MT-303 / CREATE Medicines - LARVOL DELTA

CREATE Medicines Announces $122 Million Series B Financing to Advance In Vivo CAR Pipeline in Autoimmune Disease and Oncology (PRNewswire) - "In autoimmune, CREATE's lead program CRT-402, a next generation CD19 targeted in vivo CAR-T therapy, has demonstrated deep and durable B cell depletion in non-human primates, with the potential to enable immune reset through the flexibility of repeat dosing. The company is also advancing a dual CAR CD19 x BCMA directed therapy designed to broaden therapeutic reach across refractory autoimmune indications...In oncology, CREATE continues to advance therapies focused on areas of high unmet need. Early clinical data from the company's MT-303 program in frontline hepatocellular carcinoma has demonstrated an extremely compelling response profile."

Financing • Immunology • Solid Tumor

MTX-GPC3-303: A Study of MT-303 in Adults With Advanced or Metastatic GPC3-Expressing Cancers, Including HCC (clinicaltrials.gov) - P1 | N=70 | Recruiting | Sponsor: Myeloid Therapeutics | N=48 ➔ 70 | Trial completion date: May 2026 ➔ May 2028 | Trial primary completion date: Jul 2025 ➔ Dec 2027

Enrollment change • First-in-human • Trial completion date • Trial primary completion date • Hepatocellular Cancer • Oncology • Solid Tumor

CREATE Medicines Doses First Patient in Frontline HCC Trial Evaluating MT-303, an In Vivo CAR Therapy, in Combination with Standard-of-Care Immunotherapy (PRNewswire) - "The frontline HCC study evaluating MT-303 (NCT06478693) is a multi-center, open-label, dose-escalation and expansion trial designed to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of MT-303 in combination with atezolizumab and bevacizumab. The trial will evaluate MT-303 in adults with unresectable or metastatic HCC who have not received prior systemic therapy."

Trial status • Hepatocellular Cancer

A first-in-human study of MT-303, an innovative in vivo mRNA chimeric antigen receptor (CAR) therapy targeting GPC3, in adults with hepatocellular carcinoma. (ASCO 2025) - P1 | "Enrollment is ongoing, with safety and preliminary efficacy data expected to inform future development. ClinicalTrials.gov: NCT06478693."

IO biomarker • P1 data • Preclinical • Hepatocellular Cancer • Oncology • Solid Tumor • GPC3

MT-303: GPC3-Targeted mRNA CAR Therapy in Hepatocellular Carcinoma (PRNewswire) - "MT-303 Clinical Trial Highlights: Design: Ongoing multicenter, open-label Phase 1 trial in advanced solid tumors expressing GPC3 (including HCC) employing a Bayesian Optimal Interval (BOIN) dose escalation....Myeloid expects to share additional clinical translational data at an upcoming medical meeting upon completion of the Phase 1 studies of MT-302 and MT-303."

Clinical protocol • P1 data • Hepatocellular Cancer

Preclinical development of MT-303, a novel LNP-formulated GPC3-specific CAR mRNA, for in vivo programming of monocytes to treat hepatocellular carcinoma (SITC 2024) - P1 | "Conclusions Here, we present a novel GPC3-targeting CAR mRNA/LNP that enables myeloid cells to directly kill tumor cells and support the establishment a cytokine-mediated immune response. MT-303 is currently being tested in phase 1 clinical trial for the treatment of HCC."

Preclinical • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor • GPC3

Myeloid Therapeutics Announces SITC 2024 Oral Presentation on MT-303, the First in vivo GPC3 Targeting mRNA CAR in Human Studies for Advanced Hepatocellular Carcinoma (HCC) (PRNewswire) - "Myeloid's treatment approach focuses on selective in vivo programming of immune cell subsets with innovative off-the-shelf mRNA-encoded CAR technologies. These candidates are administered without the need for preconditioning. MT-303 arms myeloid cells with a proprietary chimeric antigen receptor that expresses specifically within myeloid cells. This approach directs and enables myeloid cells to kill GPC3 expressing cancers while orchestrating a coordinated adaptive immune anti-tumor response marked by expansion of new T cell clones."

Preclinical • Hepatocellular Cancer

Myeloid Therapeutics Initiates Patient Dosing with MT-303, a Novel GPC3 Targeting RNA CAR, in Phase 1 Study for Advanced Hepatocellular Carcinoma (HCC) (PRNewswire) - "Myeloid Therapeutics, Inc...has dosed the first patient with MT-303 in a Phase 1 study for hepatocellular carcinoma (HCC)....Dosing with MT-303 represents a significant milestone to bring advanced novel therapies to people with liver cancer."

Trial status • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

A Study of MT-303 in Adults With Advanced or Metastatic GPC3-Expressing Cancers, Including HCC (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Myeloid Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

A Study of MT-303 in Adults With Advanced or Metastatic GPC3-Expressing Cancers, Including HCC (clinicaltrials.gov) - P1 | N=48 | Not yet recruiting | Sponsor: Myeloid Therapeutics

Metastases • New P1 trial • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor