Polyphor par­lays a pathogen-spe­cif­ic an­tibi­ot­ic and I/O work in­to a $165M IPO for its PhI­II pro­gram

Polyphor has suc­cess­ful­ly com­plet­ed an IPO, rais­ing about $165 mil­lion to back its Phase III de­vel­op­ment of a new an­tibi­ot­ic specif­i­cal­ly de­signed to coun­ter­at­tack against Pseudomonas aerug­i­nosa along with an easy-stage shot at im­muno-on­col­o­gy.

The biotech priced an up­sized lot of shares at 38 Swiss Francs — or about $38 — for the of­fer­ing on the Swiss bourse. That makes for a fair­ly un­usu­al hit, with many Eu­ro­pean biotechs drawn to try their luck on the free­wheel­ing Nas­daq, where ear­ly-stage, high-risk biotechs have pulled off a string of suc­cess­ful rais­es.

Dubbed murepavadin (POL7080), their lead an­tibi­ot­ic had stirred some ex­cite­ment a few years ago when Roche stepped in with a deal to col­lab­o­rate with the com­pa­ny, then backed out in late 2015 say­ing that a stream­lined de­vel­op­ment path­way was no longer avail­able to the phar­ma gi­ant.

But Polyphor con­tin­ued to press for­ward, though, with help from the Well­come Trust and oth­ers. This is the first new class of an­tibi­otics to come along in 50 years, the biotech says, which they call Out­er Mem­brane Pro­tein Tar­get­ing An­tibi­otics. Its pitch to break from the usu­al brand of broad-spec­trum an­tibi­otics and de­vel­op a pathogen-spe­cif­ic rem­e­dy at a time of ris­ing drug re­sis­tance res­onat­ed in the com­mu­ni­ty. And Polyphor has been build­ing a pipeline of new prod­ucts in the process, with the Phase III fo­cused on ven­ti­la­tor-as­so­ci­at­ed bac­te­r­i­al pneu­mo­nia.

More re­cent­ly, Polyphor has al­so been at­tract­ing at­ten­tion in the boom­ing I/O field, where its drug, the an­ti-CX­CR4 drug bal­ix­afor­tide, com­bined with Halaven (eribu­lin) achieved a 38% over­all re­sponse rate.

Big Phar­ma has been a re­luc­tant play­er in an­tibi­ot­ic de­vel­op­ment for years now, put off by thin mar­gins and cheap gener­ics. De­spite the in­crease in drug re­sis­tance, the mar­ket it­self hasn’t been gen­er­ous and in­cen­tives by them­selves have not been enough to reawak­en their in­ter­est. That has left the bulk of the work to a start­up gen­er­a­tion of biotechs like Polyphor, which are ex­pect­ing to see the num­bers im­prove as the sit­u­a­tion wors­ens.

In this par­tic­u­lar case, murepavadin has the po­ten­tial to ad­dress hos­pi­tal cas­es, where the mor­tal­i­ty rate has been high and re­im­burse­ment can be as well.

Im­age: SIX Swiss Ex­change. SHUT­TER­STOCK

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.

On­ly five months af­ter a Se­ries A launch, Taysha goes pub­lic with $157M IPO

As has been the trend in 2020, Taysha Gene Therapies has become the latest biotech to make a quick ascent from a small, privately-funded company to enjoying its very own Nasdaq ticker.

The Dallas-based biotech raised $157 million for its IPO after pricing shares at $20 apiece Thursday, the high-point of its expected range. Initially pegging $100 million in financing, Taysha offered a little less than 8 million shares and will trade under the $TSHA symbol.

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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.