NEW YORK – The US Food and Drug Administration has granted fast track designation to Precigen for its CAR T-cell therapy for relapsed or refractory acute myeloid leukemia, PRGN-3006. The product is made using Precigen's overnight non-viral gene delivery manufacturing, overcoming current limitations on availability of CAR T therapies due to the time required for ex vivo expansion. Precigen is advancing another CAR T-cell therapy, PRGN-3007, in a Phase I/Ib trial in ROR1-positive blood cancers.
OncoHost said this week that the Roswell Park Comprehensive Cancer Center has joined its study evaluating the ability of its Prophet platform to predict immunotherapy response in patients with malignant melanoma, small cell lung cancer, and non-small cell lung cancer. The study, dubbed Prophetic, now has more than 35 trial sites globally. In data presented last year, researchers used the Prophet platform to identify a signature of eight proteins and two clinical parameters that could differentiate NSCLC patients who are likely to respond to immune checkpoint inhibitors from those who are not. OncoHost expects to launch the Prophet platform in the US later this year.
Artios Pharma said this week that it has begun the Phase Ib dose expansion portion of its ongoing clinical trial evaluating its ATR inhibitor, ART0380, for patients with ATM-deficient tumors, as determined by immunohistochemistry. The two-part trial, which commenced in February, is designed to evaluate ART0380 in 180 patients with advanced cancers including ovarian, peritoneal, and fallopian tube cancer. Artios also said this week that it will present biomarker and pharmacokinetic data behind the clinical dose selection at the upcoming American Association for Cancer Research annual meeting.
Korea's Ministry of Food and Drug Safety this week approved Qiagen's Therascreen KRAS RGQ PCR Kit as a companion diagnostic test to identify patients with KRAS G12C-mutated non-small cell lung cancer eligible for Amgen's KRAS inhibitor Lumakras (sotorasib). The US Food and Drug Administration previously approved the Therascreen kit as one of two companion diagnostics for Lumakras patient selection last May.
Ultivue and Paige said this week that they will codevelop and comarket AI-powered spatial immunophenotyping for pharmaceutical and research customers. The collaboration will focus on developing AI to enable improved understanding of the tumor microenvironment and support the interpretation of Ultivue's multiplex immunofluorescence immuno-oncology biomarker panels. Ultivue's InSituPlex technology provides up to 12-plex analysis of biologically relevant targets with same-slide hematoxylin and eosin analysis for precious tissue samples. The Paige Platform is a comprehensive imaging solution for pathology scans.
Oncimmune Holdings this week signed two commercial contracts with pharmaceutical companies, both of which involve using the firm's ImmunoInsights platform to inform cancer patients' responses to immunotherapy. For the first contract, Oncimmune partnered with a US-based pharmaceutical company developing off-the-shelf natural killer (NK) and CAR-NK cell therapies to treat cancer. Oncimmune will use its high-throughput biomarker discovery platform, SeroTag, to home in on autoantibodies to predict solid and hematological cancer patients' response and resistance to engineered cell therapies.
Oncimmune has also inked a second deal with a pharma company developing immunotherapies. In that partnership, Oncimmune will longitudinally profile patients' autoantibodies after treatment with a virus-like particle that stimulates anti-tumor T cells with the aim of showing how the therapy affects patients' immune systems.
In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared in Precision Oncology News.