This multicenter, prospective Phase I study is aimed at testing the safety of F8IL10 via i.a. administration once every 4 weeks over 8 weeks in patients with RA who, despite treatment with stable doses (at least 3 months) of DMARDs (conventional, biologic and/or targeted synthetic), present arthritis flare(s) suitable for i.a. injections.

Start Date31 Mar 2023

Sponsor / Collaborator

Philogen SpA

NCT03414788 / WithdrawnPhase 1

PHASE 1B, OPEN LABEL STUDY TO CHARACTERIZE THE DISTRIBUTION OF A SINGLE INTRAVENOUS DOSE OF [124I]-IODOBENZOYL (IB)-PF-06687234 WITH CONCURRENT ADMINISTRATION OF NON-RADIOLABELED PF-06687234 AS ASSESSED WITH POSITRON EMISSION TOMOGRAPHY AND COMPUTED TOMOGRAPHY (PET-CT) IMAGING IN MODERATE TO SEVERE ULCERATIVE AND CROHN'S COLITIS SUBJECTS

The purpose of the study is to evaluate the PK, safety and tolerability of PF-06687234 and [124I]IB-PF-06687234 (simultaneously given) in subjects with moderate to severe Ulcerative Colitis or Crohn's Disease. The study used PET-CT scan imaging to assess the distribution of PF-06687234 and [124I]IB-PF-06687234 over 24 and 72 hours in colon (inflamed and non-inflamed), plasma, colon, liver, spleen, kidney and small intestine.

Start Date07 Dec 2020

Sponsor / Collaborator

Pfizer Inc.

NCT03269695 / TerminatedPhase 2

A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06687234 AS ADD-ON THERAPY TO INFLIXIMAB IN ACTIVE ULCERATIVE COLITIS SUBJECTS WHO ARE NOT IN REMISSION (BUILD UC)

The purpose of this study is to determine if PF-06687234 is effective and safe as add-on therapy to infliximab in subjects with active ulcerative colitis who are not in remission.

Start Date20 Dec 2017

Sponsor / Collaborator

Pfizer Inc.

100 Clinical Results associated with F8-IL10

100 Translational Medicine associated with F8-IL10

100 Patents (Medical) associated with F8-IL10

Literatures (Medical) associated with F8-IL10

01 Dec 2019·BMC rheumatology

Fibroblast-like synovial cell production of extra domain A fibronectin associates with inflammation in osteoarthritis

Article

Author: Sohn, Dong H ; Onuma, Kazuhiro ; Kragstrup, Tue W ; Wang, Qian ; Robinson, William H ; Lepus, Christin M ; Sokolove, Jeremy

Abstract:

Background:

The pathophysiology of osteoarthritis (OA) involves wear and tear, and a state of low-grade inflammation. Tissue repair responses include transforming growth factor beta (TGFβ)-induced myofibroblast production of extracellular matrix. Fibronectins are an essential part of the extracellular matrix, and injection of fibronectin fragments into rabbit joints is a previously established animal model of OA. Fibronectin containing the ED-A domain is currently being used as drug delivery target in the development of anti-inflammatory drugs (e.g. Dekavil).

Methods:

In this study, samples of synovial membrane were obtained from patients with knee OA undergoing joint replacement surgery. Immunostaining for ED-A fibronectin and the myofibroblast marker alpha smooth muscle actin (αSMA) was performed on fibroblast-like synovial cells (FLS) and synovial membranes. RAW 264.7 macrophages were incubated with recombinant ED-A fibronectin.

Results:

The staining of ED-A fibronectin in OA FLS was increased by TGFβ but not by TNFα, lipopolysaccharide, or IL-6 (n = 3). ED-A fibronectin co-stained with the myofibroblast marker αSMA in both the OA FLS (n = 3) and in the OA synovial membranes (n = 8). ED-A fibronectin staining was associated with both number of lining layer cells (rho = 0.85 and p = 0.011) and sublining cells (rho = 0.88 and p = 0.007) in the OA synovium (n = 8), and co-distributed with TNFα (n = 5). Recombinant ED-A fibronectin increased the production of TNFα by RAW 264.7 macrophages (n = 3).

Conclusions:

The disease process in OA shares features with the chronic wound healing response. Our findings support utilizing ED-A fibronectin for drug delivery or therapeutic targeting to reduce pro-inflammatory responses in OA.

