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.”

Qual­i­ty Con­trol in Cell and Gene Ther­a­py – What’s Re­al­ly at Stake?

In early 2021, Bluebird Bio was forced to suspend clinical trials of its gene therapy for sickle cell disease after two patients in the trial developed cancer. As company scientists rushed to assess whether there was any causal link between the therapy and the cancer cases, Bluebird’s stock value plummeted – as did those of multiple other biopharma companies developing similar therapies.

While investigations concluded that the gene therapy was unlikely to have caused cancer, investors and the public may be more skittish regarding the safety of gene and cell therapies after this episode. This recent example highlights how delicate the fields of cell and gene therapy remain today, even as they show great promise.

Chris Gibson (Photo By Vaughn Ridley/Sportsfile for Web Summit via Getty Images)

Re­cur­sion founders gin for­tunes as IPO back­ers show­er $436M on one of the biggest boasts in AI -- based on some very small deals

In the AI drug development world, boasting often comes with the territory. Yet few can rival Recursion when it comes to claiming the lead role in what company execs like to call the industrialization of drug development, with promises of continued exponential growth in the number of drugs it has in the pipeline.

On Friday, the Salt Lake City-based biotech translated its unicorn-sized boasts into a killer IPO, pricing more than 24 million shares at the high end of its range and bringing in $436 million — with a large chunk of that promised by some deep-pocket backers.

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Tillman Gerngross (Adagio)

Till­man Gern­gross' Covid-19 an­ti­body moon­shot scores $336M with the help of new ace CFO. Is an IPO next?

Less than a year into its existence, serial biotech entrepreneur Tillman Gerngross’ antibody play Adagio has raced ahead into a pivotal trial for its lead drug for Covid-19 on the back of some very promising preclinical data. Now, crossover investors led by Peter Kolchinsky at RA are rolling up the Brinks truck — and that could spell an IPO in the offing for Adagio.

Adagio has bagged $336 million as part of a Series C round led by RA Capital to advance lead single-shot antibody ADG20 through a pivotal Phase I/II/III trial for the treatment of mild to moderate Covid-19 patients at high risk of infection, the biotech said Monday.

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UP­DAT­ED: New Kaiser analy­sis shows how lim­it­ing price ne­go­ti­a­tions to tar­get­ed drugs may bet­ter fo­cus up­com­ing leg­is­la­tion

As Congress considers whether to adopt sweeping new legislation to lower prescription drug prices across the board, the Kaiser Family Foundation is out with a new report on Monday showing how a more targeted approach on a subset of drugs might be a more efficient way to save government funds.

“This analysis shows that Medicare Part D and Part B spending is highly concentrated among a relatively small share of covered drugs, mainly those without generic or biosimilar competitors,” wrote Juliette Cubanski, deputy director of the program on Medicare policy at KFF, and Tricia Neuman, SVP of KFF. “Focusing drug price negotiation or reference pricing on a subset of drugs that account for a disproportionate share of spending would be an efficient use of administrative resources, though it would also leave some potential savings on the table.”

Biotech's IPO raise ap­proach­es $5.5B as Nas­daq con­tin­ues to prove fruit­ful with 2 de­buts and three new fil­ings

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

It was another busy week in the biotech IPO market as the second quarter continues to churn out significant investment into the sector.

Recursion led the way with a $436 million raise on Friday, pricing its IPO at $18, the high end of its range. Our own John Carroll went in depth on that raise over the weekend. Also on Friday, preclinical cancer biotech Biomea Fusion debuted with a $153 million raise priced at its own high end of $17 per share. The two companies helped push the combined IPO raise for 2021 to nearly $5.5 billion.

When is a drug re­al­ly a de­vice? Court knocks down FDA ap­peal in try­ing to sort that grey area

It’s always a surprise when a court has to step in to tell the FDA that it erred in performing one of its main duties: classifying whether a medical product is drug or a device.

But that’s what the US Court of Appeals for the District of Columbia did on Friday, making clear to the world’s top drug regulator that Genus Medical Technologies’ contrast agent barium sulfate (also known as Vanilla SilQ) should not be considered a drug, as the FDA had said, but a medical device.

Q1: A flood of in­vestor cash drove biotech's num­bers to new record highs, and the tor­rent of cash is mov­ing up­stream fast

If you thought biotech was booming last year, wait until you get a load of the numbers from Q1 2021.

On virtually every level, with one exception, the money engine was working around the clock in the first 3 months of this year. Venture capital has reached such a fever peak that the average B round now weighs in at an average mega-weight value of $100 million. The money flow is also finding its way to the mouth of the R&D river, where discovery work now merits the big bucks instead of cautionary seed funds.

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Jami Rubin (EQRx)

Ja­mi Ru­bin, once fa­bled for grilling bio­phar­ma ex­ecs, de­camps to head fi­nance at drug pric­ing dis­rupter

As Goldman Sachs’ top pharmaceutical analyst, Jami Rubin was known for asking the tough questions. Now, as she takes the lead on EQRx’s mission to rewrite the rules of drug pricing, we’ll see how good her answers are.

Rubin made the jump to biotech on April 5, becoming EQRx’s new CFO, the company said Monday. She’s coming from PJT Partners, where she’s been a partner providing strategic guidance for biotech and pharmaceutical companies for the last couple years. With EQRx’s recent $500 million Series B round in the books, it wouldn’t be a surprise if she was already lining up a public debut.

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Seagen gets Au­gust PDU­FA for Pad­cev ex­pan­sions; Adap­tate pulls in new cash for gam­ma delta T cell an­ti­bod­ies

Seagen is riding the wave of two new priority reviews straight to the FDA.

The Bothell, WA-based biotech and their partners at Astellas announced Monday that two supplemental BLAs for Padcev had been accepted by US regulators. FDA has set Aug. 17 as the PDUFA date for the reviews.

“With our recent regulatory submissions, we intend to provide the highest level of clinical evidence supporting Padcev use — overall survival data from a randomized Phase III trial — and expand availability in multiple countries where there is unmet medical need,” said Astellas oncology chief Andrew Krivoshik.