Bris­tol-My­ers of­fers a pos­i­tive snap­shot on ear­ly da­ta for an IDO1 ri­val to In­cyte

WASH­ING­TON, DC — While In­cyte and the founders of Flexus scrap in court over who owns the IDO1 tech­nol­o­gy that Bris­tol-My­ers Squibb $BMY bought in a $1.25 bil­lion deal a cou­ple of years ago, Bris­tol-My­ers is ready to start putting the ear­ly-stage da­ta from a com­bi­na­tion study with Op­di­vo on dis­play.

To­day at the SITC meet­ing, in­ves­ti­ga­tors say their on­go­ing Phase I/II study of the check­point drug Op­di­vo plus BMS-986205 pro­duced some vary­ing pos­i­tive re­sults for heav­i­ly pre-treat­ed blad­der (25 cas­es) and cer­vi­cal can­cer pa­tients (22 pa­tients).

Bot­tom line:

— In the blad­der can­cer co­hort, the ob­jec­tive re­sponse rate and dis­ease con­trol rate were 32% and 44%, re­spec­tive­ly.

— In the cer­vi­cal can­cer co­hort, the ORR was 14% and DCR was 64%.

PD-L1 ex­pres­sion mat­tered. Ze­ro­ing in on pa­tients who ex­press PD-L1 more than 1%, ORR was 46% and 25% in the blad­der and cer­vi­cal can­cer groups, re­spec­tive­ly, while for pa­tients who ex­press PD-L1 less than 1%, ORR was 22% in the blad­der can­cer co­hort with no re­spons­es ob­served in cer­vi­cal can­cer pa­tients.

In a court case filed in Delaware, In­cyte claimed that Jor­dan Frid­man, a sci­en­tist in its ranks, had sys­tem­at­i­cal­ly lift­ed its IDO1 se­crets be­fore mak­ing his way to Flexus, which sub­se­quent­ly ac­cept­ed a jaw-drop­ping buy­out of­fer from Bris­tol-My­ers. The law­suit filed against Flexus founders Ter­ry Rosen and Juan Jean seeks more than a bil­lion dol­lars in dam­ages.

In­cyte $IN­CY has the most ad­vanced IDO1 in the clin­ic — epaca­do­stat — and is clear­ly in­tent on de­fend­ing its IP turf. Bris­tol-My­ers, mean­while, is plac­ing a heavy em­pha­sis on mov­ing as fast as pos­si­ble on the IDO1 front as it push­es ahead with its big check­point ther­a­py and com­bos around it.

Bris­tol-My­ers IDO de­vel­op­ment lead Mark Rut­stein not­ed:

We are ur­gent­ly pur­su­ing trans­for­ma­tive re­search to bet­ter un­der­stand tu­mor eva­sion mech­a­nisms to help in­form po­ten­tial new treat­ment op­tions for pa­tients with ad­vanced can­cers. BMS-986205 has shown en­cour­ag­ing char­ac­ter­is­tics, in­clud­ing po­tent and se­lec­tive in­hi­bi­tion of IDO1, as well as phar­ma­co­ki­net­ic da­ta that sup­port once-dai­ly dos­ing. We look for­ward to ad­di­tion­al da­ta from this study.

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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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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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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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.

Re­searchers move clos­er to de­ci­pher­ing blood clots from As­traZeneca, J&J's Covid-19 vac­cines

Researchers may be nearing an answer for the mysterious and life-threatening blood clots that appeared on very rare occasions in people who received the J&J or AstraZeneca Covid-19 vaccine.

The new work builds on an early hypothesis researchers in Norway put forward last spring, when the cases first cropped up. They proposed the events were similar to blood clots that can occur in a small subset of patients who receive heparin, one of the most commonly used blood thinners.

Ed Kaye, Stoke Therapeutics CEO

Stoke touts ear­ly signs of ef­fi­ca­cy for Dravet syn­drome drug

Two and a half years after driving his antisense oligonucleotide platform to Wall Street, Stoke Therapeutics CEO Ed Kaye is painting a fuller picture of the company’s first clinical data. And though the trial wasn’t powered to detect statistical significance, Kaye says the readout shows early signs of efficacy in kids with a rare, drug-resistant form of epilepsy

STK-001 was well-tolerated in single and multiple doses in 22 Dravet syndrome patients between the ages of 2 and 18 years old, Stoke announced on Friday. What’s more, 12 of the 17 evaluable patients at the time (70.6%) saw reductions from baseline in convulsive seizure frequency, according to the company.