Raju Mohan, Ventyx Biosciences CEO

Months af­ter a mam­moth raise, Ven­tyx Bio­sciences dips back in­to ven­ture well

Sev­er­al months af­ter emerg­ing from what CEO Ra­ju Mo­han called “qui­et mode” with a mam­moth $114 mil­lion raise, Ven­tyx Bio­sciences is now mak­ing its plans for the clin­ic loud and clear.

The Cal­i­for­nia-based im­mune mod­u­la­tion play­er kicked the week off with a $51 mil­lion Se­ries B, while al­so nam­ing some key hires ahead of its big clin­i­cal push.

The CMO slot is go­ing to Jörn Drap­pa, for­mer CMO at Viela Bio be­fore it was bought out by Hori­zon Ther­a­peu­tics ear­li­er this year. The As­traZeneca vet stayed on at Hori­zon for a while as ex­ec­u­tive VP of R&D be­fore mak­ing the jump to Ven­tyx.

Sheila Gu­jrathi

Sheila Gu­jrathi, the for­mer Gos­samer Bio CEO, is com­ing on board as Ven­tyx’s new ex­ec­u­tive chair. Gu­jrathi spent just over two years at Gos­samer be­fore leav­ing the helm on the heels of a hard fail­ure for the com­pa­ny’s lead pro­gram. And Luisa Salter-Cid, CSO at Pi­o­neer­ing Med­i­cines and for­mer CSO of Gos­samer, will chair the sci­en­tif­ic ad­vi­so­ry board.

“Sheila’s and Jörn’s depth of ex­pe­ri­ence in de­vel­op­ing im­munol­o­gy drugs and ex­per­tise in build­ing and lead­ing biotech com­pa­nies will be in­valu­able as we ad­vance our port­fo­lio of clin­i­cal pro­grams and con­tin­ue to grow the com­pa­ny,” Mo­han said in a state­ment.

Ven­tyx’s re­designed pipeline com­bines pro­grams from three com­pa­nies all found­ed by Mo­han and New Sci­ence Ven­tures. The lead pro­gram is an S1P1 re­cep­tor mod­u­la­tor that’s al­ready in Phase II for IBD, which the joint en­ti­ty ab­sorbed from Op­pi­lan Phar­ma. The can­di­date was de­signed specif­i­cal­ly for IBD, un­like oth­er S1P1s re­pur­posed from mul­ti­ple scle­ro­sis ap­pli­ca­tions, and is de­signed to mod­u­late the blood-brain bar­ri­er.

Right be­hind that is a Phase I TKY2 in­hibitor for au­toim­mune dis­eases, which was plucked straight from the orig­i­nal Ven­tyx formed in 2019. Back in March, Mo­han told End­points News that Ven­tyx plans to go af­ter Crohn’s dis­ease first, though the team al­so has as­pi­ra­tions in pso­ri­a­sis, pso­ri­at­ic athri­tis and lu­pus, to name a few.

A third can­di­date tar­get­ing the NL­RP3 in­flam­ma­some is Phase I-ready ac­cord­ing to Ven­tyx. The NL­RP3 in­flam­ma­some, a key sig­nal­ing pro­tein com­plex in the in­nate im­mune sys­tem, re­ceived a big boost as an an­ti­body tar­get for car­dio­vas­cu­lar and CNS dis­eases af­ter No­var­tis re­leased da­ta in 2017, show­ing it re­duced the risk of heart dis­ease and stroke.

Is an IPO next for Ven­tyx? Mo­han told End­points months ago that he could be open to a pub­lic de­but in the fu­ture, whether it be through an IPO or re­verse merg­er.

Sur­vey­or Cap­i­tal led the Se­ries B round, with a hand from ven­Bio Part­ners, Third Point, RTW In­vest­ments, LP, Janus Hen­der­son In­vestors, Welling­ton Man­age­ment, Or­biMed, Far­al­lon Cap­i­tal, Vi­vo Cap­i­tal, Lo­gos Cap­i­tal, Qim­ing Ven­ture Part­ners USA and Cor­morant As­set Man­age­ment.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

So — that pig-to-hu­man trans­plant; Po­ten­tial di­a­betes cure reach­es pa­tient; Ac­cused MIT sci­en­tist lash­es back; 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.

