Phase II Study of PolyPEPI1018 Vaccine in Combination With Atezolizumab in Participants With Relapsed or Refractory Microsatellite-stable Metastatic Colorectal Cancer.

This is a multicenter, open label, phase II trial to determine the safety, tolerability, and immunogenicity and initial clinical activity of the combination treatment of PolyPEPI1018 vaccine and atezolizumab in participants with MSS CRC who have progressed on 2 or 3 prior regimens.

Start Date02 Jun 2022

Sponsor / Collaborator

Treos Bio Ltd.

[+2]

NCT05130060 / CompletedPhase 1

Phase Ib Open-Label Study to Evaluate Safety, Tolerability, Immunogenicity and Efficacy of Multiple Subcutaneous Injections of PolyPEPI1018 Vaccine as an Add-on Immunotherapy to TAS-102 in Late-Stage Metastatic Colorectal Cancer Subjects

This phase Ib trial studies the safety and side effects of a vaccine (PolyPEPI1018 vaccine) in combination with TAS-102 in treating patients with colorectal that has spread to other parts of the body (metastatic). PolyPEPI1018 peptide vaccine is used to immunize against proteins present on the surface of tumor cells. This vaccine can activate the body's immune cells, called T cells. T cells fight infections and can also kill cancer cells. TAS-102 may help block the formation of growths that may become cancer. Giving PolyPEPI1018 and TAS-102 may kill more tumor cells in patients with metastatic colorectal cancer.

Start Date10 Jan 2022

Sponsor / Collaborator

Mayo Clinic

NCT03391232 / CompletedPhase 1/2

Safety, Tolerability, Immunogenicity and Efficacy of Multiple PolyPEPI1018 Vaccinations as an Add-on Immunotherapy to the Standard-of-Care Maintenance Therapy in Subjects With Metastatic Colorectal Cancer

Phase I/II clinical trial investigates the safety, tolerability, immunogenicity and preliminary efficacy of multiple doses of PolyPEPI1018 CRC vaccine as an add-on treatment to the standard-of-care maintenance therapy in patients with metastatic colorectal cancer. Clinical responses will be evaluated by indiction of T cell responses, T lymphocyte infiltration in accessible biopsy sites, and by objective tumor responses. This study will also explore the accuracy of the predicted T cell responses in each patient using the candidate companion diagnostic test and the correlations between clinical responses and predicted T cell responses.

Start Date03 May 2018

Sponsor / Collaborator

Treos Bio Zrt

[+5]

100 Clinical Results associated with PolyPEPI 1018 CRC vaccine(Treos Bio)

100 Translational Medicine associated with PolyPEPI 1018 CRC vaccine(Treos Bio)

100 Patents (Medical) associated with PolyPEPI 1018 CRC vaccine(Treos Bio)

Literatures (Medical) associated with PolyPEPI 1018 CRC vaccine(Treos Bio)

01 Jul 2022·Clinical Cancer ResearchQ1 · MEDICINE

Safety and Activity of PolyPEPI1018 Combined with Maintenance Therapy in Metastatic Colorectal Cancer: an Open-Label, Multicenter, Phase Ib Study

Q1 · MEDICINE

Article

Author: Tőke, Enikő R. ; Wessling, Jaclynn ; Moretto, Roberto ; Csiszovszki, Zsolt ; Tóth, József ; Lőrincz, Orsolya ; Molnár, Levente ; Youssoufian, Hagop ; Graham, Rondell P. ; Mitchell, Jessica L. ; Hubbard, Joleen M. ; Cremolini, Chiara

Abstract:

Purpose::

Although chemotherapy is standard of care for metastatic colorectal cancer (mCRC), immunotherapy has no role in microsatellite stable (MSS) mCRC, a “cold” tumor. PolyPEPI1018 is an off-the-shelf, multi-peptide vaccine derived from 7 tumor-associated antigens (TAA) frequently expressed in mCRC. This study assessed PolyPEPI1018 combined with first-line maintenance therapy in patients with MSS mCRC.

