Pfiz­er in­fus­es $200M in­to CStone, scor­ing a sec­ond PD-L1 and out­lin­ing a sprawl­ing Chi­na pact

Pfiz­er has en­gi­neered a wide-rang­ing Chi­na pact with CStone, with an ini­tial $200 mil­lion in­vest­ment and a li­cense to the late-stage PD-L1 drug to get things start­ed.

The US gi­ant now claims 9.90% of CStone’s shares on the Hong Kong stock ex­change, rights to com­mer­cial­ize sug­e­mal­imab in main­land Chi­na, as well as plans to co-de­vel­op can­cer drugs — ei­ther in its own pipeline or in-li­censed from oth­er drug­mak­ers — in the Chi­nese mar­ket. It’s al­so on the hook for $280 mil­lion in mile­stones for the PD-L1 pro­gram alone, in ad­di­tion to roy­al­ties.

Pierre Gau­dreault

Big Phar­ma in the US is in­creas­ing­ly lay­ing claims to Chi­na’s ris­ing stars, whether it’s Am­gen’s $2.7 bil­lion stake in BeiGene, Eli Lil­ly’s $1 bil­lion PD-1 deal with long­time part­ners at In­novent, or Ab­b­Vie pay­ing $180 mil­lion up­front to li­cense I-Mab’s CD47 an­ti­body.

But the Pfiz­er/CStone deal ap­pears to blaze a dif­fer­ent trail.

While Am­gen was fo­cused on find­ing a com­pa­ny that can both build up its can­cer drug rev­enue and con­duct R&D work for its ex­per­i­men­tal drugs, Eli Lil­ly and Ab­b­Vie were both scout­ing made-in-Chi­na in­no­va­tion to bring to the US.

Pfiz­er, on the oth­er hand, is set to do both: lock in an R&D part­ner while lever­ag­ing its own com­mer­cial mus­cles in Chi­na to push a do­mes­tic drug.

“Our com­pa­ny has an ex­ten­sive and proud his­to­ry of bring­ing in­no­v­a­tive med­i­cines to pa­tients in Chi­na,” Pierre Gau­dreault, act­ing pres­i­dent of Pfiz­er’s Chi­na group, said in a state­ment. “This col­lab­o­ra­tion with CStone builds on that his­to­ry by help­ing to de­vel­op a po­ten­tial best-in-class PD-L1 treat­ment that we can com­mer­cial­ize up­on ap­proval. It al­so fos­ters our col­lab­o­ra­tion with a part­ner that has ex­cep­tion­al clin­i­cal de­vel­op­ment ca­pa­bil­i­ties that can help us meet the clear need for nov­el on­col­o­gy treat­ments in Chi­na.”

Frank Jiang

No­tably, Pfiz­er al­ready does have a PD-L1 to its name in Baven­cio. Un­like As­traZeneca or Roche (or the PD-1 mak­ers, Mer­ck and Bris­tol My­ers Squibb, for that mat­ter), though, Pfiz­er and its part­ners at Mer­ck KGaA show no signs of push­ing it in­to Chi­na.

Po­si­tioned for “high-in­ci­dence can­cer in­di­ca­tions in Chi­na” such as lung, gas­tric and esophageal can­cers among oth­ers, CStone’s sug­e­mal­imab was dis­cov­ered in-house on San Diego-based biotech Lig­and’s an­i­mal plat­form.

Last month the biotech re­port­ed a slate of pos­i­tive in­ter­im Phase III da­ta on non-small cell lung can­cer, sug­gest­ing that adding it to plat­inum-based chemother­a­py can im­prove pro­gres­sion-free sur­vival by 2.8 months.

“By join­ing forces with Pfiz­er and lever­ag­ing its com­mer­cial­iza­tion in­fra­struc­ture, we will en­sure that pa­tients across a vast­ly ex­pand­ed num­ber of mar­kets in Chi­na have quick­er ac­cess to our high­ly dif­fer­en­ti­at­ed PD-L1 treat­ment,” CEO Frank Jiang said.

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.

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Pascal Soriot (AP Images)

UP­DAT­ED: As­traZeneca, Ox­ford her­ald 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine, tout­ing eas­i­er dis­tri­b­u­tion, low­er price

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 may appear 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 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.

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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.

Eiger nabs the first FDA ap­proval for Prog­e­ria, an ul­tra-rare pre­ma­ture ag­ing dis­ease, af­ter Mer­ck gave them the drug for free

Eiger BioPharmaceuticals $EIGR has received an FDA OK for a drug Merck licensed to them at no cost — and now reportedly plans to charge a level consistent with other ultra-rare disease medicines.

The biotech announced Friday evening that regulators had approved lonafarnib for the treatment of Hutchinson-Gilford progeria syndrome, also known as Progeria, as well as some progeroid laminopathies in children older than one year. It’s the first approval granted for the condition, and the drug will be marketed and sold as Zokinvy.

Vipin Suri, Catamaran Bio CSO

Cata­ma­ran Bio sails in­to the CAR-NK wa­ters with a $42M launch round

Catamaran Bio’s founding members decided to jump into the CAR-NK game last December over drinks at a trendy bar in Boston.

They were sitting around a table, discussing an MD Anderson study which provided some of the first clinical proof that natural killer (NK) cells can be reengineered to attack tumors, much like CAR-T therapies. It was a “long and lively” discussion, COO Mark Boshar recalls. And by the time it was over, they had a starting point to launch a company.

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.

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Simeon George, SR One CEO (SR One)

Scoop: SR One crew com­pletes a com­pli­cat­ed spin­out from Glax­o­SmithK­line. And now they have a $500M fund to in­vest on their own

It’s taken close to 2 years, but Simeon George and his team at SR One have completed their spinout from GlaxoSmithKline, ending a saga as one of the longest running venture arms of Big Pharma as they go out on their own to forge the next chapter with a new and independent $500 million fund.

GSK is sticking with the spinout, this time as a minority investor — though a big one. And I’m told that the R&D group at GSK will remain involved in evaluating their new plays, helping with the scientific due diligence involved in scouting the world for new opportunities during a period of explosive growth in biotech investing.

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UP­DAT­ED: Eli Lil­ly's Covid-19 part­ner Ab­Cellera pays $90M for some very spe­cial mice as Pe­ter Thiel jumps on the board and IPO ru­mors heat up

AbCellera Biologics is stepping onto Regeneron’s turf, putting down $90 million in cash to buy out Trianni and its humanized mouse technology for developing antibodies.

The 7-year-old biotech out of British Columbia is after the Trianni Mouse: a genetically engineered rodent that can generate fully human monoclonal antibodies. It’s also scooping up several “next-generation” mice under development. The move comes as AbCellera preps one of the biggest IPOs in an already record-breaking year for public debuts, unnamed sources told Bloomberg. 

Giovanni Caforio, Bristol Myers Squibb CEO (Pablo Martinez Monsivais/AP Images)

Rene­go­ti­ate the $6B CVR deal Bris­tol My­ers made for the Cel­gene buy­out? Caforio says that’s not hap­pen­ing

Bristol Myers Squibb has $6 billion riding on its CVR ($BMYRT) for the Celgene buyout, and one essential element of that is now hanging by a thread after the FDA has delayed the application for liso-cel.

The delay came about as a result of the pandemic, which Bristol maintains prevented the FDA from inspecting one of the manufacturing facilities to be used for its production. That has the second of 3 deadlines built into the all-or-nothing CVR agreement teetering on the brink. But if you own any part of that $9 CVR, you can forget about working any changes in the terms just because a completely unexpected global pandemic broke out since they struck the deal to buy Celgene.

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