Af­ter build­ing a rep as an ar­chi­tect of ex­per­i­ments, Rx­Cel­er­ate plants its flag in Amer­i­ca

When XO1 was bought out by J&J a cou­ple of years ago, the seed in­vestors at In­dex, now Medicxi, made it Ex­hib­it A for their busi­ness mod­el on cre­at­ing a port­fo­lio of as­set-based biotechs.

What start­ed off with a bit of sci­en­tif­ic sleuthing by a pair of re­searchers at Cam­bridge Uni­ver­si­ty — Trevor Baglin and Jim Hunt­ing­ton — led to an an­ti­body pro­gram for a drug dubbed ichor­cum­ab that promised to po­ten­tial­ly act as an an­ti­co­ag­u­lant, with­out the in­her­ent risk of se­vere bleed­ing that in­evitably haunts the class.

Patrick Ver­heyen, who was run­ning the J&J In­no­va­tion of­fice in Lon­don at the time, called this deal a prime ex­am­ple of the way the phar­ma gi­ant was able to reel in top sci­en­tif­ic pro­grams around the world.

But be­tween the chance dis­cov­ery based on an odd med­ical case dat­ing back to 2008 and J&J’s ac­qui­si­tion, XO1, with­out build­ing a staff or do­ing all the nor­mal things as­so­ci­at­ed with biotech star­tups, had to push through a crit­i­cal pre­clin­i­cal study that could prove it had some­thing of re­al val­ue.

Richard Ma­son

“What we re­al­ly need­ed to do in XO1,” XO1 for­mer chief and sole full time staffer Richard Ma­son tells me, “was to show this an­ti­body we cre­at­ed was an an­ti­co­ag­u­lant that didn’t in­crease bleed­ing risk.”

That’s nev­er been done in any sim­i­lar de­vel­op­ment pro­gram be­fore, by any­one.

To do that, Ma­son re­lied on a group in Cam­bridge, UK called Rx­Cel­er­ate. Co-found­ed by David Grainger, a Medicxi part­ner who al­so act­ed as chief sci­en­tif­ic of­fi­cer for XO1, the lab staff didn’t just run a pre­clin­i­cal study un­der con­tract. They built the study from the ground up, ques­tion­ing every step along the way in a field be­set by ques­tions of le­git­i­ma­cy and in­tegri­ty.

Says Ma­son: “They are the ar­chi­tects of the ex­per­i­ment.”

XO1’s ex­pe­ri­ence un­der­scores one of the hard truths about drug dis­cov­ery projects. The lit­er­a­ture is of­ten mis­lead­ing, the mod­els in use may be sus­pect, some­times some of the hard­ware de­scribed doesn’t even ex­ist, says Ma­son. And all of that was on dis­play in their ground­work on an­ti­co­ag­u­la­tion.

A sci­en­tist by train­ing, Grainger and his col­leagues at Medicxi have carved out a rep­u­ta­tion for com­bin­ing sci­en­tif­ic rig­or in ear­ly-stage re­search with a rep for carv­ing the hard costs of do­ing a start­up down to the bare es­sen­tials — in­clud­ing the cre­ative use of out­sourc­ing to keep their star­tups vir­tu­al.

Now Rx­Cel­er­ate has opened up a Boston/Cam­bridge of­fice to in­tro­duce their work un­der US EVP Lau­ra Hamil­ton, the for­mer BD chief at Mass­Bio.

David Grainger

“We are not a CRO,” Grainger tells me lev­el­ly. So I asked for a look at one case to ex­plain what they do. And that led me to Ma­son, who didn’t just do a deal with J&J — a few months lat­er he took Ver­heyen’s job run­ning J&J In­no­va­tion in Lon­don. (Ver­heyen was pro­mot­ed to run BD for all of J&J. Hunt­ing­ton, mean­while, caught the se­r­i­al en­tre­pre­neur bug and has since launched a se­ries of biotech up­starts out of his Cam­bridge lab.)

The way Rx­Cel­er­ate works, Ma­son says, “it starts with the ba­sic sci­ence and takes noth­ing for grant­ed.”

Jill Reck­less — the CEO at Rx­Cel­er­ate, who left with a group of re­searchers at Cam­bridge to launch the lab at Rx­Cel­er­ate with Grainger — start­ed by re­view­ing the lit­er­a­ture on throm­bo­sis and bleed­ing mod­els.

“We found that many of those pa­pers had some prob­lems with them,” says Ma­son. Then there was the rat tail clip mod­el used to mea­sure bleed­ing in ro­dents.

“We found sub­stan­tial prob­lems with the way that was done in the lit­er­a­ture,” adds Ma­son. “Prob­lems with re­pro­ducibil­i­ty.”

Rather than repli­cate bad sci­ence, Rx­Cel­er­ate cre­at­ed new mod­el ex­per­i­ments where nec­es­sary, and dou­bled down with larg­er an­i­mal mod­els to demon­strate po­ten­tial in hu­mans.

“What we are try­ing to of­fer is the abil­i­ty to out­source the think­ing be­hind drug de­vel­o­ment,” says Grainger. CROs are great for de­fined tasks, he adds, but when it comes to do­ing the ar­chi­tec­ture: “CROs don’t do that very well.”

Jill Reck­less

It’s the kind of work that ap­peals to any­one in a cash con­strained en­vi­ron­ment, says Reck­less, whether that’s a biotech start­up or a ma­jor bio­phar­ma, work­ing on a bud­get to see where it has as­sets of re­al val­ue to pur­sue. It’s all about stay­ing fo­cused while re­main­ing skep­ti­cal about what’s come be­fore.

