BITAP
Individualized peptide immunotherapy
Prostate, pancreatic and breast cancer
Individual treatment experience3 published case reports
Published case reportsPipeline
Our development
programs.
Our lead program is PanBITAP for secondary prevention in high-risk prostate cancer after primary therapy. The pipeline also includes individualized BITAP treatment experience and two further PanBITAP indications in target evaluation.
Current development stageIndividual treatment experience
| Program | Indication | Target evaluation | Preclinical | Phase I | Phase II | Phase III |
|---|---|---|---|---|---|---|
BITAPIndividualized peptide immunotherapy | Prostate, pancreatic and breast cancer | Individual treatment experience3 published case reports Published case reports | ||||
PanBITAPFixed-composition peptide vaccine | High-risk prostate cancer after primary therapy | Preclinical validation Phase I proposed; subject to protocol and regulatory review. | ||||
PanBITAPFixed-composition peptide vaccine | Undisclosed indication 01 | Bioinformatic target evaluation | ||||
PanBITAPFixed-composition peptide vaccine | Undisclosed indication 02 | Bioinformatic target evaluation | ||||
PanBITAP
Fixed-composition peptide vaccine
High-risk prostate cancer after primary therapy
Preclinical validation
Phase I proposed; subject to protocol and regulatory review.
PanBITAP
Fixed-composition peptide vaccine
Undisclosed indication 01
Bioinformatic target evaluation
PanBITAP
Fixed-composition peptide vaccine
Undisclosed indication 02
Bioinformatic target evaluation
Individual treatment attempts are distinct from clinical trials. PanBITAP is in preclinical development; Phase I is proposed and has not started.
Lead program · Preclinical
PanBITAP for
prostate cancer.
PanBITAP is our fixed-composition peptide vaccine in preclinical development for high-risk prostate cancer after primary therapy.
Secondary prevention
Our goal is to help the immune system recognize and control residual cancer cells after primary therapy, before the cancer returns.
Primary therapy can leave microscopic cancer cells below imaging detection. We are developing PanBITAP for this minimal residual disease (MRD) setting, aiming for immune control while tumor burden is low and before macroscopic recurrence.
Clinical rationale
Recurrence risk after primary therapy
Published surgical cohorts show substantial differences in biochemical recurrence risk after prostatectomy. These data support the clinical rationale for secondary prevention.
Estimated 5-year biochemical recurrence-free survival
European CAPRA-S validation · n = 14,532
CAPRA-S score
Tilki et al. · J Urol. 2015 (opens in a new tab)A broader high-risk cohort
55.2%BCR-free at 2 years
After prostatectomy in two French centers, including patients with positive lymph nodes (pN1).
Beauval et al. · BMC Urol. 2016 (opens in a new tab)SEARCH analyses
Fischer et al.
n = 4592-year BCR risk
14–66%
Across pathological Gleason 8–10 subgroups, depending on surgical margins, extracapsular extension and seminal vesicle invasion.
Fischer et al. · BJU Int. 2016 (opens in a new tab)Simon et al.
n = 4113-year BCR risk
~50% vs ~12%Simon et al. · BJU Int. 2016 (opens in a new tab)
Higher-risk pathology subgroup versus the remaining patients, despite undetectable postoperative PSA. All patients had adverse pathology.
Subgroup definition
The higher-risk subgroup had Gleason ≥8 with positive margins or extraprostatic extension, or seminal vesicle invasion. Postoperative PSA was <0.01 ng/mL.
PanBITAP design
One formulation for eligible patients
Shared prostate cancer targets in a predefined peptide panel, designed for broad HLA coverage and batch manufacturing.
- 01
Patient cohort
Shared prostate tumor antigens and frequent relapse-related mutations.
- 02
Bioinformatics platform
Cohort immunogenicity ranking and broad HLA-binding coverage.
- 03
Fixed peptide panel
One predefined panel, with in silico design and in vitro validation.
- 04
Batch production
Designed for GMP batch manufacturing, with the same composition for eligible patients.
Evidence-guided patient selection
Clinical recurrence risk, tumor antigen evidence, peptide–HLA presentation and functional immune testing guide patient-selection research. Preclinical and patient-level data, together with regulatory advice, will determine the final population, eligibility criteria and protocol.
The proposed Phase I study will assess safety, tolerability and immunogenicity. PanBITAP remains preclinical; recurrence prevention is the development goal and has not been established clinically.
Peptide design and functional testingDevelopment priorities
Path to clinical development.
- 01Current focus
Functional candidate validation
Generate immunogenicity data and refine candidate selection, including patient-derived testing.
- 02Next milestone
Composition and formulation lock
Define the fixed PanBITAP peptide panel and formulation using the functional evidence.
- 03Planned
Nonclinical package and clinical supply
Complete the required safety and CMC work and prepare GMP clinical material.
- 04Planned
Regulatory submission and Phase I
Submit the clinical package and prepare the study assessing safety, tolerability and immunogenicity.
The clinical program follows the required nonclinical and manufacturing package, regulatory authorization and site readiness.
