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26 Diseases |  |
30 Trials |
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30 Trials |  |
518 News |  |
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- || PD-L1.t-haNK / ImmunityBio, Anktiva (nogapendekin alfa inbakicept-pmln) / ImmunityBio
Trial completion date, Trial primary completion date, Checkpoint inhibition: QUILT-3.055: a Study of Combination Immunotherapies in Patients Who Have Previously Received Treatment with Immune Checkpoint Inhibitors (clinicaltrials.gov) - Aug 25, 2021
P2b, N=145, Active, not recruiting, Sponsor: ImmunityBio, Inc.
Trial completion date: Aug 2021 --> Dec 2023 | Trial primary completion date: Jun 2021 --> May 2023
- | 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) - Aug 18, 2021
P1, N=12, Recruiting, Sponsor: Dana-Farber Cancer Institute
Trial completion date: Aug 2021 --> Dec 2023 | Trial primary completion date: Jun 2021 --> May 2023 Trial completion date: Sep 2022 --> May 2022 | Trial primary completion date: Sep 2021 --> Apr 2022
- || Cyramza (ramucirumab) / Eli Lilly, Anktiva (inbakicept) / ImmunityBio, Tecentriq (atezolizumab) / Roche
New P2 trial, Checkpoint inhibition, Checkpoint block: RAN: Ramucirumab, Atezolizumab and N-803 After Progression on Any Immune Checkpoint Blocker in NSCLC (clinicaltrials.gov) - Aug 16, 2021
P2, N=21, Not yet recruiting, Sponsor: Washington University School of Medicine
- Anktiva (inbakicept) / ImmunityBio
[VIRTUAL] Phase 2/3 clinical results of IL-15RαFc superagonist N-803 with BCG in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in-situ (CIS) patients. () - Aug 5, 2021 - Abstract #AUA2021AUA_1366;
P2/3
With a CR rate of 72%, N-803 has met its primary endpoint with 59% probability of CR patients maintaining CR for at least 12 months. With the observed strong efficacy and an SAE rate of 1%, N-803 represents a novel treatment option for BCG unresponsive CIS with a favorable benefit:risk ratio, in a therapeutically challenging disease.
- || Anktiva (inbakicept) / ImmunityBio
Clinical, Clinical data, Clinical Trial,Phase I, Journal: Safety, Tolerability, and Long-Term Clinical Outcomes of an IL-15 analogue (N-803) Admixed with Bacillus Calmette-Guérin (BCG) for the Treatment of Bladder Cancer. (Pubmed Central) - Aug 4, 2021
Furthermore, 6 y after treatment, all 9 participants (100%) were disease free with no evidence of disease progression and an intact bladder. This phase 1b trial found the combination of intravesical N-803 and BCG to be associated with modest toxic effects, low immunogenicity, and substantial prolonged antitumoral activity; phase 2 trials are in progress.
- | Anktiva (inbakicept) / ImmunityBio
Journal: The COVID-19 pandemic and maternal mental health in a fragile and conflict-affected setting in Tumaco, Colombia: a cohort study. (Pubmed Central) - Aug 1, 2021
Considering the vulnerability and pre-existing mental health conditions of this population, the estimated effects are substantial. Policies in fragile and conflict-affected settings targeting IDP and other vulnerable people will be important to mitigate further mental health and socioeconomic problems.
- | Anktiva (nogapendekin alfa inbakicept-pmln) / ImmunityBio
Enrollment closed, Enrollment change, Trial primary completion date, Combination therapy: Phase I Trial of Universal Donor NK Cell Therapy in Combination With ALT803 (clinicaltrials.gov) - Jul 27, 2021
P1, N=14, Active, not recruiting, Sponsor: David Wald
Policies in fragile and conflict-affected settings targeting IDP and other vulnerable people will be important to mitigate further mental health and socioeconomic problems. Recruiting --> Active, not recruiting | N=54 --> 14 | Trial primary completion date: Dec 2021 --> Jun 2021
- || m-ceNK cells / ImmunityBio
Enrollment open, Metastases: QUILT-3.076: Study of Autologous M-CENK in Subjects With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - Jul 26, 2021
P1, N=30, Recruiting, Sponsor: ImmunityBio, Inc.
