Rendering courtesy of The RMR Group Unison LifeScience

Sono­ma Bio to ce­ment its roots in Seat­tle with a new wa­ter­front man­u­fac­tur­ing and R&D site

Jeff Blue­stone

A year af­ter Jeff Blue­stone’s Sono­ma Bio­ther­a­peu­tics net­ted $265 mil­lion in a huge Se­ries B, the biotech is now look­ing to es­tab­lish it­self in the man­u­fac­tur­ing ecosys­tem of the Pa­cif­ic North­west.

Sono­ma has en­tered in­to a lease agree­ment to de­vel­op an 83,000-square-foot man­u­fac­tur­ing and R&D cen­ter in Seat­tle, the com­pa­ny said Wednes­day. The com­pa­ny’s gene mod­i­fied Treg ther­a­pies, born out of the R&D lab in South San Fran­cis­co, will be made at the site.

In an in­ter­view with End­points News, Sono­ma’s chief tech­ni­cal of­fi­cer Hei­di Ha­gen said the com­pa­ny is plant­i­ng its man­u­fac­tur­ing flag in Seat­tle to gain ac­cess to the re­gion’s tal­ent and ex­pe­ri­ence with cell ther­a­py and its gen­er­al man­u­fac­tur­ing pedi­gree. Blue­stone al­so high­light­ed the Seat­tle area’s “deep lo­cal ca­pa­bil­i­ties and ex­per­tise” in pre­pared re­marks.

“Seat­tle has an es­tab­lished lega­cy of de­liv­er­ing many firsts in the cell ther­a­py field for can­cer, and we are build­ing up­on those in­sights to ad­vance our pipeline of en­gi­neered Treg ther­a­pies for au­toim­mune and in­flam­ma­to­ry dis­eases,” the CEO said in a state­ment.

Hei­di Ha­gen

While the cost of the fa­cil­i­ty was not dis­closed to End­points, Ha­gen said that some of the funds from the last in­vest­ment round were ear­marked to es­tab­lish the site. Be­tween its two West Coast sites, the com­pa­ny has 120 peo­ple on staff, with the new site ex­pect­ed to bring aboard 100 ad­di­tion­al work­ers, Ha­gen said. The site is ex­pect­ed to be re­fur­bished and fit­ted for mov­ing in by the end of next year.

“We’re build­ing it out with the abil­i­ty to have a sig­nif­i­cant num­ber of man­u­fac­tur­ing, process de­vel­op­ment and QC folks nec­es­sary that en­ables us to re­al­ly be able to do mul­ti­ple clin­i­cal tri­als and man­u­fac­tur­ing for those clin­i­cal tri­als over the com­ing years. So, we don’t re­al­ly have a tar­get num­ber, but (we’re) re­al­ly look­ing to be able to lever­age the space and be able to man­age mul­ti­ple clin­i­cal tri­als,” she said.

Ha­gen said the com­pa­ny is prepar­ing its first cell ther­a­pies for clin­i­cal tri­als and al­ready had IND ap­proval for its an­ti­body, which has been used for pre­con­di­tion­ing.

The com­pa­ny’s fund­ing pedi­gree has been high, as it got off the ground with a $30 mil­lion launch round, but it comes amid sev­er­al oth­er gene ther­a­py star­tups al­so se­cur­ing a high amount of cash from big names. Sono­ma’s in­vest­ment al­so comes from oth­er start­up ven­tures, such as Syn­thego, which are us­ing fund­ing pro­ceeds to es­tab­lish man­u­fac­tur­ing sites as well.

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.

Feng Zhang (Susan Walsh/AP Images)

In search of new way to de­liv­er gene ed­i­tors, CRISPR pi­o­neer turns to mol­e­c­u­lar sy­ringes

Bug bacteria are ruthless.

Some soil bacteria have evolved tiny, but deadly injection systems that attach to insect cells, perforate them and release toxins inside — killing a bug in just a few days’ time. Scientists, on the other hand, want to leverage that system to deliver medicines.

In a paper published Wednesday in Nature, MIT CRISPR researcher Feng Zhang and his lab describe how they engineered these syringes made by bacteria to deliver potential therapies like toxins that kill cancer cells and gene editors. With the help of an AI program, they developed syringes that can load proteins of their choice and selectively target human cells.

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Dif­fu­sion to hand Nas­daq spot to EIP Phar­ma for PhI­Ib de­men­tia study of ex-Ver­tex drug

One of the more than a dozen bidders for Diffusion Pharmaceuticals’ spot on Nasdaq has prevailed.

Boston biotech EIP Pharma will merge with Diffusion in an all-stock deal, with plans to start a Phase IIb clinical trial in the coming months in a common form of dementia with no approved treatments. The combined company will be renamed CervoMed.

The nine-year-old privately-held EIP is working on a former Vertex drug that it will test in a 160-person Phase IIb in patients with dementia with Lewy bodies, or DLB. The National Institute on Aging is expected to fund that trial with a $21 million grant. With the reverse merger, slated for closing in the middle of this year, EIP will be funded through that readout in the second half of 2024. EIP’s equity and debt holders will own about 77.25% of the combined company.

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Luke Miels, GSK chief commercial officer

GSK picks up Scynex­is' FDA-ap­proved an­ti­fun­gal drug for $90M up­front

GSK is dishing out $90 million cash to add an antifungal drug to its commercial portfolio, in a deal spotlighting the pharma giant’s growing focus on infectious diseases.

The upfront will lock in an exclusive license to Scynexis’ Brexafemme, which was approved in 2021 to treat a yeast infection known as vulvovaginal candidiasis, except in China and certain other countries where Scynexis already out-licensed the drug.

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See­los Ther­a­peu­tics 'tem­porar­i­ly' stops study in rare neu­ro dis­or­der for busi­ness rea­sons

Microcap biotech Seelos Therapeutics is halting enrollment of its study in spinocerebellar ataxia type 3 (also known as Machado-Joseph disease) because of “financial considerations,” and in order to focus on other studies, the company said today, adding that the pause would be temporary.

The study will continue with the patients who have already enrolled, and the data from them will be used to decide whether to continue enrolling others in the future.

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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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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J&J bows out of RSV vac­cine race, end­ing PhI­II study and ced­ing to Pfiz­er, GSK

Johnson & Johnson announced Wednesday morning it is ending development of its adult RSV vaccine that was in the middle of a 27,200-patient trial, giving up a big slice of what’s expected to be the next multibillion-dollar pharma market.

The decision came down to the shifting RSV “competitive landscape,” a company spokesperson tells Endpoints News, adding the “breadth of options” was much different than when J&J first started its pivotal study. The spokesperson declined to comment on the Phase III data, saying only the shot is undergoing an “ongoing assessment.”

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No longer ‘dead or just hi­ber­nat­ing,’ drug­mak­ers re­turn to heart med­i­cines

In 2015, now-FDA Commissioner Robert Califf joined industry, academic and regulatory representatives in Washington to discuss why more drugs weren’t in development for cardiovascular diseases, the leading US cause of death and once a mainstay of pharmaceutical industry blockbusters.

The group pointed to many reasons. Clinical trials could take years and testing was expensive. Wide availability of generic drugs made the commercial prospects uncertain. Their paper title summed up the mood: “Cardiovascular Drug Development: Is it Dead or Just Hibernating?”

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