Re­gen­eron, Sanofi are ready to de­but the 6th PD-1/L1. Is it still pos­si­ble to stand out from the grow­ing crowd?

Re­gen­eron $REGN and Sanofi $SNY rolled out an up­date on their PD-1 check­point cemi­plimab this morn­ing, demon­strat­ing that the promis­ing ear­ly da­ta they had seen on a high re­sponse rate for a dead­ly skin can­cer re­mained in­tact for close to half of all the pa­tients en­rolled in the piv­otal Phase II tri­al.

In­ves­ti­ga­tors came up with a 46.3% ORR for ad­vanced cu­ta­neous squa­mous cell car­ci­no­ma in the study, which is be­ing tak­en to reg­u­la­tors in search of a quick OK for what will like­ly be the world’s sixth PD-1/L1 ther­a­py to hit the mar­ket. Ac­cord­ing to re­cent re­search from the Can­cer Re­search In­sti­tute, there are an­oth­er 49 PD-1/L1 check­points in clin­i­cal de­vel­op­ment, with hun­dreds more in pre­clin­i­cal re­search.

Is­rael Lowy, Re­gen­eron

This one, though, has been held up by the re­search team as po­ten­tial­ly su­pe­ri­or to much of the rest of the field. Top in­ves­ti­ga­tors in the pro­gram have high­light­ed their be­lief that PD-1 is a fun­da­men­tal­ly su­pe­ri­or ap­proach than PD-L1 — though they have yet to prove that. The two big part­ners are al­so once again re­ly­ing on Re­gen­eron’s fa­mous an­ti­body fac­to­ry to stand out from the crowd with a check­point that won the FDA’s break­through des­ig­na­tion.

There’s still no fi­nal take on the du­ra­tion of the re­sponse, with Sanofi say­ing that 32 of 38 re­spons­es among the 82 pa­tients en­rolled are con­tin­u­ing.

It’s no co­in­ci­dence that Sanofi arranged to de­clare the piv­otal da­ta to­day, right at the be­gin­ning of its an­nu­al R&D day. For the phar­ma gi­ant it’s a chance to demon­strate that it has the R&D fire­pow­er need­ed to come up with im­por­tant new ther­a­pies — even if much of the in­no­va­tion is still com­ing from its part­ners at Re­gen­eron.

Skep­tics, though, aren’t see­ing any­thing new with to­day’s up­dates. Still, Sanofi can use this PD-1 to cre­ate its own com­bos as it sets the stage for a re­newed R&D ef­fort on the on­col­o­gy front, af­ter some se­ri­ous set­backs forced an ear­li­er re­or­ga­ni­za­tion. But Baird’s Bri­an Sko­r­ney says that at this point no-one should think a launch will be easy, or quick­ly prof­itable. He notes;

Sales of Keytru­da and Op­di­vo are on track for $3.8B and $4.8B, re­spec­tive­ly, this year. Tecen­triq, the third to mar­ket two years lat­er, is on track for about $500M, while Baven­cio and Imfinzi, both ap­proved this year, have sold close to noth­ing. Com­pet­ing in the ma­jor PD-(L)1 in­di­ca­tions such as melanoma, NSCLC, etc. will there­fore like­ly be very dif­fi­cult. Though we don’t dis­agree that front-line NSCLC is a huge op­por­tu­ni­ty, the pletho­ra of dis­ap­point­ing da­ta in NSCLC with ap­proved agents presents an un­re­al­is­ti­cal­ly high hur­dle for man­age­ment to ex­pect to eas­i­ly cross.

Is­rael Lowy, Re­gen­eron’s lead sci­en­tist on the pro­gram, had this to say:

This is the largest prospec­tive study ever con­duct­ed in this dis­ease, and we are pleased that many peo­ple were able to achieve deep and durable re­spons­es with cemi­plimab monother­a­py. The high and durable re­sponse rates seen in this study are par­tic­u­lar­ly no­table giv­en that the study en­rolled pa­tients re­gard­less of bio­mark­er sta­tus.

The rolling sub­mis­sion will be wrapped in Q1.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

The End­points 11: They've got mad mon­ey and huge am­bi­tions. It's time to go big or go home

These days, selecting a group of private biotechs for the Endpoints 11 spotlight begins with a sprint to get ahead of IPOs and the M&A teams at Big Pharma. I’ve had a couple of faceplants earlier this year, watching some of the biotechs on my short list choose a quick leap onto Nasdaq or into the arms of a buyer.

Vividion, you would have been a great pick for the Endpoints 11. I’m sorry I missed you.

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Dave Lennon, former president of Novartis Gene Therapies

So what hap­pened with No­var­tis Gene Ther­a­pies? Here's your an­swer

Over the last couple of days it’s become clear that the gene therapy division at Novartis has quietly undergone a major reorganization. We learned on Monday that Dave Lennon, who had pursued a high-profile role as president of the unit with 1,500 people, had left the pharma giant to take over as CEO of a startup.

Like a lot of the majors, Novartis is an open highway for head hunters, or anyone looking to staff a startup. So that was news but not completely unexpected.

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Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

FDA+ roundup: Bs­U­FA III ready for show­time, court tells FDA to re-work com­pound­ing plan, new guid­ance up­dates and more

The FDA has now spelled out what exactly will be included in the third iteration of Biosimilar User Fee Act (BsUFA) from 2023 through 2027, which similarly to the prescription drug deal, sets fees that industry has to pay for submitting applications, in exchange for firm timelines that the agency must meet.

This latest deal includes several sweeteners for the biosimilar industry, which has yet to make great strides in the US market, with shorter review timelines for safety labeling updates and updates to add or remove an indication that does not contain efficacy data.

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Joshua Liang, Clover Biopharmaceuticals CEO

With world still in sore need of dos­es, Clover says its Covid-19 vac­cine is 67% ef­fec­tive in Phase III

With concerns about the Delta variant rising and much of the world still in desperate need of vaccine doses, a Chinese biotech announced Wednesday that a new shot has shown positive results in a large trial against Covid-19, including new variants.

Clover Biopharmaceuticals announced Wednesday that its vaccine candidate showed 79% efficacy against the Delta variant in a Phase II/III trial dubbed Spectra, and 67% effective against Covid-19 overall.

Jean Bennett (Brent N. Clarke/Invision/AP Images)

Lux­tur­na in­ven­tor Jean Ben­nett starts a new gene ther­a­py com­pa­ny to tack­le rare dis­eases left be­hind by phar­ma, VCs

A few years ago Jean Bennett found herself in a surprising place for a woman who invented the first gene therapy ever approved in the United States: No one, it seemed, wanted her work.

Bennett, who designed and co-developed Luxturna, approved in 2018 for a rare form of blindness, had kept building new gene therapies for eye diseases at her University of Pennsylvania lab. But although the results in animals looked promising, pharma companies and investors kept turning down the pedigreed ophthalmology professor.

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David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.