BeiGene lines up a next-gen CT­LA-4 to com­ple­ment its PD-1 pil­lar in new deal worth up to $270M

BeiGene is jump­ing on the band­wag­on for PD-(L)1/CT­LA-4 com­bos — with a twist.

Through a de­vel­op­ment and com­mer­cial­iza­tion pact with San Diego-based BioAt­la, BeiGene is pair­ing its PD-1 drug tislelizum­ab with BA3071, a CT­LA-4 block­ing “con­di­tion­al­ly ac­tive bi­o­log­ic” that gets turned on or off based on whether it’s in­side the tu­mor mi­croen­vi­ron­ment.

Scott Smith

San Diego-based BioAt­la is re­spon­si­ble for ear­ly clin­i­cal work, while BeiGene will lead the joint ef­forts there­after to de­vel­op the com­bo and deal with reg­u­la­tors around the world. The Chi­nese biotech, which is com­mit­ting $20 mil­lion up­front and $249 mil­lion in biobucks as well as a cost-shar­ing scheme, is al­so pick­ing up all costs in Asia (ex­cept Japan), Aus­tralia and New Zealand from here on out. It has a full li­cense to com­mer­cial­iza­tion rights.

CT­LA-4 was the first check­point to hit the mar­ket, with Bris­tol-My­ers snag­ging boast­ing rights with Yer­voy. But while ef­fec­tive in un­leash­ing a T cell re­sponse and im­prov­ing sur­vival rates, their sig­nif­i­cant tox­i­c­i­ty has al­so made their use prob­lem­at­ic and thus thwart­ed their promi­nence. In re­cent years, though, a crop of biotechs has risen up on the promise to tar­get CT­LA-4 with high­er speci­fici­ty as CT­LA-4 re­mains the hottest add-on in PD-(L) com­bo stud­ies.

It is this back­drop that BioAt­la has en­tered with its plat­form, which de­signs drugs that on­ly bind to the tar­get when they sense the unique phys­i­ol­o­gy and me­tab­o­lism of a tu­mor. In ad­di­tion to an­ti­bod­ies like BA3071, the plat­form can al­so give birth to an­ti­body drug con­ju­gates, bis­pecifics and CAR-Ts.

BioAt­la pres­i­dent Scott Smith (yes, the for­mer Cel­gene COO) says the deal fits with its strat­e­gy for ad­vanc­ing CABs be­yond clin­i­cal proof-of-con­cept, as BeiGene is “a rec­og­nized leader in Chi­na-in­clu­sive glob­al clin­i­cal de­vel­op­ment.”

The com­pa­ny is prep­ping an im­mi­nent first IND fil­ing for both the BA3071 monother­a­py and the com­bo with tislelizum­ab, with a Phase I/II ex­pect­ed to start in the sec­ond half of 2019.

For BeiGene, the deal marks an­oth­er ad­di­tion to the broad pipeline around tislelizum­ab, which spans a dozen so­lo in­di­ca­tions as well as ear­ly com­bo stud­ies with its own PARP and BTK in­hibitors.


Im­age: BeiGene

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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Cracks in the fa­cade: Is phar­ma's pan­dem­ic ‘feel good fac­tor’ wan­ing?

The discordant effects of the Covid-19 pandemic on pharma reputation continues. While the overall industry still retains a respectable halo from its Covid-19 quick response and leadership, a new patient group study reveals a different story emerging in the details.

On one hand, US patient advocacy groups rated the industry higher-than-ever overall. More than two-thirds (67%) of groups gave the industry a thumbs up for 2021, a whopping 10 percentage point increase over the year before, according to the PatientView annual study, now in its 9th year.

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Michael Corbo, Pfizer CDO of inflammation & immunology

UP­DAT­ED: Plan­ning ahead for crowd­ed ul­cer­a­tive col­i­tis mar­ket, Pfiz­er spells out PhI­II da­ta on $6.7B Are­na drug

Pfizer has laid out the detailed results behind its boast that etrasimod — the S1P receptor modulator at the center of its $6.7 billion buyout of Arena Pharma — is the winner of the class, potentially leapfrogging an earlier entrant from Bristol Myers Squibb.

