David Bejker, Affibody CEO

Chiesi puts down $200M+ to col­lab­o­rate with Af­fi­body for res­pi­ra­to­ry dis­eases

The Ital­ian drug de­vel­op­er Chiesi will be look­ing to drop nine fig­ures to de­vel­op sev­er­al treat­ments for res­pi­ra­to­ry dis­eases in a deal with Swedish biotech Af­fi­body.

Chiesi and Af­fi­body will work to­geth­er on three pro­grams us­ing Af­fi­body’s mol­e­cules against three tar­gets. Chiesi will al­so fund the dis­cov­ery and de­vel­op­ment work as well as com­mer­cial­ize the can­di­dates world­wide, but Af­fi­body will hold on to co-pro­mot­ing the can­di­dates in the Nordic re­gion.

Af­fi­body will re­ceive up to $214 mil­lion in up­front, de­vel­op­ment and com­mer­cial mile­stone pay­ments, as well as “mid-sin­gle to low dou­ble-dig­it” roy­al­ty pay­ments on sales for the first pro­gram. The agree­ment can be ex­pand­ed to in­clude all three pro­grams, which could see Af­fi­body col­lect up to $637 mil­lion.

“Our col­lab­o­ra­tion with Af­fi­body adds an im­por­tant new modal­i­ty to our R&D port­fo­lio that has par­tic­u­lar­ly in­ter­est­ing prop­er­ties for in­hala­tion, and we look for­ward to de­vel­op­ing new treat­ments for peo­ple with un­met med­ical needs based on this part­ner­ship,” Thomas Eich­holtz, the head of glob­al R&D at Chiesi Group, said in a re­lease.

Af­fi­body CEO David Be­jk­er told End­points News in an email that the com­pa­ny can­not give any de­tails for the time­line of when the can­di­dates will be mov­ing to­ward the clin­ic, as it is in the ear­ly stages of de­vel­op­ment. But Be­jk­er did say the pro­grams be­ing de­vel­oped will aim to treat chron­ic dis­eases such as asth­ma, COPD, id­io­path­ic pul­monary fi­bro­sis and pul­monary hy­per­ten­sion.

Be­jk­er said in the email:

We ac­knowl­edge and ap­pre­ci­ate Chiesi’s sig­nif­i­cant com­mit­ment and ex­per­tise in the de­vel­op­ment of in­haled drugs and be­lieve that this part­ner­ship will help max­i­mize the val­ue of in­haled Af­fi­body mol­e­cules. This fur­ther val­i­dates our com­pa­ny and tech­nol­o­gy and has the po­ten­tial of de­liv­er­ing im­por­tant med­i­cines to pa­tients.

Chiesi has been ac­tive in the deal space so far this year. At JPM in Jan­u­ary, the drug de­vel­op­er an­nounced it was shelling out $1.25 bil­lion to pur­chase rare dis­ease biotech Am­ryt Phar­ma, with that deal ex­pect­ed to close some­time be­fore the end of the first half of 2023.

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.

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. The company said last October it was letting go 40% of its staff and winding down promotional activities for the drug, saying the drug “requires a larger organization with more resources, more women’s health experience and a bigger commercial footprint.”

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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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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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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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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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