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.

IDC: Life Sci­ences Firms Must Em­brace Dig­i­tal Trans­for­ma­tion Now

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

FDA ap­proves one of the prici­est new treat­ments of all time — blue­bird's gene ther­a­py for be­ta tha­lassemia

The FDA on Wednesday approved the first gene therapy for a chronic condition — bluebird bio’s new Zynteglo (beti-cel) as a potentially curative treatment for those with transfusion-dependent thalassemia.

The thumbs-up from the FDA follows a unanimous adcomm vote in June, with outside experts pointing to extraordinary efficacy, with 89% of subjects with TDT who received beti-cel having achieved transfusion independence.

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Joel Dudley, new partner at Innovation Endeavors (Bosch Health Campus)

For­mer Google CEO’s VC is mak­ing a big­ger push in­to the biotech world, hir­ing promi­nent Ther­a­nos skep­tic

Venture capital firm Innovation Endeavors has mainly had its focus on investments across the tech space, but it has been slowly turning its attention to the biotech world. Now, a new partner is coming into the fold showing that its interest in biotech is likely to grow further.

The Silicon Valley-based company, which is headed up by former Google CEO Eric Schmidt, has brought on Joel Dudley as a partner. According to Dudley’s LinkedIn page, he is joining Innovation Endeavors after serving as the chief science officer of biotech startup Tempus Labs since 2020.

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James Sabry, Roche global head of pharma partnering

Roche, Genen­tech plunk down $60M up­front to part­ner with Chi­nese phar­ma on PRO­TAC-based prostate can­cer drug

Roche and Genentech are always on the hunt for deals, and on Thursday they found their newest partner.

The pair will team up with the Chinese pharma company Jemincare to push forward a new program for prostate cancer, the companies announced. Roche is ponying up $60 million upfront to get its hands on the candidate and promising up to $590 million in biobucks, plus royalties, down the line.

In return, Genentech will get a worldwide license to develop the program, known as JMKX002992, and bring it to market.

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Andrew Hopkins, Exscientia CEO

Ex­sci­en­tia ter­mi­nates Bay­er pact half a year ear­ly, col­lect­ing small por­tion of €240M promised

Bayer and Exscientia are winding down their three-year collaboration, leaving the big German pharma to take the AI-designed compounds born out of the pact further.

London-based Exscientia revealed in its Q2 update that the partners have “mutually agreed to end” their collaboration, which kicked off in early 2020, after recently achieving a drug discovery milestone. In an SEC filing, Exscientia said it terminated the pact on May 30, about six months early.

Bayer's first DTC ad campaign for chronic kidney disease drug Kerendia spells out its benefits

Bay­er aims to sim­pli­fy the com­plex­i­ties of CKD with an ABC-themed ad cam­paign

Do you know the ABCs of CKD in T2D? Bayer’s first ad campaign for Kerendia tackles the complexity of chronic kidney disease with a play on the acronym (CKD) and its connection to type 2 diabetes (T2D).

Kerendia was approved last year as the first and only non-steroidal mineralocorticoid receptor antagonist to treat CKD in people with type 2 diabetes.

In the TV commercial launched this week, A is for awareness, B is for belief and C is for cardiovascular, explained in the ad as awareness of the connection between type 2 and kidney disease, belief that something can be done about it, and cardiovascular events that may be reduced with treatment.

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James Mock, incoming CFO at Moderna

Mod­er­na taps new CFO from PerkinElmer af­ter for­mer one-day CFO oust­ed

When Moderna hired a new CFO last year,  it didn’t expect to see him gone after only one day. Today the biotech named his — likely much more vetted — replacement.

The mRNA company put out word early Wednesday that after the untimely departure of then brand-new CFO Jorge Gomez, it has now found a replacement in James Mock, the soon-to-be former CFO at diagnostics and analytics company PerkinElmer.

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Etleva Kadilli, director of UNICEF’s supply division

GSK lands first-ever UNICEF con­tract for malar­ia vac­cine worth $170M

GSK has landed a new first from UNICEF the first-ever contract for malaria vaccines, worth up to $170 million for 18 million vaccine doses distributed over the next three years.

The vaccine, known as Mosquirix or RTS,S, won WHO’s backing last October after a controversial start, but UNICEF said these doses will potentially save thousands of lives every year.

“We hope this is just the beginning,” Etleva Kadilli, director of UNICEF’s supply division, said. “Continued innovation is needed to develop new and next-generation vaccines to increase available supply, and enable a healthier vaccine market. This is a giant step forward in our collective efforts to save children’s lives and reduce the burden of malaria as part of wider malaria prevention and control programmes.”

Joe Jonas (Photo by Anthony Behar/Sipa USA)(Sipa via AP Images)

So­lo Jonas broth­er car­ries Merz's new tune in Botox ri­val cam­paign

As the lyrics of his band’s 2019 pop-rock single suggest, Joe Jonas is only human — and that means even he gets frown lines. The 33-year-old singer-songwriter is Merz’s newest celebrity brand partner for its Botox rival Xeomin, as medical aesthetics brands target a younger audience.

Merz kicked off its “Beauty on Your Terms” campaign on Tuesday, featuring the Jonas brother in a video ad for its double-filtered anti-wrinkle injection Xeomin.

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