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- || ANV419 / Anaveon
Trial primary completion date, Combination therapy, Monotherapy, Metastases: A Study of ANV419 Alone or in Combination With Approved Treatment in Patients With Cutaneous Melanoma (OMNIA-1). (clinicaltrials.gov) - Feb 15, 2024
P1/2, N=130, Recruiting, Sponsor: Anaveon AG
Trial primary completion date: Jun 2024 --> Sep 2024
- || ANV419 / Anaveon
P1 data, Journal, Metastases: Phase 1 first-in-human dose-escalation study of ANV419 in patients with relapsed/refractory advanced solid tumors. (Pubmed Central) - Jan 20, 2024
P1
Trial primary completion date: Jun 2024 --> Sep 2024 ANV419 at doses up to 243?
- ANV419 / Anaveon
Enrollment change, Trial completion date, Trial termination, Trial primary completion date, Combination therapy, Monotherapy: A Study of ANV419 Alone or in Combination With Approved Treatments in Patients With Multiple Myeloma (OMNIA-2) (clinicaltrials.gov) - Aug 14, 2023
P1, N=4, Terminated, Sponsor: Anaveon AG
ANV419 at doses up to 243? N=52 --> 4 | Trial completion date: Mar 2025 --> Jul 2023 | Recruiting --> Terminated | Trial primary completion date: Sep 2024 --> Jul 2023; The study was ended due to a lack of recruitment
- ANV419 / Anaveon
ANV419, a selective IL-2R?/? agonist in patients with relapsed/refractory advanced solid tumors () - Jul 27, 2023 - Abstract #ESMO2023ESMO_2564;
P1
Preliminary anti-tumor activity was observed including durable response in NSCLC. Further studies assessing the antitumor activity of ANV419 in melanoma and myeloma are ongoing.
- || ANV419 / Anaveon
Enrollment open, Metastases: BaseTIL-03M: ACT-TIL and ANV419 for Advanced Melanoma. (clinicaltrials.gov) - Jul 21, 2023
P1, N=10, Recruiting, Sponsor: University Hospital, Basel, Switzerland
Further studies assessing the antitumor activity of ANV419 in melanoma and myeloma are ongoing. Not yet recruiting --> Recruiting
- || ANV419 / Anaveon
Enrollment change, Combination therapy, Metastases: ANV419-001: A Study Evaluating Safety and Therapeutic Activity of ANV419 in Patients With Advanced Cancer. (clinicaltrials.gov) - Jul 3, 2023
P1, N=80, Recruiting, Sponsor: Anaveon AG
Not yet recruiting --> Recruiting N=60 --> 80
- || ANV419 / Anaveon
New P1 trial, Metastases: BaseTIL-03M: ACT-TIL and ANV419 for Advanced Melanoma. (clinicaltrials.gov) - May 22, 2023
P1, N=10, Not yet recruiting, Sponsor: University Hospital, Basel, Switzerland
- OMNIA-1: A phase I/II study, an IL-2R-?? targeted antibody-IL-2 fusion protein, as monotherapy or in combination with anti?PD-1 or anti-CTLA-4 antibodies, in patients with advanced melanoma. (On Demand | Hall A; Poster Bd # 358b) - Apr 26, 2023 - Abstract #ASCO2023ASCO_2573;
P1/2
N=60 --> 80 Recombinant IL-2 (proleukin) induces durable responses in approximately 10% of patients with melanoma...In Part 3, the efficacy and safety of ANV419 in combination with the approved doses pembrolizumab or ipilimumab will be evaluated using a Simon
- ANV419 / Anaveon
OMNIA-2: Phase I/II study of ANV419, an IL-2R-?? targeted antibody-IL-2 fusion protein, in patients with relapsed or refractory multiple myeloma. (On Demand | Hall A; Poster Bd # 57b) - Apr 26, 2023 - Abstract #ASCO2023ASCO_1425;
P1
The OMNIA-2 study (ANV419-102; NCT 05641324) will evaluate safety and preliminary efficacy of ANV419 as monotherapy and in combination with daratumumab (dara), or lenalidomide with low dose dexamethasone (lena/dex), in patients with relapsed or refractory multiple myeloma...OMNIA-2 is being conducted in Denmark, France, Germany, Spain, Switzerland, UK and enrolment began in January 2023 and preliminary data are expected in Q1 2024. Clinical trial information: NCT05641324.