07 Jan 2019·Molecular pharmaceuticsQ2 · MEDICINE

F8-IL10: A New Potential Antirheumatic Drug Evaluated by a PET-Guided Translational Approach

Q2 · MEDICINE

Article

Author: Guus A M S van Dongen ; Gerrit Jansen ; Danielle J Vugts ; Conny J van der Laken ; Adriaan A Lammertsma ; Otto S Hoekstra ; Dario Neri ; Carla F M Molthoff ; Marc C Huisman ; Durga M S H Chandrupatla ; René J P Musters ; Stefan T G Bruijnen ; Leonardo Giovanonni

Antibody fragment F8-mediated interleukin 10 (IL10) delivery is a novel treatment for rheumatoid arthritis (RA). F8 binds to the extra-domain-A of fibronectin (ED-A). In this study, in vivo biodistribution and arthritis targeting of radiolabeled F8-IL10 were investigated in RA patients, followed by further animal studies. Therefore, three RA patients (DAS28 > 3.2) received 0.4 mg of 30-74 megabecquerel [¹²⁴I]I-F8-IL10 for PET-CT and blood sampling. In visually identified PET-positive joints, target-to-background was calculated. Healthy mice, rats, and arthritic rats were injected with iodinated F8-IL10 or KSF-IL10 control antibody. Various organs were excised, weighed, and counted for radioactivity. Tissue sections were stained for fibronectin ED-A. In RA patients, [¹²⁴I]I-F8-IL10 was cleared rapidly from the circulation with less than 1% present in blood after 5 min. PET-CT showed targeting in 38 joints (11-15 per patient) and high uptake in the liver and spleen. Mean target-to-background ratios of PET-positive joints were 2.5 ± 1.2, 1.5 times higher for clinically active than clinically silent joints. Biodistribution of radioiodinated F8-IL10 in healthy mice showed no effect of the radioiodination method. [¹²⁴I]I-F8-IL10 joint uptake was also demonstrated in arthritic rats, ∼14-fold higher than that of the control antibody [¹²⁴I]I-KSF-IL10 ( p < 0.001). Interestingly, liver and spleen uptake were twice as high in arthritic than in healthy rats and were related to increased (∼7×) fibronectin ED-A expression in these tissues. In conclusion, [¹²⁴I]I-F8-IL10 uptake was observed in arthritic joints in RA patients holding promise for visualization of inflamed joints by PET-CT imaging and therapeutic targeting. Patient observations and, subsequently, arthritic animal studies pointed to awareness of increased [¹²⁴I]I-F8-IL10 uptake in the liver and spleen associated with moderate systemic inflammation. This translational study demonstrated the value of in vivo biodistribution and PET-CT-guided imaging in development of new and potential antirheumatic drugs'.

01 Sep 2015·International journal of cardiologyQ2 · MEDICINE

Targeted delivery of interleukin-10 to chronic cardiac allograft rejection using a human antibody specific to the extra domain A of fibronectin

Q2 · MEDICINE

Article

Author: Köse, Nilay ; Jung, Christian ; Ziffels, Barbara ; Franz, Marcus ; Richter, Petra ; Doll, Fabia ; Figulla, Hans R ; Gummert, Jan ; Grün, Katja ; Schubert, Harald ; Neri, Dario ; Berndt, Alexander ; Renner, André

BACKGROUND AND AIMS:

Management of chronic rejection is challenging since there are not sufficient preventive or therapeutic strategies. The rejection process leads to overexpression of ED-A(+) fibronectin (ED-A(+) Fn). The human antibody F8, specific to ED-A(+) Fn, may serve as a vehicle for targeted delivery of bioactive payloads, e.g. interleukin 10 (IL-10). The aim of this study was to investigate the therapeutic effects of the fusion protein F8-interleukin-10 (F8-IL10) in the process of chronic rejection development.

METHODS:

A heterotopic rat heart transplantation model was used to induce chronic rejection. For therapeutic interventions, the immunocytokines F8-humanIL10 (DEKAVIL), F8-ratIL10 as well as KSF-humanIL10 (irrelevant antigen-specificity) were used. Treatment was performed weekly for 10 weeks starting at day 7 after transplantation (1mg/animal).

