- |||||||||| Anktiva (inbakicept) / ImmunityBio
CD8 depletion and N-803 plus anti-SIV Env RhmAbs in ART-suppressed rhesus macaques () - Jun 19, 2022 - Abstract #AIDS2022AIDS_3248; During latency reversal with CD8a depletion + N-803 in combination with RhmAbs, we demonstrate a similar but diminished magnitude of on-ART viremia compared to prior work by McBrien et al ( Nature 2020). This effect may result from RhmAb neutralization of virions released from infected cells and, combined with the additional antibody effector functions identified, supports a role for therapeutic RhmAbs as potential clearance agents in cure approaches.
- |||||||||| Anktiva (nogapendekin alfa inbakicept-pmln) / ImmunityBio
Trial completion date, Combination therapy: Phase I Trial of Universal Donor NK Cell Therapy in Combination With ALT803 (clinicaltrials.gov) - Jun 15, 2022 P1, N=14, Active, not recruiting, This effect may result from RhmAb neutralization of virions released from infected cells and, combined with the additional antibody effector functions identified, supports a role for therapeutic RhmAbs as potential clearance agents in cure approaches. Trial completion date: May 2022 --> Nov 2022
- |||||||||| Journal, PD(L)-1 Biomarker: Emerging treatment landscape of non-muscle invasive bladder cancer. (Pubmed Central) - Jun 11, 2022
The increasing number of newer therapeutic agents for patients with NMIBC poses challenges regarding the choice of the most suited treatment option for each patient and the best treatment sequence, given their diverse mechanisms of action and varying degrees of activity. Tailored treatment approaches are advocated, based on a deeper comprehension of disease features, available therapies, patient's characteristics, and consequently, on the identification and validation of prognostic and predictive biomarkers.
- |||||||||| Anktiva (inbakicept) / ImmunityBio
vesAnktiva (Twitter) - May 30, 2022
- |||||||||| Trial primary completion date, Metastases: Phase II Trial of Combination Immunotherapy in Subjects With Advanced Small Bowel and Colorectal Cancers (clinicaltrials.gov) - May 25, 2022
P2, N=80, Recruiting, Tailored treatment approaches are advocated, based on a deeper comprehension of disease features, available therapies, patient's characteristics, and consequently, on the identification and validation of prognostic and predictive biomarkers. Trial primary completion date: Jul 2023 --> Jul 2024
- |||||||||| AZD5582 / AstraZeneca, Anktiva (inbakicept) / ImmunityBio
AZD5582 and SIV Env-targeting rhesus monoclonal antibodies (RhmAbs) ± N-803 in SIV-infected ART-suppressed rhesus macaques (Room 510/Channel 8) - May 12, 2022 - Abstract #AIDS2022AIDS_456; Our findings give insight into HIV cure interventions in a relevant preclinical model, confirm the efficacy of AZD5582 in inducing SIV reactivation, and provide new in vivo data showing latency reversal in all RMs treated with the combination of AZD5582+N-803. This study also suggests that elimination of infected cells in tissues using an IAP inhibitor and anti-SIV Env RhmAb cocktail is possible.
- |||||||||| Anktiva (inbakicept) / ImmunityBio
Pharmacological enhancement of IL-15 signaling to improve 'shock-and-kill' strategies against latent HIV (Room 511/Channel 7) - May 12, 2022 - Abstract #AIDS2022AIDS_12; Among the clinically relevant latency reversing agents (LRA) under investigation, IL-15 or the IL-15 superagonist N-803 have been shown to reactivate latent HIV ex vivo and in vivo... In conclusion, retinol derivatives have the potential to enhance IL-15 LRA activity and can be ideal candidates for the development of STESK strategies against latent HIV.
- |||||||||| lirilumab (BMS-986015) / Innate, BMS, Ono Pharma, monalizumab (IPH2201) / AstraZeneca, Innate, Anktiva (inbakicept) / ImmunityBio
Journal: NK cell-based therapies for HIV infection: Investigating current advances and future possibilities. (Pubmed Central) - May 12, 2022 Some of the treatments currently under consideration are CAR-NK cell therapy, facilitating ADCC, TLR agonists, bNAbs, and BiKEs/TriKEs, blocking inhibitory NK receptors during infection, IL-15 and IL-15 superagonists (eg: ALT-803), and so on. This review aims to discuss the NK cell-based therapies currently under experimentation against HIV infection and finally highlight the challenges associated with NK cell-based immunotherapies.
- |||||||||| Anktiva (inbakicept) / ImmunityBio
P1 data, Clinical Trial,Phase I, Journal: Safety and virologic impact of the IL-15 superagonist N-803 in people living with HIV: a phase 1 trial. (Pubmed Central) - Apr 27, 2022 P1 HIV transcription in memory CD4 T cells and intact proviral DNA initially increased after N-803 treatment; however, there was a small but significant decrease in the frequency of peripheral blood mononuclear cells with an inducible HIV provirus that persisted for up to 6 months after therapy. These data suggest that N-803 administration in ART-suppressed people living with HIV is safe and that larger clinical trials are needed to further investigate the effects of N-803 on HIV reservoirs.
- |||||||||| teropavimab (GS-5423) / Rockefeller University, Gilead, zinlirvimab (GS-2872) / National Institute of Allergy and Infectious Diseases, Rockefeller University, Gilead
Trial initiation date: 3BNC117-LS and 10-1074-LS Plus N-803 (bNAb+N-803) (clinicaltrials.gov) - Apr 20, 2022 P1, N=36, Not yet recruiting, Overall, same-donor ML NK cell therapy with 3 weeks of N-803 support safely augmented RIC haplo-HCT for AML. Initiation date: Mar 2022 --> Jun 2022
- |||||||||| CIML NK - Dana / Farber Cancer Institute
Trial completion date, Trial primary completion date, Combination therapy, Metastases, Immune cell: CIML NK Cell in Head & Neck Cancer (clinicaltrials.gov) - Apr 18, 2022 P1, N=12, Recruiting, Initiation date: Mar 2022 --> Jun 2022 Trial completion date: May 2022 --> Jun 2023 | Trial primary completion date: Apr 2022 --> Dec 2022
- |||||||||| CIML NK cells / Washington University School of Medicine in St. Louis
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date: Cytokine-induced Memory-like NK Cells in Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) (clinicaltrials.gov) - Apr 15, 2022 P1/2, N=91, Active, not recruiting, Trial completion date: May 2022 --> Jun 2023 | Trial primary completion date: Apr 2022 --> Dec 2022 Recruiting --> Active, not recruiting | N=140 --> 91 | Trial completion date: Sep 2029 --> Dec 2024 | Trial primary completion date: Sep 2024 --> Dec 2021
- |||||||||| Opdivo (nivolumab) / BMS, Anktiva (nogapendekin alfa inbakicept-pmln) / ImmunityBio
Trial completion date, Trial primary completion date: ALT-803 Plus Nivolumab in Patients With Pretreated, Advanced or Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov) - Apr 8, 2022 P1/2, N=58, Active, not recruiting, Recruiting --> Active, not recruiting | N=140 --> 91 | Trial completion date: Sep 2029 --> Dec 2024 | Trial primary completion date: Sep 2024 --> Dec 2021 Trial completion date: May 2022 --> Dec 2022 | Trial primary completion date: Mar 2022 --> Jun 2022
- |||||||||| Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche, Anktiva (inbakicept) / ImmunityBio
Clinical, P1 data, Journal, IO biomarker: Phase 1 trial of N-803, an IL-15 receptor agonist, with rituximab in patients with indolent non-Hodgkin lymphoma. (Pubmed Central) - Apr 8, 2022 P1/2 Trial completion date: May 2022 --> Dec 2022 | Trial primary completion date: Mar 2022 --> Jun 2022 N-803 combines with mAbs to enhance tumor-targeting in patients, and warrants further investigation in combination with immunotherapies.
- |||||||||| mitomycin / Generic mfg.
Journal: Adjuvant instillation therapy for non-muscle invasive bladder cancer - beyond BCG und mitomycin C (Pubmed Central) - Apr 5, 2022 GemRIS is an implantable novel form of intravesical drug delivery of gemcitabine and is currently being investigated with cetrelimab, a checkpoint inhibitor, in patients with high-risk NMIBC and MIBC...Nadofaragene firadenovec (rAd-IFN-α/Syn3) is a recombinant adenovirus that induces release of interferon-alpha in the urothelium...N-803 is an interleukin (IL)-15 analogue, which has been investigated in a phase 1b study in combination with BCG and has shown durable complete response in all nine patients for 72 months. It was granted breakthrough designation status by the FDA in 2019.
- |||||||||| Trial completion date, Trial primary completion date, Metastases: QUILT-3.071: QUILT 3.071: NANT Colorectal Cancer (CRC) Vaccine (clinicaltrials.gov) - Mar 29, 2022
P1b/2, N=332, Active, not recruiting, Trial completion date: Jan 2020 --> Jan 2023 | Trial primary completion date: Dec 2019 --> Dec 2022 Trial completion date: Dec 2021 --> Dec 2022 | Trial primary completion date: Dec 2021 --> Dec 2022
- |||||||||| Anktiva (inbakicept) / ImmunityBio
Clinical, Journal: Systemic IL-15 promotes allogeneic cell rejection in patients treated with natural killer cell adoptive therapy. (Pubmed Central) - Mar 16, 2022 P1/2, P2 Correlative studies from 2 independent clinical trial cohorts treated with major histocompatibility complex-haploidentical NK cell therapy for relapsed/refractory acute myeloid leukemia revealed that cytokine support by systemic interleukin-15 (IL-15; N-803) resulted in reduced clinical activity, compared with IL-2...Thus, systemic IL-15 used to support allogeneic cell therapy may paradoxically limit their therapeutic window of opportunity and clinical activity. This study indicates that stimulating patient CD8 T cell allo-rejection responses may critically limit allogeneic cellular therapy supported with IL-15.
- |||||||||| Anktiva (nogapendekin alfa inbakicept-pmln) / ImmunityBio
Enrollment closed, Phase classification, Enrollment change, Trial primary completion date, Metastases: IP ALT-803 Followed by SQ ALT-803 for Ovarian Cancer (clinicaltrials.gov) - Mar 14, 2022 P2, N=7, Active, not recruiting, Thus, N-803 can be modified as a functional scaffold for the creation of cytokine immunotherapies with multiple receptor specificities to activate NK cells for adoptive cellular therapy. Suspended --> Active, not recruiting | Phase classification: P1 --> P2 | N=28 --> 7 | Trial primary completion date: Mar 2022 --> Sep 2021
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