- || ANV419 / Anaveon
Trial completion date, Trial primary completion date, Combination therapy, Metastases: ANV419-001: A Study Evaluating Safety and Therapeutic Activity of ANV419 in Patients With Advanced Cancer. (clinicaltrials.gov) - Mar 10, 2023
P1, N=60, Recruiting, Sponsor: Anaveon AG
Clinical trial information: NCT05641324. Trial completion date: Jul 2023 --> Dec 2024 | Trial primary completion date: Jul 2023 --> Jul 2024
- ||| ANV419 / Anaveon
Enrollment open, Trial completion date, Combination therapy, Monotherapy: A Study of ANV419 Alone or in Combination With Approved Treatments in Patients With Multiple Myeloma (OMNIA-2) (clinicaltrials.gov) - Mar 9, 2023
P1, N=52, Recruiting, Sponsor: Anaveon AG
Trial completion date: Jul 2023 --> Dec 2024 | Trial primary completion date: Jul 2023 --> Jul 2024 Not yet recruiting --> Recruiting | Trial completion date: Sep 2024 --> Mar 2025
- ||| ANV419 / Anaveon
Enrollment open, Trial primary completion date, Combination therapy, Monotherapy, IO biomarker, Metastases: A Study of ANV419 Alone or in Combination With Approved Treatment in Patients With Cutaneous Melanoma (OMNIA-1). (clinicaltrials.gov) - Feb 2, 2023
P1/2, N=130, Recruiting, Sponsor: Anaveon AG
Not yet recruiting --> Recruiting | Trial completion date: Sep 2024 --> Mar 2025 Not yet recruiting --> Recruiting | Trial primary completion date: Mar 2024 --> Jun 2024
- ||| ANV419 / Anaveon
New P1 trial, Combination therapy, Monotherapy: A Study of ANV419 Alone or in Combination With Approved Treatments in Patients With Multiple Myeloma (OMNIA-2) (clinicaltrials.gov) - Dec 7, 2022
P1, N=52, Not yet recruiting, Sponsor: Anaveon AG
- |||| ANV419 / Anaveon
New P1/2 trial, Combination therapy, Monotherapy, IO biomarker, Metastases: A Study of ANV419 Alone or in Combination With Approved Treatment in Patients With Cutaneous Melanoma (OMNIA-1). (clinicaltrials.gov) - Oct 13, 2022
P1/2, N=130, Not yet recruiting, Sponsor: Anaveon AG
- ANV419 / Anaveon
ANV419 is a novel CD122-biased IL-2/anti-IL-2 fusion protein showing increased efficacy in combination with checkpoint inhibitors and treatments acting through antibody dependent cellular cytotoxicity (Hall C) - Oct 6, 2022 - Abstract #SITC2022SITC_1407;
NK cell killing was analyzed in combination with trastuzumab...Treatment of whole blood with a combination of ANV419 and pembrolizumab (anti-PD1) or ipilimumab (anti-CTLA4) induced only slightly increased cytokine secretion compared to ANV419 alone and is therefore considered to have a reasonable safety profile. Conclusions The data presented here further elucidate the in vitro and in vivo effects of ANV419 and support the rationale for clinical development in indications where NK and CD8 T cells are involved in tumor resolution as well as in combination with ADCC inducing treatments or checkpoint inhibitors.
- ANV419 / Anaveon
Phase I dose escalation study in patients with advanced solid tumors with ANV419, a novel fusion protein selective for IL-2Rβ/γ (Hall C) - Oct 6, 2022 - Abstract #SITC2022SITC_954;
P1
Trial Registration NCT04855929 Ethics Approval The study ANV419-001 has been approved by the following Ethics committee: - HM Hospitals Drug Research Ethics Committee (CEIm) (ID: 20.12.1736-GHM) - EKNZ – Ethikkommission Nordwest und Zentralschweiz ( ID 2021-00911) - London – Surrey Borders Research Ethics Committee (ID: 21/LO/0213) Written consent was obtained from all patients prior taking part into this study. Consent Written informed consent was obtained from the patient for publication of this abstract.
- | ANV419 / Anaveon
Phase classification, Combination therapy, Metastases: ANV419-001: A Study Evaluating Safety and Therapeutic Activity of ANV419 in Patients With Advanced Cancer. (clinicaltrials.gov) - Sep 2, 2022
P1, N=60, Recruiting, Sponsor: Anaveon AG
Consent Written informed consent was obtained from the patient for publication of this abstract. Phase classification: P1/2 --> P1
- ANV419 / Anaveon
ANV419 is a novel CD122-biased IL-2/anti-IL-2 fusion protein with potent CD8 T cell and NK cell stimulating capacity that shows additive efficacy in combination with checkpoint inhibitors and treatments acting through antibody dependent cellular cytotoxicity (Poster Area, Hall 4) - Jul 28, 2022 - Abstract #ESMO2022ESMO_3232;
In vitro combination of ANV419 with the antibody dependent cellular cytotoxicity (ADCC) inducing anti-HER2 antibody trastuzumab showed additive effects in NK cell killing compared to single trastuzumab treatment...To assess the role of ANV419 in indications where T cells are involved in tumor resolution, ANV419 combination with the checkpoint inhibitors anti-PD1 or anti-CTLA4 was tested and showed additive effects in tumor growth retardation in mice bearing H22 tumors compared to single treated mice. Conclusions The data presented here, support the initiation of clinical phase II studies assessing ANV419 treatment in indications in which NK and CD8 T cells are involved in tumor resolution and in combination with ADCC inducing treatments or checkpoint inhibitors.
