Aaron Ring, Simcha Therapeutics founder

Go­ing af­ter an old GSK tar­get in a new way, a Yale spin­out hits the clin­ic and nabs a mod­est raise

About a year and a half ago, a Yale pro­fes­sor took a shot at en­gi­neer­ing a can­cer ther­a­py that had once flum­moxed re­searchers at Glax­o­SmithK­line. The com­pa­ny an­nounced its next steps Thurs­day, earn­ing a mod­est fundraise and en­ter­ing the clin­ic.

Sim­cha Ther­a­peu­tics closed a $40 mil­lion Se­ries B and has be­gun dos­ing pa­tients in a Phase I/II tri­al for its lead pro­gram, the biotech an­nounced. The raise should take Sim­cha in­to 2024 and help com­plete the just-launched Phase I por­tion, a Phase II monother­a­py study and a Phase Ib com­bi­na­tion tri­al with a check­point in­hibitor, founder Aaron Ring told End­points News.

Ring’s the­o­ry re­volves around stim­u­lat­ing the IL-18 path­way, try­ing to in­crease the body’s im­mune re­sponse to tu­mor mi­croen­vi­ron­ments us­ing what Sim­cha calls a “de­sign­er cy­tokine.” It’s es­sen­tial­ly the re-en­gi­neer­ing of an old GSK ef­fort that be­gan in 2004 and scut­tled ear­ly, as pa­tients’ tu­mors pro­gressed re­gard­less of how much IL-18 was ag­o­nized.

But by tar­get­ing a group of re­cep­tors that the mi­croen­vi­ron­ments had all but shut down, Ring found he could cre­ate a de­coy to evade the can­cer’s jam­ming sys­tem and get the prop­er cy­tokines where they need­ed to go. He out­lined the ini­tial re­sults in a Na­ture pa­per from June 2020, which proved foun­da­tion­al to Sim­cha’s ef­forts.

It’s part of a broad­er ef­fort by im­munother­a­py re­searchers to find the next big can­cer drug, fol­low­ing the suc­cess of oth­er med­i­cines like an­ti-PD-1 an­ti­bod­ies — though Ring not­ed Sim­cha is tak­ing the op­po­site ap­proach in an IL-18 ag­o­nist.

“Our con­vic­tion shared by many is that we can’t ac­cept a na­ture so­lu­tion. When it comes to cy­tokines, we need to en­gi­neer them for a de­lib­er­ate ther­a­peu­tic pur­pose,” Ring said. “What’s lim­it­ed many cy­tokines to date is just the fact that they’re too broad­ly ac­tive, too broad and a non­spe­cif­ic set of im­mune cells.”

Sim­cha’s mol­e­cule, known as ST-067, is the first IL-18 path­way ag­o­nist be­ing stud­ied in hu­mans since GSK’s last study was shut­tered near­ly 10 years ago, Ring added. Those ef­forts went through a Phase II melanoma study, and though it was well tol­er­at­ed for a cy­tokine, it in­duced on­ly one par­tial re­sponse out of 63 pa­tients.

When Ring first came across these re­sults, he found them “re­al­ly shock­ing,” be­cause it ap­peared to be the right sig­nal hit­ting the right cells. It led him to the mi­croen­vi­ron­ment bi­ol­o­gy Sim­cha is now try­ing to ag­o­nize, bring­ing a “laser fo­cus” on try­ing to repli­cate his ini­tial pre­clin­i­cal tests back in 2017.

The biotech is start­ing on a broad slate of sol­id tu­mors for its ini­tial test­ing, uti­liz­ing the Phase I por­tion as a dose-es­ca­la­tion study. Sim­cha’s plan is to re­cruit any pa­tient that’s pro­gressed on ex­ist­ing check­point im­munother­a­pies, not fo­cus­ing on spe­cif­ic can­cer types or ge­net­ic mu­ta­tion sub­sets.

It’s too ear­ly to say when Sim­cha might have the da­ta it needs to move on to Phase II, but Ring said he’s aim­ing for the typ­i­cal time­lines for what sim­i­lar agents in the class have achieved. The plan is to test the com­pound broad­ly, look­ing at monother­a­py reg­i­mens as well as in com­bi­na­tion with oth­er ap­proved ther­a­pies.

But Ring hopes his ap­proach will set Sim­cha apart from oth­er im­munother­a­py com­pa­nies.

“What dif­fer­en­ti­ates us from the oth­er path­ways is that there are now dozens of com­pa­nies pur­su­ing cy­tokine ther­a­pies in the IL-2, IL-15 space,” Ring said. “But this is a com­plete­ly dif­fer­ent path­way…Nev­er be­fore in pa­tients has any­one been able to de­cou­ple the ef­fects of IL-18 sig­nal­ing from the bind­ing pro­tein.”

Thurs­day’s round was led by SR One Cap­i­tal Man­age­ment and joined by oth­er new in­vestors, in­clud­ing BVF Part­ners, Sam­sara Bio­Cap­i­tal, Rock Springs Cap­i­tal, Ar­row­Mark Part­ners and Lo­gos Cap­i­tal.

Paul Hudson, Sanofi CEO (Cyril Marcilhacy/Bloomberg via Getty Images)

FDA side­lines Paul Hud­son's $3.7B MS drug af­ter es­tab­lish­ing link to liv­er dam­age

One of Sanofi CEO Paul Hudson’s top picks in the pipeline — picked up in a $3.7 billion buyout 2 years ago — has just been sidelined in the US by a safety issue.

The pharma giant put out word early Thursday that the FDA has put their Phase III studies of tolebrutinib in multiple sclerosis and myasthenia gravis on partial clinical hold, halting enrollment and suspending dosing for patients who have been on the drug for less than 60 days. Patients who have completed at least 60 days of treatment can continue therapy as researchers explore a “limited” — but unspecified in Sanofi’s statement — number of cases of liver injury.

