Anthony Fauci (Greg Nash/Pool via AP Images)

Fau­ci calls for de­vel­op­ment of pan-coro­n­avirus and in­tranasal vac­cines in fight against Covid vari­ants

Even as vac­cine man­u­fac­tur­ers plow a path to mar­ket for Omi­cron-spe­cif­ic boost­er shots this fall, NI­AID di­rec­tor An­tho­ny Fau­ci’s mes­sage is clear: “Our job is not done.”

Fau­ci, who al­so serves as chief med­ical ad­vi­sor to Pres­i­dent Joe Biden, took the White House podi­um on Tues­day to of­fer a glimpse at where next-gen­er­a­tion vac­cines are head­ed — specif­i­cal­ly high­light­ing the need for pan-coro­n­avirus can­di­dates and mu­cos­al op­tions that can be ad­min­is­tered in­tranasal­ly.

“In­no­v­a­tive ap­proach­es are clear­ly need­ed to in­duce broad and durable pro­tec­tion against coro­n­avirus­es known and un­known,” he said.

At the end of last month, the FDA rec­om­mend­ed that vac­cine man­u­fac­tur­ers like Pfiz­er and Mod­er­na move for­ward with Omi­cron-spe­cif­ic for­mu­la­tions, which may be avail­able in ear­ly- to mid-fall.

Thanks to cur­rent vac­cines, we’ve avert­ed well over two mil­lion deaths and about a tril­lion dol­lars in health­care costs, Fau­ci said. How­ev­er, vac­cine de­vel­op­ment is be­com­ing in­creas­ing­ly com­pli­cat­ed, as we’re now see­ing “sub­lin­eages of sub­lin­eages” of Covid vari­ants.

“These in­jectable vac­cines do a great job at pre­vent­ing se­vere dis­ease, but they do lit­tle to pre­vent in­fec­tion and trans­mis­sion, and trans­mis­sion is the en­gine of vari­ant evo­lu­tion,” said Mar­tin Moore, CSO and co­founder of Meis­sa Vac­cines.

Down the road, Fau­ci ad­vo­cat­ed for pan-coro­n­avirus vac­cines, or mu­cos­al op­tions that could po­ten­tial­ly stop trans­mis­sion in its tracks.

“When you have a mu­cos­al, and in this case, in­tranasal, what you do is you stim­u­late at the lo­cal lev­el,” Fau­ci said dur­ing the sum­mit, which was broad­cast live on Zoom. “The goal of that is not on­ly to pro­tect against dis­ease, but to pro­tect against ac­qui­si­tion and by ac­qui­si­tion, trans­mis­sion. And that’s re­al­ly the holy grail.”

Akiko Iwasa­ki

Cur­rent vac­cines in­duce ro­bust sys­temic im­mune re­spons­es, but do not in­duce a mu­cos­al re­sponse, ac­cord­ing to Akiko Iwasa­ki, an im­munol­o­gy pro­fes­sor at Yale Uni­ver­si­ty. She’s al­so the co-founder of Xanadu Bio, a Yale spin­out look­ing to bring an in­tranasal Covid can­di­date in­to the clin­ic. Mu­cos­al vac­cines are de­signed to pre­vent a virus from ever get­ting to a host cell, like putting a guard out­side your house to pro­tect from in­vaders, Iwasa­ki said.

Iwasa­ki re­cent­ly co-au­thored a pa­per in Sci­ence Im­munol­o­gy along­side Scripps Re­search Trans­la­tion­al In­sti­tute founder Er­ic Topol that ad­vo­cates for an ac­cel­er­at­ed ini­tia­tive for in­tranasal Covid-19 vac­cines, sim­i­lar to Op­er­a­tion Warp Speed.

“We know from 200 years of vac­ci­nol­o­gy … that vac­cines that mim­ic nat­ur­al in­fec­tion tend to work best,” Moore said. “No one here to­day can tell you that mu­cos­al COVID vac­cines work, we’re not there yet. We need clin­i­cal ef­fi­ca­cy da­ta to an­swer that ques­tion, and that’s why we’re here.”

Paul Bur­ton

Man­u­fac­tur­ing is al­so “a key part of the fu­ture,” Mod­er­na’s CMO Paul Bur­ton said at the sum­mit, adding that the com­pa­ny has re­cent­ly struck deals to build new plants and R&D sites in Aus­tralia, the Unit­ed King­dom, Cana­da and Kenya.

“We have to con­tin­ue these dis­cus­sions, con­tin­ue these col­lab­o­ra­tions to in­still con­fi­dence,” Bur­ton said. “Get­ting that con­fi­dence and then the abil­i­ty to get these shots made in coun­tries and in­to peo­ple’s arms I think is how we’re go­ing to con­tin­ue to get out of the pan­dem­ic.”

Pfiz­er bio­phar­ma group pres­i­dent An­gela Hwang added that the de­vel­op­ers con­tin­ue to im­ple­ment lessons learned from the pan­dem­ic to make the process more ef­fi­cient.

“Prob­a­bly two and a half bil­lion peo­ple have re­ceived the Pfiz­er vac­cine,” she said. “That’s an in­cred­i­ble wealth of re­al world ev­i­dence that we’re sit­ting on. And so I think that we have a great op­por­tu­ni­ty, hav­ing that strong depth and breadth of da­ta, to use that to al­so help us to un­der­stand, how can we de­sign new ther­a­pies?”

*A cor­rec­tion has been made to the at­tri­bu­tion of two quotes by Mar­tin Moore.

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.

Cy­to­ki­net­ics’ ALS drug fails PhI­II, leav­ing the biotech with a sin­gle late-stage prospect

Cytokinetics’ candidate for the muscle disease amyotrophic lateral sclerosis, or ALS, failed a Phase III trial, the Bay Area biotech announced Friday morning.

At a second interim analysis of the trial, an independent review committee recommended that Cytokinetics discontinue its COURAGE-ALS trial for reldesemtiv, as it “found no evidence of effect” compared to placebo on the primary or key secondary endpoints.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,900+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,900+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,900+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,900+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,900+ biopharma pros reading Endpoints daily — and it's free.

CHMP gives thumbs-up for We­govy use in ado­les­cents, along with nine new drug rec­om­men­da­tions

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended nine drugs for approval this week while also giving thumbs up for six expanded indications, including Novo Nordisk’s approved obesity medication Wegovy for younger people. Wegovy is already approved as an obesity treatment in the EU for adults, and the new indication would allow prescriptions for adolescents aged 12 and older.

Green­Light re­ceives buy­out of­fer; Apol­lomics com­pletes SPAC merg­er

RNA biotech GreenLight Biosciences has been handed an offer for potential acquisition.

GreenLight said in a release that it has received a non-binding “indication of interest” from Fall Line Endurance Fund to acquire GreenLight’s capital stock for $0.60 per share in cash. The release said any potential agreement between the two parties would depend on certain conditions.

Through a special committee, the biotech will evaluate the offer but added there’s no certainty a deal will go forward. GreenLight will also not make any more announcements until a deal comes through or “otherwise determines” a statement is necessary.

TScan Therapeutics' departing CEO David Southwell and CSO/COO Gavin MacBeath

TCR up­start an­nounces CEO ex­it, with CSO now act­ing re­place­ment

A public T cell biotech’s chief executive has decided to leave the company.

TScan Therapeutics said Friday morning that CEO David Southwell stepped down earlier this week, leaving both his chief executive and board member roles. Filling in is Gavin MacBeath, the company’s CSO and COO. He became the acting CEO on Tuesday, and will continue to remain CSO and COO, TScan’s announcement read.