Lindy Durrant, Scancell CEO

Giv­ing first glimpse of da­ta, Scan­cell looks for Covid-19 vac­cine part­ner

UK-based biotech Scan­cell is lift­ing the veil off a Phase I tri­al for its Covid-19 vac­cine, but it’ll al­so be mak­ing a piv­ot on the vac­cine’s strat­e­gy.

Scan­cell said in a re­lease on Mon­day that it is pre­sent­ing the pre­lim­i­nary da­ta from its Phase I clin­i­cal tri­al, which was con­duct­ed at the Uni­ver­si­ty of Cape Town Lung In­stitue in South Africa. The tri­al was in­tend­ed to look at two of vac­cine Scan­cell’s can­di­dates, SCOV1 and SCOV2, in pa­tients be­fore test­ing them as a boost­er. Ac­cord­ing to the biotech, both can­di­dates are plas­mid DNA-based vac­cines.

The re­sults showed an­ti­body and T cell re­spons­es, with the lev­el of the de­tectable an­ti­bod­ies in the blood at 67% fol­low­ing vac­ci­na­tion by the two can­di­dates. Scan­cell al­so stat­ed that the vac­cines had an im­pact against sev­er­al vari­ants, in­clud­ing Omi­cron. No se­vere ef­fects or ma­jor safe­ty is­sues were re­port­ed dur­ing the tri­al.

But Scan­cell said in the re­lease that it will not be go­ing to take the vac­cine for­ward on its own. Be­cause of the larg­er size of lat­er-stage trails and the com­pet­i­tive­ness of the cur­rent Covid-19 field, the biotech will be look­ing for a part­ner.

Scan­cell CEO Lindy Dur­rant said in the re­lease:

Fur­ther large stud­ies would be re­quired to con­firm the po­ten­tial of the CO­VID­I­TY vac­cine can­di­dates to stim­u­late broad, cross-vari­ant re­ac­tiv­i­ty and com­pete with the cur­rent­ly ap­proved COVID-19 vac­cines. There­fore, and as pre­vi­ous­ly dis­closed, the Board has de­cid­ed to seek a part­ner to fur­ther progress this pro­gramme. Go­ing for­wards, Scan­cell will fo­cus its re­sources on pro­gress­ing the port­fo­lio of in­no­v­a­tive im­muno-on­col­o­gy drug can­di­dates that we have gen­er­at­ed from our plat­forms

How­ev­er, no de­tails on po­ten­tial part­ners or when Scan­cell will be trans­fer­ring the can­di­date were dis­closed. End­points News reached out to the biotech for more in­for­ma­tion.

The Covid-19 mar­ket has changed quite dras­ti­cal­ly since the big vac­cine push­es a few years ago. Phar­ma gi­ant Pfiz­er said on its Q4 earn­ings call that it is ex­pect­ing much low­er sales of Covid-19 prod­ucts due to a low­er fol­low­ing of com­pli­ance with vac­cine reg­u­la­tions and few­er vac­cines be­ing ad­min­is­tered, among oth­er fac­tors. This is lead­ing to an an­tic­i­pat­ed drop of around 60% in vac­cine sales rev­enue.

Last week, Japan can­celed an or­der for more than 140 mil­lion dos­es of No­vavax’s Covid-19 vac­cine, af­ter agree­ing to pur­chase around 150 mil­lion dos­es from Take­da in 2021. Take­da CFO Cos­ta Saroukos said on a pre­vi­ous call that it is see­ing “low mar­ket de­mand” for the vac­cine due to vac­ci­na­tion in Japan and the Omi­cron vari­ant’s pres­ence.

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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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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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.

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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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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Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Van­da wins court case against FDA over dis­clo­sure of CRL de­tails for sleep drug

DC District Court Judge Christopher Cooper today granted Vanda Pharma’s request to require the FDA to disclose more info on the complete response letter for its sleep disorder drug Hetlioz.

The melatonin receptor agonist is approved by the FDA to treat non-24-hour sleep-wake disorder, a circadian rhythm disorder. But in 2018 Vanda filed a supplemental application to market Hetlioz as a treatment for jet lag, which the FDA rejected in August 2019, with few details on what Vanda needed to correct course, according to the company.