Fresh out of the blue­bird bio on­col­o­gy split, Joanne Smith-Far­rell flies the coop to Be Bio and its B cell plat­form

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.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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Ted White, Verrica Pharmaceuticals CEO

'Hands may be tied': FDA slaps Ver­ri­ca with 3rd CRL due to prob­lems with con­tract man­u­fac­tur­er

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.

Anthony Fauci (AP Images)

West Vir­ginia man faces prison time for threat­en­ing emails to Fau­ci, oth­er health of­fi­cials

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.

Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Phar­ma com­pa­ny con­tin­ues its FDA law­suit spree, this time af­ter agency de­nies fast-track des­ig­na­tion

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.”

Stéphane Bancel, Moderna CEO (Charles Krupa/AP Images)

Mod­er­na chief Ban­cel to do­nate about $355M worth of ear­ly stock to char­i­ty

Four days ago, Moderna CEO Stéphane Bancel was made a Chevalier — basically knighted — in his home country of France. And now the billionaire CEO said he will exercise and donate about  $355 million in stock options.

Bancel announced early Tuesday via a blog post that he and his wife Brenda will be donating the after-tax proceeds of his original stock options to charity — the stock options Bancel was granted back in 2013 after he became CEO, two years after he first joined the mRNA specialist outfit.

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Mod­er­na seeks to dis­miss Al­ny­lam suit over Covid-19 vac­cine com­po­nent, claim­ing wrong venue

RNAi therapeutics juggernaut Alnylam Pharmaceuticals made a splash in March when it sued and sought money from both Pfizer and Moderna regarding their use of Alnylam’s biodegradable lipids, which Alnylam claims have been integral to the way both companies’ mRNA-based Covid-19 vaccines work.

But now, Moderna lawyers are firing back, telling the same Delaware district court that Alnylam’s claims can only proceed against the US government in the Court of Federal Claims because of the way the company’s contract is set up with the US government. The US has spent almost $10 billion on Moderna’s Covid-19 vaccine so far.

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Cracks in the fa­cade: Is phar­ma's pan­dem­ic ‘feel good fac­tor’ wan­ing?

The discordant effects of the Covid-19 pandemic on pharma reputation continues. While the overall industry still retains a respectable halo from its Covid-19 quick response and leadership, a new patient group study reveals a different story emerging in the details.

On one hand, US patient advocacy groups rated the industry higher-than-ever overall. More than two-thirds (67%) of groups gave the industry a thumbs up for 2021, a whopping 10 percentage point increase over the year before, according to the PatientView annual study, now in its 9th year.

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David Sinclair, Genocea Biosciences co-founder (Alpha Wave Global)

Geno­cea reach­es end of road, delist­ing from Nas­daq and let­ting go of re­main­ing staff

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.

Michael Corbo, Pfizer CDO of inflammation & immunology

UP­DAT­ED: Plan­ning ahead for crowd­ed ul­cer­a­tive col­i­tis mar­ket, Pfiz­er spells out PhI­II da­ta on $6.7B Are­na drug

Pfizer has laid out the detailed results behind its boast that etrasimod — the S1P receptor modulator at the center of its $6.7 billion buyout of Arena Pharma — is the winner of the class, potentially leapfrogging an earlier entrant from Bristol Myers Squibb.

Pivotal data from the ELEVATE program in ulcerative colitis — which consists of two Phase III trials, one lasting 52 weeks and the other just 12 weeks — illustrate an “encouraging balance of efficacy and safety,” according to Michael Corbo, chief development officer of inflammation & immunology at Pfizer. The company is presenting the results as a late breaker at Digestive Disease Week.

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