Launched by MIT grads, a small start­up gets $20M to back a ro­bot­ics rev­o­lu­tion in cell ther­a­py man­u­fac­tur­ing

As co-di­rec­tor of an ex­per­i­men­tal cel­lu­lar ther­a­py process de­vel­op­ment and man­u­fac­tur­ing group at UCSF spe­cial­iz­ing in T cell ther­a­pies for au­toim­mune con­di­tions, Jonathan Es­en­sten has learned a lot about the chal­lenges in­volved when his group hand-fash­ions a cell ther­a­py. Es­en­sten — who was a post­doc in Wen­dell Lim’s lab and counts the leg­endary Jef­frey Blue­stone as a men­tor — gives them all high marks at be­ing great at what they do, but time and again there are vari­a­tions in the treat­ments they con­struct.

And that’s a prob­lem.

Jonathan Es­en­sten

Es­en­sten can’t of­fer any da­ta, and these are high­ly trained in­di­vid­u­als we’re talk­ing about, but “my in­tu­ition is that small dif­fer­ences in tech­nique can make a dif­fer­ence in the out­come of a cell ther­a­py man­u­fac­tur­ing run,” he says.

As any­one in bio­phar­ma can tell you, vari­a­tions in ther­a­peu­tic out­put are not OK. You want to set a stan­dard and hit it every time.

So when Fred Pari­et­ti came in a cou­ple of years ago to take a first-hand look at what they were do­ing at UCSF and see for him­self what cell ther­a­py man­u­fac­tur­ing was all about, they got to talk­ing.

It wasn’t just that there were vari­a­tions in the prod­uct, Es­en­sten says. It’s ex­pen­sive to get a trained group to­geth­er. Hard­er to pre­vent them from be­ing raid­ed by the grow­ing mul­ti­tude of biotechs in the area, who find it easy to beat a uni­ver­si­ty salary.

For Pari­et­ti, who joined a band of MIT grads and jour­neyed to the Bay Area to launch a ro­bot­ics up­start called Mul­ti­ply Labs, it was an eye-open­ing ex­pe­ri­ence, and one that led to a unique al­liance. Now Pari­et­ti’s start­up is fund­ing work in Es­en­sten’s group to de­vel­op a ro­bot­ic sys­tem to do that work — an ap­proach that he feels has near-term com­mer­cial po­ten­tial.

And af­ter rais­ing $5 mil­lion in seed cash to get them go­ing, he’s won over some key con­verts. The team at Mul­ti­ply can now boast of a $20 mil­lion fol­lowup round to get the prod­uct through test­ing and in­to the hands of an in­dus­try he feels is ripe for this kind of pre­ci­sion man­u­fac­tur­ing tech as cell ther­a­pies boom.

Cas­din Cap­i­tal led the round, with new in­vestors Lux Cap­i­tal and Pathfind­er, Founders Fund’s ear­ly stage in­vest­ment ve­hi­cle, al­so par­tic­i­pat­ing along with seed in­vestors Fifty Years and Garage Cap­i­tal.

Fred Pari­et­ti

Mul­ti­ply got start­ed man­u­fac­tur­ing a ro­bot­ics sys­tem that can make cus­tom de­signed pills, of­ten us­ing spe­cif­ic com­bos — a grow­ing fea­ture in the man­u­fac­tur­ing world. Once they get their new sys­tem set up for cell ther­a­pies, Pari­et­ti al­so be­lieves that there are a num­ber of play­ers in the cell ther­a­py field that can see the ad­van­tage of us­ing ro­bots in place of peo­ple, work­ing 24/7, with­out any vari­a­tions in tech­nique. With no pen­chant for mak­ing mis­takes. And no new salary de­mands.

“Es­sen­tial­ly the cell ther­a­py process­es are all lab process­es adapt­ed for GMP, but they were nev­er cre­at­ed to scale … ,” he says. “Peo­ple make mis­takes. That’s the de­f­i­n­i­tion of peo­ple.”

“The peo­ple are the biggest dan­ger for the drug,” Pari­et­ti adds. “In cell ther­a­py you want to pro­tect the drug from the peo­ple, not the peo­ple from the drug … Our job is to make stuff ef­fi­cient and au­to­mat­ed.”

It’s al­so a ques­tion of ef­fi­cien­cy, which re­volves around what Pari­et­ti calls par­al­lelism. With au­to­mat­ed sys­tems, you can con­tin­u­ous­ly use mul­ti­ple biore­ac­tors in par­al­lel. With peo­ple, or the al­ter­na­tive sys­tems on the mar­ket that Es­en­sten points to, biore­ac­tors have to be seg­re­gat­ed in in­di­vid­ual spaces to avoid cross con­t­a­m­i­na­tion.

That’s a big job, but Mul­ti­ply is still small, with 10 peo­ple plus an­oth­er 5 con­sul­tants. That should grow sig­nif­i­cant­ly with the cur­rent ven­ture round.

