The $165M im­munol­o­gy start­up Sheila Gu­jrathi bet on af­ter Re­cep­tos, Gos­samer is shoot­ing for an IPO

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Sheila Gu­jrathi has kept her­self busy since leav­ing the helm of Gos­samer Bio in the af­ter­math of a mid-stage flop. She signed on to a few biotech boards, most re­cent­ly to be­come Ven­tyx Bio’s ex­ec­u­tive chair.

Sheila Gu­jrathi

But it turns out her con­nec­tion with the biotech runs much deep­er. As Ven­tyx re­vealed in its S-1, Gu­jrathi made a small in­vest­ment in the com­pa­ny dur­ing the Se­ries A — which took place be­tween Feb­ru­ary and June 2021.

The goal is noth­ing short of be­com­ing a leader in the im­munol­o­gy mar­ket Gu­jrathi knows in­ti­mate­ly.

Ven­tyx, which has pen­ciled in the stan­dard fig­ure of $100 mil­lion for its IPO, is look­ing to chal­lenge one of the top drugs she had helped set on a path to ap­proval while at Re­cep­tos: ozan­i­mod, now mar­ket­ed as Zeposia. Its lead drug will al­so be com­pet­ing with the key TYK2 pro­gram at Bris­tol My­ers Squibb, where Gu­jrathi used to work and which al­so owns Zeposia via a game of big fish eats small fish eats small­er fish.

VTX002, which is list­ed in sec­ond place in its pipeline, is ac­tu­al­ly the most ad­vanced as­set with a Phase II tri­al in ul­cer­a­tive col­i­tis slat­ed for Q4. The drug is a S1P1 re­cep­tor mod­u­la­tor, and Ven­tyx isn’t shy to name its biggest ri­val.

BMS’ Zeposia (ozan­i­mod) be­came the first S1P1R mod­u­la­tor ap­proved for treat­ment of UC in May 2021. How­ev­er, based on VTX002’s ef­fects on lym­pho­cyte low­er­ing in our Phase 1 tri­al, as well as its phar­ma­co­ki­net­ic prop­er­ties that al­low for rapid on­set of ac­tiv­i­ty and rapid nor­mal­iza­tion of lym­pho­cyte counts up­on dis­con­tin­u­a­tion of ther­a­py, may lead to an im­proved clin­i­cal pro­file rel­a­tive to ozan­i­mod. Fur­ther, based on the lack of liv­er func­tion test el­e­va­tions in our Phase 1 tri­al and our pe­riph­er­al­ly re­strict­ed drug ac­tiv­i­ty, we be­lieve VTX002 may avoid cer­tain warn­ings in­clud­ed with­in the Zeposia la­bel, in­clud­ing those around liv­er in­jury and mac­u­lar ede­ma screen­ing, re­spec­tive­ly.

VTX-958 — the oral, al­losteric TYK2 in­hibitor cur­rent­ly be­ing de­vel­oped for mod­er­ate-to-se­vere pso­ri­a­sis — will be com­pet­ing with a slate of fierce com­peti­tors in­clud­ing the dom­i­nant in­jecta­bles like Hu­mi­ra, En­brel and Ste­lara, as well as top­i­cal and gener­ic ther­a­pies.

New Sci­ence Ven­tures, which had weaved three of its port­fo­lio com­pa­nies and their im­mune mod­u­la­tors to cre­ate Ven­tyx, is the largest share­hold­er at 42.46%, fol­lowed by ven­Bio (11.89%) and Third Point Ven­tures (8.51%). CEO Ra­ju Mo­han claims 4.8% pre-IPO, dwarf­ing Gu­jrathi’s share, which stands at less than 1%.

It took less than six months for Ven­tyx to come out of stealth in­to an IPO fil­ing, and it’s al­ready raised $165 mil­lion along the way. As of June, the ex­ecs have burned through $87.3 mil­lion.

The biotech IPO mar­ket re­mains on pace to eclipse last year’s record sum of $16.5 bil­lion, per the End­points News tal­ly, but ac­tiv­i­ty slowed down con­sid­er­ably dur­ing the third quar­ter.

