MT-302 / CREATE Medicines - LARVOL DELTA

CREATE Medicines Announces Positive First-in-Human Results for MT-302 (PRNewswire) - "27 patients with advanced TROP2-positive solid tumors were treated with MT-302 across seven dose cohorts....Dose and tumor burden dependent low grade cytokine release syndrome observed in 51.9% of participants with kinetics consistent with tumor target engagement. There were no events of grade 3 or higher CRS....Clinical signal: one confirmed partial response in HR⁺ breast cancer in a patient on treatment for 16 months (20 doses) with pharmacological activity observed at 0.015 mg/kg."

P1 data • Solid Tumor

First-in-human dose escalation study to investigate the safety, pharmacokinetics, pharmacodynamics and initial efficacy of mRNA-LNP MT-302 in vivo CAR therapy in solid tumors (SITC 2025) - P1 | "This trial was sponsored by Myeloid Therapeutics and conducted in collaboration with the participating investigators and institutions. All authors declare compliance with SITC's disclosure and conflict of interest policies."

First-in-human • Late-breaking abstract • P1 data • PK/PD data • Preclinical • Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • CXCL9 • IFNG • SPP1 • TACSTD2

First-in-human dose escalation study to investigate the safety, pharmacokinetics, pharmacodynamics and initial efficacy of mRNA-LNP MT-302 in vivo CAR therapy in solid tumors (SITC 2025) - P1 | "This trial was sponsored by Myeloid Therapeutics and conducted in collaboration with the participating investigators and institutions. All authors declare compliance with SITC's disclosure and conflict of interest policies."

First-in-human • Late-breaking abstract • P1 data • PK/PD data • Preclinical • Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • CXCL9 • IFNG • SPP1 • TACSTD2

CREATE Medicines…announced that clinical results from its Phase 1 MYE Symphony trial evaluating MT-302 have been accepted for a late-breaking oral presentation at the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC 2025)… (PRNewswire) - "Findings demonstrate potential to create new class of in vivo CAR therapeutics to treat solid tumors."

Late-breaking abstract • P1 data • Solid Tumor

CREATE Medicines, Inc., formerly Myeloid Therapeutics, Inc. (“CREATE“), announced today that Amsterdam University Medical Center (“Amsterdam UMC“) has dosed the first patient in the SPaCE-MT clinical trial. (PRNewswire) - "The trial will evaluate the treatment of advanced gastroesophageal cancer with CREATE's MT-302 with capecitabine, oxaliplatin (CAPOX) with or without nivolumab or trastuzumab, representing the first clinical evaluation of an in vivo CAR therapy combined with a standard frontline regimen for solid tumors."

Trial status • Gastroesophageal Cancer

First-in-human mRNA CAR therapy: Correlative biomarker analysis from the MT-302 phase 1 study targeting TROP2 in patients with advanced epithelial tumors. (ASCO 2025) - P1 | "This Phase 1 study provides the first evidence of successful delivery of mRNA-CAR therapy in humans. These biomarker findings demonstrate that MT-302 selectively engages myeloid cells and induces robust innate and adaptive anti-tumor pharmacodynamic responses, providing support for further investigation of MT-302's potential as a transformative treatment for patients with TROP2-expressing epithelial cancers."

Biomarker • Clinical • IO biomarker • Metastases • P1 data • Gastrointestinal Cancer • Oncology • Solid Tumor • TACSTD2

MT-302: TROP2-Targeted mRNA CAR Therapy in Advanced Epithelial Tumors (PRNewswire) - "Key MT-302 Findings Include: Immune Activation: Single-cell RNA sequencing demonstrated selective CAR expression in myeloid cells and increased pro-inflammatory gene signatures across tumor types; Target Engagement: Pharmacodynamic markers confirmed successful delivery and CAR expression following systemic administration; Continued dose escalation: Dose escalation continues with an optimized liner mRNA based on preclinical demonstration of expression beyond 12 days....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."

