Polyphor bags sec­ond grant in two years for a new class of an­tibi­otics to fight drug-re­sis­tant bac­te­ria

A year af­ter re­ceiv­ing its first grant from Boston Uni­ver­si­ty’s CARB-X part­ner­ship, Swiss biotech Polyphor is back for more. It re­cent­ly bagged a sec­ond award of up to $18.44 mil­lion for work on what it calls a new class of an­tibi­otics to fight drug-re­sis­tant Gram-neg­a­tive bac­te­ria.

The grant in­cludes $2.62 mil­lion for Polyphor’s “hit-to-lead” stage and $15.82 mil­lion in mile­stones.

Polyphor calls its class of an­tibi­otics, dis­cov­ered with the Uni­ver­si­ty of Zurich, Out­er Mem­brane Pro­tein Tar­get­ing An­tibi­otics (OMP­TA). They tar­get the lipopolysac­cha­ride trans­port pro­tein A, and have shown an­timi­cro­bial ac­tiv­i­ty against drug-re­sis­tant strains of En­ter­obac­te­ri­aceae, which are among the WHO’s pri­or­i­ty-1 pathogens, ac­cord­ing to Polyphor.

But the jour­ney hasn’t been easy. News of the grant comes just over a year af­ter the biotech halt­ed en­roll­ment in a piv­otal tri­al of its an­tibi­ot­ic murepavadin for noso­co­mi­al pneu­mo­nia due to high rates of acute kid­ney in­jury. Shares dropped 20% to just over $10 apiece when the halt was an­nounced.

Now the com­pa­ny is de­vel­op­ing murepavadin to fight a type of Gram-neg­a­tive bac­te­ria called Pseudomonas in cys­tic fi­bro­sis pa­tients. Its lead drug, a CX­CR4 in­hibitor called bal­ix­afor­tide, is cur­rent­ly in Phase III for metasta­t­ic breast can­cer in com­bi­na­tion with eribu­lin. In Sep­tem­ber, Fo­s­un Phar­ma­ceu­ti­cals paid Polyphor $15 mil­lion up­front for rights to de­vel­op and com­mer­cial­ize bal­ix­afor­tide for the Chi­nese mar­ket.

“Se­ri­ous in­fec­tions are a glob­al health threat, due in part to the emer­gence of drug-re­sis­tant bac­te­ria for which we do not have ther­a­pies,” CARB-X R&D chief Erin Duffy said in a state­ment. “Polyphor’s project en­rich­es the pool of nov­el ap­proach­es to de­liv­er a ther­a­peu­tic that can treat in­fec­tions caused by mul­tidrug-re­sis­tant Gram-neg­a­tive pathogens for which we have few op­tions.”

Gokham Batur

CARB-X is a glob­al part­ner­ship look­ing to spur the de­vel­op­ment of new an­tibac­te­r­i­al drugs. De­spite in­creas­es in re­sis­tance to cur­rent an­tibi­otics, Big Phar­ma has re­treat­ed from the risky field, fraught with cheap gener­ics and poor fi­nan­cial re­turns.

“Nev­er has the threat of an­timi­cro­bial re­sis­tance been more im­me­di­ate and the need for so­lu­tions more ur­gent,” Tedros Ad­hanom Ghe­breye­sus, WHO di­rec­tor-gen­er­al, said in a state­ment back in Jan­u­ary.

“This award pro­vides fur­ther sup­port to our re­search ef­forts in pro­gress­ing a new class of an­tibi­otics to com­bat an­timi­cro­bial re­sis­tance, one of the great­est glob­al chal­lenges for health­care,” Polyphor CEO Gokhan Batur said.

Charles Baum, Mirati CEO

Mi­rati plots a march to the FDA for its KRAS G12C drug, breath­ing down Am­gen’s neck with bet­ter da­ta

Mirati Therapeutics $MRTX took another closely-watched step toward a now clearly defined goal to file for an approval for its KRAS G12C cancer drug adagrasib (MRTX849), scoring a higher response rate than the last readout from the class-leading rival at Amgen but still leaving open a raft of important questions about its future.

Following a snapshot of the first handful of responses, where the drug scored a tumor response in 3 of 5 patients with non-small cell lung cancer, the response rate has now slid to 45% among a pooled group of 51 early-stage and Phase II patients, 43% — 6 of 14 — when looking solely at the Phase I/Ib. Those 14 patients had a median treatment duration of 8.2 months, with half still on therapy and 5 of 6 responders still in response.

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In his­toric Covid-19 ad­comm, vac­cine ex­perts de­bate a sea of ques­tions — but of­fer no clear an­swers

The most widely anticipated and perhaps most widely watched meeting in the FDA’s 113-year history ended late Thursday night with a score of questions and very few answers.

For nearly 9 hours, 18 different outside experts listened to public health agencies and foundations present how the United States’ Covid-19 vaccine program developed through October, and they debated where it should go from there: Were companies testing the right metrics in their massive trials? How long should they track patients before declaring a vaccine safe or effective? Should a vaccine, once authorized, be given to the volunteers in the placebo arm of a trial?

