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PolyPEPI 1018
i
Other names: PolyPEPI 1018, PolyPEPI 1018 CRC vaccine, PolyPEPI1018
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Company:
Treos Bio
Drug class:
Immunostimulant
Related drugs:
10ms
A phase II, multicenter, open-label study of PolyPEPI1018 in combination with atezolizumab in participants with relapsed or refractory microsatellite-stable metastatic colorectal (MSS mCRC) cancer (Oberto-301): Initial results (ESMO 2023)
Methods Patients with MSS mCRC who have progressed on 2-3 lines of prior chemotherapy regimen received PolyPEPI1018 (1.2 mg, sc) and atezolizumab (1,200 mg, iv) Q3W. PolyPEPI1018 induced immunological responses at both peripheral and tumor level, converted "cold" tumor into "hot", although to date no responses per RECIST have been noted. The study is on-going.
Combination therapy • P2 data • Clinical • PD(L)-1 Biomarker • MSi-H Biomarker • IO biomarker • Metastases
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MSI (Microsatellite instability) • CD8 (cluster of differentiation 8)
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PD-L1 expression • MSI-H/dMMR
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Immunoscore®
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Tecentriq (atezolizumab) • Tecentriq SC (atezolizumab/hyaluronidase) • PolyPEPI 1018
10ms
OBERTO-201: A Vaccine (PolyPEPI1018 Vaccine) and TAS-102 for the Treatment of Metastatic Colorectal Cancer (clinicaltrials.gov)
P1, N=15, Completed, Mayo Clinic | Active, not recruiting --> Completed | Trial completion date: May 2025 --> Jun 2023 | Trial primary completion date: May 2024 --> Jun 2023
Trial completion • Trial completion date • Trial primary completion date • Metastases
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Lonsurf (trifluridine/tipiracil) • PolyPEPI 1018
11ms
OBERTO-201: A Vaccine (PolyPEPI1018 Vaccine) and TAS-102 for the Treatment of Metastatic Colorectal Cancer (clinicaltrials.gov)
P1, N=15, Active, not recruiting, Mayo Clinic | Trial completion date: May 2024 --> May 2025 | Trial primary completion date: May 2023 --> May 2024
Trial completion date • Trial primary completion date • Metastases
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Lonsurf (trifluridine/tipiracil) • PolyPEPI 1018
over1year
Trial in progress: A phase II, multicenter, open-label study of PolyPEPI1018 in combination with atezolizumab in participants with relapsed or refractory microsatellite-stable metastatic colorectal (MSS mCRC) cancer (Oberto-301). (ASCO-GI 2023)
P2 | "In first line metastatic MSS CRC, PolyPEPI1018 in combination with fluoropyrimidine/bevacizumab vaccine was safe and demonstrated early evidence of clinical activity. The study is open with 10 patients enrolled at time of submission. Clinical trial information: NCT05243862."
Combination therapy • P2 data • Clinical
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PD-L1 (Programmed death ligand 1) • MSI (Microsatellite instability)
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MSI-H/dMMR
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Immunoscore® IC Assay
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Avastin (bevacizumab) • Tecentriq (atezolizumab) • PolyPEPI 1018
almost2years
Safety and activity of PolyPEPI1018 combined with maintenance therapy in metastatic colorectal cancer: an open-label, multicenter, phase 1b study. (PubMed, Clin Cancer Res)
PolyPEPI1018 added to maintenance chemotherapy for patients with unresectable, MSS mCRC was safe and associated with specific immune responses and antitumor activity warranting further confirmation in a randomized, controlled setting.
P1 data • Journal • IO biomarker
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CD8 (cluster of differentiation 8)
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PolyPEPI 1018
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