Raymond Stevens, ShouTi Pharma CEO

A new Schrödinger-backed start­up emerges from the sci­en­tist who mapped the first hu­man GPCR

One of the most pop­u­lar tar­gets in drug de­vel­op­ment, rep­re­sent­ing about a third of ex­ist­ing drugs, are G-pro­tein cou­pled re­cep­tors — the tiny but in­te­gral mem­brane pro­teins re­spon­si­ble for rec­og­niz­ing things like light, taste, smell, hor­mones and pain.

But due to chal­lenges in map­ping their struc­ture, the pro­tein fam­i­ly re­mains large­ly un­ex­plored.

A slate of com­pa­nies has emerged over the last few years to change that. If one can fig­ure out the struc­ture of these elu­sive mem­brane re­cep­tors, it might be pos­si­ble to cre­ate small mol­e­cule drugs that over­come the lim­i­ta­tions of, say, bi­o­log­ic and pep­tide ther­a­pies. That promise is what gets se­r­i­al en­tre­pre­neur Ray­mond Stevens out of bed in the morn­ing.

It’s al­so what re­cent­ly got his com­pa­ny ShouTi $100 mil­lion from a syn­di­cate of blue-chip in­vestors.

ShouTi, a Schrödinger-part­nered start­up, un­cloaked Wednes­day morn­ing with a hefty Se­ries B round led by BVF Part­ners. Stevens launched the com­pa­ny four years ago with Schrödinger co-founder Rich Fries­ner and land­ed a $58 mil­lion Se­ries A back in 2019. Why wait so long to come out of stealth?

“We asked for the time so that we could stay fo­cused at the be­gin­ning,” Stevens told End­points News. 

Now the com­pa­ny has 50 staffers and three pro­grams in the works, the first of which is al­ready in the clin­ic for pul­monary ar­te­r­i­al hy­per­ten­sion, or high blood pres­sure that af­fects ar­ter­ies in the lungs and heart. It’s a con­di­tion that Stevens and his team be­lieve goes un­di­ag­nosed in much of the world.

The sec­ond pro­gram should be head­ed for the clin­ic ear­ly next year, Stevens said, while the third is still in ear­ly de­vel­op­ment. The CEO is keep­ing the tar­gets for those pro­grams un­der wraps for now.

ShouTi’s roots trace back to Syrrx, a com­pa­ny Stevens found­ed in 1998 fo­cused on high-through­put struc­ture-based drug dis­cov­ery. The com­pa­ny was par­tic­u­lar­ly pas­sion­ate about GPCRs, which sci­en­tists knew lit­tle about at the time. In 2007, Stevens and his col­leagues pub­lished the first high-res­o­lu­tion struc­ture of a hu­man GPCR. Short­ly af­ter that, he launched Re­cep­tos with a plat­form around the tricky re­cep­tors.

“There was a com­bi­na­tion of about, you know, 15 dif­fer­ent tech­nol­o­gy de­vel­op­ments that all had to come to­geth­er in or­der for us to get those very first G-pro­tein cou­pled re­cep­tors,” he said.

Re­cep­tos al­so had an as­set that proved quite at­trac­tive: an S1P1 ag­o­nist now bet­ter known as Zeposia, a pre­scrip­tion drug for re­laps­ing forms of mul­ti­ple scle­ro­sis. The drug was a key point of in­ter­est in Cel­gene’s ac­qui­si­tion of Re­cep­tos in 2015, and sub­se­quent­ly Bris­tol My­ers Squibb’s ac­qui­si­tion of Cel­gene in 2019.

When all was said and done, Stevens was left want­i­ng to build out Re­cep­tos’ old GPCR plat­form. So when Fries­ner called him with an of­fer to col­lab­o­rate in 2017, he jumped.

Some big-name back­ers have come aboard as well, in­clud­ing Cas­din Cap­i­tal, Cor­morant As­set Man­age­ment, Janus Hen­der­son In­vestors, Lil­ly Asia Ven­tures, Monashee Cap­i­tal, Sage Part­ners, Stork Cap­i­tal, Sur­vey­or Cap­i­tal, TCG X, Ter­ra Mag­num Cap­i­tal Part­ners, Wood­line Part­ners, Schrödinger, Eight Roads, F-Prime Cap­i­tal Part­ners, Qim­ing Ven­ture Part­ners, Se­quoia Cap­i­tal Chi­na, TF Cap­i­tal and Wuxi AppTec.

ShouTi isn’t the on­ly GPCR-fo­cused com­pa­ny get­ting at­ten­tion from Big Phar­ma. Japan’s So­sei Hep­tares joined forces with both Roche’s Genen­tech and Take­da back in 2019 to de­vel­op med­i­cines that mod­u­late GPCRs. And it’s es­ti­mat­ed that more than 30% of FDA-ap­proved drugs tar­get this class of pro­teins.

“We’ve re­al­ly dug in deeply in­to un­der­stand­ing the func­tion, and we re­al­ly un­der­stand the phar­ma­col­o­gy quite well,” Stevens said. “So I think that’s prob­a­bly one of our biggest ad­van­tages is that un­der­stand­ing.”

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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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.

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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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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