Mer­ck hands Sutro $60M to start on im­munomod­u­la­to­ry drug dis­cov­ery; Eli Lil­ly spin­ning out an­i­mal health group

→ Drugs that can tune the hu­man im­mune sys­tem are all the rage these days, es­pe­cial­ly at Big Phar­ma R&D groups like Mer­ck’s. And to­day the phar­ma gi­ant is spot­light­ing a deal to de­vel­op more of these drugs with the help of Sutro Bio­Phar­ma in South San Fran­cis­co. 

Mer­ck is pay­ing Sutro $60 mil­lion up­front to get start­ed on the dis­cov­ery deal, look­ing for im­munomod­u­la­to­ry drugs that can work on can­cer or au­toim­mune dis­eases — ei­ther tap­ping the gas or the brakes on an im­mune re­sponse. The deal in­cludes a hefty $1.6 bil­lion in mile­stones to keep things go­ing.

Sutro gets to han­dle the pre­clin­i­cal work in the deal, with the gi­ant Mer­ck tak­ing the best drugs in­to the clin­ic with world­wide rights.

Eli Lil­ly will spin out its an­i­mal health unit Elan­co, sell­ing a mi­nor­i­ty in­ter­est in an IPO and then di­vest­ing the rest in what it calls a “tax-ef­fi­cient trans­ac­tion.”

→ The FDA has hand­ed Apel­lis Phar­ma­ceu­ti­cals $APLS a fast track des­ig­na­tion for its ad­vanced dry AMD drug called APL-2. The med is a nov­el in­hibitor of com­ple­ment fac­tor C3 meant to treat pa­tients with ge­o­graph­ic at­ro­phy, an ad­vanced form of age-re­lat­ed mac­u­lar de­gen­er­a­tion, as a monother­a­py. Apel­lis plans to start a Phase III tri­al of the drug lat­er this year, it said in a state­ment.

→ Chi­na’s Vi­va Biotech Hold­ings has ap­plied for an IPO in Hong Kong to both fund their pur­suit of promis­ing up­starts and boost their man­u­fac­tur­ing ca­pa­bil­i­ties. The Shang­hai-based com­pa­ny is half in­cu­ba­tor and half drug dis­cov­ery busi­ness, of­fer­ing both “eq­ui­ty for ser­vice” and “cash for ser­vice” mod­els to bio­phar­mas look­ing for out­sourc­ing ser­vices. Its port­fo­lio cur­rent­ly in­cludes 21 biotech star­tups.

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.”