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

Tar­get­ing a Po­ten­tial Vul­ner­a­bil­i­ty of Cer­tain Can­cers with DNA Dam­age Re­sponse

Every individual’s DNA is unique, and because of this, every patient responds differently to disease and treatment. It is astonishing how four tiny building blocks of our DNA – A, T, C, G – dictate our health, disease, and how we age.

The tricky thing about DNA is that it is constantly exposed to damage by sources such as ultraviolet light, certain chemicals, toxins, and even natural biochemical processes inside our cells.¹ If ignored, DNA damage will accumulate in replicating cells, giving rise to mutations that can lead to premature aging, cancer, and other diseases.

Roivant par­lays a $450M chunk of eq­ui­ty in biotech buy­out, grab­bing a com­pu­ta­tion­al group to dri­ve dis­cov­ery work

New Roivant CEO Matt Gline has crafted an all-equity upfront deal to buy out a Boston-based biotech that has been toiling for several years now at building a supercomputing-based computational platform to design new drugs. And he’s adding it to the Erector set of science operations that are being built up to support their network of biotech subsidiaries with an eye to growing the pipeline in a play to create a new kind of pharma company.

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Ken Frazier, Merck CEO (Bess Adler/Bloomberg via Getty Images)

UP­DAT­ED: Mer­ck takes a swing at the IL-2 puz­zle­box with a $1.85B play for buzzy Pan­dion and its au­toim­mune hope­fuls

When Roger Perlmutter bid farewell to Merck late last year, the drugmaker perhaps best known now for sales giant Keytruda signaled its intent to take a swing at early-stage novelty with the appointment of discovery head Dean Li. Now, Merck is signing a decent-sized check to bring an IL-2 moonshot into the fold.

Merck will shell out roughly $1.85 billion for Pandion Pharmaceuticals, a biotech hoping to gin up regulatory T cells (Tregs) to treat a range of autoimmune disorders, the drugmaker said Thursday.

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Doug Ingram (file photo)

Why not? Sarep­ta’s third Duchenne MD drug sails to ac­cel­er­at­ed ap­proval

Sarepta may be running into some trouble with its next-gen gene therapy approach to Duchenne muscular dystrophy. But when it comes to antisense oligonucleotides, the well-trodden regulatory path is still leading straight to an accelerated approval for casimersen, now christened Amondys 45.

We just have to wait until 2024 to find out if it works.

Amondys 45’s approval was unceremonious, compared to its two older siblings. There was no controversy within the FDA over approving a drug based on a biomarker rather than clinical benefit, setting up a powerful precedent that still haunts acting FDA commissioner Janet Woodcock as biotech insiders weighed her potential permanent appointment; no drama like the FDA issuing a stunning rejection only to reverse its decision and hand out an OK four months later, which got more complicated after the scathing complete response letter was published; no anxious tea leaf reading or heated arguments from drug developers and patient advocates who were tired of having corticosteroids as their loved ones’ only (sometimes expensive) option.

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Mark Mal­lon charts post-Iron­wood course by tak­ing CEO job at NeoGe­nomics; Glax­o­SmithK­line vet Feng Ren joins In­sil­i­co as CSO

Mark Mallon steps aside at Ironwood on March 12 after close to two years at the helm, and he already has a new change of scenery squared away. Beginning April 19, Mallon takes charge as CEO of cancer-focused genetic test maker NeoGenomics out of Fort Myers, FL while his predecessor, Douglas VanOort, is retiring after 12 years as NeoGenomics’ chairman and CEO.

It’s a fresh start for Mallon after what will amount to a tumultuous 23 months as Ironwood’s chief executive. Last year was marked by trial failures that spelled double trouble, leaving the Ironwood cupboard bare: first, a Linzess reformulation for irritable bowel syndrome with diarrhea (IBS-D) in May, and then the drug IW-3718 for persistent acid reflux in September. After IW-3718’s discontinuation, Ironwood chopped its staff by 35%. On Feb. 8, Mallon announced his departure at Ironwood, with president Tom McCourt getting bumped up to interim CEO.

Fol­low biotechs go­ing pub­lic with the End­points News IPO Track­er

The Endpoints News team is continuing to track IPO filings for 2021, and we’ve designed a new tracker page for the effort.

Check it out here: Biopharma IPOs 2021 from Endpoints News

You’ll be able to find all the biotechs that have filed and priced so far this year, sortable by quarter and listed by newest first. As of the time of publishing on Feb. 25, there have already been 16 biotechs debuting on Nasdaq so far this year, with an additional four having filed their S-1 paperwork.

Steve Cutler, Icon CEO (Icon)

In the biggest CRO takeover in years, Icon doles out $12B for PRA Health Sci­ences to fo­cus on de­cen­tral­ized clin­i­cal work

Contract research M&A had a healthy run in recent years before recently petering out. But with the market ripe for a big buyout and the Covid-19 pandemic emphasizing the importance of decentralized trials, Wednesday saw a tectonic shift in the CRO world.

Icon, the Dublin-based CRO, will acquire PRA Health Sciences for $12 billion in a move that will shake up the highest rungs of a fragmented market. The merger would combine the 5th- and 6th-largest CROs by 2020 revenue, according to Icon, and the merger will set the newco up to be the second-largest global CRO behind only IQVIA.

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S&P ex­pects steady ero­sion in Big Phar­ma's cred­it pro­file in 2021 as new M&A deals roll in — but don't un­der­es­ti­mate their un­der­ly­ing strength

S&P Global has taken a look at the dominant forces shaping the pharma market and come to the conclusion that there will be more downgrades than upgrades in 2021 — the 8th straight year of steady decline.

But it’s not all bad news. Some things are looking up, and there’s still plenty of money to be made in an industry that enjoys a 30% to 40% profit margin, once you factor in steep R&D expenses.

Tal Zaks, Moderna CMO (AP Photo/Rodrique Ngowi, via still image from video)

CMO Tal Zaks bids Mod­er­na a sur­prise adieu as biotech projects $18.4B in rev­enue, plots post-Covid ex­pan­sion

How do you exit a company after six years in style? Developing one of the most lucrative and life-saving products in pharma history is probably not the worst way to go.

Tal Zaks, Moderna’s CMO since 2015, will leave the mRNA biotech in September, the biotech disclosed in their annual report this morning. The company has already retained the recruitment firm Russell Reynolds to find a replacement.

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