Look­ing for an on­col­o­gy re­boot, Sanofi, Re­gen­eron shoot for a fast and flashy FDA OK of a promis­ing new PD-1

There’s an­oth­er PD-1 drug head­ed to­ward the mar­ket. And this fast-mov­ing — and of­ten over­looked — pro­gram is due to ar­rive at the FDA for mar­ket­ing re­view in just a mat­ter of months.

In an out­line of Sanofi’s R&D work for the Q2 call this week, re­search chief Elias Zer­houni was clear­ly ex­cit­ed by the “fast-to-mar­ket strat­e­gy in the PD-1 space” that has been set up with its big de­vel­op­ment part­ner Re­gen­eron $REGN.

Here’s what Zer­houni had to say:

At AS­CO, we pre­sent­ed pos­i­tive clin­i­cal da­ta from a Phase I study, which showed that in pa­tients with ad­vanced CSCC (cu­ta­neous squa­mous cell car­ci­no­ma — the sec­ond dead­liest form of skin can­cer be­hind melanoma), our PD-1 was as­so­ci­at­ed with a 46% over­all re­sponse rate, a 69% dis­ease con­trol rate, and was gen­er­al­ly well tol­er­at­ed. So, we look for­ward to the re­sults of our reg­is­tra­tion study and are plan­ning to sub­mit to the FDA in metasta­t­ic cu­ta­neous squa­mous cell car­ci­no­ma in Q1 2018.

We al­so start­ed sev­er­al stud­ies of our PD-1 in oth­er in­di­ca­tions this past quar­ter, and these in­clude a Phase 3 in first line non-small cell lung can­cer and a Phase 2 in metasta­t­ic and lo­cal­ly ad­vanced basal cell car­ci­no­ma.

Is­rael Lowy

With 5 PD-(L)1 drugs on the mar­ket and hun­dreds of stud­ies un­der­way to ad­vance new ap­provals, the con­ver­sa­tion in can­cer cir­cles these days tends to fo­cus on whether these mul­ti­ply­ing check­point in­hibitors are be­com­ing swift­ly com­modi­tized.

That’s not the way Sanofi and Re­gen­eron are ap­proach­ing this. At all.

As Re­gen­eron’s top re­searcher on the pro­gram Is­rael Lowy told me at AS­CO last sum­mer, REGN2810 has con­vinced him PD-1 is a sig­nif­i­cant­ly bet­ter way to tack­le the check­point hur­dle than PD-L1. And the part­ners be­lieve they can quick­ly start by leapfrog­ging the PD-L1s from As­traZeneca, Roche and Pfiz­er/Mer­ck KGaA.

If he’s right, the im­pli­ca­tions in this megablock­buster field are enor­mous.

Elias Zer­houni

Zer­houni — who was diplo­mat­ic enough to thrive as head of the NIH — wasn’t will­ing to go that far right now. But for some­one who’s look­ing to this drug to help re­boot what has been a dis­ap­point­ing for­ay in­to on­col­o­gy for years, he may be work­ing up to it. Pressed on the point, he added:

Now, we, as I told you, be­lieve that PD-1 is the right se­lec­tion, the right tar­get based on many da­ta that we have gen­er­at­ed our­selves and our part­ner, Re­gen­eron. We do be­lieve that there is a po­ten­tial for PD-1 to be su­pe­ri­or. We do not know that at this point. I wouldn’t ven­ture to say that this is proven at this point. There are hints that in­deed tell us that, and we’ve made a choice and this is the choice we’re mak­ing here. We’re go­ing af­ter PD-1. We do not have a PD-L1 in de­vel­op­ment.

A suc­cess here would set up Sanofi as a play­er in on­col­o­gy, with a com­bo ap­proach that could well help over­come the sting of past set­backs. Sanofi’s in­ter­nal pipeline has been unin­spired at best for years, with Re­gen­eron lend­ing a big hand to pro­vide the kind of re­mark­able in­no­va­tion that is need­ed for a re­boot. That part­ner­ship has al­ready land­ed sev­er­al land­mark drug OKs, and now it’s lin­ing up an­oth­er.

Look for the num­ber 6 PD-(L)1 to hit the reg­u­la­to­ry re­view path soon. It isn’t an­gling for last place.

