Igor Khandros, Nutcracker Therapeutics CEO

GMP-in-a-box com­pa­ny with Bob Nelsen back­ing lands $167M to de­vel­op its own can­cer drugs

For the fourth time in as many weeks, a com­pa­ny fo­cused on portable drug man­u­fac­tur­ing is mak­ing noise.

This time, Nut­crack­er Ther­a­peu­tics has brought in $167 mil­lion in a Se­ries C round led by ARCH Ven­ture Part­ners. The com­pa­ny will use the fi­nanc­ing to help ad­vance its pipelines of mR­NA med­i­cines for on­col­o­gy, in ad­di­tion to re­fin­ing the man­u­fac­tur­ing tech­nol­o­gy that spurred the biotech’s launch. Nut­crack­er will al­so grow its team, par­tic­u­lar­ly on the med­ical side of things, as it has re­cent­ly round­ed out its ex­ec­u­tive team.

Ge­off Nos­rati

Chief busi­ness of­fi­cer Ge­off Nos­rati said in a call with End­points News that what makes Nut­crack­er’s plat­form unique from oth­ers who oc­cu­py a sim­i­lar space is that it deals with more than just man­u­fac­tur­ing. Nut­crack­er says it de­vel­ops new drugs in-house, and it has de­vel­oped its own de­liv­ery sys­tem, which it calls Nut­shells, to get the RNA to its tar­get.

Nut­crack­er’s man­u­fac­tur­ing plat­form com­bines RNA bio­chem­istry with mi­cro flu­idic en­gi­neer­ing, semi­con­duc­tor-line biochips and nanopar­ti­cle de­liv­ery tech. In a sin­gle man­u­fac­tur­ing unit, its de­vice can car­ry out DNA tem­plate ex­pan­sion, pro­duce drug sub­stance, and for­mu­late the drug prod­uct. The team hopes to speed up the man­u­fac­tur­ing process, and make scal­ing eas­i­er.  Nut­crack­er switch­es be­tween drugs by swap­ping out a nanochip.

What hasn’t been broad­cast yet is the com­pa­ny’s push to­ward its own can­cer drugs us­ing mR­NA. That is some­thing Nut­crack­er hopes to change soon, Nos­rati said.

“We’re re­al­ly de­vel­op­ing ag­gres­sive­ly our whol­ly-owned pipeline of on­col­o­gy ther­a­peu­tics, and look­ing to ex­pand that even fur­ther, both on our own and through part­ner­ships with biotechs,” he said. “It’s a pret­ty sub­stan­tial change in our mes­sag­ing, and we’ve been pret­ty qui­et so far.”

Bob Nelsen

The com­pa­ny, which is based in Cal­i­for­nia’s Bay Area, was found­ed in 2019, be­fore Covid-19 made mR­NA a house­hold name. CEO Ig­or Khan­dros brought Mad­hu Bal­achan­dran out of re­tire­ment to be­come the COO, and the ef­forts sparked the in­ter­est of Bob Nelsen, who led the way for the com­pa­ny’s $60 mil­lion in fundrais­ing back in 2020.

Nut­crack­er’s join­ing a slew of com­pa­nies look­ing to shake up the in­dus­try’s ap­proach to build­ing com­plex bi­o­log­ic ther­a­pies.

A month ago, BioN­Tech held a press con­fer­ence ad­dress­ing its af­ford­able man­u­fac­tur­ing fa­cil­i­ties, dubbed the BioN­Tain­er, that it will de­liv­er to Sene­gal and Rwan­da as a part of its ef­forts to im­prove the lack of man­u­fac­tur­ing on the con­ti­nent. Its pri­ma­ry fo­cus will be on Covid-19, but the com­pa­ny has said it plans to piv­ot to malar­ia drugs when the time is right.

Then Cure­Vac came out and an­nounced that it was spin­ning out a ful­ly-owned com­pa­ny specif­i­cal­ly for its mR­NA print­er, a portable man­u­fac­tur­ing de­vice that, ide­al­ly, could be dropped off at hos­pi­tals around the world. A week lat­er, Mytide Ther­a­peu­tics an­nounced a $7 mil­lion Se­ries A to de­vel­op a sim­i­lar piece of tech­nol­o­gy that spe­cial­izes in pep­tide man­u­fac­tur­ing. That com­pa­ny has land­ed in­vest­ment from Al­loy Ther­a­peu­tics.

Nut­crack­er has al­so added Michael Bigham, the for­mer CEO of Paratek Phar­ma­ceu­ti­cals, to its board of di­rec­tors. He will bring more than 30 years of lead­er­ship to the team.

“RNA has unique qual­i­ties as a ther­a­peu­tic modal­i­ty and could prove to be a first-line tool for many dis­eases,” he said in a state­ment. “Nut­crack­er Ther­a­peu­tics is well-po­si­tioned to de­vel­op RNA ther­a­peu­tics in a scal­able and ef­fi­cient man­ner with its in­no­v­a­tive plat­form.”

UP­DAT­ED: In a fresh dis­ap­point­ment, Am­gen spot­lights a ma­jor safe­ty is­sue with KRAS com­bo

Amgen had hoped that its latest study matching its landmark KRAS G12C drug Lumakras with checkpoint inhibitors would open up its treatment horizons and expand its commercial potential. Instead, the combo spurred safety issues that blunted efficacy and forced the pharma giant to alter course on its treatment strategy, once again disappointing analysts who have been tracking the drug’s faltering sales and limited therapeutic reach.

