Can B cells break the bound­aries of cell ther­a­py? Long­wood start­up has $52M to prove a new en­gi­neer­ing tech

Back in De­cem­ber 2017, as the cell ther­a­py world was still bask­ing in the vir­tu­al­ly back-to-back ap­provals of two pi­o­neer­ing CAR-Ts, re­searchers at Seat­tle Chil­dren’s Re­search In­sti­tute re­port­ed a sci­en­tif­ic first in a dif­fer­ent cor­ner of the field: en­gi­neer B cells to treat dis­ease.

Aleks Radovic-Moreno

The team, led by David Rawl­ings and Richard James, even­tu­al­ly worked with Long­wood Fund to start a biotech around those find­ings. And now At­las Ven­ture and RA Cap­i­tal Man­age­ment are com­ing on board to lead a $52 mil­lion launch round, joined by Al­ta Part­ners, for Be Bio­phar­ma.

“B cells have been such an at­trac­tive cell type,” Aleks Radovic-Moreno, an en­tre­pre­neur-in-res­i­dence who co-found­ed the biotech, told End­points News. “It just wasn’t their time yet. But now we feel con­fi­dent that it’s their time to step in­to the lime­light.”

The two clas­sic stum­bling blocks, he added, are fig­ur­ing out how to en­gi­neer them ef­fi­cient­ly and cul­ture them in suf­fi­cient quan­ti­ties.

David Rawl­ings

But once Rawl­ings and James cracked the code through ho­mol­o­gy-di­rect­ed re­pair, it opened up po­ten­tial ap­pli­ca­tions be­yond what cur­rent cell ther­a­pies can do. While T cells are de­signed to kill cells marked by cer­tain anti­gens, B cells’ unique func­tion is that they make “un­be­liev­able quan­ti­ties of pro­teins” — from an­ti­bod­ies to im­mune mod­u­lat­ing fac­tors.

You can al­so pro­gram a B cell to go to a spe­cif­ic tis­sue, with­out the need for con­di­tion­ing or lym­phode­ple­tion, while re­tain­ing an op­tion to titrate and re­dose if you don’t get it right the first time.

“If you think about what dis­ease you want where you want a pro­tein to be se­cret­ed in a tar­get­ed fash­ion, that’s ac­tu­al­ly a re­al­ly big list,” Radovic-Moreno said, list­ing can­cer, au­toim­mune dis­eases, mono­genic dis­or­ders and in­fec­tious dis­eases as ar­eas be­ing ex­plored.

Richard James

In a pre­vi­ous in­ter­view, James al­so gave he­mo­phil­ia B as an ex­am­ple of a pro­tein de­fi­cien­cy dis­ease where a B cell ther­a­py can po­ten­tial­ly cure pa­tients.

Be Bio ben­e­fits from the trail that hun­dreds of T cell ther­a­py play­ers have now trav­eled, step­ping in­to a world where lo­gis­tics, ge­net­ic mod­i­fi­ca­tion and cell pu­rifi­ca­tion tools are read­i­ly avail­able. But its core area of ex­per­tise — map­ping out the bi­ol­o­gy of B cells and ma­nip­u­lat­ing them — re­mains one that’s on­ly hous­ing aca­d­e­m­ic groups so far.

David Stein­berg

Cur­rent­ly man­aged by an in­ter­im team con­sist­ing of Radovic-Moreno as pres­i­dent and David Stein­berg as CEO, the team is grow­ing every week at the Alexan­dria Launch­Labs in Kendall Square. In ad­di­tion to the sci­en­tif­ic founders, it’s al­so guid­ed by an il­lus­tri­ous sci­en­tif­ic ad­vi­so­ry board, con­sist­ing of Frances Eun-Hyung Lee, an asth­ma ex­pert at Emory, as well as Har­vard’s Shiv Pil­lai and UCSF’s Ja­son Cys­ter, who bring years of ex­pe­ri­ence study­ing B cells.

He may not be ready to dis­cuss con­crete drug tar­gets or time­lines yet, but for Radovic-Moreno, who played a lead­ing role in get­ting Sid­dhartha Mukher­jee’s en­gi­neered hematopoi­et­ic stem cells off the ground at Vor Bio, it’s all rem­i­nis­cent of the ear­ly days of T cell work.

“I wouldn’t be sur­prised if we see a sim­i­lar tra­jec­to­ry 5 years from to­day,” he said. “I don’t think there will be hun­dreds of B cell com­pa­nies, but I’m gonna bet it’s more than one.”

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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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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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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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.

Tony Johnson, Goldfinch Bio CEO (Goldfinch via YouTube)

Kid­ney dis­ease drug­mak­er Goldfinch Bio shuts down

Goldfinch Bio, attempting to make treatments for kidney diseases and diabetic nephropathy, is shutting down.

President and CEO Tony Johnson confirmed to Endpoints News Friday afternoon that the biotech shut down after “fundraising challenges in the current macro-environment.” Fierce Biotech first reported the news.

Johnson, who joined in 2017 after a stint as SVP of early clinical development at AstraZeneca, said in a text that the company “entered the ABC process recently,” referring to an assignment for the benefit of the creditors, which provides a different wind-down avenue than a bankruptcy.

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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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Steve Harr, Sana Biotechnology CEO

Four years in, Sana gets first FDA go-ahead to bring can­cer treat­ment in­to the clin­ic

Sana Biotechnology is finally headed to the clinic.

Thursday afternoon, the biotech announced the FDA had cleared its application to start a clinical trial for its allogeneic, or “off-the-shelf,” CAR-T cell therapy targeting the antigen CD19 for patients with B-cell lymphomas and leukemias. Sana said its therapy, dubbed SC291, was designed to evade the immune system, which could help cell therapy produce a more durable response in patients, a concern that has followed such off-the-shelf therapies that use donor cells as opposed to a patient’s own cells.

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Ying Huang, Legend CEO

J&J, Leg­end say Carvyk­ti beat stan­dard ther­a­py in ear­li­er-line blood can­cer

J&J and Legend Biotech’s next step in turning their CAR-T therapy Carvykti into a potential megablockbuster has succeeded, the companies said Friday.

Carvykti achieved the primary endpoint — progression-free survival — in an open-label Phase III study testing the treatment in second- to fourth-line multiple myeloma patients. The CARTITUDE-4 trial, for which there aren’t any hard data yet, represents the biggest development for Carvykti’s ability to compete with Bristol Myers Squibb’s Abecma since its approval last February.

Eliot Forster, F-star CEO (Rachel Kiki for Endpoints News)

F-star gets down to the wire with $161M sale to Chi­nese buy­er as na­tion­al se­cu­ri­ty con­cerns linger

With the clock ticking on F-star Therapeutics’ takeover by a Chinese buyer, the companies are still scrambling to remove a hold on the deal from the US government’s Committee on Foreign Investment in the United States.

F-star and invoX Pharma said they are “actively negotiating” with CFIUS “about the terms of a mitigation agreement to address CFIUS’s concerns regarding potential national security risks posed by the transaction.”

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