Periodic Reporting for period 1 - MaxONCO (A cancer vaccine to boost body’s natural defences to fight chordoma and head and neck cancer)
Reporting period: 2020-01-01 to 2021-03-31
MaxONCO is a 30-month project (January 2020 – June 2022), funded by the European Commission within Horizon 2020 to support the clinical development and commercialization of a cancer immunotherapy product created by MaxiVAX, a clinical stage (Phase II) Swiss biotech company working to develop best in-class therapeutics for the treatment of various cancers.
The aim of the MaxONCO project is to conduct 2 phase 2 clinical trials in two indications (Head and Neck cancer and Chordoma) and prepare for the manufacturing and commercialization of MaxONCO, MaxiVAX’s first immunotherapy product.
Head and neck cancer is one of the most common malignancies worldwide, accounting for more than 650,000 new cases and 380,000 deaths annually. Despite advances in surgical, radiation techniques, chemotherapy and monoclonal antibodies in the treatment of advanced head and neck cancer; it remains that about 50% of patients with this condition will die within 5 years.
Chordoma is a rare tumour that develops in the bones of the skull and the spine. Currently, there are no drugs approved for the treatment of Chordoma. Therefore, there is an urgent need for a systemic treatment for this type of cancer. However, the Phase II Chordoma study planned within the MaxONCO project is currently on hold due to several reasons, which are detailed in the technical report.
MaxiVAX’s therapy uses the patient’s own natural addressing direct immunization against the patients’ own cancer cells, making it applicable to multiple type of cancers including head and neck cancer, and chordoma. The anti-cancer therapy consists of two components: 1) biocompatible capsules, loaded with a genetically modified cell-line that secretes a strong immune-booster GM-CSF (granulocyte macrophage colony stimulating factor) and 2) irradiated patients’ tumour cells, isolated from patients which serve as tumour antigens. To induce an efficient anti-tumour response against the patients’ own tumour cells, the encapsulated GM-CSF secreting cells are implanted subcutaneously at the site of tumour-cell vaccination.
If the results from Phase II Head and Neck are positive, MaxiVAX will seek to start a Phase III trial, involving a larger population to further test the efficacy of MaxONCO for this indication.
The aim of the MaxONCO project is to conduct 2 phase 2 clinical trials in two indications (Head and Neck cancer and Chordoma) and prepare for the manufacturing and commercialization of MaxONCO, MaxiVAX’s first immunotherapy product.
Head and neck cancer is one of the most common malignancies worldwide, accounting for more than 650,000 new cases and 380,000 deaths annually. Despite advances in surgical, radiation techniques, chemotherapy and monoclonal antibodies in the treatment of advanced head and neck cancer; it remains that about 50% of patients with this condition will die within 5 years.
Chordoma is a rare tumour that develops in the bones of the skull and the spine. Currently, there are no drugs approved for the treatment of Chordoma. Therefore, there is an urgent need for a systemic treatment for this type of cancer. However, the Phase II Chordoma study planned within the MaxONCO project is currently on hold due to several reasons, which are detailed in the technical report.
MaxiVAX’s therapy uses the patient’s own natural addressing direct immunization against the patients’ own cancer cells, making it applicable to multiple type of cancers including head and neck cancer, and chordoma. The anti-cancer therapy consists of two components: 1) biocompatible capsules, loaded with a genetically modified cell-line that secretes a strong immune-booster GM-CSF (granulocyte macrophage colony stimulating factor) and 2) irradiated patients’ tumour cells, isolated from patients which serve as tumour antigens. To induce an efficient anti-tumour response against the patients’ own tumour cells, the encapsulated GM-CSF secreting cells are implanted subcutaneously at the site of tumour-cell vaccination.
If the results from Phase II Head and Neck are positive, MaxiVAX will seek to start a Phase III trial, involving a larger population to further test the efficacy of MaxONCO for this indication.
To date, 9 Head and Neck cancer patients have been treated with MaxONCO in the Phase II clinical trial. Preliminary clinical results are encouraging, with patients surviving beyond the primary efficacy end-point of 6 months.
