Final phase II data showing improved survival rates in cervical cancer is giving Nykode Therapeutics ASA even more confidence in taking vaccine candidate VB10.16 further into oncology. The company had been considering targeting head and neck cancer for months. Now, with these new data, it said it’s fully behind focusing on PD-L1 patients with up to one prior line of systemic therapy.
Immuneering Corp.’s positive pharmacokinetic, pharmacodynamic and safety phase I data with universal RAS inhibitor IMM-1-104 let the company move up the timeline for a recommended phase II dose from previous guidance of mid-2024 to early next year.
Combining the personalized cancer vaccine mRNA-4157 (V-940, Moderna Inc.) with Keytruda (pembrolizumab, Merck & Co. Inc.) significantly extended recurrence-free survival in patients with stage III/IV resected high-risk melanoma in the randomized phase II KEYNOTE-942/mRNA-4157-P201 trial. Compared to Keytruda alone, adding the vaccine cut the risk of recurrence or death by 44% 18 months after treatment, lead investigator Jeffrey Weber reported at the opening clinical trials plenary of the 2023 annual meeting of the American Association for Cancer Research (AACR).
Junshi Biosciences Co. Ltd.’s PARP inhibitor, senaparib (JS-109/IMP4297), met the primary endpoint of progression-free survival in a phase III ovarian cancer study, according to a prespecified interim analysis.
Immutep Ltd.’s lead immunotherapy candidate, eftilagimod (IMP-321, efti), plus pembrolizumab reverted previous resistance to PD-1/PD-L1 therapy in part B of the TACTI-002 phase II trial in second-line metastatic non-small-cell lung cancer (NSCLC) in patients refractory to anti-PD-1/PD-L1 therapy.
On Vaccine Day, Moderna Inc. had to tell the world there weren’t enough flu cases to get a good reading in one of its two phase III vaccine studies. The northern hemisphere clinical trial of mRNA-1010, a seasonal quadrivalent vaccine, did not meet the statistical threshold because there were not enough sick participants to test to determine an interim efficacy analysis.
Human Immunology Biosciences Inc. (Hi-Bio) is moving ahead to late-stage work after disclosing positive phase II data from two trials testing the monoclonal antibody felzartamab for primary membranous nephropathy (PMN), a rare autoantibody-mediated autoimmune kidney disease and a leading cause of nephrotic syndrome. CEO Travis Murdoch told BioWorld that his firm is “working through designs for the next study, and planning to engage with regulators,” after which more details will be shared. PMN, he added, has “not been heavily trodden, but increasingly there’s a recognition that there’s an important patient and commercial opportunity” in the indication.
Word recently from Nexcella Inc. of progress in its potentially BLA-enabling phase Ib/IIa study, with the BCMA-targeted, autologous CAR T therapy called NXC-201 for relapsed/refractory (r/r) multiple myeloma and r/r amyloid light chain amyloidosis, helped put nearer to center stage the class, which has proven attractive to a handful of developers. Among others in the space are Arcellx Inc. and Gracell Biotechnologies Inc.
In the string of successes and frustrations generated by their five-year collaboration, Merck & Co. Inc. and Eisai Inc. can now add a few more frustrations. The companies are discontinuing the phase III LEAP-003 study of Keytruda (pembrolizumab) plus Lenvima (lenvatinib) for first-line treatment of unresectable or metastatic melanoma because it did not improve overall survival (OS) vs. Keytruda as a monotherapy. Also, the phase III LEAP-017 trial evaluating the combination in unresectable and metastatic colorectal cancer did not meet its primary endpoint of OS.
Beckley Psytech Ltd. is advancing lead BPL-003 psychedelic therapy on two fronts, opening phase IIa trials in alcohol use disorder and in treatment-resistant depression.
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