Rituximab biosimilar (Innovent Biologics)

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

Eli Lilly is moving to expand the label for Jaypirca (pirtobrutinib) after reporting a fourth Phase III leukaemia study, with new data showing the non-covalent BTK inhibitor significantly prolonged progression-free survival (PFS) when added to a time-limited venetoclax-based regimen.The results "outperformed our expectations," stated Jacob Van Naarden, Lilly Oncology president, in a release Monday.The BRUIN CLL-322 study enrolled 639 patients, most of whom had prior exposure to covalent BTK inhibitors. Participants were randomly assigned to receive Jaypirca added to venetoclax plus rituximab, or venetoclax plus rituximab alone. Treatment in both study arms was given for up to two years, after which patients do not take any CLL therapy until their disease progresses.OS trending in favourThe Jaypirca regimen outperformed venetoclax and rituximab alone in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL), meeting the study's main goal. The key secondary endpoint of overall survival is "trending in favour" of the Jayprica combo arm, though the data are still immature, according to Lilly.The regimen's overall safety profile was consistent with the known profiles of each drug. More results will be presented at a medical congress and submitted for peer review.Lilly will submit the results to regulators later this year to broaden Jaypirca's use beyond its current approvals in previously treated CLL/SLL following a covalent BTK inhibitor and in later-line mantle cell lymphoma."Modern CLL treatment regimens provide such durable disease control that the vast majority of patients see their entire disease course managed by only one or two lines of therapy," Van Naarden said. The BRUIN CLL-322 results "reinforce the potential role that [Jaypirca] may have, whether as a time-limited combination as a second line treatment or as a continuously dosed monotherapy in either line of therapy."Monday's readout is the latest to emerge from the BRUIN programme. The company previously reported results from the Phase III BRUIN CLL-321 trial in post-covalent BTK inhibitor patients testing Jaypirca against investigator's choice of Gilead Sciences' Zydelig (idelalisib) plus rituximab or bendamustine plus rituximab.Last year, it also unveiled data from BRUIN CLL-313 in which patients with treatment-naïve disease received either Jaypirca or bendamustine plus rituximab; and BRUIN CLL-314, which compared Jaypirca head-to-head with AbbVie and Johnson & Johnson's Imbruvica (ibrutinib) in patients who were treatment-naïve or BTK inhibitor-naïve.