AACR21: iTeos busts out ear­ly hu­man da­ta for an­ti-TIG­IT an­ti­body. Is it enough to match up with Roche, Mer­ck?

The TIG­IT pro­tein has turned in­to an arms race for Big Phar­ma, with Mer­ck and Roche look­ing to add their own can­di­dates to check­point in­hibitor com­bos. A small­er play­er in that race, iTeos Ther­a­peu­tics, is one step be­hind those big names and is rolling out ear­ly da­ta that looks pret­ty par for the course.

iTeos’ an­ti-TIG­IT im­mune re­cep­tor an­ti­body EOS-448 post­ed one con­firmed par­tial re­sponse and churned up no sur­pris­ing safe­ty sig­nals in the dose-es­ca­la­tion, monother­a­py por­tion of a Phase I/IIa study in pa­tients with ad­vanced sol­id tu­mors, ac­cord­ing to da­ta pre­sent­ed Sat­ur­day at the vir­tu­al AACR an­nu­al meet­ing.

One par­tial re­sponse isn’t enough to make in­vestors eyes pop, but EOS-448’s re­sults are pret­ty stan­dard com­pared with its near­est com­peti­tors. Re­mem­ber that Roche’s tiragolum­ab showed ze­ro ob­jec­tive re­spons­es in its Phase Ia monother­a­py study and just three across non-small cell lung can­cer and head and neck squa­mous cell car­ci­no­ma in Phase Ib. Mer­ck’s an­ti-TIG­IT, MK-7684, showed just a sin­gle par­tial re­sponse in its monother­a­py Phase I study, but ramped up quick­ly to eight par­tial re­spons­es as a com­bi­na­tion with Keytru­da.

There’s been a lot of fo­cus on an­ti-TIG­ITs to show ben­e­fit as a monother­a­py be­fore com­bi­na­tion stud­ies with oth­er im­munother­a­pies giv­en a high pos­si­bil­i­ty of fail­ure in late-stage stud­ies, but all three of the ma­jor play­ers in the race have fo­cused far more on safe­ty and tol­er­a­bil­i­ty ear­ly on than im­me­di­ate bio­mark­er ef­fi­ca­cy.

As of De­cem­ber, iTeos’ study had en­rolled 22 pa­tients with no es­tab­lished stan­dard of care and added an ad­di­tion­al 11 to the study af­ter the March 9 fol­low-up cut­off. The sin­gle par­tial re­sponse was in a melanoma pa­tient who had stopped re­spond­ing to Keytru­da, and EOS-448 al­so showed dis­ease sta­bi­liza­tion in nine pa­tients. Pri­or to March 9, a sin­gle se­ri­ous treat­ment-re­lat­ed side ef­fect was re­port­ed, a Grade 2 sys­temic in­flam­ma­to­ry re­sponse. Af­ter March 9, two more se­ri­ous TRAEs were re­port­ed, in­clud­ing a Grade 2 sys­temic in­flam­ma­to­ry re­sponse and a Grade 3 in­fu­sion-re­lat­ed re­ac­tion.

iTeos was pleased enough with the re­sults that it plans to ex­pand en­roll­ment in the Phase I/IIa to 40 pa­tients. Mean­while, the com­pa­ny is plan­ning to en­roll a suite of Phase Ib stud­ies com­bin­ing EOS-448 with Keytru­da and iTeos’ own in­u­padenant for check­point-naive and and re­sis­tant pa­tients with sol­id tu­mors, and as a monother­a­py and com­bo with an im­munomod­u­la­to­ry drug in mul­ti­ple myelo­ma. The com­pa­ny will al­so con­duct mul­ti­ple Phase IIa stud­ies in non-small cell lung can­cer, head and neck can­cer, melanoma and myelo­ma.

So­cial: Michel De­theux, iTeos CEO

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

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.

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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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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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Lisa Deschamps, AviadoBio CEO

Ex-No­var­tis busi­ness head hops over to a gene ther­a­py start­up — and she's reeled in $80M for a dash to the clin­ic

Neurologist and King’s College London professor Christopher Shaw has been researching neurodegenerative diseases like ALS and collaborating with drugmakers for the last 25 years in the hopes of pushing new therapies forward. But unfortunately, none of those efforts have come anywhere close to fruition.

“So, you know, after 20 years in the game, I said, ‘Let’s try and do it ourselves,’” he told Endpoints News. 

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

With gener­ic com­pe­ti­tion heat­ing up, Vas Narasimhan out­lines No­var­tis' growth plans at R&D day

Thursday marks Novartis’ annual R&D day, and with it comes CEO Vas Narasimhan’s attempt to spotlight the company’s pipeline strategy and emerging stars.

The biggest question entering Thursday’s presentation dealt with how the big biopharma will make up revenues from upcoming generic competition — Novartis says within the next five years, generics will eat away roughly $9 billion in sales. To offset this, Narasimhan outlined a strategy for 4% growth or higher until 2026, focusing on six key medicines he believes will see multibillion dollar profits during this time.

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.

Reshma Kewalramani, Vertex CEO (Vertex via YouTube)

Bat­tling a line­up of skep­tics, Ver­tex claims an­oth­er ear­ly clin­i­cal win — this time in kid­ney dis­ease

Vertex claimed its second early-stage win of the fall Wednesday, announcing positive results in a small study on a genetically defined form of kidney disease.

The 16-patient, Phase II trial focused on patients with focal segmental glomerulosclerosis, a rare disease where kidneys are unable to filter blood properly. Over 13 weeks on an experimental pill, the level of protein in the patients’ urine fell by an average of 47.6%.

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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