Periodic Reporting for period 2 - MaxONCO (A cancer vaccine to boost body’s natural defences to fight chordoma and head and neck cancer)
Reporting period: 2021-04-01 to 2022-12-31
MaxONCO is a 36-month project (January 2020 – December 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 a Phase II clinical trial in Head and Neck cancer indication 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.
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.
The Phase II Head and Neck clinical trial has reached positive outcome. A clinical study report, providing the clinical and statistical analyses of the trial will be produced, as per protocol and applicable regulations. MaxiVAX is preparing clinical trials to test the new generation therapeutic product MaxONCO 2, involving a larger population to further test the efficacy of MaxONCO for this indication.
The aim of the MaxONCO project is to conduct a Phase II clinical trial in Head and Neck cancer indication 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.
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.
The Phase II Head and Neck clinical trial has reached positive outcome. A clinical study report, providing the clinical and statistical analyses of the trial will be produced, as per protocol and applicable regulations. MaxiVAX is preparing clinical trials to test the new generation therapeutic product MaxONCO 2, involving a larger population to further test the efficacy of MaxONCO for this indication.
To date, 16 Head and Neck cancer patients have been treated with MaxONCO 1 in the Phase II clinical trial and the trial has reached positive outcome.
The next important milestone to achieve is the lock of database, upon which further data analysis depend. MaxiVAX is overseeing the final cleaning, reconciliation, and verifications activities of the clinical database.
MaxiVAX and SOHUG (seconded personnel) have generated a large amount of translational research data on the biological samples from participating HNSCC patients in our trials (Phase I and Phase II Head and Neck). The aim of this translational research is to obtain molecular (biomarkers) and cellular information. The biomarkers can be used to select patients most likely to benefit from MaxONCO treatments, forecast future health status and survival.
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 and process development have been achieved in order to develop a robust scale-up GMP manufacturing process.
Cytotoxicity and chemical characterization of the new capsules remains compliant and valid. MaxiVAX is committed to fulfil all safety conditions prior to starting MaxONCO 2 clinical trials.
To date, a total of 50 patients were treated with MaxiVAX’s first-generation therapy MaxONCO 1 in this phase II trial andthe previously completed phase I trial. Through these trials, we have been gathering substantial clinical and immunological data. The generated data on our first-generation therapy will be invaluable in driving the company’s future clinical development strategy.
The next important milestone to achieve is the lock of database, upon which further data analysis depend. MaxiVAX is overseeing the final cleaning, reconciliation, and verifications activities of the clinical database.
MaxiVAX and SOHUG (seconded personnel) have generated a large amount of translational research data on the biological samples from participating HNSCC patients in our trials (Phase I and Phase II Head and Neck). The aim of this translational research is to obtain molecular (biomarkers) and cellular information. The biomarkers can be used to select patients most likely to benefit from MaxONCO treatments, forecast future health status and survival.
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 and process development have been achieved in order to develop a robust scale-up GMP manufacturing process.
Cytotoxicity and chemical characterization of the new capsules remains compliant and valid. MaxiVAX is committed to fulfil all safety conditions prior to starting MaxONCO 2 clinical trials.
To date, a total of 50 patients were treated with MaxiVAX’s first-generation therapy MaxONCO 1 in this phase II trial andthe previously completed phase I trial. Through these trials, we have been gathering substantial clinical and immunological data. The generated data on our first-generation therapy will be invaluable in driving the company’s future clinical development strategy.
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 I - III clinical trials with MaxONCO 2, MaxiVAX’s 2nd generation therapeutic product, 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 I - III clinical trials with MaxONCO 2, MaxiVAX’s 2nd generation therapeutic product, 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.