Sanofi, Re­gen­eron earn ‘break­through’ sta­tus for a fast-track drug out to prove PD-1 dom­i­nance

Can an ex­per­i­men­tal PD-1 drug still of­fer break­through po­ten­tial?

The FDA to­day said yes, hand­ing out its break­through ther­a­py des­ig­na­tion for the new­ly dubbed cemi­plimab (REGN2810) from Re­gen­eron and its long­time Big Phar­ma part­ner Sanofi.

Reg­u­la­tors hand­ed out the ti­tle — good for open­ing doors at the FDA for de­vel­op­ment ex­ec­u­tives in a rush — in metasta­t­ic cu­ta­neous squa­mous cell car­ci­no­ma and adults with lo­cal­ly ad­vanced and un­re­sectable CSCC, the sec­ond dead­liest skin can­cer af­ter melanoma.

In an ear­ly-stage co­hort with on­ly 26 pa­tients, the PD-1 drug was as­so­ci­at­ed with a 46% over­all re­sponse rate and a 69% dis­ease con­trol rate. The FDA, which now has con­sid­er­able ex­pe­ri­ence in shep­herd­ing the first 5 PD-(L)1 to their first ap­provals, did not over­look the im­pli­ca­tions here.

With the help of reg­u­la­tors, can­cer-fo­cused bio­phar­ma com­pa­nies have rev­o­lu­tion­ized on­col­o­gy pro­grams. In this case, Re­gen­eron and Sanofi are al­ready gear­ing up for a reg­u­la­to­ry fil­ing with­in the next 7 months — on a new ther­a­py al­ready al­so in a late-stage study as a first-line drug for non-small cell lung can­cer and a Phase II in metasta­t­ic and lo­cal­ly ad­vanced basal cell car­ci­no­ma.

Re­searchers for these two com­pa­nies tell me that this ther­a­py has the po­ten­tial to prove that a PD-1 is in­her­ent­ly su­pe­ri­or to PD-L1. (Sanofi R&D chief Elias Zer­houni is re­luc­tant to go that far at this point, but is hap­py to hint it may prove so.)

If they’re right, the com­pa­nies have a chance of leapfrog­ging check­points al­ready on the mar­ket as they look to grab the lead in key can­cer types. To­day’s BTD helps keep them in a spot­light at a time that PD-(L)1s have been mul­ti­ply­ing in the clin­ic, with a host of com­pa­nies look­ing to de­vel­op an in-house drug they can use for their own com­bi­na­tions.

Un­less these drugs can clear­ly dis­tin­guish them­selves from each oth­er, as Sanofi and Re­gen­eron plan to do, then we could be on the verge of see­ing a com­modi­ti­za­tion of check­points.

Bil­lions of dol­lars in rev­enue is at stake.

Im­age: Elias Zer­houni, Sanofi’s pres­i­dent of glob­al R&D, speaks in Paris last year Vin­cent Isore/IP3/Get­ty

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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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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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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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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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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Fangliang Zhang (Imaginechina via AP Images)

The big mon­ey: Poised to make drug R&D his­to­ry, a Chi­na biotech un­veils uni­corn rac­ing am­bi­tions in a bid to raise $350M-plus on Nas­daq

Almost exactly three years after Shanghai-based Legend came out of nowhere to steal the show at ASCO with jaw-dropping data on their BCMA-targeted CAR-T for multiple myeloma, the little player with Big Pharma connections is taking a giant step toward making it big on Wall Street. And this time they want to seal the deal on a global rep after staking out a unicorn valuation in what’s turned out to be a bull market for biotech IPOs — in the middle of a pandemic.

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No­var­tis chips in $10M for IPO-bound part­ner Pli­ant; Tenax shares soar on heart drug da­ta

Novartis is coming in with $10 million to help support the looming IPO of a partner. Pliant Therapeutics posted a new filing with the SEC showing that Novartis is buying the shares at $15, the mid-point of the range. It’s adding several million shares to the offering, bringing the total to around $135 million. Biotech companies have been enjoying quite a run on virtual Wall Street, with investors boosting new offerings to some big hauls.