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.

Spe­cial re­port: Meet 20 ex­tra­or­di­nary women who are su­per­charg­ing bio­phar­ma R&D

Even though many biopharma leaders have come together in recent years to address its gender gap, the consensus is clear: We still have a long way to go.

Companies this year were 2.5 times more likely than last year to have a diversity and inclusion program in place, according to a recent BIO survey, but women are still largely absent from executive roles. Getting women to enter the industry isn’t the problem — studies show that they represent just under half of all biotech employees around the world. But climbing through the ranks can be challenging, as women still report facing stereotypes, and, unfortunately, harassment.

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Op­ti­miz­ing Oral Drug De­liv­ery us­ing Zy­dis® Oral­ly Dis­in­te­grat­ing Tablet Tech­nol­o­gy to Ad­dress Pa­tient Chal­lenges


Patients prefer oral dosing, but swallowing tablets can be a challenge for many patients.
The Zydis® orally disintegrating tablet (ODT) platform addresses challenges associated with oral dosing, expanding benefits for patients and options for healthcare providers.
A strong growth trajectory is expected for ODTs given therapeutic innovation and continued technology development.

Many patients prefer conventional tablets for the administration of medications, but some geriatric and pediatric patients and those with altered mental status and physical impairments find swallowing tablets to be difficult. Orally disintegrating tablets (ODTs), which dissolve completely without chewing or sucking, offer a patient-friendly dosage form for the administration of small-molecule drugs, peptides and proteins. With the potential for multiple sites of drug absorption, often faster onset action for the active pharmaceutical ingredient (API), and potentially greater bioavailability, ODTs are an attractive option for drug developers considering first-to-market formulations or product line extensions of existing drugs with compatible API. In this report, we look at how innovation in the industry-leading Zydis ODT platform is expanding oral formulation options and bringing benefits to patients.

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Geoffrey Porges (SVB Leerink)

The 2022 wave com­ing? Top an­a­lyst says Big Phar­ma will have more than $1T avail­able to sat­is­fy its grow­ing ap­petite for biotech M&A

All through this year you could practically feel the frustration of the biotech investor class as M&A activity continued to drag behind expectations — or desires. Buyouts of public companies provide the essential juice for keeping stocks lively, and there’s been a notable lack of juice in 2021.

So is all that about to change, big time?

SVB Leerink’s Geoffrey Porges, a longtime student of biotech M&A, thinks so. In a lengthy analysis he put out last week, Porges totted up the cash flow of the major pharmas and determined that there was a good long list of industry buyers who would have around a half trillion dollars of cash to play with in 2022. Leverage that up with added debt and you could get that deal cache to $1.6 trillion.

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Róbert Wessman, Alvotech chairman and founder

Ice­landic bil­lionare's biosim­i­lar com­pa­ny rais­es $450M, preps for Nas­daq launch with SPAC merg­er

As Icelandic billionaire Róbert Wessman tries to take down AbbVie’s megablockbuster Humira in court, he’s also taking his biosimilar upstart to the big time with a $2.25 billion SPAC merger, Nasdaq launch and $450 million raise announced early Tuesday.

While Wessman’s Alvotech has not won FDA approval for any of its biosimilar candidates yet, the company was the first to file with the FDA for approval of its high-concentration Humira biosimilar and to have successfully conducted a switching study in support of a highly-coveted interchangeability designation. But other companies like Amgen, Boehringer Ingelheim and Pfizer have since caught up ahead of the launches of their own Humira biosimilar competitors in 2023.

Gary Glick, Odyssey Therapeutics founder

Al­ways busy, Gary Glick re­cruits Or­biMed in a mas­sive $218M Se­ries A for enig­mat­ic da­ta sci­ence biotech

Gary Glick is back at it again, founding yet another biotech company. And by the sheer size of its first raise, this may be the biggest one yet.

Glick has assembled what he calls an all-star roster and recruited one of the biggest healthcare investors in OrbiMed to put together a massive $218 million Series A for his newest venture, Odyssey Therapeutics. The launch, announced Tuesday morning and co-led by SR One Capital Management, comes not three months after Glick sold First Wave Bio to AzurRx for $229 million.

Mar­ket­ingRx Matchup: How Ab­b­Vie and Bio­haven ads rank in head-to-head mi­graine chal­lenge

Are you ready to rumble? DTC brands that is. MarketingRx is launching a new monthly feature today called MarketingRx Matchup. We’re pitting two pharma brands’ DTC advertising in the same therapeutic category against each other to find out what consumers and patients really think.

Market research company Leger is handling the polling and analysis each month, and I’ll be writing up the results — along with my own take — inside MRx on the first Tuesday of the month.

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Wendy Lund, Organon chief communications officer

Q&A: Organon chief com­mu­ni­ca­tions of­fi­cer Wendy Lund talks about the Mer­ck spin­off, women’s health and why it mat­ters

One of Wendy Lund’s earliest jobs was head of marketing at Planned Parenthood. As the youngest person on its management team, she introduced them to emerging new technologies, and in return, she learned the importance of fighting for what you believe in.

Now as chief communications officer at Organon, the women’s health company recently spun off by Merck, Lund is keeping that point top of mind. That’s in part because women’s health hasn’t been a spotlight therapy area for Big Pharma in years. Several companies have spun off, sold or at least considered selling women’s health assets to focus on “core” products.

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Mar­ket­ingRx roundup: Pfiz­er re-ups pneu­mo­nia ads as Mer­ck threat looms; Re­al Chem­istry founder CEO Jim Weiss steps back

Every autumn, leaves fall from the trees and people start holiday shopping – and for the last few years Pfizer debuts a new “Know Pneumonia” awareness TV ad. This year the commercial, launched a week ago, features different people who talk about why they got vaccinated against pneumococcal pneumonia. Actors portray a young female firefighter with asthma, a mechanic with heart disease and an older woman with her grandchild. A Pfizer spokesperson declined comment on the latest iteration of the long-running campaign.

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Mer­ck pumps the brakes on two more PhI­II tri­als for its lead an­ti-HIV drug

After trial investigators flagged a drop in immune cell counts that an external committee determined was related to treatment last month, Merck has been pausing HIV-related Phase II and III trials ever since.

On Monday, the biopharma company announced it’s pausing enrollment in two of its Phase III trials evaluating its leading anti-HIV drug candidate, which is the once-monthly, oral islatravir.

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