Adel Nada, GentiBio CEO

At an 'in­flec­tion point': Gen­tiBio reels in $157M ahead of what CEO Adel Na­da sees as a Treg boom

Gen­tiBio CEO Adel Na­da says reg­u­la­to­ry T cells (or Tregs) are now where CAR-Ts were at the be­gin­ning of the last decade — at an in­flec­tion point. With a hand­ful of drug­mak­ers ze­ro­ing in on the pro­tec­tive class of im­mune cells, Na­da says big de­vel­op­ments are com­ing. And the proof, he says, is in his com­pa­ny’s lat­est megaround.

Na­da un­veiled a $157 mil­lion Se­ries A round on Wednes­day morn­ing from some big-name back­ers like the No­var­tis Ven­ture Fund and RA Cap­i­tal Man­age­ment. With a raise like that, it’s hard to imag­ine that a pub­lic de­but is too far down the road for Gen­tiBio.

When asked, Na­da re­spond­ed: “We are an en­gi­neered cell ther­a­py com­pa­ny…We’re very, very am­bi­tious, and we will have to find ways to se­cure the cap­i­tal that we need, and we’re con­fi­dent we’ll be able to do that ei­ther pri­vate­ly or in the pub­lic mar­kets.”

Treg cells po­lice the im­mune sys­tem, rec­og­niz­ing the body’s own pro­teins and telling oth­er im­mune cells not to at­tack when they see cells stud­ded with those re­cep­tors. In some dis­eases, like au­toim­mune dis­or­ders, that sys­tem goes awry, and the im­mune sys­tem at­tacks healthy cells.

Gen­tiBio’s look­ing to re­store im­mune in­tol­er­ance with en­gi­neered Tregs. But un­like oth­er drug­mak­ers that are try­ing to iso­late or tar­get a pa­tient’s own Tregs, Gen­tiBio plans to col­lect an­oth­er type of cell from pa­tients — in­clud­ing CD4+ im­mune cells, or so-called helper T cells — and then re­pro­gram them in­to spe­cial­ized Tregs.

“En­doge­nous Tregs are a rare pop­u­la­tion that are dif­fi­cult to iso­late from pe­riph­er­al blood,” Na­da said. “By be­ing able to work with a much more abun­dant cell pop­u­la­tion, such as CD4s for ex­am­ple, we’re able to over­come that rar­i­ty in a scal­able way.”

The com­pa­ny’s tech­nol­o­gy stems from the work of David Rawl­ings and Andy Scharen­berg at the Seat­tle Chil­dren’s Re­search In­sti­tute. Its oth­er co-founders hail from the Be­naroya Re­search In­sti­tute at Vir­ginia Ma­son (BRI), and the MI­GAL Galilee Re­search In­sti­tute (MI­GAL).

While Na­da has plans to tack­le a va­ri­ety of au­toim­mune, al­loim­mune, au­toin­flam­ma­to­ry and al­ler­gic dis­eases, the pri­ma­ry fo­cus is on type 1 di­a­betes, where the team is aim­ing to elim­i­nate or re­duce pa­tients’ de­pen­dence on in­sulin. Sci­en­tists be­lieve the en­gi­neered Tregs could be vi­able for up to six years, Na­da said, mean­ing there’s po­ten­tial for a “one and done” ther­a­peu­tic.

The team is cur­rent­ly se­lect­ing a can­di­date for that pro­gram, and will use the Se­ries A funds to push it in­to the clin­ic, with IND-en­abling stud­ies ex­pect­ed to launch by the end of this year.

Ma­trix Cap­i­tal Man­age­ment led Gen­tiBio’s Se­ries A round, with Avid­i­ty Part­ners, the JDRF T1D Fund, Or­biMed, RA Cap­i­tal Man­age­ment, No­var­tis Ven­ture Fund, and the Seat­tle Chil­dren’s Re­search In­sti­tute chim­ing in. Add in the com­pa­ny’s $20 mil­lion seed round from last sum­mer, and its raise is now up to $177 mil­lion.

Drug­mak­ers big and small are now turn­ing their at­ten­tion to Tregs, in­clud­ing Mer­ck, which put down $1.85 bil­lion in Feb­ru­ary to ac­quire Pan­dion Phar­ma­ceu­ti­cals and its pipeline of drugs tar­get­ing Tregs for au­toim­mune con­di­tions. TRexBio re­cent­ly emerged from stealth with a $59 mil­lion Se­ries A and back­ing from Big Phar­ma gi­ants Eli Lil­ly, J&J and Pfiz­er to map Tregs in hu­man tis­sue. And Treg-fo­cused Aba­ta Ther­a­peu­tics launched in June with $95 mil­lion and its sights set on mul­ti­ple scle­ro­sis.

Just last week, Jeff Blue­stone took the wraps off a $265 mil­lion B round to tar­get en­gi­neered Treg cell ther­a­pies against dif­fi­cult dis­eases like rheuma­toid arthri­tis and type 1 di­a­betes. His com­pa­ny, Sono­ma Bio­ther­a­peu­tics, has raised $335 mil­lion in two years’ time.

“I think the mo­men­tum, and the pas­sion that we’re ex­pe­ri­enc­ing right now in Treg ther­a­peu­tics, across the board, (at) dif­fer­ent com­pa­nies, dif­fer­ent leagues of in­vestors… re­al­ly po­si­tions the field to ad­vance to the next in­flec­tion point,” Na­da said. “We’re very ex­cit­ed about be­ing part of this, be­ing at the fore­front of this.”

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

KEY POINTS

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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