Sanofi be­lieves it’s still not too late to be­come a top play­er in can­cer drug mar­ket

A lit­tle more than two years ago, Sanofi R&D chief Elias Zer­houni sig­naled the phar­ma gi­ant’s sore dis­ap­point­ment in its can­cer pipeline by ax­ing group leader Tal Zaks and 100 in­ves­ti­ga­tors who failed to de­liv­er the kind of ex­cit­ing new on­col­o­gy pro­grams the phar­ma gi­ant had promised to in­vestors.

At the time, Sanofi said it was re­or­ga­niz­ing to cut back ex­pens­es and ab­sorb­ing the rest of the can­cer R&D group in­to the glob­al re­search struc­ture. Then it turned to Re­gen­eron to go to work on a block­buster PD-1 part­ner­ship, which now is mov­ing di­rect­ly in­to piv­otal stud­ies. And Sanofi, which has strug­gled to find a ma­jor ac­qui­si­tion deal it can com­plete, has been ea­ger­ly sig­nal­ing its in­ten­tion to be­come a play­er in im­muno-on­col­o­gy, cer­tain that the big sur­pris­es of the past year — like Bris­tol-My­ers’ big set­back on first-line lung can­cer — in­di­cate that there’s still plen­ty of tro­phies to hunt in the game of block­busters played by the lead­ers in bio­phar­ma.

“It’s not a sprint to one tar­get and that’s it, you’re the win­ner,” Zer­houni told Bloomberg in a new up­date. “The im­muno-on­col­o­gy field will be go­ing through up­heaval and changes in po­si­tion for the next 20 years.”

Sanofi — like Glax­o­SmithK­line, which has al­so been sig­nal­ing a big move back in­to on­col­o­gy — finds it­self way be­hind lead­ers like Mer­ck and Roche and Bris­tol-My­ers Squibb. As­traZeneca has been mak­ing a con­cert­ed ef­fort to be a big play­er in can­cer, and has drugs like Tagris­so, Lyn­parza and its PD-L1 drug Imfinzi to boast about — when they aren’t try­ing to ex­plain away ma­jor set­backs like the failed first-round on the MYS­TIC com­bo in first-line lung can­cer.

While Zer­houni won’t come out and say so, its part­ners at Re­gen­eron have been as­sert­ing for months now that PD-1 is a much bet­ter tar­get than PD-L1 for im­muno-on­col­o­gy. Both dis­man­tle a mech­a­nism that can­cer cells use to di­vert at­ten­tion from im­mune cells, but there’s been a grow­ing dis­cus­sion that PD-1 could prove bet­ter than the oth­ers.

PD-L1 play­ers like Roche would beg to dif­fer, so ex­pect plen­ty of more dis­cus­sion on that point in the years ahead. Iron­i­cal­ly, this de­bate is al­so com­ing at a time that there’s been grow­ing dis­cus­sion around the idea that I/O could be­come com­modi­tized, with a grow­ing sec­ond wave of check­points com­ing from BeiGene/Cel­gene, No­var­tis, In­cyte and more that could wreck pric­ing.

If Sanofi is right, the phar­ma gi­ant could steal a march in a huge and grow­ing new on­col­o­gy mar­ket. But prac­ti­cal­ly all the an­a­lysts have been wait­ing for Sanofi to fol­low up on its failed Medi­va­tion bid and go af­ter a can­cer com­pa­ny that would pro­vide a pipeline at a time the com­pa­ny is fo­cus­ing more on in­ter­nal pro­grams.

“I see lit­tle op­por­tu­ni­ty for late en­trants,” Nick Turn­er, an an­a­lyst at Mirabaud Se­cu­ri­ties in Lon­don, told Bloomberg. “I find it dif­fi­cult, with­out an ac­qui­si­tion, to see how any­body else is go­ing to build a com­pet­i­tive po­si­tion in the PD-1 space.”

That won’t come cheap, es­pe­cial­ly if Em­ma Walm­s­ley at GSK brings out the check­book to mount their own come-from-be­hind strat­e­gy. GSK swapped their late-stage and com­mer­cial can­cer pro­grams to No­var­tis, and now want to be a play­er in the hottest field in bio­phar­ma R&D. Like GSK, Sanofi al­so has to over­come a his­to­ry of mis­er­able in­ter­nal R&D re­sults, which has been aug­ment­ed on­ly through pacts with com­pa­nies like Re­gen­eron or its ac­qui­si­tion of Gen­zyme.

Elias Zer­houni, Sanofi pres­i­dent, glob­al R&D, speak­ing at Sanofi’s gen­er­al share­hold­ers meet­ing last year in Paris. 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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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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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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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.

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.

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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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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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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