Periodic Reporting for period 1 - Lottare GBM (LOcalized Targeted Therapy to Avoid REcurrent GlioBlastoma Multiforme)
Periodo di rendicontazione: 2019-12-01 al 2020-05-31
TargTex’s therapy for Glioblastoma Multiforme (GBM) addresses the most common type of malignant primary brain tumor affecting nearly a quarter of a million patients globally. After diagnosis, these patients go through surgical resection, followed by radiotherapy and chemotherapy but almost invariably lead to GBM recurrence. Given the aggressiveness of recurrent tumor, several therapeutic approaches are considered, but still the average life expectancy is between 12-18 months (survival rate lower than 5% after 2 years).
TargTex has developed a localized treatment to be applied in the brain as adjunct to surgery. Our active drug is formulated in a hydrogel and engineered to provide a sustained drug release to selectively eliminate tumor cells that were not fully removed during surgery, thus avoiding recurrence. In this project, we aim to devise a strategic plan that incorporates a Scientific, Regulatory and IP strategy aligned with financial needs that will allow the company to submit a CT application and develop its product into the clinical stage.
TargTex has developed a localized treatment to be applied in the brain as adjunct to surgery. Our active drug is formulated in a hydrogel and engineered to provide a sustained drug release to selectively eliminate tumor cells that were not fully removed during surgery, thus avoiding recurrence. In this project, we aim to devise a strategic plan that incorporates a Scientific, Regulatory and IP strategy aligned with financial needs that will allow the company to submit a CT application and develop its product into the clinical stage.
TargTex has established an IP strategy addressing particularities of the EPO and USPTO. We have also performed a gap analysis with our regulatory partner and we continuously align our strategy with the regulatory requirements, namely by assessing the envisioned Toxicology and Safety Pharmacology plan. During the SME project, TargTex contacted the medical community and attended specialized conferences where we were able to interact with KOLs of the field and ascertain acceptance and willingness to adopt our treatment methodology. During this period, we have also contacted several CROs responsible for coordinating Phase I clinical trials to devise a preliminary clinical development plan and estimate costs for the next stage. Finally, we have identified the technical limitations of our technology and are currently overcoming these difficulties.
We expect this project to demonstrate the feasibility of TargTex’s therapeutic approach. Once fulfilled, this therapy offers unique advantages to patients and doctors, such as the fact that it explores a novel target widely expressed in the general GBM population, therefore, not restricted to a sub-population of patients. A drug with a mechanism of action that may lead to reduced side effects, that does not require to cross the BBB to exert pharmacological activity since is locally administered, and effective with one single administration, during surgery.