Ex­clu­sive: Ready to ex­it 'qui­et mode,' joint en­ti­ty Ven­tyx de­buts its im­mune mod­u­la­tor pipeline with $114M round

In the crazy world of biotech fi­nanc­ing, pre­co­cious star­tups are scor­ing big checks from in­vestors with some of­ten laugh­ably ear­ly da­ta. Now, a Cal­i­for­nia im­mune mod­u­la­tion play­er is ready to un­cloak with a nine-fig­ure down pay­ment in hand and an un­usu­al­ly ad­vanced pipeline.

Encini­tas-based Ven­tyx Bio­sciences has scored a $114 mil­lion eq­ui­ty in­vest­ment to try three dif­fer­ent im­mune mod­u­la­tor tar­gets in the clin­ic, one of which is al­ready squared up for a Phase II study in ul­cer­a­tive col­i­tis.

Part of a joint en­ti­ty weav­ing to­geth­er three New Sci­ence Ven­tures com­pa­nies work­ing on im­mune mod­u­la­tors, a re­designed Ven­tyx sports an S1P1 re­cep­tor mod­u­la­tor for IBD as well as a TYK2 in­hibitor the biotech will ini­tial­ly pit against Crohn’s dis­ease in an up­com­ing Phase I.

Ra­ju Mo­han

The de­ci­sion to un­cloak its pre­vi­ous­ly-un­der-wraps pipeline — what CEO Ra­ju Mo­han called a “qui­et mode,” rather than stealth — was an op­por­tunis­tic play for Ven­tyx spurred by in­vestor in­ter­est in what the team was work­ing on.

“Part of the goal of set­ting up the sin­gle com­pa­ny is to have sin­gle in­ter­est from in­vestors,” Mo­han told End­points News. “This was not a plan — we had a lot of in­bound in­ter­est in our port­fo­lio, and we felt that com­bin­ing these to­geth­er, both for the com­pa­ny and for in­vestors, would be re­al­ly at­trac­tive.”

The round is led by ven­Bio Part­ners, which will plant Richard Gaster and Aaron Roys­ton on­to the com­pa­ny’s board. Third Point’s Ji­gar Chok­sey will al­so join the board as part of the fi­nanc­ing round.

Mo­han, the founder and CEO of Al­ler­gan-ac­quired NASH play­er Akar­na Ther­a­peu­tics, said Ven­tyx’s two lead com­pounds and a third tar­get­ing the NL­RP3 in­flam­ma­some are “tru­ly dif­fer­en­ti­at­ed” in a space brim­ming with big-name com­peti­tors.

The fur­thest along of Ven­tyx’s pipeline is its S1P1 re­cep­tor mod­u­la­tor pro­gram — OPL-002 — which the joint en­ti­ty ab­sorbed from Op­pi­lan Phar­ma. The “pe­riph­er­al­ly-re­strict­ed” mol­e­cule was de­signed specif­i­cal­ly for IBD, un­like oth­er S1P1s re­pur­posed from mul­ti­ple scle­ro­sis ap­pli­ca­tions — think mol­e­cules like fin­golimod or ozan­i­mod — and de­signed to mod­u­late the blood-brain bar­ri­er.

That speci­fici­ty for IBD, par­tic­u­lar­ly ul­cer­a­tive col­i­tis where Ven­tyx is hop­ing for an ini­tial ap­proval, means Ven­tyx can be ex­treme­ly spe­cif­ic in the drug’s tar­get­ing to lim­it down­stream tox­i­c­i­ties, Mo­han said.

Mean­while, Ven­tyx is al­so gun­ning for a Phase I study for its TYK2 pro­gram, VTX-958, an im­port from the orig­i­nal Ven­tyx Bio­sciences formed in 2019 and tar­get­ing a range of im­munol­o­gy con­di­tions. The first of those, Mo­han said, is Crohn’s dis­ease, but the biotech has as­pi­ra­tions in pso­ri­a­sis, pso­ri­at­ic arthri­tis and lu­pus, to name a few.

