Ar­cus and As­traZeneca part­ner on a high stakes an­ti-TIG­IT/PD-L1 PhI­II can­cer study, look­ing to im­prove on a stan­dard of care

For As­traZeneca, the PA­CIF­IC tri­al in Stage III non-small cell lung can­cer re­mains one of the big tri­umphs for As­traZeneca’s on­col­o­gy R&D group. It not on­ly made their PD-L1 Imfinzi a fran­chise play­er with a sol­id ad­vance in a large niche of the lung can­cer mar­ket, the study — which con­tin­ues to of­fer da­ta on the long-range ef­fi­ca­cy of their drug — al­so helped salve the vi­cious sting of the fail­ure of the CT­LA-4 com­bo in the MYS­TIC study.

José Basel­ga

Now head­ed by José Basel­ga, the phar­ma gi­ant’s can­cer re­search arm is out to ce­ment its lead­er­ship po­si­tion with a new com­bo strat­e­gy. And they’ve turned to Ter­ry Rosen’s com­pa­ny Ar­cus $RCUS for one of the lead­ing an­ti-TIG­ITs for a reg­is­tra­tional Phase III study.

This morn­ing Rosen and Basel­ga are tak­ing the wraps off an al­liance built around Ar­cus’s dom­vanal­imab (AB154). Shar­ing costs, they’ll each con­tin­ue to own their own drugs through the process, with Basel­ga con­duct­ing the study. And Gilead, which has a slate of opt-ins avail­able un­der their $2 bil­lion dol­lar deal signed with Ar­cus last May, is keep­ing a close eye on things as they judge their next steps — all the more im­por­tant now with the fate of fil­go­tinib hang­ing in the bal­ance af­ter an FDA re­jec­tion for rheuma­toid arthri­tis.

Ter­ry Rosen

“The po­ten­tial here for do­ing this to­geth­er with As­traZeneca re­al­ly po­si­tions you to lever­age the knowl­edge and ex­per­tise they have built to date with the PA­CIF­IC plat­form,” Rosen tells me in a pre­view of to­day’s an­nounce­ment.

It al­so pro­vides a high-pro­file Phase III that will go a long way to de­ter­min­ing whether TIG­IT of­fers the kind of back­bone ther­a­py that can be used to ad­vance can­cer ther­a­py to a whole new lev­el.

Even­tu­al­ly, says Rosen, the top play­ers are go­ing to have to de­cide if they want both PD-(L)1 and an­ti-TIG­IT in their tool box­es. And one key cat­a­lyst to all this — in­clud­ing the Gilead opt in — will be an up­com­ing read­out on their Phase II study for front­line NSCLC that com­bines their PD-1 with the an­ti-TIG­IT and AB928, an in­ves­ti­ga­tion­al A2aR/A2bR an­tag­o­nist. That could set up a whole new treat­ment strat­e­gy for pa­tients, says Rosen — pro­vid­ed it sur­vives the tri­al process.

“In the end, those are go­ing to be the ta­ble stakes,” says Rosen.

There are a num­ber of de­tails that still aren’t on pub­lic view, in­clud­ing the pre­cise de­tails on the fi­nan­cials as well as the ex­act tim­ing of the Phase III.

“We’re go­ing to go as ag­gres­sive and fast as pos­si­ble,” says Rosen, promis­ing more on the tim­ing as they get clos­er to the first pa­tient in. But he adds that the Gilead team, led by CMO Mer­dad Parsey, have been en­thu­si­as­tic sup­port­ers of the As­traZeneca al­liance, with near­ly dai­ly con­tact over the col­lab­o­ra­tion they’ve been ham­mer­ing out.

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.

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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Tom Barnes (Orna)

The mR­NA era is here. MPM be­lieves the fu­ture be­longs to oR­NA — and Big Phar­ma wants a seat at the ta­ble

If the ultra-fast clinical development of Covid-19 vaccines opened the world’s eyes to the promises of messenger RNA, the subsequent delays in supply offered a crash course on the ultra-complex process of producing them. Even before the formulation and fill-finish steps, mRNA is the precious end product from an arduous journey involving enzyme-aided transcription, modification and purification.

For Bristol Myers Squibb, Novartis Institutes for Biomedical Research, Gilead’s Kite and Astellas, it’s time to rethink the way therapeutic RNA is engineered.

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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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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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Glax­o­SmithK­line re­thinks strat­e­gy for Covid-19 an­ti­body — not the Vir ones — af­ter tri­al flop. Is there hope in high-risk pa­tients?

In the search for a better Covid-19 therapeutic, GlaxoSmithKline and Vir have partnered up on two antibodies they hope have a chance. GSK is also testing its own in-house antibody, and early results may have shut the door on its widespread use.

A combination of GSK’s monoclonal antibody otilimab plus standard of care couldn’t best standard of care alone in preventing death and respiratory failure in hospitalized Covid-19 patients after 28 days, according to data from the Phase IIa OSCAR study unveiled Thursday.

Photo: Shutterstock

Bio­phar­ma's suc­cess rate in bring­ing drugs to mar­ket has long been abysmal. Can new tools help rewrite that trou­bled past?

In 2011, a team of researchers at British drugmaker AstraZeneca had a problem they were looking to solve.

For years, drug discovery and development were a wasteland for innovation. Novel drugs largely fell into one of two categories — monoclonal antibodies and small molecules — and new therapeutic modalities were hard to come by. After a rush of promising approvals in the late 1990s — including then-Biogen’s CD20 targeting antibody breakthrough Rituxan — the field stagnated and attrition rates stayed sky-high. What exactly is the industry doing wrong? AstraZeneca asked itself.

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