CEL-SCI’s LEAPS Vaccine Offers Promising New Paradigm to Treat Rheumatoid Arthritis: Published in Frontiers in Immunology
CEL-4000 may deliver safe and effective therapy for RA by rebalancing the inflammatory response, without weakening important immune defense mechanisms, risking infections or cancer, as current treatments may
In the article, the authors note that the currently available therapeutic arsenal for the treatment of RA consists mainly of immunosuppressive or ablative drugs, which may carry the potential risk of facilitating recurrent or primary infectious diseases or cancer.
They also underscore that a therapeutic vaccine that can rebalance the inflammatory disease process, promoting antigen-specific disease-directed T cell immune responses, is highly desirable. CEL-4000, an antigen specific immunomodulating vaccine, is provided as a new treatment paradigm that should deliver therapy for RA without weakening important immune defense mechanisms against microbial infections or cancer.
The authors also emphasized that the most appropriate way to advance the LEAPS vaccines to the clinic would be an adaptive study design for clinical trials, enrollment of patients with early-stage RA, and using the Bayesian optimal design model, currently used in oncology studies, as well as the use of disease-related biomarkers to ascertain responsiveness to treatment and introduce additional tools to assess outcome at the disease level.
“At CEL-SCI, we focus on utilizing a healthy immune system to overcome disease safely and with minimal side effects. Our LEAPS platform, and CEL-4000 specifically approaches the treatment of auto immune diseases like rheumatoid arthritis in a completely different way. By rebalancing the immune system to its original healthy state, CEL-4000 could protect patients from the risk of cancer and infection,” stated
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After analyzing data from the Phase 3 study, we have better defined the target head and neck cancer population for Multikine, which is advanced primary head and neck cancer patients with no lymph node involvement and with low PD-L1 tumor expression. In the Phase 3 study, we observed statistically significant survival data in the final target population, showing that Multikine cut the risk of death in half at five years vs control. We plan to submit the proposed study protocol to the FDA in Q1 2024, with the goal to get FDA buy-in for a confirmatory clinical trial, and also to discuss potential accelerated approval pathways.
Multikine (Leukocyte Interleukin, Injection) received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck.
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* Multikine (Leukocyte Interleukin, Injection) is the trademark that
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