TB-403 / Oxurion, BioInvent - LARVOL DELTA

A Phase I Trial of TB-403 in Relapsed Medulloblastoma, Neuroblastoma, Ewing Sarcoma, and Alveolar Rhabdomyosarcoma. (PubMed, Clin Cancer Res) - "TB-403 was safe and well tolerated at all dose levels. No MTD was reached. The results look encouraging and therefore warrant further evaluation of efficacy in pediatric subjects with MB."

Journal • P1 data • Brain Cancer • Embryonal Tumor • Ewing Sarcoma • Medulloblastoma • Neuroblastoma • Oncology • Pediatrics • Rhabdomyosarcoma • Sarcoma • Solid Tumor • NRP1 • PGF

[VIRTUAL] A phase 1 dose escalation study of TB-403 in pediatric relapsed or refractory medulloblastoma, neuroblastoma, Ewing sarcoma, or alveolar rhabdomyosarcoma (AACR 2021) - "After cycle 1, temozolomide or etoposide could be added at the investigator’s discretion... TB-403 was shown to be safe at all dose levels evaluated without reaching a MTD in pediatric subjects. Initial results look encouraging for incurable relapsed disease."

Clinical • P1 data • Ewing Sarcoma • Medulloblastoma • Neuroblastoma • Oncology • Rhabdomyosarcoma • Sarcoma • Solid Tumor • NRP1 • PGF

Oncurious NV Reports Encouraging Data from Phase 1 Dose Escalation Study of TB-403 in Paediatric Subjects with Relapsed or Refractory Medulloblastoma Presented at the American Association for Cancer Research 2021 Annual Meeting (GlobeNewswire) - P1, N=18; NCT02748135; Sponsor: Oncurious NV; "ONCURIOUS...announces that encouraging data from a Phase 1 dose escalation study of TB-403 in pediatric subjects with relapsed or refractory medulloblastoma (MB), was presented at the annual meeting of the American Association for Cancer Research (AACR)...The Phase 1 trial (ONC-403-001) was an open--label, multi-center, dose escalation study of TB--403 in a total of 15 pediatric subjects - 11 with relapsed or refractory MB, 2 with Ewing Sarcoma (ES) and 2 with alveolar rhabdomyosarcoma (ARMS)....Exploratory biomarker analysis showed a decrease in plasma levels of free placental growth factor (PlGF) to undetectable levels at all doses of TB-403, with no apparent changes in other angiogenic or inflammatory factors."

P1 data • Medulloblastoma • Oncology • Rhabdomyosarcoma • Sarcoma

ONCURIOUS Presenting Clinical and Preclinical Data at Upcoming American Association for Cancer Research (AACR) 2021 Annual Meeting (GlobeNewswire) - "ONCURIOUS...today announces that it will make two presentations at the upcoming AACR Virtual Annual Meeting 2021 which will take place from 9 to 14 April....The first of these is an oral presentation of data from a Phase 1 dose escalation study of TB-403, a humanized monoclonal antibody against placental growth factor (PlGF), in pediatric cancer subjects for treatment of medulloblastoma....The second presentation is an e-poster presentation of preclinical data."

P1 data • Preclinical • Medulloblastoma • Oncology

A Study of TB-403 in Pediatric Subjects With Relapsed or Refractory Medulloblastoma (clinicaltrials.gov) - P1; N=18; Completed; Sponsor: Oncurious NV; Active, not recruiting ➔ Completed; Trial completion date: Mar 2023 ➔ Oct 2020; Trial primary completion date: Jun 2022 ➔ Oct 2020

Clinical • Trial completion • Trial completion date • Trial primary completion date • Brain Cancer • Ewing Sarcoma • Medulloblastoma • Neuroblastoma • Oncology • Pediatrics • Rhabdomyosarcoma • Sarcoma • Solid Tumor

Genome-wide interaction study of early-life smoking exposure on time-to-asthma onset in childhood. (PubMed, Clin Exp Allergy) - "We identified novel candidate genes interacting with ELTS exposure on time-to-asthma onset in childhood. These genes have plausible biological relevance related to tobacco smoke exposure. Further epigenetic and functional studies are needed to confirm these findings and to shed light on the underlying mechanisms."

