R&D channel feed

Hervé Hoppenot, Incyte CEO

In­cyte touts mid-stage da­ta for new JAK in­hibitor but stops short of se­lect­ing PhI­II dose

Incyte is rolling out more mid-stage data for its next-gen oral JAK inhibitor, this time in an indication where it’s recently scored an approval with another drug.

Over the weekend at the 2023 American Academy of Dermatology Annual Meeting, the company spelled out results from a Phase IIb trial of povorcitinib among patients with extensive nonsegmental vitiligo, a condition where people’s skin loses color. In the study, the once-daily pill helped more patients than placebo regain color on their skin, as measured by a score of depigmentation called T-VASI (total Vitiligo Area Scoring Index).

Guido Oelkers, Sobi CEO

So­bi's PhI­II gout win sets up a po­ten­tial ri­val­ry with fu­ture Am­gen as­set

Almost three years after Swedish Orphan Biovitrum — perhaps better known as Sobi — shelled out $100 million in cash to license Selecta’s experimental drug for chronic refractory gout, the partners have clinched the Phase III data they were striving for.

The drug, SEL-212, met the primary endpoint across two trials in a Phase III program, the companies reported, measured by the percentage of patients achieving a response. They added that there was no difference in gout flares between the treatment and placebo arms at the six-month time point, a secondary endpoint, suggesting the drug was able to suppress gout flares.

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Athenex dis­clos­es pa­tient death, clin­i­cal hold on CAR-NKT tri­al as it seeks strate­gic al­ter­na­tives

A neuroblastoma patient has died after receiving Athenex’s natural killer cell therapy, triggering a clinical hold, the company revealed.

Baylor College of Medicine, which is running the trial, has identified some of the conditions leading up to the patient’s death and is “devising a safety risk mitigation plan” to reopen the trial, according to Athenex. It did not return requests for comment on when the patient’s death occurred.

Gilead taps Nurix pro­tein de­grad­er op­tion for $20M

Four years after first entering a collaboration with Nurix, Gilead is ponying up an option exercise payment of $20 million to license targeted protein degrader GS-6791.

It’s the first candidate to come from the agreement, with the potential for $425 million in milestone payments and low double-digit tiered royalties on product net sales.

GS-6791 is an oral IRAK4 degrader that targets inflammatory responses. Degrading IRAK4 could lead to potential treatments in rheumatoid arthritis and other inflammatory diseases, according to a press release.

Zymeworks CEO Kenneth Galbraith and Daiichi Sankyo CEO Sunao Manabe

Dai­ichi and Zymeworks end an­ti­body pact af­ter sev­en years

Zymeworks and Daiichi Sankyo ended a seven-year collaboration on bispecific antibodies last week.

Under the 2016 agreement, Zymeworks licensed its Azymetric and Efect platforms to Daiichi Sankyo to develop one bispecific antibody therapy in exchange for technology access fees and milestone payments and royalties, according to SEC filings. But Zymeworks also got something else in return, in the form of licenses to certain immuno-oncology antibodies from Daiichi.

Bill Meury, Karuna Therapeutics CEO

Karuna’s schiz­o­phre­nia drug clears an­oth­er PhI­II as biotech seeks 2024 launch

Karuna Therapeutics said its investigational schizophrenia treatment cleared the bar in another Phase III clinical trial, which the biotech hopes will open the doors for a new class of medication for the millions of people living with the disorder as it tees up a mid-2023 approval request.

The Boston biotech’s KarXT drug showed a statistically significant and clinically meaningful reduction in symptoms compared to placebo on the main study goal in patients with schizophrenia, Karuna said before Monday’s opening bell. The design of the 256-patient Phase III EMERGENT-3 was essentially a “carbon copy” of the company’s two other Phase III and Phase II studies of the drug, CEO and president Bill Meury told Endpoints News on Sunday afternoon, in a preview of the data drop.

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Gossamer Bio CEO Faheem Hasnain at BIO22 (J.T. MacMillan Photography)

Gos­samer stops en­roll­ment on BTK in­hibitor pro­gram, goes all in on PAH drug

Gossamer Bio is stopping enrollment on a Phase Ib/II trial of its BTK inhibitor in CNS lymphoma, it said in its annual report Friday morning.

The San Diego-based biotech said, “​​Based upon the benefit / risk profile observed to date and a prioritization of resources to support the seralutinib program,” it decided to stop enrolling the trial of the BTK inhibitor known as GB5121. Next, Gossamer plans to discuss the available data with the trial’s data review committee, an independent panel of experts, to figure out next steps. The trial originally expected to enroll around 160 patients, according to a federal clinical trials database.

Pfiz­er, Astel­las tout pos­i­tive PhI­II da­ta to po­ten­tial­ly ex­pand Xtan­di la­bel

Pfizer and Astellas are gunning to add a fourth indication to their cancer drug Xtandi with Phase III trial results released today.

The study, looking at Xtandi plus leuprolide and Xtandi as a monotherapy in men with non-metastatic hormone-sensitive prostate cancer, met its primary endpoint with a “statistically significant and clinically meaningful improvement” in metastasis-free survival in the patients treated with Xtandi plus leuprolide, according to the companies, though no detailed data was given.

Eliav Barr, Merck Research Laboratories chief medical officer

Mer­ck­'s Keytru­da plus TIG­IT com­bo proves less ef­fec­tive than chemo in open-la­bel lung can­cer study

Ahead of Keytruda’s patent cliff in 2028, Merck is trying to develop a variety of combination therapies that can extend the megablockbuster’s potential. But one of those combos just hit a snag, and it’s putting the company in damage control mode.

MK-7684A, a brew of pembrolizumab (Keytruda’s chemical name) and Merck’s in-house anti-TIGIT compound vibostolimab, failed the open-label portion of a Phase II study measuring it against chemotherapy in metastatic non-small cell lung cancer, the Big Pharma announced Thursday afternoon. The regimen did not improve patients’ progression-free survival odds compared to the control and was less effective than chemo.

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Andrew Hall, IMV CEO

'Very re­al' head­winds: With lean­er staff, can­cer vac­cine mak­er search­es for help

Cancer vaccine biotech IMV said it will look at “strategic alternatives following a review of its business” as the Canadian company continues clinical trials.

The Nova Scotia and Cambridge, MA biotech laid off about one-third of its staff last fall to “maximize shareholder value.” Now, IMV wants to “realize its full clinical potential” in solid and hematologic cancers and has tapped Stonegate Healthcare Partners to figure that out.

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