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.”

How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Pearl Huang, Dunad Therapeutics CEO (Ken Richardson, PR Newswire)

Long­time biotech leader Pearl Huang takes the reins as CEO of No­var­tis-backed up­start

It has only been a few months since Pearl Huang exited the top seat at Cygnal Therapeutics, but now she’s back at the helm of another biotech.

After taking a few months off — passing an exam in that time to get her captain’s license from the US Coast Guard — she’s been named CEO of Dunad Therapeutics, a biotech focused on developing a small molecule covalent therapies that was founded in 2020. Huang told Endpoints News that two factors attracted her to going back to the c-suite: the company’s technology and its co-founders.

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Alex­ion puts €65M for­ward to strength­en its po­si­tion on the Emer­ald Isle

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

Matt Gline, Roivant CEO (John Sciulli/Getty Images for GLG)

Roivant chops sick­le cell gene ther­a­py, der­ma­tol­ogy drugs to fo­cus on 'high­er val­ue pro­ject­s'

Roivant is sweeping a suite of drugs, including a gene therapy for sickle cell disease already in the clinic, out of its pipeline.

Six programs from four of its “vants” are being wound down as part of “a company-wide cost optimization and pipeline reprioritization initiative to reduce our expected operating expenses and prioritize our capital resources.”

When reached by Endpoints News, a spokesperson said, “We don’t anticipate a material reduction in headcount but we will likely reassign some folks to higher value projects as part of winding down specific programs.”

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Members of the G7 from left to right: Prime Minister of Italy Mario Draghi, European Commission President Ursula von der Leyen, President Joe Biden, German Chancellor Olaf Scholz, British Prime Minister Boris Johnson, Canadian Prime Minister Justin Trudeau, Prime Minister of Japan Fumio Kishida, French President Emmanuel Macron and European Council President Charles Michel (AP Photo/Susan Walsh)

Biden and G7 na­tions of­fer funds for vac­cine and med­ical prod­uct man­u­fac­tur­ing project in Sene­gal

Amidst recently broader vaccine manufacturing initiatives from the EU and European companies, the G7 summit in the mountains of Bavaria has brought about some positive news for closing vaccine and medical product manufacturing gaps around the globe.

According to a statement from the White House, the G7 leaders have formally launched the partnership for global infrastructure, PGII. The effort will aim to mobilize hundreds of billions of dollars to deliver infrastructure projects in several sectors including the medical and pharmaceutical manufacturing space.

Fed­er­al judge de­nies Bris­tol My­er­s' at­tempt to avoid Cel­gene share­hold­er law­suit

Some Celgene shareholders aren’t happy with how Bristol Myers Squibb’s takeover went down.

On Friday, a New York federal judge ruled that they have a case against the pharma giant, denying a request to dismiss allegations that it purposely slow-rolled Breyanzi’s approval to avoid paying out $6.4 billion in contingent value rights (CVR).

When Bristol Myers put down $74 billion to scoop up Celgene back in 2019, liso-cel — the CAR-T lymphoma treatment now marketed as Breyanzi — was supposedly one of the centerpieces of the deal. After going back and forth on negotiations for about six months, BMS put $6.4 billion into a CVR agreement that required an FDA approval for Zeposia, Breyanzi and Abecma, each by an established date.

Laurence Reid, Decibel CEO

Still in pre­clin­i­cal test­ing for ear gene ther­a­pies, Deci­bel touts small snap­shot of chemo-in­duced hear­ing loss drug

Though Decibel Therapeutics has largely pivoted toward gene therapies for the inner ear, its lead clinical candidate simply aims to protect cancer patients from chemotherapy-induced hearing loss. On Tuesday, the biotech presented its first efficacy data for the program, and execs like what they see.

Decibel reported interim results from a Phase Ib study showing the experimental drug, dubbed DB-020, largely protected a small group of patients from losing their hearing. Researchers used a particularly unique study design, administering the compound in one of each patients’ ears before they received cisplatin chemotherapy and placebo in the other.