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latikafusp (AMG 256)
i
Other names: AMG 256, AMG256, AMG-256
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News alerts, weekly reports and conference planners
Company:
Amgen, BeiGene
Drug class:
PD1 inhibitor, IL-21 agonist
Related drugs:
9ms
Translatability of findings from cynomolgus monkey to human suggests a mechanistic role for IL-21 in promoting immunogenicity to an anti-PD-1/IL-21 mutein fusion protein. (PubMed, Front Immunol)
ADA responses were not associated with any type of adverse event. The AMG 256 program represents a unique case where nonclinical studies informed on the risk of immunogenicity in humans, due to the IL-21-driven nature of the response.
Preclinical • Journal
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IL21 (Interleukin 21)
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latikafusp (AMG 256)
over3years
[VIRTUAL] Design and rationale of a phase 1 study evaluating AMG 256, a novel, targeted, PD-1 antibody x IL-21 mutein bifunctional fusion protein, in patients with advanced solid tumors (AACR 2021)
The primary endpoints are incidence of dose-limiting toxicities and adverse events, MTD, and recommended phase 2 dose. Secondary objectives will evaluate PK parameters, preliminary antitumor activity (objective response, duration of response, progression-free survival, disease control rate, duration of stable disease, overall survival), and immunogenicity of AMG 256 via incidence of anti-AMG 256 antibodies.
Clinical • P1 data
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IL21 (Interleukin 21)
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latikafusp (AMG 256)
4years
[VIRTUAL] Design and rationale of a phase 1 study evaluating AMG 256, a novel, targeted, IL-21 receptor agonist and anti-PD-1 antibody, in patients with advanced solid tumors (SITC 2020)
Secondary objectives will evaluate PK parameters, preliminary antitumor activity (objective response, duration of response, progression-free survival, disease control rate, duration of stable disease, overall survival), and immunogenicity of AMG 256 via incidence of anti-AMG 256 antibodies. Results N/A Conclusions N/A
Clinical • P1 data • PD(L)-1 Biomarker • IO biomarker
|
IL21 (Interleukin 21)
|
latikafusp (AMG 256)
4years
[VIRTUAL] Design and rationale of a phase 1 study evaluating AMG 256, a novel, targeted, IL-21 receptor agonist and anti-PD-1 antibody, in patients with advanced solid tumors (SITC 2020)
Secondary objectives will evaluate PK parameters, preliminary antitumor activity (objective response, duration of response, progression-free survival, disease control rate, duration of stable disease, overall survival), and immunogenicity of AMG 256 via incidence of anti-AMG 256 antibodies. Results N/A Conclusions N/A
Clinical • P1 data • PD(L)-1 Biomarker • IO biomarker
|
IL21 (Interleukin 21)
|
latikafusp (AMG 256)
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