CAR-T play­er Po­sei­da march­es on with $30.5M Se­ries B; Kymera inks dis­cov­ery deal with GSK

→ In­vestors have in­fused $30.5 mil­lion in Se­ries B cash in­to Po­sei­da Ther­a­peu­tics’ pipeline of au­tol­o­gous T cell and NK cell ther­a­pies. Us­ing its gene en­gi­neer­ing tech, the San Diego com­pa­ny has iden­ti­fied sev­er­al CAR-T and gene ther­a­pies, with the lead pro­gram, P-BC­MA-101 for mul­ti­ple myelo­ma, cur­rent­ly in a Phase I tri­al. The new round of fi­nanc­ing will go to­wards that study, and push Po­sei­da to­ward INDs for two pro­grams in PS­MA CAR-T and al­lo­genic BC­MA CAR-T. Lon­gi­tude Cap­i­tal led the round, flanked by fel­low new in­vestors Vi­vo Cap­i­tal and the Tavi­s­tock Group, and David Hirsch — its man­ag­ing di­rec­tor — will join Po­sei­da’s board of di­rec­tors.

→ Glax­o­SmithK­line is team­ing up with Cam­bridge, MA-based Kymera Ther­a­peu­tics on a dis­cov­ery pact re­lat­ed to pro­tein degra­da­tion, a hot field that’s seen a va­ri­ety of star­tups come along. The 2-year deal cov­ers new small mol­e­cules and E3 lig­as­es – the en­zymes that do trig­ger the degra­da­tion of pro­teins that cause dis­eases.

→ Bay Area Stan­ford spin­out Sur­rozen, which re­cent­ly grabbed a $33M Se­ries A, just ap­point­ed a new CEO and sci­en­tif­ic co-founder. Craig Park­er, the for­mer SVP of cor­po­rate de­vel­op­ment at Jazz Phar­ma­ceu­ti­cals, is com­ing on board as the com­pa­ny’s new chief ex­ec­u­tive. He’s tak­ing the reins from Tim Kutzkey, a man­ag­ing part­ner at The Col­umn Group, who’s in­stead tak­ing up the role of chair­man of the board. The com­pa­ny, found­ed in 2016, is re­search­ing the Wnt path­way and the role it plays in re­gen­er­a­tive med­i­cine. In the same news re­lease, Sur­rozen al­so ap­point­ed a new sci­en­tif­ic co-founder in Hans Clevers, a pro­fes­sor of mol­e­c­u­lar ge­net­ics at the Hubrecht In­sti­tute. “The chal­lenge of pro­duc­ing Wnt has been a great source of frus­tra­tion in the field, im­ped­ing the ad­vance­ment of organoid tech­nol­o­gy and a deep­er dis­sec­tion of Wnt sig­nal­ing,” Clevers said in a state­ment. “Sur­rozen’s abil­i­ty to gen­er­ate po­tent and se­lec­tive Wnt path­way ag­o­nists with drug-like prop­er­ties is a re­al break­through.  I’m thrilled to join an es­teemed group of co-founders as Sur­rozen con­tin­ues its rapid pace of dis­cov­ery and fur­ther in­no­vates with its tech­nol­o­gy plat­forms.”

UP­DAT­ED: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

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Pascal Soriot, AstraZeneca CEO (AP Images)

Pas­cal So­ri­ot cash­es in As­traZeneca’s chips on Mod­er­na for $1.2B cash in­jec­tion

While still working to prove its own Covid-19 vaccine, AstraZeneca has reportedly capitalized on the success of another.

The company has sold off its 7.7% stake in Moderna and turned it into $1.2 billion in cash, according to the Times, beefing up the reserves just as Pascal Soriot is wrapping up his $39 billion acquisition of Alexion and its rare disease pipeline.

AstraZeneca’s stock sale follows a similar move by Merck in December. But like its pharma brethren, the British giant is keeping its R&D collaborations with Moderna.

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Bob Nelsen (Photo by Michael Kovac/Getty Images)

With stars aligned and cash in re­serve, Bob Nelsen's Re­silience plans a makeover at 2 new fa­cil­i­ty ad­di­tions to its drug man­u­fac­tur­ing up­start

Bob Nelsen’s new, state-of-the-art drug manufacturing initiative is taking shape.

Just 3 months after gathering $800 million of launch money, a dream team board and a plan to shake up a field where he found too many bottlenecks and inefficiencies for the era of Covid-19, Resilience has snapped up a pair of facilities now in line for a retooling.