Despite the broad-ranging challenges presented by the COVID-19; all 5 clinical sites across Switzerland have been trained and activated. MaxiVAX has also provided refreshers training on the procedure of MaxONCO treatment to study teams after patient enrolment suspension due to the COVID-19 pandemic.
MaxiVAX is regularly monitoring the clinical trial by working closely with Principal Investigators, Chief Investigator and Swiss Group for Clinical Cancer Research (SAKK) in order to ensure patient safety and improve patient recruitment rate.
The GMP manufacturing and biosafety characterization of the myoblast cell-line (for the production of GM-CSF) as well as the cytotoxicity and chemical characterization of the new capsules have been completed. Both the myoblast cell-line and new capsules are validated for the commercial manufacturing of “MaxONCO-2”.
MaxiVAX SA, and Minaris Regenerative Medicine GmbH (“Minaris”), a leading contract development and manufacturing service provider for the cell and gene therapy industry, have entered into a manufacturing agreement for MaxONCO 2. Minaris is responsible for the GMP manufacturing, freezing and shipping of the MaxONCO 2 capsules. Process transfer from MaxiVAX to Minaris has been fully achieved. Process development is underway in order to develop a robust scale-up GMP manufacturing process.
Despite the broad-ranging challenges presented by the COVID-19; all 5 clinical sites across Switzerland have been trained and activated. MaxiVAX has also provided refreshers training on the procedure of MaxONCO treatment to study teams after patient enrolment suspension due to the COVID-19 pandemic.
MaxiVAX is regularly monitoring the clinical trial by working closely with Principal Investigators, Chief Investigator and Swiss Group for Clinical Cancer Research (SAKK) in order to ensure patient safety and improve patient recruitment rate.
The GMP manufacturing and biosafety characterization of the myoblast cell-line (for the production of GM-CSF) as well as the cytotoxicity and chemical characterization of the new capsules have been completed. Both the myoblast cell-line and new capsules are validated for the commercial manufacturing of “MaxONCO-2”.
MaxiVAX SA, and Minaris Regenerative Medicine GmbH (“Minaris”), a leading contract development and manufacturing service provider for the cell and gene therapy industry, have entered into a manufacturing agreement for MaxONCO 2. Minaris is responsible for the GMP manufacturing, freezing and shipping of the MaxONCO 2 capsules. Process transfer from MaxiVAX to Minaris has been fully achieved. Process development is underway in order to develop a robust scale-up GMP manufacturing process.
MaxiVAX’s mission is to develop treatments that will be instrumental in improving and saving many patients’ lives.
The results of the Phase II Head and Neck clinical trial will provide valuable efficacy, safety and quality-of-life data. Positive findings will lead to Phase III clinical trial, that may ultimately lead to a much-needed new efficacious treatment option for patients with Head and Neck cancers.
Head and neck cancer is the sixth most common cause of cancer death worldwide. Its treatment is complex, requiring a multi-modality approach. However, despite many approved therapies available for this disease, many patients progress and succumb to the cancer.
MaxONCO is a targeted cancer therapy with promising efficacy and proven safety profile. While MaxONCO could be effective as a monotherapy option, MaxONCO could be also combined (due to its proven safety profile) with other immunotherapy agents so that maximum therapeutic benefits can be obtained for the patients.
The results of the Phase II Head and Neck clinical trial will provide valuable efficacy, safety and quality-of-life data. Positive findings will lead to Phase III clinical trial, that may ultimately lead to a much-needed new efficacious treatment option for patients with Head and Neck cancers.
Head and neck cancer is the sixth most common cause of cancer death worldwide. Its treatment is complex, requiring a multi-modality approach. However, despite many approved therapies available for this disease, many patients progress and succumb to the cancer.
MaxONCO is a targeted cancer therapy with promising efficacy and proven safety profile. While MaxONCO could be effective as a monotherapy option, MaxONCO could be also combined (due to its proven safety profile) with other immunotherapy agents so that maximum therapeutic benefits can be obtained for the patients.