NEW YORK – Alphageneron Pharmaceuticals said this week that it has completed a pre-investigational new drug meeting with the US Food and Drug Administration regarding a clinical trial of the firm's autologous NK cell therapy Enkastim for advanced non-small cell lung cancer. Alphageneron is now in the process of finalizing the design of the Phase II trial, which it will initiate in 2022. The firm has previously evaluated Enkastim in two small clinical trials in Germany, in which the autologous cell therapy demonstrated encouraging response rates and safety signals in colorectal and NSCLC patients.
Bioinformatics firm Deep Lens and health system Ocala Oncology/Florida Cancer Affiliates this week said they would expand their clinical research program using Viper, Deep Lens' artificial intelligence-based clinical trial matching solution. Ocala Oncology/Florida Cancer Affiliates hopes to identify more cancer patients eligible for clinical trials using Deep Lens' automated technology. Viper will integrate with the health system's electronic medical records and also incorporate patients' pathology and molecular testing data from Caris Life Sciences, Foundation Medicine, and Guardant Health.
TCR2 Therapeutics this week said it is shifting away from developing its autologous cell therapy TC-110 for patients with CD19-positive non-Hodgkin lymphoma and adult acute lymphoblastic leukemia. The choice to deprioritize this therapy will allow TCR2 to focus on treating solid tumors. The firm also said that by the end of the year it anticipates selecting a recommended Phase II dose for its autologous cell therapy gavocabtagene autoleucel, which it is developing for patients with mesothelin-expressing solid tumors. Finally, during the first quarter of 2022, the company will file an investigational new drug application for TC-510, a treatment involving T cells bound to T-cell receptor fusion constructs, or TRuC-T cells, and enhanced with a PD1xCD28 switch receptor.
Viome Life Sciences this week said it has expanded an existing R&D partnership with GlaxoSmithKline to develop new therapeutic interventions for chronic diseases, including autoimmune diseases and cancers. The new deal builds on a previously announced collaboration investigating the prevention of specific chronic diseases using Viome's microbiome analysis and artificial intelligence platform. Under the terms of the renewed agreement, the partners intend to conduct a clinical validation trial. Financial terms were not disclosed.
Biological Dynamics said this week that the US Food and Drug Administration has granted breakthrough device designation for its liquid biopsy Exo-PDAC assay. The test is designed to detect pancreatic ductal adenocarcinoma early by identifying exosomal biomarkers. Exo-PDAC is the first assay to use Biological Dynamics' Verita platform, an alternating current electrokinetic-based technology, which the firm is exploring for cancer, Alzheimer's disease, and infectious disease detection. The test uses a small blood sample from patients and requires minimal sample preparation or processing.
Virginia Commonwealth University Massey Cancer Center and Virginia State University this week said they've received a $1.7 million team science grant from the National Cancer Institute that they will use to support projects focused on reducing cancer disparities. In one study backed by the grant, researchers are searching for genetic explanations for why Black Americans are more susceptible to liver and gastrointestinal cancers than white Americans. The funding, for the first time, brings together a Virginia-based cancer center and a historically Black college or university, and will also support hands-on research opportunities for underrepresented science students.
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.