Agenus’ lead can­cer vac­cine flops, in­ves­ti­ga­tors read last rites over glioblas­toma PhII

Just days af­ter hand­ing over the reins on a big an­ti­body col­lab­o­ra­tion to In­cyte, Agenus is now slam­ming the brakes on its top can­cer vac­cine tri­al, con­ced­ing a flop.

The Lex­ing­ton, MA-based biotech $AGEN says an in­de­pen­dent da­ta mon­i­tor­ing com­mit­tee over­see­ing the Phase II com­bi­na­tion study of its can­cer vac­cine Prophage with Avastin (be­va­cizum­ab) found no en­cour­age­ment that the vac­cine — made of heat shock pro­tein-pep­tide com­plex­es tak­en from a pa­tient’s tu­mor tis­sue — was any bet­ter than be­va­cizum­ab alone in pro­long­ing sur­vival among brain can­cer pa­tients.

The study was launched in 2013 and in­tend­ed to re­cruit 165 pa­tients. Agenus qui­et­ly not­ed the fail­ure in a fil­ing with the SEC on Tues­day.

The bot­tom line in the 8-K:

The in­ter­im analy­sis sug­gest­ed that the tri­al is un­like­ly to demon­strate that the vac­cine in com­bi­na­tion with be­va­cizum­ab will lead to a bet­ter sur­vival than be­va­cizum­ab as a monother­a­py. There­fore, up­on the DSMB’s rec­om­men­da­tion, the ac­cru­al for the tri­al has been closed.

The biotech’s shares were down 5.5% in pre­mar­ket trad­ing Wednes­day.

A spokesper­son for the biotech says that while that Phase II has been closed, the pro­gram for Prophage is def­i­nite­ly con­tin­u­ing. Just a few weeks ago Agenus an­nounced plans to com­bine Prophage and the PD-1 drug Keytru­da in a new tri­al. The failed study was in late-stage pa­tients and this next study will be for new­ly di­ag­nosed glioblas­toma pa­tients.

“The ra­tio­nale for syn­er­gy be­tween Prophage and a check­point in­hibitor is much greater,” she adds. “This, along with ear­li­er stage pa­tients be­ing stud­ied in the tri­al, leads to ex­pec­ta­tions of bet­ter out­comes.”

Like a long line­up of can­cer vac­cines in re­cent years, Agenus’ at­tempt to kick­start an im­mune sys­tem at­tack ap­peared safe but in­ef­fec­tive in the most re­cent set­back, too weak to make a sig­nif­i­cant dif­fer­ence. The biotech al­so has a slate of check­points in the clin­ic, look­ing to fol­low up on a new ap­proach to re­mov­ing can­cer cells’ nat­ur­al de­fens­es so that they can be elim­i­nat­ed by the im­mune sys­tem.

A few days ago Agenus backed away from a 50/50 deal split arrange­ment that it had with In­cyte on an­ti­body de­vel­op­ment, trig­ger­ing some spec­u­la­tion that the com­pa­ny was too weak fi­nan­cial­ly to keep up its end of the bar­gain. Agenus set­tled for an $80 mil­lion cash in­fu­sion and a roy­al­ty stream on any prod­ucts that hit the mar­ket.

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

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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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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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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.

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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