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Full of flavor Announce R&D program Update
Fibrin display Activity in Pretreatment Patients with glioma and sarcoma; OncoFAP Targeting tumor lesions in cancer patients; A kind New product in cooperation with AbbVie enters clinical research
Siena (Italy), July 2nd, 2021 – (Global News Line) – Philogen SpA (BIT: PHIL) is a clinical-stage biotechnology company focusing on the development of innovative drugs based on tumor-targeting antibodies and small molecule ligands. We are pleased to provide the latest information on three R&D projects : Fibromun, OncoFAP and ABBV-022. The company will conduct a complete pipeline update to the market in the company’s half-year results announcement on September 28, 2021.
Professor Dario Neri, Co-founder, CEO and Chief Scientific Officer Full of flavor spa. , Say: “We are very pleased to see that our technology provides exciting product candidates of various natures owned by our partners (such as AbbVie) and us in various clinical trials. Early signs of activity are supported. We bring innovative treatment options for patients with severely ambitious unmet medical needs.”
Fibrin
Fibromun (L19TNF), wholly owned by Philogen, is a fully human immunomodulatory product consisting of L19 antibody and TNF (a strong pro-inflammatory cytokine). So far, recombinant TNF has only been approved for clinical applications in certain local areas.
- The European Phase I/II trial demonstrated promising mid-term survival benefits, which examined Fibromun as a monotherapy for the first recurrence/relapse of IDH wild-type WHO grade III-IV high-grade glioma. The 6-month progression-free survival data is being finalized, and the overall survival data will be integrated before the end of 2021 and is expected to be published in a peer-reviewed scientific journal in 2022.
- In the European phase I/II trial, Fibromun was used in combination with lomustine for the treatment of first relapse/relapsed glioblastoma. Part of the response has been observed in the first patient treated in this study. The historical overall response rate for this patient population was 4.3% (Wick et al., J Clin Oncol 2010, 28,1168)
- The Parallel Scientific Advice (PSA) with the European Medicines Agency and the US Food and Drug Administration was completed in June 2021. The development plan for glioblastoma treatment and the proposed marketing authorization strategy have been discussed and agreed with the competent authorities. Philogen will follow the advice provided during the PSA.
- In the European phase II trial, Fibromun and dacarbazine were used in combination to treat preconditioned advanced/metastatic soft tissue sarcoma (3road line), the second patient treated in the study received a partial response. The historical overall response rate for this patient population was 4.0% (Garcia-del-Muro et al., J Clin Oncol 2011, 29, 2528). After the running-in part of the test, the test progressed to the random part.
- Fibromun has been studied in six clinical trials, five of which have key potential. In soft tissue sarcoma, the European phase III trial is in 1Yingshi Line and phase II trials in 3road It is expected to be read out at the end of 2023.
The full story on Benzinga.com
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