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Ad­dress­ing the ‘Ca­pac­i­ty Crunch’ with a Scal­able Plat­form Process Ap­proach

The field of gene therapy has been diligently moving forward over the past several decades to bring potentially life-saving treatments to patients with genetic diseases. In addition to two approved adeno-associated viral (AAV) gene therapies, there are more than 250 AAV gene therapies in various clinical trial stages.1 AAV vectors remain the most frequently used vector for delivering therapeutic transgenes to target tissues due to their demonstrated and lasting clinical efficacy and extensive safety track record. As AAV therapies advance through clinical trials and into commercialization, many biotech companies are turning to contract development and manufacturing organizations (CDMOs) to prepare their programs for late-stage clinical and commercial scale manufacturing. Given the scope and scale of the manufacturing needs that will accompany regulatory approvals for these assets, CDMOs continue to expand their capacity to meet the needs of increasing prevalent patient populations. However, despite rapid growth, projected gene therapy manufacturing demands still outpace the collective capacity of the CDMO industry.

A $5B Pfiz­er buy­out? Am­gen, Gilead head­line M&A Thurs­day; Al­ny­lam's AT­TR sweep; An­drew Lo's rare dis­ease quest; 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.

One of the cool things about adding EndpointsPharma to the daily roster is that my colleagues can now dedicate time to tracking quarterly updates and tuning into calls with Big Pharma companies. Check out their dispatch from the Q2 earnings below.

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George Yancopoulos, Regeneron president and CSO (Brendan McDermid/Reuters/Alamy)

George Yan­copou­los says he's on the trail of the holy grail: ‘This could rep­re­sent the next break­through for im­munother­a­py’

Two of the most outspoken — and successful — drug developers in biotech say they’ve collected early-stage clinical data that are pointing them down the trail to the holy grail in cancer immunotherapy R&D.

While analysts largely busied themselves today with chronicling the ongoing success of Regeneron’s two big cash cows — Dupixent and Eylea — chief scientist George Yancopoulos and CEO Len Schleifer used the Q2 call to spotlight their early success with a combination of the “homegrown” PSMAxCD28 costimulatory bispecific antibody REGN5678 in combination with their PD-1 checkpoint Libtayo. The presentation comes just weeks after Regeneron completed a deal to gather all rights to the PD-1 that had been in Sanofi’s hands. And the two top execs are unstinting in their praise of the potential of a whole set of costimulatory pipeline projects which they say may finally deliver the long-awaited next-level approach to broadening the immunotherapy field of drugs.

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Albert Bourla, Pfizer CEO (Laurent Gillieron/Keystone via AP)

Break­ing: Pfiz­er in hot pur­suit of a $5B buy­out of Glob­al Blood Ther­a­peu­tics — re­port

Pfizer CEO Albert Bourla has vowed to leave no stone unturned in the search for new biotech deals, and the BD team is not letting him down.

The Wall Street Journal reported today that Pfizer is in the final stages of acquiring Global Blood Therapeutics for $5 billion. According to the Journal report, though, Pfizer is not the only buyer at the deal table and while the pharma giant may be close to clinching it, there are no guarantees it will continue.

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Bob Bradway, Amgen CEO (Justin Kase Conder/AP Images for Amgen)

UP­DAT­ED: Am­gen chief Brad­way nabs a rare dis­ease play­er in $4B buy­out as the M&A tem­po ac­cel­er­ates

Amgen CEO Bob Bradway is bellying up to the M&A table today, scooping up the newly anointed commercial biotech ChemoCentryx $CCXI and its recently approved rare disease drug for $3.7 billion out of the cash stockpile. The deal comes in at $52 a share — a hefty increase over the $24.11 close yesterday.

Bradway and the Amgen team get a drug called Tavneos (avacopan) in the deal, a complement factor C5a inhibitor OK’d to treat anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis, an autoimmune disease which can be lethal.

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(AP Photo/Richard Vogel, File)

US de­clares mon­key­pox a na­tion­al health emer­gency, as new drug­mak­ers con­sid­er en­ter­ing vac­cine race

Rising monkeypox cases have put the US on high alert as it announces a national health emergency, which grants the government more power in its response.

The news comes as Bavarian Nordic continues to fill orders for its Jynneos vaccine and other companies – including Moderna – consider jumping into the vaccine race. Meanwhile, the New York Times reports that the US has allowed around 20 million doses of smallpox vaccine in its stockpile to expire.

Vlad Coric, Biohaven CEO

Bio­haven touts surge in Nurtec sales ahead of Pfiz­er takeover

Forget buyer’s remorse, Pfizer is likely feeling pretty good about its $11.6 billion Biohaven takeover deal following reports of a 57% sales boost for migraine med Nurtec.

Biohaven reported in Q2 results on Friday that it’s cleared the necessary antitrust hurdles to move forward with the sale of its calcitonin gene-related peptide (CGRP) assets to Pfizer. However, because the company is “focused on workstreams related to the closing” of the deal, it did not host a call with analysts and investors.

Pharma ads are showing up on cooler screens at retail pharmacies, including Walgreens and CVS, under a new OptimizeRx deal (OptimizeRx)

Phar­ma brands chill in the phar­ma­cy re­tail aisle with new style ads on re­frig­er­a­tion screens

Want a prescription drug with that soda? While not directly possible, ads for pharma brands now running on beverage and snack cooler screens at pharmacy retailers may at least inspire customers to think about it.

OptimizeRx is hooking up with Cooler Screens media company to bring prescription drug advertising to refrigerator front doors at pharmacies including Walgreens, CVS and Kroger.

The “point of dispense” ads show a full-door image on the cooler doors when a shopper is 12 feet away, but shrinks down to a smaller banner-sized ad so that the refrigerator contents can be seen when a person gets closer. The doors — which have to be specially installed by Cooler Screens — can detect when a person is nearby, how long a person “dwells” in front of the ad and if they do or don’t open the door.

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