A new CAR-T is cred­it­ed with a 'sur­pris­ing' im­pact in tiny study of ad­vanced liv­er can­cer — rais­ing hopes on sol­id tu­mors

A tiny study has pro­vid­ed the first glim­mer of hope that Eu­re­ka Ther­a­peu­tics’ CAR-T ther­a­py may work in sol­id tu­mors.

In a proof-of-con­cept study in­volv­ing six pa­tients with he­pa­to­cel­lu­lar car­ci­no­ma — the most preva­lent form of liv­er can­cer — re­searchers re­port­ed that one pa­tient had a com­plete re­sponse, which was main­tained at the sev­en-month check­up. Two oth­ers saw their tu­mors shrink.

These, the biotech em­pha­sizes, are pa­tients who have failed mul­ti­ple pri­or treat­ments.

“The re­sults were ex­treme­ly sur­pris­ing,” Chang Liu, a physi­cian at Xi’an Jiao­tong Uni­ver­si­ty in Chi­na and the pri­ma­ry in­ves­ti­ga­tor of the study, told Bloomberg. “This is a break­through in an area where there was pre­vi­ous­ly no known treat­ment. To be more dra­mat­ic, we can say it’s cre­at­ed a mir­a­cle.”

Cheng Liu

Emeryville, CA-based Eu­re­ka added that none of the pa­tients ex­pe­ri­enced cy­tokine re­lease syn­drome or drug-re­lat­ed neu­ro­tox­i­c­i­ty — well-known safe­ty con­cerns that have lim­it­ed the use of T cell ther­a­pies.

Of note, three pa­tients in the study died due to what the com­pa­ny de­scribes as “non-drug-re­lat­ed com­pli­ca­tions of liv­er dis­ease.”

The first CAR-Ts on the mar­ket from Gilead/Kite and No­var­tis have demon­strat­ed some amaz­ing re­sults for blood can­cers, but sol­id tu­mors rep­re­sent a high hur­dle for these new drugs. Clear­ing it — safe­ly — would open up a ma­jor mar­ket.

“We are en­cour­aged by the safe­ty pro­file and the po­ten­tial ef­fi­ca­cy of ET140202 for AFP-pos­i­tive liv­er can­cer,” said Cheng Liu, Eu­re­ka’s pres­i­dent and CEO. “Com­bin­ing T-cell ther­a­py with a TCR-mim­ic an­ti­body to tar­get in­tra­cel­lu­lar anti­gens is a nov­el ap­proach and can po­ten­tial­ly rep­re­sent a pow­er­ful way to treat sol­id tu­mors, and in par­tic­u­lar, liv­er can­cer, an area of sig­nif­i­cant un­met med­ical need.”

The treat­ment, dubbed ET140202, works by tar­get­ing a liv­er can­cer mark­er called al­pha-fe­to­pro­tein, or AFP.

In 2019, the com­pa­ny plans to launch a mul­ti­cen­ter Phase I tri­al for ET140202, in the US, where it’s al­so test­ing its lead pro­gram fo­cused on CD19+ non-Hodgkin lym­phoma.

John Hood [file photo]

UP­DAT­ED: Cel­gene and the sci­en­tist who cham­pi­oned fe­dra­tinib's rise from Sanofi's R&D grave­yard win FDA OK

Six years after Sanofi gave it up for dead, the FDA has approved the myelofibrosis drug fedratinib, now owned by Celgene.

The drug will be sold as Inrebic, and will soon land in the portfolio at Bristol-Myers Squibb, which is finalizing a deal to acquire Celgene.

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Health­i­er, longer lifes­pans will be a re­al­i­ty soon­er than you think, Ju­ve­nes­cence promis­es as it clos­es $100M round

Earlier this year, an executive from Juvenescence-backed AgeX predicted the field of longevity will eventually “dwarf the dotcom boom.” Greg Bailey, the UK-based anti-aging biotech’s CEO, certainly hopes so.

On Monday, Juvenescence completed its $100 million Series B round of financing. The company is backed by British billionaire Jim Mellon — who wrote his 400-page guide to investing in the field of longevity shortly after launching the company in 2017.  Bailey, who served as a board director for seven years at Medivation before Pfizer swallowed the biotech for $14 billion, is joined by Declan Doogan, an industry veteran with stints at Pfizer and Amarin.

UP­DAT­ED: AveX­is sci­en­tif­ic founder was axed — and No­var­tis names a new CSO in wake of an ethics scan­dal

Now at the center of a storm of controversy over its decision to keep its knowledge of manipulated data hidden from regulators during an FDA review, Novartis CEO Vas Narasimhan has found a longtime veteran in the ranks to head the scientific work underway at AveXis, where the incident occurred. And the scientific founder has hit the exit.

