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BITAP

How do cancer cells evade the immune system?

Cancer cells possess remarkable abilities and employ various strategies to camouflage themselves and evade detection by our immune system. These mechanisms not only help them avoid attacks from immune cells but also enable them to actively suppress immune responses. As a result, treating cancer remains one of the most challenging areas in medicine. Despite significant advancements, therapeutic success is often still limited.

BioInformatic Tumor Address Peptides

Individualized immunotherapy based on tumor-neoantigens

Each tumor has a unique genetic signature that distinguishes it from healthy tissue and varies between patients. Our innovative approach utilizes patient-specific, neoantigen-based peptides to generate a potent immune response against the tumor. This is enabled by our proprietary bioinformatics platform, which integrates next-generation sequencing (NGS) analysis of tumor and reference samples with advanced machine learning models to accurately predict and optimize neoantigen selection. One application of this approach is INT-005, a personalized peptide cancer immunization designed for pancreatic cancer. Developed using NGS data and our in-house bioinformatics pipeline, INT-005 incorporates multiple modified neoantigen peptides to enhance immune activation. It is intended for use in combination with INT-004 (Pan-BITAP, see below) and standard-of-care (SoC) therapies, providing a tailored and highly targeted immunotherapeutic strategy.

Personalized BITAP workflow

 Targeting each tumor's unique neoantigen signature

1

The patient's tumor tissue, along with peripheral blood,

is collected for genetic analysis.

2

Next-Generation Sequencing (NGS) of the patient's genetic material is performed to analyze somatic mutations and RNA expression levels.

3

Using bioinformatic analysis, tumor antigens and HLA‑specific neoepitopes are selected and prioritized.

4

The identified epitopes are modified and designed as a series of synthetic peptides to enhance immune system stimulation.

5

The designed peptides corresponding to the selected neoantigens are chemically synthesized, following standard and regulated manufacturing procedures.

6

The peptides contain tumor antigens and undergo a fill‑and‑finish process to formulate a personalized immunization.

7

Immunogenicity testing involves assessing each peptide in the pool through both in vitro and subsequent ex vivo assays.

8

The peptide pool is combined with adjuvants at the bedside to prepare it for subcutaneous injection.

The Mechanism of BITAP Immunization

From bedside to bench and back

1

Subcutaneous injection of the finalized BITAP formulation.

2

The neopeptides are captured by antigen-presenting cells (APCs) for immune processing.

3

APCs migrate to the lymph nodes and activate T cells by presenting neoantigens to T cell receptors (TCRs).

4

The activated T cells then target and destroy tumor cells displaying these specific neoantigens.

5

As tumor cells are destroyed, more neoantigens are released and captured by APCs, leading to the expansion of the immune response to secondary epitopes.

Real-World Clinical Insights

Data from Individual Treatment Attempts (ITAs)

We are conducting multiple individual treatment attempts (ITAs) for various entities under the German "Heilversuche" framework, which permits physicians to use unapproved therapeutic approaches when standard therapies have failed or are unavailable. These ITAs are ethically justified as an ultima ratio method and are the full responsibility of the treating physicians.


As published examples, our study in Vaccines details a personalized peptide immunization for a patient with HER2-positive metastatic breast cancer, leading to improved survival. Similarly, our Frontiers in Immunology publication describes an individualized neoantigen peptide immunization for a patient with metastatic pancreatic cancer, designed using tumor and liquid biopsy sequencing. The patient exhibited a positive immune response, demonstrating the potential of our approach.


Beyond their immediate clinical impact, these ITAs allow us to gather valuable data, refine our methodologies, and continuously improve our bioinformatics platform for future personalized therapies. All ITAs are conducted in accordance with German regulatory requirements for individualized treatment (Heilversuche), under physician supervision with patient safety as the primary focus, and with informed consent and comprehensive patient information.

Pan-BITAP for immediate treatment

An off-the-shelf solution suitable for a large subset of patients

Pan-BITAP is a broad-spectrum cancer immunotherapy designed around shared tumor-specific (TSA) and tumor-associated antigens (TAA) across multiple cancer types. Using our proprietary algorithm and a wealth of publicly available and in-house generated data, we have identified and formulated these antigens into off-the-shelf neo-peptides. One application of this approach is INT-004, a cancer immunization under development for pancreatic cancer. The selected TSA and TAA peptides are modified/conjugated to enhance immunogenicity across major HLA subtypes and can be used therapeutically and preventively. INT-004 is being developed for combination with the standard of care (SoC) and immune checkpoint inhibitors (ICIs), with patient eligibility determined through molecular diagnostics. By leveraging shared tumor antigens, Pan-BITAP aims to reduce both the cost and time required for personalized cancer vaccines, making immunotherapy accessible to a larger patient population.

The Pan-BITAP Development Pipeline

From Common Mutations to Effective Treatment

1

We mine a wealth of publicly available data, as well as an increasing body of in-house generated NGS data. 

2

Our proprietary machine learning approach identifies optimal neoantigens by analyzing shared antigens across multiple cancer types.

3

We design entity-specific peptide platforms optimized for broad immune activation.

4

We evaluate immunogenicity in vitro using our preclinical testing platform.

5

We confirm preclinical efficacy in cell-based assays and mouse models.

6

We select the final cancer indication based on preclinical data and unmet medical needs.

7

The final vaccine is manufactured under GMP conditions, following our specifications.

8

We are developing a cost-effective PCR test to identify patients likely to benefit from Pan-BITAP.

9

Pan-BITAP is used therapeutically to treat patients based on their neoantigen profile.

10

Pan-BITAP is also considered for preventive use to reduce post-operative cancer recurrence.

1

We mine a wealth of publicly available data, as well as an increasing body of in-house generated NGS data. 

2

Our proprietary machine learning approach identifies optimal neoantigens by analyzing shared antigens across multiple cancer types.

BIVAP

Peptide-based Immunotherapy Against Infectious Diseases

Building on the success of our BITAP platform, we have developed BIVAP (BioInformatic Virus Address Peptides), a proprietary bioinformatics algorithm designed for the rapid identification of viral epitopes. This cutting-edge system accelerates the development of prophylactic vaccines, enabling a swift response to emerging outbreaks. BIVAP-generated epitopes, formulated as modified or conjugated peptides, are engineered to elicit strong humoral and cellular immune responses. One application of this technology is BIVAP-COVID-19, which has been developed and pre-clinically validated as a proof of concept. Beyond COVID-19, BIVAP holds significant potential for vaccine development against a broad range of infectious diseases.

BISS

Bioinformatics and Epitope Prediction as a Service

The development of our BITAP and Pan-BITAP platforms has provided us with significant advantages in epitope prediction, enabling more precise and reliable identification of immunogenic targets. We are excited to offer these capabilities as a service partner, helping researchers and clinicians harness the power of bioinformatics for therapeutic innovation.


BISS delivers innovative bioinformatics services and software solutions tailored for personalized medicine. With the rapid evolution of next-generation sequencing (NGS) technologies and the increasing availability of online data, researchers and clinicians face both immense opportunities and complex analytical challenges. Our mission is to bridge this gap by providing state-of-the-art computational methods and customized analytical workflows designed to meet the unique demands of each research question.


With BISS, we specialize in multi-omics analysis and AI-driven biomarker discovery, supporting the development of personalized therapeutic strategies. Our advanced algorithms and machine-learning pipelines have been successfully applied across a range of diseases, with a particular focus on oncology, helping to unlock new insights and treatment possibilities.