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DRUG:

AFM24

i
Other names: AFM24, AFM-24, AFM 24
Company:
Affimed, Xoma
Drug class:
EGFR inhibitor, CD16A agonist
Related drugs:
2ms
AFM24-102: Study to Assess AFM24 in Combination with Atezolizumab in Selected Advanced/Metastatic EGFR-expressing Cancers (clinicaltrials.gov)
P1/2, N=148, Recruiting, Affimed GmbH | Trial completion date: Jun 2025 --> Nov 2025 | Trial primary completion date: Sep 2024 --> Feb 2025
Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation • EGFR T790M • EGFR wild-type • EGFR positive
|
Tecentriq (atezolizumab) • AFM24
3ms
Study to Assess AFM24 in Advanced Solid Cancers (clinicaltrials.gov)
P1/2, N=85, Completed, Affimed GmbH | Active, not recruiting --> Completed | Trial completion date: Dec 2024 --> Jun 2024
Trial completion • Trial completion date
|
KRAS (KRAS proto-oncogene GTPase)
|
AFM24
9ms
Safety, Tolerability, and Anti-Tumor Activity of AFM24 in Combination With SNK01 in Subjects With Advanced/Metastatic EGFR-Expressing Cancers (clinicaltrials.gov)
P1/2, N=11, Terminated, NKGen Biotech, Inc. | N=121 --> 11 | Trial completion date: Nov 2025 --> Sep 2023 | Active, not recruiting --> Terminated | Trial primary completion date: Nov 2025 --> Sep 2023; Affimed and NKGen have mutually decided to discontinue the study. Affimed will evaluate the best options to advance this project with an allogeneic off-the-shelf NK cell product while NKGen will focus on CNS with SNK01.
Enrollment change • Trial completion date • Trial termination • Trial primary completion date • Combination therapy • Metastases
|
EGFR expression • EGFR wild-type • EGFR positive
|
troculeucel (SNK01) • AFM24
1year
Study to Assess AFM24 in Advanced Solid Cancers (clinicaltrials.gov)
P1/2, N=85, Active, not recruiting, Affimed GmbH | Recruiting --> Active, not recruiting | N=155 --> 85 | Trial primary completion date: Apr 2024 --> Jul 2023
Enrollment closed • Enrollment change • Trial primary completion date • Metastases
|
KRAS (KRAS proto-oncogene GTPase)
|
KRAS wild-type • RAS wild-type
|
AFM24
over1year
Enrollment change • Combination therapy • Metastases
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation • EGFR T790M • EGFR wild-type • EGFR positive
|
Tecentriq (atezolizumab) • AFM24
over1year
Investigating the novel CD16A and epidermal growth factor receptor (EGFR) bispecific innate cell engager, AFM24, to leverage the innate immune system: Interim results from the colorectal cancer (CRC) cohort. (ASCO 2023)
The novel mechanism of action of AFM24 may provide an alternative treatment approach for patients with EGFR+ solid tumors. In this study, AFM24 monotherapy was adequately tolerated in a heavily pretreated population of patients with EGFR+ CRC. AFM24 is also being investigated in combination with atezolizumab and autologous NK cells in various EGFR+ solid tumors.
PD(L)-1 Biomarker
|
EGFR (Epidermal growth factor receptor) • FCGR3A (Fc Fragment Of IgG Receptor IIIa)
|
EGFR mutation • EGFR expression • EGFR wild-type • RAS wild-type
|
Tecentriq (atezolizumab) • AFM24
over1year
Leveraging innate immunity with AFM24, a novel CD16A and epidermal growth factor receptor (EGFR) bispecific innate cell engager: Interim results for the non-small cell lung cancer (NSCLC) cohort. (ASCO 2023)
AFM24 demonstrated clinical activity and acceptable safety in heavily pretreated patients with EGFR mutant NSCLC. The novel mechanism of action of AFM24 could add to the therapeutic options for patients with EGFR expressing tumors and is under clinical evaluation as a single agent and in combination with atezolizumab or autologous NK cells. Clinical trial information: NCT04259450.
PD(L)-1 Biomarker
|
EGFR (Epidermal growth factor receptor) • FCGR3A (Fc Fragment Of IgG Receptor IIIa)
|
EGFR mutation • EGFR positive
|
Tecentriq (atezolizumab) • AFM24
2years
Clinical • P1 data • PD(L)-1 Biomarker • IO biomarker
|
EGFR (Epidermal growth factor receptor) • FCGR3A (Fc Fragment Of IgG Receptor IIIa)
|
EGFR expression
|
Tecentriq (atezolizumab) • AFM24
2years
Targeting epidermal growth factor receptor (EGFR)-expressing solid tumors with AFM24, a novel CD16A bispecific innate cell engager: Comprehensive correlative science findings from a Phase 1 study (SITC 2022)
T cells are activated within the periphery, and T cell numbers increase in tumors, which may indicate stimulation of anti-cancer activity of the adaptive immune system as an indirect effect of AFM24. Clinical and correlative science from the escalation phase of the study supports further investigation of AFM24 anti-tumor activity in EGFR-expressing tumor-specific cohorts.
P1 data
|
EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog) • CD8 (cluster of differentiation 8) • CD69 (CD69 Molecule) • FCGR3A (Fc Fragment Of IgG Receptor IIIa)
|
EGFR mutation • BRAF mutation • EGFR expression • EGFR positive
|
AFM24
2years
Study to Assess AFM24 in Combination With Atezolizumab in Selected Advanced/Metastatic EGFR-expressing Cancers (clinicaltrials.gov)
P1/2, N=105, Recruiting, Affimed GmbH | Trial completion date: Sep 2024 --> Jun 2025 | Trial primary completion date: Jan 2023 --> Sep 2024
Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
EGFR (Epidermal growth factor receptor)
|
EGFR wild-type • EGFR positive
|
Tecentriq (atezolizumab) • AFM24
2years
Study to Assess AFM24 in Advanced Solid Cancers (clinicaltrials.gov)
P1/2, N=155, Recruiting, Affimed GmbH | Trial completion date: Mar 2024 --> Dec 2024 | Trial primary completion date: Sep 2022 --> Apr 2024
Trial completion date • Trial primary completion date • Metastases
|
KRAS (KRAS proto-oncogene GTPase)
|
KRAS wild-type • RAS wild-type
|
AFM24
over2years
A phase I/IIa dose escalation study of AFM24 in patients with epidermal growth factor receptor-expressing (EGFR) solid tumors: Results from phase I (ESMO 2022)
Early biomarker data demonstrate target engagement with expected immune activation. Studies are also evaluating AFM24 in combination with atezolizumab, or with autologous NK cells exploring its potential to activate the innate immune response.
Clinical • P1/2 data • PD(L)-1 Biomarker
|
EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • IFNG (Interferon, gamma) • TNFA (Tumor Necrosis Factor-Alpha) • FCGR3A (Fc Fragment Of IgG Receptor IIIa)
|
KRAS mutation • EGFR mutation • EGFR expression
|
Tecentriq (atezolizumab) • AFM24
over2years
The combination of CD16A/EGFR innate cell engager, AFM24, with SNK01 autologous natural killer cells in patients with advanced solid tumors. (ASCO 2022)
Efficacy will also be assessed by assessing progression-free and overall survival. Secondary endpoints for both phases include treatment-emergent adverse events, serious adverse events, pharmacokinetics and immunogenicity.
Clinical
|
EGFR (Epidermal growth factor receptor) • FCGR3A (Fc Fragment Of IgG Receptor IIIa)
|
troculeucel (SNK01) • AFM24
over2years
AFM24 in combination with atezolizumab in patients with advanced EGFR-expressing solid tumors: Phase 1/2a study design and rationale. (ASCO 2022)
The Phase 2a study will then establish the overall response rate (as per RECIST v1.1) and safety of combination therapy in patients with advanced/ metastatic, or treatment refractory gastric, esophagogastric, hepatocellular, hepatobiliary, pancreatic, or non-small cell lung cancer. For both phases, secondary endpoints include treatment-emergent adverse events, serious adverse events, pharmacokinetics, pharmacodynamics, and immunogenicity.
