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.”

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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David Ricks, Eli Lilly CEO (David Paul Morris/Bloomberg via Getty Images)

Eli Lil­ly set to in­vest $2.1B in home state man­u­fac­tur­ing boost

Eli Lilly is looking to expand its footprint in its home Hoosier State by making a major investment in manufacturing.

The pharma is investing $2.1 billion in two new manufacturing sites at Indiana’s LEAP Lebanon Innovation and Research District in Boone County, northwest of Lilly’s headquarters in Indianapolis.

The two new facilities will expand Lilly’s manufacturing network for active ingredients and new therapeutic modalities, including genetic medicines, according to a press release.

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US sees spike in Paxlovid us­age as Mer­ck­'s mol­nupi­ravir and As­traZeneca's Evusheld are slow­er off the shelf

New data from HHS show that more than 162,000 courses of Pfizer’s Covid-19 antiviral Paxlovid were administered across the US over the past week, continuing a streak of increased usage of the pill, and signaling not only rising case numbers but more awareness of how to access it.

In comparison to this week, about 670,000 courses of the Pfizer pill have been administered across the first five months since Paxlovid has been on the US market, averaging about 33,000 courses administered per week in that time.

Pfiz­er and CD­MOs ramp up Paxlovid man­u­fac­tur­ing with Kala­ma­zoo plant ex­pan­sion lead­ing the way

As the Covid-19 pandemic continues to evolve, pharma companies and manufacturers are exploring how to step up production on antivirals.

Pfizer is planning to expand its Kalamazoo-area facility to increase manufacturing capabilities for the oral Covid-19 antiviral Paxlovid, according to a report from Michigan-based news site MLive. The expansion of the facility, which serves as Pfizer’s largest manufacturing location, is expected to create hundreds of “high-skilled” STEM jobs, MLive reported. No details about the project’s cost and timeline have been released, but according to MLive, Pfizer will announce the details of the expansion at some point in early June.

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FDA spells out the rules and re­stric­tions for states seek­ing to im­port drugs from Cana­da

The FDA is offering more of an explanation of the guardrails around its program that may soon allow states to import prescription drugs in some select circumstances from Canada, but only if such imports will result in significant cost reductions for consumers.

While the agency has yet to sign off on any of the 5 state plans in the works so far, and PhRMA’s suit to block the Trump-era rule allowing such imports is stalled, the new Q&A guidance spells out the various restrictions that states will have to abide by, potentially signaling that a state approval is coming.

Simba Gill, CEO of Evelo Biosciences

While down 87% YOY, Evelo gets Flag­ship and oth­ers to in­fuse new cap­i­tal for come­back hope

Just four years after Flagship spinout Evelo Biosciences went public in an IPO worth $85 million, the biotech has seen its share price tank from $13 a share this time last year (ultimately reaching a peak of over $17) to now under $1.50. And today, it looks like Flagship still thinks the fledging biotech, in a down market, is still worth something after initial pre-IPO backing from the likes of Google’s GV, Celgene, Mayo Clinic and Alexandria Venture.

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Peter Thompson, Terremoto Biosciences interim CEO

For­mer Prin­cip­ia team looks to shake up co­va­lent small mol­e­cules again, this time at 'earthquake' scale

Terremoto Biosciences goes back a long ways, in a sense, to about a dozen years ago when Principia Biopharma was founded by UCSF professor Jack Taunton. Peter Thompson initially helmed the biotech.

The company helped expand covalent small molecule inhibitors beyond oncology and into autoimmune disease by targeting cystine. But that amino acid is uncommon in a lot of proteins, offering fewer drug targets than, say, lysine, which is present in most proteins of interest. So, over the years, Taunton went back to the drawing board to check out that second amino acid.

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Pfizer CEO Albert Bourla at the World Economic Forum (Gian Ehrenzeller/Keystone via AP Images)

All about ac­cess: Pfiz­er moves to a non-prof­it mod­el for drug sales in 45 low­er-in­come coun­tries

Leading the way to increase access to cheaper drugs worldwide, Pfizer said Wednesday it will provide all current and future patent-protected medicines and vaccines available in the US or EU on a not-for-profit basis to about 1.2 billion people in 45 lower-income countries.

Rwanda, Ghana, Malawi, Senegal and Uganda are the first five countries to sign on to this accord, which will also seek to blaze new paths for quick and efficient regulatory and procurement processes to reduce the usual delays in making new medicines and vaccines available in these countries.

Almirall is tapping artificial intelligence on behalf of its sales force for insights and efficiencies. (via Shutterstock)

Almi­rall rolls out sales rep ar­ti­fi­cial in­tel­li­gence sys­tem, cut­ting pre-call prep and 'wind­shield time'

Dermatology specialty pharma Almirall is making its sales reps smarter. Not with extra training or educational courses, but instead with artificial intelligence tools.

It began a soft launch of a sales rep AI and machine learning platform it calls Polaris last August in one of its 7 US coverage regions. The platform from Aktana gathers information from across Almirall internal sources and external ones – such as claims and prescribing data – to generate insights for reps. Now, instead of spending hours prepping for a sales call, Polaris can generate details about a physician’s preferences, past behaviors and prescription habits for reps in minutes, said Almirall head of commercial operations Vincent Cerio.

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