Lung cancer remains a leading cause of cancer deaths, creating a significant unmet need for new therapeutic options. Recent advancements in cell and gene therapies offer hope, with several companies and institutions making strides in developing innovative treatments for both non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC).
Kiromic BioPharma's Deltacel Shows Disease Stabilization in NSCLC
Kiromic BioPharma's investigational allogeneic gamma delta T-cell (GDT) therapy, KB-GDT-01 (Deltacel), is currently being evaluated in the phase 1/2 Deltacel-01 clinical trial (NCT06069570) for NSCLC. Updated data from the study indicates continued disease stabilization in treated patients. One patient showed stable disease at the 6-month follow-up with a 5.3% reduction in tumor size, while another had stable disease at 2 months with no new lesions. The median progression-free survival (PFS) for all treated patients reached 6 months, with a median follow-up of 7.7 months.
"The follow-up results we are seeing in the Deltacel-01 trial are encouraging, especially for patients with limited treatment options," said Dr. Afshin Eli Gabayan, principal investigator of Deltacel-01 at the Beverly Hills Cancer Center. "The stabilization of disease, combined with early signs of tumor reduction in some cases, speaks to the potential of this therapy to make an impact in the treatment of advanced solid tumors."
Achilles Therapeutics Advances Neoantigen T-Cell Therapy
Achilles Therapeutics has dosed the first patients with enhanced host conditioning (EHC) in its phase 1/2 CHIRON (NCT04032847) study in NSCLC and THETIS (NCT03997474) study in melanoma. Both trials are evaluating ATL001, a clonal neoantigen reactive T-cell (cNeT) therapy. Early results show improved cNeT persistence and engraftment in patients receiving EHC. The company has delivered multiple products containing over 100 million cNeTs and some with over 1 billion cNeTs, with clinical activity and translational science findings expected before the end of the year. Achilles is also collaborating with Arcturus Therapeutics to evaluate second-generation mRNA cancer vaccines using Achilles' AI-powered tumor targeting technology and Arcturus’ self-amplifying mRNA platform.
Genprex's Reqorsa Shows Promise in Lung Cancer Trials
Genprex reported positive preliminary results from the Acclaim-1 (NCT04486833) and Acclaim-3 (NCT05703971) trials, which are evaluating combination treatments including quaratusugene ozeplasmid (Reqorsa), an investigational immunogene therapy. In the Acclaim-1 trial, two patients treated with Reqorsa in combination with osimertinib (Tagrisso) achieved long-term progression-free survival (PFS). One patient, previously treated with Tagrisso and chemotherapy, achieved a partial response (PR) after the second course of combination therapy and maintained PFS for over two years. The other patient had stable disease for over 15 months. Genprex has scaled back the phase 2a expansion portion of Acclaim-1 to focus on patients most likely to benefit from Reqorsa and expects an interim analysis after enrolling 19 patients.
Viral Immunotherapy Combo Improves Survival in NSCLC
Data presented at the 2024 ASCO Annual Meeting from a phase 2 trial (NCT04495153) showed that CAN-2409, combined with valacyclovir and standard of care (SoC) immune checkpoint inhibitor (ICI) therapy, improved survival in patients with Stage III/IV NSCLC whose disease was not adequately responding to anti-PD-L1 ICI therapy.
"Current therapeutic options for advanced NSCLC patients whose disease progresses despite ICI treatment are limited; they are characterized by poor tolerability and limited clinical benefit," said Dr. Charu Aggarwal from the University of Pennsylvania. "The data reported today suggest that CAN-2409 can reactivate these patients’ exhausted immune systems, including those with low PD-(L)1 expression. This systemic anti-tumor immune response translated to a durable response; increased numbers of circulating cytotoxic and memory T cells were associated with subsequent prolonged survival."