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- || APVO436 / Medexus
Congrats on exciting reaults for #APVO's APVO436. Looking forward to opening our trial here! ...As soon as they call me back, hint hint, hello is this thing on? (Twitter) - Dec 12, 2022
- APVO436 / Medexus
Updated Results from a Phase 1 Study of APVO436, a Novel Bispecific Anti-CD123 x Anti-CD3 Adaptir™ Molecule, in Relapsed/Refractory Acute Myeloid Leukemia and Myelodysplastic Syndrome (ENMCC - Hall D) - Nov 4, 2022 - Abstract #ASH2022ASH_4191;
P1b
Conclusions Preliminary results from the dose-expansion phase indicate that APVO436 is well tolerated and safe as single agent and in combination across cohorts with different underlying leukemic conditions. Furthermore, anti-leukemic activity has been observed.
- |||||| APVO436 / Medexus
Clinical: Open @MDAndersonNews #ClinicalTrial 2021-0659 Phase 1b Study of APVO436 In Patients with High Risk Leukemias, Including R/R #AML, or High-Grade #MDS PI: Gautam Borthakur @GBorthakur NCT03647800 https://t.co/annHLCWON5 #leusm (Twitter) - Oct 14, 2022
P1b
- || APVO436 / Medexus
Review, Journal, Myeloid-derived suppressor cells: CD123-Directed Bispecific Antibodies for Targeting MDS Clones and Immunosuppressive Myeloid-Derived Suppressor Cells (MDSC) in High-Risk Adult MDS Patients. (Pubmed Central) - Jul 14, 2022
This article discusses the clinical impact potential of bispecific antibodies (BiAB) capable of redirecting host T-cell cytotoxicity in an MHC-independent manner to malignant clones as well as immunosuppressive myeloid-derived suppressor cells (MDSC) as a new class of anti-MDS drug candidates. T-cell engaging BiAB targeting the CD123 antigen may help delay disease progression in high-risk adult MDS and potentially reduce the risk of transformation to secondary AML.
- || Venclexta (venetoclax) / Roche, AbbVie, APVO436 / Medexus
PK/PD data, Retrospective data, Journal: Post-hoc Analysis of Pharmacodynamics and Single-Agent Activity of CD3xCD123 Bispecific Antibody APVO436 in Relapsed/Refractory AML and MDS Resistant to HMA or Venetoclax Plus HMA. (Pubmed Central) - Feb 1, 2022
The median survival for the combined group of 14 R/R AML/MDS patients was 282 days. This early evidence of single-agent activity of APVO436 in R/R AML/MDS patients who failed HMA with or without venetoclax provides proof of concept supporting its in vivo immunomodulatory and anti-leukemic activity and warrants further investigation of its clinical impact potential.
- || Actemra IV (tocilizumab) / Roche, JW Pharma, APVO436 / Medexus
Biomarker, Clinical, Journal, Cytokine release syndrome: Risk, Characteristics and Biomarkers of Cytokine Release Syndrome in Patients with Relapsed/Refractory AML or MDS Treated with CD3xCD123 Bispecific Antibody APVO436. (Pubmed Central) - Nov 17, 2021
P1b
Notably, the development of CRS after APVO436 therapy did not appear to be associated with a response. The prolonged stabilization of disease, partial remissions and complete remissions were achieved in both patients who experienced CRS, as well as patients who did not experience CRS after APVO436 infusions.
- Actemra IV (tocilizumab) / Roche, JW Pharma, APVO436 / Medexus
Risk and Severity of Cytokine Release Syndrome in Patients with Relapsed/Refractory (R/R) AML or MDS Treated with CD3xCD123 Bispecific Antibody APVO436 (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_5098;
P1b
APVO436-related CRS was not required for clinically meaningful responses in R/R AML patients, and it did not affect the survival outcome. Prolonged stabilization of disease, partial remissions and complete remissions were achieved in both patients who experienced CRS as well as patients who did not experience CRS after APVO436 infusions.
- APVO436 / Medexus
Tolerability and Single Agent Anti-Neoplastic Activity of the CD3xCD123 Bispecific Antibody APVO436 in Patients with Relapsed/Refractory AML or MDS (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_5097;
P1b
Three of these 6 patients had marrow CRs. In conclusion, the safety and preliminary evidence of efficacy of APVO436 in R/R AML and MDS patients warrant further investigation of its clinical impact potential.