RESULTS:

In the cardiac allografts, treatment with F8-huIL10 or F8-ratIL10 was associated with increased heart weights, a higher grade of chronic rejection, increased CIF, higher protein expression levels of alpha-smooth muscle actin (α-SMA), an augmented infiltration with inflammatory cells (CD4+, CD8+ and CD68+ cells) and higher serum levels of brain natriuretic peptide (BNP) compared to the control groups.

CONCLUSIONS:

All observed treatment effects are transplantation-specific since the F8 antibody is specific to ED-A(+) Fn that is not expressed in healthy hearts. A clear targeting effect of F8-huIL10 as well as F8-ratIL10 could be proven. Against that background, a further study is needed to address the question, if F8-IL10 treatment is capable to reduce CAV and CIF starting at a time point when chronic rejection has fully developed (therapeutic approach).

News (Medical) associated with F8-IL10

09 Jan 2023

·www.prnewswire.com

Rheumatoid Arthritis Market is Expected to Showcase Significant Growth in the 7MM at a Minimal CAGR of 1.9% During the Study Period (2019-2032), Predicts DelveInsight

The dynamics of the rheumatoid arthritis market are anticipated to change in the coming years owing to the increasing awareness and expected increase in investment in the R&D activities. Companies like GlaxoSmithKline [Otilimab (MOR103/GSK3196165)], Taisho Pharmaceutical [Ozoralizumab (TS-152)], Aclaris Therapeutics [Zunsemetinib (ATI-450)], Abivax [ABX464], and others with their key candidates are in the late clinical and filing stage. LAS VEGAS, Jan. 9, 2023 /PRNewswire/ -- DelveInsight's Rheumatoid Arthritis Market Insights report includes a comprehensive understanding of current treatment practices, rheumatoid arthritis emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into the 7MM [the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Key Takeaways from the Rheumatoid Arthritis Market Report As per DelveInsight analysis, the rheumatoid arthritis market size in the 7MM was approximately USD 27 billion in 2021. According to the assessment done by DelveInsight, the estimated total rheumatoid arthritis prevalent population in the 7MM was approximately 4. 7 million in 2021. Leading rheumatoid arthritis companies such as Taisho Pharmaceuticals, R-Pharm, GlaxoSmithKline, Aclaris Therapeutics, Pfizer, Abivax, Bristol Myers Squibb, Oscotec/Genosco, Mesoblast, Pfizer Akros Pharma/Japan Tobacco, Abbvie, Horizon Therapeutics, Eli Lilly and Company, Taiho Pharmaceutical, Gilead Sciences, Kiniksa Pharmaceuticals, Istesso, SynAct Pharma, Cyxone, and others are developing novel rheumatoid arthritis drugs that can be available in the rheumatoid arthritis market in the coming years. The promising rheumatoid arthritis therapies in the pipeline include Ozoralizumab (TS-152), Artlegia (Olokizumab), Otilimab (GSK3196165/MOR103), Zunsemetinib (ATI-450), Ritlecitinib (PF-06651600), ABX464, Branebrutinib, Cevidoplenib (SKI-O-703), MPC-300-IV, PF-06650833, JTE -051, ABBV-154, TAS5315, MBS2320, AMT-101, AP1189, Rabeximod (Rob 803), and others. In June 2022, Cyxone received a response from a Type B Pre-IND meeting with the US FDA. The response from the FDA facilitates Cyxone to continue planning the Phase IIb study with Rabeximod in RA. In December 2021, Taisho Pharmaceuticals presented the interim results from a 24-week administration in Phase II/III clinical trial (OHZORA study) of ozoralizumab in adult patients with RA at the annual meeting of the Japanese Society for Clinical Rheumatology and Related Research. Discover which therapies are expected to grab the major rheumatoid arthritis market share @ Rheumatoid Arthritis Market Report Rheumatoid Arthritis Overview Rheumatoid arthritis is a type of autoimmune disease. It happens when our immune system, which is supposed to defend us, malfunctions and starts attacking our own tissues. It causes inflammation in the joint lining (the synovium). As a result, joints may become red, warm, swollen, and painful, which are all symptoms of rheumatoid arthritis. The precise causes of rheumatoid arthritis are still unknown. Because the early signs and symptoms of rheumatoid arthritis are similar to those of many other diseases, it can be difficult to detect in its early stages. There is no single blood test or physical finding that can confirm the diagnosis of