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our Premium Content: News alerts, weekly reports and conference plannersDRUG:
pegenzileukin (SAR444245)
i
Other names: IBI-127, SAR'245, SAR444245, THOR-707, not alpha synthorin of IL-2, non alpha IL-2, THOR 707, recombinant human IL-2
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Company:
Innovent Biologics, Sanofi
Drug class:
IL-2 stimulant
Related drugs:
3ms
HAMMER: A Study Evaluating Safety and Therapeutic Activity of THOR-707 in Adult Subjects With Advanced or Metastatic Solid Tumors (THOR-707-101) (clinicaltrials.gov)
P1/2, N=250, Active, not recruiting, Synthorx, Inc, a Sanofi company | Trial completion date: Jun 2026 --> Nov 2025 | Trial primary completion date: Jun 2026 --> Nov 2025
Trial completion date • Trial primary completion date
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KRAS (KRAS proto-oncogene GTPase)
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KRAS mutation
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Keytruda (pembrolizumab) • Erbitux (cetuximab) • pegenzileukin (SAR444245)
4ms
SAR-444245, an engineered not-alpha IL-2 leveraging synthetic biology, modulates critical components of the immune system for durable anti-tumoral activity. (PubMed, J Immunol)
Overall, we demonstrate that the IL-2 not-alpha agent SAR'245 induces immune responses that promote infiltration of CD8+ T and NK cells with enhanced effector function, leading to durable antitumoral response. These findings suggest SAR'245 potential for the treatment of solid tumors, particularly in combination with inhibitors of PD-1.
Journal • PD(L)-1 Biomarker • IO biomarker
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CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule) • IL2 (Interleukin 2)
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pegenzileukin (SAR444245)
5ms
KEYNOTE-B78: A Study of SAR444245 Combined With Other Anticancer Therapies for the Treatment of Participants With Gastrointestinal Cancer (Master Protocol) (Pegathor Gastrointestinal 203) (clinicaltrials.gov)
P2, N=138, Completed, Sanofi | Terminated --> Completed
Trial completion
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MSI (Microsatellite instability)
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Keytruda (pembrolizumab) • Erbitux (cetuximab) • oxaliplatin • irinotecan • pegenzileukin (SAR444245)
12ms
A Study of SAR444245 Combined With Cemiplimab for the Treatment of Participants With Various Advanced Skin Cancers (Pegathor Skin 201) (clinicaltrials.gov)
P1/2, N=46, Terminated, Sanofi | Active, not recruiting --> Terminated; Early discontinuation based on strategic sponsor decision not driven by any safety concerns
Trial termination • Metastases
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Libtayo (cemiplimab-rwlc) • pegenzileukin (SAR444245)
12ms
KEYNOTE-B75: A Study of SAR444245 Combined With Other Anticancer Therapies for the Treatment of Participants With HNSCC (Master Protocol) (Pegathor Head and Neck 204) (clinicaltrials.gov)
P2, N=59, Terminated, Sanofi | Active, not recruiting --> Terminated; Early discontinuation based on strategic sponsor decision not driven by any safety concerns.
Trial termination
|
Keytruda (pembrolizumab) • Erbitux (cetuximab) • pegenzileukin (SAR444245)
1year
KEYNOTE-B71: A Study of SAR444245 Combined With Other Anticancer Therapies for the Treatment of Participants With Lung Cancer or Mesothelioma (Pegathor Lung 202) (clinicaltrials.gov)
P2, N=106, Terminated, Sanofi | Active, not recruiting --> Terminated; Early discontinuation based on strategic sponsor decision not driven by any safety concerns.
Trial termination
|
PD-L1 expression
|
Keytruda (pembrolizumab) • pegenzileukin (SAR444245)
1year
KEYNOTE-B78: A Study of SAR444245 Combined With Other Anticancer Therapies for the Treatment of Participants With Gastrointestinal Cancer (Master Protocol) (Pegathor Gastrointestinal 203) (clinicaltrials.gov)
P2, N=138, Terminated, Sanofi | Active, not recruiting --> Terminated; Early discontinuation based on strategic sponsor decision not driven by any safety concerns.
Trial termination
|
PD-L1 (Programmed death ligand 1) • MSI (Microsatellite instability)
|
Keytruda (pembrolizumab) • Erbitux (cetuximab) • pegenzileukin (SAR444245)
1year
Isatuximab in Combination With Novel Agents in RRMM - Master Protocol (clinicaltrials.gov)
P1/2, N=258, Recruiting, Sanofi | N=197 --> 258
Enrollment change • Combination therapy
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pomalidomide • Sarclisa (isatuximab-irfc) • evorpacept (ALX148) • Blenrep (belantamab mafodotin-blmf) • SAR439459 • pegenzileukin (SAR444245)
1year
A precision engineered interleukin-2 (IL-2) for bolstering CD8+ T- and NK-cell activity without eosinophilia and vascular leak syndrome in non-human primates. (PubMed, Cancer Res Commun)
We have created a precisely pegylated IL-2 [SAR-444245 (SAR'245) or pegenzileukin, previously THOR- 707] designed for proliferation of target CD8+ T and NK cells for anti-cancer activity, with minimal expansion of anti-target regulatory CD4+ T cells (Tregs) that counter their action, or eosinophils that trigger vascular leak syndrome (VLS)...Ex vivo, SAR'245 enhanced T-cell receptor responses alone and in combination with PD-1 inhibitors without inducing cytokines associated with cytokine release syndrome or VLS. Results support the clinical development of SAR'245 as a drug candidate for the treatment of solid tumors, alone or in combination with PD-1 inhibitory agents.
Journal
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CD4 (CD4 Molecule) • IL2 (Interleukin 2)
|
pegenzileukin (SAR444245)
1year
KEYNOTE-C39: A Study of SAR444245 With or Without Other Anticancer Therapies for the Treatment of Adults and Adolescents With Relapsed or Refractory B Cell Lymphoma (Master Protocol) [Pegathor Lymphoma 205] (clinicaltrials.gov)
P2, N=14, Terminated, Sanofi | Trial completion date: Jan 2025 --> Sep 2024 | Active, not recruiting --> Terminated; Early discontinuation based on strategic sponsor decision not driven by any safety concerns.
Trial completion date • Trial termination
|
Keytruda (pembrolizumab) • pegenzileukin (SAR444245)
1year
HAMMER: A Study Evaluating Safety and Therapeutic Activity of THOR-707 in Adult Subjects With Advanced or Metastatic Solid Tumors (THOR-707-101) (clinicaltrials.gov)
P1/2, N=250, Active, not recruiting, Synthorx, Inc, a Sanofi company | Recruiting --> Active, not recruiting
Enrollment closed • Combination therapy • Metastases
|
KRAS (KRAS proto-oncogene GTPase)
|
KRAS mutation
|
Keytruda (pembrolizumab) • Erbitux (cetuximab) • pegenzileukin (SAR444245)
over1year
KEYNOTE-B75: A Study of SAR444245 Combined With Other Anticancer Therapies for the Treatment of Participants With HNSCC (Master Protocol) (Pegathor Head and Neck 204) (clinicaltrials.gov)
P2, N=59, Active, not recruiting, Sanofi | Trial completion date: Feb 2025 --> Nov 2024
Trial completion date
|
Keytruda (pembrolizumab) • Erbitux (cetuximab) • pegenzileukin (SAR444245)
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