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Phar­ma re­acts to post-Roe; Drug­mak­ers beef up cy­ber de­fense; Boehringer, Roche qui­et­ly axe 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.

As a reminder, we are off on Monday for the Fourth of July. I hope this recap will kick off your (long) weekend well and that the rest of it will be just what you need. See you next week for a shortened edition!

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Eric Hughes, incoming Teva EVP of global R&D and CMO

Te­va chief raids Ver­tex for his new glob­al head of re­search and de­vel­op­ment

Teva CEO Kåre Schultz has found his new R&D chief and CMO in Vertex’s ranks.

The global generics giant, which has some 3,500 staffers in the R&D group, has named Eric Hughes to the top research spot in the company. He’ll be replacing Hafrun Fridriksdottir, who held the role for close to five years, on Aug. 1.

Hughes hasn’t been at Vertex for long, though. He jumped from Novartis less than a year ago, after heading the immunology, hepatology & dermatology global development unit. Before that, he completed a five-year stint as head of early clinical research for the specialty discovery medicine department in the exploratory clinical & translational research group at Bristol Myers Squibb, according to his LinkedIn profile.

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#BIO22: Man­ag­ing a biotech in tur­bu­lent times. 'There's a per­fect shit­show out there'

On Tuesday, June 14, Endpoints News EIC John Carroll sat down with a group of biotech execs to discuss the bear market for industry stocks and how they were dealing with it. Here’s the conversation, which has been lightly edited for brevity.

Martin Meeson, sponsor opening:

Thank you, John. Hello everyone. My name’s Martin Meeson, I’m the CEO of Fujifilm Diosynth. For those of you who don’t know Fujifilm Diosynth, we operate in the development of clinical and commercial product scale up, we have facilities in Europe and the US, and around about 4,000 employees. We run on average about 150 programs, so when it comes to managing in turbulent times over the last two years, we’ve had quite a lot of experience of that. Not just keeping the clinical pipelines and the commercial pipelines open, but also our response to the pandemic and the molecules that we’ve had within there. One of the phrases that I coined probably about a year ago when we were talking at JP Morgan, was I talked about managing through turbulent times. Well, it’s become the fact that we are not managing and leading through these times, we are managing in them, which is why that’s really the purpose of and the topic that we’ve got today.

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On Friday, Lonza announced plans to construct a large-scale commercial drug product fill and finish facility in the town of Stein, Switzerland.

Lon­za to in­vest $500M+ on fill-fin­ish fa­cil­i­ty on its home turf

Lonza has been expanding its reach across the globe, bringing sites in China and the US online this year, but now they are looking closer to home for their next major investment.

The Swiss manufacturer on Friday announced plans to construct a large-scale commercial drug fill and finish facility in the town of Stein, Switzerland. The new facility will be delivered through an investment of approximately CHF 500 million, or $519 million, and is expected to be completed in 2026. The facility will also be constructed on the same campus as Lonza’s current clinical drug product facility.

Kate Haviland, Blueprint Medicines CEO

What bear mar­ket? Blue­print lines up $1.25B to ex­pand la­bels, maybe tack on more drugs

As it works to pad the case for expanding its Ayvakit and Gavreto labels, Blueprint Medicines has lined up $1.25 billion in funding, with some of that money seemingly earmarked for acquisitions or pipeline expansion projects.

Following the likes of BioCryst, Cytokinetics and MorphoSys, Blueprint is aiming to monetize the royalties of its RET+ non-small cell lung cancer and thyroid cancer drug Gavreto with Royalty Pharma. The investment group will dole out $175 million upfront and might tack on another $165 million in biobucks as part of Blueprint’s royalties receivable from net sales of the drug by Roche outside the US, sans China.

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Fu­ji­film in­vests an­oth­er $1.6B in­to its CD­MO arm to up­grade facil­lites in the US and Eu­rope

Fujifilm’s spending spree into its CDMO arm is not slowing down.

The multinational announced on Wednesday that it will invest $1.6 billion to enhance and expand the cell culture manufacturing services of the CDMO arm of the Japanese conglomerate Fujifilm Diosynth.

The investment will enhance Fujifilm Diosynth Biotechnologies’ sites in Hillerød, Denmark, and College Station, TX. The investment is expected to create approximately 450 jobs across both facilities.

Anand Parikh, Faeth Therapeutics CEO

Sid Mukher­jee, Lew Cant­ley be­hind new can­cer biotech with food+drug com­bo treat­ment am­bi­tions 

Famed oncologist Sid Mukherjee and repeat biotech co-founder Lew Cantley have teamed up to form Faeth Therapeutics, a startup aiming to treat cancer the way other conditions are addressed: pairing nutrition with therapeutics.

The goal is to transform cancer treatment with nutrition and make it the fourth “pillar” in the oncology regimen, which to date has centered on radiotherapy, surgery and drugs, Faeth CEO Anand Parikh told Endpoints News. Other conditions have already been addressed with a side of nutrients or diet, he said, pointing to diabetes, irritable bowel syndrome and other diseases.

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Amgen's taking social media followers around the globe as it introduces the many different

From Tam­pa to Mu­nich, Am­gen’s ‘Places’ cam­paign in­tro­duces its lo­ca­tions around the world

Amgen is taking social media followers around the world with its latest corporate campaign. Called “Places of Amgen,” the twice monthly posts highlight the biopharma’s different offices and sites – and the people who work there.

Each post runs on LinkedIn, Facebook and Instagram with details about the work Amgen does in that location, when it was established, comments from people who work there and other interesting facts. The most recent one about Paris, France, for example, notes that Amgen France last year signed a French association charter committed to the inclusion of LBGT+ people in the workplace.

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