CNA3103 / Carina Biotech, Bionomics - LARVOL DELTA

Research funding for ovarian cancer treatment (The University of Adelaide) - "Adelaide Medical School’s Dr Carmela Ricciardelli and team have received $84,000 through the Cancer Council SA Project Grant scheme to research the use of a novel immunotherapy as a way forward for people with ovarian cancer...The funding will allow Dr Ricciardelli to employ a research officer on the project, which aims to create proof-of-concept pre-clinical evidence that chimeric antigen receptor (CAR-T) cell therapy, which is already used on some blood cancers can be used to treat ovarian cancer....The LRG5 CAR-T will now be tested on normal cells and chemotherapy resistant cells isolated from ovarian cancer patients."

Financing • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

Carina Biotech to Present Three Poster Presentations at AACR Annual Meeting 2024 (GlobeNewswire) - "Carina Biotech Limited...announced three poster presentations from studies of its LGR5-targeting CAR-T program in colorectal cancer and ovarian cancer at the American Association for Cancer Research (AACR) Annual Meeting 2024....'One of the posters will highlight the GMP manufacturing and testing findings for our lead LGR5-targeted CAR-T cell therapy candidate CNA3103, that is currently being evaluated in a Phase 1/2 clinical trial for the treatment of adult patients with metastatic colorectal cancer'....'Our research team will also be presenting preclinical data that demonstrate the potential to develop our LGR5-targeting CAR-T cells as a novel immunotherapy for ovarian cancer and that expand the preclinical body of evidence across a diverse range of cancer families'..."

Preclinical • Colorectal Cancer • Ovarian Cancer

A Study of CNA3103 (LGR5-targeted, Autologous CAR-T Cells) Administered to Subjects With Metastatic Colorectal Cancer (clinicaltrials.gov) - P1/2 | N=45 | Recruiting | Sponsor: Carina Biotech Limited

CAR T-Cell Therapy • Metastases • Trial completion date • Trial primary completion date • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • LGR5

Carina Biotech Doses First Patient in Phase 1/2a Clinical Trial of LGR5-Targeted CAR-T Cell Therapy (GlobeNewswire) - "Carina Biotech Limited (Carina)...today announced the dosing of the first patient in a Phase 1/2a clinical trial of its LGR5-targeted CAR-T cell therapy candidate CNA3103 for the treatment of adult patients with metastatic colorectal cancer (mCRC). Enrolment in the Phase 1 segment commenced in Australia with three sites currently activated."

Trial status • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

A Study of CNA3103 (LGR5-targeted, Autologous CAR-T Cells) Administered to Subjects With Metastatic Colorectal Cancer (clinicaltrials.gov) - P1/2 | N=45 | Recruiting | Sponsor: Carina Biotech Limited | Not yet recruiting ➔ Recruiting | Initiation date: Jul 2023 ➔ Oct 2023

CAR T-Cell Therapy • Enrollment open • Metastases • Trial initiation date • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • LGR5

Carina Biotech to Present Preclinical Data Evaluating LGR5-Targeted CAR-T Cell Therapy in Human Cancer Models at 8th CAR-TCR Summit (GlobeNewswire) - "LGR5-targeting CAR-T cells effectively kill LGR5-expressing cancer cells in in vitro cytotoxicity assays and display significant anti-tumor activity in vivo in a subcutaneous human colorectal cancer xenograft mouse model; In vivo spatiotemporal distribution and repeated dosing studies demonstrate that LGR5-targeting CAR-T cells do not persist in off-target organs and are safe and well-tolerated under the conditions tested; These studies allowed selection of a clinical candidate (CNA3103) for a Phase 1/2a clinical trial in patients with advanced colorectal cancer....'we are pleased to report that patient screening has commenced.'"

Preclinical • Trial status • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

A phase 1/2a, multicenter, open-label study of CNA3103 (LGR5-targeted, autologous CAR-T cells) in patients with metastatic colorectal cancer (mCRC). (ASCO 2023) - "Main inclusion criteria: mCRC subjects positive for LGR5 expression and failing prior treatment with 5-FU, oxaliplatin and irinotecan-based regimens for metastatic disease; >1 radiologically measurable lesion per RECISTv1.1; >1 biopsiable lesion at baseline; ECOG 0 or 1; serum albumin >3 g/dL; and normal organ and marrow function...Phase 2a enrolment will take place in Australia and the US. For information, contact Lina Jablonskis lina@carinabiotech.com or +61 437 891 563."

CAR T-Cell Therapy • Clinical • IO biomarker • Metastases • P1/2 data • Colorectal Cancer • Gastroenterology • Gastrointestinal Cancer • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Oncology • Peptic Ulcer • Respiratory Diseases • Rheumatology • Solid Tumor • BRAF • LGR5

Carina Biotech to Present Details of Planned Phase 1/2a Clinical Trial of LGR5-Targeted CAR-T Cell Therapy Candidate CNA3103 for Metastatic Colorectal Cancer at 2023 ASCO Annual Meeting (GlobeNewswire) - "Carina Biotech...announced a poster presentation showcasing its planned Phase 1/2a clinical trial of its LGR5-targeted CAR-T cell therapy candidate CNA3103 in patients with metastatic colorectal cancer (mCRC) at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting that will take place in Chicago, Illinois on June 2-6....The Phase 1/2a clinical trial is designed to enrol up to 44 patients with metastatic disease failing prior lines of chemotherapy and who express LGR5 on their cancer cells....Phase 1 segment of the trial to follow a BOIN design with a minimum of three consecutively enrolled subjects per cohort."

P1/2 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Development of a flow cytometry-based assay for measuring specific CAR expression on LGR5-targeting CAR-T cells (AACR 2023) - "We have developed several CARs targeting the cancer stem cell marker LGR5, one of which (CNA3103) is the lead candidate in an upcoming clinical trial in advanced metastatic colorectal cancer...This resulted in development of an assay that yielded very similar reproducibility and sensitivity to that previously observed with the indirect tEGFR surrogate assay. Overall, the findings highlight the utility of using CAR-targeting recombinant proteins for evaluating CAR expression on CAR-T cells, providing a general flow cytometry-based staining strategy that may be adapted for assessing a diverse repertoire of CARs."

CAR T-Cell Therapy • IO biomarker • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CD19 • LGR5

Carina Biotech to Present Preclinical Data Evaluating LGR5-Targeted CAR-T Cell Therapy in Colorectal Cancer Models at 2023 AACR (GlobeNewswire) - "Carina Biotech...announced four poster presentations from preclinical studies of its LGR5-targeting CAR-T platform in colorectal cancer at the 2023 American Association for Cancer Research (AACR) Annual Meeting that will take place in Orlando, Florida on April 14-19....Preclinical data demonstrates that LGR5-targeting CAR-T therapy has high potential as an effective therapeutic for human colorectal cancer. LGR5-targeting CAR-T cells effectively kill LGR5-expressing cancer cells in in vitro assays....Evidence that detection of LGR5 expression in cancer biopsies may be used to identify eligible colorectal (bowel) cancer patients for inclusion into the planned Phase1/2a clinical trial will also be presented."

Preclinical • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

A Study of CNA3103 (LGR5-targeted, Autologous CAR-T Cells) Administered to Subjects With Metastatic Colorectal Cancer (clinicaltrials.gov) - P1/2 | N=44 | Not yet recruiting | Sponsor: Carina Biotech Pty Ltd

CAR T-Cell Therapy • Metastases • New P1/2 trial • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • LGR5

Carina Biotech to Present Preclinical Data at Lorne Cancer 2023 Supporting Effectiveness of LGR5-Targeted CAR-T Cell Therapy Platform in Ovarian Cancer Tumor Models (GlobeNewswire) - "The poster presentation summarizes preclinical results of LGR5 CAR-T cells in two ovarian cancer models. The data shows that LGR5 CAR-T cells have significantly higher killing effects on OVCAR3 (an ovarian cancer cell line) and primary ovarian cancer cells compared to control T cells. In animal models, LGR5 CAR-T cells significantly decreased tumor burden. The data supports the conclusion that LGR5 CAR-T cells have potential to be developed as a novel immunotherapy for ovarian cancer."

Preclinical • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

Carina Biotech Receives FDA “Safe to Proceed” Letter for IND Application for Phase 1/2a Clinical Trial of LGR5-Targeted CAR-T Cell Therapy Candidate for Treatment of Advanced Colorectal Cancer (GlobeNewswire) - "Carina Biotech Pty Ltd...announced today that it has received the 'safe to proceed' letter from the U.S. FDA for its Investigational New Drug (NDA) application to conduct a first-in-human Phase 1/2a clinical trial of CNA3103, its LGR5-targeted chimeric antigen receptor T cell (CAR-T) therapy candidate, in patients with advanced colorectal cancer (CRC). The Phase 1/2a clinical trial will enroll a total of 44 patients with metastatic disease failing prior lines of chemotherapy and who express LGR5 on their cancer cells. Twenty-four patients in the Phase 1 segment will be enrolled in select Australian centers....'Preparations, including site selection, are underway as we aim to commence enrolling patients during the first half of 2023'."

IND • New P1/2 trial • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Carina Biotech Submits an Investigational New Drug (IND) Application to US FDA for LGR5-Targeted CAR-T Cell Therapy Candidate (GlobeNewswire) - "Carina Biotech Pty Ltd...announced the submission of an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) for first-in-human Phase 1/2a clinical trial of CNA3103, its LGR5-targeted chimeric antigen receptor T cell (CAR-T) therapy candidate, in patients with advanced colorectal cancer....'We are targeting the recruitment of the first patients in the Phase 1/2a trial in early 2023'."

IND • New P1/2 trial • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor