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DRUG CLASS:

CD16A agonist

2ms
CD16A Shedding Regulates Innate Cell Engager-Induced Serial Killing by Natural Killer Cells. (PubMed, Eur J Immunol)
The bispecific innate cell engager acimtamig (AFM13) was superior to IgG1 monoclonal antibodies in ADCC and in increasing the fraction of cytotoxic NK cells and serial killers...These results demonstrate that CD16A shedding represents an intrinsic feature of NK cell biology that is critical to sustain the antitumoral cytotoxicity of NK cells. This has implications for CD16A engineering of NK cell products and their combination with CD16A-directed NK cell engagers.
Journal
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FCGR3A (Fc Fragment Of IgG Receptor IIIa)
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acimtamig (AFM13)
2ms
Study of MK-4464 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced/Metastatic Solid Tumors (MK-4464-001) (clinicaltrials.gov)
P1, N=64, Completed, Merck Sharp & Dohme LLC | Active, not recruiting --> Completed | N=260 --> 64 | Trial completion date: Mar 2026 --> Sep 2025 | Trial primary completion date: Mar 2026 --> Sep 2025
Trial completion • Enrollment change • Trial completion date • Trial primary completion date
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Keytruda (pembrolizumab)
2ms
NCI-2019-03536: Modified Immune Cells (AFM13-NK) and A Monoclonal Antibody (AFM13) in Treating Patients With Recurrent or Refractory CD30 Positive Hodgkin or Non-Hodgkin Lymphomas (clinicaltrials.gov)
P1/2, N=45, Completed, M.D. Anderson Cancer Center | Active, not recruiting --> Completed | N=30 --> 45 | Trial completion date: Apr 2027 --> Sep 2025 | Trial primary completion date: Apr 2027 --> Sep 2025
Trial completion • Enrollment change • Trial completion date • Trial primary completion date
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TNFRSF8 (TNF Receptor Superfamily Member 8)
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TNFRSF8 positive
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cyclophosphamide • fludarabine IV • acimtamig (AFM13)
4ms
The bispecific innate cell engager AFM28 eliminates CD123+ leukemic stem and progenitor cells in AML and MDS. (PubMed, Nat Commun)
In addition, AFM28 is well tolerated and demonstrates pharmacodynamic activity in cynomolgus monkeys. Altogether, our results indicate that AFM28 has the potential to reduce relapse-inducing residual disease and promote long-term remissions for patients with AML and MDS with a favorable safety profile.
Journal
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CD123 (Interleukin 3 Receptor Subunit Alpha) • FCGR3A (Fc Fragment Of IgG Receptor IIIa) • IL3RA (Interleukin 3 Receptor Subunit Alpha)
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AFM28
4ms
AFM24-102: Study to Assess AFM24 in Combination With Atezolizumab in Selected Advanced/Metastatic EGFR-expressing Cancers (clinicaltrials.gov)
P1/2, N=112, Terminated, Affimed GmbH | Trial completion date: Nov 2025 --> Jun 2025 | Recruiting --> Terminated; The trial was prematurely discontinued due to the financial situation of the sponsor and not for safety or efficacy reasons.
Trial completion date • Trial termination
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EGFR (Epidermal growth factor receptor)
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EGFR mutation • EGFR T790M • EGFR wild-type • EGFR positive
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Tecentriq (atezolizumab) • AFM24
4ms
LuminICE-203: Phase 2 Study of AFM13 in Combination With AB-101 in Subjects With R/R HL and CD30+ PTCL (clinicaltrials.gov)
P2, N=25, Terminated, Affimed GmbH | N=154 --> 25 | Trial completion date: Nov 2027 --> Jun 2025 | Recruiting --> Terminated | Trial primary completion date: Apr 2026 --> Nov 2024; Due to sponsor decision
Enrollment change • Trial completion date • Trial termination • Trial primary completion date
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ALK (Anaplastic lymphoma kinase) • TNFRSF8 (TNF Receptor Superfamily Member 8)
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ALK positive • TNFRSF8 positive • ALK negative
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cyclophosphamide • fludarabine IV • acimtamig (AFM13) • AFM13/AB-101 • AlloNK (GCC4001)
4ms
AFM28-101: First-in-Human Dose Escalation Study of AFM28 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (clinicaltrials.gov)
P1, N=30, Terminated, Affimed GmbH | Trial completion date: Mar 2026 --> Jun 2025 | Recruiting --> Terminated | Trial primary completion date: Mar 2025 --> Nov 2024; As decided by sponsor
Trial completion date • Trial termination • Trial primary completion date
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IL3RA (Interleukin 3 Receptor Subunit Alpha)
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AFM28
5ms
Study to Assess AFM24 in Advanced Solid Cancers (clinicaltrials.gov)
P1/2, N=85, Terminated, Affimed GmbH | Completed --> Terminated; Enrollment into expansion cohorts in Phase 2 part was terminated due to sponsor decision
Trial termination
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KRAS (KRAS proto-oncogene GTPase)
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KRAS wild-type • RAS wild-type
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AFM24
6ms
Study of MK-4464 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced/Metastatic Solid Tumors (MK-4464-001) (clinicaltrials.gov)
P1, N=260, Active, not recruiting, Merck Sharp & Dohme LLC | Trial completion date: Jul 2026 --> Mar 2026 | Trial primary completion date: Jul 2026 --> Mar 2026
Trial completion date • Trial primary completion date
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Keytruda (pembrolizumab)
6ms
Study of CC-96191 in Participants With Relapsed or Refractory Acute Myeloid Leukemia (clinicaltrials.gov)
P1, N=45, Terminated, Celgene | N=80 --> 45 | Active, not recruiting --> Terminated; Business objectives have changed
Enrollment change • Trial termination
8ms
NCI-2019-03536: Modified Immune Cells (AFM13-NK) and A Monoclonal Antibody (AFM13) in Treating Patients With Recurrent or Refractory CD30 Positive Hodgkin or Non-Hodgkin Lymphomas (clinicaltrials.gov)
P1/2, N=30, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Apr 2025 --> Apr 2027 | Trial primary completion date: Apr 2025 --> Apr 2027
Trial completion date • Trial primary completion date
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TNFRSF8 (TNF Receptor Superfamily Member 8)
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TNFRSF8 positive
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cyclophosphamide • fludarabine IV • acimtamig (AFM13)
8ms
Allogeneic NK cells with a bispecific innate cell engager in refractory relapsed lymphoma: a phase 1 trial. (PubMed, Nat Med)
Outcomes of patients with CD30-positive (CD30+) lymphomas have improved with the advent of brentuximab vedotin (BV) and, in Hodgkin lymphoma, anti-PD1 checkpoint inhibitors (CPI)...AFM13-a CD30/CD16A bispecific antibody-activates natural killer (NK) cells to kill CD30+ cells...This therapy showed encouraging preliminary safety and efficacy. ClinicalTrials.gov Identifier: NCT04074746 .
P1 data • Journal
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TNFRSF8 (TNF Receptor Superfamily Member 8) • FCGR3A (Fc Fragment Of IgG Receptor IIIa)
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TNFRSF8 positive
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Adcetris (brentuximab vedotin) • acimtamig (AFM13)