VTX-958 is what’s known as an al­losteric TYK2, which can in the­o­ry in­hib­it down­stream sig­nal­ing to IL-12, IL-23 and Type I in­ter­fer­on cy­tokines linked to in­flam­ma­tion with­out the nasty side ef­fects of the pan-JAK in­hibitor class with which it shares a mech­a­nism of ac­tion. Re­searchers have strug­gled to de­vel­op a TYK2 that is far more se­lec­tive in its tar­get­ing than the JAKs — but Mo­han be­lieves al­losteric VTX-958 could prove a win­ner there.

“A tru­ly se­lec­tive TYK2 does not cross over in­to the JAK fam­i­ly — and that’s what we have,” he said. “We think it has the po­ten­tial to be best in class.”

Even if VTX-958 does keep chug­ging along, it’s like­ly to face at least one com­peti­tor.

In No­vem­ber, Bris­tol My­ers Squibb rolled out Phase III head-to-head ear­ly da­ta for its own TYK2 hope­ful deu­cravac­i­tinib show­ing the drug beat out no less a chal­lenger than block­buster Ote­zla in clear­ing pso­ri­a­sis pa­tients’ skin. It was an ear­ly re­ward for Bris­tol, which opt­ed to stick with deu­cravac­i­tinib and bail on Ote­zla as part of its merg­er with Cel­gene. Mean­while, even small play­ers like Neu­ron23 are in the game for the first FDA-ap­proved TYK2. The biotech scored a $113 mil­lion com­bined Se­ries A and B in De­cem­ber and is ad­vanc­ing a TYK2 it be­lieves can stave off neu­ro-in­flam­ma­tion.

On top of those two lead com­pounds, Ven­tyx al­so has a NL­RP3 mod­u­la­tor in the pre­clin­i­cal stage for pe­riph­er­al, CNS-pen­e­trant and tis­sue-se­lec­tive ap­pli­ca­tions, which could reach a broad range of ther­a­peu­tic ar­eas. The NL­RP3 in­flam­ma­some, a key sig­nal­ing pro­tein in the in­nate im­mune sys­tem, re­ceived a big boost as an an­ti­body tar­get for CV and CNS fol­low­ing No­var­tis’ read­out from its CAN­TOS study in 2017 show­ing its IL-1be­ta block­er Ilaris sig­nif­i­cant­ly re­duced CV risks.

Ven­tyx’s pro­gram, ZMG-2735, which tar­gets NL­RP3 to reg­u­late down­stream IL-1be­ta cy­tokines, is “very close” to the clin­ic, Mo­han said, with­out of­fer­ing time­lines.

With its slate stacked, Mo­han said Ven­tyx was im­me­di­ate­ly fo­cused on get­ting its clin­i­cal pro­grams through the next cou­ple years — but could be open in the fu­ture to cap­i­tal­iz­ing on the ris­ing tide of biotech val­u­a­tions, whether that’s an IPO, re­verse merg­er or oth­er­wise.

“We’re well fund­ed, we can take all these com­pounds through proof of con­cept for the next cou­ple of years, we’ve got a bunch of re­al­ly ex­cit­ing dis­cov­ery pro­grams — so hon­est­ly our laser fo­cus is on build­ing this com­pa­ny,”  he said. “That is the near term goal, but hav­ing said that we will look at all op­por­tu­ni­ties whether they’re fi­nanc­ing or strate­gic at the ap­pro­pri­ate time.”

Ven­Bio, Third Point and New Sci­ence were joined by new in­vestors in the round, in­clud­ing RTW In­vest­ments, LP, Janus Hen­der­son In­vestors, Welling­ton Man­age­ment, Or­biMed, Sur­vey­or Cap­i­tal (a Citadel com­pa­ny), Far­al­lon Cap­i­tal, Vi­vo Cap­i­tal, Lo­gos Cap­i­tal, Qim­ing Ven­ture Part­ners USA and Cor­morant As­set Man­age­ment.

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

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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)

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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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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.

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

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

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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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