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.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; and more

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Usama Malik

Ex-Im­munomedics CFO charged with in­sid­er trad­ing, faces up to 20 years in prison af­ter al­leged­ly tip­ping off girl­friend and rel­a­tives of a PhI­II suc­cess

The former CFO of Immunomedics, who helped steer the company to its $21 billion buyout by Gilead last year, has been charged with insider trading, the Department of Justice announced Thursday.

Usama Malik tipped off his then-girlfriend and four others that a Phase III study for Trodelvy would be stopped early four days before Immunomedics publicly announced the result in April 2020, DoJ alleged in its complaint. The individuals then purchased Immunomedics shares, selling them after the news broke and Immunomedics’ stock price doubled.

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Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Radek Spisek, Sotio CEO (Cellestia)

A qui­et Czech biotech bags $315M to dri­ve its blos­som­ing can­cer pipeline through the clin­ic

In the rather insular world of biotech, most innovation inevitably comes from a cluster of R&D hubs — Cambridge, San Francisco, etc. But sometimes success stories sprout from rocky soil, which is most certainly the case with Prague-based Sotio Biotech and its suddenly jam-packed pipeline of cancer drugs.

After years in quiet development, Sotio now has $315 million in new funds to play with from parent company PPF Group, an investment group founded in the Czech Republic, as the biotech looks to advance its growing pipeline through early- and mid-stage trials.

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In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

Ab­b­Vie tacks on a new warn­ing to Rin­voq la­bel as safe­ty frets crimp JAK class

The safety problems that continue to plague the JAK class as new data highlight some severe side effects are casting a large shadow over AbbVie’s Rinvoq.

As a result of a recent readout highlighting major adverse cardiac events (MACE), malignancy, mortality and thrombosis with Xeljanz a couple of months ago, AbbVie put out a notice late Friday afternoon that it is adding the new class risks to its label for their rival drug.

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Biospec­i­men M&A: Dis­cov­ery ac­quires Al­bert Li's he­pa­to­cyte project; PhI­II tri­al on Bay­er's Nube­qa reached pri­ma­ry end­point

Discovery Life Sciences has acquired what claims to be the Maryland-based host of the world’s largest hepatocyte inventory, known as IVAL, to help researchers select more effective and safer drug candidates in the future.

The combined companies will now serve a wider range of drug research and development scientists, according to Albert Li, who founded IVAL in 2004 and is set to join the Discovery leadership team as the CSO of pharmacology and toxicology.

Pfiz­er, Am­gen and Janssen seek fur­ther clar­i­ty on FDA's new ben­e­fit-risk guid­ance

Three top biopharma companies are seeking more details from the FDA on how the agency conducts its benefit-risk assessments for new drugs and biologics.

While Pfizer, Amgen and Janssen praised the agency for further spelling out its thinking on the subject in a new draft guidance, including a discussion of patient experience data as part of the assessment, the companies said the FDA could’ve included more specifics in the 20-page draft document.

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