SQZ play: Roche dou­bles down on a $1.37B-plus deal for a new ap­proach to im­muno-on­col­o­gy out of Bob Langer's lab

Ar­mon Sharei

What­ev­er Roche $ROG learned about SQZ over the last 33 months clear­ly on­ly whet­ted their ap­petite for much, much more.

This morn­ing SQZ is un­veil­ing a re­vise-re­place-and-ex­pand de­vel­op­ment pact with the Wa­ter­town, MA-based biotech, one of many to emerge from the lab of MIT’s Bob Langer. 

In this new deal Roche is putting up $125 mil­lion for an up­front and near-term mile­stones in a col­lab­o­ra­tion deal em­bed­ded with $1 bil­lion in de­vel­op­ment goal mon­ey. An­oth­er $250 mil­lion is on the line for each new ther­a­py that man­ages to make it all the way to an ap­proval.

“It’s a huge step for us,” CEO Ar­mon Sharei told me over the week­end in an ad­vance re­view of the news that ar­rived Mon­day morn­ing. 

An per­haps it’s an even big­ger step than he may be will­ing to al­low right now.

Amy Schul­man

Sharei popped up over the sum­mer with a $72 mil­lion round to back his com­pa­ny, which start­ed 5 years ago on a shoe­string bud­get to es­sen­tial­ly work on an in­ter­est­ing de­vel­op­ment tool. Now the com­pa­ny has 76 staffers — head­ed to 100 — with a gi­ant part­ner al­lied on a clin­i­cal de­vel­op­ment pro­gram set to be­gin next year.

Add in a Big Phar­ma vet, Po­laris part­ner Amy Schul­man, as ex­ec­u­tive chair­man, and you have the per­fect pro­file for an IPO.

Sharei and Schul­man veered away from that top­ic in our dis­cus­sion, pre­fer­ring to talk about a ma­tur­ing de­vel­op­ment strat­e­gy to build a pipeline around their plat­form cell tech­nol­o­gy.

Bob Langer

What Sharei had worked on in Langer’s lab was a de­vice that squeezed a cell, cre­at­ing open­ings for reengi­neer­ing the cell in­to some­thing new. In this case, they’re adding anti­gens that are in­tend­ed to pro­voke a storm of CD8 killer cells that can be di­rect­ed against can­cer, the kind of im­muno-on­col­o­gy play that’s at­trac­tive on Wall Street. And they’re promis­ing that their drugs can be man­u­fac­tured rel­a­tive­ly eas­i­ly, giv­ing them a clear com­mer­cial path to fol­low.

This new deal is with Basel-based pRED, as op­posed to Genen­tech’s gRED side of the R&D op­er­a­tion at Roche. 

That’s the kind of com­pa­ny you want to keep in a lead-up to an IPO, es­pe­cial­ly when the VC mon­ey has piled up.

We’ll like­ly see how the SQZ play works on Wall Street.

Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

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Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

Rodney Rietze, iVexSol CEO

Bris­tol My­ers, Charles Riv­er join Se­ries A fund­ing for iVex­Sol

Massachusetts-based iVexSol has secured funding to the tune of $23.8 million in its latest Series A round. The new investors include Bristol Myers Squibb, manufacturer Charles River Laboratories and Asahi Kasei Medical.

iVexSol is a manufacturer of lentiviral vectors (LVV), used in making gene therapies, and this latest round of fundraising brings its total Series A total over $39 million, which will be used to recruit more employees and bolster its technology.

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John Rim, Samsung Biologics CEO (Samsung/PR Newswire)

Sam­sung Bi­o­log­ics spells out ex­pan­sion plans in South Ko­rea and US

The CDMO arm of one of South Korea’s largest conglomerates has posted its year-end results and plans for 2023, which include new construction.

Samsung Biologics netted north of KRW 3 trillion ($2.4 billion) in 2022 revenue and an operating profit of KRW 983.6 billion ($799 million), which the company touted on Friday as “record-high earnings.” The revenue boost was 55% compared to 2021.

No­var­tis' ap­proved sick­le cell dis­ease drug fails to beat place­bo in PhI­II

Novartis’ sickle cell drug, approved in 2019 and branded as Adakveo, has failed an ongoing Phase III, according to preliminary results.

The Swiss pharma giant unveiled early data from the ongoing STAND Phase III study on Friday, saying that crizanlizumab showed no statistically significant difference between the drug at two different dose levels compared to placebo in annualized rates of vaso-occlusive crises that lead to a healthcare visit over the first year since being randomized into the trial.

Sen. Elizabeth Warren (D-MA) (Michael Brochstein/Sipa USA/Sipa via AP Images)

Sen. Eliz­a­beth War­ren urges FTC to 'scru­ti­nize' two phar­ma buy­outs

Sen. Elizabeth Warren (D-MA) is calling on senior Federal Trade Commission officials to “closely scrutinize” two proposed pharma mergers.

Warren expressed concern over “rampant consolidation in the pharmaceutical industry,” in particular Amgen’s $28 billion plans to take over Horizon Therapeutics, and Indivior’s proposed acquisition of Opiant for $145 million upfront, in a letter to FTC Chair Lina Khan and Commissioners Alvaro Bedoya and Rebecca Kelly Slaughter earlier this week.