New­ly named Abeona chief Carsten Thiel boot­ed af­ter the board ac­cus­es him of mis­con­duct in­volv­ing col­leagues

Just 6 months af­ter land­ing the top job at Abeona Ther­a­peu­tics $ABEO, CEO Carsten Thiel has been un­cer­e­mo­ni­ous­ly boot­ed from the ex­ec­u­tive suite, ac­cused of un­spec­i­fied “per­son­al mis­con­duct” in­volv­ing his in­ter­ac­tions with col­leagues at the com­pa­ny.

Ac­cord­ing to Abeona, a cell and gene ther­a­py start­up:

Dr. Thiel’s ter­mi­na­tion fol­lows an in­ves­ti­ga­tion by in­de­pen­dent mem­bers of the Com­pa­ny’s Board of Di­rec­tors and ex­ter­nal coun­sel in­to al­le­ga­tions of mis­con­duct to­wards col­leagues that the Board con­clud­ed vi­o­lat­ed the Com­pa­ny’s Code of Busi­ness Con­duct and Ethics and was in­con­sis­tent with its ex­pec­ta­tions for Abeona’s CEO.

And the sack­ing came with a lec­ture.

“We ex­pect all em­ploy­ees, re­gard­less of ti­tle or re­spon­si­bil­i­ty, to con­duct them­selves eth­i­cal­ly and in ac­cor­dance with com­pa­ny poli­cies, and are com­mit­ted to en­sur­ing an en­vi­ron­ment of re­spect, in­tegri­ty and eth­i­cal con­duct at Abeona,” said ex­ec­u­tive chair­man Steven Rouhan­deh in a pre­pared state­ment.

End­points News reached out to the com­pa­ny to see if we could round up some specifics of what hap­pened, but a spokesper­son was tight-lipped about the de­tails, stick­ing with the state­ment.

João Sif­fert

Thiel had been swept out of his job as com­mer­cial chief at Alex­ion in the spring of 2017 as the then new CEO Lud­wig Hantson cleaned house and brought in his own ex­ec­u­tive crew. Hantson’s ar­rival fol­lowed the de­par­ture of the pre­vi­ous Alex­ion CEO, who had been im­pli­cat­ed in an ethics scan­dal of his own af­ter ques­tions re­gard­ing the way they han­dled ad­vanced sales came up.

He’s be­ing re­placed on an in­ter­im ba­sis by an­oth­er new staffer: R&D chief João Sif­fert, who was brought in just a few weeks ago. Jef­feries notes that Sif­fert ap­pears to have the in­side track on the job, but adds that Abeona will look around for the best re­place­ment.

Pri­or to ABEO, Dr. Sif­fert was CMO at Cere­gene (ac­quired by SG­MO in 2013) and held lead­er­ship roles at AVNR and Av­era with his most re­cent role as Chief Sci­en­tif­ic and Med­ical of­fi­cer for Nes­tle Health Sci­ence. No­tably, he has Board lev­el per­spec­tive at AVXS (was ap­point­ed to the AVXS Board 4/19/17). In gen­er­al, he has ex­pe­ri­ence with neu­ro­log­i­cal drug and gene ther­a­py de­vel­op­ment. With ex­pe­ri­ence from pre­clin to drug ap­proval, Dr. Sif­fert brings a breadth of lead­er­ship-based qual­i­fi­ca­tions that should be rel­e­vant to ABEO’s cur­rent stage of growth. Though Dr. Sif­fert has a head start, ABEO has re­tained a search firm to look ex­ter­nal­ly too.

FDA commissioner Stephen Hahn at the White House (AP Images)

Un­der fire, FDA to is­sue stricter guid­ance for Covid-19 vac­cine EUA this week — re­port

The FDA has been insisting for months that a Covid-19 vaccine had to be at least 50% effective – a measure of transparency meant to shore public trust in the agency and in a vaccine that had been brought forward at record speed and record political pressure. But now, with concerns of a Trump-driven authorization arriving before the election, the agency may be raising the bar.

The FDA is set to release new guidance that would raise safety and efficacy requirements for a vaccine EUA above earlier guidance and above the criteria used for convalescent plasma or hydroxychloroquine, The Washington Post reported. Experts say this significantly lowers the odds of an approval before the election on November 3, which Trump has promised despite vocal concerns from public health officials.

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.

Anthony Coyle (Repertoire)

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.

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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Blueprint CEO Jeff Albers (file photo)

Blue­print plots re­turn to FDA with new Ay­vak­it da­ta in rare con­di­tion — and the an­a­lysts cheer

Over a decade after launch, Blueprint Medicines nabbed the first approval for their first drug earlier this year. Now, as they move forward with a Roche-partnered global launch, they’re touting data that could push them into more patients.

The Jeff Albers-led Cambridge biotech released their full pivotal data for Ayvakit in patients with advanced systemic mastocytosis. In one 53-person study, they showed that 76% of patients responded to the drug, 36% had complete responses and that on average their responses lasted for just over 3 years. A smaller, 32-patient study had a 75% response rate and most were still responding after 10.4 months, the last follow-up.

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: 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.

Frank Zhang (AP Images)

UP­DAT­ED: Rocked by cus­toms in­ves­ti­ga­tion, Leg­end's CFO takes over as CEO Frank Zhang placed un­der house ar­rest

When Frank Zhang stepped down from GenScript — the contract research group he’s run for 18 years — to take up the CEO post at its CAR-T focused spinout Legend Biotech, he assured analysts that he was in for the long haul.

Just 49 days later, though, he’s been forced to hand back the title.

In a dramatic turn of events, Legend disclosed that Zhang is under house arrest in China as part of a customs investigation involving GenScript. While he remains the chairman, CFO Ying Huang has been tapped to double as interim CEO.

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UP­DAT­ED: Two wild weeks for Grail end in $8B Il­lu­mi­na buy­out

Grail’s whirlwind two weeks have ended in the wealthy arms of its former founder and benefactors.

Illumina has shelled out $8 billion to reacquire the closely-watched liquid biopsy startup they spun out just 5 years ago and sold off much of its shares just 3 years ago. The deal comes nearly two weeks after the well-heeled startup filed for a potentially massive IPO — one that was disrupted just a week later when Bloomberg reported that Illumina was in talks to buy their former spinout for up to $8 billion.

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