Recruiting --> Active, not recruiting | N=54 --> 14 | Trial primary completion date: Dec 2021 --> Jun 2021 Not yet recruiting --> Recruiting
- |||||| Anktiva (inbakicept) / ImmunityBio
Clinical: Multiple studies highlighting importance of Fc mediated treg depletion in the TME. We are now enrolling patients on a trial combining memory like NK cells with Ipi plus IL15 superagonist N803 led by @HeadNeckMD @DanaFarber #https://clinicaltrials.gov/ct2/show/NCT04290546 (Twitter) - Jul 14, 2021
P1
- || Anktiva (inbakicept) / ImmunityBio
Clinical, Journal: Global Dietary Database 2017: data availability and gaps on 54 major foods, beverages and nutrients among 5.6 million children and adults from 1220 surveys worldwide. (Pubmed Central) - Jun 26, 2021
Not yet recruiting --> Recruiting This systematic search, retrieval and standardised effort provides the most comprehensive empirical evidence on dietary intakes across and within countries worldwide.
- || 10-1074 / National Institute of Allergy and Infectious Diseases, Rockefeller University, Gilead, VRC07-523LS / National Institute of Allergy and Infectious Diseases, IAVI, TaiMed Biologics
Enrollment open: Safety, Tolerability, and Efficacy of IL-15 Superagonist (N-803) With and Without Combination Broadly Neutralizing Antibodies to Induce HIV-1 Control During Analytic Treatment Interruption (clinicaltrials.gov) - Jun 15, 2021
P1, N=46, Recruiting, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
This systematic search, retrieval and standardised effort provides the most comprehensive empirical evidence on dietary intakes across and within countries worldwide. Not yet recruiting --> Recruiting
- | bintrafusp alfa (M7824) / EMD Serono, Anktiva (nogapendekin alfa inbakicept-pmln) / ImmunityBio
Enrollment change, Trial suspension, Combination therapy: Anti-PD-L1/TGF-beta Trap (M7824) Alone and in Combination With TriAd Vaccine and N-803 for Resectable Head and Neck Squamous Cell Carcinoma Not Associated With Human Papillomavirus Infection (clinicaltrials.gov) - Jun 9, 2021
P1/2, N=8, Suspended, Sponsor: National Cancer Institute (NCI)
Not yet recruiting --> Recruiting N=40 --> 8 | Recruiting --> Suspended
- || PD-L1.t-haNK / ImmunityBio, Anktiva (inbakicept) / ImmunityBio
Clinical, Journal, Myeloid-derived suppressor cells, PD(L)-1 Biomarker, IO biomarker: PD-L1 targeting high-affinity NK (t-haNK) cells induce direct antitumor effects and target suppressive MDSC populations. (Pubmed Central) - Jun 8, 2021
N=40 --> 8 | Recruiting --> Suspended These studies demonstrate the antitumor efficacy of PD-L1 t-haNK cells and provide a rationale for the potential use of these cells in clinical studies.
- ||| PD-L1.t-haNK / ImmunityBio, Anktiva (nogapendekin alfa inbakicept-pmln) / ImmunityBio
Enrollment closed, Enrollment change, Checkpoint inhibition: QUILT-3.055: a Study of Combination Immunotherapies in Patients Who Have Previously Received Treatment with Immune Checkpoint Inhibitors (clinicaltrials.gov) - Jun 2, 2021
P2b, N=145, Active, not recruiting, Sponsor: ImmunityBio, Inc.
These studies demonstrate the antitumor efficacy of PD-L1 t-haNK cells and provide a rationale for the potential use of these cells in clinical studies. Recruiting --> Active, not recruiting | N=636 --> 145
- || Anktiva (nogapendekin alfa inbakicept-pmln) / ImmunityBio
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date, Immunomodulating: Study of the Safety of Therapeutic Treatment With an Immunomodulatory Agent (N-803) in Adults With COVID-19 (clinicaltrials.gov) - May 28, 2021
P1b, N=1, Active, not recruiting, Sponsor: ImmunityBio, Inc.
