In 2020, the InnoMedica team, now counting 39 employees, was able to reach important milestones. The increase in personnel was a reflection of the company’s development: in oncology, for example, the company is working towards market approval, and in neurology, a trial submission is imminent. The production facility in Marly was also further expanded. The construction of a new, larger Cleanroom II is intended to ensure production volumes for a future market launch of the first drug.
Clinical study with cancer therapy and compilation of the eCTD well underway
The clinical trial with the oncology product, conducted in collaboration with the Swiss Group for Clinical Cancer Research (SAKK), has recruited 23 patients. In parallel, the compilation of the marketing authorization dossier (eCTD) is progressing well. The goal is to submit the complete dossier with preclinical, clinical, manufacturing and marketing data to Swissmedic, the Swiss regulatory authority for medicinal products, in the next six months. Further studies are planned that will compare the application with other drugs in oncology at an earlier stage of the disease in an international setting.
Submission for Orphan Drug Designation as a treatment of ALS
Preclinical studies with InnoMedica’s drug for neurodegenerative diseases have shown that in addition to Parkinson’s patients, a treatment of patients with amyotrophic lateral sclerosis (ALS) could also have potential. As ALS is a rare disease with virtually no treatment available to date, InnoMedica immediately applied for “orphan drug” status with the EMA and FDA, which will facilitate cooperation with the authorities and thus could make it easier to bring the product to market. In parallel, study protocols for the use of the product in Parkinson’s disease and ALS patients are being finalized so that clinical testing in humans can begin.
Potential treatment of COVID-19 patients with severe neurological symptoms
80% of COVID-19 patients develop neurological symptoms over the course of the disease, which in severe cases lead to longer hospitalization and higher mortality. There is a corresponding acute medical need for neuroprotective and neuroregenerative therapies. InnoMedica is in discussions with Swissmedic and physicians from the Inselspital Bern about the use of InnoMedica's application for the treatment of such neurological symptoms. This shows a strong potential of the product to provide a therapeutic application for a wide range of neurodegenerative symptoms of different diseases.
Extraordinary General Meeting of December 10, 2020
For the vote on the amendments to the Articles of Association, the Board of Directors of InnoMedica Holding convened an Extraordinary General Meeting on December 10. Due to the Corona pandemic, this took place under exclusion of the shareholders, whereby shareholders could exercise their rights in writing. Both proposals of the Board of Directors were approved – the increase of the authorized capital to CHF 202,888.80 / 2,028,888 shares with 99.7% and the amendment of the Articles of Association in connection with the conversion of bearer shares into registered shares with 99.9%. The Board of Directors thanks the shareholders for their active participation.
The conversion of the electronic bearer shares (ISIN: CH0498286258) into registered shares (ISIN: CH0558973902) will be implemented as of December 30, 2020. For the management of the shareholder register with interface to SIX SIS, InnoMedica will cooperate with Nimbus AG.