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.”

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His­toric drug pric­ing re­forms pass; Pfiz­er ac­quires GBT; The long search for non-opi­oid pain drugs; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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Seagen interim CEO Roger Dansey and Daiichi Sankyo CEO Sunao Manabe

Paving the way for Mer­ck­'s buy­out, Seagen los­es ar­bi­tra­tion dis­pute with Dai­ichi over ADC tech

As Seagen awaits a final buyout offer from Merck that could be in the territory of $40 billion, Seagen revealed Friday afternoon that it lost an arbitration dispute with Daiichi Sankyo relating to the companies’ 2008 collaboration around the use of antibody-drug conjugate (ADC) technology.

But that loss likely won’t matter much when it comes to Merck’s deal.

After breaking off its pact with Daiichi in mid-2015, the two companies battled over “linker” tech — a chemical bridge between an ADC’s antibody component and the cytotoxic payload — that Seagen claims Daiichi would improve upon and implement in its current generation of ADCs.

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Tony Coles, Cerevel CEO

Cerev­el takes the pub­lic of­fer­ing route, with a twist — rais­ing big mon­ey thanks to ri­val da­ta

As public biotechs seek to climb out of the bear market, a popular strategy to raise cash has been through public offerings on the heels of positive data. But one proposed raise Wednesday appeared to take advantage not of a company’s own data, but those from a competitor.

Cerevel Therapeutics plans to raise $250 million in a public offering and another $250 million in debt, the biotech announced Wednesday afternoon, even though it did not report any news on its pipeline. However, the move comes days after rival Karuna Therapeutics touted positive Phase III data in schizophrenia, a field where Cerevel is pursuing a similar program.

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House pass­es his­toric drug pric­ing re­forms, lin­ing up decades-in-the-mak­ing win for Biden and De­moc­rats

The US House of Representatives today voted along party lines (all Dems voted for it), 220-207 to pass new, wide-ranging legislation that will allow Medicare drug price negotiations for the first time ever, and cap seniors’ drug expenses to $2,000 per year and seniors’ insulin costs at $35 per month.

Setting up a major victory for President Joe Biden, representatives returned from their summer recess to pass the Inflation Reduction Act, even as many noted the bill would only modestly reduce inflation.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.