Sanj Patel, Kiniksa CEO (Kiniksa via YouTube)

UP­DAT­ED: Roche, Genen­tech place a $100M bet on fi­bro­sis, nab­bing PhII pro­gram from Kiniksa

As par­ent com­pa­ny Roche aims to se­cure a place in the al­lo­gene­ic CAR-T ther­a­py race, Genen­tech is spin­ning its own deal to jump in­to fi­bro­sis with a pro­gram from Kiniksa.

Genen­tech shelled out $80 mil­lion in up­front cash and an­oth­er $20 mil­lion in near-term pay­ments to li­cense Kiniksa’s vixare­limab, for­mer­ly known as KPL-716, and shep­herd it in­to new clin­i­cal stud­ies, the com­pa­nies an­nounced Wednes­day. If all the mile­stones are achieved, Kiniksa could stand to gain an­oth­er $600 mil­lion. In­vestor re­ac­tion to the deal was mut­ed, as Kiniksa shares $KN­SA were up about 1% in pre-mar­ket trad­ing Wednes­day.

Sep­pi Lin, Genen­tech’s ear­ly de­vel­op­ment chief for oph­thal­mol­o­gy, me­tab­o­lism, neu­ro­science and im­munol­o­gy, tells End­points News in an email that the com­pa­ny in­tends to launch Phase II stud­ies for vixare­limab in id­io­path­ic pul­monary fi­bro­sis/in­ter­sti­tial lung dis­ease some­time in 2023.

With the fo­cus in IPF, the pro­gram will face a bit of a shift as Kiniksa had been de­vel­op­ing vixare­limab pri­mar­i­ly in pruri­go nodu­laris, a chron­ic skin con­di­tion. The biotech had re­ceived break­through ther­a­py des­ig­na­tion in the in­di­ca­tion in 2020, but Kiniksa now will not re­port da­ta from a Phase IIb tri­al in pruri­go nodu­laris pa­tients, even though it plans to com­plete the study.

Roche and Genen­tech pulled off the deal the same day the big Swiss con­glom­er­ate signed a new part­ner­ship with Po­sei­da Ther­a­peu­tics, plac­ing a big bet on al­lo­gene­ic CAR-T. Roche plunked down $220 mil­lion in up­front and near-term cash and is promis­ing Po­sei­da more than $6 bil­lion in biobucks.

Vixare­limab, mean­while, is a mon­o­clon­al an­ti­body that tar­gets on­co­statin M re­cep­tor be­ta, or OSM­Rβ, which Kiniksa says can af­fect the sig­nal­ing of both IL-31 and on­co­statin M, two cy­tokines im­pli­cat­ed in fi­brot­ic dis­eases. Kiniksa had start­ed the Phase IIb tri­al in late 2020, aim­ing to test three dos­ing lev­els com­pared to place­bo.

A pre­vi­ous Phase IIa study met its pri­ma­ry end­point in pruri­go nodu­laris, Kiniksa said in April 2020.

For Kiniksa, the deal will al­low ex­ecs to con­tin­ue pur­su­ing oth­er BD op­por­tu­ni­ties and pro­vide run­way in­to 2025, CEO Sanj Pa­tel said on an in­vestor call Wednes­day morn­ing. He de­clined to get in­to more specifics, how­ev­er, say­ing on­ly the com­pa­ny would be ac­tive in do­ing so in re­sponse to an an­a­lyst ques­tion.

Ed­i­tor’s note: This ar­ti­cle has been up­dat­ed to in­clude com­ment from Genen­tech.

UP­DAT­ED: In a fresh dis­ap­point­ment, Am­gen spot­lights a ma­jor safe­ty is­sue with KRAS com­bo

Amgen had hoped that its latest study matching its landmark KRAS G12C drug Lumakras with checkpoint inhibitors would open up its treatment horizons and expand its commercial potential. Instead, the combo spurred safety issues that blunted efficacy and forced the pharma giant to alter course on its treatment strategy, once again disappointing analysts who have been tracking the drug’s faltering sales and limited therapeutic reach.

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Ad­dress­ing the ‘Ca­pac­i­ty Crunch’ with a Scal­able Plat­form Process Ap­proach

The field of gene therapy has been diligently moving forward over the past several decades to bring potentially life-saving treatments to patients with genetic diseases. In addition to two approved adeno-associated viral (AAV) gene therapies, there are more than 250 AAV gene therapies in various clinical trial stages.1 AAV vectors remain the most frequently used vector for delivering therapeutic transgenes to target tissues due to their demonstrated and lasting clinical efficacy and extensive safety track record. As AAV therapies advance through clinical trials and into commercialization, many biotech companies are turning to contract development and manufacturing organizations (CDMOs) to prepare their programs for late-stage clinical and commercial scale manufacturing. Given the scope and scale of the manufacturing needs that will accompany regulatory approvals for these assets, CDMOs continue to expand their capacity to meet the needs of increasing prevalent patient populations. However, despite rapid growth, projected gene therapy manufacturing demands still outpace the collective capacity of the CDMO industry.

