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 for Talidox, 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 Talidox and compilation of the eCTD well underway
The clinical trial with Talidox, conducted in collaboration with the Swiss Group for Clinical Cancer Research (SAKK), has recruited 23 patients. Talidox continues to deliver good tolerability and efficacy results and final adjustments regarding indications and treatment patterns are expected to further optimize the benefit/side-effect profile. 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 Talidox with other drugs in oncology at an earlier stage of the disease in an international setting. Due to its benefit/side effect profile, Talidox is also particularly well suited for combination therapies with immune checkpoint inhibitors. Negotiations on cooperation to this effect are currently taking place. Overall, the findings of recent months confirm InnoMedica’s firm belief that Talidox can fundamentally improve cancer therapy.
Submission for Orphan Drug Designation for Talineuren as a treatment of ALS
Preclinical studies with Talineuren, InnoMedica’s drug for neurodegenerative diseases, have shown that in addition to Parkinson’s patients, good results can also be expected in the treatment of patients with amyotrophic lateral sclerosis (ALS). 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 make it easier to bring the product to market. In parallel, study protocols for the use of Talineuren in Parkinson’s disease and ALS patients are being finalized so that clinical testing in humans can begin. Dr. Michael Schüpbach, who has been working with InnoMedica on the planning of the clinical trials with Talineuren, regards the drug as a promising product for treating neurodegenerative diseases: “Orphan drug status would be a significant step for Talineuren towards a swift market approval”.
Talineuren for the 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. Talineuren is known to protect and regenerate the nervous system and thus promises important therapeutic advances in severe COVID-19 conditions. InnoMedica is in discussions with Swissmedic and physicians from the Inselspital Bern about the use of Talineuren for the treatment of such neurological symptoms. This shows a strong potential of Talineuren 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.
InnoMedica has fulfilled its responsibility as a pharmaceutical company by launching the TaliCoVax-19 vaccine project. The public interest in a Swiss vaccine encouraged InnoMedica to pursue the project even when setbacks occurred. Finally, a successful virus neutralization test conducted at the Institute of Virology and Immunology (IVI) with real COVID-19 viruses demonstrated that the liposomal technology platform can also be used in infectious diseases. In this context, the SRF health program “Puls” visited InnoMedica in Marly and interviewed Dr. Stéfan Halbherr about the vaccination project. The recordings will be broadcast in a special program on vaccination against SARS-CoV-2 on January 4, 2021.