handed priority review to Bristol Myers Squibb and bluebird bio’s BCMA CAR-T, keeping a narrow window open for Celgene investors to still cash in on the $9 CVR from the $63 billion Celgene merger.

The acceptance comes five months after the two companies weres slammed with a surprise refuse-to-file that threatened to foreclose the CVR entirely. Today’s acceptance sets the FDA decision date for March 27, 2021 – or precisely 4 days before the CVR deadline of March 31. Given the breakthrough designation and strong pivotal data — 81.5% response rate, 35.2% complete response rate — priority review was largely expected.

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Embattled CDC director Robert Redfield (AP Images)

Covid-19 roundup: CDC ad­vi­so­ry com­mit­tee de­lays pri­or­i­ty dis­tri­b­u­tion vote; EU re­port­ed­ly in­dem­ni­fy­ing vac­cine mak­ers

A federal committee that advises the CDC was expected to hold a vote Tuesday on a plan regarding the distribution for initial doses of approved Covid-19 vaccines. But that vote has been scrapped.

The Advisory Committee on Immunization Practices, or ACIP, won’t be voting until the committee members learn more about which vaccines become available first, the Wall Street Journal reported. The vote could potentially wait until a specific vaccine is authorized before recommending how to dole out the first doses.

Anthony Coyle (Pfizer via Youtube)

Flag­ship's merged biotech Reper­toire nets ex-Pfiz­er CSO An­tho­ny Coyle as R&D chief

Flagship is building a big-name C-Suite at its new, $220 million merged biotech.

Repertoire Immune Medicines, which already boasts former Bioverativ chief John Cox as its CEO, announced yesterday that Anthony Coyle, the former Pfizer CSO and the founding CEO of Pandion, will join as their head of R&D.

“As we progress clinical trials for our multi-clonal T cell candidates in immuno-oncology, Tony’s deep expertise in cellular immunology and novel therapeutic development will help us achieve our vision of creating a new class of transformative medicines for patients,” Cox said in a statement.

President Donald Trump (via AP Images)

Signs of an 'Oc­to­ber Vac­cine Sur­prise' alarm ca­reer sci­en­tists. HHS con­tin­ues to claim Azar “will de­fer com­plete­ly to the FDA"

President Donald Trump, who seems intent on announcing a Covid-19 vaccine before Election Day, could legally authorize a vaccine over the objections of experts, officials at the FDA and even vaccine manufacturers, who have pledged not to release any vaccine unless it’s proved safe and effective.

In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Trump — who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA — will take matters into his own hands, running roughshod over the usual regulatory process.

#ES­MO20: Bris­tol My­ers marks Op­di­vo's sec­ond ad­ju­vant win — eye­ing a stan­dard of care gap

Moving into earlier and earlier treatment lines, Bristol Myers Squibb is reporting that adjuvant treatment with Opdivo has doubled the time that esophageal or gastroesophageal junction cancer patients stay free of disease.

With the CheckMate-577 data at ESMO, CMO Samit Hirawat said, the company believes it can change the treatment paradigm.

While a quarter to 30% of patients typically achieve a complete response following chemoradiation therapy and surgery, the rest do not, said Ronan Kelly of Baylor University Medical Center. The recurrence rate is also high within the first year, Hirawat added.