Patients and Methods::

Eleven patients with MSS mCRC received PolyPEPI1018 and Montanide ISA51VG adjuvant subcutaneously, combined with fluoropyrimidine/biologic following first-line induction with chemotherapy and a biologic (NCT03391232). In Part A of the study, 5 patients received a single dose; in Part B, 6 patients received up to three doses of PolyPEPI1018 every 12 weeks. The primary objective was safety; secondary objectives were preliminary efficacy, immunogenicity at peripheral and tumor level, and immune correlates.

Results::

PolyPEPI1018 vaccination was safe and well tolerated. No vaccine-related serious adverse event occurred. Eighty percent of patients had CD8+ T-cell responses against ≥3 TAAs. Increased density of tumor-infiltrating lymphocytes were detected post-treatment for 3 of 4 patients’ liver biopsies, combined with increased expression of immune-related gene signatures. Three patients had objective response according to RECISTv1.1, and 2 patients qualified for curative surgery. Longer median progression-free survival for patients receiving multiple doses compared with a single dose (12.5 vs. 4.6 months; P = 0.017) suggested a dose–efficacy correlation. The host HLA genotype predicted multi-antigen–specific T-cell responses (P = 0.01) indicative of clinical outcome.

Conclusions::

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.

News (Medical) associated with PolyPEPI 1018 CRC vaccine(Treos Bio)

