On June 23, 2022 Philogen S.p.A., a clinical-stage biotechnology company focused on antibody- and small molecule-based targeted therapeutics, reported an update regarding recent corporate developments (Press release, Philogen, JUN 23, 2022, View Source [SID1234616198]).
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Prof. Dr. Dario Neri, Chief Executive Officer of Philogen commented: "Philogen has made significant progress over the past few months as we continue investing our IPO proceeds to strengthen our GMP manufacturing capacity and speed up patient enrolment in clinical trials. We are particularly pleased with the progress of our Phase III European study investigating Nidlegy treatment of Stage IIIB/C melanoma, of which we have nearly completed patient recruitment.
Fibromun’s trials in soft-tissue sarcoma are also ongoing in the U.S., Germany, Poland, Spain, and Italy (France planned), with the participation of leading clinical centers. We expect to have more than 30 active clinical centers by the end of this year for the European and US pivotal studies.
My thanks go to our investors and to everyone at Philogen for their hard work and unwavering support."
MAIN EVENTS AND RECENT HIGHLIGHTS
Proprietary products
Nidlegy is a pharmaceutical product, proprietary to Philogen, consisting of two active ingredients, L19IL2 and L19TNF. The L19 antibody is specific to the B domain of Fibronectin, a protein expressed in tumors (and other diseases) but absent in most healthy tissues. Interleukin 2 (IL2) and Tumor Necrosis Factor (TNF) are inflammatory cytokines with anti-tumor activities
Phase III European study in Stage IIIB/C melanoma
211 out of 214 patients have been recruited. The trial will read when 95 events (tumor recurrence or patient death) have occurred, as per protocol
21 clinical centers opened in Germany, France, Italy, and Poland
Phase III U.S. study in Stage IIIB/C melanoma
13 clinical sites are currently open. We expect to have more than 25 centers active by the end of 2022 to speed up recruitment
Non-melanoma skin cancer
Progress in Phase II studies ongoing in France, Germany, Poland, and soon in Italy
Fibromun (L19TNF) is a pharmaceutical product, proprietary to Philogen, consisting of the L19 antibody fused to TNF
European Phase III study in metastatic/advanced soft-tissue sarcoma
32 patients have been recruited. The recruitment rate of patients is progressing according to planned timelines
10 clinical centers opened in Germany, Spain, Italy, and Poland. We expect to have more than 20 centers active by the end of 2022
Phase I/II study in glioblastoma at first progression
The Phase I dose escalation part of the study is exploring different doses of Fibromun and Lomustine (3-6 subjects per cohort)
Cohort 1 has been completed with 6 patients.
Recruitment for cohort 2 is ongoing, with 4 out of 6 patients recruited.
The historical objective response rate (ORR) for recurrent glioblastoma treated with Lomustine is 4.3-13.9%. The median progression free survival of these patients with lomustine monotherapy is 6 weeks. In unmethylated MGMT tumors, objective responses are virtually never observed (0% ORR) (Wick et al., J Clin Oncol 2010, 28,1168; Weller and Le Rhun et al., Cancer Treat Rev 2020, 87,102029). In cohort 1, we observed durable major responses in 2 out of 6 patients which are ongoing for more than 12 months. In addition, 3 patients had disease stabilization for over 4.5 months (follow up ongoing), while one patient had Covid-19 and had to exit the study without receiving the combination treatment.
OncoFAP is a small organic molecule ligand with ultra-high affinity for Fibroblast Activation Protein (FAP)
OncoFAP-radio conjugates
Imaging – excellent targeting properties of 68Ga-DOTAGA-OncoFAP confirmed in more than 50 patients with various types of malignancies.
Therapy – 177Lu-DOTAGA-BiOncoFAP, featuring a bivalent OncoFAP ligand, cures cancer in murine models and has been identified as the therapeutic candidate for clinical development.
Signed a contract with Senn Chemicals to manufacture DOTAGA-BiOncoFAP
OncoFAP-drug conjugates – these drugs consist of (i) the OncoFAP ligand, (ii) a cleavable linker and (iii) a cytotoxic payload, which is released selectively at the tumor site. A novel OncoFAP-drug conjugate, featuring an optimized cleavable linker, is being studied in animal models of cancer and may represent a novel potential clinical candidate.
The R&D center in Zürich has recently generated promising novel prototypes, including a highly active small molecule drug conjugate targeting PSMA. The company is well poised for the definition of the clinical candidates to be moved into the clinic in 2023.