Bris­tol-My­ers part­ner In­nate con­cedes a PhII flop for I/O drug lir­ilum­ab in fight­ing AML

Mond­her Mahjoubi, In­nate Phar­ma CEO

More than five years ago Bris­tol-My­ers Squibb her­ald­ed a $465 mil­lion deal to part­ner with In­nate Phar­ma on its nat­ur­al killer cell can­cer drug lir­ilum­ab. But to­day the French biotech was forced to con­cede that its lead drug was no bet­ter than a place­bo in fight­ing acute myeloid leukemia as a monother­a­py.

Car­ry­ing out plans to han­dle de­vel­op­ment through Phase II, Mar­seilles-based In­nate ex­ecs said that lir­ilum­ab flunked a Phase II tri­al test­ing the drug as a sin­gle agent. There was no ev­i­dence that the drug was any bet­ter than place­bo in spurring a leukemia-free out­come for pa­tients in a main­te­nance set­ting.

Shares of In­nate (Eu­ronext Paris: IPH) dropped 14% on the news, which must have come as an un­wel­come sur­prise to new CEO Mond­her Mahjoubi, who re­cent­ly took the helm af­ter he was wooed from a top-lev­el job at As­traZeneca.

In­ves­ti­ga­tors had al­ready halt­ed work on one of two dos­es — the 1 mg/kg q1month group — close to two years ago af­ter the da­ta safe­ty mon­i­tor­ing board con­clud­ed that it wasn’t work­ing to pa­tients’ ad­van­tage. The fi­nal read­out came on the 0.1 mg/kg q3months group.

The drug is an an­ti­body de­signed to in­ter­fere with the in­ter­ac­tion of killer-cell im­munoglob­u­lin-like re­cep­tors on NK cells with their lig­ands, hope­ful­ly spurring a more ef­fec­tive nat­ur­al killer cell at­tack on can­cer cells. Bris­tol-My­ers saw that as a nat­ur­al com­bi­na­tion ap­proach with Op­di­vo and the two com­pa­nies launched six oth­er stud­ies for var­i­ous com­bi­na­tion ap­proach­es. Those com­bo tri­als will pro­ceed.

This is the lat­est in a se­ries of clin­i­cal set­backs for Bris­tol-My­ers’ Op­di­vo, which has been pum­meled by the swift ad­vance of Mer­ck’s Keytru­da in front­line lung can­cer. Check­point in­hibitors have been put in­to dozens of com­bi­na­tion stud­ies as de­vel­op­ers look for bet­ter re­sults in fight­ing can­cer.

In­ves­ti­ga­tors re­cruit­ed 150 pa­tients for the study.

Pierre Do­di­on, Chief Med­ical Of­fi­cer of In­nate Phar­ma, said:

“Al­though we knew that this set­ting was chal­leng­ing, we are dis­ap­point­ed by the re­sults of the Ef­fiKIR study and will in­ves­ti­gate fur­ther to bet­ter un­der­stand the da­ta in its en­tire­ty. How­ev­er, Ef­fikir is on­ly one of sev­en stud­ies cur­rent­ly in­ves­ti­gat­ing lir­ilum­ab. Lir­ilum­ab is test­ed in a broad and com­pre­hen­sive com­bi­na­tion pro­gram in mul­ti­ple in­di­ca­tions and we saw en­cour­ag­ing ear­ly ef­fi­ca­cy sig­nals of lir­ilum­ab in com­bi­na­tion with nivolum­ab at the 2016 SITC meet­ing. We are look­ing for­ward to the next da­ta sets as well as the next steps for the pro­gram in 2017.”

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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Novavax site in Gaithersburg, MD. Novavax

Beef­ing up its new gene ther­a­py unit, Catal­ent inks $18M deal to snap up No­vavax fa­cil­i­ties

Catal­ent’s hunt for rapid growth on the gene ther­a­py front — ce­ment­ed with a $1.2 bil­lion ac­qui­si­tion of Paragon Bio­sciences two months ago — has led them to the vac­cine mak­ers at No­vavax.

With an $18 mil­lion pay­ment, Paragon is tak­ing over two No­vavax sites in Gaithers­burg, MD, in­clud­ing more than 100 of the em­ploy­ees al­ready work­ing there. That’s in ad­di­tion to a sig­nif­i­cant re­duc­tion in op­er­at­ing costs, says the com­pa­ny, as No­vavax shifts to re­ly on Paragon for GMP ma­te­ri­als in clin­i­cal tri­als and, even­tu­al­ly, com­mer­cial sup­ply of their prod­ucts.

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.