03 Jun 2024

·www.globenewswire.com

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

PolyPEPI1018 is the first cancer vaccine to demonstrate promising results when combined with a PD-(L)1 inhibitor in late-stage microsatellite stable colorectal cancer (MSS CRC), a form of cancer —representing 96% of all metastatic CRC — historically resistant to checkpoint inhibitor immunotherapy. LONDON and BOSTON, June 03, 2024 (GLOBE NEWSWIRE) -- Treos Bio Limited, a clinical-stage biotechnology company using data science and proprietary biomarkers to develop precision peptide immunotherapies, today announced the presentation of results from its phase 2 OBERTO-301 study of the company’s lead product candidate, PolyPEPI1018, in combination with atezolizumab in patients with late-stage microsatellite stable metastatic colorectal cancer (MSS mCRC) at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. PolyPEPI1018 is an off-the-shelf, multi-peptide vaccine that has previously demonstrated the ability to induce immunological responses at both the peripheral and tumor levels, effectively turning immunologically ‘cold’ tumors into ‘hot’ ones. This was observed in first-line maintenance MSS mCRC (OBERTO-101) and late-stage MSS mCRC (OBERTO-201), providing a strong rationale for testing PolyPEPI1018 in combination with PD-(L)1 inhibitors in MSS mCRC. OBERTO-301 is a multicenter, open-label, phase 2 clinical trial, conducted at the Mayo Clinic in Minnesota, Florida and Arizona, evaluating the combination treatment of PolyPEPI1018 and atezolizumab in patients with MSS mCRC who have progressed on two or three prior treatment regimens. The primary endpoint of the study is the incidence and severity of treatment-related adverse events. Secondary endpoints include objective response rate, duration of response, progression-free survival, and overall survival. Key Study Findings: Patient Enrolment and Treatment: The study enrolled 18 patients with refractory non-MSI-H metastatic colorectal cancer who were administered PolyPEPI1018 (1.2 mg) and atezolizumab (1,200 mg) every three weeks. Of these, 67% had undergone three or more prior therapy lines, and 44% had active liver metastasis.Safety and Tolerability: PolyPEPI1018 in combination with atezolizumab was well tolerated, with no unexpected toxicities or serious adverse events related to treatment.Survival Benefits: The median overall survival (mOS) was 12.8 months (95% CI 8.8 - NE) and the 12-months survival was 60%; this compares favorably to the historical data of 7.1 months and 27% respectively for atezolizumab monotherapy in a similar patient population. Differences between the survival of patients with and without liver metastasis were not statistically significant (HR: 0.58 [95% CI 0.18 - 1.90]; P=0.36): Patients without active liver metastases (NLM) had a 12-month overall survival (OS) estimate of 67% and a median OS of 16.5 months.Patients with active liver metastases (LM) had a 12-month OS estimate of 50% and a median OS of 8.6 months. Progression-Free Survival (PFS) and Disease Control Rate (DCR): The median PFS was 2.7 months (95% CI 1.4-4.0), and the DCR was 61%. No tumor responses by RECIST 1.1 were observed.Immune Response and Tumor Microenvironment: PolyPEPI1018-specific CD8+ and/or CD4+ T cell responses were detected in 13 out of 16 subjects (ex vivo FluoroSpot), complemented by humoral responses against multiple PolyPEPI1018-antigens. Patients with available biopsy pairs (n=8) showed significant increases in average PD-L1 expression (IC%, p=0.029) and CD8+ tumor infiltrating lymphocytes (TILs, p=0.019) post-treatment, demonstrating an immune conversion from ‘cold’ to ‘hot’ tumor.Correlation with PFS and Immunological Markers: Patients with increased PFS (>12 weeks) showed significant increases in both post-treatment PD-L1 expression (p=0.007) and TILs (p=0.016) versus patients with PFS ≤ 12 weeks. Pre-treatment levels were not prognostic.T Cell Responses and Survival: Patients with robust CD8+ T cell responses had improved OS compared to patients with poor immunological responses (HR=0.13, p=0.022). Dr. Joleen Hubbard, Deputy Director for Clinical Research at Allina Health Cancer Institute and principal investigator of three clinical studies with PolyPEPI1018 at Mayo Clinic, commented, “MSS mCRC patients represent the largest population of mCRC, most of whom have poor-prognostic metastatic sites, where survival beyond one year with standard care is rare. In this latest study, I was particularly intrigued by the correlative data showing that the combination of PolyPEPI1018 and atezolizumab actually increased TILs and PD-L1 expression, which correlated