Publications by authors named "Lennie Sender"
Multimodal temporal therapy orchestrated to leverage immunotherapy, tumor-targeted chemotherapy, and natural killer (NK) cell therapy may provide an opportunity to induce immunogenic cell death for tumor response and increased survival in patients with recurrent cancer. The interleukin-15 (IL-15) superagonist N-803, an enhancer of NK cells, CD4 + T cells, cytotoxic CD8 + T cells, and memory T-cell activity, combined with off-the-shelf PD-L1-targeted high-affinity NK (PD-L1 t-haNK) cells represent novel immunotherapies designed to overcome an immunosuppressive tumor microenvironment (TME). The epidermal growth factor receptor-targeted antibody-nanocell conjugate E-EDV-D682 provides tumor-targeted chemotherapy in the form of its anthracycline metabolite PNU159682 (nemorubicin) cargo and is currently being studied in combination with immunomodulatory EDVs delivering the adjuvant α-galactosyl ceramide (GC).
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- The summary discusses two studies evaluating the safety and efficacy of N-803 (Anktiva) combined with the standard treatment BCG for patients with non-muscle invasive bladder cancer (NMIBC).
- The Phase 1b study used increasing doses of N-803 in BCG-naive participants, while the Phase 2/3 study included participants with BCG-unresponsive disease and a cohort treated solely with N-803.
- Key findings showed that the combination treatment was effective, eliminating NMIBC in all nine BCG-naive participants and leading to long-lasting results, with a significant percentage of participants avoiding bladder surgery and experiencing minimal adverse effects.
Article Synopsis
- In the phase 2/3 QUILT-3.032 study, the combination of the IL-15RαFc superagonist N-803 and BCG effectively achieved durable complete responses in patients with nonmuscle-invasive bladder cancer that did not respond to BCG alone.
- Patient-reported outcomes were assessed through standardized questionnaires at multiple time points, revealing relatively stable scores in physical function and global health throughout the study period.
- The findings suggest that the treatment not only shows efficacy but also indicates a favorable risk-benefit ratio and maintained quality of life for the patients involved.
Article Synopsis
- * In the study, 71% of patients receiving NAI plus BCG achieved complete responses (CRs), with a median duration of over 26 months, suggesting that this combination is effective in prolonging patient remission and avoiding surgical procedures like cystectomy.
- * The results show a 55.4% disease-free survival rate at 12 months for a different subgroup treated with NAI plus BCG, while the majority of side effects were mild,
We have developed a dual-antigen COVID-19 vaccine incorporating genes for a modified SARS-CoV-2 spike protein (S-Fusion) and the viral nucleocapsid (N) protein with an Enhanced T-cell Stimulation Domain (N-ETSD) to increase the potential for MHC class II responses. The vaccine antigens are delivered by a human adenovirus serotype 5 platform, hAd5 [E1-, E2b-, E3-], previously demonstrated to be effective in the presence of Ad immunity. Vaccination of rhesus macaques with the hAd5 S-Fusion + N-ETSD vaccine by subcutaneous prime injection followed by two oral boosts elicited neutralizing anti-S IgG and T helper cell 1-biased T-cell responses to both S and N that protected the upper and lower respiratory tracts from high titer (1 x 10 TCID) SARS-CoV-2 challenge.
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