News brief­ing: Lo­cus Bio­sciences bags up to $12.1M for CRISPR an­tibac­te­r­i­al; Old Ver­tex drug heads to PhI­II for de­men­tia

In its lat­est ef­fort to spur the de­vel­op­ment of new an­tibac­te­r­i­al drugs, the non-prof­it CARB-X is award­ing Lo­cus Bio­sciences up to $12.1 mil­lion for its CRISPR Cas-3-en­hanced bac­te­rio­phage for se­ri­ous re­cur­ring uri­nary tract in­fec­tions (rUTIs).

The Mor­risville, NC-based biotech will re­ceive up to $2.05 mil­lion ini­tial­ly, fol­lowed by up to $10 mil­lion more if it meets cer­tain mile­stones. Its can­di­date, LBP-KP01, tar­gets Kleb­siel­la pneu­mo­ni­ae, a com­mon cause of an­tibi­ot­ic-re­sis­tant in­fec­tions like rUTIs. The CARB-X funds will sup­port pre­clin­i­cal de­vel­op­ment, po­ten­tial­ly lead­ing up to Phase I.

Paul Garo­fo­lo

“This fund­ing is an­oth­er im­por­tant val­i­da­tion of Lo­cus’ rapid de­vel­op­ment of in­no­v­a­tive CRISPR-Cas3 en­hanced bac­te­rio­phage prod­ucts, en­abling Lo­cus to ad­vance a ro­bust pipeline that in­cludes prod­ucts tar­get­ing four of the most com­mon bac­te­r­i­al pathogens as well as prod­ucts tar­get­ing mi­cro­bio­me-re­lat­ed dis­or­ders such as in­flam­ma­to­ry bow­el dis­ease, phar­ma­ceu­ti­cal re­sponse to im­mune-on­col­o­gy ther­a­pies, in­fec­tions as­so­ci­at­ed with im­mune check­point in­hibitors and col­orec­tal can­cer,” Lo­cus CEO Paul Garo­fo­lo said in a state­ment.

Erin Duffy

LBP-KP01 is a bac­te­rio­phage cock­tail, en­gi­neered with a CRISPR-Cas3 con­struct. The ap­proach “has the po­ten­tial to kill with laser-sharp pre­ci­sion the bac­te­ria caus­ing an in­fec­tion with­out caus­ing dam­age to oth­er cells,” CARB-X R&D chief Erin Duffy said in a state­ment.

Back in Sep­tem­ber, BAR­DA promised Lo­cus up to $77 mil­lion for its LBP-EC01 pro­gram, in­tend­ed to treat re­cur­rent UTIs caused by E. coli. The award start­ed with $11 mil­lion and ex­tends 5 years. If ap­proved, the E. coli and K. pneu­mo­ni­ae cock­tails could treat more than 90% of UTIs, ac­cord­ing to CARB-X.

CARB-X is a glob­al non-prof­it part­ner­ship led by Boston Uni­ver­si­ty to sup­port the de­vel­op­ment of prod­ucts that tar­get an­tibi­ot­ic-re­sis­tant bac­te­r­i­al in­fec­tions. Since 2016, it’s giv­en out 72 awards to­tal­ing $257 mil­lion, with the po­ten­tial for more funds if mile­stones are met. It plans on pour­ing up to $480 mil­lion to­tal in non-di­lu­tive fund­ing in­to an­tibac­te­r­i­al de­vel­op­ment by 2022. — Nicole Feud­is

An old Ver­tex drug heads to Phase III for de­men­tia

EIP Phar­ma has re­port­ed new pos­i­tive da­ta for an old Ver­tex drug and hopes to send it in­to Phase III next year.

The com­pa­ny was eval­u­at­ing ne­flamapi­mod, a p38 ki­nase in­hibitor in-li­censed from Ver­tex in 2014, in a Phase II study for Lewy body de­men­tia. The study met its pri­ma­ry end­point, with pa­tients on the drug show­ing a greater im­prove­ment in cog­ni­tion than pa­tients on place­bo, per an at­ten­tion and ex­ec­u­tive func­tion as­sess­ment.

EIP said the treat­ment ef­fect emerged by the fourth week and main­tained lev­els through the 16-week study pe­ri­od. The p-val­ue on the pri­ma­ry end­point was 0.015.

There were no se­ri­ous drug-re­lat­ed side ef­fects. The study it­self en­rolled 91 pa­tients and ran­dom­ized them even­ly in­to the drug arm and place­bo arm. – Max Gel­man

Ver­ri­ca her­alds suc­cess in gen­i­tal warts

The FDA just re­buffed Ver­ri­ca’s bid for their first ap­proved drug, hand­ing them a CRL for a drug/de­vice top­i­cal treat­ment known as VP-102 in mol­lus­cum con­ta­gio­sum. But the com­pa­ny is try­ing to ex­pand the drug’s po­ten­tial for when­ev­er they can get it across the fin­ish line.

On Tues­day, they an­nounced the drug had cleared an 87-per­son Phase II for ex­ter­nal gen­i­tal warts. In the study, 35% of pa­tients on the drug saw their warts clear, com­pared with 2% of pa­tients who re­ceived the place­bo (tech­ni­cal­ly known as a “ve­hi­cle” in der­ma­to­log­i­cal stud­ies).

With a Phase III in com­mon warts al­ready sched­uled, that sets up Ver­ri­ca to have VP-102 in late stage for three in­di­ca­tions. Still, they will have to deal with the is­sues they say the FDA flagged in the CRL, in­clud­ing hu­man fac­tors study and CMC is­sues. — Ja­son Mast

Is­raeli life sci­ences fund rais­es new $300 mil­lion round

Pere­grine Ven­tures, an Is­raeli life sci­ences fund, an­nounced to­day that it had se­cured a new $300 mil­lion round, more than triple the size of its pre­vi­ous pot.

The firm fo­cus­es on $20-$30 mil­lion in com­pa­nies ei­ther near­ing an M&A or an IPO. Much of their fo­cus so far has been on med tech and health tech, but they’ve had sev­er­al biotech place­ments and plan to con­tin­ue those with the newest fund. That in­cludes in­vest­ments in Ot­ic Phar­ma (now known as Novus) and Ra­ziel Ther­a­peu­tics.

“With the re­newed fo­cus on biotech, health, and life sci­ence in the wake of the Covid-19 cri­sis, the po­ten­tial of Pere­grine Growth is great,” co-founder and man­ag­ing part­ner Eyal Lif­schitz said in a state­ment. – Ja­son Mast

In­side Track: Be­hind the Scenes of a Ma­jor Biotech SPAC

Dr. David Hung and Michelle Doig are no strangers to the SPAC phenomenon. As Founder and CEO of Nuvation Bio, a biotech company tackling some of the greatest unmet needs in oncology, Dr. Hung recently took the company public in one of this year’s biggest SPAC related deals. And as Partner at Omega Funds, Doig not only led and syndicated Nuvation Bio’s Series A, but is now also President of the newly formed, Omega-sponsored, Omega Alpha SPAC (Nasdaq: OMEG; oversubscribed $138m IPO priced January 6, 2021).

Aduhelm OK 'bit­ter­sweet' for ALS ad­vo­cates; Con­trast­ing Covid-19 vac­cine read­outs; GSK joins TIG­IT bat­tle; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

With the busiest days of June now behind us, we’re starting to think seriously about the second half of the year. In August, we have scheduled a special report where Endpoints will compile a list of the 20 most influential R&D executives in biopharma. Know a luminary who should definitely be included? Nominate them now.

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Who are the lu­mi­nar­ies dri­ving the biggest ad­vances in bio­phar­ma R&D? End­points News is ask­ing for your nom­i­na­tions for a spe­cial re­port

In biopharma, driving a drug to market is the ultimate goal — but none of that happens without a strong research and development program. At the most successful companies, those R&D efforts are spearheaded by true innovators in the field who are always looking for that next novel mechanism of action or breakthrough safety profile.

Now, Endpoints News is asking you to tell us who those guiding lights are.

Leen Kawas, Athira CEO

Biotech founder placed on leave as $400M Alzheimer's start­up idea comes un­der scruti­ny

Athira Pharma, the Alzheimer’s biotech that emerged out of obscurity last year and raised nearly $400 million for a dark-horse approach to treating neurodegeneration, has found itself in sudden turmoil.

On Tuesday evening, the company released a terse statement announcing that CEO and founder Leen Kawas had been placed on administrative leave while an independent review board investigated “actions stemming” from her doctoral research at Washington State University. Mark Litton, who joined the company as COO two years ago, will take over day-to-day operations, they said.

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Bris­tol My­ers breaks the bank on Ei­sai's fo­late re­cep­tor ADC drug, lay­ing out more than $3B+ for rights

For years, innovation in oncology has been a crapshoot with Big Pharma — the whales at the table — dropping the big bucks for the key to the next generation of tumor fighters. Bristol Myers Squibb hasn’t exactly made a name for being an innovator in the space, but that doesn’t mean it won’t splash in when it sees a potential winner.

Now, with a massive check in hand, the drugmaker is willing to put its intuition to the test.

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Michael Chambers (L) and John Ballantyne

Dana­her strikes deal to buy boom­ing next-gen man­u­fac­tur­er Alde­vron for $9.6B

Life sciences conglomerate Danaher Corp. $DHR has struck a deal to buy the fast-growing Aldevron, one of the world’s top manufacturers of hotly sought-after plasmid DNA, mRNA and recombinant proteins for the burgeoning world of vaccine and drugmakers pushing some game-changing technologies.

Buyout talks set the stage for Danaher to settle on a $9.6 billion cash pact to acquire the private Fargo, ND-based company — a key supplier for a disruptive new Covid vaccine as well as a host of gene and cell therapy and CRISPR gene editing players — founded by Michael Chambers and CSO John Ballantyne as a crew of 2 back in 1998.

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FDA's con­tro­ver­sial Aduhelm de­ci­sion leaves ALS pa­tients feel­ing spurned

The FDA’s controversial approval of Biogen’s Aduhelm drug for Alzheimer’s disease has been met with fierce resistance from all corners of the biopharma industry, but few seem to be as upset with the decision as ALS patients and advocacy groups.

For all that’s already been written and discussed about the agency’s announcement, from the drug’s exorbitantly high price of $56,000 per year to criticism over lowered standards, ALS patients see something more. ALS patients and associations say they largely regarded Aduhelm’s approval as a bittersweet double standard: happy that those with Alzheimer’s have a new drug available, but questioning how the FDA evaluated Biogen’s drug compared to the experimental programs being studied for their own disease.

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Jim Green­wood opens new pol­i­cy shop, with an eye on drug price con­trols; Mod­er­na, CRISPR, Mus­tang re­ceive tax breaks in Mass­a­chu­setts

Capitol Hill heavyweight Jim Greenwood is taking his decades of experience in the intertwining worlds of biopharma and Congress to the law firm DLA Piper, where he’s opening up a new policy and regulatory practice alongside former Pfizer lawyer Geoffrey Levitt.

As Congress wrangles over how to bring down drug prices, the former BIO CEO told Endpoints News in an interview that his top three priorities will be, “Price controls, price controls and price controls.”

Spring reg­u­la­to­ry agen­da: What’s com­ing soon-ish from the FDA

The FDA’s lack of a permanent commissioner does not seem to be halting its progress to propose and finalize dozens of new regulations, with the latest batch covering everything from adverse event reporting to supplemental application submissions to annual reports for INDs.

Overall, FDA expects to release more than 40 new proposed regulations and finalize another 24 in the coming months and years.

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