News brief­ing: Top FDA of­fi­cial ex­its; Sun Ge­nomics clos­es $9.25M Se­ries A

Low­ell Schiller

The FDA’s prin­ci­pal as­so­ciate com­mis­sion­er for pol­i­cy, Low­ell Schiller, has left the agency, ac­cord­ing to a Politi­co re­port.

Schiller was hired by for­mer com­mis­sion­er Scott Got­tlieb in 2017, and pre­vi­ous­ly served as act­ing chief coun­sel. Ac­cord­ing to Politi­co, Schiller’s deputy Lau­ren Roth will step in as act­ing head of the pol­i­cy of­fice.

The news comes just weeks af­ter FDA com­mis­sion­er Stephen Hahn oust­ed the agency’s new­ly-hired chief spokesper­son, Emi­ly Miller. The One Amer­i­ca News vet was at the FDA 11 days be­fore los­ing her po­si­tion. That an­nounce­ment fol­lowed a week of con­tro­ver­sy for Hahn over mis­lead­ing com­ments about the ef­fi­ca­cy of con­va­les­cent plas­ma as a Covid-19 treat­ment.

NYU bioethi­cist Art Ca­plan, who had been crit­i­cal of the de­ci­sion to au­tho­rize plas­ma, spoke with End­points last month about con­cerns of po­lit­i­cal med­dling at the FDA.

“Well look, let­ting go peo­ple who got caught up in con­tro­ver­sy shows noth­ing about what’s next,” Ca­plan said. “These are heav­i­ly tilt­ed right-wing ap­point­ments. I ex­pect to see more of the same. The pres­i­dent wants it.” — Nicole De­Feud­is 

Sun Ge­nomics clos­es $9.25 mil­lion Se­ries A

Sun Ge­nomics, a cus­tom pro­bi­otics and gut health start­up, closed a Se­ries A fi­nanc­ing Wednes­day worth $9.25 mil­lion. Fund­ing will be used for scal­ing up the com­pa­ny’s de­liv­ery ser­vices and help­ing pub­lish re­search stud­ies as it pre­pares to en­ter in­ter­na­tion­al mar­kets.

The round was led by Pan­gaea Ven­tures with new in­vest­ments from Ori­on Fund, Danone Man­i­festo Ven­tures, SOSV, Hu­man Longevi­ty, and Nasci­ta Ven­tures.

Sun Ge­nomics was found­ed in 2016 with the re­lease of its Floré prod­uct, a mi­cro­bio­me test and gut pro­bi­otics so­lu­tion that uti­lizes genome se­quenc­ing to eval­u­ate dif­fer­ent di­ges­tive sys­tem da­ta points. The com­pa­ny then us­es that da­ta to send cus­tomers a per­son­al­ized prod­uct based on their gut pro­files.

More re­cent­ly, Sun Ge­nomics launched Floré De­fense in Ju­ly, a for­mu­la prod­uct aimed at boost­ing im­mu­ni­ty and res­pi­ra­to­ry health. — Max Gel­man

In­hibikase an­nounces terms for $25 mil­lion IPO

In­hibikase Ther­a­peu­tics is look­ing to raise $25 mil­lion in an IPO to de­vel­op its pipeline of ki­nase in­hibitors. And to do so, the Geor­gia-based com­pa­ny plans to of­fer 2.3 mil­lion shares at a range of $10 to $12.

The pre­clin­i­cal biotech has filed two INDs for its lead can­di­date, IkT-148009 — one of which is for the treat­ment of Parkin­son’s dis­ease-re­lat­ed gas­troin­testi­nal com­pli­ca­tions. It plans to dose the first pa­tients with the c-Abl pro­tein ki­nase in­hibitor af­ter the of­fer clos­es.

The com­pa­ny will list un­der the sym­bol $IKT. — Nicole De­Feud­is 

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.

President Donald Trump (via AP Images)

Signs of an 'Oc­to­ber Vac­cine Sur­prise' alarm ca­reer sci­en­tists

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.

News brief­ing: Bausch Health clos­ing in on deal to ac­quire Al­le­gro as­sets; PharmAbcine strikes deal with Sam­sung Bi­o­log­ics to de­vel­op an­ti­body pro­gram

Bausch Health is closing in on a deal that would allow it to buy out all of Allegro Ophthalmics’ eye-related assets — including the rights to lead candidate risuteganib — for $50 million.

The payment would be made in two tranches: $10 million at signing, and $40 million in 2021.

Risuteganib is in clinical development for intermediate dry Age-related Macular Degeneration (AMD). It’s expected to enter two concurrent Phase III trials for that indication in the next year. The drug is also being tested in patients with diabetic macular edema (DME), and last year met the primary endpoint in a Phase II study, with 48% of patients gaining 8 or more letters in visual acuity from baseline at week 28, compared to 7% in the control group at week 12.

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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Roche vaults to the front of the NL­RP3 clin­i­cal race, pay­ing $448M up­front to bag In­fla­zome

Roche is going all in on NLRP3.

The pharma giant is putting down $448 million (€380 million) upfront to snatch Novartis-backed Inflazome, which makes it a clinical player in the space overnight.

Dublin and Cambridge, UK-based Inflazome is the second NLRP3-focused biotech Roche has acquired in less than two years, and although no numbers were disclosed in the Jecure buyout, this is almost certainly a much larger deal.

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Anthony Fauci (AP Images)

A press of­fi­cer at An­tho­ny Fau­ci’s NI­AID was un­masked as a hard-right Covid troll. He just re­tired to­day

William B Crews had been a public affairs specialist at the NIH’s National Institute of Allergy and Infectious Diseases.

That ended today when he informed the agency of his decision to retire, after he was identified as the managing editor at RedState, a prominent Trump loyalist website.

Crews’ RedState duties are performed under the alias streiff. While enjoying the benefits of pseudonymity, he disparaged and worked against NIAID with an incendiary level of rhetoric in the midst of a pandemic.

#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.

Donald Trump, AP

Covid-19 roundup: Trump sug­gests Pfiz­er vac­cine could be first ap­proved; VBI Vac­cines inks de­vel­op­ment deal with Cana­da

President Donald Trump commented Monday morning that Pfizer’s Covid-19 vaccine candidate could be the first to win approval by regulators.

During an interview on a Fox News’ morning show, the president said Pfizer was doing “very well” when asked which candidate could be approved, according to a Reuters report. He added that J&J could follow up afterward, saying “they’ll probably be a little later.”