P1 data • Preclinical • Solid Tumor

Myeloid Therapeutics: In vivo CAR-T enters clinical trials [Google translation] (Sohu.com) - "MYE Symphony is a multicenter clinical trial of MT-302 in patients with advanced epithelial cancer with high TROP2 expression. MT-302 is administered three times every 14 days and then once every 28 days. The dose escalation adopts a Bayesian optimal interval design with backfill for further dose evaluation. The primary endpoint is to evaluate safety and determine the MTD and RP2D. Secondary endpoints include determining the incidence of PK and ICAN and CRS. Exploratory endpoints include efficacy indicators (such as ORR and DOR) and immunological effects caused by treatment (such as peripheral CAR expression, cytokine release and T cell receptor clonality, as well as changes in the tumor immune environment and TROP2 expression). Patients have been enrolled in all three dose level groups."

Enrollment status • Trial status • Oncology • Solid Tumor

MYE Symphony: A first-in-human study to investigate the safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of the in vivo mRNA CAR therapy, MT-302, targeting TROP2 in adults with advanced epithelial tumors (ESMO 2024) - P1 | "The first three dose level cohorts have been enrolled. NCT05969041."

IO biomarker • Metastases • P1 data • PK/PD data • Preclinical • Breast Cancer • Oncology • Solid Tumor • CD8 • TACSTD2

Myeloid Therapeutics Presents Multiple Posters at the American Society of Gene & Cell Therapy (ASGCT) 2024 Annual Meeting (PRNewswire) - "Myeloid Therapeutics, Inc...announced multiple poster presentations at the American Society of Gene & Cell Therapy (ASGCT) 2024 Annual Meeting, taking place May 7 – 11, 2024...Poster presentation details and abstract highlights include...Myeloid has designed novel CARs that achieve expression and function in targeted immune cell populations. These CARs, by activating innate and adaptive immune responses following the in vivo delivery of LNP-formulated mRNA encoded CARs, are capable of eliciting anti-tumor efficacy against a range of multiple target antigens evaluated...MT302, an in vivo CAR targeting TROP2+ epithelial malignancies (NCT05969041), is being evaluated in a Phase 1 clinical trial to assess the candidate's safety and preliminary efficacy....CREATE merges the capabilities of CRISPR/Cas9 with human L1 retrotransposon to insert gene-sized payloads without DNA donors or double strand breaks."

Preclinical • Trial status • Oncology • Solid Tumor

Myeloid Therapeutics to Showcase In Vivo CAR Data and its Diverse mRNA Platform at AACR (PRNewswire) - "Myeloid Therapeutics, Inc...announced that it will provide a preclinical update for MT-302, its novel TROP2-targeting RNA CAR at the 2024 American Association for Cancer Research (AACR) Annual Meeting. MT-302 is currently in a Phase 1 study to assess the therapy's safety and activity in patients with advanced or metastatic epithelial tumors. This advancing study represents the first human trial of any in vivo chimeric antigen receptor (CAR) therapy. Myeloid will also share information on its portfolio of immune cell programming CARs...Poster presentation details and abstract highlights include...Myeloid has demonstrated CAR activity in human cells, and following systemic mRNA/LNP delivery in mouse and non-human primates....The programed NK cells induce cytotoxicity against antigen-expressing tumor cells and trigger the release of cytokines and chemokines, important factors to a full immune response."

Preclinical • Trial status • Oncology • Solid Tumor

Myeloid Therapeutics Initiates Patient Dosing with MT-302, a Novel TROP2-Targeting RNA CAR, in Phase 1 Study for Advanced or Metastatic Epithelial Tumors (PRNewswire) - "Myeloid Therapeutics...has dosed the first patient with MT-302 in a Phase 1 study for advanced or metastatic epithelial tumors....The MT-302 Phase 1 study (NCT05969041) is an open-label dose escalation study to investigate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of MT-302 in adults with advanced or metastatic epithelial tumors that overexpress TROP2. This study will also define the recommended Phase 2 dose (RP2D) of MT-302. The study is currently enrolling patients at multiple clinical sites in Australia."

