Lung Cancer Awareness Month 2024: Looking Back at Progress for Cell and Gene Therapy
In observance of Lung Cancer Awareness Month, held annually in November, we took a look back at the past few months' news in cell and gene therapy for lung cancer indications.
According to the American Lung Association, lung cancer is the leading cause of cancer deaths in both men and women. For men, this has been the case since the 1950s, and for women it has been the case since 1987. In 2021 alone, 134,592 patients died from lung cancer. As such, great unmet need remains for patients with lung cancer. Notably, lung cancer is divided into 2 main types: non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC).
Important areas of interest for new therapeutic development in lung cancer are cell therapy and gene therapy. A number of companies and academic institutions are now pursuing the development of such advanced treatments. In honor of Lung Cancer Awareness Month, observed annually in November by the patient and clinician communities, CGTLive® is taking a look back at the progress that has been made for cell/gene therapy candidates in lung cancer over the past few months. Click the "READ MORE" buttons for more details and information about each item.
Kiromic BioPharma’s NSCLC T-cell Therapy Deltacel Continues to Provide Disease Stabilization in Updated Data
October 10, 2024 — Kiromic BioPharma’s KB-GDT-01 (Deltacel), an investigational allogeneic gamma delta T-cell (GDT) therapy being evaluated in the phase 1/2 Deltacel-01 clinical trial (NCT06069570) for the treatment NSCLC, has continued to show evidence of providing disease stabilization in updated data from the study.
Kiromic reported that the fourth patient to have been treated in the trial showed stable disease at their 6-month follow-up visit and a 5.3% reduction in tumor size with regard to baseline. In addition, the sixth patient to have been treated had stable disease at their 2-month follow-up visit, with no evidence of new lesions observed. Furthermore, Kiromic stated that the median progression-free survival (PFS) for all patients treated thus far has reached 6 months, with a median follow-up time 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,” Afshin Eli Gabayan, MD, a medical oncologist, medical director, and the principal investigator of Deltacel-01 at the Beverly Hills Cancer Center, said in a statement. “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. We are hopeful that continued follow-up will support the promising outcomes we’ve seen to date.”
Achilles Therapeutics Makes Progress in Phase 1/2a Clinical Trials for Neoantigen Reactive T-Cell Therapy in NSCLC and Melanoma
August 20, 2024 — Achilles Therapeutics has dosed the first patients with enhanced host conditioning (EHC) in its phase 1/2 CHIRON study (NCT04032847) in NSCLC and its phase 1/2 THETIS study (NCT03997474) in melanoma, which are both evaluating ATL001, a clonal neoantigen reactive T-cell (cNeT) therapy, for the treatment of the aforementioned cancers, respectively.
The company noted that the first 3 patients with EHC have been dosed in CHIRON and THETIS and that improved cNeT persistence and engraftment was observed in these patients. Achilles additionally stated that it has delivered 10 products containing more than 100 million cNeT and 5 products containing more than 1 billion cNeT. The company also pointed out that it anticipates announcing results from CHIRON and THETIS, including clinical activity and translational science findings with regard to potential EHC benefit, before the end of this year.
Alongside the update regarding these trials, Achilles also announced a new collaboration with Arcturus Therapeutics. The research collaboration will utilize Achille’s artificial intelligence-powered, tumor targeting technology and Arcturus’ self-amplifying mRNA platform in pursuit of evaluating the potential of second-generation mRNA cancer vaccines.
Genprex Makes Progress in 2 of 3 Lung Cancer Trials for Gene Therapy Reqorsa, but Drops the Other
August 15, 2024 — Genprex has reported positive preliminary results from 2 trials, Acclaim-1 (NCT04486833) and Acclaim-3 (NCT05703971), evaluating combination treatments including quaratusugene ozeplasmid (Reqorsa), its investigational immunogene therapy intended to treat various forms of lung cancer. On the other hand, the company has decided to discontinue Acclaim-2 (NCT05062980), its other trial for a Reqorsa combination treatment.
The phase 1/2 Acclaim-1 clinical trial is evaluating Reqorsa in combination with the marketed epidermal growth factor receptor tyrosine kinase inhibitor osimertinib (Tagrisso; AstraZeneca) for the treatment of NSCLC. Genprex reported that 2 patients who are were treated in the phase 1 dose escalation portion of Acclaim-1, and are continuing to receive the combination therapy, have achieved long-term progression-free survival (PFS). One of these patients, who had previously been treated with Tagrisso and chemotherapy, achieved a partial response (PR) after receiving the second course of the trial’s combination therapy, and has maintained PFS for over 2 years since then. The other patient has had stable disease for over 15 months.
Alongside this update, Genprex also noted that it has scaled back the phase 2a expansion portion of Acclaim-1 to a single cohort that will aim to enroll approximately 33 patients who have had prior treatment with Tagrisso alone. A previously planned separate cohort for patients who have had prior treatment with both Tagrisso and chemotherapy has been eliminated from the protocol. The company cited resource prioritization and a desire to focus on patients most likely to benefit from Reqorsa as the motivation for the change. Genprex expects that it will have enrolled 19 patients in the phase 2a expansion portion by the first half of next year, at which point it will carry out an interim analysis.
Viral Immunotherapy Combo Improves Survival in Patients With NSCLC
June 9, 2024 — CAN-2409 in combination 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.
Data from a phase 2 trial (NCT04495153) evaluating the combination were presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, held May 31 to June 4, in Chicago, Illinois, by coprincipal investigator Charu Aggarwal, MD, MPH, FASCO, Leslye M. Heisler Associate Professor for Lung Cancer Excellence at the Perelman School of Medicine, University of Pennsylvania.
“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,” Aggarwal said in a statement. “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. I look forward to the continued development of CAN-2409 in NSCLC as a promising approach in an area of unmet therapeutic need.”
