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Cytovac is on the threshold of being able to provide effective cancer patient treatment without the serious adverse effects typically associated with traditional cancer therapies. In several clinical trials, the ALECSAT therapy has proved to be safe, well tolerated and without significant serious adverse effects.

In ALECSAT therapy the patient’s own potential cancer-fighting cells are provided with an opportunity to grow and become active – outside the cancer cells’ inhibiting and negative influence.

 

Promising results

Together with the experienced Cytovac researchers, the company now works on an ambitious clinical development plan focused on development of the clinical phase II for ALECSAT therapy of Glioblastoma brain cancer.

Cytovac has documented and shown the established production method to be efficient and potentially scalable.

Provided that current promising results are confirmed in the clinical phase II trial, it may be possible to obtain an extraordinary marketing authorization for ALECSAT as early as in 2019 for Glioblastoma brain cancer.

When, in 2015, Cytovac had the opportunity to open a study with newly diagnosed Glioblastoma patients in Sweden, the company decided to go through with this plan which has far better potential for success, since patients are not at very late stages of disease progression when treatment is initiated. This marks a huge breakthrough in Cytovac’s research as it provides far better potentials for detecting positive effects and cure as results of the therapy.

Future clinical trials will test the ALECSAT therapy’s efficacy on other cancer types, which is why the continuation of the clinical phase I trials – such as the planned melanoma skin-cancer trial – constitutes an important element in Cytovac’s commercial strategy.

Together with the experienced Cytovac researchers, the company now works on an ambitious clinical development plan focused on development of ALECSAT therapy for glioblastoma brain cancer. Clinical phase II studies may fully validate the potential of ALECSAT treatments for this disease.
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Strategies

With particular focus on the manufacturing process and logistics related to the therapies, Cytovac has come far in, for instance, the process that enables the freezing of the product used for ALECSAT therapy and thus facilitating transport over longer distances. Also automation of manufacture and cost reduction are focus areas for Cytovac R&D. The objective is to enable the manufacture and distribution of the products on a worldwide basis.

The clinical development strategy for Cytovac is to initiate new and potential early clinical development initiatives and establish partnerships to bring the existing clinical activities forward into later stage development.

Cytovac is investigating several options for funding our future activities. Future funding could potentially include both an IPO and stock exchange listing, private placement, entering into commercial partnership or out licensing projects.

Cytovac – in brief

  • The Cytovac immunotherapy, ALECSAT, introduces cells that will attack cancer cells and stimulate the patient’s immune system.
  • ALECSAT is distinct from other immunotherapies as it is exclusively based on the patient’s own cells.
  • In total, 5 clinical phase I and phase II trials have been performed within prostate, pancreatic and brain cancer.
  • More than 100 patients have been treated and more than 250 doses administered – without the serious adverse effects known form existing cancer therapies.
  • There are indications of positive clinical effects for many of the patients treated.
  • Cytovac’s production platform can be scaled up and potentially disseminated globally.
  • The current ongoing clinical phase II trial (in GBM brain cancer) may lead directly to registration studies.
  • Patent protection of the ALECSAT therapy has been secured in 36 countries.
  • Cytovac’ dendritic -cell production technology and specialized cell production bottle are similarly protected by patent.
  • The ALECSAT therapy has been granted Orphan Drug Designation by EMA and FDA.
More than 100 patients have been treated and more than 250 doses administered – without the detection of adverse the serious adverse effects associated with existing cancer therapies.