Oncofid-P (paclitaxel-hyaluronic acid conjugate) / Fidia Farmaceutici - LARVOL DELTA

Novel intravesical delivery systems for nonmuscle invasive bladder cancer. (PubMed, Curr Opin Urol) - "Novel intravesical delivery systems show to enhance drug retention, improve tissue penetration, and potentially reduce adverse events. While traditional chemotherapy or BCG remain the gold-standard adjuvant treatments for NMIBC, these novel approaches offer promising alternatives for selected patients pending on ongoing clinical validation."

Journal • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • FGFR

Phase III, single-arm study to evaluate the efficacy and safety of intravesical paclitaxel-hyaluronic acid conjugate in patients with BCG-unresponsive Carcinoma in situ of the bladder +/- Ta-T1 papillary disease (Orion-BC study) (AUA 2025) - P3 | "Up to date, Oncofid-P-B has confirmed an excellent safety profile. Preliminary clinical outcomes are aligned with the results obtained in previous clinical trials, confirming the validity of the target specific mechanism of action."

Clinical • P3 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • CD44

A phase III single-arm study to evaluate the efficacy and safety of paclitaxel-hyaluronic acid conjugate administered intravesically to patients with BCG-unresponsive carcinoma in situ of the bladder with or without Ta-T1 papillary disease (Orion-BC study). (ASCO-GU 2025) - P3 | "The study is currently enrolling in Europe and US. So far, 63 patients were screened and 49 were enrolled (Ta/T1 subgroup: 10 subjects)."

Clinical • P3 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • CD44

Modeling and estimation of physiochemical properties of cancer drugs using entropy measures. (PubMed, Sci Rep) - "Hyaluronic acid-paclitaxel conjugate is a nanoparticle-based drug delivery system that combines hyaluronic acid with paclitaxel, enhancing its solubility, stability, and targeting specificity. We conclude that physical properties, including boiling point, enthalpy of vaporization, flash point, molar refractivity, molar volume, polarization, molecular weight, monoisotopic mass, topological polar surface area, and complexity, can be predicted using reverse entropy measures. We propose models for each relationship, including only the most significant models for estimating uncalculated physical properties."

Journal • Oncology • Ovarian Cancer • Solid Tumor

A phase III, single-arm study to evaluate the efficacy and safety of paclitaxel-hyaluronic acid conjugate administered intravesically to patients with BCG-unresponsive Carcinoma in Situ of the bladder with or without Ta-T1 papillary disease (Orion-BC study) (EMUC 2024) - No abstract available

Clinical • P3 data • Bladder Cancer • Oncology • Solid Tumor

Novel intravesical therapies and delivery systems for the management of bladder cancer. (PubMed, Curr Opin Urol) - "The armamentarium for the treatment of bladder cancer patients is expanding, notably with HIVEC, hydrogels, drug-RIS and novel therapies. However, accurate patients' selection is key to prevent disease progression in any bladder-sparing strategy, and radical cystectomy remains the gold-standard to date."

Journal • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

A PHASE III, SINGLE-ARM STUDY TO EVALUATE THE EFFICACYAND SAFETY OF PACLITAXEL-HYALURONIC ACID CONJUGATE ADMINISTERED INTRAVESICALLY TO PATIENTS WITH BCG-UNRESPONSIVE CARCINOMA IN SITU OF THE BLADDER WITH OR WITHOUT TA-T1 PAPILLARY DISEASE (ORION-BC STUDY) (AUA 2024) - P3 | "InJanuary 2020, the Food and Drug Administration (FDA) approvedpembrolizumab (Keytruda, Merck&Co) for the systemic treatment ofpatients with BCGeunresponsive, high-risk NMIBC with CIS, with orwithout papillary tumors, who are ineligible for or choose not to undergoRC...In 2022 intravesical Adstiladrin (Ferring), which acts bystimulating immune responses, was approved by the FDA based onefficacy on 50 subjects out of 107 enrolled [51% (95% CI: 41%, 61%)]who experienced a CR at the first disease assessment three monthsafter initial treatment...gemcitabine and docetaxel, Milbar 2017)...Up to 146 patients will be enrolled: up to now 9 patientswere enrolled and treated. The first DSMB meeting is scheduled end of January 2024."