- ANV419 / Anaveon
ANV419, a selective IL-2R-beta-gamma targeted antibody-IL-2 fusion protein, in patients with advanced solid tumors, a phase I/II study (Poster Area, Hall 4) - Jul 28, 2022 - Abstract #ESMO2022ESMO_2463;
P1
Conclusions ANV419 shows a favorable and consistent safety profile across doses and selectively induces expansion and proliferation of CD8 T and NK cells, but not Tregs. Updated clinical data including additional dose cohorts, long term PK/PD and histology will be shared at the meeting.
- ANV419 / Anaveon
A phase I/II study of ANV419, a selective IL-2R-beta-gamma targeted antibody-IL-2 fusion protein, in patients with advanced solid tumors. () - Apr 28, 2022 - Abstract #ASCO2022ASCO_3557;
P1/2
Overall, ANV419 is well tolerated and selectively induces expansion and proliferation of CD8 T cells and NK cells, but not Tregs up to a dose of at least 48mcg/kg. Updated data will be shared during the meeting.
- ANV419 / Anaveon
ANV419, an IL-2R-beta-gamma targeted antibody-IL-2 fusion protein, induces selective effector cell proliferation in patients with progressed cancer (Section 35) - Mar 9, 2022 - Abstract #AACR2022AACR_3940;
ANV419 is very well tolerated and induces a high degree of proliferation in CD8 T cells and NK cells but not Tregs. ANV419-001 will further evaluate the safety and efficacy of ANV419 alone and in combination with other immunotherapy drugs.
- ANV419 / Anaveon
Favorable pre-clinical safety profile of the novel not-alpha IL-2 agonist ANV419 supports first in human clinical development (Poster Hall) - Oct 1, 2021 - Abstract #SITC2021SITC_536;
In the part A single patient escalation cohort, two patients have been dosed Q2W multiple times with 0.003mg/kg and 0.006mg/kg respectively with the expected PD profile and no DLT observed. Conclusions Consistent findings, relating to expected effects of ANV419 as a not-alpha IL-2 agonist, demonstrated a favorable tolerability and safety profile at pharmacodynamically relevant doses that strongly support its translational development in cancer patients to identify clinical benefits.
- ||| ANV419 / Anaveon
Enrollment open, Combination therapy, Metastases: ANV419-001: A Study Evaluating Safety and Therapeutic Activity of ANV419 in Patients With Advanced Cancer. (clinicaltrials.gov) - Jun 24, 2021
P1/2, N=75, Recruiting, Sponsor: Anaveon AG
Conclusions Consistent findings, relating to expected effects of ANV419 as a not-alpha IL-2 agonist, demonstrated a favorable tolerability and safety profile at pharmacodynamically relevant doses that strongly support its translational development in cancer patients to identify clinical benefits. Not yet recruiting --> Recruiting
- Proleukin (aldesleukin) / Clinigen, Novartis, Prometheus, ANV419 / Anaveon, Herceptin (trastuzumab) / Roche
[VIRTUAL] ANV419 is a new generation CD122-biased IL-2/anti-IL-2 antibody fusion protein with potent stimulatory function on immune effector cells in vitro and in vivo (eTalks Room) - May 11, 2021 - Abstract #CIMT2021CIMT_46;
Novel interleukin-2 (IL-2)-based therapeutic modalities with preferential signaling through the IL-2 β/γ receptor (IL-2Rβ/γ) are entering clinical trials and have the potential to substantially increase the therapeutic index of recombinant IL-2 (aldesleukin) for cancer therapy...The combination treatment with anti-HER2 antibody trastuzumab led to an increased anti-tumor activity of the monoclonal antibody in the gastric cancer N87 xenograft model...Aligned to its potent proliferative effect on CD8 and NK cells, ANV419 induces strong anti- tumor responses in various mouse models of cancer. This pre-clinical data and the marked safety window of ANV419 in non-human primates support its translational development as immunotherapeutic agent in oncology.
- | ANV419 / Anaveon
New P1/2 trial, Combination therapy, Metastases: ANV419-001: A Study Evaluating Safety and Therapeutic Activity of ANV419 in Patients With Advanced Cancer. (clinicaltrials.gov) - Apr 22, 2021
P1/2, N=75, Not yet recruiting, Sponsor: Anaveon AG