10x Genomics and Parse single-cell sequencing patents split fates, Rasonque (daraxonrasib) approval, and autogene cevumeran phase 2 study termination
IP litigation between 10x Genomics and Parse Biosciences in single-cell sequencing turned on Aug 28, when a Delaware jury found that Parse’s Evercode Whole Transcriptome products willfully infringed three Roche-originating patents exclusively licensed to Scale Biosciences ruled, which 10x Genomics acquired in 2025. The verdict came just nine days after the Federal Circuit held three different patents to 10x Genomics unpatentable for obviousness, affirming PTAB final written decisions in inter partes review (IPR) petitioned by Parse. Specifically, the Federal Circuit found that a person of ordinary skill in the art would have been motivated to combine a cell-of-origin tag taught by Linnarsson with Unique Molecular Identifiers (UMIs) taught by McCloskey to reduce amplification bias and modify the combination through ligation as it was one of the two conventional techniques to attach a second tag. The technologies in the contested patents lie similarly in the combinatorial-barcoding domain but faced opposite outcomes. Even though 10x Genomics lost its own patents, its portfolio lives on through acquisition and license. As part of its strategy to maintain leadership in single-cell sequencing and spatial transcriptomics, 10x Genomics has litigated against several of their competitors including NanoString/Bruker, Vizgen, Curio Bioscience, and most recently Illumina.
On pancreatic cancer therapy front, the FDA approved Revolution Medicines’ Rasonque (daraxonrasib) as a first in class treatment for adults with metastatic pancreatic cancer who have received at least one prior systemic therapy or are not candidates for multiagent systemic therapy on Aug 26. Daraxonrasib works by inhibiting RAS, a cell-growth control switch, which is often mutated in pancreatic cancer to be locked at the ON state and cause uncontrolled tumor cell proliferation. It is a molecular glue that binds to RAS superfamily proteins and block downstream signaling pathways to limit pancreatic tumor growth. The approval came after success of daraxonrasib in reducing the risk of death by 60% in a large phase 3 trial compared with standard chemotherapy. The result may represent a significant advance at treating one of the deadliest cancers.
Despite breakthrough by Moderna’s intismeran autogene as adjuvant therapy for melanoma in combination with KEYTRUDA in a phase 3 trial, BioNTech faced a setback in its individualized mRNA immunotherapy autogene cevumeran as an adjuvant monotherapy for resected colorectal cancer. The company announced on Aug 28 to terminate the phase 2 trial of autogene cevumeran according to DSMB recommendation over “a numerical imbalance in overall survival between treatment arms” and that “further continuation of the trial was unlikely to change the efficacy outcome”. The discontinuation of the trial hints at the high uncertainty that remains in the emerging field of individualized neoantigen therapy (INT). It may signal limited efficacy for INT given as monotherapy alone without concurrent checkpoint inhibition in treating one specific tumor type, but the halt should not be read as a verdict on the technology. Much remains to be explored across indications and in combination regimens. In fact, BioNTech continues to evaluate the efficacy and safety of autogene cevumeran in combination with checkpoint inhibition and chemotherapy in treating patients with pancreatic ductal adenocarcinoma (PDAC) in a separate phase 2 trial.
[This post is for educational purposes only. It reflects my own analysis of publicly available information, does not constitute legal advice, and does not create an agent-client relationship. Views expressed are my own, not those of any employer or client.]
