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.

Qual­i­ty Con­trol in Cell and Gene Ther­a­py – What’s Re­al­ly at Stake?

In early 2021, Bluebird Bio was forced to suspend clinical trials of its gene therapy for sickle cell disease after two patients in the trial developed cancer. As company scientists rushed to assess whether there was any causal link between the therapy and the cancer cases, Bluebird’s stock value plummeted – as did those of multiple other biopharma companies developing similar therapies.

While investigations concluded that the gene therapy was unlikely to have caused cancer, investors and the public may be more skittish regarding the safety of gene and cell therapies after this episode. This recent example highlights how delicate the fields of cell and gene therapy remain today, even as they show great promise.

Brad Bolzon (Versant)

Ver­sant pulls the wraps off of near­ly $1B in 3 new funds out to build the next fleet of biotech star­tups. And this new gen­er­a­tion is built for speed

Brad Bolzon has an apology to offer by way of introducing a set of 3 new funds that together pack a $950 million wallop in new biotech creation and growth.

“I want to apologize,” says the Versant chairman and managing partner, laughing a little in the intro, “that we don’t have anything fancy or flashy to tell you about our new fund. Same team, around the same amount of capital, same investment strategy. If it ain’t broke, don’t fix it.”

But then there’s the flip side, where everything has changed. Or at least speeded into a relative blur. Here’s Bolzon:

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Law pro­fes­sors call for FDA to dis­close all safe­ty and ef­fi­ca­cy da­ta for drugs

Back in early 2018 when Scott Gottlieb led the FDA, there was a moment when the agency seemed poised to release redacted complete response letters and other previously undisclosed data. But that initiative never gained steam.

Now, a growing chorus of researchers are finding that a dearth of public data on clinical trials and pharmaceuticals means industry and the FDA cannot be held accountable, two law professors from Yale and New York University write in an article published Wednesday in the California Law Review.

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Steffen Schuster, ITM CEO

Ra­dio­phar­ma re­mains hot as Ger­many's ITM rais­es $109M to ad­vance neu­roen­docrine can­cer pro­gram

The world of radiopharmaceuticals has been heating up over the last few years, and Thursday saw another company focused on the field pull in a new nine-figure raise.

Germany’s ITM, or Isotopen Technologien München, scored a $109 million round of loan financing to push forward its precision oncology pipeline and fund late-stage development for its lead program. As part of the agreement, the loan will convert to shares in the event of future financial or corporate transactions, ITM said.

Jenny Rooke (Genoa Ventures)

Ear­ly Zymer­gen in­vestor Jen­ny Rooke re­flects on 'chimeras' in biotech, what it takes to spot a $500M gem

When Jenny Rooke first heard of Zymergen back in 2014, she knew she was looking at something different and exciting. The Emeryville, CA biotech held the promise of blending biology and technology to solve a huge unmet need for cost-effective chemicals — of all things — and a stellar founding team to boot.

But back then, West Coast venture capitalists didn’t see in Zymergen the one thing they were looking for in a winning biotech: therapeutic potential. Rooke, however, saw an opportunity and made her bets. Seven years later, that bet is paying off in a big way.

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Saurabh Saha at Endpoints News' #BIO19

On the heels of $250M launch, Centes­sa barges ahead with an IPO to fu­el its 10-in-1 Medicxi pipeline

Francesco De Rubertis made no secret of IPO plans for Centessa, his 10-in-1 legacy play. Barely two months later, the S-1 is in.

The hot-off-the-press filing depicts the same grand vision that the longtime VC touted when he did the rounds in February: Take the asset-centric mindset that he’s been preaching at Medicxi over the years, and roll up a bunch of biotech upstarts, with unrelated risk profiles, into 1 pharma company that can carry on the development at scale.

Novavax CEO Stanley Erck at the White House in 2020 (Andrew Harnik, AP Images)

As fears mount over J&J and As­traZeneca, No­vavax en­ters a shaky spot­light

As concerns rise around the J&J and AstraZeneca vaccines, global attention is increasingly turning to the little, 33-year-old, productless, bankruptcy-flirting biotech that could: Novavax.

In the now 16-month race to develop and deploy Covid-19 vaccines, Novavax has at times seemed like the pandemic’s most unsuspecting frontrunner and at times like an overhyped also-ran. Although they started the pandemic with only enough cash to last 6 months, they leveraged old connections and believers into $2 billion and emerged last summer with data experts said surpassed Pfizer and Moderna. They unveiled plans to quickly scale to 2 billion doses. Then they couldn’t even make enough material to run their US trial and watched four other companies beat them to the finish line.

FDA of­fers scathing re­view of Emer­gent plan­t's san­i­tary con­di­tions, em­ploy­ee train­ing af­ter halt­ing pro­duc­tion

The FDA wrapped up its inspection of Emergent’s troubled vaccine manufacturing plant in Baltimore on Tuesday, after halting production there on Monday. By Wednesday morning, the agency already released a series of scathing observations on the cross contamination, sanitary issues and lack of staff training that caused the contract manufacturer to dispose of millions of AstraZeneca and J&J vaccine doses.

Bay­er plots a ma­jor facelift at Berke­ley cam­pus, un­cork­ing a 30-year, $1.2B plan to dri­ve cell and gene ther­a­pies

Bayer first set roots in Berkeley back in 1974, when it was still operating as Miles Labs. The site has pumped out three hemophilia A treatments for distribution worldwide; but now, as the pharma continues its cell and gene therapy push, it has something bigger in mind.

Bayer is planning a 30-year revamp at the campus, which includes 918,000 square feet in new buildings and double the jobs, according to a report by the Bay Area Council Economic Institute.