with improved PFS. I am enthusiastic about the potential of PolyPEPI1018 in the development of new treatment alternatives for this challenging disease.” “We are highly encouraged by the consistency observed across three clinical trials in MSS mCRC in different settings. The survival and biomarker data from this study further highlight the potential benefit of PolyPEPI1018 either as an add-on to standard-of-care or as part of a chemo-free IO-IO combination for treating refractory MSS mCRC. We look forward to progressing PolyPEPI1018 to randomized, controlled trials in combination with chemotherapy, biologics, and PD-(L)1 inhibitor,” added Christopher C. Gallen, M.D., Ph.D., CEO of Treos Bio. The poster can be accessed at http://treosbio.com/index.php/publications-2/ References: Hubbard et al, Safety and Activity of PolyPEPI1018 Combined with Maintenance Therapy in Metastatic Colorectal Cancer: An Open-Label, Multicenter, Phase Ib Study. Clin Cancer Res 2022.Hubbard et al, PolyPEPI1018 Vaccine in Combination with TAS-102 in Participants with Late-Stage Microsatellite-Stable Metastatic Colorectal Cancer (MSS mCRC): A Phase Ib Study to Evaluate Safety, Tolerability, Immunogenicity, and Efficacy (OBERTO-201). ASCO2023.Eng et al, Atezolizumab with or without Cobimetinib versus Regorafenib in Previously Treated Metastatic Colorectal Cancer (IMblaze370): A Multicentre, Open-Label, Phase 3, Randomised, Controlled Trial. Lancet Oncol 2019. About Colorectal Cancer:Colorectal cancer (CRC) is the third most common cancer and cause of cancer-related deaths in the United States and worldwide. There are approximately 1.4 million people living with colorectal cancer in the United States. Current treatments for CRC include surgery and chemotherapy in early stages, and chemotherapy, biologics, and targeted therapies in later stages. Microsatellite stable (MSS) CRC accounts for approximately 85% of all colorectal cancers and approximately 96% of all metastatic CRC. Patients with MSS CRC do not benefit from available immunotherapies. About PolyPEPI1018:PolyPEPI1018, Treos’ lead product candidate, is an immunotherapy in clinical development for the treatment of metastatic colorectal cancer, with plans to incorporate a candidate companion diagnostic in future clinical trials. The therapy is in development as an add-on to first-line maintenance therapy and to third-line treatment. PolyPEPI1018 has been developed using Treos’ proprietary PASCal computational tool to identify Personal EPItopes (PEPIs) likely to induce multiple tumor-specific T cell responses in a patient. Prior to the OBERTO-301 clinical trial, PolyPEPI1018 was evaluated in two Phase Ib clinical trials: OBERTO-101 in the first-line maintenance setting and OBERTO-201 in the advanced, refractory setting of MSS mCRC. These trials explored treatment combinations that had not been previously tested. In the first-line maintenance setting, adding PolyPEPI1018 to fluoropyrimidine and bevacizumab led to unprecedented tumor responses according to RECIST v1.1 and dose-dependent improvements in progression-free survival (PFS). To explore the potential of PolyPEPI1018 in treating advanced, refractory MSS mCRC, Treos adopted a stepwise approach. This involved initially assessing the safety, immunogenicity, and preliminary efficacy of PolyPEPI1018 as an add-on to standard chemotherapy, TAS-102 (OBERTO-201). Following this, the effect of PolyPEPI1018 in combination with an experimental immunotherapy in MSS CRC, atezolizumab, was tested in a similar patient population (OBERTO-301). Treos now plans to advance the testing of PolyPEPI1018 in a randomized, controlled phase 2 study comparing a complex chemo-immunotherapeutic regimen to standard of care. About Treos Bio Limited:Treos Bio develops precision peptide cancer immunotherapies combined with novel biomarkers using proprietary computational data science integrating HLA genetics, tumor profile, and clinical outcome of thousands of real subjects. Treos has conducted three clinical trials in the United States and the European Union of its lead candidate, PolyPEPI1018, an off-the-shelf immunotherapy for the treatment of metastatic colorectal cancer. Treos has completed preclinical development of additional off-the-shelf immunotherapies for ovarian, breast, bladder, gastric, lung cancers, and melanoma. The Company is also developing off-the-shelf immunotherapies personalized to an individual patient’s HLA genotype for several types of solid tumors. Treos has raised $45 million to date. More information can be found at www.treosbio.com. Media Contact: Daniel LevineLevine Media Group+1 (510) 280-5405danny@levinemediagroup.com