Recruiting --> Active, not recruiting | N=636 --> 145 Not yet recruiting --> Active, not recruiting | N=30 --> 1 | Trial completion date: Jul 2020 --> Jul 2022 | Trial primary completion date: Jul 2020 --> Jul 2022
- | Anktiva (inbakicept) / ImmunityBio
Journal, PD(L)-1 Biomarker, IO biomarker: Functional and mechanistic advantage of the use of a bifunctional anti-PD-L1/IL-15 superagonist. (Pubmed Central) - May 27, 2021
Overall, these novel effects of N-809 promote an inflamed TME, leading to lower tumor burden and increased survival. These results provide mechanistic insight and rationale supporting the potential clinical study of N-809 in patients with carcinoma.
- || cisplatin / Generic mfg., docetaxel / Generic mfg.
Clinical, Journal: The current landscape of salvage therapies for patients with bacillus Calmette-Guérin unresponsive nonmuscle invasive bladder cancer. (Pubmed Central) - May 26, 2021
Several novel salvage therapies offer promise for patients with BCG-unresponsive NMIBC. Patient selection, efficacy, safety, cost and ease of administration must be carefully considered to determine the optimal treatment approach.
- | Anktiva (nogapendekin alfa inbakicept-pmln) / ImmunityBio
Trial completion date, Trial primary completion date, Combination therapy: Phase I Trial of Universal Donor NK Cell Therapy in Combination With ALT803 (clinicaltrials.gov) - May 24, 2021
P1, N=54, Recruiting, Sponsor: David Wald
Patient selection, efficacy, safety, cost and ease of administration must be carefully considered to determine the optimal treatment approach. Trial completion date: Aug 2021 --> May 2022 | Trial primary completion date: Feb 2021 --> Dec 2021
- || m-ceNK cells / ImmunityBio
New P1 trial, Metastases: QUILT-3.076: Study of Autologous M-CENK in Subjects With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - May 24, 2021
P1, N=30, Not yet recruiting, Sponsor: ImmunityBio, Inc.
- | Anktiva (inbakicept) / ImmunityBio
Journal: Investigating the clearance of VWF A-domains using site-directed PEGylation and novel N-linked glycosylation. (Pubmed Central) - May 15, 2021
These novel data demonstrate that site specific PEGylation but not site specific N-glycosylation modifies LRP1-dependent uptake of the A1A2A3-VWF by macrophages. This suggests that PEGylation, within the A1- and A3-domains in particular, may be used to attenuate LRP1-mediated clearance of VWF.
- || Anktiva (inbakicept) / ImmunityBio
Clinical, Journal: Interleukin-15 superagonist (N-803) treatment of PML and JCV in a post-allogeneic hematopoietic stem cell transplant patient. (Pubmed Central) - May 11, 2021
This suggests that PEGylation, within the A1- and A3-domains in particular, may be used to attenuate LRP1-mediated clearance of VWF. No abstract available
- | Anktiva (inbakicept) / NantWorks
Journal, IO biomarker: IL-15 superagonist N-803 improves IFNγ production and killing of leukemia and ovarian cancer cells by CD34 progenitor-derived NK cells. (Pubmed Central) - May 5, 2021
In conclusion, N-803 is a promising IL-15-based compound that boosts HPC-NK cell expansion and functionality in vitro and in vivo. Adding N-803 to HPC-NK cell therapy could improve cancer immunotherapy.
