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 Talidox and Talineuren in the last months and make progress in the project TaliCoVax-19 with the financial resources available:
Successful completion of patient recruitment in the Phase I study with Talidox
According to the protocol, a total of 21 patients have been treated with Talidox in the Phase I clinical trial to date. After the maximum dose was set at 45 mg/m2, 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. The positive impression of Talidox therapy gained from the SAKK interim report was strengthened by further treatments at therapy-relevant doses. It appears that Talidox allows a higher dosage than Doxil, but is gentler on the patient. Much attention from the medical profession was attracted by the current results regarding efficacy that include cases of significant tumor shrinkage through treatment with Talidox.
Amendment for the treatment of additional patients with Talidox put into effect
To further document the efficacy, 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 benefit from participation in the study, providing more information on the indication, treatment regimen and success of the treatment.
Pathway to approval and future planned studies with Talidox
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 Talidox 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, Talidox 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 provide better evidence of its pharmacokinetics (distribution in the blood) in a first study and its efficacy compared to the standard of care (Caelyx or Paclitaxel) in a second step.
Talineuren ready to apply for the first clinical trial
With additional preclinical study results, the high potential of Talineuren, which can cross the blood-brain barrier and pursues a regenerative approach to neuro degenerative diseases, is further demonstrated. Both results of Talineuren in the preclinical Parkinson’s model and clinical data on the effect of GM1 in Parkinson’s patients impressively show what the use of Talineuren could imply for these patients. After consultation with the Principal Investigator, Michael Schüpbach, MD, it is planned to submit the application for the first clinical trial with Talineuren to Swissmedic before the end of the year. In the meantime, three Talineuren batches have been produced under GMP conditions in the Marly Manufacturing Unit and the documents for the study application can now be created.
Preclinical study results with Talineuren on ALS successfully replicated
Following initial positive preclinical study data in Parkinson’s models, Talineuren has now also been used in preclinical studies on amyotrophic lateral sclerosis (ALS). This indication paves the way for Talineuren to apply for Orphan Drug Status, which supports faster marketing approval for drugs. Since ALS is merely poorly treatable today, drug development of Talineuren may be especially fast in this indication because direct comparison to established treatments may be omitted. The repeatedly strong results in the ALS model confirm InnoMedica’s decision to apply for a clinical trial with Talineuren as early as this year, which according to the scientific advice may potentially include Parkinson’s disease as well as ALS and Huntington’s patients.
Expansion of the infrastructure in Marly
In view of the upcoming possible market approval of Talidox as well as the planned clinical trial with Talineuren, 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 the TaliCoVax-19 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. This well-known and widely used formulation of the vaccine showed a good immune response in the pseudo virus tests of the Institute of Virology and Immunology (IVI), but failed to achieve sufficient virus protection in a more demanding test with the actual Corona virus, possibly due to the complex protein folding of the Corona virus.
InnoMedica is now investigating the 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 distinguishes itself by its already highly developed liposome technology, with which a dummy virus can be built from the vaccine and the liposome that can be produced in large quantities and is very well tolerated.
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. This would allow Talidox to be even better positioned as the most advanced product in development.
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 Talidox being the first product to be launched on the market and reaching break-even.