Thiel-backed Az­i­tra rais­es $3M for skin mi­cro­bio­me R&D; Crushed by clin­i­cal fail­ure, Avi­ra­gen launch­es strate­gic re­view

Travis Whit­fill

→  Farm­ing­ton, CT-based Az­i­tra has raised close to $3 mil­lion in a Se­ries A de­signed to fu­el its re­search on mi­cro­bio­me ther­a­pies for the skin. Seed­ed by Pe­ter Thiel’s Break­out Labs, the com­pa­ny iden­ti­fied a strain of bac­te­ria that can be used in lo­tions to treat con­di­tions like eczema and staph in­fec­tions. Bios Part­ners led the round. “The cur­rent ap­proach of on­ly ad­dress­ing a dis­ease’s symp­toms alone is in­ef­fec­tive, and the mi­cro­bio­me is a nascent area of ground­break­ing sci­ence that has enor­mous po­ten­tial,” said Az­i­tra co-founder Travis Whit­fill. “That’s why we were pas­sion­ate about launch­ing a com­mer­cial or­ga­ni­za­tion that har­ness­es the pow­er of the skin’s own mi­cro­bio­me to de­vel­op a new kind of der­ma­tol­ogy treat­ment. Such treat­ments are po­ten­tial­ly safer, more high­ly tar­get­ed, and work bet­ter with few­er side ef­fects than what’s cur­rent­ly avail­able for of­ten in­tractable con­di­tions.”

→ Cam­bridge, MA-based Sen­tien Biotech­nolo­gies closed a $12 mil­lion Se­ries A in­vest­ment round. The fi­nanc­ing was co-led by Boehringer In­gel­heim Ven­ture Fund USA and BioIn­no­va­tion Cap­i­tal, and joined by Chiesi Ven­tures, MBL Ven­ture Cap­i­tal and Mass Med­ical An­gels. The Se­ries A round will be used to fund ini­tial clin­i­cal de­vel­op­ment of Sen­tien’s SBI-101 for the treat­ment of acute kid­ney in­jury.

→ At­lanta-based Avi­ra­gen has be­gun a strate­gic re­view af­ter a clin­i­cal fail­ure left the biotech mired in pen­ny stock ter­ri­to­ry. In back-to-back set­backs, Avi­ra­gen Ther­a­peu­tics $AVIR said that its lead drug vapen­davir flunked a Phase IIb in mod­er­ate to se­vere asth­mat­ics with a rhi­novirus in­fec­tion. Every­thing is on the ta­ble, in­clud­ing a merg­er, in-li­cens­ing and an ac­qui­si­tion.

→ A new bill pro­vid­ing tax cred­its for con­tract re­search has been filed in the House of Rep­re­sen­ta­tives. The leg­is­la­tion, if ever passed, would ben­e­fit CROs.

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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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.

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.

New York governor Andrew Cuomo (AP Images)

An­drew Cuo­mo says New York will un­der­take its own vac­cine re­view process, and wouldn’t rec­om­mend trust­ing the fed­er­al gov­ern­ment

The concerns keep mounting over President Donald Trump’s politicization of the FDA and other federal agencies guiding the development of a safe and effective vaccine. And today, the telegenic New York governor Andrew Cuomo appeared to introduce even more politics into the matter — latest in an ongoing series of incidents that have cast the proudly independent FDA in starkly political terms.

During his daily press conference Cuomo said that the state will review any coronavirus vaccines approved by the federal government, citing a lack of trust in the Trump administration. The announcement comes one day after Trump accused the FDA of making an “extremely political” move in proposing stricter vaccine guidance.

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.

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.