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.”

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Rick Modi, Affinia Therapeutics CEO

Ver­tex-part­nered gene ther­a­py biotech Affinia scraps IPO plans

Affinia Therapeutics has ditched its plans to go public in a relatively closed-door market that has not favored Nasdaq debuts for the drug development industry most of this year. A pandemic surge in 2020 and 2021 opened the doors for many preclinical startups, which caught Affinia’s attention and gave the gene therapy biotech confidence in the beginning days of 2022 to send in its S-1.

But on Friday, Affinia threw in the S-1 towel and concluded now is not the time to step onto Wall Street. The biotech has put out few public announcements since the spring of this year. Endpoints News picked the startup as one of its 11 biotechs to watch last year.

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Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Albert Bourla, Pfizer CEO (Efren Landaos/Sipa USA/Sipa via AP Images)

Pfiz­er makes an­oth­er bil­lion-dol­lar in­vest­ment in Eu­rope and ex­pands again in Michi­gan

Pfizer is continuing its run of manufacturing site expansions with two new large investments in the US and Europe.

The New York-based pharma giant’s site in Kalamazoo, MI, has seen a lot of attention over the past year. As a major piece of the manufacturing network for Covid-19 vaccines and antivirals, Pfizer is gearing up to place more money into the site. Pfizer announced it will place $750 million into the facility, mainly to establish “modular aseptic processing” (MAP) production and create around 300 jobs at the site.

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Vas Narasimhan, Novartis CEO (Thibault Camus/AP Images, Pool)

No­var­tis bol­sters Plu­vic­to's case in prostate can­cer with PhI­II re­sults

The prognosis is poor for metastatic castration-resistant prostate cancer (mCRPC) patients. Novartis wants to change that by making its recently approved Pluvicto available to patients earlier in their course of treatment.

The Swiss pharma giant unveiled Phase III results Monday suggesting that Pluvicto was able to halt disease progression in certain prostate cancer patients when administered after androgen-receptor pathway inhibitor (ARPI) therapy, but without prior taxane-based chemotherapy. The drug is currently approved for patients after they’ve received both ARPI and chemo.

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Pfiz­er-backed Me­di­ar Ther­a­peu­tics ropes in an­oth­er Big Phar­ma in­vestor

A biotech centered on treating fibrosis — born out of Mass General and Brigham and Women’s Hospital — has received a financial boost.

According to an SEC filing, the company has raised $31,761,186 in its latest funding round, which includes 17 investors. The filing lists six names attached to the company, including Meredith Fisher, a partner at Mass General Brigham Ventures and Mediar’s acting CEO.

Ken Greenberg, SonoThera CEO

Gene ther­a­py goes acoustic as ARCH-backed biotech launch­es with ul­tra­sound gene de­liv­ery plat­form

After co-founding two biotechs off virus-based therapies, one for pain and one for cancer, Ken Greenberg decided to go in a different direction for his newest biotech, SonoThera.

Based out of San Francisco, SonoThera announced Monday morning that it raised $60.75 million to develop new gene therapies — but delivered by ultrasound, which Greenberg says can address the major challenges facing more conventional viral gene therapies.

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Af­ter M&A fell through, Ther­a­peu­tic­sMD sells hor­mone ther­a­py, con­tra­cep­tive ring for $140M cash plus roy­al­ties

TherapeuticsMD, a women’s health company whose one-time billion-dollar valuation seems a distant memory as its blockbuster aspirations petered out, is finally cashing out.

Australia’s Mayne Pharma is paying $140 million upfront to license essentially TherapeuticsMD’s whole portfolio, including two prescription drugs that treat conditions relating to menopause, a contraceptive vaginal ring as well as its prescription prenatal vitamin brands.

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Big week for Alzheimer’s da­ta; As­traZeneca buys cell ther­a­py start­up; Dig­i­tal ther­a­peu­tics hits a pay­er wall; and more

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