The in­spi­ra­tion for the team start­ed at MIT, where Pari­et­ti, who was work­ing on ex­oskele­tons in the ro­bot­ics group, met up with Al­ice Me­loc­chi, who was de­vot­ed to health­care sys­tems. To­geth­er, they built a team that tar­get­ed man­u­al drug man­u­fac­tur­ing, get­ting a foothold with their cap­sule tech. Now they feel equipped to go af­ter a much more am­bi­tious tar­get in cell ther­a­pies.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

The End­points 11: They've got mad mon­ey and huge am­bi­tions. It's time to go big or go home

These days, selecting a group of private biotechs for the Endpoints 11 spotlight begins with a sprint to get ahead of IPOs and the M&A teams at Big Pharma. I’ve had a couple of faceplants earlier this year, watching some of the biotechs on my short list choose a quick leap onto Nasdaq or into the arms of a buyer.

Vividion, you would have been a great pick for the Endpoints 11. I’m sorry I missed you.

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Dave Lennon, former president of Novartis Gene Therapies

So what hap­pened with No­var­tis Gene Ther­a­pies? Here's your an­swer

Over the last couple of days it’s become clear that the gene therapy division at Novartis has quietly undergone a major reorganization. We learned on Monday that Dave Lennon, who had pursued a high-profile role as president of the unit with 1,500 people, had left the pharma giant to take over as CEO of a startup.

Like a lot of the majors, Novartis is an open highway for head hunters, or anyone looking to staff a startup. So that was news but not completely unexpected.

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Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

Jean Bennett (Brent N. Clarke/Invision/AP Images)

Lux­tur­na in­ven­tor Jean Ben­nett starts a new gene ther­a­py com­pa­ny to tack­le rare dis­eases left be­hind by phar­ma, VCs

A few years ago Jean Bennett found herself in a surprising place for a woman who invented the first gene therapy ever approved in the United States: No one, it seemed, wanted her work.

Bennett, who designed and co-developed Luxturna, approved in 2018 for a rare form of blindness, had kept building new gene therapies for eye diseases at her University of Pennsylvania lab. But although the results in animals looked promising, pharma companies and investors kept turning down the pedigreed ophthalmology professor.

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FDA au­tho­rizes Pfiz­er's vac­cine boost­er for se­niors, those at high risk for se­vere Covid-19

The Biden administration’s goal of kicking off its booster shot drive for the entire US population this week is not quite going as planned.

First, Pfizer applied for approval of a supplemental application for the booster shots, but since last Friday’s adcomm reviewing them, the plan has devolved into an EUA, which the FDA issued late Thursday evening.

The population that is now eligible for the booster, six months after receiving the first pair of Pfizer-BioNTech vaccines, also narrowed from what Pfizer applied for (everyone who’s eligible for the initial Pfizer shots) to just those who are 65 or older, or at high-risk of a Covid infection, including health care workers and others with occupational hazards.

Stéphane Bancel, AP Images

Fi­nal analy­sis of US-fund­ed Mod­er­na Covid vac­cine tri­al shows 98% ef­fi­ca­cy against se­vere dis­ease

A final look at the results of the placebo-controlled Moderna trial in the New England Journal of Medicine, published Thursday afternoon, shows how the vaccine continues to prevent Covid-19 and severe cases after more than five months following the second shot.

Of the more than 30,000 enrolled in the trial that ultimately led to the vaccine’s EUA, only two people in the vaccine group got a severe form of the disease, compared to 106 in the placebo group — leading to an efficacy of 98%.

Emma Walmsley, GlaxoSmithKline CEO (Credit: Fang Zhe/Xinhua/Alamy Live News)

The fire un­der Glax­o­SmithK­line's Em­ma Walm­s­ley grows as an­oth­er well-known ac­tivist in­vestor grabs its pitch­fork — re­port

Bluebell Capital Partners, a proxy brawler fresh off a campaign to oust global food giant Danone’s CEO and most of its board of directors, has bought a stake in UK drugmaker GlaxoSmithKline with its eyes trained directly on Emma Walmsley, the Financial Times reported Wednesday.

The London-based hedge fund joins another notorious activist firm in Paul Singer’s Elliott Management, which earlier this year called for a shakeup in leadership at GSK to handle what the company described as a wealth of riches across the drug giant’s portfolio hindered by limited vision from top staff.

FDA+ roundup: Bs­U­FA III ready for show­time, court tells FDA to re-work com­pound­ing plan, new guid­ance up­dates and more

The FDA has now spelled out what exactly will be included in the third iteration of Biosimilar User Fee Act (BsUFA) from 2023 through 2027, which similarly to the prescription drug deal, sets fees that industry has to pay for submitting applications, in exchange for firm timelines that the agency must meet.

This latest deal includes several sweeteners for the biosimilar industry, which has yet to make great strides in the US market, with shorter review timelines for safety labeling updates and updates to add or remove an indication that does not contain efficacy data.

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