Trial status • Skin Cancer

Study of MT-302 in Adults With Advanced or Metastatic Epithelial Tumors (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Myeloid Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Ductal Adenocarcinoma • Solid Tumor • Triple Negative Breast Cancer • HER-2

Study of MT-302 in Adults With Advanced or Metastatic Epithelial Tumors (clinicaltrials.gov) - P1 | N=48 | Not yet recruiting | Sponsor: Myeloid Therapeutics

Metastases • New P1 trial • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Ductal Adenocarcinoma • Solid Tumor • Triple Negative Breast Cancer • HER-2

In vivo Programming with MT-302 (PEGS 2023) - "Through this approach, Myeloid demonstrates that delivery of lipid-nanoparticles (LNPs) encapsulating mRNA results in selective uptake and expression by myeloid cells in vivo, leading to potent tumor killing in multiple cold tumor models. These data demonstrate the potential for Myeloid's technology to program cells directly in vivo."

Preclinical • Oncology

Myeloid Therapeutics Announces $73 Million Financing to Advance mRNA-based Immunotherapy Pipeline (PRNewswire) - "Myeloid Therapeutics...announced today the completion of a $73 million financing led by Hatteras Investment Partners, with participation from new investors ARCH Venture Partners and Moore Strategic Ventures. All existing investors, including Newpath Partners, 8VC and Alexandria Venture Investments, also participated....Proceeds from the financing will support the continued clinical development of MT-101, Myeloid's lead cell therapy program in Phase 1/2 for T cell lymphoma, and will accelerate the development of MT-302, a first-in-class TROP2-FcA mRNA-LNP product, into a Phase 1/2 study for TROP2-expressing tumors."

Financing • Hematological Malignancies • Lymphoma • Oncology • Solid Tumor

Myeloid Therapeutics Presents Late-Breaking Data on Multiple Platforms at the American Association for Cancer Research (AACR) 2023 Annual Meeting (PRNewswire) - "Myeloid Therapeutics, Inc...announced its presentation of two posters at the American Association for Cancer Research (AACR) Annual Meeting, being held in Orlando, Florida....Myeloid's most-advanced in vivo programming candidate is a candidate referred to as MT-302, targeting trophoblast cell surface antigen 2 (TROP2) on cancer cells....Within immunodeficient xenograft models of hepatocellular carcinoma and triple negative breast cancer, delivery of LNP mRNA encoding GPC3-CD89 or TROP2-CD89 fusion proteins resulted in anti-tumor efficacy, confirming the ability of this approach to program myeloid cells. Repeat dosing studies showed significant anti-tumor efficacy following bi-weekly administration of TROP2-CD89."

Late-breaking abstract • Preclinical • Breast Cancer • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Oncology • Triple Negative Breast Cancer

Myeloid Therapeutics Presents Update On Myeloid Cell Programming Technologies, Including Non-Human Primate Proof-Of-Concept Data Delivering in vivo mRNA TROP-2 Targeting CAR (MT-302) at Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting (PRNewswire) - "Myeloid Therapeutics...presented multiple posters on its therapeutics platforms, ATAK™ CAR receptors and in vivo mRNA programming, at the Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting, being held in Boston, MA, November 8-12, 2022....'In particular, we are really excited about the progress we've made with in vivo programming with MT-302, our TROP2-FcA-LNP, that has shown confirmed tumor killing activity and strong expression in myeloid cells in non-human primates. We are planning to advance this program into the clinic and expect to file an IND in 2023.' Myeloid's novel in vivo engineering platform specifically targets and activates myeloid cells to elicit broader anti-tumor adaptive immunity. Through this approach, Myeloid demonstrates that delivery of lipid-nanoparticles (LNPs) encapsulating mRNA results in selective uptake and expression by myeloid cells in vivo, leading to potent tumor killing in multiple cold tumor models."

IND • Preclinical • Acute Myelogenous Leukemia • Hematological Malignancies • Oncology • Solid Tumor