As­traZeneca lines up a $20M in­stall­ment plan to launch a new on­col­o­gy col­lab­o­ra­tion with mi­cro­bio­me play­er Seres

As­traZeneca has set up a re­search deal with Seres Ther­a­peu­tics, agree­ing to pay the biotech $20 mil­lion in in­stall­ment pay­ments for their col­lab­o­ra­tion on ex­plor­ing how the gut can in­flu­ence the ef­fi­ca­cy of im­muno-on­col­o­gy drugs like their PD-L1 Imfinzi.

Er­ic Shaff, CEO (Seres)

The phar­ma gi­ant — which hasn’t been do­ing a lot of ear­ly-stage re­search col­lab­o­ra­tions like this — is al­so hand­ing over some re­search sub­si­dies to cov­er the cost of the work at the Cam­bridge, MA-based biotech $MCRB.

In­vestors liked the sound of that, dri­ving up Seres’ shares — still suf­fer­ing since a ma­jor clin­i­cal set­back close to 3 years ago — by 25% by the bell. Seres’ new CEO just ex­e­cut­ed a sig­nif­i­cant re­or­ga­ni­za­tion, lay­ing off the CSO and 30% of the staff.

Med­Im­mune vet Jean-Charles So­ria, who now re­ports to As­traZeneca on­col­o­gy chief Jose Basel­ga in the new­ly re­vamped R&D or­ga­ni­za­tion, says I/O re­search is still on­ly fo­cused on “the tip of the ice­berg.” Af­ter the ini­tial wave of 6 PD-1/L1 drugs hit the mar­ket, the lead­ers in the field have been scram­bling to find ways to gain a leg up on the com­pe­ti­tion. And there have been a num­ber of new for­ays us­ing the mi­cro­bio­me in search of en­hanced im­mune re­spons­es to can­cer.

Jean-Charles So­ria (As­traZeneca)

In ad­di­tion to look­ing for new ways to iden­ti­fy which pa­tients are most like­ly to re­spond, com­ing up with a more com­pelling pa­tient pro­file, the part­ners al­so plan to ex­plore the po­ten­tial of com­bos, pos­si­bly us­ing Seres SER-401 along with As­traZeneca’s I/O drugs.

As­traZeneca had been a late­com­er to the check­point par­ty, hop­ing that a matchup of Imfinzi with their CT­LA-4 drug treme­li­mum­ab would pro­vide a way to leapfrog the lead­ers. That hasn’t worked so far, but As­traZeneca has made im­por­tant in­roads in the mar­ket with Imfin­za as a monother­a­py. That’s what they’re hop­ing to build on now.

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

FDA chief Stephen Hahn on Capitol Hill earlier this week (Getty Images)

As FDA buck­les un­der the strain of a pan­dem­ic work­load, Trump again ac­cus­es the agency of a po­lit­i­cal hit job

Peter Marks appeared before a virtual SVB Leerink audience yesterday and said that his staff at FDA’s CBER is on the verge of working around the clock. Manufacturing inspections, policy work and sponsor communications have all been pushed down the to-do list so that they can be responsive to Covid-related interactions. And the agency’s objective right now? “To save as many lives as we can,” Marks said, likening the mortality on the current outbreak as equivalent to “a nuclear bomb on a small city.”

Daniel O'Day, Gilead CEO (Kevin Dietsch/UPI/Bloomberg via Getty Images)

Play-by-play of Gilead­'s $21B Im­munomedics buy­out de­tails a fren­zied push — and mints a new biotech bil­lion­aire

Immunomedics had not really been looking for a buyout when the year began. Excited by its BLA for Trodelvy, submitted to the FDA in late 2019, executive chairman Behzad Aghazadeh started off looking for potential licensing deals and zeroed in on four potential partners, including Gilead, following January’s JP Morgan Healthcare Conference in San Francisco. Such talks advanced throughout the year, with discussions advancing to the second round in mid-August.

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President Donald Trump reacts after signing an executive order following his remarks on his healthcare policies yesterday in Charlotte, North Carolina (Getty Images)

Op-ed: Will phar­ma re­al­ly pay for Trump’s lat­est law­less promise to 33 mil­lion Medicare ben­e­fi­cia­ries? Not like­ly

Sitting atop the executive branch, President Donald Trump is the ultimate authority at the FDA. He can fast track any vaccine to approval himself. If it came to that, of course.

What he can’t do is unilaterally order the legislative branch to loosen the Treasury’s coffers for $6.6 billion. Nor can he command pharmaceutical companies to pay for $200 vouchers sent to 33 million Medicare beneficiaries for prescription drugs before the election.

President Donald Trump and FDA Commissioner Stephen Hahn (AP Images)

FDA is­sues fi­nal rule al­low­ing im­por­ta­tion of drugs from Cana­da — but al­so keeps the pow­er to re­voke it

Just over a month away from the presidential election, the FDA has issued a final regulation fulfilling President Trump’s promise to let states import certain prescription drugs from Canada.

On Thursday, Trump told a crowd in North Carolina that the new rule goes into effect “today.” But the published regulation states that it won’t take effect for 60 days. And even then, it could be a while before cheaper drugs make it across the border.

The win­dow is wide open as four more biotechs join the go-go IPO class of 2020

It’s another day of hauling cash in the biopharma world as four more IPOs priced Friday and a fifth filed its initial paperwork.

The biggest offering comes from PMV Pharma, an oncology biotech focusing on p53 mutations, which raised $211.8 million after pricing shares at $18 apiece. Prelude Therapeutics, developing PRMT5 inhibitors for rare cancers, was next with a $158 million raise, pricing shares at $19 each. Graybug Vision raised $90 million after pricing at $16 per share for its wet AMD candidates, and breast cancer biotech Greenwich Lifesciences brought up the rear with a small, $7 million raise after pricing shares at $5.75.

J&J of­fers PhI/IIa da­ta show­ing its sin­gle-dose vac­cine can stir up suf­fi­cient im­mune re­sponse

Days after J&J dosed the first participants of its Phase III ENSEMBLE trial, the pharma giant has detailed the early-stage data that gave them confidence in a single-dose regimen.

Testing two dose levels either as a single dose or in a two-dose schedule spaced by 56 days in, the scientists from Janssen, the J&J subsidiary developing its vaccine, reported that the low dose induced a similar immune response as the high dose. The interim Phase I/IIa results were posted in a preprint on medRxiv.

Sil­ver­back dish­es out two pro­mo­tions in C-suite; Leg­end CEO post changes hands again

→ Accompanying the news that they just scored an $85 million Series C round, Laura Shawver-led Silverback Therapeutics has promoted two execs, with Valerie Odegard adding president to her CSO duties and Naomi Hunder moving to CMO. A Novo Nordisk alum, Odegard has been with the Seattle-based biotech since 2016 and the CSO the last 2 years. Before Silverback, she was VP of research at Juno Therapeutics.

Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

Covid-19 roundup: Mon­cef Slaoui says 'e­nough' af­ter War­ren calls for his fir­ing; Sci­en­tists spot­light role of in­ter­fer­ons in se­vere dis­ease

Operation Warp Speed chief Moncef Slaoui said he’s had it with accusations about conflicts of interests due to his industry ties, after Sen. Elizabeth Warren (D-MA) called for his firing in a Wednesday hearing.

Since taking on the role to spur ultra-fast development of a Covid-19 vaccine months ago, Slaoui — the former head of vaccine at GlaxoSmithKline and a partner at Medicxi — and his industry ties have come under intense scrutiny. He’s called the media coverage “insulting” and “deeply painful.”

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