Cam­bridge spin­out Cell­Cen­tric gets $26M for sin­gle-as­set epi­ge­net­ics ap­proach to prostate can­cer

Can a biotech de­vel­op­ing an epi­ge­net­ics drug squeeze in­to J&J and Pfiz­er’s turf fight in prostate can­cer? Cam­bridge, UK-based Cell­Cen­tric now has $26 mil­lion to find out.

Morn­ing­side Ven­ture In­vest­ments pro­vid­ed all of the fund­ing, con­tin­u­ing to throw its weight be­hind UK-based Cell­Cen­tric’s lead and on­ly as­set, CCS1477. The mon­ey is ex­pect­ed to car­ry the p300/CBP in­hibitor through Phase IIb in prostate can­cer and al­low the small vir­tu­al team to es­tab­lish sep­a­rate pro­grams in hema­to­log­i­cal or oth­er can­cers.

“The idea is to stay very as­set cen­tric, very fo­cused on one pro­gram, but look for mul­ti­ple op­por­tu­ni­ties now to use it,” CEO Will West tells me.

Ja­son Dinges

And he’s con­fi­dent CCS1477 is the as­set to cen­ter around. As re­cent­ly as five years ago, Cell­Cen­tric was a “knowl­edge com­pa­ny” that helped oth­er com­pa­nies ex­plore epi­ge­net­ic path­ways and cel­lu­lar re­pro­gram­ming. When it tran­si­tioned in­to an R&D op­er­a­tion in 2013 — thanks to ma­jor sup­port from Morn­ing­side — the team hand picked p300/CBP out of 50 po­ten­tial epi­ge­net­ic-re­lat­ed drug tar­gets.

Giv­en the role of hor­mones in fu­el­ing prostate can­cer cell growth, an­dro­gen re­cep­tors are a pop­u­lar tar­get for drug de­vel­op­ers — but even sec­ond gen­er­a­tion an­ti-an­dro­gen treat­ments have proven sus­cep­ti­ble to re­sis­tance. Down­reg­u­lat­ing the twin tar­gets of p300/CBP, West ex­plains, dri­ves down not on­ly an­dro­gen re­cep­tors but al­so all its vari­ants. That po­si­tions them as a fol­low up, com­pan­ion, or even pos­si­ble re­place­ment for block­busters like J&J’s Zyti­go and Er­lea­da as well as Pfiz­er/Astel­las’ Xtan­di.

“For the prostate in­di­ca­tion, it’s very clear and clean what we’re try­ing to do,” West says.

While Cell­Cen­tric’s drug be­longs to the BET in­hibitor fam­i­ly, it’s dis­tinct in both its speci­fici­ty and (based up­on pre­clin­i­cal stud­ies) du­ra­tion of ef­fect — al­low­ing for flex­i­bil­i­ty in dos­ing sched­ule, which is “ab­solute­ly key.” That means while the cur­rent plan is for pa­tients to take the oral cap­sule once a day, they could switch to an in­ter­mit­tent sched­ule or a “three week on, one week off hol­i­day ap­proach” if nec­es­sary.

The prostate can­cer clin­i­cal pro­gram is slat­ed to be­gin this sum­mer. By the end of the year West hopes to have a hema­to­log­i­cal can­cer pro­gram run­ning, with par­tic­u­lar fo­cus on acute myeloid leukemia and mul­ti­ple myelo­ma. Look­ing down the road, he al­so sees the drug treat­ing sub-pop­u­la­tions of blad­der can­cer and small cell lung can­cer pa­tients.

West has four col­leagues spread be­tween Cam­bridge, Ox­ford and Man­ches­ter to man­age 10 times as many con­sul­tants work­ing on the drug. And he doesn’t see the core team chang­ing much — un­less a big­ger play­er comes in to snap them up.

For now, New­ton, MA-based Morn­ing­side con­tin­ues to be Cell­Cen­tric’s largest share­hold­er, fol­lowed by Prov­i­dence In­vest­ment Com­pa­ny.

“On­col­o­gy prod­uct de­vel­op­ment is high­ly com­pet­i­tive. There are few gen­uine first-in-class new drug op­por­tu­ni­ties which have a large but spe­cif­ic pa­tient pop­u­la­tion to treat,” said Morn­ing­side’s Ja­son Dinges, who’s al­so on Cell­Cen­tric’s board. “We are de­light­ed to sup­port the Cell­Cen­tric team with their con­tin­ued mo­men­tum.”

The home run count: The $100M+ mega-round boom in biotech in­spired a $6.7B feed­ing fren­zy — so far this year

Over the last 6 months there’s been a blizzard of money piling up drifts of the green stuff through the biotech landscape. And the forecast calls for more cash windfalls ahead.

Even as a global pandemic has killed more than half a million people, blighted economies and divided nations over the proper response, it’s also helped ignite an unprecedented burst of big-time investing. And not just in Covid-19 deals, as we’ve looked at before.

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Atul Deshpande, Harbour BioMed chief strategy officer & head, US operations (Harbour BioMedO

An­oth­er biotech IPO set-up? Multi­na­tion­al biotech leaps from round to round, scoop­ing up cash at a blis­ter­ing pace

A short four months after announcing a $75 million haul in Series B+ fundraising, the multinational biotech Harbour BioMed pulled in another round of investments and eclipsed the nine-digit mark in the process.

Harbour completed its Series C financing, the company announced Thursday morning, raising $102.8 million and bringing its total investment sum to over $300 million since its founding in late 2016. The biotech plans to use the money to transition early-stage candidates from the discovery phase, fund candidates already in the clinic, and prep late-stage candidates for commercialization.