rheumatoid arthritis. There is no known cure for rheumatoid arthritis. However, clinical trials of rheumatoid arthritis show that remission of symptoms is more common when rheumatoid arthritis treatment with disease-modifying antirheumatic medicines begins early (DMARDs). Rheumatoid Arthritis Epidemiology Segmentation DelveInsight estimates that there were approximately 4.7 million prevalent cases of rheumatoid arthritis in the 7MM in 2021. Among the EU4 and the UK countries, Germany accounted for the highest number of rheumatoid arthritis cases, whereas France accounted for the lowest cases in 2021 The rheumatoid arthritis market report proffers epidemiological analysis for the study period 2019–2032 in the 7MM segmented into: Total Prevalent Cases Total Diagnosed Prevalent Cases Gender-specific Prevalent Cases Age-specific Prevalent Cases Severity-specific Prevalent Cases Patients on Targeted Therapies Line-Wise Treated Cases Download the report to understand which factors are driving rheumatoid arthritis epidemiology trends @ Rheumatoid Arthritis Epidemiological Insights Rheumatoid Arthritis Treatment Market Over the last few years, there has been a dramatic improvement in rheumatoid arthritis outcomes as a direct result of paradigm shifts in rheumatoid arthritis treatment. At the moment, the main rheumatoid arthritis treatment options are Medicine (for long-term relief of symptoms and slowing the progression of the condition), Supportive treatments (including physiotherapy and occupational therapy, to help keep the patient mobile and manage any problems related to daily activities), and Surgery (to correct any joint problems that develop over a period of time). Nonsteroidal anti-inflammatory drugs (NSAIDs) are typically used only for symptomatic treatment until a rheumatoid arthritis diagnosis is established because they reduce pain and stiffness in patients but have no effect on disease progression. Moreover, disease-modifying antirheumatic drugs (DMARDs) are used to target inflammation and prevent further joint damage and disease progression. DMARDs are a class of drugs that have been shown to affect the underlying cause of rheumatoid arthritis by reducing immune system overactivity, thereby alleviating pain, swelling, and stiffness and preventing joint changes. DMARDs can be prescribed singly or in combination as an initial part of treatment. Methotrexate is the first-line DMARD agent for the majority of rheumatoid arthritis patients. It has a relatively quick onset of action at therapeutic doses (6-8 weeks), good efficacy, a low toxicity profile, is easy to administer, and is relatively inexpensive. To know more about rheumatoid arthritis guidelines, visit @ Rheumatoid Arthritis Management Rheumatoid Arthritis Pipeline Therapies and Key Companies Artlegia (Olokizumab): R-Pharm TS-152 (Ozoralizumab): Taisho Pharmaceuticals Otilimab (GSK3196165/MOR103): GlaxoSmithKline ATI-450 (Zunsemetinib/CDD-450): Aclaris Therapeutics Branebrutinib: Bristol Myers Squibb LY3462817: Eli Lilly and Company TAS5315: Taiho Pharmaceutical Rabeximod (Rob 803): Cyxone GS-5718: Gilead Sciences KPL-404: Kiniksa Pharmaceuticals MBS2320: Istesso AMT-101: Applied Molecular Transport Dazodalibep (HZN-4920): Horizon Therapeutics Cevidoplenib (SKI-O-703): Genosco/Oscotec HB-AdMSCs: Hope Biosciences ABX464: Abivax MPC-300-IV: Mesoblast PF-06650833: Pfizer JTE 051: Akros Pharma/Japan Tobacco Dekavil (F8IL10): Pfizer/Philogen ABBV-154: AbbVie PF-06651600 (Ritlecitinib): Pfizer AP1189: SynAct Pharma Learn more about the FDA-approved drugs for rheumatoid arthritis @ Drugs for Rheumatoid Arthritis Treatment Rheumatoid Arthritis Market Dynamics The dynamics of the rheumatoid arthritis market is anticipated to change in the future due to the increasing awareness and expected increase in investment in the R&D activities by the leading companies working in the rheumatoid arthritis market space. Moreover, current therapies, such as biological DMARDs, have shown promising results in treating rheumatoid arthritis patients, and market penetration is expected to increase in the future, driving rheumatoid arthritis market growth. Furthermore, there is still a high demand for therapies with a similar efficacy profile to current therapies but a better safety profile and a more patient-friendly RoA. Oral classes, such as JAKi and the