As a result of the successful financing round of CHF 10 million in April 2020, the InnoMedica team was able to reach important milestones in the main projects in oncology and neurology in the last months and make progress in the vaccine project with the financial resources available:
Successful completion of patient recruitment in the Phase I study in oncology
According to the protocol, a total of 21 patients have been treated with InnoMedica's chemotherapy in the Phase I clinical trial to date. After the maximum dose was set, recruitment progressed rapidly in the first half of 2020, hardly affected by the COVID-19 pandemic, and more patients with breast and ovarian cancer were enrolled in the study.
To gather further data, an extension of the Phase I study was applied for in collaboration with the Swiss Group for Clinical Cancer Research (SAKK) and implemented with immediate effect. This will allow the recruitment of 9 additional patients who will participate in the study, providing more information on the indication, treatment regimen and success of the treatment.
Pathway to approval and future planned studies in oncology
With a view to the imminent completion of the successful Phase I study, work on the submission of the Electronic Common Technical Document (eCTD) and the application for marketing authorization for the chemotherapy is already in progress. The Regulatory team is identifying work still to be performed, such as validations or technical adaptations, and is compiling the necessary data and information on preclinical, clinical, manufacturing and marketing aspects in the eCTD dossier. According to Swissmedic, InnoMedica's cancer drug is considered a known active substance with innovation and, according to the EMA guidelines, a hybrid marketing authorization is to be pursued (known active substance, improvements in the transport system). Both approaches tend to lead to a faster approval process compared to a completely new drug. Complementary to the eCTD application, further clinical studies in collaboration with SAKK are already in development in order to investigate the pharmacokinetics (distribution in the blood) in a first study and the efficacy compared to the standard of care in a second step.
Neurology application ready to apply for the first clinical trial
After obtaining preclinical trial results in a Parkinson's disease model, InnoMedica aims to investigate its neurology product also in clinical trials in Parkinson's disease. After consultation with the Principal Investigator, Michael Schüpbach, MD, it is planned to submit the application for the first clinical trial in neurology to Swissmedic before the end of the year. In the meantime, three batches of the product have been produced under GMP conditions in the nanofactory in Marly and the documents for the study application can now be created.
Expansion of the infrastructure in Marly
In view of the upcoming possible market approval in oncology as well as the planned clinical trial in neurology, it is valuable that InnoMedica has started early with the expansion of the infrastructure. Despite difficult circumstances due to the COVID-19 pandemic, Cleanroom II was completed in summer 2020. Last deliveries of components and qualification of equipment are still outstanding; thereafter the final inspection can take place. With the acceptance of Cleanroom II by Swissmedic, one of the most important prerequisites for the scale-up of the batch size, which affects all products simultaneously, has been met.
Growth of the team at InnoMedica
Since the beginning of the year InnoMedica has welcomed 13 new employees to the team. With the growing staff and now 36 employees, the fluctuation has increased somewhat. However, we are pleased that InnoMedica has highly qualified and motivated employees in all areas (Process Engineering, Production, Quality Control & Analytics, Quality Assurance, Research & Development, Medical Affairs, Regulatory Affairs, Finance, Legal, IT and HR).
Concerned about the great consequences of the COVID-19 pandemic for health and economy, InnoMedica presented a vaccination project in April 2020. Based on InnoMedica’s technology platform, a liposome is used as carrier for the vaccine protein. In a first prototype, the proteins were produced in bacterial cultures of E. coli based on synthetic genetic material. InnoMedica is now investigating the suitable production of the proteins in higher developed cells as well as the construction of a mRNA-based liposomal Corona vaccine. Both methods are known and are being pursued also by other pharmaceutical companies. InnoMedica's goal is to build a dummy virus from the vaccine and the liposome that can be produced in large quantities and is well tolerated, thanks to its already well-developed liposome technology.
There is good collaboration with the FOPH (Federal Office of Public Health) and Swissmedic regarding the vaccination project. The possibility of start-up financing by the Swiss Confederation was also discussed in this context. However, the view has prevailed that such a project will only be viable once its feasibility has been demonstrated in the virus neutralization test with Corona viruses. This places higher demands on the financing by the investors, but also secures the company’s freedom of decision and ability to react quickly and clearly separates the state and the economy.
Though InnoMedica still has considerable cash and cash equivalents of over CHF 18 million as of today’s date, a cautious and well-considered approach to investments is appropriate. The continuation of all three product lines (oncology, neurology and infectiology) with limited budgets will result in higher costs and require more time. At the same time diversification allows a reasonable sharing of risk and thus ensures greater security for medium and long-term success. InnoMedica continues to build its pipeline and develop innovations such as personalization using Companion Diagnostic.
At an annual expense of approximately CHF 10 million, a capital increase in spring 2021 at the latest seems inevitable in this context. InnoMedica is currently discussing different financing options with larger investors in a preliminary round, possibly with the prospect of a subsequent IPO. Regardless of the form of capital increase, the subscription rights of the shareholders remain guaranteed. Tradability on the stock exchange does, however, require that larger liquid holdings be available in the company, at least CHF 50 – 80 million at the discretion of management, in order to guarantee the long-term stability and security of the share investment. An alternative is an early financing of CHF 12 – 15 million, which would offer good chances of the application in oncology being the first product to be launched on the market and reaching break-even.