Pivotal data from the ELEVATE program in ulcerative colitis — which consists of two Phase III trials, one lasting 52 weeks and the other just 12 weeks — illustrate an “encouraging balance of efficacy and safety,” according to Michael Corbo, chief development officer of inflammation & immunology at Pfizer. The company is presenting the results as a late breaker at Digestive Disease Week.

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Lil­ly's mirik­izum­ab, once a con­tender for pso­ri­a­sis, bol­sters case for UC in­di­ca­tion in main­te­nance tri­al da­ta read­out

Early last year, Eli Lilly announced that instead of taking its blockbuster contender mirikizumab forward to the FDA for psoriasis, it would be essentially going nowhere in the indication. Instead, the pharma then announced in its Q1 ’21 earnings statement that it would be focusing on ulcerative colitis and Crohn’s disease indications in a sudden about-face.

And as the drug is before the FDA for potential approval for the first indication of ulcerative colitis, the megapharma is now ready to reveal more data to bolster its case.

Co­pay coupons gone wrong, again: Pfiz­er pays al­most $300K to set­tle com­plaints in four states

Pfizer has agreed to pay $290,000 to settle allegations of questionable copay coupon practices in Arizona, Colorado, Kansas, and Vermont from 2014 to 2018.

While the company has not admitted any wrongdoing as part of the settlement, Pfizer has agreed to issue restitution checks to about 5,000 consumers.

A Pfizer spokesperson said the company has “enhanced its co-pay coupons to alleviate the concerns raised by states and agreed to a $30,000 payment to each.”

Delaware court rules against Gilead and Astel­las in years-long patent case

A judge in Delaware has ruled against Astellas Pharma and Gilead in a long-running patent case over Pfizer-onwed Hospira’s generic version of Lexiscan.

The case kicked off in 2018, after Hospira submitted an Abbreviated New Drug Application (ANDA) for approval to market a generic version of Gilead’s Lexiscan. The drug is used in myocardial perfusion imaging (MPI), a type of nuclear stress test.

Taye Diggs (courtesy Idorsia)

Idor­sia inks an­oth­er celebri­ty en­dors­er deal with ac­tor and dad Taye Dig­gs as Qu­viviq in­som­nia am­bas­sador

Idorsia’s latest Quviviq insomnia campaign details the relatable dad story of a well-known celebrity — actor and Broadway star Taye Diggs.

Diggs stopped sleeping well after the birth of his son, now more than 10 years ago. Switching mom-and-dad nightly shifts to take care of a baby interrupted his sleep patterns and led to insomnia.

“When you’re lucky enough to be living out your dream and doing what you want, but because of something as simple as a lack of sleep, you’re unable to do that, it felt absolutely — it was treacherous,” he says in an interview-style video on the Quviviq website.

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Belén Garijo, Merck KGaA CEO (Kevin Wolf/AP Images for EMD Serono)

Mer­ck KGaA pumps €440M in­to ex­pand­ing and con­struct­ing Irish man­u­fac­tur­ing fa­cil­i­ties

The area of Ireland famous for Blarney Castle and its cliffsides along the Atlantic Ocean is seeing Merck KGaA expand its commitment there.

The German drug manufacturer is expanding its membrane and filtration manufacturing capabilities in Ireland. The company will invest approximately €440 million ($470 million) to increase membrane manufacturing capacity in Carrigtwohill, Ireland, and build a new manufacturing facility at Blarney Business Park, in County Cork, Ireland.

Rep. Katie Porter (D-CA) (Michael Brochstein/Sipa USA/Sipa via AP Images)

House Dems to Sen­ate lead­er­ship: Quick­ly move a rec­on­cil­i­a­tion bill with drug price ne­go­ti­a­tion re­forms

Twenty House Democrats, including Reps. Katie Porter of California and Susan Wild of Pennsylvania, are calling on Senate leaders to move quickly with a reconciliation bill (meaning they only need a simple majority for passage) with prescription drug pricing reforms, and to include adding new authority for Medicare to negotiate drug prices.

They also called on the Senate to specifically follow suit with the House passage of a $35 per month insulin cap (as Senate Majority Leader Chuck Schumer’s deadline for a vote on that provision has come and gone), and to cap Medicare Part D costs at $2,000 per year for seniors.