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PD-L1, PD-L2 peptides with Montanide ISA51

Phase 2

Chronic Lymphocytic Leukemia | Small molecule | Oncology |IO Biotech, Inc.|Last Updated: Feb 21, 2022

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment19

FDA Designations

No designations recorded

Clinical trial landscape

PD-L1, PD-L2 peptides with Montanide ISA51 · 1 trial · 1 indication

Phase 2 1
NCT03939234Peptide Vaccination With PD-L1 and PD-L2 Peptides in Untreated Chronic Lymphatic Leukemia.Chronic Lymphocytic Leukemia
COMPLETED19 Analytics
PHASE2COMPLETED
Peptide Vaccination With PD-L1 and PD-L2 Peptides in Untreated Chronic Lymphatic Leukemia.
Chronic Lymphocytic LeukemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Clinical response according to IW-CLL
1 year

Progressive disease (PD), stable disease (SD), partial response (PR), complete response (CR) calculated on basis of changes in circulating lymphocytes and lymphnode/spleen/liver size according to criteria from the international working group on CLL (IW-CLL).

Secondary Endpoints

Immune response by elispot
1 year
Grades of adverse events (AE)
1 year
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
VaccinationEXPERIMENTALUntreated CLL patients with unmutated IgHV gene with a cut of at maximum of 2 % mutations. According to guidelines from the European Research Initiative on CLL (ERIC).

Interventions

NameTypeDescription
PD-L1, PD-L2 peptides with Montanide ISA51COMBINATION_PRODUCTPD-L1: 19 amino acid sequence from the PD-L1 protein; PD-L2: 21 amino acid sequence from the PD-L2 protein; The peptides are dissolved in dimethyl sulphoxide (DMSO) and mixed with Montanide.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * CLL according to national guidelines (Lymphoma.dk). * Unmutated IGHV gene according to ERIC recommendations.(25) * No prior CLL directed treatment * Age ≥ 18 * Eastern cooperative oncology group (ECOG) performance status of 0 or 1 * No life-threatening conditions * Adequate bo...

Countries:Denmark
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Frequently asked questions about PD-L1, PD-L2 peptides with Montanide ISA51

What is PD-L1, PD-L2 peptides with Montanide ISA51 used for?

PD-L1, PD-L2 peptides with Montanide ISA51 is an investigational peptide vaccine being studied for high risk non-muscle invasive bladder urothelial carcinoma and chronic lymphocytic leukemia. It is also known as PD-L1/IDO Peptide Vaccine and is developed by IO Biotech, Inc. (IOBT).

What does PD-L1, PD-L2 peptides with Montanide ISA51 target?

PD-L1, PD-L2 peptides with Montanide ISA51 targets PD-L1 and PD-L2, which are immune checkpoint proteins. By vaccinating against these targets, the therapy aims to stimulate an immune response against cancer cells that express these proteins.

Who makes PD-L1, PD-L2 peptides with Montanide ISA51?

PD-L1, PD-L2 peptides with Montanide ISA51 is developed by IO Biotech, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker IOBT. The company is conducting clinical trials to evaluate the vaccine in oncology indications.

What phase is PD-L1, PD-L2 peptides with Montanide ISA51 in?

PD-L1, PD-L2 peptides with Montanide ISA51 is in Phase 2 clinical development. It is investigational and not yet approved by regulatory authorities. The vaccine is being studied in patients with high risk non-muscle invasive bladder cancer and chronic lymphocytic leukemia.

What clinical trials is PD-L1, PD-L2 peptides with Montanide ISA51 in?

PD-L1, PD-L2 peptides with Montanide ISA51 has been studied in two clinical trials. NCT03939234, a completed Phase 2 trial in chronic lymphocytic leukemia, enrolled 19 patients in Denmark. NCT05843448, a recruiting Phase 1 trial, is evaluating the vaccine with pembrolizumab in non-muscle invasive bladder cancer in the United States.

Is PD-L1, PD-L2 peptides with Montanide ISA51 the same as PD-L1/IDO Peptide Vaccine?

Yes, PD-L1, PD-L2 peptides with Montanide ISA51 is also known as PD-L1/IDO Peptide Vaccine. The alternative name reflects the vaccine's inclusion of IDO peptides, which are being studied for their immune-modulatory effects in cancer treatment.