Ar­cus grabs US rights to a WuXi-built PD-1 as sec­ond wave of check­points builds

Chris Chen

West Coast up­start Ar­cus Bio­sciences has bagged its very own PD-1 an­ti­body to take in­to the clin­ic with its im­muno-on­col­o­gy pipeline drugs.

Ar­cus turned to WuXi Bi­o­log­ics and its Chi­nese part­ner Harbin Glo­ria Phar­ma­ceu­ti­cals for re­gion­al North Amer­i­can, Eu­ro­pean and Japan­ese rights to GLS-010. The US biotech is pay­ing $18.5 mil­lion up­front along with a po­ten­tial moth­er­load of de­vel­op­ment and sales mile­stones amount­ing to $816 mil­lion.

In ad­di­tion, Ar­cus signed a 3-year deal with WuXi on de­vel­op­ing its pipeline ther­a­pies.

Dis­cov­ered by WuXi un­der con­tract to Glo­ria, us­ing Lig­and’s trans­genic rat plat­form tech, this is the lat­est in a long string of PD-(L)1 check­points that’s form­ing be­hind the front-5 pi­o­neers from Mer­ck, Bris­tol-My­ers and oth­ers.

Just weeks ago, Cel­gene proved it was will­ing to weigh in with a ma­jor league pact when it struck a PD-1 deal with Chi­na’s BeiGene for $413 mil­lion down and about a bil­lion dol­lars in mile­stones. In the cur­rent case, Ar­cus — found­ed by a suc­cess­ful team out of Flexus — is gain­ing a pro­gram that is cur­rent­ly in a Phase I study in Chi­na, un­der­scor­ing the grow­ing role that de­vel­op­ers are play­ing in Chi­na in this sec­ond wave of I/O drugs.

As the bi­ol­o­gy in­volved in PD-(L)1 check­points has grown ever clear­er to bio­phar­ma sci­en­tists, it seems that every­one would pre­fer to have their own check­point rather than sim­ply com­bine their drugs with ap­proved ther­a­pies like Op­di­vo and Keytru­da, the two lead­ers in the field. So In­cyte has its own, as does No­var­tis and oth­ers. Re­gen­eron and Sanofi are ea­ger to show they can leap in next year as they line up their own PD-1 for reg­u­la­to­ry re­view.

For many, the big ques­tion now is whether the en­tire PD-(L)1 field will be­come com­modi­tized, though front-lead­ing de­vel­op­ers in­sist that there are still plen­ty of ways to dis­tin­guish your­self — and make bil­lions.

“We are pleased that our in­te­grat­ed plat­form has en­abled com­pa­nies such as Glo­ria to en­ter in­to bi­o­log­ics with an ex­cit­ing pro­gram. We are al­so ex­cit­ed to en­ter in­to this agree­ment to ex­pe­dite bi­o­log­ics de­vel­op­ment to treat pa­tients glob­al­ly,” com­ment­ed Dr. Chris Chen, CEO and ex­ec­u­tive di­rec­tor of WuXi Bi­o­log­ics. “This new part­ner­ship con­tin­ues to re­in­force the val­ue of our in­te­grat­ed ser­vice plat­form, the glob­al qual­i­ty WuXi Bi­o­log­ics com­mits to, and the suc­cess of our ‘fol­low-the-mol­e­cule strat­e­gy.

Im­ple­ment­ing re­silience in the clin­i­cal tri­al sup­ply chain

Since January 2020, the clinical trials ecosystem has quickly evolved to manage roadblocks impeding clinical trial integrity, and patient care and safety amid a global pandemic. Closed borders, reduced air traffic and delayed or canceled flights disrupted global distribution, revealing how flexible logistics and supply chains can secure the timely delivery of clinical drug products and therapies to sites and patients.

John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

Al­ny­lam gets the green light for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,100+ biopharma pros reading Endpoints daily — and it's free.

In fi­nal days at Mer­ck, Roger Perl­mut­ter bets big on a lit­tle-known Covid-19 treat­ment

Roger Perlmutter is spending his last days at Merck, well, spending.