Clinical • Journal • Asthma • Respiratory Diseases

A Study to Evaluate THR-317 Treatment for Macular Telangiectasia Type 1 (MacTel 1) (clinicaltrials.gov) - P2; N=8; Completed; Sponsor: ThromboGenics; Recruiting ➔ Completed

Clinical • Trial completion

A Study of TB-403 in Pediatric Subjects With Relapsed or Refractory Medulloblastoma (clinicaltrials.gov) - P1; N=18; Active, not recruiting; Sponsor: Oncurious NV; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Brain Cancer • Ewing Sarcoma • Medulloblastoma • Neuroblastoma • Oncology • Pediatrics • Rhabdomyosarcoma • Sarcoma • Solid Tumor

An apparent clinical pharmacokinetic drug-drug interaction between bevacizumab and the anti-placental growth factor monoclonal antibody RO5323441 via a target-trapping mechanism. (PubMed) - "The exact reason for the increase in RO5323441 exposure following bevacizumab co-administration is not currently known. One possibility is a drug-drug interaction via a target-trapping mechanism that is mediated by the vascular endothelial growth factor receptor-1 (VEGFR-1)."

Journal • Biosimilar • Colorectal Cancer • Hepatocellular Cancer • Ovarian Cancer

Genetic Variants in the 3'UTR of BRCA1 and BRCA2 Genes and their Putative Effects on the microRNA Mechanism in Hereditary Breast and Ovarian Cancer. (PubMed, Diagnostics (Basel)) - "We detected nine polymorphisms in 3'UTR, namely: four in BRCA1 (rs3092995 (C/G), rs8176318 (C/T), rs111791349 (G/A), and rs12516 (C/T)) and five in BRCA2 (rs15869 (A/C), rs7334543 (A/G), rs1157836 (A/G), and rs75353978 (TT/del TT))...The presence/absence of these polymorphisms may influence the loss/creation of miRNA binding sites, such as hsa-miR-1248 in BRCA1 3'UTR or the hsa-miR-548 family binding site in BRCA2. Our results add new evidence of miRNA participation in the pathogenesis of HBOC."

Journal • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor • BRCA1 • BRCA2

A Study of TB-403 in Pediatric Subjects With Relapsed or Refractory Medulloblastoma (clinicaltrials.gov) - P1; N=24; Recruiting; Sponsor: Oncurious NV; Suspended ➔ Recruiting; Phase classification: P1/2 ➔ P1; N=36 ➔ 24

Clinical • Enrollment change • Enrollment open • Phase classification

A Two-Part Study of TB-403 in Pediatric Subjects With Relapsed or Refractory Medulloblastoma (clinicaltrials.gov) - P1/2; N=36; Suspended; Sponsor: Oncurious NV; Recruiting ➔ Suspended

Clinical • Trial suspension

A Study to Evaluate THR-317 and Ranibizumab Combination Treatment for Diabetic Macular Oedema (DME) (clinicaltrials.gov) - P2; N=70; Completed; Sponsor: Oxurion; Active, not recruiting ➔ Completed

Clinical • Combination therapy • Trial completion

A Study to Evaluate THR-317 Treatment for Macular Telangiectasia Type 1 (MacTel 1) (clinicaltrials.gov) - P2; N=10; Recruiting; Sponsor: ThromboGenics; Trial completion date: Jul 2019 ➔ Dec 2019; Trial primary completion date: Jul 2019 ➔ Dec 2019

Clinical • Trial completion date • Trial primary completion date

A Two-Part Study of TB-403 in Pediatric Subjects With Relapsed or Refractory Medulloblastoma (clinicaltrials.gov) - P1/2; N=36; Recruiting; Sponsor: Oncurious NV; Trial completion date: Aug 2020 ➔ Mar 2023; Trial primary completion date: Aug 2020 ➔ Jun 2022

Clinical • Trial completion date • Trial primary completion date

A Study to Evaluate THR-317 and Ranibizumab Combination Treatment for Diabetic Macular Oedema (DME) (clinicaltrials.gov) - P2; N=70; Active, not recruiting; Sponsor: Oxurion; Recruiting ➔ Active, not recruiting

Clinical • Combination therapy • Enrollment closed