- Anktiva (inbakicept) / ImmunityBio
[VIRTUAL] Preliminary data from QUILT 3.055: A phase 2 multi-cohort study of N803 (IL-15 superagonist) in combination with checkpoint inhibitors (CPI). () - Apr 28, 2021 - Abstract #ASCO2021ASCO_2653;
P2b
QUILT 3.055, (NCT03228667) a phase 2b study of N803 plus investigator choice CPI in 11 tumor types: NSCLC, SCLC, Urothelial carcinoma, HNSCC, Merkel cell carcinoma, Melanoma (single PD-1/PD-L1 CPI or w/ ipilimumab), Renal cell carcinoma (RCC), Gastric cancer, Cervical cancer, Hepatocellular carcinoma, Microsatellite instability-high (MSI-H)/ mismatch repair deficient (dMMR) solid tumors, with a heterogeneous mix of prior therapies . N803 demonstrates low toxicity in patients previously treated with CPI and promising efficacy of cessation of progression and induction of response and durable stable disease in patients who had previously progressed on a CPI containing regimen in multiple tumor types and different CPIs.
- aldoxorubicin (INNO-206) / ImmunityBio, Abraxane (albumin-bound paclitaxel) / BMS, Otsuka, Anktiva (inbakicept) / ImmunityBio
[VIRTUAL] Trial in progress: Open-label, randomized, comparative phase 2/3 study of combination immunotherapy plus standard-of-care chemotherapy and SBRT versus standard-of-care chemotherapy for the treatment of locally advanced or metastatic pancreatic cancer. () - Apr 28, 2021 - Abstract #ASCO2021ASCO_1586;
P2
The ongoing QUILT 88 phase II/III, multi-center, three-cohort, open-label, US study (NCT04390399) to evaluate the comparative efficacy and overall safety of standard-of-care chemotherapy versus standard-of-care chemotherapy in combination with aldoxorubicin HCl, N-803, and PD-L1 t-haNK in subjects with locally advanced or metastatic pancreatic cancer...Subjects with locally advanced or metastatic pancreatic cancer who have received at least 16 weeks of treatment with gemcitabine plus nab-paclitaxel, and have had either a partial response (PR), CR, or stable disease (SD), will be enrolled into Cohort A to receive first-line maintenance therapy...Primary endpoints by cohort are: A) PFS per RECIST V1., B & C) OS . The secondary endpoints include overall response rate, DoR, DCR, OS(cohort A) and QoL by patient-reported outcomes.
- | Anktiva (inbakicept) / ImmunityBio
Trial completion, Trial completion date, Trial primary completion date: Adoptive Transfer of Haploidentical NK Cells and N-803 (clinicaltrials.gov) - Apr 23, 2021
P1, N=9, Completed, Sponsor: University of Minnesota
The secondary endpoints include overall response rate, DoR, DCR, OS(cohort A) and QoL by patient-reported outcomes. Recruiting --> Completed | Trial completion date: Nov 2020 --> Apr 2021 | Trial primary completion date: Nov 2020 --> Apr 2021
- | Anktiva (inbakicept) / ImmunityBio
Enrollment open: Effect of N-803 on B Cell Follicles in Antiretroviral Treated HIV Disease (clinicaltrials.gov) - Apr 23, 2021
P1, N=10, Recruiting, Sponsor: University of Minnesota
Recruiting --> Completed | Trial completion date: Nov 2020 --> Apr 2021 | Trial primary completion date: Nov 2020 --> Apr 2021 Not yet recruiting --> Recruiting
- | Keytruda (pembrolizumab) / Merck (MSD), Anktiva (nogapendekin alfa inbakicept-pmln) / ImmunityBio
New P2 trial, Metastases: Immunotherapy Combination: Irradiated PD-L1 CAR-NK Cells Plus Pembrolizumab Plus N-803 for Subjects With Recurrent/Metastatic Gastric or Head and Neck Cancer (clinicaltrials.gov) - Apr 18, 2021
P2, N=55, Not yet recruiting, Sponsor: National Cancer Institute (NCI)
- | Anktiva (inbakicept) / ImmunityBio
New P1 trial: Effect of N-803 on B Cell Follicles in Antiretroviral Treated HIV Disease (clinicaltrials.gov) - Mar 21, 2021
P1, N=10, Not yet recruiting, Sponsor: University of Minnesota
- | Anktiva (inbakicept) / ImmunityBio
Enrollment open, Trial initiation date, Trial primary completion date: Reducing HIV Persistence in Lymph Nodes by Interleukin-15 (IL-15) Receptor Super-agonist (N-803) in Acute HIV Infection (clinicaltrials.gov) - Mar 18, 2021
P2, N=15, Recruiting, Sponsor: Thai Red Cross AIDS Research Centre
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting | Initiation date: Dec 2020 --> Mar 2021 | Trial primary completion date: May 2021 --> May 2022
- || NIZ985 / Novartis, Anktiva (inbakicept) / NantWorks
Review, Journal: Heterodimeric IL-15 in Cancer Immunotherapy. (Pubmed Central) - Mar 7, 2021
In clinical trials, IL-15-based therapies are overall well-tolerated and result in the expansion and activation of NK and memory CD8 T cells. Combinations with other immunotherapies are being investigated to improve the anti-tumor efficacy of IL-15 agents in the clinic.