upcoming BTKi, are expected to contribute to the rheumatoid arthritis market growth due to patient-friendly RoA. However, several factors are likely to hamper the rheumatoid arthritis market growth. The rheumatoid arthritis market is highly competitive, and new entrants are expected to face some resistance and low uptake because anti-TNFs currently dominate the rheumatoid arthritis market, and the entry of biosimilars will pose significant challenges to new and upcoming treatment options in the rheumatoid arthritis market. In addition, the entry of biosimilars has already begun in the US and EU (i.e., Remicade biosimilars), and as a result, sales value has started to decline. The impact will be more pronounced when biosimilars/ generics of some blockbuster drugs, such as Humira (i.e., 2023 in the US), Xeljanz (i.e., 2025 in the US), will enter the rheumatoid arthritis market, and this will significantly impact the growth of the rheumatoid arthritis market. Scope of the Rheumatoid Arthritis Market Report Therapeutic Assessment: Rheumatoid Arthritis current marketed and emerging therapies Rheumatoid Arthritis Market Dynamics: Rheumatoid Arthritis market drivers and barriers Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies Unmet Needs, KOL's views, Analyst's views, Rheumatoid Arthritis Market Access and Reimbursement Discover more about rheumatoid arthritis drugs in development @ Rheumatoid Arthritis Clinical Trials Table of Contents Related Reports Rheumatoid Arthritis Epidemiology Forecast Rheumatoid Arthritis Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted rheumatoid arthritis epidemiology in the 7MM, i.e., the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan. Juvenile Rheumatoid Arthritis Pipeline Juvenile Rheumatoid Arthritis Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products and the key juvenile rheumatoid arthritis companies, including Novartis, AbbVie, Eli Lilly and Company, Sanofi, among others. Juvenile Rheumatoid Arthritis Market Juvenile Rheumatoid Arthritis Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key juvenile rheumatoid arthritis companies, including Novartis, AbbVie, Eli Lilly and Company, Sanofi, among others. Psoriatic Arthritis Pipeline Psoriatic Arthritis Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key psoriatic arthritis companies, including Mylan, Celltrion, Pfizer, Amgen, among others. Psoriatic Arthritis Market Psoriatic Arthritis Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key psoriatic arthritis companies, including Mylan, Celltrion, Pfizer, Amgen, among others. Other Trending Reports Tay-sachs Disease Or Gm2 Gangliosidosis Market | Onycholysis Market | Diagnostic Imaging Equipment Market | Chemotherapy-induced Peripheral Neuropathy Market | Global Electrophysiology Devices Market | Anaphylaxis Market | Atherectomy Devices Market | Helicobacter Pylori Infections Market | Ophthalmic Imaging Equipment Market | Androgenetic Alopecia Market | Allergic Rhinitis Market | Chronic Inflammatory Demyelinating Polyneuropathy Market | Chronic Inflammtory Demyelinating Polyneuropathy Market | Colorectal Cancer Crc Market | Opioid Induced Constipation Market | Vertigo Market | Bone Anchored Hearing Systems Market | Wound Closure Devices Market | Hip Replacement Devices Market | Hemodynamic Monitoring Systems Market | Egfr Non-small Cell Lung Cancer Market | Helicobacter Pylori Infection Market | Hyperkalemia Market | Polycythemia Market Neurostimulation Devices Market | Carpal Tunnel Syndrome Market | Ventilator Market | Cerebral Aneurysm Market | Alpha Antitrypsin Market | Binge Eating Disorder Market | Bunion Market | Concussions Market Size | Exocrine Pancreatic Insufficiency Market | Healthcare Due Diligence Services | Minimal Residual Disease Market Related Healthcare Blogs Rheumatoid Arthritis Emerging Drugs Knee Osteoarthritis Pipeline Rheumatoid Arthritis Market Scenario Juvenile Idiopathic Arthritis Therapy Market Related Healthcare Services Healthcare Business Consulting Healthcare Competitive Intelligence Services Healthcare Asset Prioritization Services About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Connect with us on LinkedIn |Facebook|Twitter Additionally, get in touch with our business executive to explore @ Healthcare Due Diligence Services Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

Clinical Result

12 Nov 2021

·www.biospace.com

Philogen Provides Corporate Update

Philogen Provides Corporate Update Nidlegy™ and Fibromunare on track with planned timelines in pivotal clinical trials Fibromun shows potent activity in last-line glioblastoma in combination with Lomustine The OncoFAP platform shows promising results beyond radio-conjugates Cash & cash equivalents of €107.8M Philogen’s management team will hold a Webinar to discuss the news on November12th, 2021, at 11:00 EST / 16:00 BST / 17:00 CEST (Please find the link to this Webinar here) Siena (Italy), 12November 2021 - Philogen S.p.A., a clinical-stage biotechnology company focused on antibody- and small molecule-based targeted therapeutics provides an update regarding the Company’s Third Quarter Results and recent corporate developments. Dario Neri, CEO of Philogen, commented on the results for the quarter and the evolution of the business: "The past few months have been very important for Philogen, and I am delighted toprovide an update on our pipeline and our financial position. Our late-stage candidates Nidlegy™and Fibromun are progressing well andpatient enrolment for their pivotal clinical trials is on track. We are expecting to complete patient enrollment in the melanoma European Phase III clinical trial of Nidlegy™ in mid-2022. The recruitment of patients in Fibromun’s two European clinical studies in newly diagnosed and last-line soft tissue sarcoma is expected to be achieved by the end of 2023. I am particularly excitedabout the emerging results in the Phase I/II study ofFibromunas a last-line treatment for glioblastoma, the most common and malignant primary brain tumor. Nine months after the beginning of treatment, the target lesion of the first evaluable patient has disappeared,and we look forward to seeing how long this potent response will last. I am also pleased to see that we are making progress in the fieldof small molecule targeted therapeutics beyond OncoFAP-radioconjugates.OncoFAP is a ligand for the delivery of radionuclides and cytotoxic drugs. The excellent targeting performance of OncoFAP in patients with solid tumors was recently validated by PET imaging procedures, and we have now generated new exciting preclinical efficacy data with Small Molecule-Drug Conjugates based on OncoFAP. Philogen remains committed to developing pharmaceutical products with game changing potential for difficult-to-treat conditions and is well capitalized to pursue this important goal." MAIN EVENTS AND RECENT HIGHLIGHTS Proprietary products Nidlegy™ is a pharmaceutical product, proprietary to Philogen, consisting of two active ingredients, L19-IL2 and L19-TNF. 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 – the study enrolled 187 patients as of November 12, 2021, with multiple clinical centers opened in Germany, France, Italy, and Poland Fibromun is a pharmaceutical product, proprietary to Philogen, consisting of the L19 antibody fused to TNF European pivotal studies in soft tissue sarcoma – the studies feature the participation of multiple clinical centers in Germany, Spain, Italy, and Poland Phase I/II study in glioblastoma at first relapse/recurrence – the Phase I part of the study foresees three cohorts (3-6 subjects per cohort), in which patients receive escalating doses of Fibromun and Lomustine. All patients in the first cohort have been enrolled. The historical response rate for recurrent glioblastoma patients treated with Lomustine monotherapy is 4.3%. However, in recurrent glioblastoma patients with unmethylated MGMT promoter status the responses are close to 0% (Wick et al., J Clin Oncol 2010, 28,1168; Weller and Le Rhun et al., Cancer Treat Rev 2020, 87,102029). In the first treated patient (with unmethylated MGMT promoter), the target glioblastoma lesion has disappeared at nine months after treatment start. Philogen is now planning to further explore different administration schedules in a new clinical trial, which is expected to start in 2022 and which will allow for the collection of more information on the combination treatment. OncoFAP is a small organic molecule, proprietary to Philogen group, with ultra-high affinity for Fibroblast Activation Protein (FAP). The product has the ability to selectively localize in a variety of solid tumors and metastatic lesions. OncoFAP-radio conjugates - excellent targeting properties of OncoFAP in patients with various tumor types. Clinicians at the Department of Nuclear Medicine of the University Hospital Münster have used OncoFAP radiolabeled with gallium-68 (OncoFAP-68Ga) to detect neoplastic lesions of both primary and metastatic origin. Of note is the intense uptake in the tumor and the low absorption in healthy organs (including kidneys) only one hour after intravenous administration of the drug. Thus, imaging results in cancer patients confirmed the excellent properties of OncoFAP observed in preclinical models, which have been published by the Philogen group in the Proceedings of the National Academy of Sciences U.S.A. Clinical investigations of the therapeutic agent (OncoFAP-177Lu) are expected to start in 2022. 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. Scientists at Philogen’s R&D center have recently discovered the optimal cleavable linker leading to complete tumor eradications in preclinical models of cancer, when administered as single agent. Philogen has discovered yet another potential clinical candidate that will expand the clinical stage pipeline over the next few years. Partnered products Dekavil is a pharmaceutical product, licensed to Pfizer, consisting of the F8 antibody specific to the A domain of Fibronectin (EDA) fused to interleukin-10 (IL10). EDA is a protein abundantly expressed at sites of inflammation, but it is virtually undetectable in healthy tissues. IL10 is an inflammatory cytokine suitable for the treatment of chronic inflammatory diseases The product will be investigated in novel clinical studies as a potential treatment in patients with certain chronic inflammatory conditions FINANCIAL UPDATE Philogen ended the third quarter of 2021 with cash and cash equivalents of €107.829M compared to €61.943M on December 31, 2020. The net financial position on September 30, 2021, was €90.905M compared to a positive net financial position of €44.238M on December 31, 2020 (an overall increase of over 100%). The change in the net financial position compared to December 31, 2020, was mainly due to the proceeds raised during the Initial Public Offering on March 3, 2021, amounting to €65.404M net of commissions paid to the syndicate for the institutional placement and costs related to the issue of new shares of approximately €3.635M. * * * Philogen Group Description 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-EncodedChemical 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. * * * FOR MORE INFORMATION: Philogen - Investor Relations IR@philogen.com - Emanuele Puca | Investor Relations Consilium Strategic Communications contacts Mary-Jane Elliott, Davide Salvi Philogen@consilium-comms.com

