Dhvanit Shah, Garuda CEO

Look­ing to make donor cells ob­so­lete, an ex-Har­vard re­searcher gets off-the-shelf stem cell biotech off the ground

A stem cell re­searcher who spent time at the Har­vard Stem Cell In­sti­tute, the Broad In­sti­tute and Brigham and Women’s Hos­pi­tal launched a new biotech Thurs­day, and he’s at­tract­ed sig­nif­i­cant blue-chip in­vest­ment to get things up and run­ning.

Dhvan­it Shah un­veiled a $72 mil­lion Se­ries A for Garu­da Ther­a­peu­tics with the goal of de­vel­op­ing off-the-shelf blood stem cell ther­a­pies. Shah, who found­ed Garu­da and serves as CEO, told End­points News that while he rec­og­nizes oth­er com­pa­nies are re­search­ing off-the-shelf cell ther­a­pies, Garu­da dif­fer­en­ti­ates it­self by try­ing to elim­i­nate the need for donor cells en­tire­ly.

“We can’t choose who our donors will be; the age, qual­i­ty and quan­ti­ty of cells from an­oth­er al­ways varies,” Shah told End­points. “There’s been noth­ing new in the last 50 years, and the promise is un­matched here. If some­one can come up with a way to make off-the-shelf hematopoi­et­ic stem cells, to me that’s the biggest break­through in the field.”

Some promi­nent in­vestors are back­ing the biotech, with Ais­ling Cap­i­tal, North­pond Ven­tures and Or­biMed lead­ing the Se­ries A.

The field of hematopoi­et­ic stem cells has pro­gressed to the point where some­thing like an off-the-shelf ther­a­py is pos­si­ble, Shah added. He de­scribed a steady rise af­ter the No­bel Prize-win­ning re­search of Shinya Ya­mana­ka and John Gur­don changed the game in 2006, when the pair showed how ma­ture stem cells could be re­pro­grammed to be “pluripo­tent,” or can di­vide in­to more stem cells.

It’s es­sen­tial­ly a way for pluripo­tent stem cells to be­come self-re­new­ing hematopoi­et­ic stem cells, Shah said, and it proves the ba­sis of Garu­da’s un­der­ly­ing the­o­ry. Af­ter re­cruit­ing a se­lect group of vol­un­teers to help gen­er­ate a “bank” of pluripo­tent stem cells, Garu­da re­searchers then con­vert these cells to the hematopoi­et­ic stem cells nec­es­sary for its ther­a­pies.

And Shah hopes hav­ing that bank on hand makes donor cells — and what can be a dif­fi­cult search to find them — com­plete­ly un­nec­es­sary.

“I’m done with peo­ple lin­ing up to be a donor,” he said. “We can do the job once in a life­time and no one ever has to look back.”

What goes in­to the tech­nol­o­gy be­hind this con­ver­sion, or how Garu­da picked the most suit­able vol­un­teers, Shah isn’t say­ing. But he claims the biotech has some stel­lar pre­clin­i­cal da­ta show­ing the tech­nol­o­gy works, ev­i­denced by the hefty Se­ries A and blue-chip syn­di­cate.

But he likened the po­ten­tial of Garu­da’s plat­form to pro­vide broad ac­cess to cu­ra­tive treat­ments to the ex­per­i­men­tal stem cell trans­plants giv­en to two HIV-pos­i­tive in­di­vid­u­als. In these in­stances, the pa­tients were giv­en new cells do­nat­ed from some­one who had a ge­net­ic mu­ta­tion re­sis­tant to HIV, al­low­ing them to stop tak­ing an­ti­retro­vi­ral drugs and be de­clared virus-free, per a 2019 Na­ture ar­ti­cle.

Those treat­ments were un­able to be brought in­to the larg­er HIV/AIDS pop­u­la­tion, Shah not­ed, but when build­ing Garu­da’s cell bank, he said the biotech is look­ing for peo­ple whose ge­net­ic make­up is suit­able for sim­i­lar ther­a­pies. If suc­cess­ful, Garu­da will be able to bring stem cell ther­a­pies to pa­tients who nor­mal­ly strug­gle to ac­cess them, such as racial and eth­nic mi­nori­ties.

Garu­da is de­vel­op­ing a pipeline of drugs as well, with ini­tial fo­cus­es in hema­to­log­ic ma­lig­nan­cies, sick­le cell dis­ease, be­ta-tha­lassemia and bone mar­row fail­ure dis­eases. But Shah said the im­me­di­ate next step is to be­gin build­ing out man­u­fac­tur­ing ca­pa­bil­i­ties to en­sure Garu­da can meet what he ex­pects will be sig­nif­i­cant de­mand.

If every­thing works out, the biotech ex­pects to launch its first in-hu­man stud­ies with­in the next two to three years, Shah said. But he cau­tioned that the es­ti­mate is just a ball­park fig­ure.

“I don’t want to over­promise and un­der­de­liv­er,” he said.

In ad­di­tion to the lead in­vestors, Thurs­day’s Se­ries A saw fund­ing from Cor­morant As­set Man­age­ment, Ridge­back Cap­i­tal In­vest­ments, Monashee In­vest­ment Man­age­ment, Sec­toral As­set Man­age­ment, Na­tion­al Re­silience, Inc. (Re­silience) and Mass Gen­er­al Brigham Ven­tures, among oth­ers.

Clar­i­fi­ca­tion: This ar­ti­cle has been up­dat­ed to clar­i­fy how pluripo­tent stem cells be­come self-re­new­ing.

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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