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. 

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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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.

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.

State bat­tles over mifepri­s­tone ac­cess could tie the FDA to any post-Roe cross­roads

As more than a dozen states are now readying so-called “trigger” laws to kick into effect immediate abortion bans following the overturning of Roe v. Wade on Friday, these laws, in the works for more than a decade in some states, will likely kick off even more legal battles as states seek to restrict the use of prescription drug-based abortions.

Since Friday’s SCOTUS opinion to overturn Americans’ constitutional right to an abortion after almost 50 years, reproductive rights lawyers at Planned Parenthood and other organizations have already challenged these trigger laws in Utah and Louisiana. According to the Guttmacher Institute, other states with trigger laws that could take effect include Arkansas, Idaho, Kentucky, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas, and Wyoming.

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Deborah Dunsire, Lundbeck CEO

Af­ter a 5-year re­peat PhI­II so­journ, Lund­beck and Ot­su­ka say they're fi­nal­ly ready to pur­sue OK to use Rex­ul­ti against Alzheimer's ag­i­ta­tion

Five years after Lundbeck and their longtime collaborators at Otsuka turned up a mixed set of Phase III data for Rexulti as a treatment for Alzheimer’s dementia-related agitation, they’ve come through with a new pivotal trial success they believe will finally put them on the road to an approval at the FDA. And if they’re right, some analysts believe they’re a short step away from adding more than $500 million in annual sales for the drug, already approved in depression and schizophrenia.

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A Mer­ck part­ner is sucked in­to the fi­nan­cial quag­mire as key lender calls in a note

Another biotech standing on shaky financial legs has fallen victim to the bears.

Merck partner 4D Pharma has reported that a key lender, Oxford Finance, shoved the UK company into administration after calling in a $14 million loan they couldn’t immediately make good on. Trading in their stock was halted with a market cap that had fallen to a mere £30 million.

“Despite the very difficult prevailing market conditions,” 4D reported on Friday, the biotech had been making progress on finding some new financing and turned to Oxford with an alternative late on Thursday and then again Friday morning.

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.

Chris Anzalone, Arrowhead CEO

Take­da, Ar­row­head spot­light da­ta from small tri­al show­ing RNAi works in a rare liv­er con­di­tion

Almost two years after Takeda wagered $300 million cash to partner with Arrowhead on an RNAi therapy for a rare disease, the companies are spelling out Phase II data that they believe put them one step closer to their big dreams.

In a small, open label study involving only 16 patients who had liver disease associated with alpha-1 antitrypsin deficiency (AATD), Arrowhead’s candidate — fazirsiran, previously ARO-AAT — spurred substantial reductions in accumulated mutant AAT protein in the liver, a hallmark of the condition. Investigators also tracked improvements in symptoms, with seven out of 12 who received the high, 200 mg dose seeing regression of liver fibrosis.

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No stranger to gene ther­a­py woes, Astel­las runs in­to an­oth­er safe­ty-re­lat­ed clin­i­cal hold

Astellas Pharma, which has been at the forefront of uncovering the risks associated with gene therapies delivered by adeno-associated viruses, must take another safety alarm head-on.

The FDA has slapped a clinical hold on Astellas’ Phase I/II trial of a gene therapy candidate for late-onset Pompe disease, after investigators flagged a serious case of peripheral sensory neuropathy.

It marks the latest in a streak of setbacks Astellas has encountered since making a splashy entry into the gene therapy space with its $3 billion buyout of Audentes. But the lead program, AT132 for the treatment of X-linked myotubular myopathy (XLMTM), had to be halted more than once after a total of four patients died in the trial — and the scientific community still doesn’t have all the answers of what caused the deaths.

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