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

F-star's sale to Chi­nese buy­er cleared by CFIUS fol­low­ing months of holdup

Af­ter tak­ing sev­er­al months to re­view F-star’s pro­posed sale to a Chi­nese com­pa­ny, the US gov­ern­ment’s Com­mit­tee on For­eign In­vest­ment in the Unit­ed States (CFIUS) has fi­nal­ly giv­en its bless­ing for the deal.

The clear­ance comes al­most nine months af­ter in­voX Phar­ma, a sub­sidiary of Chi­na’s Sino Bio­pharm, first struck a deal to buy out F-star for $161 mil­lion in cash.

CFIUS is a long­stand­ing group tasked with scru­ti­niz­ing trans­ac­tions in­volv­ing for­eign in­vest­ments in the US and block­ing any deals it deems threat­en­ing. But in re­cent years, the White House has sig­naled that biotech could be a top area for crack­down, trig­ger­ing fears that it would cre­ate road­blocks for Asian in­vestors in­ter­est­ed in US com­pa­nies.

Thanks to the re­view, the com­pa­nies have ex­tend­ed the of­fer pe­ri­od mul­ti­ple times. In De­cem­ber, CFIUS went as far as to put the buy­out on hold, cit­ing “un­re­solved na­tion­al se­cu­ri­ty risks.”

F-star sug­gest­ed a month lat­er that to­geth­er with in­voX, it was ne­go­ti­at­ing a “mit­i­ga­tion agree­ment” to ad­dress CFIUS’ con­cerns.

Once a high fly­er in UK biotech, F-star makes bis­pe­cif­ic an­ti­bod­ies de­signed to trig­ger more spe­cif­ic im­mune ac­ti­va­tion against can­cer. While it boast­ed siz­able deals with Bris­tol My­ers Squibb and lat­er Mer­ck KGaA, it was in dire need of cash to pay off its debt and stay afloat. Sino Bio­pharm, which was look­ing to ex­pand its over­seas pres­ence, of­fered ex­act­ly that.

With the fi­nal hur­dle cleared, the deal is all but sealed as 70% of the F-star stock has al­ready been ten­dered, ac­cord­ing to a press re­lease, and it on­ly needs more than 50%. The ten­der of­fer is sched­uled to ex­pire on Wednes­day.

Shares of F-star $FSTX rose more than 16% to $7.11.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Hugo Peris, Spiral Therapeutics CEO

Hear­ing-fo­cused biotech grabs trio of pro­grams from Oton­o­my's fire sale

Otonomy may be shutting down, but the lessons learned there will live on at another biotech working on new treatments for hearing loss.

San Francisco-based Spiral Therapeutics has bought certain assets related to three of Otonomy’s programs, ranging from data, patent rights, and know-how to inventory. That includes data around Otonomy’s twice-failed lead program, OTO-104 (Otividex), a sustained-exposure formulation of dexamethasone.

Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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Alec­tor cuts 11% of work­force as it dou­bles down on late-stage neu­ro pro­grams part­nered with GSK, Ab­b­Vie

A month after revealing plans to concentrate on its late-stage immuno-neurology pipeline, Alector is trimming its headcount by 11%.

The layoffs will impact around 30 employees across the organization, the company disclosed in an SEC filing, adding that the plan will “better align the company’s resources” with the new strategy. With $712.9 million in cash, cash equivalents and investments as of the end of 2022, Alector believes the reserves will now get it through 2025.

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Jeff Bluestone (R), Sonoma Biotherapeutics CEO

Jef­frey Blue­stone brings his start­up haul to $400M+, join­ing forces with Re­gen­eron on cell ther­a­pies

These days, when Jeffrey Bluestone gets together with his contemporaries in science, the conversation often turns to retirement plans.

But a little more than three years ago, Bluestone reached a momentous turning point in his career, exiting a prestigious post at UCSF, where he had spent decades in the scientific pursuit of new therapies. And it had nothing to do with retirement anytime in the near future.

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Kevin Lee, Bicycle Therapeutics CEO

No­var­tis rides with Bi­cy­cle for new pact on tar­get­ed ra­dio­ther­a­pies

Novartis has inked a three-year deal with Bicycle Therapeutics to develop new targeted radiotherapies for cancer.

Novartis will pay Bicycle $50 million upfront, with downstream milestones adding up to a potential $1.7 billion. In exchange, Bicycle will use its virus-based platform to discover new bicyclic peptides, which it calls bicycles, that would be used for radiotherapies. Those bicycles would act as a homing beacon for radioactive isotopes, delivering them to cancer cells to kill the cells while limiting radiation to healthy tissue.

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Covant acting CEO Matt Maisak (L) and CSO Iván Cornella

With Boehringer In­gel­heim’s help, Roivant churns out an­oth­er Vant to go up against En­deav­or, Im­pact founders

Roivant Sciences has added another branch to its family tree, unveiling Covant Therapeutics with a $10 million upfront commitment from Boehringer Ingelheim to turn up the heat in cancer.

The Boston-based drug discovery startup will jointly create a new small molecule immunotherapy with the private German pharma giant. The deal, made public Tuesday morning, includes up to $471 million in future payments and tiered royalties, should the product make it to market.

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CSL CEO Paul McKenzie (L) and CMO Bill Mezzanotte

Q&A: New­ly-mint­ed CSL chief ex­ec­u­tive Paul McKen­zie and chief med­ical of­fi­cer Bill Mez­zan­otte

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

Phar­maron ex­pand­ing Liv­er­pool man­u­fac­tur­ing fa­cil­i­ty with a $186M+ price tag

Liverpool may be known for rock and roll and premier league football, but the China-based contract manufacturer Pharmaron is looking to make it a bigger hub for cell and gene therapy manufacturing.

As part of Pharmaron’s further commitment to Merseyside county, it plans to build an 8,000-square-meter facility, or around 86,000 square feet, which includes a boost to the manufacturing capacity of 3,500 square meters, or 37,600 square feet. The price tag for the expansion will be £151 million ($186 million), with Pharmaron receiving a grant from the UK Government’s Life Sciences Innovation Manufacturing Fund (LSIMF).