Analy­sis: Pfiz­er tal­lies an im­pres­sive ar­ray of late-stage cat­a­lysts for can­cer, gene ther­a­pies and more

Pfiz­er ex­ecs ran through their 2018 late-stage pipeline plan on Tues­day, high­light­ing the key cat­a­lysts that await dur­ing their Q4 call with an­a­lysts. And can­cer drugs fig­ured promi­nent­ly in the dis­cus­sion.

We won’t have long to wait be­fore the news gets start­ed.

Mikael Dol­sten

First up, the Phase III PROS­PER da­ta for Xtan­di, which is po­si­tion­ing it­self against J&J’s next-gen drug for Zyti­ga. Pfiz­er and its part­ners at Astel­las are anx­ious to get the FDA re­view un­der­way for non­metasta­t­ic prostate can­cer, which could add con­sid­er­ably to its fran­chise val­ue as gener­ics start to slice and dice the mar­ket for J&J’s ri­val ther­a­py Zyti­ga. J&J has a next-gen drug in late-stage de­vel­op­ment for non­metasta­t­ic prostate can­cer which is cru­cial to its near-term abil­i­ty to com­pete with Pfiz­er.

Then there’s ta­la­zoparib, the PARP in­hibitor that Pfiz­er ac­quired in the big $14 bil­lion Medi­va­tion buy­out, with pos­i­tive late-stage da­ta on BR­CA-pos­i­tive metasta­t­ic breast can­cer.

Their PD-L1 in­hibitor Baven­cio, al­lied with Mer­ck KGaA, stum­bled bad­ly on third-line gas­tric can­cer re­cent­ly. But re­searchers are fol­low­ing up on sec­ond-line non-small cell lung can­cer and first-line re­nal cell car­ci­no­ma in com­bi­na­tion with In­ly­ta. A triple com­bo us­ing Baven­cio, Pfiz­er’s 4-1BB agent, and their OX40 mon­o­clon­al an­ti­body in sol­id tu­mors is be­ing stud­ied.

R&D chief Mikael Dol­sten sum­ma­rized the top on­col­o­gy tri­als this way:

We have now five piv­otal stud­ies over the next 18 to 24 months with var­i­ous Baven­cio com­bi­na­tions that we think will be re­al­ly in­ter­est­ing to watch. Ovar­i­an sec­ond-line and third-line with chemo, re­nal first-line…, gas­tric first-line on main­te­nance of Baven­cio af­ter chemo, blad­der first-line…Baven­cio com­bined with var­i­ous chemo com­bi­na­tions….”

And fi­nal­ly, I want to say that we are re­al­ly one of the few that have both an IO agent Baven­cio and a PARP in­hibitor ta­la­zoparib and we do think that will be a very pow­er­ful com­bi­na­tion and we’re run­ning broad bas­ket stud­ies over many sol­id tu­mors and ex­pect op­por­tu­ni­ties to take from those dataset in­to piv­otal stud­ies in the near term.

Ian Read

Pfiz­er CEO Ian Read had this to add:

I would like to point out that while we are be­hind in lung now our ex­pec­ta­tions are we have two im­por­tant read­outs; one this year and one lat­er on which is in – we have very cre­ative de­sign and let’s see what re­sults are in lung and how pos­i­tive it can be. We haven’t any­way giv­en up and our at­tempt to par­tic­i­pate in that large mar­ket.

Then Read ticked off three more top prospects in on­col­o­gy: Lor­la­tinib for ALK-pos­i­tive cas­es, the two-time los­er da­comi­tinib — a TKI — that came through in EGFR mu­tat­ed non-small cell lung can­cer and glas­deg­ib, an oral SMO in­hibitor ini­tial­ly cod­ed PF-04449913, for acute myeloid leukemia, based on Phase II re­sults.

There’s a ma­jor Phase III pro­gram un­der­way for their JAK1 in atopic der­mati­tis, a Phase III C diff vac­cine and a big ef­fort un­der­way in gene ther­a­pies for he­mo­phil­ia A and B — which in­spired the phar­ma gi­ant to spend $100 mil­lion on build­ing a gene ther­a­py man­u­fac­tur­ing cen­ter­ing Sand­ford, NC.

Dol­sten took on the piv­otal pro­gram for the NGF pain drug tanezum­ab, part­nered with Lil­ly. He said:

We are very ex­cit­ed about the tri­al of six dif­fer­ent stud­ies, 7000 pa­tients that are start­ing to read out ear­ly fall this year and then each of the tri­als fur­ther on in­to 2019. We have a unique po­si­tion in the space as we gath­ered tremen­dous ex­pe­ri­ence and in­sight in how to man­age our NGF an­ti­body and deal with rare events….

An­a­lysts have been rigid­ly fo­cused on M&A at Pfiz­er, which put the BD team on pause as they wait­ed for tax re­form to come through. Now that that smoke has be­gun to clear, cut­ting Pfiz­er’s prospec­tive tax rate by 6 points, to 17%, we’re like­ly to see the phar­ma gi­ant get back in­to the M&A game as well. Now that Pfiz­er has lopped off neu­ro­sciences, it should have plen­ty of abil­i­ty to add fresh pro­grams to the pipeline. And Read’s track record sug­gests he’d like to stay fo­cused on late-stage de­vel­op­ment.

