CEO Mark McKenna (Prometheus Biosciences)

Prometheus Bio is ready for its close-up shot, fol­low­ing a $130M round to back IBD drugs now head­ed to the clin­ic

A lit­tle over a year ago, Take­da lined up a deal to col­lab­o­rate with a low-pro­file San Diego up­start called Prometheus Bio­sciences on a string of new drugs for in­flam­ma­to­ry bow­el dis­ease. The phar­ma play­er tossed an undis­closed up­front and up to $420 mil­lion in mile­stones to get the al­liance start­ed.

These days, pre­clin­i­cal deals are com­mon, mile­stones are hazy mark­ers of fi­nan­cial health and the pact didn’t get a lot of at­ten­tion. But that ob­scu­ri­ty should start to dis­si­pate this week.

To­day, Prometheus, which had been cre­at­ed by the ac­qui­si­tion of Prometheus Labs by Pre­ci­sion IBD, is show­ing off a whop­ping $130 mil­lion raise from some fa­mil­iar biotech in­vestors jump­ing in to stretch the run­way at the 4-year-old pre­clin­i­cal biotech out in­to 2023, when CEO Mark McKen­na is promis­ing to have 3-4 IBD drugs ei­ther in the clin­ic or IND ready. The first of those clin­i­cal pro­grams is slat­ed to be­gin in a mat­ter of weeks, putting McKen­na’s team on track to their first round of hu­man da­ta.

Spun out of Cedars-Sinai Med­ical Cen­ter, the com­pa­ny built a con­sid­er­able por­tion of its sci­en­tif­ic foun­da­tion around the work of Stephan Tar­gan, an IBD spe­cial­ist who found­ed the IBD Cen­ter at the med­ical cen­ter some 28 years ago.

“We lever­aged this big da­ta set built over 20 years to iden­ti­fy new tar­gets in IBD and de­vel­op com­pan­ion di­ag­nos­tics for the drugs,” says McKen­na, cit­ing 20,000 sam­ples in the da­ta bank. Us­ing bioin­for­mat­ics tech, they have been work­ing on spot­light­ing tar­get­ed ther­a­peu­tics that can do bet­ter — in a much more durable fash­ion — than the cur­rent gen­er­a­tion of IBD drugs.

Their lead pro­gram — PRA023 — is an an­ti-TL1A an­ti­body. But they’re not alone. Pfiz­er has a sim­i­lar pro­gram. But McKen­na has am­bi­tions to build a broad pipeline around IBD.

“We be­lieve we can put out a new tar­get every year,” he tells me.

You may re­call that McKen­na spent a 4-year stretch fo­cused on Bausch sub Sal­ix Phar­ma­ceu­ti­cals, where he won ku­dos for the turn­around work he ac­com­plished there. Once seen as a pos­si­ble suc­ces­sor to Bausch chief Joe Pa­pa, he now wants to take this new com­pa­ny all the way through to com­mer­cial­iza­tion. And Pa­pa has joined his board at Prometheus, watch­ing the work from a front-row seat.

It was Prometheus chair­man Tachi Ya­ma­da, a leg­end in the biotech busi­ness, who reached out to McKen­na to see if he would be in­ter­est­ed in run­ning Prometheus, af­ter watch­ing his work at Sal­ix.

Ya­ma­da, no doubt, al­so played a role in bring­ing to­geth­er a large syn­di­cate of in­vestors.

Even­tide As­set Man­age­ment and RTW In­vest­ments led the round with a slate of new in­vestors: Per­cep­tive Ad­vi­sors, Cor­morant Cap­i­tal, Cowen Health­care In­vest­ments, Point72 As­set man­age­ment and Irv­ing In­vestors. Then there are the ex­ist­ing in­vestors: As­cend Glob­al In­vest­ment Fund, Cedars-Sinai Med­ical Cen­ter and Nestlé SA. Joy Ghosh of Even­tide As­set Man­age­ment and Adam Stone of Per­cep­tive Ad­vi­sors will be join­ing the Prometheus board to watch over their in­vest­ments.

They’re back­ing a com­pa­ny that has grown to 125 staffers, in a mar­ket that might sug­gest they’re think­ing about an IPO.

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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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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Stéphane Bancel, Moderna CEO (AP Photo/Markus Schreiber)

Mod­er­na so­lid­i­fies deal with Kenya to build mR­NA man­u­fac­tur­ing fa­cil­i­ty

The mRNA player Moderna is further cementing its presence on the African continent.

Moderna announced on Thursday that it has finalized an agreement with Kenya’s government to partner up and bring an mRNA manufacturing facility to the east African nation. The new facility aims to manufacture up to 500 million doses of vaccines annually. Moderna also said the new facility will have the ability to spike its production capabilities to respond to public health emergencies on the continent or globally.

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.

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Deborah Waterhouse, ViiV Healthcare CEO

MPP re­cruits three gener­ic man­u­fac­tur­ers to ex­pand use of Vi­iV's in­jectable PrEP drug

ViiV Healthcare has teamed up with the UN-backed Medicines Patent Pool and three generic manufacturers to expand access to medicine that can prevent HIV.

ViiV and the Medicines Patent Pool jointly announced Thursday that the MPP signed sub-licensing agreements with Aurobindo, Cipla and Viatris to manufacture generics of a long-acting form of cabotegravir for HIV pre-exposure prophylaxis (PrEP). As a result of the agreement, the manufacturers will be able to develop, manufacture and supply generic versions of cabotegravir LA in 90 countries — subject to regulatory approvals.

Four community leaders who are living with HIV celebrate life and accomplishments in Theratechnologies' new campaign

Re­al pa­tient ‘cham­pi­ons’ liv­ing with HIV star in Ther­at­e­ch­nolo­gies cam­paign

Over the past several years, people living with HIV have been more often telling Theratechnologies that they wanted more representation. Specifically, they wanted more African American people and more focus on living and thriving versus more typical medication regimen messaging.

So Theratechnologies came up with a new campaign called “I Am A Champion,” initially launched at the US Conference on HIV last year. The initial conference, print and digital media efforts highlight the triumphs of four long-term survivors from across the US.

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