Drugs / PolyPEPI1018
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05130060 | Jan 2022 → Jun 2023 | colon adenocarcinoma, metastatic malignant neoplasm in the colon, rectum adenocarcinoma | Mayo Clinic | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT03391232 | May 2018 → Jul 2019 | colorectal cancer | Treos Bio Zrt | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT05243862 | Jun 2022 → Jul 2024 overdue | colorectal cancer | Treos Bio Limited | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 12
| Date | Issuer | Release |
|---|---|---|
| 2026-07-02 | Treos Bio Zrt | Results Treos Bio Presents New Translational Data Showing PolyPEPI1018 Plus Anti-PD-L1 Immunotherapy Remodels the Tumor Immune Microenvironment in MSS Colorectal Cancer treostherapeutics.com ↗
Post-treatment tumor samples showed increased CD8+ T-cell density and PD-L1 expression, indicating conversion toward a more inflamed tumor microenvironment. |
| 2026-06-09 | Treos Bio Zrt | Results TREOS Bio Presents New PEPI Technology Data at EACR 2026, Including Six-Year Cancer-Free Outcome in MSS Metastatic Colorectal Cancer (mCRC) treostherapeutics.com ↗
A patient treated with PolyPEPI1018 at Mayo Clinic in 2019 remains disease-free 77.2 months later, with pathological complete response confirmed across resected tissues, including liver lesions. |
| 2025-11-06 | Treos Bio Zrt | Results TREOS Bio Announces Publication of Phase 1b Clinical Trial Results of PolyPEPI1018 Plus TAS-102 in Refractory MSS mCRC in JCO Oncology Advances treostherapeutics.com ↗
The combination achieved a 53.3% disease control rate (DCR) ; median progression-free survival (mPFS) was 4.0 months and median overall survival (mOS) was 8.7 months , representing promising improvements versus historical TAS-102 monotherapy . |
| 2024-09-09 | Treos Bio Zrt | Results New Meta-Analysis Shows Treos Bio’s Promiscuous Epitopes in Their Off-The-Shelf Colorectal Cancer Immunotherapy Produce Stronger Immune Response than Traditional Epitopes treostherapeutics.com ↗
Treos Bio announced the results of a meta-analysis from three clinical trials evaluating its investigational off-the-shelf immunotherapy, PolyPEPI1018, for the treatment of microsatellite stable metastatic colorectal cancer (MSS mCRC). |
| 2024-06-03 | Treos Bio Zrt | Results At ASCO 2024, Treos Bio Reports Key Survival Results for Chemo-Free Regimen of PolyPEPI1018 Peptide Immunotherapy and Roche’s PD-L1 Inhibitor in Late-Stage Colorectal Cancer treostherapeutics.com ↗ |
| 2023-06-05 | Treos Bio Zrt | Results Treos Bio Announces Presentation of Final Results from Phase 1b Study of PolyPEPI1018 Immunotherapy for Late-Stage Metastatic Colorectal Cancer at 2023 ASCO Annual Meeting treostherapeutics.com ↗
Final results from the study, conducted by Mayo Clinic in Minnesota, demonstrate that PolyPEPI1018 in combination with TAS-102 improved progression free-survival (PFS) and overall survival (OS) compared to historical data for standard of care TAS-102 alone. |
| 2021-08-18 | Treos Bio Zrt | Regulatory Treos Bio Announces FDA Clearance of IND Application for PolyPEPI1018 Immunotherapy for the Treatment of Metastatic Colorectal Cancer treostherapeutics.com ↗
“The acceptance of this IND for mCRC marks another milestone in the advancement of our lead cancer immunotherapy program, PolyPEPI1018,” said Dr. Christopher C. Gallen, M.D., Ph.D., Chief Executive Officer of Treos. |
| 2020-05-29 | Treos Bio Zrt | Results Treos Bio Reports Positive Final Results of Phase I/II Off-The-Shelf CRC Cancer Immunotherapy in 2020 ASCO Poster Presentation treostherapeutics.com ↗
Given the encouraging results of this clinical trial, we are moving forward with further studies of PolyPEPI1018 in conjunction with our companion diagnostic. |
| 2019-11-07 | Treos Bio Zrt | Results Treos Bio Presents Positive Data on Its Shared Antigen-Based Cancer Vaccine Against Microsatellite-Stable Metastatic Colorectal Cancer and Personalized Vaccines Against Three Metastatic Cancers treostherapeutics.com ↗
PolyPEPI1018 off-the-shelf vaccine as an add-on to maintenance therapy achieved durable treatment responses in patients with microsatellite-stable metastatic colorectal cancer patients (MSS mCRC) |
| 2019-09-26 | Treos Bio Zrt | Results Treos Bio Reports Updated Positive Results from a Phase 1/2 Clinical Trial of Precision Cancer Vaccine Plus Maintenance Therapy in Patients with Metastatic Colorectal Cancer treostherapeutics.com ↗ |
| 2019-05-28 | Treos Bio Zrt | Results Treos Bio Announces Positive Interim Results from a Phase 1/2 Clinical Trial of Precision Cancer Vaccine Plus Maintenance Therapy in Patients with Metastatic Colorectal Cancer treostherapeutics.com ↗
Preliminary results of the first part of the study are now available and results of the second part of the study are expected to be published in the third quarter of this year. |
| 2018-01-24 | Treos Bio Zrt | Regulatory Treos Bio Announces FDA Approval of IND of Its First PolyPEPI™ Precision Cancer Vaccine for Metastatic Colorectal Cancer treostherapeutics.com ↗
Treos Bio ZRT, an operating subsidiary of Treos Bio Limited, submitted the IND to the FDA on December 21, 2017 and clearance was received on January 19, 2018. |
All press releases naming this drug 16 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | PolyPEPI1018 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05243862 ↗ |
| Modality | Vaccine | “PolyPEPI1018 is an off-the-shelf, multi-peptide vaccine derived from 7 tumor-associated antigens (TAA) frequently expressed in mCRC.” PMID 35472243 ↗ Jul 2022 |
| Route | Subcutaneous | “Eleven patients with MSS mCRC received PolyPEPI1018 and Montanide ISA51VG adjuvant subcutaneously” PMID 35472243 ↗ Jul 2022 |