We’re incredibly excited to welcome Beth Bulik, seasoned pharma marketing reporter, to the team. You can find much of her work in our new Marketing channel — and in her weekly newsletter, Endpoints PharmaRx, which will launch in early November. Add it to your subscriptions here.

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NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

No, sci­en­tists are not any clos­er to pig-to-hu­man trans­plants than they were last week

Steve Holtzman was awoken by a 1 a.m. call from a doctor at Duke University asking if he could put some pigs on a plane and fly them from Ohio to North Carolina that day. A motorcyclist had gotten into a horrific crash, the doctor explained. He believed the pigs’ livers, sutured onto the patient’s skin like an external filter, might be able to tide the young man over until a donor liver became available.

UP­DAT­ED: Agenus calls out FDA for play­ing fa­vorites with Mer­ck, pulls cer­vi­cal can­cer BLA at agen­cy's re­quest

While criticizing the FDA for what may be some favoritism towards Merck, Agenus on Friday officially pulled its accelerated BLA for its anti-PD-1 inhibitor balstilimab as a potential second-line treatment for cervical cancer because of the recent full approval for Merck’s Keytruda in the same indication.

The company said the BLA, which was due for an FDA decision by Dec. 16, was withdrawn “when the window for accelerated approval of balstilimab closed,” thanks to the conversion of Keytruda’s accelerated approval to a full approval four months prior to its PDUFA date.

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How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data are messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data are exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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David Livingston (Credit: Michael Sazel for CeMM)

Renowned Dana-Far­ber sci­en­tist, men­tor and bio­phar­ma ad­vi­sor David Liv­ingston has died

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

No­vo CEO Lars Fruer­gaard Jør­gensen on R&D risk, the deal strat­e­gy and tar­gets for gen­der di­ver­si­ty

 

I kicked off our European R&D summit last week with a conversation involving Novo Nordisk CEO Lars Fruergaard Jørgensen. Novo is aiming to launch a new era of obesity management with a new approval for semaglutide. And Jørgensen had a lot to say about what comes next in R&D, how they manage risk and gender diversity targets at the trendsetting European pharma giant.

John Carroll: I’m here with Lars Jørgensen, the CEO of Novo Nordisk. Lars, it’s been a really interesting year so far with Novo Nordisk, right? You’ve projected a new era of growing sales. You’ve been able to expand on the GLP-1 franchise that was already well established in diabetes now going into obesity. And I think a tremendous number of people are really interested in how that’s working out. You have forecast a growing amount of sales. We don’t know specifically how that might play out. I know a lot of the analysts have different ideas, how those numbers might play out, but that we are in fact embarking on a new era for Novo Nordisk in terms of what the company’s capable of doing and what it’s able to do and what it wants to do. And I wanted to start off by asking you about obesity in particular. Semaglutide has been approved in the United States for obesity. It’s an area of R&D that’s been very troubled for decades. There have been weight loss drugs that have come along. They’ve attracted a lot of attention, but they haven’t actually ever gained traction in the market. My first question is what’s different this time about obesity? What is different about this drug and why do you expect it to work now whereas previous drugs haven’t?

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René Russo, Xilio CEO (Alicia Petitti for Xilio)

Xilio Ther­a­peu­tics goes pub­lic as bio­phar­ma IPOs rum­ble for­ward in Q4

It’s been a busy fall on Wall Street — and this week, we’ve got another biotech going public after Ventyx yesterday.

Massachusetts solid-tumor biotech Xilio Therapeutics made its public debut today, joining 149 other biotechs that have gone public so far this year.

Back on October 1st, Xilio filed its S-1 with the SEC to make its IPO debut for $100 million — the next step in financing after completing a $95 million Series C back in February.

Luc Boblet, Egle Therapeutics CEO

A new Treg play­er emerges with $46M and back­ing from Take­da

In recent years, the chorus of biotechs and Big Pharma backers targeting regulatory T cells — also known as “Tregs” — for cancer and autoimmune diseases has only grown louder.

The newest voice is from Egle Therapeutics, which sang out a $46.4 million Series A round on Friday led by LSP and Bpifrance through their InnoBio 2 fund. Takeda’s venture arm also chipped in, about a year after the pharma struck a research pact with the Paris-based upstart.

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