A $5B Pfiz­er buy­out? Am­gen, Gilead head­line M&A Thurs­day; Al­ny­lam's AT­TR sweep; An­drew Lo's rare dis­ease quest; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

One of the cool things about adding EndpointsPharma to the daily roster is that my colleagues can now dedicate time to tracking quarterly updates and tuning into calls with Big Pharma companies. Check out their dispatch from the Q2 earnings below.

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Albert Bourla, Pfizer CEO (Laurent Gillieron/Keystone via AP)

Break­ing: Pfiz­er in hot pur­suit of a $5B buy­out of Glob­al Blood Ther­a­peu­tics — re­port

Pfizer CEO Albert Bourla has vowed to leave no stone unturned in the search for new biotech deals, and the BD team is not letting him down.

The Wall Street Journal reported today that Pfizer is in the final stages of acquiring Global Blood Therapeutics for $5 billion. According to the Journal report, though, Pfizer is not the only buyer at the deal table and while the pharma giant may be close to clinching it, there are no guarantees it will continue.

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Bob Bradway, Amgen CEO (Justin Kase Conder/AP Images for Amgen)

UP­DAT­ED: Am­gen chief Brad­way nabs a rare dis­ease play­er in $4B buy­out as the M&A tem­po ac­cel­er­ates

Amgen CEO Bob Bradway is bellying up to the M&A table today, scooping up the newly anointed commercial biotech ChemoCentryx $CCXI and its recently approved rare disease drug for $3.7 billion out of the cash stockpile. The deal comes in at $52 a share — a hefty increase over the $24.11 close yesterday.

Bradway and the Amgen team get a drug called Tavneos (avacopan) in the deal, a complement factor C5a inhibitor OK’d to treat anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis, an autoimmune disease which can be lethal.

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George Yancopoulos, Regeneron president and CSO (Brendan McDermid/Reuters/Alamy)

George Yan­copou­los says he's on the trail of the holy grail: ‘This could rep­re­sent the next break­through for im­munother­a­py’

Two of the most outspoken — and successful — drug developers in biotech say they’ve collected early-stage clinical data that are pointing them down the trail to the holy grail in cancer immunotherapy R&D.

While analysts largely busied themselves today with chronicling the ongoing success of Regeneron’s two big cash cows — Dupixent and Eylea — chief scientist George Yancopoulos and CEO Len Schleifer used the Q2 call to spotlight their early success with a combination of the “homegrown” PSMAxCD28 costimulatory bispecific antibody REGN5678 in combination with their PD-1 checkpoint Libtayo. The presentation comes just weeks after Regeneron completed a deal to gather all rights to the PD-1 that had been in Sanofi’s hands. And the two top execs are unstinting in their praise of the potential of a whole set of costimulatory pipeline projects which they say may finally deliver the long-awaited next-level approach to broadening the immunotherapy field of drugs.

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(AP Photo/Richard Vogel, File)

US de­clares mon­key­pox a na­tion­al health emer­gency, as new drug­mak­ers con­sid­er en­ter­ing vac­cine race

Rising monkeypox cases have put the US on high alert as it announces a national health emergency, which grants the government more power in its response.

The news comes as Bavarian Nordic continues to fill orders for its Jynneos vaccine and other companies – including Moderna – consider jumping into the vaccine race. Meanwhile, the New York Times reports that the US has allowed around 20 million doses of smallpox vaccine in its stockpile to expire.

Vlad Coric, Biohaven CEO

Bio­haven touts surge in Nurtec sales ahead of Pfiz­er takeover

Forget buyer’s remorse, Pfizer is likely feeling pretty good about its $11.6 billion Biohaven takeover deal following reports of a 57% sales boost for migraine med Nurtec.

Biohaven reported in Q2 results on Friday that it’s cleared the necessary antitrust hurdles to move forward with the sale of its calcitonin gene-related peptide (CGRP) assets to Pfizer. However, because the company is “focused on workstreams related to the closing” of the deal, it did not host a call with analysts and investors.

Pharma ads are showing up on cooler screens at retail pharmacies, including Walgreens and CVS, under a new OptimizeRx deal (OptimizeRx)

Phar­ma brands chill in the phar­ma­cy re­tail aisle with new style ads on re­frig­er­a­tion screens

Want a prescription drug with that soda? While not directly possible, ads for pharma brands now running on beverage and snack cooler screens at pharmacy retailers may at least inspire customers to think about it.

OptimizeRx is hooking up with Cooler Screens media company to bring prescription drug advertising to refrigerator front doors at pharmacies including Walgreens, CVS and Kroger.

The “point of dispense” ads show a full-door image on the cooler doors when a shopper is 12 feet away, but shrinks down to a smaller banner-sized ad so that the refrigerator contents can be seen when a person gets closer. The doors — which have to be specially installed by Cooler Screens — can detect when a person is nearby, how long a person “dwells” in front of the ad and if they do or don’t open the door.

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