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Regeneron CEO Leonard Schleifer speaks at a meeting with President Donald Trump, members of the Coronavirus Task Force, and pharmaceutical executives in the Cabinet Room of the White House (AP Photo/Andrew Harnik)

OWS shifts spot­light to drugs to fight Covid-19, hand­ing Re­gen­eron $450M to be­gin large scale man­u­fac­tur­ing in the US

The US government is on a spending spree. And after committing billions to vaccines defense operations are now doling out more of the big bucks through Operation Warp Speed to back a rapid flip of a drug into the market to stop Covid-19 from ravaging patients — possibly inside of 2 months.

The beneficiary this morning is Regeneron, the big biotech engaged in a frenzied race to develop an antibody cocktail called REGN-COV2 that just started a late-stage program to prove its worth in fighting the virus. BARDA and the Department of Defense are awarding Regeneron a $450 million contract to cover bulk delivery of the cocktail starting as early as late summer, with money added for fill/finish and storage activities.

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Ed Engleman (Stanford Blood Center)

Stan­ford star on­col­o­gy sci­en­tist Ed En­gle­man helped cre­ate the im­munother­a­py field. Now he wants to shake up neu­rode­gen­er­a­tion R&D

Over the last generation of drug R&D, Ed Engleman has been a standout scientist.

The Stanford professor co-founded Dendreon and provided the scientific insights needed to develop Provenge into a pioneering — though not particularly marketable — immunotherapy. He’s spurred a slate of startups, assisted by his well-connected perch as a co-founder of Vivo Capital, and took the dendritic cell story into its next chapter at a startup called Bolt.

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Nello Mainolfi (Kymera via YouTube)

Out to re­vive R&D, a resur­gent Sanofi pays $150M cash to part­ner up with a pi­o­neer­ing pro­tein degra­da­tion play­er

Frank Nestle was appointed Sanofi’s global head of immunology and inflammation research therapeutic area just days before dupilumab, the blockbuster-to-be IL-4 antibody, would be accepted for priority review. After four years of consolidating immunology expertise from multiple corners of the Sanofi family and recruiting new talents to build the discovery engine, he’s set eyes on a Phase I-ready program that he believes can grow into a Dupixent-sized franchise.

UP­DAT­ED: Bio­gen shares spike as ex­ecs com­plete a de­layed pitch for their con­tro­ver­sial Alzheimer's drug — the next move be­longs to the FDA

Biogen is stepping out onto the high wire today, reporting that the team working on the controversial Alzheimer’s drug aducanumab has now completed their submission to the FDA. And they want the agency to bless it with a priority review that would cut the agency’s decision-making time to a mere 6 months.

The news drove a 10% spike in Biogen’s stock $BIIB ahead of the bell.

Part of that spike can be attributed to a relief rally. Biogen execs rattled backers and a host of analysts earlier in the year when they unexpectedly delayed their filing to the third quarter. That delay provoked all manner of speculation after CEO Michel Vounatsos and R&D chief Al Sandrock failed to persuade influential observers that the pandemic and other factors had slowed the timeline for filing. Actually making the pitch at least satisfies skeptics that the FDA was not likely pushing back as Biogen was pushing in. From the start, Biogen execs claimed that they were doing everything in cooperation with the FDA, saying that regulators had signaled their interest in reviewing the submission.

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Covid-19 roundup: CDC de­bat­ing who should get first avail­able vac­cines; EU in Gilead talks af­ter US gob­bled first remde­sivir dos­es

The federal government has now spent billions of dollars accelerating the development of a Covid-19 vaccine, and yet they’ve remained hush-hush on who, precisely, would actually get inoculated once the first doses are approved and available. Internally, though, they have been debating it.

The CDC and an advisory committee of outside health experts have been working since April to devise a ranking system that would determine who receives a vaccine and when, The New York Times reported. The question of who is first in line for inoculation is important because no matter how many doses developers can make or how quickly they can make them, doses will still come out in batches; 300 million inoculations will not appear overnight.

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Daniel O'Day, Gilead CEO (Kevin Dietsch/UPI/Bloomberg via Getty Images)

A new study points to $6.5B in pub­lic sup­port build­ing the sci­en­tif­ic foun­da­tion of Gilead­'s remde­sivir. Should that be re­flect­ed in the price?

By drug R&D standards, Gilead’s move to repurpose remdesivir for Covid-19 and grab an emergency use authorization was a remarkably easy, low-cost layup that required modest efficacy and a clean safety profile from just a small group of patients.

The drug OK also arrived after Gilead had paid much of the freight on getting it positioned to move fast.

In a study by Fred Ledley, director of the Center for Integration of Science and Industry at Bentley University in Waltham, MA, researchers concluded that the NIH had invested only $46.5 million in the research devoted to the drug ahead of the pandemic, a small sum compared to the more than $1 billion Gilead expected to spend getting it out this year, all on top of what it had already cost in R&D expenses.

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Sin­gu­lar fo­cus on ROR1 earns Velos­Bio $137M to fund PhI ADC and oth­er pro­grams

Years after selling Acerta to AstraZeneca for $7 billion, largely on the promise of its BTK inhibitor, Dave Johnson has once again gathered hefty financial support behind a new cancer target.

Matrix Capital Management and Surveyor Capital are leading a $137 million round for VelosBio, which has recently begun a Phase I study for its lead antibody-drug conjugate targeted against ROR1. Johnson took up the CEO post in October 2018.