- | APVO436 / Medexus
Enrollment change, Trial completion date, Trial initiation date, Trial withdrawal, Trial primary completion date, Combination therapy: Study of APVO436 in Elderly or Unfit Patients With Newly Diagnosed AML (clinicaltrials.gov) - Sep 17, 2021
P1b, N=0, Withdrawn, Sponsor: Aptevo Therapeutics
In conclusion, the safety and preliminary evidence of efficacy of APVO436 in R/R AML and MDS patients warrant further investigation of its clinical impact potential. N=20 --> 0 | Trial completion date: Dec 2023 --> Jan 2027 | Initiation date: Aug 2021 --> Jan 2025 | Not yet recruiting --> Withdrawn | Trial primary completion date: Jun 2022 --> Jan 2026
- || APVO436 / Medexus
Clinical, P1 data, Journal: A Clinical Phase 1B Study of the CD3xCD123 Bispecific Antibody APVO436 in Patients with Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome. (Pubmed Central) - Aug 28, 2021
Three of six evaluable MDS patients had marrow CRs. The safety and preliminary evidence of efficacy of APVO436 in R/R AML and MDS patients warrant further investigation of its clinical impact potential.
- || APVO436 / Medexus
New P1 trial, Combination therapy: Study of APVO436 in Elderly or Unfit Patients With Newly Diagnosed AML (clinicaltrials.gov) - Jul 22, 2021
P1b, N=20, Not yet recruiting, Sponsor: Aptevo Therapeutics
- ||| APVO436 / Medexus
Enrollment open: Study of APVO436 in Patients With AML or MDS (clinicaltrials.gov) - Jul 20, 2021
P1b, N=136, Recruiting, Sponsor: Aptevo Research and Development LLC
The safety and preliminary evidence of efficacy of APVO436 in R/R AML and MDS patients warrant further investigation of its clinical impact potential. Active, not recruiting --> Recruiting
- || APVO436 / Medexus
Enrollment closed, Phase classification: Study of APVO436 in Patients With AML or MDS (clinicaltrials.gov) - May 26, 2021
P1b, N=136, Active, not recruiting, Sponsor: Aptevo Research and Development LLC
Active, not recruiting --> Recruiting Recruiting --> Active, not recruiting | Phase classification: P1 --> P1b
- || APVO436 / Medexus
Trial completion date, Trial primary completion date: Study of APVO436 in Patients With AML or MDS (clinicaltrials.gov) - Feb 21, 2021
P1, N=108, Recruiting, Sponsor: Aptevo Research and Development LLC
Recruiting --> Active, not recruiting | Phase classification: P1 --> P1b Trial completion date: Dec 2021 --> Jun 2023 | Trial primary completion date: Aug 2020 --> Dec 2022
- APVO436 / Medexus
[VIRTUAL] Preliminary Results from a Phase 1 Study of APVO436, a Novel Anti-CD123 x Anti-CD3 Bispecific Molecule, in Relapsed/Refractory Acute Myeloid Leukemia and Myelodysplastic Syndrome (Poster Hall (Virtual Meeting)) - Nov 5, 2020 - Abstract #ASH2020ASH_3656;
P1
Conclusions Preliminary results indicate that APVO436 is tolerated in patients with R/R AML and MDS at the doses and schedules tested to date, with a manageable safety profile. Dose escalation continues and the results will be updated for this ongoing study.
- | APVO436 / Medexus
Trial completion date, Trial primary completion date: Study of APVO436 in Patients With AML or MDS (clinicaltrials.gov) - Sep 11, 2019
P1, N=108, Recruiting, Sponsor: Aptevo Research and Development LLC
Dose escalation continues and the results will be updated for this ongoing study. Trial completion date: Nov 2019 --> Dec 2021 | Trial primary completion date: Aug 2019 --> Aug 2020
- ||| APVO436 / Medexus
Enrollment open: Study of APVO436 in Patients With AML or MDS (clinicaltrials.gov) - Dec 19, 2018
P1, N=108, Recruiting, Sponsor: Aptevo Therapeutics
Trial completion date: Nov 2019 --> Dec 2021 | Trial primary completion date: Aug 2019 --> Aug 2020 Not yet recruiting --> Recruiting
- | APVO436 / Medexus
New P1 trial: Study of APVO436 in Patients With AML or MDS (clinicaltrials.gov) - Aug 26, 2018
P1, N=108, Not yet recruiting, Sponsor: Aptevo Therapeutics