Two weeks after snapping up the antibody-drug conjugate biotech VelosBio for $2.75 billion, Merck announced today that it had purchased OncoImmune and its experimental Covid-19 drug for $425 million. The drug, known as CD24Fc, appeared to reduce the risk of respiratory failure or death in severe Covid-19 patients by 50% in a 203-person Phase III trial, OncoImmune said in September.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,100+ biopharma pros reading Endpoints daily — and it's free.

Pascal Soriot (AP Images)

UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,100+ biopharma pros reading Endpoints daily — and it's free.

Bahija Jallal (file photo)

TCR pi­o­neer Im­muno­core scores a first with a land­mark PhI­II snap­shot on over­all sur­vival for a rare melanoma

Bahija Jallal’s crew at TCR pioneer Immunocore says they have nailed down a promising set of pivotal data for their lead drug in a frontline setting for a solid tumor. And they are framing this early interim readout as the convincing snapshot they need to prove that their platform can deliver on a string of breakthrough therapies now in the clinic or planned for it.

In advance of the Monday announcement, Jallal and R&D chief David Berman took some time to walk me through the first round of Phase III data for their lead TCR designed to treat rare, frontline cases of metastatic uveal melanoma that come with a grim set of survival expectations.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Bob Nelsen (Photo by Michael Kovac/Getty Images)

Bob Nelsen rais­es $800M and re­cruits a star-stud­ded board to build the 'Fox­con­n' of biotech

Bob Nelsen spent his pandemic spring in his Seattle home, talking on the phone with Luciana Borio, the scientist who used to run pandemic preparedness on the National Security Council, and fuming with her about the dire state of American manufacturing.

Companies were rushing to develop vaccines and antibodies for the new virus, but even if they succeeded, there was no immediate supply chain or infrastructure to mass-produce them in a way that could make a dent in the outbreak.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,100+ biopharma pros reading Endpoints daily — and it's free.

Am­gen sev­ers 14-year Cy­to­ki­net­ics part­ner­ship, bail­ing on ome­cam­tiv af­ter mixed PhI­II re­sults

Amgen is shrugging off a 14-year development alliance and the tens of millions of dollars spent to develop a new heart drug at Cytokinetics after a Phase III trial turned up weak data — leaving Cytokinetics to soldier on alone.

Omecamtiv mecarbil technically worked, meeting the primary composite endpoint in the Phase III GALACTIC-HF study. But it missed a key secondary endpoint, which analysts had been following as a key marker for success — reduction of cardiovascular (CV) death. While Cytokinetics celebrated the results, its stock tanked 43% upon the news, and analysts warned of an uncertain path ahead. Now, Amgen wants out.

Carl Hansen, AbCellera CEO (University of British Columbia)

From a pair of Air Jor­dans to a $200M-plus IPO, Carl Hansen is craft­ing an overnight R&D for­tune fu­eled by Covid-19

Back in the summer of 2019, Carl Hansen left his post as a professor at the University of British Columbia to go full time as the CEO at a low-profile antibody shop he had founded called AbCellera.

As biotech CEOs go, even after a fundraise Hansen wasn’t paid a whole heck of a lot. He ended up earning right at $250,000 for the year. His compensation package included a loan — which he later paid back — and a pair of Air Jordan tennis shoes. His newly-hired CFO, Andrew Booth, got a sweeter pay packet than that — which included his own pair of Air Jordans.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Leonard Schleifer, Regeneron CEO (Andrew Harnik/AP)

Trail­ing Eli Lil­ly by 12 days, Re­gen­eron gets the FDA OK for their Covid-19 an­ti­body cock­tail

A month and a half after becoming the experimental treatment of choice for a newly diagnosed president, Regeneron’s antibody cocktail has received emergency use authorization from the FDA. It will be used to treat non-hospitalized Covid-19 patients who are at high-risk of progressing.

Although the Rgeneron drug is not the first antibody treatment authorized by the FDA, the news comes as a significant milestone for a company and a treatment scientists have watched closely since the outbreak began.