“By not do­ing the things that don’t need to be done,” says Grainger,  “that’s where the bulk of the cost sav­ings come.”

How’s J&J’s team do­ing with XO1’s drug, now dubbed “9375”?

So far so good, says Ma­son, who vis­it­ed with the group in charge at J&J as they look for a next-gen­er­a­tion an­tithrom­bin to fol­low Xarel­to. They’re through Phase I and ex­am­in­ing next steps for Phase II.

Says Ma­son: “Stay tuned.”

How one start­up fore­told the neu­ro­science re­nais­sance af­ter '50 years of shit­show'

In the past couple of years, something curious has happened: Pharma and VC dollars started gushing into neuroscience research.

Biogen’s controversial new Alzheimer’s drug Aduhelm has been approved on the basis of removing amyloid plaque from the brain, but the new neuro-focused pharma and biotechs have much loftier aims. Significantly curbing or even curing the most notorious disorders would prove the Holy Grail for a complex system that has tied the world’s best drug developers in knots for decades.

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Ryan Watts, Denali CEO

De­nali slips as a snap­shot of ear­ly da­ta rais­es some trou­bling ques­tions on its pi­o­neer­ing blood-brain bar­ri­er neu­ro work

Denali Therapeutics had drummed up considerable hype for their blood-brain barrier technology since launching over six years ago, hype that’s only intensified in the last 14 months following the publications of a pair of papers last spring and proof of concept data earlier this year. On Sunday, the South San Francisco-based biotech gave the biopharma world the next look at in-human data for its lead candidate in Hunter syndrome.

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Why is On­col­o­gy Drug De­vel­op­ment Re­search Late to the Dig­i­tal Bio­mark­ers Game?

During the recent Annual ASCO Meeting, thousands of cancer researchers and clinicians from across the globe joined together virtually to present and discuss the latest findings and breakthroughs in cancer research and care. There were more than 5000+ scientific abstracts presented during this event, yet only a handful involved the use of motion-tracking wearables to collect digital measures relating to activity, sleep, mobility, functional status, and/or quality of life. Although these results were a bit disappointing, they should come as no surprise to those of us in the wearable technology field.

Bob Bradway, Amgen CEO (Scott Eisen/Bloomberg via Getty Images)

Am­gen bel­lies back up to the M&A ta­ble for an­oth­er biotech buy­out, this time with a $2.5B deal for an an­ti­body play­er fo­cused on PS­MA

Five months after Amgen CEO Bob Bradway stepped up to the M&A table and acquired Five Prime for $1.9 billion, following up with the smaller Rodeo acquisition, he’s gone back in for another biotech buyout.

This time around, Amgen is paying $900 million cash while committing up to $1.6 billion in milestones to bag the privately held Teneobio, an antibody drug developer that has expertise in developing new bispecifics and multispecifics. In addition, Amgen cited Teneobio’s “T-cell engager platform, which expands on Amgen’s existing leadership position in bispecific T-cell engagers by providing a differentiated, but complementary, approach to Amgen’s current BiTE platform.”

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Luciana Borio (Susan Walsh/AP Images)

UP­DAT­ED: Bob Nelsen's ARCH adds FDA, biode­fense ex­per­tise with ap­point­ment of Lu­ciana Bo­rio

Once vetted by the Biden team to lead the FDA as commissioner, Luciana Borio is now compiling quite the résumé.

Borio has now been named a venture partner at Bob Nelsen’s ARCH Venture Partners, and Nelsen told Endpoints News, “She will be involved in projects across the portfolio, including ongoing projects in manufacturing, clinical trials, gene therapy and gene editing, cell therapy, and delivery. We are exploring multiple projects in infectious disease, and next generation manufacturing.”

Art Levinson (Calico)

Google-backed Cal­i­co dou­bles down on an­ti-ag­ing R&D pact with Ab­b­Vie as part­ners ante up $1B, start to de­tail drug tar­gets

Seven years after striking up a major R&D alliance, AbbVie and Google-backed anti-aging specialist Calico are doubling down on their work with a joint, $1 billion commitment to continuing their work together. And they’re also beginning to offer some details on where this project is taking them in the clinic.

According to their statement, each of the two players is putting up $500 million more to keep the labs humming.

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Busi­ness­es and schools can man­date the use of Covid-19 vac­cines un­der EUAs, DOJ says

As public and private companies stare down the reality of the Delta variant, many are now requiring that their employees or students be vaccinated against Covid-19 prior to attending school or to returning or starting a new job. Claims that such mandates are illegal or cannot be used for vaccines under emergency use authorizations have now been dismissed.

Setting the record straight, the Department of Justice on Monday called the mandates legal in a new memo, even when used for people with vaccines that remain subject to EUAs.

Ugur Sahin, BioNTech CEO (Bernd von Jutrczenka/dpa via AP Images)

BioN­Tech is spear­head­ing an mR­NA vac­cine de­vel­op­ment pro­gram for malar­ia, with a tech trans­fer planned for Africa

Flush with the success of its mRNA Covid-19 vaccine, BioNTech is now gearing up for one of the biggest challenges in vaccine development — which comes without potential profit.

The German mRNA pioneer says it plans to work on a jab for malaria, then transfer the tech to the African continent, where it will work with partners on developing the manufacturing ops needed to make this and other vaccines.

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No­var­tis reshuf­fles its wild cards; Tough sell for Bio­gen? Googling pro­teins; Ken Fra­zier's new gig; 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.

If you enjoy the People section in this report, you may also want to check out Peer Review, my colleagues Alex Hoffman and Kathy Wong’s comprehensive compilation of comings and goings in biopharma.

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