Ralph Passarella, Reify Health CEO

A uni­corn bags an­oth­er $220M to fund its plans to up­end the clin­i­cal tri­al process

The fo­cus on de­cen­tral­ized tri­als amid the pan­dem­ic has led in­vestors to make some big bets on com­pa­nies promis­ing to shake up the con­tract re­search space. Reify Health is the lat­est, com­ing away with $220 mil­lion to end what it calls the “sit and wait” pe­ri­od dur­ing tri­al en­roll­ment.

“What we’re do­ing, and the fu­ture of clin­i­cal tri­als over­all, goes be­yond de­cen­tral­ized tri­als,” ex­ec­u­tive chair­man Michael Lin said in a state­ment. “We need to have a glob­al health­care sys­tem proac­tive­ly reach­ing out to pa­tients every­where and mo­bi­liz­ing the re­sources nec­es­sary to bring tri­als to them.”

Coat­ue Man­age­ment led the hefty Se­ries C round, bring­ing Reify’s val­u­a­tion to $2.2 bil­lion, the com­pa­ny said on Tues­day morn­ing. The mon­ey will sup­port its two en­ti­ties, StudyTeam and Care Ac­cess, which are fo­cused on op­ti­miz­ing pa­tient re­cruit­ment and run­ning de­cen­tral­ized tri­als, re­spec­tive­ly.

“If we want to con­sis­tent­ly en­roll tri­als in three to four months in­stead of 18 months, there are two key things we must achieve,” CEO Ralph Pas­sarel­la said in a state­ment. “First, we must be able to rapid­ly iden­ti­fy enough in­ter­est­ed pa­tients. Sec­ond, we have to make it fea­si­ble for those pa­tients to par­tic­i­pate in the rel­e­vant tri­al.”

In 2015, the com­pa­ny be­gan build­ing more than 60 new re­search sites and lat­er brought on mo­bile site ve­hi­cles to spread their reach. To help op­ti­mize re­cruit­ment, they launched StudyTeam, which promis­es to save study spon­sors an av­er­age of six weeks in pa­tient en­roll­ment. The tech plat­form is used by some of the big play­ers, like Am­gen, Eli Lil­ly and As­traZeneca, ac­cord­ing to Reify.

ICONIQ Growth, Adams Street Part­ners, Sier­ra Ven­tures and Bat­tery Ven­tures al­so chipped in on the round.

Reify is one of many com­pa­nies look­ing to rev­o­lu­tion­ize clin­i­cal tri­als. Just two months ago, Gold­man Sachs made a $230 mil­lion eq­ui­ty in­vest­ment in 4G Clin­i­cal, a ser­vices firm that pro­vides cloud-based ran­dom­iza­tion and clin­i­cal tri­al ser­vices. Hobo­ken, NJ-based Cas­tor raised a mod­est $45 mil­lion for its de­cen­tral­ized ap­proach last month. And in May, Leaps by Bay­er led a $200 mil­lion ven­ture round for Hu­ma Ther­a­peu­tics and its dig­i­tal “hos­pi­tal at home” tech. And those are just a few of the con­tenders in that space.

“We’ve now op­er­at­ed mas­sive and com­plex tri­als in ways that, just five years ago, would have felt like sci­ence fic­tion,” said Ah­mad Nam­var­go­lian, CEO of Care Ac­cess. “The fu­ture of clin­i­cal tri­als is here.”

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; 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.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

A star Stan­ford pro­fes­sor leaves his lab for a start­up out to re­make psy­chi­a­try

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

Susan Galbraith, Executive VP, Oncology R&D, AstraZeneca

As­traZeneca on­col­o­gy R&D chief Su­san Gal­braith: 'Y­ou're go­ing to need or­thog­o­nal com­bi­na­tion­s'

 

Earlier in the week we broadcast our 4th annual European Biopharma Summit with a great lineup of top execs. One of the one-on-one conversations I set up was with Susan Galbraith, the oncology research chief at AstraZeneca. In a wide-ranging discussion, Galbraith reviewed the cancer drug pipeline and key trends influencing development work at the pharma giant. You can watch the video, above, or stick with the script below. — JC

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Roche's Tecen­triq cross­es the fin­ish line first in ad­ju­vant lung can­cer, po­ten­tial­ly kick­ing off gold rush

While falling behind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecentriq with a growing expertise in lung cancer. The drug will now take an early lead in the sought-after adjuvant setting — but competitors are on the way.

The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.

Yao-Chang Xu, Abbisko Therapeutics founder and CEO

Qim­ing-backed Ab­bisko makes $200M+ Hong Kong de­but, as a SPAC and Agenus spin­out al­so price on Nas­daq

Three new entities priced their public debuts late Thursday and early Friday, including a SPAC, a traditional Nasdaq IPO and a Chinese biotech joining the Hong Kong Index.

Shanghai-based Abbisko Therapeutics raised the most money of the triumvirate, garnering $226 million in its Hong Kong debut and pricing at HK$12.46, or roughly $1.60 in US dollars. The blank check company followed up with a $150 million raise, while MiNK Therapeutics priced on Nasdaq at $12 per share and a $40 million raise.

Paul Grayson, Tentarix CEO (Versant)

Phar­ma vet­er­ans re­group with $50M and a plan to dis­cov­er new mul­ti-specifics

While a horde of drugmakers develops bispecific antibodies to more directly target tumor cells — there were about 100 programs in or nearing clinical trials back in May — a new company is emerging to go one step further.

On Thursday, Tentarix Biotherapeutics unveiled a $50 million Series A round to support its next-gen multi-specifics platform. While the field has largely focused on bispecifics, which engage two targets, Tentarix believes its multifunctional programs have the potential to be even more specific, since more conditions must be met for potent activity to occur.

FDA ad­comm votes unan­i­mous­ly in sup­port of a J&J Covid-19 boost­er two months af­ter one-dose shot

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Friday voted 19-0 in favor of authorizing a second shot of J&J’s Covid-19 vaccine to follow at least two months after the initial dose.

Regulators don’t have to follow VRBPAC’s recommendation, but they almost always do. Considering that the CDC’s advisory committee has already been set to review the expanded EUA, VRBPAC’s recommendation is likely to be adopted.