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Michel Vounatsos, Biogen CEO (via YouTube)

Bio­gen spot­lights a pair of painful pipeline set­backs as ad­u­canum­ab show­down looms at the FDA

Biogen has flagged a pair of setbacks in the pipeline, spotlighting the final failure for a one-time top MS prospect while scrapping a gene therapy for SMA after the IND was put on hold due to toxicity.

Both failures will raise the stakes even higher on aducanumab, the Alzheimer’s drug that Biogen is betting the ranch on, determined to pursue an FDA OK despite significant skepticism they can make it with mixed results and a reliance on post hoc data mining. And the failures are being reported as Biogen was forced to cut its profit forecast for 2020 as a generic rival started to erode their big franchise drug.

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Stephen Hahn, FDA commissioner (AP Images)

As FDA sets the stage for the first Covid-19 vac­cine EUAs, some big play­ers are ask­ing for a tweak of the guide­lines

Setting the stage for an extraordinary one-day meeting of the Vaccines and Related Biological Products Advisory Committee this Thursday, the FDA has cleared 2 experts of financial conflicts to help beef up the committee. And regulators went on to specify the safety, efficacy and CMC input they’re looking for on EUAs, before they move on to the full BLA approval process.

All of this has already been spelled out to the developers. But the devil is in the details, and it’s clear from the first round of posted responses that some of the top players — including J&J and Pfizer — would like some adjustments and added feedback. And on Thursday, the experts can offer their own thoughts on shaping the first OKs.

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Bo Cumbo, AavantiBio CEO (file photo)

Bo Cum­bo jumps from the top com­mer­cial post at Sarep­ta to the helm of a gene ther­a­py start­up with some in­flu­en­tial back­ers, big plans and $107M

After a 7-year stretch building the commercial team at Sarepta, longtime drug salesman Bo Cumbo is jumping to the entrepreneurial side of the business, taking the helm of a startup that’s got several deep-pocket investors. And he’s not just bringing his experience in selling drugs.

He tells me that when he told Sarepta CEO Doug Ingram about it, his boss got excited about the venture and opted to jump in with a $15 million investment from Sarepta to add to the launch money, alongside 3 of the busiest investors in biotech.

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Pascal Soriot, AstraZeneca CEO (Zach Gibson/Bloomberg via Getty Images)

UP­DAT­ED: FDA gives As­traZeneca the thumbs-up to restart PhI­II Covid-19 vac­cine tri­als, and J&J is prepar­ing to re­sume its study

Several countries had restarted their portions of AstraZeneca’s global Phase III Covid-19 vaccine trial after the study was paused worldwide in early September, but the US notably stayed on the sidelines — until now. Friday afternoon the pharma giant announced the all clear from US regulators. And on top of that, J&J announced Friday evening that it’s preparing to resume its own Phase III vaccine trial.

Ul­tragenyx in­jects $40M to grab Solid's mi­crody­s­trophin trans­gene — while side­step­ping the AAV9 vec­tor that stirred up safe­ty fears

Since before Ilan Ganot started Solid Bio to develop a gene therapy for kids like his son, who has Duchenne muscular dystrophy, Ultragenyx CEO Emil Kakkis has been watching and advising the former investment banker as he navigated the deep waters of drug development.

Just as Solid is getting back up on its feet after a yearlong clinical hold, Kakkis has decided to jump in for a formal alliance.

With a $40 million upfront, Ultragenyx is grabbing 14.45% of Solid’s shares $SLDB and the rights to its microdystrophin construct for use in combination with AAV8 vectors. Solid’s lead program, which utilizes AAV9, remains unaffected. The company also retains rights to other applications of its transgene.

A top drug pro­gram at Bay­er clears a high bar for CKD — open­ing the door to an FDA pitch

Over the past 4 years, Bayer has been steering a major trial through a pivotal program to see if their drug finerenone could slow down the pace of chronic kidney disease in patients suffering from both CKD as well as Type 2 diabetes.

Today, their team jumped on a virtual meeting hosted by the American Society of Nephrology to offer a solid set of pivotal data to demonstrate that the drug can delay dialysis or a kidney replacement as well as cardio disease, while also adding some worrying signs of hyperkalemia among the patients taking the drug. And they’re hustling it straight to regulators in search of an approval for kidney disease and cardio patients — one of the toughest challenges in the book, as demonstrated by repeated past failures.

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Adam Koppel and Jeffrey Schwartz, Bain

Bain ex­ecs Adam Kop­pel and Jef­frey Schwartz line up $125M for their first blank check deal as Wall Street con­tin­ues to em­brace biotech

Adam Koppel and Jeffrey Schwartz have jumped into the blank check game, raising $125 million for a stock listing in search of a company.

Their SPAC, BCLS Acquisition Corp, raised $125 million this week, with a line on $25 million more as it scouts for a biotech in search of money and a place on Wall Street.

The two principals at Bain Life Sciences have been on a romp since they set up the Bain operation 4 years ago. Their S-1 spells out a track record of 22 deals totaling $650 million for the life sciences group, which led to 9 IPOs.