Source: Inato.com

The Sanofi-part­nered start­up find­ing clin­i­cal tri­als for the 90%

Sanofi want­ed help find­ing new tri­al sites, so a cou­ple years ago they start­ed talk­ing with a start­up down the street – who sent them to Chi­na.

The Paris-based start­up, Ina­to, was build­ing a plat­form to ex­pand the pool of pa­tients for clin­i­cal tri­als. On­ly in­stead of ad­ver­tis­ing or match­ing pa­tients with tri­als, as oth­er young com­pa­nies have, Ina­to was try­ing to match phar­ma com­pa­nies with the vast ma­jor­i­ty of hos­pi­tals that rarely, if ever, host a tri­al, even if they have pa­tients bet­ter suit­ed to a par­tic­u­lar study than a mar­quee name hos­pi­tal. Call them a tri­al plat­form for the 99% – or, by Ina­to’s cal­cu­la­tions, the 90% of sites that are gen­er­al­ly ig­nored in clin­i­cal re­search.

That might mean con­nect­ing Eli Lil­ly to a hos­pi­tal up­state of New York City’s Mt. Sinai Hos­pi­tal with less ex­pe­ri­ence but more melanoma pa­tients. Or, in Sanofi’s case, it meant help­ing ex­pand the com­pa­ny’s foothold Chi­na, where the health­care sys­tem is grow­ing rapid­ly but is still young and where the gov­ern­ment has re­cent­ly re­formed tri­al stan­dards and in­cen­tives.

“The plat­form was so well re­ceived by the clinops in­ter­nal­ly that they de­cid­ed to ramp up very rapid­ly,” Ina­to CEO Kourosh Davarpanah told End­points News.

Kourosh Davarpanah

Davarpanah says Sanofi – the world’s sev­enth largest phar­ma by R&D spend­ing – now us­es Ina­to to se­lect sites for “vir­tu­al­ly all” of their tri­als. And the com­pa­ny hopes to soon ex­pand their rolodex. To­day, they an­nounced a $14 mil­lion Se­ries A round led by Ob­vi­ous Ven­tures and Cathay In­no­va­tion, and joined by Ser­e­na and Fly Ven­tures.

The CEO said he told in­vestors that he was tak­ing the same ad­vanced da­ta sci­ence that has re­made ther­a­peu­tics and bring­ing it to the clin­i­cal tri­al space. They did not im­me­di­ate­ly jump in­to his open arms.

“I would say we had a dif­fi­cult time ex­plain­ing the en­tire clin­i­cal tri­al space to in­vestors,” Davarpanah said.

Skep­ti­cism from ven­ture cap­i­tal­ists is to be ex­pect­ed, but Ina­to is far from alone in re­think­ing how clin­i­cal tri­als are done. DNA se­quenc­ing com­pa­nies such as Genap­sys are try­ing to use their tech to se­lect pa­tients most like­ly to be sus­cep­ti­ble to drugs. Tri­als.Ai is us­ing ma­chine learn­ing to an­a­lyze pub­lished ar­ti­cles and troves of da­ta on ge­nomics and past stud­ies to im­prove tri­al de­sign. Deep 6 AI promis­es to help you “find more pa­tients in min­utes, not months.”

Ina­to has tak­en a dif­fer­ent tack. It’s one of the few com­pa­nies work­ing on find­ing new clin­i­cal tri­al sites, which they say will then lead to phar­ma com­pa­nies and biotechs find­ing more and bet­ter pa­tients. They point to fig­ures that sug­gest 75% of clin­i­cal tri­als are held in around 10% of all hos­pi­tals. These se­lect hos­pi­tals have ex­pe­ri­ence and pres­tige, Davarpanah said, but they might lack the ide­al pa­tient pop­u­la­tion for any giv­en tri­al.

Ina­to’s plat­form shows phar­ma com­pa­nies a world map made up of lit­tle dots, like those seen in old TV news sta­tions. Dots rep­re­sent­ing po­ten­tial tri­al sites are lit up in green, yel­low or red. Click on one and it will show you that hos­pi­tal’s ac­cess to pa­tients and oth­er fac­tors, such as “ex­pe­ri­ence,” “in­ves­ti­ga­tor mo­ti­va­tion,” “com­pe­ti­tion.” There’s al­so a “qual­i­ty” rat­ing and a list of “ca­pa­bil­i­ties.”

On the oth­er end, Ina­to helps sites with lit­tle ex­pe­ri­ence pre­pare for a tri­al. They al­so fa­cil­i­tate com­mu­ni­ca­tion be­tween sites and de­vel­op­ers, help­ing phar­ma com­pa­nies gauge in­ter­est. They claim to have tri­als on 32 in­di­ca­tions and in over 2000 sites across 75 coun­tries so far.

So far, Sanofi is the on­ly ma­jor phar­ma part­ner. But Davarpanah said there’s broad­er in­ter­est, in­clud­ing from big phar­ma com­pa­nies.

“Very few hos­pi­tals have had the op­por­tu­ni­ty to par­tic­i­pate in clin­i­cal tri­als,” Davarpanah said. “We’re com­ing at a very old prob­lem.”

Cor­rec­tion: An ear­li­er ver­sion of the ar­ti­cle in­cor­rect­ly al­lud­ed to talks with a phar­ma com­pa­ny. The ref­er­ence has been re­moved. 

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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Sen. Patty Murray (D-WA) (Graeme Sloan/Sipa USA/Sipa via AP Images)

Sen­a­tors to NIH: Do more to pro­tect US bio­med­ical re­search from for­eign in­flu­ence

Although Thursday’s Senate health committee hearing was focused on how foreign countries and adversaries might be trying to steal or negatively influence biomedical research in the US, the only country mentioned by the senators and expert witnesses was China.

Committee chair Patty Murray (D-WA) made clear in her opening remarks that the US cannot “let the few instances of bad actors” overshadow the hard work of the many immigrant researchers in the US, many of which have won Nobel prizes for their work. But she also said, “There is more the NIH can be doing here.”

JP Gabriel, Ocugen

JP Gabriel watched from the bleach­ers as the pan­dem­ic raged. Now head of sup­ply chain at Ocu­gen, he's ready to bat

The world was in the middle of the most pressing public health risk his generation had ever seen, and JP Gabriel felt like he was sitting on the sidelines. As a VP of biologics and mRNA manufacturing at Ultragenyx, Gabriel watched from the sidelines as players like Pfizer/BioNTech and Moderna used mRNA tech to chase their own Covid-19 vaccines.

This month, Gabriel got the chance to get his hands dirty against the pandemic — but it won’t be with mRNA.

Covid-19 man­u­fac­tur­ing roundup: Mary­land looks to grow biotech ca­pac­i­ty with $400M check; Rus­sia lands sec­ond Sput­nik V part­ner this week

A Maryland real estate project has added three new biotech-focused manufacturing and research buildings to an office park to keep up with demand created by the pandemic, the Washington Business Journal reported.

The Milestone Business Park — located off of I-270 in Germantown, MD — will see the new buildings and a total of 532,000 square feet as the campus rebrands to Milestone Innovation Park.

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.

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.

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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