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.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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Sen­ate Fi­nance Com­mit­tee lobs more bi­par­ti­san pres­sure on­to PBMs

Congress is honing in on how it wants to overhaul the rules of the road for pharmacy benefit managers, with a Senate Finance Committee hearing Thursday serving as the latest example of the Hill’s readiness to make changes to how pharma middlemen operate.

While pledging to ensure patients and pharmacies “don’t get a raw deal,” Finance Committee Chair Ron Wyden (D-OR) laid out the beginning of what looks like a major bipartisan effort — moves the PBM industry is likely to challenge vigorously.

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Nicklas Westerholm, Egetis Therapeutics CEO

Ac­qui­si­tion talks on­go­ing for Swedish rare dis­ease biotech Egetis, shares up al­most 40%

Shares of the Sweden-based rare disease biotech Egetis Therapeutics skyrocketed on Thursday afternoon as the company said it’s engaged in “ongoing discussion” with external parties regarding a “potential acquisition.”

Egetis confirmed rumors with a statement on Thursday while noting that there is no certainty that a takeover offer will be made.

Nonetheless, the possibility of an acquisition has shot up Egetis’ share price. By the afternoon on Thursday, its stock price was {$EGTX.ST} up over 38%. An Egetis spokesperson told Endpoints News in an email that it has no further comments.

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Lu­pus drug de­vel­op­ment mar­ket heat­ing up, while FDA links with ad­vo­ca­cy group to fur­ther ac­cel­er­ate re­search

The long-underserved systemic lupus erythematosus (SLE) market is suddenly buzzing with treatment possibilities. Less than two years after AstraZeneca’s approval for Saphnelo — the first new SLE drug in a decade and joining just one other approved in GSK’s Benlysta – the pipeline of potential drugs numbers in the dozens.

Although most are very early stage — Spherix Global Insights estimates five in Phase II/III — the pharma R&D enthusiasm is catching on among doctors, patients and advocacy groups. On Wednesday, the Lupus Research Alliance and the FDA formed a novel private-public partnership called Lupus Accelerating Breakthroughs Consortium (Lupus ABC) to help advance lupus clinical trial success.

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Stéphane Bancel, Moderna CEO (AP Photo/Markus Schreiber)

Mod­er­na so­lid­i­fies deal with Kenya to build mR­NA man­u­fac­tur­ing fa­cil­i­ty

The mRNA player Moderna is further cementing its presence on the African continent.

Moderna announced on Thursday that it has finalized an agreement with Kenya’s government to partner up and bring an mRNA manufacturing facility to the east African nation. The new facility aims to manufacture up to 500 million doses of vaccines annually. Moderna also said the new facility will have the ability to spike its production capabilities to respond to public health emergencies on the continent or globally.

Luke Miels, GSK chief commercial officer

GSK picks up Scynex­is' FDA-ap­proved an­ti­fun­gal drug for $90M up­front

GSK is dishing out $90 million cash to add an antifungal drug to its commercial portfolio, in a deal spotlighting the pharma giant’s growing focus on infectious diseases.

The upfront will lock in an exclusive license to Scynexis’ Brexafemme, which was approved in 2021 to treat a yeast infection known as vulvovaginal candidiasis, except in China and certain other countries where Scynexis already out-licensed the drug.

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Deborah Waterhouse, ViiV Healthcare CEO

MPP re­cruits three gener­ic man­u­fac­tur­ers to ex­pand use of Vi­iV's in­jectable PrEP drug

ViiV Healthcare has teamed up with the UN-backed Medicines Patent Pool and three generic manufacturers to expand access to medicine that can prevent HIV.

ViiV and the Medicines Patent Pool jointly announced Thursday that the MPP signed sub-licensing agreements with Aurobindo, Cipla and Viatris to manufacture generics of a long-acting form of cabotegravir for HIV pre-exposure prophylaxis (PrEP). As a result of the agreement, the manufacturers will be able to develop, manufacture and supply generic versions of cabotegravir LA in 90 countries — subject to regulatory approvals.

Four community leaders who are living with HIV celebrate life and accomplishments in Theratechnologies' new campaign

Re­al pa­tient ‘cham­pi­ons’ liv­ing with HIV star in Ther­at­e­ch­nolo­gies cam­paign

Over the past several years, people living with HIV have been more often telling Theratechnologies that they wanted more representation. Specifically, they wanted more African American people and more focus on living and thriving versus more typical medication regimen messaging.

So Theratechnologies came up with a new campaign called “I Am A Champion,” initially launched at the US Conference on HIV last year. The initial conference, print and digital media efforts highlight the triumphs of four long-term survivors from across the US.

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