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.

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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Ken Frazier, AP Images

Why Mer­ck wait­ed, and what they now bring to the Covid-19 fight

Nicholas Kartsonis had been running clinical infectious disease research at Merck for almost 2 years when, in mid-January, he got a new assignment: searching the pharma giant’s vast libraries for something that could treat the novel coronavirus.

The outbreak was barely two weeks old when Kartsonis and a few dozen others got to work, first in small teams and then in a larger task force that sucked in more and more parts of the sprawling company as Covid-19 infected more and more of the globe. By late February, the group began formally searching for vaccine and antiviral candidates to license. Still, while other companies jumped out to announce their programs and, eventually and sometimes controversially, early glimpses at human data, Merck remained silent. They made only a brief announcement about a data collection partnership in April and mentioned vaguely a vaccine and antiviral search in their April 28 earnings call.

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Gilead re­leas­es an­oth­er round of murky remde­sivir re­sults

A month after the NIH declared the first trial on remdesivir in Covid-19 a success, Gilead is out with new results on their antiviral. But although the study met one of its primary endpoints, the data are likely to only add to a growing debate over how effective the drug actually is.

In a Phase III trial, patients given a 5-day dose of remdesivir were 65% more likely to show “clinical improvement” compared to an arm given standard-of-care. The trial, though, gave little indication for whether the drug had an impact on key endpoints such as survival or time-to-recovery. And in a surprising twist, a 10-day dosing arm of remdesivir didn’t lead to a statistically significant improvement over standard of care.

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Len Schleifer (left) and George Yancopoulos, Regeneron (Vimeo)

Eyes on he­mo­phil­ia prize, Re­gen­eron adds a $100M wa­ger on joint de­vel­op­ment cam­paign with In­tel­lia

When George Yancopoulos first signed up Intellia to be its CRISPR/Cas9 partner on gene editing projects 4 years ago, the upstart smartly ramped up its IPO at the same time. Today, Regeneron $REGN is coming back in, adding $100 million in an upfront fee and equity to significantly boot up a whole roster of new development projects.

And they’re highlighting some clinical hemophilia research plans in the process.

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Mark Genovese (Stanford via Twitter)

Gilead woos fil­go­tinib clin­i­cal in­ves­ti­ga­tor from Stan­ford to lead the charge on NASH, in­flam­ma­to­ry dis­eases

With an FDA OK for the use of filgotinib in rheumatoid arthritis expected to drop any day now, Gilead has recruited a new leader from academia to lead its foray into inflammatory diseases.

Mark Genovese — a longtime Stanford professor and most recently the clinical chief in the division of immunology and rheumatology — was the principal investigator in FINCH 2, one of three studies that supported Gilead’s NDA filing. In his new role as SVP, inflammation, he will oversee the clinical development of the entire portfolio.

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Bris­tol My­ers Squib­b's just-launched MS drug Zeposia makes the cut in key ul­cer­a­tive col­i­tis tri­al

In March, Zeposia became the third oral S1P modulator to secure US approval for multiple sclerosis. Now, the drug has succeeded in a key ulcerative colitis study.

The immunomodulator, akin to others in its class, controls lymphocyte trafficking by limiting the white blood cells to the lymphatic system, in the lymph nodes, and thwarting their ability to jam up lymph nodes — precluding their ability to penetrate the bloodstream and the central nervous system.

Stephen Isaacs, Aduro president and CEO (Aduro)

Once a high fly­er, a stag­ger­ing Aduro is auc­tion­ing off most of the pipeline as CEO Stephen Isaacs hands off the shell to new own­ers

After a drumbeat of failure, setbacks and reorganizations over the last few years, Aduro CEO Stephen Isaacs is handing over his largely gutted-out shell of a public company to another biotech company and putting up some questionable assets in a going-out-of-business sale.

Isaacs —who forged a string of high-profile Big Pharma deals along the way — has wrapped a 13-year run at the biotech with one program for kidney disease going to the new owners at Chinook Therapeutics. A host of once-heralded assets like their STING agonist program partnered with Novartis (which dumped their work on ADU-S100 after looking over weak clinical results), the Lilly-allied cGAS-STING inhibitor program and the anti-CD27 program out-licensed to Merck will all be posted for auction under a strategic review process.

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Hill­house re­casts spot­light on Chi­na's biotech scene with $160M round for Shang­hai-based an­ti­body mak­er

Almost two years after first buying into Genor Biopharma’s pipeline of cancer and autoimmune therapies, Hillhouse Capital has led a $160 million cash injection to push the late-stage assets over the finish line while continuing to fund both internal R&D and dealmaking.

The Series B has landed right around the time Genor would have listed on the Hong Kong stock exchange, according to plans reported by Bloomberg late last year. Insiders had said that the company was looking to raise about $200 million.

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