5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

Hal Barron, GSK via YouTube

What does $29B buy you in Big Phar­ma? In Glax­o­SmithK­line’s case, a whole lot of un­com­fort­able ques­tions about the pipeline

Talk about your bad timing.

A little over a week ago, GSK R&D chief Hal Barron marked his third anniversary at the research helm by taking a turn at the virtual podium during JP Morgan to make the case that he and his team had built a valuable late-stage pipeline capable of churning out more than 10 blockbusters in the next 5 years.

And then, just days later, one of the cancer drugs he bet big on as a top prospect — bintrafusp, partnered with Merck KGaA — failed its first pivotal test in non-small cell lung cancer.

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Eli Lil­ly's an­ti­body cuts risk of Covid-19 by up to 80% among the most vul­ner­a­ble — but will it have a place next to vac­cines?

Eli Lilly says bamlanivimab lowered the risk of contracting symptomatic Covid-19 in a first-of-its-kind trial involving nursing home residents and staff, paving the way for a new option to protect against the virus.

But how big of an impact it might have, and what role it will play, at a time vaccines are being rolled out to the exact population it is targeting still remains unclear.

Among 965 participants in the study — all of whom tested negative for the coronavirus at baseline — the number of symptomatic cases reported in the bamlanivimab arm was 57% lower than that in the placebo arm (odds ratio 0.43, p=0.00021). In addition to that primary endpoint, all secondary endpoints reached statistical significance.

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Janet Woodcock (AP Images)

End­points poll: Janet Wood­cock takes the (in­ter­im) helm at the FDA. And a large ma­jor­i­ty of our read­ers want her to stay there

It’s official: Janet Woodcock is now the acting chief of the FDA.

And — according to an Endpoints poll — most industry readers would like her to stay there, although a significant minority is strongly opposed.

To recap: Joe Biden is reportedly choosing between Woodcock and former deputy FDA commissioner Joshua Sharfstein as his nominee for the permanent position. Given their respective track records, the decision is set to determine the agency’s lodestar for years to come.

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What’s next for End­points — and how to sup­port our in­de­pen­dent bio­phar­ma news mis­sion

The firehose of biopharma news is gushing these days.

That’s why broader and deeper is the theme for 2021 at Endpoints. You can expect new coverage outside our core R&D focus, with deeper reporting in some key areas. When John Carroll and I launched Endpoints nearly five years ago, we were wading in waist-high waters. Now we’re a team of 25 full-time staffers (and growing) with plans to cover the flood of biopharma news, Endpoints-style.

Charlie Fuchs, Roche and Genentech global head of product development for oncology and hematology (Yale Cancer Center)

Yale can­cer spe­cial­ist Char­lie Fuchs tapped as new glob­al de­vel­op­ment chief for Roche/Genen­tech

Roche and their big sub Genentech have just recruited a top cancer specialist at Yale to head up global product development in oncology and hematology.

I just got word that the pharma giant, which leads one of the most active cancer research operations in the world, recruited Charlie Fuchs, director of the Yale Cancer Center and physician-in-chief of Smilow Cancer Hospital. He’ll join the global operation March 1 and will be based in South San Francisco, where Genentech is based.

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Jonathan Weissman (MIT)

Can a new CRISPR tech­nique un­lock the se­crets of how can­cer spreads?

Jonathan Weissman’s team watched the cancer cells spread across the doomed mouse. Engineered with a bioluminescent enzyme, they appeared in scans first as a small navy blue diamond lodged near the heart; a week later, as a triangle splayed across the mouse’s upper body, with streaks of green and two distinct bright red hubs of activity. By day 54, the mouse resembled a lava lamp.

The images would have been familiar to any cancer biologist, but they didn’t actually tell you much about what was going on: why the cancer was metastasizing or which cells were responsible. For that, Weissman’s team had designed a new tool. Inside the original navy blue diamond, they had engineered the microbiological equivalent of an airplane’s black box — a “molecular recorder” that, after the mouse’s death, could allow them to extract the cells and wind back intimate footage of a single cancer’s ascent.

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Glax­o­SmithK­line scraps a LAG3 study, mark­ing an­oth­er fail­ure for the pipeline af­ter a crit­i­cal set­back

Another gap has appeared in GlaxoSmithKline’s pipeline.

Friday morning the Australian biotech Immutep put out word that Hal Barron’s R&D group at GSK had decided to scrap a Phase II proof-of-concept study in ulcerative colitis for their anti-LAG3 therapy GSK2831781. According to the biotech, the program didn’t survive an interim review.

The trial was stopped by GSK based on the assessment of clinical data as part of a planned interim analysis conducted in consultation with the trial’s Data Review Committee. GSK is conducting further reporting, assessment and analyses of the efficacy and safety data and evaluating the biology to determine next steps for the GSK2831781 development program.

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Janet Woodcock and Joshua Sharfstein (AP, Images)

Poll: Should Joshua Sharf­stein or Janet Wood­cock lead the FDA from here?

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.