Clinical • P3 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • CD44

A phase III, single-arm study to evaluate the efficacy and safety of paclitaxel-hyaluronic acid conjugate administered intravesically to patients with BCG-unresponsive Carcinoma in Situ of the bladder with or without Ta-T1 papillary disease (Orion-BC stud (AUA 2024) - No abstract available

Clinical • P3 data • Bladder Cancer • Oncology • Solid Tumor

A paclitaxel-hyaluronan conjugate (ONCOFID-P-B™) in patients with BCG-unresponsive carcinoma in situ of the bladder: a dynamic assessment of the tumor microenvironment. (PubMed, J Exp Clin Cancer Res) - P1 | "The clinical response to ONCOFID-P-B™ in bladder CIS likely relies on several components of the TME, and the combined evaluation of intra-tumoral macrophages density and CD44v6 expression is a potentially new predictive biomarker for patient response. Overall, our data allow to advance a potential rationale for combinatorial treatments targeting the immune infiltrate such as immune checkpoint inhibitors, to make bladder CIS more responsive to ONCOFID-P-B™ treatment."

Biomarker • IO biomarker • Journal • Tumor microenvironment • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • CD8 • ICAM1

A paclitaxel-hyaluronan conjugate (ONCOFID-P-B) in patients with BCG-unresponsive carcinoma in situ of the bladder: a dynamic assessment of the tumor microenvironment (J Exp Clin Cancer Res) - P1 | N=20 | NCT04798703 | Sponsor: Fidia Farmaceutici s.p.a. | "In baseline biopsies, patients achieving CR after the intensive phase had a lower density of intra-tumoral CD8+ cytotoxic T lymphocytes (CTL), but also fewer interactions between CTL and macrophages or T-regulatory cells, as compared to non-responders (NR). NR expressed higher levels of the HA receptors CD44v6, ICAM-1 and RHAMM. The intra-tumoral macrophage density was positively correlated with the expression of the pro-metastatic and aggressive variant CD44v6, and the combined score of intra-tumoral macrophage density and CD44v6 expression had an AUC of 0.85 (95% CI 0.68–1.00) for patient response prediction."

Biomarker • P1 data • Bladder Cancer

Study of ONCOFID-P-B (PACLITAXEL-HYALURONIC ACID) (clinicaltrials.gov) - P3 | N=112 | Recruiting | Sponsor: Fidia Farmaceutici s.p.a.

Trial completion date • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Colon targeted releases and uptakes of paclitaxel loaded in modified porous starch. (PubMed, Carbohydr Polym) - "Cell internalization of paclitaxel mediated by hyaluronic acid was approximately 1.97 times that of raw paclitaxel, higher than that of receptor-shielded cells and cells incubated with unmodified carriers, as evidenced by the accumulation of fluorescent paclitaxel in the nucleus and marked cell apoptosis. The hyaluronic acid-modified porous starch system is an effective method for the high-load and targeted release of hydrophobic anticancer drugs."

Journal • Oncology

Curvilinear regression analysis of benzenoid hydrocarbons and computation of some reduced reverse degree based topological indices for hyaluronic acid-paclitaxel conjugates. (PubMed, Sci Rep) - "Also, we have compared the predictive capability of reduced reverse degree based topological descriptors against 16 existing degree based indices. Further, we compute the defined reduced reverse degree based topological indices for Hyaluronic Acid-Paclitaxel Conjugates [Formula: see text], [Formula: see text]."

Journal

Study the Behavior of Drug Structures via Chemical Invariants Using TOPSIS and SAW. (PubMed, Comput Math Methods Med) - "This research paper will analyze some of the molecular drug structures, i.e., hyaluronic acid-paclitaxel conjugates G , anticancer drug SP[n], polyomino chain of n-cycle Z , triangular benzenoid T , and circumcoronene benzenoid series H using multicriteria decision-making techniques including TOPSIS and SAW. The topological indices used in this research paper include the Randić index for α = 1, -1, 1/2, the augmented Zagreb index and the forgotten topological index."

