PHIL Philogen

Philogen enters into a Service and Supply Agreement with IBSA for the GMP Production of a Therapeutic Protein

Philogen enters into a Service and Supply Agreement with IBSA for the GMP Production of a Therapeutic Protein

Philogen enters into a Service and Supply Agreement with IBSA for the GMP Production of a Therapeutic Protein

Siena, Italy, 28th June 2023 – Philogen S.p.A (BIT: PHIL) today announced that it has entered into a Service and Supply Agreement with IBSA (Institut Biochimique SA) to produce a recombinant therapeutic protein at Philogen GMP Facilities in Siena (Italy).

Philogen owns a GMP production facility in Montarioso (Siena, Italy) which is authorized and operational for the manufacturing of investigational therapeutic proteins in mammalian cells. The facility has been formally certified by AIFA since 2004 and is subject to strict regulatory and manufacturing requirements. It features fermenters ranging from 30- to 200-liters, thus providing a flexible approach to manufacturing, depending on the quantity of product needed by the client. Pharmaceuticals manufactured at the Montarioso Facility have been used in clinical trials in several European Countries (Italy, Switzerland, Germany, Austria, France, Spain, Denmark, U.K., The Netherlands, Belgium, Poland) and in the United States.

Philogen has also recently constructed a second, larger, state-of-the art GMP facility in Rosia (Siena, Italy), which is devised to manufacture biologics for commercial and investigational purposes. The facility features the most advanced technical equipment, including a 200-liter fermentation unit, identical to the one in Montarioso.

Prof. Dr. Dario Neri, CEO and CSO of Philogen, commented: “We are pleased to establish a new collaboration with IBSA, a leading multinational pharmaceutical company. Philogen uses its production facilities both to manufacture its own proprietary products and to run GMP lots for third parties. Our recent investments in both the Montarioso and Rosia plants have strengthened our position as a leading company in manufacturing recombinant biologics in mammalian cells in Italy.”

***

About Philogen group

Philogen is an Italian-Swiss company active in the biotechnology sector, specialized in the research and development of pharmaceutical products for the treatment of highly lethal diseases. The Group mainly discovers and develops targeted anticancer drugs, exploiting high-affinity ligands for tumor markers (also called tumor antigens). These ligands - human monoclonal antibodies or small organic molecules - are identified using Antibody Phage Display Libraries and DNA-Encoded Chemical Library technologies.

The Group's main therapeutic strategy for the treatment of these diseases is represented by the so-called tumor targeting. This approach is based on the use of ligands capable of selectively delivering very potent therapeutic active ingredients (such as pro-inflammatory cytokines) to the tumor mass, sparing healthy tissues. Over the years, Philogen has mainly developed monoclonal antibody-based ligands that are specific for antigens expressed in tumor-associated blood vessels, but not expressed in blood vessels associated with healthy tissues. These antigens are usually more abundant and more stable than those expressed directly on the surface of tumor cells. This approach, so called vascular targeting, is used for most of the projects pursued by the Group.

The Group's objective is to generate, develop and market innovative products for the treatment of diseases for which medical science has not yet identified satisfactory therapies. This is achieved by exploiting (i) proprietary technologies for the isolation of ligands that react with antigens present in certain diseases, (ii) experience in the development of products targeted at the tissues affected by the disease, (iii) experience in drug manufacturing and development, and (iv) an extensive portfolio of patents and intellectual property rights.

Although the Group's drugs are primarily oncology applications, the targeting approach is also potentially applicable to other diseases, such as certain chronic inflammatory diseases.

About IBSA

IBSA (Institut Biochimique SA) is a Swiss multinational pharmaceutical Company, founded in 1945 in Lugano. Today, its products are present in over 90 Countries on 5 continents, through the Company’s 17 subsidiaries located in Europe, China, and the United States. The company has a consolidated turnover of 800 million CHF, and employs over 2,000 people between headquarters, subsidiaries and production sites. IBSA holds 90 families of approved patents, plus others under development, as well as a vast portfolio of products, covering 10 therapeutic areas: reproductive medicine, endocrinology, pain and inflammation, osteoarticular, aesthetic medicine, dermatology, uro-gynaecology, cardiometabolic, respiratory, consumer health. It is also one of the largest operators worldwide in the area of reproductive medicine, and one of the world’s leaders in hyaluronic acid-based products. IBSA has based its philosophy on four pillars: Person, Innovation, Quality and Responsibility.

***

Contacts:

Philogen contacts

IR:                 Dr. Emanuele Puca

Tel                 +41 (0) 43 544 88 00

E mail                



EN
28/06/2023

Underlying

To request access to management, click here to engage with our
partner Phoenix-IR's CorporateAccessNetwork.com

Reports on Philogen

 PRESS RELEASE

Philogen provides update on pre-planned interim analysis of the Phase ...

Philogen provides update on pre-planned interim analysis of the Phase III FIBROSARC trial investigating Onfekafusp alfa (L19TNF) in patients with first-line advanced or metastatic Soft Tissue Sarcoma FIBROSARC (NCT04650984) is a Phase III trial evaluating Onfekafusp alfa (L19TNF, also known as Fibromun) plus doxorubicin versus doxorubicin alone as front-line therapy for patients with advanced or metastatic Soft Tissue Sarcoma An Independent Data and Safety Monitoring Board reviewed safety and efficacy data of the pre-planned interim analysis and recommended continuing the study as planned...

 PRESS RELEASE

Philogen S.p.A. announces receipt of the Good Manufacturing Practice C...

Philogen S.p.A. announces receipt of the Good Manufacturing Practice Certificate for its new Production facility in Rosia (Siena, Italy) by Competent Authorities SIENA, Italy, Dec. 05, 2023 (GLOBE NEWSWIRE) -- Philogen S.p.A. (BIT:PHIL) is pleased to announce that its new GMP facility located in Rosia Siena, is now GMP certified. The certification was granted by the GMP MED office of the Agenzia Italiana del Farmaco (AIFA) following an inspection occurred in July 2023. AIFA confirmed that Philogen new facility complies with the requirements and guidelines of Good Manufacturing Practice ou...

 PRESS RELEASE

Philochem and Blue Earth Diagnostics Announce First Three Patients Ima...

Philochem and Blue Earth Diagnostics Announce First Three Patients Imaged in Phase 1 Clinical Trial of 68Ga-OncoFAP (68Ga-OncoFAP-DOTAGA) for Diagnostic Imaging in Solid Tumors Novel ultra-high affinity ligand OncoFAP targets Fibroblast Activation Protein (FAP), associated with a variety of solid tumorsLicensing agreement between Philochem and Blue Earth Diagnostics, one of the Bracco family of companies, encompasses applications of OncoFAP for diagnostic and medical imagingPhilogen’s Phase I clinical trial with investigational 68Ga-OncoFAP is underway in Europe, with first three patients s...

 PRESS RELEASE

Nidlegy™ Phase III PIVOTAL trial meets the study’s primary objective d...

Nidlegy™ Phase III PIVOTAL trial meets the study’s primary objective demonstrating statistically significant and clinically meaningful improvement in Recurrence-Free Survival for patients with locally advanced fully resectable melanoma Intratumoral Nidlegy™ followed by surgery significantly improved the Recurrence-Free Survival compared to surgery alone PIVOTAL (NCT02938299) is the first and so far only Phase III trial demonstrating statistically significant and clinically meaningful benefit of a neoadjuvant therapy in fully resectable locally advanced melanoma patients Nidlegy™ is the f...

 PRESS RELEASE

Philogen enters into a Service and Supply Agreement with IBSA for the ...

Philogen enters into a Service and Supply Agreement with IBSA for the GMP Production of a Therapeutic Protein Philogen enters into a Service and Supply Agreement with IBSA for the GMP Production of a Therapeutic Protein Siena, Italy, 28th June 2023 – Philogen S.p.A (BIT: PHIL) today announced that it has entered into a Service and Supply Agreement with IBSA (Institut Biochimique SA) to produce a recombinant therapeutic protein at Philogen GMP Facilities in Siena (Italy). Philogen owns a GMP production facility in Montarioso (Siena, Italy) which is authorized and operational for the manufa...

ResearchPool Subscriptions

Get the most out of your insights

Get in touch