Clinical ResultImmunotherapyPhase 2ASCOPhase 3

08 May 2024

·www.globenewswire.com

Treos Bio to Present New Clinical Data on Off-the-Shelf Peptide Immunotherapy for Colorectal Cancer at 2024 ASCO Annual Meeting

LONDON and BOSTON, May 08, 2024 (GLOBE NEWSWIRE) -- Treos Bio, a clinical stage biotechnology company using data science and proprietary biomarkers to develop precision peptide immunotherapies, said investigators will present new results from a phase 2 trial of the company’s lead product candidate PolyPEPI1018 in combination with Roche’s PD-L1 inhibitor atezolizumab in patients with late-stage microsatellite stable metastatic colorectal cancer at the 2024 ASCO Annual Meeting. Colorectal cancer (CRC) is the third most common cancer and the second leading cause of cancer-related deaths worldwide, according to the World Health Organization. In the United States, there are approximately 1.4 million people living with colorectal cancer, according to the National Cancer Institute. Current treatments for CRC include surgery and chemotherapy in early stages of disease and chemotherapy, biologics and targeted therapies in later stages. Microsatellite Stable (MSS) CRC accounts for approximately 85 percent of all colorectal cancers and nearly all cases of metastatic CRC (mCRC). Patients with MSS CRC do not benefit from available immunotherapies. PolyPEPI1018, Treos’ lead product candidate, is an off-the-shelf immunotherapy in clinical development for the treatment of metastatic colorectal cancer, co-developed with a candidate companion diagnostic. The therapy is in development as a first-line maintenance therapy and as a third line treatment. The companion diagnostic uses Treos’ proprietary PASCal computational tool to identify Personal EPItopes (PEPIs) that are likely to induce antigen-specific T Cell responses in a patient. Investigators will present a poster with new data from OBERTO 301, a multicenter, open label, phase 2 trial evaluating the combination treatment of PolyPEPI1018 and atezolizumab in patients with MSS mCRC who have progressed on two or three prior treatment regimens. The primary endpoint of the study is incidence and severity of treatment related adverse events and secondary endpoints include objective response rate, duration of response, progression-free survival, and overall survival. “We are highly encouraged by the consistency observed across three clinical trials in MSS metastatic colorectal cancer in different settings and the unique ability of PolyPEPI1018 to turn ‘cold’ tumors into ‘hot’ tumors,” said Christopher C. Gallen, M.D., Ph.D., CEO of Treos Bio. About Treos Bio LimitedTreos Bio develops precision peptide cancer immunotherapies combined with novel biomarkers using proprietary computational data science integrating HLA genetics, tumor profile, and clinical outcome of thousands of real subjects. Treos has conducted three clinical trials in the United States and the European Union of its lead candidate, PolyPEPI1018, an off-the-shelf immunotherapy for the treatment of metastatic colorectal cancer. Treos has completed preclinical development of additional off-the-shelf immunotherapies in ovarian, breast, bladder, gastric, lung cancers, and melanoma. The Company is also developing off-the-shelf immunotherapies personalized to an individual patient’s HLA genotype for several types of solid tumors. Treos has raised $45 million to date. More information can be found at www.treosbio.com. Contact:Daniel LevineLevine Media Groupdanny@levinemediagroup.com(510) 280-5405

Phase 2Immunotherapy

29 Jun 2022

·www.biospace.com

Global Roundup: Italfarmaco Makes Progress against DMD, Clover Scores on Omicron

Italfarmaco Group, based in Milan, Italy, is making headway against Duchenne muscular dystrophy (DMD). The company announced positive results from the Phase III EPIDYS study assessing Givinostat, a histone deacetylase (HDAC) inhibitor that received a Rare Pediatric Disease Designation from the U.S. Food and Drug Administration. The study met its primary endpoint, a positive change from baseline in the time to climb four stairs at 18 months compared to placebo. The results demonstrated a slower decline in performing this functional task in the Givinostat-treated group. Additionally, the company noted that key secondary endpoints were also met, consistent with the primary endpoint. Givinostat continued to demonstrate a tolerability pro line with previous studies. In all, the study results show that the addition of Givinostat to steroid treatment leads to clinical benefits for DMD patients. Italfarmaco intends to submit the data to the FDA as well as European regulators for potential approval. Additionally, the company will present the results of the Phase III study for publication in a peer-reviewed journal. “These topline Phase III results in DMD add to the growing dataset we have collected over the last years which have shown positive outcomes with our investigational therapeutic candidate, Givinostat, when taken together with steroids in patients with DMD, providing new hope for boys with DMD, their families and the medical community,” Paolo Bettica, chief medical officer of Italfarmaco Group said in a statement. “There is a tremendous unmet medical need for additional drugs to treat this debilitating rare disease and with these positive results, we intend to meet with regulatory agencies to share these findings and discuss a path forward to submit the complete dataset in a marketing application for potential approval.” Elsewhere around the Globe: Clover Biopharmaceuticals: Based in Shanghai, Clover announced new positive clinical data in individuals who have received a third dose of SCB-2019 (CpG 1018/Alum) as a homologous booster against the Omicron variant of COVID-19. The third dose demonstrated a significant, 19-fold increase in neutralizing antibody levels against the Omicron BA.2 variant compared to pre-booster levels among baseline seronegative participants. Immutep Limited: Australia’s Immutep announced new data from second-line non-small cell lung cancer patients in the Phase II TACTI-002 trial will be presented at the IASLC 2022 World Conference on Lung Cancer in August. EnGeneIC: Also based in Australia, EnGeneIC, is conducting studies of its COVID-19 vaccine that it says provides immunity against all known variants. Trials have shown the novel vaccine works by stimulating an entirely different immune pathway from other vaccines, producing “high affinity” antibodies that neutralize all COVID-19 variants, EnGeneIC said. Thirty-two healthy participants received two doses three weeks apart. Of those, 27 have passed the 28-day safety assessment with no side effects. Critically, they all have high-affinity antibodies capable of neutralizing all COVID-19 mutants, including Omicron. Noema Pharma: Switzerland-based Noema’s Investigational New Drug Application for a Phase IIb study of the company’s PDE10A inhibitor gemlapodect has been greenlit by the U.S FDA. The company will evaluate the drug candidate in Childhood Onset Fluency Disorder, also known as stuttering. The Phase IIb study is expected to read out at the end of 2023. Treos Bio Limited: Based in London, Treos Bio announced the dosing of its first patient in the Phase II OBERTO 301 study of PolyPEPI1018, the company’s lead product candidate. In the trial, PolyPEPI1018 is being combined with atezolizumab, Roche’s PD-L1 inhibitor, for the treatment of patients with late-stage microsatellite stable metastatic colorectal cancer. Ixaka Ltd.: Also based in London, Ixaka Ltd. and Germany’s Minaris Regenerative Medicine GmbH have signed an agreement that enables technology transfer and clinical and commercial manufacture of REX-001, Ixaka’s lead autologous multi-cell therapy. REX-001 is being developed for the treatment of chronic limb-threatening ischemia in patients with diabetes. The scope of the manufacturing agreement includes the scale-up and technology transfer with the goal of supplying the Phase II clinical trials and supporting commercial supplies in the EU and later in the United States. Xenikos B.V.: Located in The Netherlands, Xenikos enrolled the first patient in its pivotal Phase III trial, comparing T-Guard with ruxolitinib for the treatment of patients with Grade III or IV steroid-refractory acute graft-versus-host disease following allogeneic hematopoietic stem cell transplant. Xenikos expects the data from this study to support the submission of a Biologics License Application in the U.S. based on Day 28 data from the first 150 patients. Cyxone: Sweden’s Cyxone filed a submission to the National Institute of Pharmacy and Nutrition, the Hungarian Medical Product Agency, for approval for a Phase IIb study assessing drug candidate rabeximod as a potential treatment for rheumatoid arthritis. Applications will follow this first submission to relevant regulatory authorities in other European countries, the company said. Transgene: Based in France, Transgene and Sweden’s BioInvent International AB announced positive safety and progress in the ongoing Phase I/IIa study assessing BT-001 in patients with solid tumors, including melanoma. The initial data generated in Phase I part A demonstrated that BT-001 alone is well tolerated, with first signs of anti-tumor activity in a hard-to-treat population. BT-001 is based on Transgene’s oncolytic vector and is encoding BioInvent’s proprietary anti‑CTLA‑4 antibody. Confo Therapeutics: Belgium’s Confo Therapeutics has been awarded a €1.7 million grant from Flanders Innovation & Entrepreneurship that will support its discovery programs for novel GPCR candidates with its proprietary ConfoBody technology. MRM Health: Also based in Belgium, MRM Health announced it received regulatory approval from the Federal Agency for Medicines and Health Products in Belgium to initiate a Phase II trial with the novel next-generation optimized consortium therapy, MH002, in patients with Pouchitis, inflammation of the surgically constructed pouch following colectomy. SciSparc Ltd.: Israel-based SciSparc announced that it completed the development of its top-tier drug candidate SCI-110, which will be used in its upcoming Phase IIb study. "Our singular objective in developing SCI-110 is to develop a safe and effective treatment for this devastating, unmet medical need as soon as possible; and this milestone brings us one step closer," SciSparc CEO Oz Adler said.