Clinical • P1/2 data • Combination therapy
|
EGFR (Epidermal growth factor receptor) • FCGR3A (Fc Fragment Of IgG Receptor IIIa)
|
EGFR expression • EGFR overexpression
|
Tecentriq (atezolizumab) • AFM24
over2years
Study to Assess AFM24 in Advanced Solid Cancers (clinicaltrials.gov)
P1/2, N=155, Recruiting, Affimed GmbH | Trial primary completion date: Apr 2022 --> Sep 2022
Trial primary completion date
|
KRAS (KRAS proto-oncogene GTPase)
|
KRAS wild-type • RAS wild-type
|
AFM24
over2years
A phase 1/2a first-in-human study of AFM24, a CD16A/epidermal growth factor (EGFR) bispecific Innate Cell Engager (ICE®), in patients with locally advanced or metastatic EGFR‑expressing solid tumors: Preliminary findings from the dose-escalation phase (AACR 2022)
In parallel to continued dose escalation, expansion in disease specific cohorts has been launched at 480 mg. Other studies are evaluating AFM24 in combination with atezolizumab, and in combination with autologous NK cells holding the potential to activate the innate immune response to fight EGFR+ cancer.
Clinical • P1/2 data • PD(L)-1 Biomarker
|
EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • IFNG (Interferon, gamma) • IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • IL10 (Interleukin 10) • FCGR3A (Fc Fragment Of IgG Receptor IIIa)
|
KRAS mutation • EGFR mutation • EGFR expression
|
Tecentriq (atezolizumab) • AFM24
almost3years
Clinical • Enrollment open • Combination therapy
|
EGFR (Epidermal growth factor receptor)
|
EGFR wild-type
|
Tecentriq (atezolizumab) • AFM24
3years
Clinical • New P1/2 trial • Combination therapy
|
EGFR (Epidermal growth factor receptor)
|
EGFR wild-type
|
Tecentriq (atezolizumab) • AFM24
3years
Study to Assess AFM24 in Advanced Solid Cancers (clinicaltrials.gov)
P1/2, N=155, Recruiting, Affimed GmbH | N=70 --> 155 | Trial completion date: Mar 2023 --> Mar 2024
Clinical • Enrollment change • Trial completion date
|
KRAS (KRAS proto-oncogene GTPase)
|
AFM24
over3years
Preclinical evaluation of AFM24, a novel CD16A-specific innate immune cell engager targeting EGFR-positive tumors. (PubMed, MAbs)
A transient elevation of interleukin-6 levels was detected at all dose levels, 2-4 hours post-dose, which returned to baseline levels after 24 hours. These results emphasize the promise of bispecific innate cell engagers as an alternative cancer therapy and demonstrate the potential for AFM24 to effectively target tumors expressing varying levels of EGFR, regardless of their mutational status.Abbreviations: ADA: antidrug antibody; ADCC: antibody-dependent cell-mediated cytotoxicity; ADCP: antibody-dependent cellular phagocytosis; AUC: area under the curve; CAR: chimeric-antigen receptor; CD: Cluster of differentiation; CRC :colorectal cancer; ECD: extracellular domain; EGF: epidermal growth factorEGFR epidermal growth factor receptor; ELISA: enzyme-linked immunosorbent assay; FACS: fluorescence-activated cell sorting; Fc: fragment, crystallizableFv variable fragment; HNSCC: head and neck squamous carcinomaIL interleukinm; Ab monoclonal antibody; MOA: mechanism of action; NK :natural killer; NSCLC: non-small cell lung cancer; PBMC: peripheral blood mononuclear cell; PBS: phosphate-buffered saline; PD: pharmacodynamic; ROCK: redirected optimized cell killing; RSV: respiratory syncytial virus; SABC: specific antibody binding capacity; SD: standard deviation; TAM: tumor-associated macrophage; TKI: tyrosine kinase inhibitor; WT: wildtype.
Preclinical • Journal
|
EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • IL6 (Interleukin 6) • FCGR3A (Fc Fragment Of IgG Receptor IIIa)
|
KRAS mutation • BRAF mutation • IL6 elevation
|
AFM24
over4years
Clinical • New P1/2 trial
|
ALK (Anaplastic lymphoma kinase)
|
BRAF V600 • EGFR expression
|
AFM24
almost5years
Study to Assess AFM24 in Advanced Solid Cancers (clinicaltrials.gov)
P1/2, N=70, Recruiting, Affimed GmbH | Not yet recruiting --> Recruiting
Clinical • Enrollment open
|
EGFR (Epidermal growth factor receptor)
|
EGFR expression
|
AFM24
almost5years
Study to Assess AFM24 in Advanced Solid Cancers (clinicaltrials.gov)
P1/2, N=70, Not yet recruiting, Affimed GmbH
Clinical • New P1/2 trial
|
EGFR (Epidermal growth factor receptor)
|
EGFR expression
|
AFM24