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.

Tim Pearson, Carrick Therapeutics CEO

Pfiz­er backs $60M in­fu­sion in­to Car­rick, teams up on breast can­cer treat­ment

In a big week for Carrick Therapeutics, the company announced $60 million in funding for its lead breast cancer drug and development of a second program, as well as a collaboration with Pfizer for combo development.

The $35 million from Pfizer comes with an agreement under which Pfizer will support Carrick’s Phase II study of samuraciclib in combination with Pfizer’s Faslodex for advanced breast cancer. Along with the investment, Adam Schayowitz, vice president and development head of breast cancer, colorectal cancer and melanoma at Pfizer global product development, will join Carrick’s scientific advisory board.

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Thomas Gad, Y-mAbs Therapeutics founder and interim CEO

FDA re­jects Y-mAbs’ neu­rob­las­toma drug af­ter tak­ing is­sue with clin­i­cal tri­al de­sign

Uncertainty about clinical trial evidence has led the FDA to hand down a complete response letter for Y-mAbs’ neuroblastoma drug, casting a cloud on the future of a candidate that had gone through a long development journey in a rare pediatric cancer.

Y-mAbs said it’s disappointed “but not surprised” given that the agency’s oncology drug advisory committee had voted 16-0 against its drug’s approval a few weeks ago.

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Philip Tagari switch­es Am­gen's dis­cov­ery lab for in­sitro's ma­chine learn­ing tools; CEO Joaquin Du­a­to to chair J&J's board

In February, Philip Tagari will take a few days of retirement and then immediately return to industry. He won’t be leading the therapeutics discovery unit for a large biopharma, though.

He’ll trade in his Amgen hat for chief scientist at a machine learning startup that has reeled in hundreds of millions in capital to lay the groundwork for a much-hyped new model of drug discovery that aims to speed up the time to new clinical assets.

Raul Rodriguez, Rigel Pharma CEO

Rigel Phar­ma scores FDA ap­proval for leukemia, kick­ing off show­down with Servi­er in IDH1

When Rigel Pharma bought olutasidenib from Forma Therapeutics, it acquired a drug that already secured a PDUFA date at the FDA — for February 2023. But regulators are ready to give their OK sooner than that.

The FDA has approved the IDH1 inhibitor as a treatment for adult patients with relapsed or refractory acute myeloid leukemia who have a susceptible IDH-1 (isocitrate dehydrogenase-1) mutation as detected by an FDA-greenlit test. Rigel will market it as Rezlidhia.

Paul Hudson, Sanofi CEO (Romuald Meigneux/Sipa via AP Images)

Sanofi and Am­gen are bring­ing cash to cov­er the ta­ble stakes for the Hori­zon M&A game

With the market cap on Horizon Therapeutics $HZNP pushed up to the $23 billion mark today, one of the Big Pharmas in the hunt for a major league buyout deal signaled it’s playing the M&A game with cash.

Paris-based Sanofi, where CEO Paul Hudson has been largely focused on some risky biotech acquisitions to win some respect for its future pipeline prospects, issued a statement early Friday — complying with Rule 2.12 of the Irish takeover rules — making clear that while the certainty or size of an offer can’t be determined, any offer “will be solely in cash.” And Amgen CEO Robert Bradway came right in behind him, filing a statement on the London Stock Exchange overnight that any offer they may make will “likely” be in cash as well.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls

Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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Uğur Şahin, BioNTech CEO (ddp images/Sipa USA/Sipa via AP Images)

BioN­Tech bets on dif­fi­cult STING field via small mol­e­cule pact with a Pol­ish biotech

BioNTech is beefing up its relatively thin small molecule pipeline by adding weight to a clinically difficult corner of oncology R&D: STING agonists. To do so, BioNTech is teaming up with a 15-year-old Polish biotech and doling out €40 million, about $41.5 million, to start.

The deal is broken into two parts: First, BioNTech obtains an exclusive global license to develop and market Ryvu Therapeutics’ STING agonist portfolio as small molecules, whether alone or in combination with other agents.

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