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Ab­b­Vie gets its FDA OK for JAK in­hibitor upadac­i­tinib, but don’t look for this one to hit ex­ecs’ lofty ex­pec­ta­tions

Another big drug approval came through on Friday afternoon as the FDA OK’d AbbVie’s upadacitinib — an oral JAK1 inhibitor that is hitting the rheumatoid arthritis market with a black box warning of serious malignancies, infections and thrombosis reflecting fears associated with the class.

It will be sold as Rinvoq — at a wholesale price of $59,000 a year — and will likely soon face competition from a drug that AbbVie once controlled, and spurned. Reuters reports that a 4-week supply of Humira, by comparison, is $5,174, adding up to about $67,000 a year.

The top 10 fran­chise drugs in bio­phar­ma his­to­ry will earn a to­tal of $1.4T (tril­lion) by 2024 — what does that tell us?

Just in case you were looking for more evidence of just how important Amgen’s patent win on Enbrel is for the company and its investors, EvaluatePharma has come up with a forward-looking consensus estimate on what the list of top 10 drugs will look like in 2024.

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UP­DAT­ED: Sci­en­tist-CEO ac­cused of im­prop­er­ly us­ing con­fi­den­tial in­fo from uni­corn Alec­tor

The executive team at Alector $ALEC has a bone to pick with scientific co-founder Asa Abeliovich. Their latest quarterly rundown has this brief note buried inside:

On June 18, 2019, we initiated a confidential arbitration proceeding against Dr. Asa Abeliovich, our former consulting co-founder, related to alleged breaches of his consulting agreement and the improper use of our confidential information that he learned during the course of rendering services to us as our consulting Chief Scientific Officer/Chief Innovation Officer. We are in the early stage of this arbitration proceeding and are unable to assess or provide any assurances regarding its possible outcome.

There’s no explicit word in the filing on what kind of confidential info was involved, but the proceeding got started 2 days ahead of Abeliovich’s IPO.

Abeliovich, formerly a tenured associate professor at Columbia, is a top scientist in the field of neurodegeneration, which is where Alector is targeted. More recently, he’s also helped start up Prevail Therapeutics as the CEO, which raised $125 million in an IPO. And there he’s planning on working on new gene therapies that target genetically defined subpopulations of Parkinson’s disease. Followup programs target Gaucher disease, frontotemporal dementia and synucleinopathies.

But this time Abeliovich is the CEO rather than a founding scientist. And some of their pipeline overlaps with Alector’s.

Abeliovich and Prevail, though, aren’t taking this one lying down.

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Chi­na has be­come a CEO-lev­el pri­or­i­ty for multi­na­tion­al phar­ma­ceu­ti­cal com­pa­nies: the trend and the im­pli­ca­tions

After a “hot” period of rapid growth between 2009 and 2012, and a relatively “cooler” period of slower growth from 2013 to 2015, China has once again become a top-of-mind priority for the CEOs of most large, multinational pharmaceutical companies.

At the International Pharma Forum, hosted in March in Beijing by the R&D Based Pharmaceutical Association Committee (RDPAC) and the Pharmaceutical Research and Manufacturers of America (PhRMA), no fewer than seven CEOs of major multinational pharmaceutical firms participated, including GSK, Eli Lilly, LEO Pharma, Merck KGaA, Pfizer, Sanofi and UCB. A few days earlier, the CEOs of several other large multinationals attended the China Development Forum, an annual business forum hosted by the research arm of China’s State Council. It’s hard to imagine any other country, except the US, having such drawing power at CEO level.

As dis­as­ter struck, Ab­b­Vie’s Rick Gon­za­lez swooped in on Al­ler­gan with an of­fer Brent Saun­ders couldn’t say no to

Early March was a no good, awful, terrible time for Allergan CEO Brent Saunders. His big lead drug had imploded in a Phase III disaster and activists were after his hide — or at least his chairman’s title — as the stock price continued a steady droop that had eviscerated share value for investors.

But it was a perfect time for AbbVie CEO Rick Gonzalez to pick up the phone and ask Saunders if he’d like to consider a “strategic” deal.

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As­traZeneca's jug­ger­naut PARP play­er Lyn­parza scoops up an­oth­er dom­i­nant win in PhI­II as the FDA adds a 'break­through' for Calquence

AstraZeneca’s oncology R&D group under José Baselga keeps churning out hits.

Wednesday morning the pharma giant and their partners at Merck parted the curtains on a successful readout for their Phase III PAOLA-1 study, demonstrating statistically significant improvement in progression-free survival for women with ovarian cancer in a first-line maintenance setting who added their PARP Lynparza to Avastin. This is their second late-stage success in ovarian cancer, which will help stave off rivals like GSK.

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