AntibodySmall molecular drugIPOCollaborate

100 Deals associated with F8-IL10

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Colitis, Ulcerative	Phase 2	US	Pfizer Inc.	20 Dec 2017
Colitis, Ulcerative	Phase 2	AU	Pfizer Inc.	20 Dec 2017
Colitis, Ulcerative	Phase 2	BE	Pfizer Inc.	20 Dec 2017
Colitis, Ulcerative	Phase 2	DE	Pfizer Inc.	20 Dec 2017
Colitis, Ulcerative	Phase 2	IL	Pfizer Inc.	20 Dec 2017
Colitis, Ulcerative	Phase 2	IT	Pfizer Inc.	20 Dec 2017
Colitis, Ulcerative	Phase 2	SA	Pfizer Inc.	20 Dec 2017
Colitis, Ulcerative	Phase 2	RS	Pfizer Inc.	20 Dec 2017
Colitis, Ulcerative	Phase 2	KR	Pfizer Inc.	20 Dec 2017
Colitis, Ulcerative	Phase 2	TR	Pfizer Inc.	20 Dec 2017

Clinical Result

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03269695 (BUILD UC, CTgov)	Phase 2	Colitis, Ulcerative	20	Placebo+Infliximab (Placebo + Infliximab)	zxirnidosw(uopxcuaqgp) = uzyeooxvor uzcibrbrdl (kdovuyiqxv, pibnksxqbs - rlcbfblvzp) View more	-	28 Dec 2021
NCT03269695 (BUILD UC, CTgov)	Phase 2	Colitis, Ulcerative	20	Infliximab+PF-06687234 (PF-06687234 20 mg + Infliximab)	zxirnidosw(uopxcuaqgp) = chpbodwdwp uzcibrbrdl (kdovuyiqxv, tkvznnxkjs - pnbxyzjfbj) View more	-	28 Dec 2021
NCT02076659 (EULAR2018) Manual	Phase 2	Rheumatoid Arthritis	-	F8-IL10	xhhmbblbhp(yxurdyobml) = rwjojindss rrqmtyzsss (qkgrrisxbh )	Positive	15 Jun 2018
phase Ib and phase II (EULAR2016)	Phase 1/2	Rheumatoid Arthritis anti-TNFα treatment	-	Dekavil 6 μg/kg	ihdkvqvshk(urnkprvnyq) = qcbipikxxv cfosipbeem (zakbwkhrrw ) View more	Positive	08 Jun 2016

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Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis