SPY-002

Analysts at Mizuho said this morning’s data “support the notion” that having around twice the overall exposure of vedolizumab is “translating to improved efficacy.”\n Spyre Therapeutics’ monoclonal antibody hit the key goal in a phase 2 study for ulcerative colitis (UC), which the company has touted as proof it can best Takeda’s Entyvio.The mid-stage trial evaluated the anti-α4β7 antibody, dubbed SPY001, in 43 patients with moderately to severely active UC. At Week 12, SPY001 had demonstrated a statistically significant 9.2-point reduction in patients’ Robarts Histopathology Index—a measure of UC disease activity—from baseline, according to an April 13 release.The company described a 40% clinical remission rate and a 51% endoscopic improvement rate as “clinically meaningful,” and claimed they supported SPY001’s “potential best-in-class profile.”SPY001 demonstrated a safety profile consistent with the α4β7 class, according to Spyre. Six participants experienced a treatment-emergent adverse event, with the most common being back pain. However, the only serious adverse event—chest pain in a patient with various other health conditions—was not deemed related to SPY001.The SPY001 results come from part A of the Skyline trial, which is also assessing Spyre’s anti-TL1A antibody, SPY002 and anti-IL23 antibody, SPY003, both as monotherapies and in various combinations. Initial data from the SPY002 and SPY003 arms are expected in mid-2026 and the third quarter of the year, respectively.SPY001 targets the same epitope as vedolizumab, the ingredient in Takeda’s UC and Crohn’s disease therapy Entyvio. Spyre has touted SPY001 as exhibiting a half-life three times greater than vedolizumab, while showing similar potency in preclinical tests. The idea is that SPY001 can be administered via autoinjector on a quarterly or biannual basis, whereas Entyvio is administered every two weeks. “SPY001 was designed to improve upon vedolizumab’s proven activity in IBD by matching its epitope and potency while increasing target coverage through an extended half-life and greater induction dosing,” Deanna Nguyen, M.D., SVP of clinical development at Sypre, explained in the release.“Our data today support the hypothesis that this approach could lead to a best-in-class anti-α4β7 product across safety, efficacy and convenience,” Nguyen added. Analysts at Mizuho said this morning’s data “support the notion” that having around twice the overall exposure of vedolizumab is “translating to improved efficacy.”“SPY001\'s week 12 clinical remission of 40% comfortably exceeds the around 20-25% range we had speculated would be viewed as class-aligned,” the analysts added in an April 13 note. “We see these results as an extremely favorable outcome, particularly for the potential efficacy that could be driven by SPY001-based combination regimens in Skyline Part B.”

Plus, news about AbbVie, SynOx, Eli Lilly’s Jaypirca, ImageneBio, Nxera Pharma, Neurocrine and Novartis: Neomorph raises $100M more for molecular glues : San Diego-based Neomorph has raised a $100 million Series B round led by its founding investor, Deerfield Management. The startup dosed its first patient in February in a trial of NEO-811, its lead molecular glue degrader that targets a hard-to-drug driver of a type of kidney cancer. Neomorph has also signed research deals with Biogen, AbbVie and Novo Nordisk since emerging from stealth in December 2020 with a $109 million Series A round. — Andrew Dunn Spyre’s positive ulcerative colitis results: Spyre Therapeutics’ experimental antibody SPY001 met the primary endpoint in the first part of a Phase 2 trial, showing a statistically significant reduction from baseline on a scale used to measure ulcerative colitis disease activity. The first part of the trial was an open-label induction period testing three of Spyre’s antibodies as monotherapies. Induction data from the other two candidates, SPY002 and SPY003, are expected later this year. The next phase of the trial will test the antibodies alone and in combinations against a placebo. SPY001 is designed to improve on Takeda’s blockbuster Entyvio, which has been approved for ulcerative colitis since 2014. Spyre’s stock $SYRE climbed 26% Monday morning. — Nicole DeFeudis AbbVie licenses non-opioid pain drugs from China: The US drugmaker is paying $30 million upfront for the ex-China rights to two analgesic candidates developed by Haisco Pharmaceutical Group. Haisco is also eligible for up to $705 million in milestones and tiered royalties on sales. The two assets, known as HSK55718 and HSK51155, have been engineered to target the Nav1.8 sodium channel. — Ayisha Sharma SynOx plans FDA filing for rare tumor type: The biotech announced on Monday that its drug emactuzumab passed a Phase 3 trial in tenosynovial giant cell tumor, or TGCT. The non-malignant growths typically occur in the knee, hip or ankle joints, and cause loss of function, pain or stiffness. Emactuzumab met the primary endpoint of objective response rate, as well as key secondary endpoints such as improvement in pain and physical function. The drug was designed to be a “short-course” alternative to chronic treatment, and patients in the Phase 3 trial were given five doses over an eight-week period. SynOx said it will bring the results to the FDA in the second half of this year. — Nicole DeFeudis Lilly touts new Jaypirca data in CLL: Adding Eli Lilly’s BTK inhibitor Jaypirca to Venclexta (venetoclax) and rituximab significantly improved patients’ progression-free survival compared to the venetoclax and rituximab combination alone, Lilly said on Monday. The open-label trial enrolled patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma. Treatment in both arms was “time-limited,” meaning it had an end date. Patients received treatment for up to two years, then took no treatment until their disease progressed. Lilly didn’t spell out the full data, but its oncology president Jacob Van Naarden said in a news release that Jaypirca “outperformed our expectations.” Lilly said it plans to submit the data to regulators later this year in hopes of a label expansion. — Nicole DeFeudis ImageneBio raises $30M: The private placement will fund the development of Imagene’s lead drug IMG-007 in alopecia areata and atopic dermatitis. The monoclonal antibody is currently in a Phase 2b trial for atopic dermatitis. Coastlands Capital led the financing, with participation from other investors including Trails Edge Capital Partners, Omega Funds and OrbiMed. — Nicole DeFeudis Nxera secures $22.5M milestone from Neurocrine: The payment was triggered by Neurocrine Biosciences dosing the first patient in a Phase 2 schizophrenia trial testing a drug called NBI-570, which was discovered using Nxera’s NxWave platform. The two companies entered a collaboration in 2021 that could be worth up to $2.7 billion. — Ayisha Sharma Novartis to lay off 114 staffers in New Jersey: The Swiss drugmaker disclosed the staff cuts in East Hanover, which will take effect from June to November, in a WARN notice for the state. Novartis did not immediately respond to a request for comment. — Ayisha Sharma