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.”

Grow­ing ac­cep­tance of ac­cel­er­at­ed path­ways for nov­el treat­ments: but does reg­u­la­to­ry ap­proval lead to com­mer­cial suc­cess?

By Mwango Kashoki, MD, MPH, Vice President-Technical, and Richard Macaulay, Senior Director, of Parexel Regulatory & Access

In recent years, we’ve seen a significant uptake in the use of regulatory options by companies looking to accelerate the journey of life-saving drugs to market. In 2018, 73% of the novel drugs approved by the U.S. Federal Drug Administration (FDA) were designated under one or more expedited development program categories (Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval).ᶦ

Sanofi out­lines big API plans as coro­n­avirus out­break re­port­ed­ly threat­ens short­age of 150 drugs

As the world becomes increasingly dependant on Asia for the ingredients of its medicines, Sanofi sees business to be done in Europe.

The French drugmaker said it’s creating the world’s second largest active pharmaceutical ingredients (API) manufacturer by spinning out its six current sites into a standalone company: Brindisi (Italy), Frankfurt Chemistry (Germany), Haverhill (UK), St Aubin les Elbeuf (France), Újpest (Hungary) and Vertolaye (France). They have mapped out €1 billion in expected sales by 2022 and 3,100 employees for the new operations headquartered in France.

UP­DAT­ED: NGM Bio takes leap for­ward in crowd­ed NASH field

South San Francisco-based NGM Bio may have underwhelmed with its interim analysis of a key cohort from a mid-stage NASH study last fall — but stellar topline data unveiled on Monday showed the compound induced significant signs of antifibrotic activity, NASH resolution and liver fat reduction, sending the company’s stock soaring.

There are an estimated 50+ companies focused on developing drugs for non-alcoholic steatohepatitis, or NASH, a common liver disease that has long flummoxed researchers. The first wave of NASH drug developers struggled with efficacy as well as safety — and companies big and small have crashed and burned.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 72,900+ biopharma pros reading Endpoints daily — and it's free.

Mickey Kertesz, KidsandArtOrg via YouTube

Soft­Bank's newest, $165M biotech in­vest­ment looks for in­fec­tious traces in the blood

SoftBank has found its newest biotech investment.

The Japanese bank has invested $165 million into Karius, a company that uses blood tests to diagnose infectious diseases, as part of its new Vision Fund 2. The full scope of the new fund has yet to be announced, but the first and newly-beleaguered Vision Fund poured $100 billion into technology companies, including the biotechs Vir Biotechnology and Roivant and the sequencing company 10x Genomics.

Methicillin-resistant Staph aureus (Shutterstock)

FDA grants ‘break­through’ sta­tus to an­tibi­ot­ic al­ter­na­tive as Con­tra­Fect rush­es to join fight against su­per­bug

An experimental drug that promises to be the first anti-infective agent to prove superior to vancomycin — an antibiotic approved in 1958 — has notched the FDA’s “breakthrough” status.

ContraFect said the designation was based on Phase II data in which exebacase was tested against a superbug known as methicillin-resistant Staph aureus, or MRSA. In a subgroup analysis, the clinical responder rate at day 14 was 42.8% higher than that among those treated with standard of care, the company said (p=0.010).

Zhong Nanshan, CGTN via YouTube

Har­vard joins coro­n­avirus fight with $115 mil­lion and a high-pro­file Chi­nese part­ner

For two months, as the novel coronavirus swelled from a few early cases tied to a Wuhan market to a global epidemic, most of the world’s focus and dollars have flowed toward emergency initiatives: building vaccines at a record pace, plucking experimental antivirals out of freezers to see what sticks and immunizing mice for new antibodies.

Now a new and well-funded collaboration between Harvard and a top Chinese research institute will play the long game. In a 5-year, $115 million initiative backed by China Evergrande Group, researchers from the Harvard Medical School, Harvard T.H. Chan School of Public Health and Guangzhou Institute for Respiratory Health will study the virus in an effort to develop therapies against infections by the novel coronavirus, known as SARS–CoV-2, and to prevent new ones.

No­var­tis gets a boost in block­buster mul­ti­ple scle­ro­sis race with Roche

In the first step of what’s likely to be a long and uphill battle for the drugmaker, the FDA has accepted Novartis’s BLA submission for a new multiple sclerosis drug and given it priority review. The PDUFA date for the potential blockbuster drug is in June.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 72,900+ biopharma pros reading Endpoints daily — and it's free.

Juergen Horn

An­i­mal health vet Juer­gen Horn makes new an­ti­body play for pets, rak­ing $15M in Se­ries A haul

Zoetis forked over $85 million in 2017 to acquire Nexvet Biopharma and its pipeline of monoclonal antibodies. Juergen Horn, Nexvet’s former chief product development officer, has now secured $15 million for his own biologic company for animals: Invetx.

Buoyed by emerging advances in gene therapies for humans, scientists have started looking at harnessing the technology for animals setting up companies such as Penn-partnered Scout Bio and George Church-founded Rejuvenate Bio. But akin to Nexvet, Invetx is working on leveraging the time-tested science of monoclonal antibodies to treat chronic diseases that afflict man’s best friend.

As coro­n­avirus out­break reach­es 'tip­ping point,' GSK lends ad­ju­vant tech to Chi­nese part­ner armed with pre­clin­i­cal vac­cine

As the coronavirus originating out of Wuhan spreads to South Korea, Italy and Iran, stoking already intense fears of a pandemic, GlaxoSmithKline has found another pair of trusted hands to place its adjuvant system. China’s Clover Biopharmaceuticals will add the adjuvant to its preclinical, protein-based vaccine candidate against SARS-CoV-2.

Clover, which is based in the inland city of Chengdu, boasts of a platform dubbed Trimer-Tag that produces covalently-trimerized fusion proteins. Its candidate, COVID-19 S-Trimer, resembles the viral spike (S)-protein found in the virus.