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100 Deals associated with PolyPEPI 1018 CRC vaccine(Treos Bio)

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic Microsatellite Stable Colorectal Carcinoma	Phase 2	US	Treos Bio Ltd.	02 Jun 2022
Metastatic Colorectal Carcinoma	Phase 2	IT	Treos Bio Zrt	03 May 2018
Metastatic colon cancer	Phase 1	US	Mayo Clinic	10 Jan 2022
Microsatellite Stable Rectal Carcinoma	Phase 1	US	Mayo Clinic	10 Jan 2022
Rectal Adenocarcinoma	Phase 1	US	Mayo Clinic	10 Jan 2022

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05243862 (Oberto-301, ASCO2024)	Phase 2	Metastatic Microsatellite Stable Colorectal Carcinoma PD-L1 expression \| PD-L1 expression	18	PolyPEPI1018	twdxjmxlfq(dmnaaiywya) = nausea, pyrexia and increased blood alkaline phosphatase ofootvdqay (wixlvpqsbz ) View more	Positive	24 May 2024
NCT05243862 (Oberto-301, ESMO2023) Manual	Phase 2	Microsatellite Stable Colorectal Carcinoma First line MSI-High \| PD-L1 expression	18	PolyPEPI1018+Atezolizumab	pmoqxjzrsl(fjmlwxlbou) = most common side effect related to treatment was Grade (Gr) 1-2 local skin reaction (n=12). Gr 3 events (n=2) at least possibly related to treatment were nausea and vomiting. xpfpdubrwe (nkgdbceyko )	Positive	22 Oct 2023
NCT05130060 (OBERTO-201, ASCO2023) Manual	Phase 1	Metastatic Microsatellite Stable Colorectal Carcinoma Second line \| Third line	15	TAS-102+PolyPEPI1018	hpnbfqmebf(vyjnutmpzt) = Gr 3 events (n = 15) at least possibly related to treatment were fatigue, decreased white blood cell, lymphocyte and neutrophil counts, nausea, diarrhea, myalgia, and maculo-papular rash. sglvihfcpc (qnpqszcqvh ) View more	Positive	31 May 2023
NCT05130060 (OBERTO-201, ASCO_GI2023) Manual	Phase 1	Metastatic Microsatellite Stable Colorectal Carcinoma MSS	15	PolyPEPI1018+TAS-102	gzwgfjiakq(wnalahhmjx) = fabjzxnhuy etgrgzklor (aakootqdwj ) View more	-	24 Jan 2023
NCT03391232 (P329 PolyPEPI1018 \| OBERTO, CTgov)	Phase 1/2	Metastatic Colorectal Carcinoma	11	PolyPEPI1018 CRC Vaccine (Single Dose of PolyPEPI1018 CRC Vaccine)	yrwieuylnz(iaxcafrolj) = ahzfbmqblu xfuwyppcww (psqozeybnk, jwkxcdkzwf - ijrediobtb) View more	-	14 Apr 2022
NCT03391232 (P329 PolyPEPI1018 \| OBERTO, CTgov)	Phase 1/2	Metastatic Colorectal Carcinoma	11	PolyPEPI1018 CRC Vaccine (Multiple Dose of PolyPEPI1018 CRC Vaccine)	yrwieuylnz(iaxcafrolj) = mrbgdzkszc xfuwyppcww (psqozeybnk, gdyelfoorx - momcrvefmd) View more	-	14 Apr 2022
NCT03391232 (ASCO2020) Manual	Phase 1	Metastatic Colorectal Carcinoma Maintenance	11	fluoropyrimidine+bevacizumab+PolyPEPI1018 + PolyPEPI1018 single dose	brvdljihyh(fkfsvswgpe) = transient skin reactions nwggtcldqi (bfydffwmhw )	Positive	25 May 2020
NCT03391232 (ASCO2020) Manual	Phase 1	Metastatic Colorectal Carcinoma Maintenance	11	fluoropyrimidine+bevacizumab+PolyPEPI1018 + PolyPEPI1018 3 doses, Q12W		Positive	25 May 2020

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