The company has acquired a 310,000-square-foot plant in Boston from Sanofi along with a 136,000-square-foot plant in Ontario to add to a network which CEO Rahul Singhvi says is just getting started on building his company’s operations up. The Sanofi deal comes with a contract to continue manufacturing one of its drugs.

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Mesoblast gets a $110M life­line from Surg­Cen­ter De­vel­op­ment; uniQure still un­sure if gene ther­a­py spurred can­cer event

Mesoblast faced rough waters in 2020, but on Monday were thrown a financial lifeline.

The Australian stem cell therapy player has raised $110 million in a private placement, the company announced, offering 60 million shares to the US investor group SurgCenter Development. SurgCenter received the shares at a 6.5% discount from Mesoblast’s closing price on Feb. 25.

Mesoblast plans to use the funds to boost supply of its lead candidate remestemcel-L ahead of what they hope is a potential approval in pediatric GvHD when they return to the FDA, as well as advancing manufacturing and development of their rexlemestrocel-L platform for chronic heart failure and chronic low back pain.

Af­ter bail­ing on Covid-19 vac­cines, Mer­ck will team up with J&J to pro­duce its shot as part of un­usu­al Big Phar­ma pact

Merck took a big gamble when it opted to jump into the Covid-19 vaccine race late, and made an equally momentous decision to back out in late January. Now, looking to chip in on the effort, Merck reportedly agreed to team up with one of the companies that has already crossed the finish line.

President Joe Biden on Tuesday is expected to announce a partnership between drugmakers Merck and Johnson & Johnson to jointly produce J&J’s recombinant protein Covid-19 vaccine that received the FDA’s emergency use authorization Saturday, the Washington Post reported.

Ab­b­Vie tees up a biotech buy­out af­ter siz­ing up their Parkin­son's drug spun out of Ke­van Shokat's lab

AbbVie has teed up a small but intriguing biotech buyout after looking over the preclinical work it’s been doing in Parkinson’s disease.

The company is called Mitokinin, a Bay Area biotech spun out of the lab of UCSF’s Kevan Shokat, whose scientific explorations have formed the academic basis of a slew of startups in the biotech hub. One of Shokat’s PhD students in the lab, Nicholas Hertz, co-founded Mitokinin using their lab work on PINK1 suggesting that amping up its activity could play an important role in regulating the mitochondrial dysfunction contributing to Parkinson’s disease pathogenesis and progression.

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Paul Sekhri

The next big biotech su­per­star? Paul Sekhri has some thoughts on that

It occasionally occurs to Paul Sekhri that if they pull this off, his company will be on the front page of the New York Times and a lead story in just about every major news outlet on the planet. He tries not to dwell on it, though.

“I just want to be laser-focused on getting to that point,” Sekhri says, before acknowledging, “Yes, it absolutely crossed my mind.”

Sekhri, a longtime biopharma executive with tenures at Sanofi and Novartis, is now entering year three as CEO of eGenesis, the biotech that George Church protégé Luhan Yang founded to genetically alter pigs so that they can be used for organ transplants. He led them through one megaround and has just closed another, raising $125 million from 17 different investors to push the first-ever (humanized) pig to human transplants into the clinic.

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Fi­bro­Gen shares skid low­er as a sur­prise ad­comm rais­es risks on roxa OK

FibroGen will likely have to delay its US rollout for roxadustat once again.

In an unexpected move, the FDA is convening its Cardiovascular and Renal Drugs Advisory Committee to review the NDA in an advisory committee meeting. The date is yet to be confirmed.

Just a few weeks ago, SVB Leerink analyst Geoffrey Porges predicted that the roxa approval could come ahead of the PDUFA date on March 20 — effusive despite already being let down once by the FDA’s extension of its review back in December. AstraZeneca, which is partnered with FibroGen on the chronic kidney disease-related anemia drug, disclosed regulators had requested further clarifying analyses of clinical data.

In­tro­duc­ing End­pointsF­DA+, our new pre­mi­um week­ly reg­u­la­to­ry news re­port led by Zachary Bren­nan

CRLs. 483s. CBER, CDER and RWE. For biopharma professionals, these acronyms command attention because of the fundamental role FDA plays in drug development. Now Endpoints is doubling down on regulatory coverage, and launching a weekly report focusing on developments out of White Oak, with analysis and insight into what it all means.

Coverage will be led by our new senior editor, Zachary Brennan. He joins Endpoints from POLITICO, where he covered pharma. Prior to that he was the managing editor for Regulatory Focus, a news publication from the Regulatory Affairs Professionals Society.