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.

Zo­genix plans quick re­turn to the FDA with their spurned ap­pli­ca­tion on Dravet syn­drome drug — shares spike

Zo­genix shares are claw­ing back some of the val­ue they lost 2 months ago af­ter the FDA hit the biotech with a refuse-to-file no­tice on their ex­per­i­men­tal ther­a­py for Dravet syn­drome. 

Com­pa­ny ex­ecs said this morn­ing that they worked out reg­u­la­tors’  is­sues with the ap­pli­ca­tion for Fin­tepla, which cen­tered on a pair of big prob­lems: the ab­sence of non-clin­i­cal stud­ies need­ed to al­low as­sess­ment of the chron­ic ad­min­is­tra­tion of fen­flu­ramine and the in­clu­sion of an in­cor­rect ver­sion of a clin­i­cal dataset. Now they plan to re­sub­mit in Q3 af­ter get­ting off the hook on both scores — which trig­gered a sigh of re­lief among in­vestors.

Brent Saunders [Getty Photos]

UP­DAT­ED: Ab­b­Vie seals $63B deal to buy a trou­bled Al­ler­gan — spelling out $1B in R&D cuts

Brent Saunders has found his way out of the current fix he’s in at Allergan $AGN. He’s selling the company to AbbVie for $63 billion in the latest example of the hot M&A market in biopharma.

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Turned back at the FDA, Im­muno­Gen is ax­ing 220 staffers, sell­ing pro­grams and hun­ker­ing down for a new PhI­II gam­ble

After being stymied by FDA regulators who were unconvinced by ImmunoGen’s $IMGN desperation shot at an accelerated OK based on a secondary endpoint, the struggling biotech is slashing its workforce, shuttering R&D projects and looking for buyers to pick up some of its experimental cancer assets as it goes back into a new Phase III with the lead drug.

We found out last month that the FDA had batted back their case for an accelerated approval of their antibody-drug conjugate mirvetuximab soravtansine, which had earlier failed a Phase III study for ovarian cancer. Now the other shoe is dropping.

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As­traZeneca chal­lenges Roche on front­line SCLC af­ter seiz­ing an in­ter­im win — and Mer­ck may not be far be­hind

The crowded playing field in the PD-1/L1 marketing game is about to get a little more complex.

This morning AstraZeneca reported that its CASPIAN study delivered a hit in an interim readout for their PD-L1 Imfinzi combined with etoposide and platinum-based chemotherapy options for frontline cases of small cell lung cancer, a tough target which has already knocked back Bristol-Myers’ shot in second-line cases. The positive data  — which we won’t see before they roll it out at an upcoming scientific conference — give AstraZeneca excellent odds of a quick vault to challenging Roche’s Tecentriq-chemo combo, approved 3 months ago for frontline SCLC in a landmark advance.

“This is the first trial offering the flexibility of combining immunotherapy with different platinum-based regimens in small cell lung cancer, expanding treatment options,” noted AstraZeneca cancer R&D chief José Baselga in a statement.

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Bridge­Bio takes crown for biggest biotech IPO of 2019, as fel­low uni­corn Adap­tive rais­es of­fer­ing size and price

Bridge­Bio Phar­ma and Adap­tive Biotech­nolo­gies have not just up­sized IPO of­fer­ings — the pair of uni­corns have al­so raised their of­fer­ing prices above the range, haul­ing in a com­bined $648.5 mil­lion.

Neil Ku­mar’s Bridge­Bio Phar­ma, found­ed in 2015, has a sta­ble of com­pa­nies fo­cused on dis­eases that are dri­ven by de­fects in a sin­gle gene — en­com­pass­ing der­ma­tol­ogy, car­di­ol­o­gy, neu­rol­o­gy, en­docrinol­o­gy, re­nal dis­ease, and oph­thal­mol­o­gy — and can­cers with clear ge­net­ic dri­vers. The start­up mill birthed a pletho­ra of firms such as Ei­dos, Navire, QED Ther­a­peu­tics and Pelle­Pharm, which func­tion as its sub­sidiaries.

Two biotech uni­corns swell pro­posed IPOs, eye­ing a $600M-plus wind­fall

We’ve been wait­ing for the ar­rival of Bridge­Bio’s IPO to top off the wave of new biotech of­fer­ings sweep­ing through Nas­daq at the end of H1. And now we learn that it’s been sub­stan­tial­ly up­sized.

Ini­tial­ly pen­ciled in at a uni­corn-sized $225 mil­lion, the KKR-backed biotech has spiked that to the neigh­bor­hood of $300 mil­lion, look­ing to sell 20 mil­lion shares at $14 to $16 each. That’s an added 5 mil­lion shares, re­ports Re­nais­sance Cap­i­tal, which fig­ures the pro­posed mar­ket val­u­a­tion for Neil Ku­mar’s com­pa­ny at $1.8 bil­lion.

No­var­tis holds back the copy­cat brigade's at­tack on its top drug fran­chise — for now

A fed­er­al judge has put a gener­ic chal­lenge to No­var­tis’ block­buster mul­ti­ple scle­ro­sis drug Gilenya on hold while a patent fight plays out in court.

Judge Leonard P. Stark is­sued a tem­po­rary in­junc­tion ear­li­er this week, forc­ing My­lan, Dr. Red­dy’s Lab­o­ra­to­ries and Au­robindo Phar­ma to shelve their launch plans to al­low the patent fight to pro­ceed. He ruled that al­low­ing the gener­ics in­to the mar­ket now would per­ma­nent­ly slash the price for No­var­tis, even if it pre­vails. 

Novotech CEO Dr. John Moller

Novotech CRO Award­ed Frost & Sul­li­van Best Biotech CRO Asia-Pa­cif­ic 2019

Known in the in­dus­try as the Asia-Pa­cif­ic CRO, Novotech is now lead CRO ser­vices provider for the grow­ing num­ber of in­ter­na­tion­al biotechs se­lect­ing the re­gion for their stud­ies.

Re­flect­ing this Asia-Pa­cif­ic growth, Novotech staff num­bers are up 20% since De­cem­ber 2018 to 600 in-house clin­i­cal re­search peo­ple across a full range of ser­vices, across the re­gion.

Novotech’s ca­pa­bil­i­ties have been rec­og­nized by an­a­lysts like Frost & Sul­li­van, most re­cent­ly with the pres­ti­gious Asia-Pa­cif­ic CRO Biotech of the year award for best prac­tices in clin­i­cal re­search for biotechs for the fifth year. See oth­er awards here.

Af­ter rais­ing $158M, this up­start's founders have star back­ers and plans to break new ground in gene ther­a­py

Back in 2014, Stephanie Tagliatela opted to take an early exit out of her PhD program after working in Mark Bear’s lab at MIT, where she specialized in the synaptic connections between neuronal cells in the brain. She never finished that PhD, but she and fellow MIT student Kartik Ramamoorthi — who was on the founding team at Voyager — came away with some ideas for a gene therapy startup.

Today, fully 5 years later, she and Ramamoorthi are taking the wraps off of a $104 million mega-round designed to take the cumulative work of their preclinical formative stage for Encoded Therapeutics into human studies. They’ve now raised $158 million since starting out in Illumina’s incubator in the Bay Area, and they believe they are firmly on track to do something unique in gene therapy.

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