The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

'Chang­ing the whole game of drug dis­cov­ery': Leg­endary R&D vet Roger Perl­mut­ter leaps back in­to work as a biotech CEO

Roger Perlmutter needs no introduction to anyone remotely involved in biopharma. As the R&D chief first at Amgen and then Merck, he’s built a stellar reputation and a prolific career steering new drugs toward the market for everything from cancer to infectious diseases.

But for years, he’s also held a less known title: science partner at The Column Group, where he’s regularly consulted about the various ideas the VCs had for new startups.

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FDA ex­tends re­search agree­ment with MIT-li­censed or­gan-on-chip sys­tems

The FDA on Wednesday extended its four-year agreement with CN Bio, a developer of single- and multi-organ-on-chip systems used for drug discovery, for another three years.

CN Bio said the scope of the research performed by the FDA’s Center for Drug Evaluation and Research has expanded to include the exploration of the company’s lung-on-a-chip system to help with the agency’s evaluation of inhaled drugs, in addition to the agency’s work on its liver model.

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In quest to meet user fee goals, FDA’s per­for­mance con­tin­ues down­ward trend

A recent update to the FDA’s running tally of how it’s meeting its user fee-related performance goals during the pandemic shows an agency that is not out of the woods yet.

The latest numbers reveal that for a second straight quarter in 2021, the FDA has met its user fee goal dates for 93% of original new drug applications, which compares with 94% and 98% for the previous two quarters in 2020, respectively.

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UP­DAT­ED: Pfiz­er hits the brakes on their piv­otal tri­al for a BC­MA/CD3 bis­pe­cif­ic on safe­ty con­cerns while FDA road­block is hold­ing up Duchenne MD PhI­II

Pfizer’s ambitious plan to take a Phase II study of its BCMA CD3-targeted bispecific antibody elranatamab (PF-06863135) and run it through to an accelerated approval has derailed.

The pharma giant said in a release this morning that they have halted enrollment for their MagnetisMM-3 study after researchers tracked three cases of peripheral neuropathy in the ongoing Phase I. They are now sharing info with the FDA as they explore the red safety flag.

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Thomas Schall, ChemoCentryx CEO (file photo)

Chemo­Cen­tryx plunges as FDA rais­es ques­tions about rare dis­ease drug ahead of ad­comm

ChemoCentryx’s stock price on Wednesday was cut in half by the release of FDA briefing documents ahead of a Thursday adcomm, raising questions on the company’s clinical data to support avacopan as a treatment for adults with a rare and serious disease known as anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis.

ANCA-associated vasculitides (AAV) affect small to medium-size blood vessels that can be fatal in less than a year if left untreated, according to FDA. Only Roche’s Rituxan is currently FDA-approved for the treatment of AAV, while glucocorticoids are approved for the broader indication of vasculitis.

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Re­gen­eron’s gold­en goose Eylea may stave off biosim­i­lar com­pe­ti­tion un­til 2024 or be­yond

Almost 10 years have passed since its first FDA approval and Regeneron’s macular degeneration injection Eylea continues to pile up sales to the tune of about $5 billion per year, or more than half of Regeneron’s annual revenues.

Those billions are not expected to go anywhere anytime soon thanks to competition, even as Novartis subsidiary Sandoz announced Monday that it’s beginning a Phase III trial for an Eylea biosimilar in 460 patients across 20 countries.

Cynthia Butitta (L) and Joe Jimenez

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Right on the heels of taking on a $160 million crossover round in a likely leap to Nasdaq, Century Therapeutics CEO Lalo Flores is now pushing ahead with the high-profile ex-Novartis chief Joe Jimenez as chairman.

Jimenez’s greatest fame at Novartis was earned for one of its weakest products, as their pioneering personalized CAR-T Kymriah won the honors for the first such drug to make it to the market. Now a host of players, including Century, are barreling in behind the frontrunners with allogeneic rivals that can be created for off-the-shelf use.

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An em­ploy­ee com­plaint at Eli Lil­ly's Branch­burg plant al­leges al­tered qual­i­ty con­trol docs amid FDA probe — re­port

Eli Lilly was one of the earliest players in the race for a Covid-19 antibody, but a series of setbacks at a New Jersey manufacturing site have set back its efforts. Now, an internal complaint reportedly claims that a director at that site knowingly fudged quality control docs right under the FDA’s nose.

An employee complaint from Eli Lilly’s manufacturing plant in Branchburg, NJ, alleged that a director altered documents handed over to FDA regulators as part of an effort to downplay serious quality control issues amid the agency’s probe at the site, Reuters reported.