Stung by set­backs and a stag­nant pipeline, blue­bird bio, the once-dar­ling of gene ther­a­py biotech, made the tough call to sev­er its rare dis­ease and on­col­o­gy units ear­li­er this year. One of the busi­ness leads on blue­bird’s on­col­o­gy side has now popped up at a new­ly launched B cell play­er — and she’s tak­ing her for­mer em­ploy­er’s “pi­o­neer­ing” ex­am­ple to heart.

Joanne Smith-Far­rell

Joanne Smith-Far­rell, for­mer­ly blue­bird’s chief op­er­at­ing of­fi­cer and head of the on­col­o­gy busi­ness unit, is now CEO at Be Bio­phar­ma, an ear­ly-stage biotech tar­get­ing en­gi­neered B cells for ther­a­peu­tic use. Smith-Far­rell is joined on the team by CSO Rick Mor­gan, an­oth­er blue­bird vet who was most re­cent­ly se­nior VP of im­muno­genet­ics at Ed­i­tas.

Tak­ing the lead at Be Bio rep­re­sents a step in­to the CEO seat for the first time for Smith-Far­rell, who cut her teeth study­ing bio­med­ical en­gi­neer­ing in Bob Langer’s famed lab at MIT be­fore mak­ing the jump to in­dus­try. She’s both a Pfiz­er and Mer­ck vet­er­an and joined blue­bird in March 2017 to head the on­col­o­gy fran­chise. The most ad­vanced can­di­date there is mul­ti­ple myelo­ma can­di­date ide-cel, a Bris­tol My­ers Squibb-part­nered CAR-T that faces an FDA re­view this year.

In her telling, Smith-Far­rell was “at the heart” of de­lib­er­a­tions over spin­ning off blue­bird’s on­col­o­gy unit in­to an as-yet-un­named busi­ness led by CEO Nick Leschly. Mean­while, the re­main­ing gene ther­a­py as­sets, in­clud­ing gene ther­a­py Zyn­te­glo and can­di­dates in be­ta tha­lassemia and sick­le cell dis­ease, will keep the blue­bird moniker. De­spite the tec­ton­ic shift in the busi­ness mod­el af­ter a dis­ap­point­ing few years, Smith-Far­rell said the spin­off “was not the rea­son” she chose to de­part.

“It was very op­por­tunis­tic,” Smith-Far­rell told End­points News. “This (op­por­tu­ni­ty) came across, and it’s very hard to see some­thing with this kind of po­ten­tial for im­pact. It’s rare. The op­por­tu­ni­ty to come out and be a CEO … feels like a great next step.”

Mean­while, Smith-Far­rell looked back at the blue­bird’s de­ci­sion to split and called it “the right de­ci­sion” at the time.

“I have a lot of con­fi­dence in the blue­bird team be­ing able to do what they need to do go­ing for­ward,” she said.

As part of a rapid ex­pan­sion tak­ing Be Bio from just two em­ploy­ees at the end of 2020 to about 20 cur­rent­ly on staff, Smith-Far­rell said her first or­ders of busi­ness are build­ing a team that can mod­el the sort of “pi­o­neer­ing” work she be­came fa­mil­iar with at blue­bird.

Rick Mor­gan

Mean­while, Mor­gan will take over a B cell ther­a­peu­tic plat­form with a lot of promise but not much to show so ear­ly in­to launch. His first fo­cus, he said, will al­so be re­fin­ing the vi­sion for the plat­form’s po­ten­tial and build­ing a team that can suc­cess­ful­ly scale the pipeline.

“With the un­der­ly­ing tech­nol­o­gy, where do you point the ap­pli­ca­tions?” he said. “We’re not there yet in terms of say­ing what the first in­di­ca­tions will be, but be­cause the plat­form lends it­self to di­verse in­di­ca­tions, we will build a pipeline that has some breadth to it and a lit­tle more ver­sa­til­i­ty than you would see at oth­er cell ther­a­py com­pa­nies.”

Be Bio launched back in Oc­to­ber with a $52 mil­lion de­but round co-led by At­las Ven­tures and RA Cap­i­tal Man­age­ment. The biotech hopes to re-en­gi­neer B cells as a nov­el ther­a­peu­tic modal­i­ty that can skip past the se­vere side ef­fects of T cell and NK cell ther­a­pies and can al­so be pro­duced al­lo­gene­ical­ly.

The FDA has rejected Verrica Pharmaceuticals’ skin disease treatment for a third time — and once again the contract manufacturer is to blame.

The biotech emphasized that the only deficiency in the complete response letter is related to a general reinspection of the CMO, Sterling Pharmaceuticals, and has nothing to do specifically with its drug-device; the rest of the NDA is good to go.

CEO Ted White said the company is “extremely disappointed,” but will keep working toward approval.

NIAID director Anthony Fauci gained hero status amid the pandemic, earning Americans’ trust and even Time magazine’s Guardian of the Year title. But he and other federal health officials have also faced intense threats, according to charges brought by the US Department of Justice.

A West Virginia man is facing up to 10 years in prison after threatening Fauci, former NIH director Francis Collins, and HHS assistant secretary for health Rachel Levine via email, the DOJ said on Monday. Thomas Patrick Connally, Jr., pleaded guilty on Monday to using an anonymous email address to threaten the officials for performing their official duties, including discussing Covid-19 testing and prevention.

Vanda Pharmaceuticals is making a name for itself, at least in terms of suing the FDA.

The DC-headquartered firm on Monday filed its latest suit against the agency, with the company raising concerns over the FDA’s failure to grant a fast track designation for Vanda’s potential chronic digestive disorder drug tradipitant, which is a neurokinin 1 receptor antagonist.

Specifically, Vanda said FDA’s “essential point” in its one-page denial letter on the designation pointed to “the lack of necessary safety data,” which was “inconsistent with the criteria for … Fast Track designation.”

A pivot into neoantigen immunotherapies was not enough to save Genocea Biosciences after all.

The 16-year-old biotech said it would be closing down and laying off all remaining employees “except those deemed necessary to complete an orderly wind down” of operations. It has also delivered a formal notice to Nasdaq, notifying the stock exchange of its intent to delist voluntarily.

The move comes a month after Genocea laid off 75% of its workforce and revealed it’s looking for strategic alternatives, such as a sale, merger or reverse merger. At the end of 2021, it had 74 employees.