- ||||||| Anktiva (inbakicept) / NantWorks
Clinical: Phase II/III clinical results of IL-15RαFc superagonist N-803 with BCG in BCG-unresponsive #NMIBC carcinoma in situ patients. Presentation by Karim Chamie, MD @UCLA. #GU21 written coverage by @WallisCJD @VUMCurology on UroToday > https://t.co/mkad9sP3ow @UroCancerMD @gonzomdphd (Twitter) - Feb 23, 2021
- | CIML NK cells / Washington University School of Medicine in St. Louis
Trial completion date, Trial primary completion date: Cytokine Induced Memory-like NK Cell Adoptive Therapy After Haploidentical Donor Hematopoietic Cell Transplantation (clinicaltrials.gov) - Feb 23, 2021
P2, N=60, Recruiting, Sponsor: Washington University School of Medicine
Combinations with other immunotherapies are being investigated to improve the anti-tumor efficacy of IL-15 agents in the clinic. Trial completion date: Jan 2023 --> Jan 2024 | Trial primary completion date: Jan 2023 --> Jan 2024
- ||| Anktiva (inbakicept) / NantWorks
N-803 is administered together with BCG according to usual #SWOG schedule for BCG. The rationale for combination was not provided – presumably this immune activation even in the BCG-unresponsive setting is necessary for drug activity. 4/n (Twitter) - Feb 15, 2021
- |||| Anktiva (inbakicept) / NantWorks
N-803 (aka ALT-803) is a fusion protein: IL15 with N72D mutation (to increase affinity) fused to IL15 receptor (IL15Ra) and IgG1 Fc (improves PK and activity). The resultant IL15 superagonist activates effector NK cells and CD8+ memory T cells, without activation of Tregs. 3/n (Twitter) - Feb 15, 2021
- |||| Anktiva (inbakicept) / NantWorks
Clinical: Still digesting #bladdercancer trials at #GU21. QUILT 3.032 trial https://t.co/csAp22qYZm testing #N803 in BCG-unresponsive CIS was an important result. Safety data appropriate for intravesical therapy – and CR rate was higher than seen with other drugs in similar trials. 1/n (Twitter) - Feb 15, 2021
- | Anktiva (nogapendekin alfa inbakicept-pmln) / ImmunityBio
Enrollment change, Trial completion date, Trial termination: QUILT-3.002: N-803 in Patients With Relapse/Refractory iNHL in Conjunction With Rituximab (clinicaltrials.gov) - Feb 15, 2021
P1/2, N=43, Terminated, Sponsor: Altor BioScience
Trial completion date: Jan 2023 --> Jan 2024 | Trial primary completion date: Jan 2023 --> Jan 2024 N=86 --> 43 | Trial completion date: Jun 2023 --> Dec 2020 | Active, not recruiting --> Terminated; Change in drug product development strategy.