Journal • Oncology

Study of ONCOFID-P-B (PACLITAXEL-HYALURONIC ACID) (clinicaltrials.gov) - P3 | N=112 | Recruiting | Sponsor: Fidia Farmaceutici s.p.a. | Not yet recruiting ➔ Recruiting | Trial completion date: Jul 2027 ➔ Nov 2027 | Trial primary completion date: Jul 2025 ➔ Nov 2025

Enrollment open • Trial completion date • Trial primary completion date • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

A study of ONCOFID-P-B administered intravesically to patients with Carcinoma in Situ of the bladder who have not responded to the standard treatment Un estudio de ONCOFID-P-B administrado por vía intravesical a pacientes con carcinoma in situ de vejiga que no han respondido al tratamiento estándar. (clinicaltrialsregister.eu) - P3 | N=146 | Ongoing | Sponsor: Fidia Farmaceutici S.p.A.

New P3 trial • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

Study of ONCOFID-P-B (PACLITAXEL-HYALURONIC ACID) (clinicaltrials.gov) - P3; N=112; Not yet recruiting; Sponsor: Fidia Farmaceutici s.p.a.; Trial completion date: Mar 2026 ➔ Jul 2027; Initiation date: Mar 2022 ➔ Jul 2022; Trial primary completion date: Mar 2025 ➔ Jul 2025

Clinical • Trial completion date • Trial initiation date • Trial primary completion date • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

Oncofid-P-B: a novel treatment for BCG unresponsive carcinoma in situ (CIS) of the bladder: Results of a prospective European Multicentre study at 15 months from treatment start. (PubMed, Urol Oncol) - "Oncofid-P-B is very safe, well tolerated and highly effective (75% CR) when administered weekly for up to 12 consecutive weeks (75% CR), with 40% CR still after 15 months from treatment start."

Clinical • Journal • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer • CD44

Study of ONCOFID-P-B (PACLITAXEL-HYALURONIC ACID) (clinicaltrials.gov) - P3; N=112; Not yet recruiting; Sponsor: Fidia Farmaceutici s.p.a.

Clinical • New P3 trial • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

Fidia announces the FDA Orphan Drug designation for ONCOFID-P for the treatment of malignant mesothelioma, the cancer caused by exposure to asbestos (PRNewswire) - “Preclinical studies are underway to complete the pharmaco-toxicological profile of ONCOFID®-P, particularly in pleural mesothelioma, with the aim of submitting the authorisation dossier for human studies to the regulatory authorities by 2022; Fidia Farmaceutici…announced today that the U.S. Food and Drug Administration has granted Orphan Drug Designation for ONCOFID®-P for the treatment of malignant mesothelioma (MM), a rare and aggressive cancer with limited therapeutic options…The Orphan Drug status has been granted according to strong preclinical data documenting the high anti-tumor activity of ONCOFID®-P on human mesothelioma lines, both in vitro and in murine models of the disease.”

Orphan drug • Preclinical • Regulatory • Lung Cancer • Malignant Pleural Mesothelioma • Mesothelioma • Oncology

Simultaneous Targeting Tumor Cells and Cancer-Associated Fibroblasts with a Paclitaxel-Hyaluronan Bioconjugate: In Vitro Evaluation in Non-Melanoma Skin Cancer. (PubMed, Biomedicines) - "Collectively, our data demonstrate that Onco-P20, exerting both a direct and an NHF-mediated indirect effect on carcinoma cells, is a candidate for an innovative therapy alternative to surgery for the treatment of NMSC."

Journal • Preclinical • Genetic Disorders • Immunology • Inflammation • Non-melanoma Skin Cancer • Skin Cancer • Solid Tumor • CAFs • CD44

Study of ONCOFID-P-B™ (PACLITAXEL-HYALURONIC ACID) (clinicaltrials.gov) - P1; N=20; Completed; Sponsor: Fidia Farmaceutici s.p.a.

Clinical • New P1 trial • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer