Ther­mo Fish­er hooks gut on­to its gene ther­a­py pipeline, inks new col­lab­o­ra­tion pact

Sev­en months ago, Ther­mo Fish­er spent $1.7 bil­lion to add a gene ther­a­py com­pa­ny to its sprawl­ing biotech busi­ness, pur­chas­ing Bram­mer Bio. Now they’ve signed a col­lab­o­ra­tion deal with an­oth­er, new­ly well-fund­ed, com­pa­ny from the same founder to ex­pand its gene ther­a­py work in­to the mi­cro­bio­me.

Ther­mo Fish­er an­nounced a col­lab­o­ra­tion with mi­cro­bio­me prod­uct man­u­fac­tur­er Ar­ran­ta Bio as the start­up an­nounced an $82 mil­lion fund­ing round. The young CD­MO will pro­vide its live bio­phar­ma­ceu­ti­cals to Ther­mo Fish­er to use in gene ther­a­py pro­duc­tion.

Ther­mo Fish­er has en­tered the gene ther­a­py space as the field fills with biotechs who, eye­ing the clin­ic, will de­mand more of the nec­es­sary ma­te­ri­als than ex­ist­ing man­u­fac­tur­ers have the ca­pac­i­ty to pro­vide. An Oc­to­ber in­vestor re­port from Jef­feries ar­gued that go­ing for­ward, the abil­i­ty to man­u­fac­ture gene ther­a­py prod­ucts may be just as im­por­tant as per­fect­ing the sci­ence be­hind them, Bio­phar­ma Dive re­port­ed.

Mark Bam­forth

“A vast ma­jor­i­ty of com­pa­nies re­ly on con­tract man­u­fac­tur­ing or­ga­ni­za­tions to fill this role,” they wrote. “How­ev­er, with the re­cent ex­plo­sion of gene ther­a­py pro­grams, a short­age of CMOs and hu­man cap­i­tal has re­sult­ed, dri­ving many com­pa­nies to bring man­u­fac­tur­ing in-house.”

Ar­ran­ta’s CEO and founder Mark Bam­forth has a long re­la­tion­ship with Ther­mo Fish­er, sell­ing them Bram­mer this year and in 2014 sell­ing Gal­lus Bio­phar­ma­ceu­ti­cals to Patheon, now a Ther­mo Fish­er sub­sidiary.  The sole in­sti­tu­tion­al in­vestor for this fund­ing round was Am­per­sand Cap­i­tal Part­ners —where Bam­forth is al­so a part­ner. The rest came from “com­pa­ny founders and col­leagues,” along with an in­fu­sion from Ther­mo Fish­er.

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.

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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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.

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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