- Anktiva (inbakicept) / NantWorks
[VIRTUAL] Unprimed CD8+ lymphocytes promote the maintenance of HIV latency in CD4+ T cells (Live channel 3) - Feb 7, 2021 - Abstract #HIVR4P2021HIVR4P_66;
Our studies demonstrated a CD8+ lymphocyte mediated suppression of HIV expression in CD4+ T cells capable of maintaining latency in the presence of activation signaling. Understanding the mechanisms by which CD8+ lymphocytes suppress virus transcription and ultimately promote HIV latency in ART-treated HIV-infected individuals may provide critical insight to the design of HIV eradication approaches.
- | Anktiva (nogapendekin alfa inbakicept-pmln) / ImmunityBio
Trial completion date, Trial suspension, Trial primary completion date, Metastases: IP ALT-803 Followed by SQ ALT-803 for Ovarian Cancer (clinicaltrials.gov) - Feb 3, 2021
P1, N=28, Suspended, Sponsor: Masonic Cancer Center, University of Minnesota
Understanding the mechanisms by which CD8+ lymphocytes suppress virus transcription and ultimately promote HIV latency in ART-treated HIV-infected individuals may provide critical insight to the design of HIV eradication approaches. Trial completion date: Dec 2021 --> Jun 2022 | Recruiting --> Suspended | Trial primary completion date: Dec 2020 --> Mar 2022
- |||||| Anktiva (inbakicept) / NantWorks
P2 data: #WCLC20 This phase II study of N-803 explored combinations with PD(L)1 inhibitors and was reasonably well tolerated. Early look but in the cohort with prior IO PD, some quality disease control observed. Need more granularity; looking forward to hearing more. #LCSM (Twitter) - Jan 29, 2021
- ||||||| Anktiva (inbakicept) / NantWorks
P2 data, Breakthrough therapy designation: #WCLC20 Results from QUILT 3.055 (phase 2 trial of N-803, an IL-15 superagonist). Compound has FDA breakthrough designation for non-invasive bladder cancer. Design can lead to activation of CD8+ T cells and NK cells (while sparing Tregs). #LCSM @IASLC (Twitter) - Jan 29, 2021
- Anktiva (nogapendekin alfa inbakicept-pmln) / ImmunityBio
Enrollment change, Trial completion date, Trial termination, Trial primary completion date, Combination therapy: PK Sub-Study of QUILT-3.032 (CA ALT-803-01-16) and of QUILT-2.005 (CA ALT-803-01-14) (clinicaltrials.gov) - Jan 22, 2021
P=N/A, N=1, Terminated, Sponsor: Altor BioScience
Trial completion date: Dec 2021 --> Jun 2022 | Recruiting --> Suspended | Trial primary completion date: Dec 2020 --> Mar 2022 N=20 --> 1 | Trial completion date: Dec 2021 --> Apr 2020 | Recruiting --> Terminated | Trial primary completion date: Dec 2021 --> Apr 2020; Study was closed due to the recent pandemic and enrollment challenges.
- Anktiva (inbakicept) / NantWorks
[VIRTUAL] Phase II/III clinical results of IL-15RαFc superagonist N-803 with BCG in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS) patients. () - Jan 8, 2021 - Abstract #ASCOGU2021ASCO_GU_674;
P2/3
With a CR rate of 72%, N-803 has met its primary endpoint with 59% probability of CR patients maintaining CR for at least 12 months. With the observed strong efficacy and an SAE rate of 1%, N-803 represents a novel treatment option for BCG unresponsive CIS with a favorable benefit:risk ratio, in a therapeutically challenging disease.
