David Veitch, Basilea CEO (Vimeo via Basilea website)

In an un­usu­al piv­ot, Swiss biotech Basilea looks to ditch can­cer pipeline in fa­vor of — an­ti-in­fec­tives?

On­col­o­gy has been the sin­gle largest dri­ver of rev­enues across bio­phar­ma for years now, and you’re more like­ly than ever to see a com­pa­ny ditch all oth­er plans to chase that white rab­bit. But a Swiss biotech is bet­ting its fu­ture on a per­pen­dic­u­lar path, opt­ing to ditch its on­col­o­gy as­sets in­stead.

Switzer­land-based Basilea will look to of­fload its on­col­o­gy pipeline in part or in full as part of a re­or­ga­ni­za­tion of its R&D pipeline around an­ti-in­fec­tives, in­clud­ing its two ap­proved drugs in that space, the biotech said Tues­day.

Here’s how Basilea CEO David Veitch ex­plained the ra­tio­nale be­hind the de­ci­sion:

Fol­low­ing a strate­gic re­view, we have de­cid­ed to sep­a­rate our ac­tiv­i­ties in an­ti-in­fec­tives from on­col­o­gy. Our two busi­ness­es are at dif­fer­ent stages of de­vel­op­ment, re­quir­ing dif­fer­ent ap­proach­es. For our on­col­o­gy as­sets, we aim to op­ti­mize the val­ue through ei­ther port­fo­lio or in­di­vid­ual as­set trans­ac­tions, with part­ners spe­cial­ized in on­col­o­gy. We will fo­cus in the fu­ture on the re­search, de­vel­op­ment and com­mer­cial­iza­tion of in­no­v­a­tive treat­ments for se­vere bac­te­r­i­al and fun­gal in­fec­tions. Basilea is unique­ly po­si­tioned to ben­e­fit from the im­prov­ing busi­ness en­vi­ron­ment for an­ti-in­fec­tives and to be­come a lead­ing com­pa­ny in this space, based on its proven ex­per­tise in ad­vanc­ing an­ti-in­fec­tives through re­search and de­vel­op­ment to the mar­ket.

In the short term, at least through this year, Basilea will hold steady with one of its can­cer drugs, the FGFR in­hibitor de­r­azan­ti­nib, in stud­ies across in­tra­hep­at­ic cholan­gio­car­ci­no­ma and gas­tric can­cer, while “de­pri­or­i­tiz­ing” the drug’s tri­al in ovar­i­an can­cer.

The com­pa­ny plans to stop en­roll­ment there across mul­ti­ple co­horts af­ter de­ter­min­ing “pa­tient en­rol­ment has been chal­leng­ing in these sub­stud­ies, due to the evolv­ing com­pet­i­tive en­vi­ron­ment in urothe­lial can­cer treat­ment,” ac­cord­ing to a re­lease.

Basilea cur­rent­ly sports two oth­er can­cer drugs in its pipeline, ac­cord­ing to the biotech’s web­site, in lisa­van­bu­lin and BAL0891, a check­point in­hibitor.

De­spite pitch­ing the re­org as a mat­ter of con­sol­i­dat­ing ex­per­tise, Basilea’s de­ci­sion has a cash im­pli­ca­tion as well. The com­pa­ny said its re­struc­tur­ing plans will cut op­er­at­ing ex­pens­es by rough­ly 30% in 2023, putting the com­pa­ny on the path to prof­itabil­i­ty, Basilea said.

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.

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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Sen­ate Fi­nance Com­mit­tee lobs more bi­par­ti­san pres­sure on­to PBMs

Congress is honing in on how it wants to overhaul the rules of the road for pharmacy benefit managers, with a Senate Finance Committee hearing Thursday serving as the latest example of the Hill’s readiness to make changes to how pharma middlemen operate.

While pledging to ensure patients and pharmacies “don’t get a raw deal,” Finance Committee Chair Ron Wyden (D-OR) laid out the beginning of what looks like a major bipartisan effort — moves the PBM industry is likely to challenge vigorously.

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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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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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Nicklas Westerholm, Egetis Therapeutics CEO

Ac­qui­si­tion talks on­go­ing for Swedish rare dis­ease biotech Egetis, shares up al­most 40%

Shares of the Sweden-based rare disease biotech Egetis Therapeutics skyrocketed on Thursday afternoon as the company said it’s engaged in “ongoing discussion” with external parties regarding a “potential acquisition.”

Egetis confirmed rumors with a statement on Thursday while noting that there is no certainty that a takeover offer will be made.

Nonetheless, the possibility of an acquisition has shot up Egetis’ share price. By the afternoon on Thursday, its stock price was {$EGTX.ST} up over 38%. An Egetis spokesperson told Endpoints News in an email that it has no further comments.

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Lu­pus drug de­vel­op­ment mar­ket heat­ing up, while FDA links with ad­vo­ca­cy group to fur­ther ac­cel­er­ate re­search

The long-underserved systemic lupus erythematosus (SLE) market is suddenly buzzing with treatment possibilities. Less than two years after AstraZeneca’s approval for Saphnelo — the first new SLE drug in a decade and joining just one other approved in GSK’s Benlysta – the pipeline of potential drugs numbers in the dozens.

Although most are very early stage — Spherix Global Insights estimates five in Phase II/III — the pharma R&D enthusiasm is catching on among doctors, patients and advocacy groups. On Wednesday, the Lupus Research Alliance and the FDA formed a novel private-public partnership called Lupus Accelerating Breakthroughs Consortium (Lupus ABC) to help advance lupus clinical trial success.

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Af­ter safe­ty re­view, EMA mir­rors FDA with up­dat­ed rec­om­men­da­tions for JAK in­hibitors

The EMA released updated recommendations today for the use of JAK inhibitors (JAKi) after reviewing data from several clinical trials that showed increased incidents of issues in certain patients who have rheumatoid arthritis and other risk factors.

The EMA noted malignancy, major adverse cardiovascular events (MACE), serious infections, venous thromboembolism (VTE) and mortality in some patients.