A2 Bio­ther­a­peu­tics nabs $71M-plus Se­ries B for se­lec­tive cell ther­a­py pipeline

More than 15 years af­ter beat­ing can­cer him­self, A2 Bio­ther­a­peu­tics CEO Scott Forak­er has pulled in a $71.5 mil­lion Se­ries B round to send a mys­tery can­di­date for sol­id tu­mors in­to the clin­ic.

“It’s quite per­son­al for me and I re­al­ly am dri­ven to make a dif­fer­ence,” said Forak­er, a non-Hodgkin’s lym­phoma sur­vivor. “I know what it’s like to sit in an in­fu­sion chair for hours and get dos­es of chemother­a­py.”

The Agoura Hills, CA-based biotech is work­ing on an en­gi­neered T-cell ther­a­py, which us­es an ac­ti­vat­ing and block­ing mech­a­nism to se­lec­tive­ly tar­get can­cer cells. The ac­ti­va­tor at­tacks tu­mor cells, while the block­er rec­og­nizes nor­mal cells and pro­tects them.

Scott Forak­er

“The de­struc­tion of nor­mal cells as you’re try­ing to kill the tu­mor cells is quite a prob­lem,” Forak­er said. “Most can­cer ther­a­peu­tics re­al­ly try to care­ful­ly bal­ance pro­vid­ing enough tox­i­c­i­ty to kill the cells, but not so much that it harms the nor­mal cells too much.”

Forak­er — along with rough­ly half of A2’s staff of more than 40 — came by way of Am­gen. For the last 8 years, he served as VP and gen­er­al man­ag­er of the com­pa­ny’s biosim­i­lars di­vi­sion. But when fel­low Am­gen col­league Sasha Kamb left to start A2, “every­one was quite in­trigued,” Forak­er said. The op­por­tu­ni­ty arose to join Kamb at A2 last May, and he jumped.

A2 has al­so tapped William Go, for­mer VP of clin­i­cal de­vel­op­ment at Kite Phar­ma, and Michelle Kreke, who led Kite’s process de­vel­op­ment, to its team. “We think we’ve com­bined the best of biotech… R&D drug de­vel­op­ment,” Forak­er said.

The biotech emerged from stealth mode last year with a $57 mil­lion Se­ries A and its sights set on the clin­ic. While Forak­er didn’t di­vulge much about the com­pa­ny’s pipeline, he said the Se­ries B will fund work on three can­di­dates, the first of which is ex­pect­ed to hit the clin­ic in 2022. The two oth­ers, he said, are not far be­hind.

“This is a re­al­ly fas­ci­nat­ing new tech­nol­o­gy that has the po­ten­tial to rev­o­lu­tion­ize the way… sol­id tu­mor can­cers are treat­ed,” he said. The com­pa­ny will work close­ly with the FDA over the next year on clin­i­cal de­vel­op­ment plans, he added.

Se­ries B fi­nanc­ing will al­so sup­port the ex­pan­sion of A2’s pipeline be­yond its cur­rent three can­di­dates. A2 re­searchers be­lieve dif­fer­ent com­bi­na­tions of ac­ti­va­tors and block­ers can be used to treat dif­fer­ent types of can­cers.

“The po­ten­tial of this ther­a­py is quite vast which is part of the rea­son we’re so ex­cit­ed about it, (and) anx­ious to get it in­to hu­man clin­i­cal test­ing,” Forak­er said.

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.

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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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.