- || 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) - Jan 8, 2021
P1/2, N=58, Active, not recruiting, Sponsor: Medical University of South Carolina
With the observed strong efficacy and an SAE rate of 1%, N-803 represents a novel treatment option for BCG unresponsive CIS with a favorable benefit:risk ratio, in a therapeutically challenging disease. Trial completion date: Dec 2020 --> Dec 2022 | Trial primary completion date: Dec 2020 --> Dec 2021
- |||||| Anktiva (inbakicept) / NantWorks
Clinical: Important preprint: #REMAPCAP, intl multifactorial, adaptive platform RCT (N=803) finds IL-6 blockade ⬆️ overall survival in pts w/ #COVID19 req organ support. Almost all on high flow O2, NIV, vent. 93% on dex. Dr. Anthony Gordon et al. #MedTwitter #pccm https://t.co/knTakulISH (Twitter) - Jan 8, 2021
- | Anktiva (inbakicept) / NantWorks
Journal: Insights from molecular dynamics simulations and steered molecular dynamics simulations to exploit new trends of the interaction between HIF-1α and p300. (Pubmed Central) - Dec 30, 2020
A H-bond existed between K351(p300) and E789 (Hif1-α). These molecules may be the key residues in the unbinding pathway via its tunnel.
- | Anktiva (inbakicept) / NantWorks
Journal: Combination of CD8β depletion and IL-15 superagonist N-803 induces virus reactivation in SHIV-infected, long-term ART-treated rhesus macaques. (Pubmed Central) - Dec 23, 2020
In this study, we tested whether the use of a CD8β-targeting antibody, which would specifically deplete CD8+ T cells, would yield similar levels of virus reactivation. We observed induction of plasma viremia which correlated with the efficacy of the CD8 depletion strategy.
- | bintrafusp alfa (M7824) / EMD Serono, Anktiva (nogapendekin alfa inbakicept-pmln) / ImmunityBio
Trial completion date, Combination therapy: Anti-PD-L1/TGF-beta Trap (M7824) Alone and in Combination With TriAd Vaccine and N-803 for Resectable Head and Neck Squamous Cell Carcinoma Not Associated With Human Papillomavirus Infection (clinicaltrials.gov) - Dec 23, 2020
P1/2, N=40, Recruiting, Sponsor: National Cancer Institute (NCI)
We observed induction of plasma viremia which correlated with the efficacy of the CD8 depletion strategy. Trial completion date: Aug 2022 --> Dec 2022
- | Anktiva (nogapendekin alfa inbakicept-pmln) / ImmunityBio
Phase classification, Combination therapy: QUILT-3.032: A Multicenter Clinical Trial of Intravesical Bacillus Calmette-Guerin (BCG) in Combination With ALT-803 (N-803) in Patients With BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer (clinicaltrials.gov) - Dec 22, 2020
P2/3, N=183, Recruiting, Sponsor: Altor BioScience
Trial completion date: Aug 2022 --> Dec 2022 Phase classification: P2 --> P2/3
- | entinostat (SNDX-275) / Kyowa Hakko Kirin, Syndax Pharma
Journal, IO Biomarker: Cooperative Immune-mediated Mechanisms of the HDAC Inhibitor Entinostat, an IL-15 Superagonist, and a Cancer Vaccine Effectively Synergize as a Novel Cancer Therapy. (Pubmed Central) - Dec 18, 2020
Collectively, these data demonstrate that the synergistic combination of entinostat, N-803, and vaccine elicits potent anti-tumor activity by generating a more inflamed TME. These findings thus form the rationale for the use of this combination of agents for patients harboring poorly or non-inflamed solid carcinomas.
- Anktiva (inbakicept) / NantWorks
[VIRTUAL] Preliminary Data from QUILT 3.055: A Phase 2 Multi-Cohort Study of N803 (IL-15 Superagonist) in Combination with Checkpoint Inhibitors in NSCLC (ePoster Hall) - Dec 17, 2020 - Abstract #IASLCWCLC2020IASLC_WCLC_1481;
P2b
N-803 is well tolerated with grade 1-2 common adverse events were injection site reaction (68%), nausea (41%) fatigue (38%), pyrexia (22%) but no individual grade 3 AEs were greater than 5%. Conclusion N803 demonstrates low toxicity in patients previously treated with checkpoint inhibitors and promising efficacy of reversal of progression and induction of durable stable disease, without interval chemotherapy or radiation, in NSCLC patients who had previously progressed on a checkpoint inhibitor containing regimen.