PROJECTS
Macrophage-based immunotherapy of platinum-resistant ovarian cancer
This project has received funding from the European Union’s Horizon 2022 research and innovation programme EIC Transition under grant agreement No. 101099232. Project started on November 1st, 2022.
Aim: The project aims to develop an innovative allogeneic, “ready-to-use” macrophage-based therapy for platinum-resistant ovarian cancer.
Planned effects: The project will generate of complete efficacy data package for the pre-clinical development of MDC-735 product, consisting of efficacy in multiple animal models for platinum-resistant ovarian cancer, PK, PD and toxicology study as well as consolidate IP and validate business case. The result of the project will be a validated cell therapy product for platinum-refractory ovarian cancer, tested for effectiveness and ready-to-use for the Phase I clinical trial.
EU funding: EUR 2,499,998.75
Project value: EUR 2,499,998.75
Website: macov.pl
Innovative cell-based glioma therapy
This project is co-financed by European Union Funds.
Aim: The aim of the project is to develop an innovative “first in class” cell therapy for glioma using macrophages loaded with a complex of protein-drug will (with cooperation with UHZ in Zurich). At the end of the project the product will be ready to enter clinical trials.
Planned effects: The main result of the project (product innovation) will be a validated glioma therapy, ready to be tested in “First in Man” clinical trial and further development by large pharmaceutical companies.
EU funding: PLN 17,359,036.24
Project value: PLN 21,890,639.07
Innovative cell therapy for pancreatic cancer
This project is co-financed by European Union Funds.
Aim:
The project aims to develop an innovative product in the form of MDC-PAN, a “first in class” breakthrough cell therapy for pancreatic cancer. Following Phase I clinical trials, the therapy will be ready for further development by large pharmaceutical companies after completing Phase II clinical trials. The planned tasks align with the goals of Cellis sp. z o.o. and its scientific partner, the Warsaw University of Life Sciences (SGGW).
Tasks:
- Task 1: Development and validation of Ft-drug complexes in MDC formulation for pancreatic cancer therapy (in vitro).
- Task 2: Preparation of macrophages for in vitro studies and assessment of the efficacy of the complexes developed in Task 1.
- Task 3: Preparation of macrophages and loading them with selected complexes to validate therapy efficacy in vivo.
- Task 4: Determination of the maximum dose of MDC-PAN, evaluation of its therapeutic efficacy in a pancreatic cancer model, and drug biodistribution (in vivo).
- Task 5: Production of MDC-PAN in GMP standards for Phase I clinical trials and generation of non-GMP material for toxicological studies.
- Task 6: Evaluation of the toxicological properties of MDC-PAN (in vivo) and preparation of the regulatory application.
- Task 7: Execution of a Phase I clinical trial in patients with pancreatic cancer.
Target groups:
Pancreatic ductal adenocarcinoma (PDAC) is the most common and deadliest form of pancreatic cancer, with a 5-year survival rate of only 11% due to its asymptomatic and aggressive nature, late diagnosis, and resistance to treatment. Currently, only 16 drugs are in Phase III clinical trials, and just two have recently been approved, impacting survival rates. MDC-PAN is designed to address critical technological challenges in PDAC treatment and significantly improve overall survival in patients.
Project value: PLN 40,900,414.58
Eligible costs: PLN 34,830,699.76
EU funding: PLN 22,343,730.25
Innovative cell therapy for head and neck cancer
This project is co-financed by European Union Funds.
Aim:
The project aims to develop an innovative product in the form of MDC-735, a “first in class” breakthrough cell therapy for head and neck cancer. Following Phase I clinical trials, the therapy will be ready for further development by large pharmaceutical companies after completing Phase II clinical trials. The planned tasks align with the goals of Cellis sp. z o.o. and its scientific partner, the Warsaw University of Life Sciences (SGGW).
Tasks:
- Task 1: Development of ferritin-drug 735 complexes.
- Task 2: Preparation of macrophages for in vivo studies.
- Task 3: Verification of MDC-735 efficacy in a head and neck cancer model and determination of drug biodistribution.
- Task 4: Production of MDC-735 in GMP standards for Phase I clinical trials and toxicology studies.
- Task 5: Evaluation of the toxicological properties of MDC-735 (in vivo) and preparation of the regulatory application.
- Task 6: Execution of a Phase I clinical trial in patients with head and neck cancer who have persistent or locally progressive disease after chemoradiotherapy or radical radiotherapy, without distant metastases.
Target groups:
Epithelial head and neck cancers—including cancers of the oral cavity, pharynx, larynx, salivary glands, auditory system, and paranasal sinuses—are a significant medical and social challenge. Due to the lack of effective therapies, patients face extremely poor prognosis, with a 5-year survival rate of approximately 30%. The innovative MDC technology aims to dramatically improve patient outcomes and has the potential for complete disease eradication.
Project value: PLN 30,213,773.26
Eligible costs: PLN 25,710,662.36
EU funding: PLN 16,281,990.78
Preparation of the technology for clinical trials of the innovative MDC-735 cell based therapy
This project is co-financed by European Union Funds.
Aim:
The project aims to develop the available preclinical data necessary to obtain approvals for conducting Phase I and II clinical trials of an innovative cell therapy: Macrophage-Drug Conjugate (MDC), targeting solid tumors. The plan includes obtaining approvals from ethical committees and regulatory authorities in Poland, Germany, and Switzerland to conduct Phase I (First in Human) clinical trials for MDC therapy. The therapy will be administered locally for the treatment of solid tumors, such as glioblastoma, bladder cancer, cervical cancer, head and neck cancer, and lung cancer. Additionally, the plan involves seeking opinions from the U.S. regulator (FDA) regarding Phase II trials for local administration and Phase I trials for intraperitoneal administration. MDC-735 – our leading product, containing a microtubule polymerization inhibitor – has the potential to revolutionize the treatment of solid tumors by enhancing therapeutic efficacy and improving patients’ quality of life. This therapy is allogeneic and cryopreserved, offering competitive advantages in the cell therapy sector. The efficacy results from preclinical studies in murine models of glioblastoma, and cancers of the lung, bladder, head and neck, pancreas, and ovary, are unprecedented.
Tasks:
The Phase I clinical trial will include 30 patients, both in monotherapy and in combination therapy with pembrolizumab. As part of the project, the team will oversee the production of a GMP-compliant product and monitor its stability for at least 12 months. Developing an effective and stable allogeneic cell therapy will be a significant achievement, addressing the limitations of autologous-based cell therapies.
Planned effects:
The project has the potential to introduce an innovative therapy to the market that could significantly improve treatment outcomes for cancer patients. The developed therapy will contribute to advancements in oncology and strengthen Poland’s position on the map of medical innovations.
