DM919 / D2M biotherap - LARVOL DELTA

A Study of DM919 Alone and in Combination With Pembrolizumab in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=160 | Active, not recruiting | Sponsor: D2M Biotherapeutics Inc. | Recruiting ➔ Active, not recruiting | Trial primary completion date: Dec 2025 ➔ Mar 2026

Enrollment closed • First-in-human • Monotherapy • Trial primary completion date • Solid Tumor

D2M Biotherapeutics Announces First Patient Dosed in A Phase 1 Study Evaluating DM919, a Novel MICA/B Antibody for Treating Patients with Advanced Solid Tumors (PRNewswire) - "D2M Biotherapeutics, Inc...today announced that the first patient had been dosed in a phase 1, open-label, dose escalation and expansion study of DM919, a novel monoclonal antibody targeting MICA/B to restore and promote anti-tumor response by T and natural killer (NK) cells for the treatment of advanced solid tumors....This phase 1, first-in-human, multicenter, dose-escalation and expansion trial...will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and clinical activity of DM919 alone and in combination with anti-PD1 therapy in patients with advanced or metastatic solid tumors."

Trial status • Oncology • Solid Tumor

D2M Biotherapeutics Announces First Patient Dosed in A Phase 1 Study Evaluating (PRNewswire) - "D2M Biotherapeutics, Inc...today announced that the first patient had been dosed in a phase 1, open-label, dose escalation and expansion study of DM919, a novel monoclonal antibody targeting MICA/B to restore and promote anti-tumor response by T and natural killer (NK) cells for the treatment of advanced solid tumors...This phase 1, first-in-human, multicenter, dose-escalation and expansion trial (NCT06328673) will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and clinical activity of DM919 alone and in combination with anti-PD1 therapy in patients with advanced or metastatic solid tumors."

Trial status • Oncology • Solid Tumor

New target for tumor immunity! Danma Biotech’s Class 1 new drug has been approved for clinical use [Google translation] (163.com) - "On April 10, D2M Biotherapeutics announced that the company’s first pipeline research and development product DM919 has recently been approved for clinical use in China. According to Danma Bio’s press release, DM919 is a pan-tumor indication checkpoint inhibitor monoclonal antibody targeting the MICA/B protein....According to Danma Bio's press release, DM919 aims to reshape and enhance the NKG2D/MICA/B mechanism that is inhibited in the tumor microenvironment and restore the killing effect of NK cells and T cells on tumors."

New trial • Oncology • Solid Tumor

A Study of DM919 Alone and in Combination With Pembrolizumab in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=160 | Recruiting | Sponsor: D2M Biotherapeutics Inc. | Active, not recruiting ➔ Recruiting

Combination therapy • Enrollment open • Metastases • Monotherapy • Oncology • Solid Tumor

A Study of DM919 Alone and in Combination With Pembrolizumab in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=160 | Active, not recruiting | Sponsor: D2M Biotherapeutics Inc.

Combination therapy • Metastases • Monotherapy • New P1 trial • Oncology • Solid Tumor

Danma Biotech: DM919 IND, the first pipeline R&D product, was accepted [Google translation] (Beijing Shangzhuangyuan Technology) - "On January 18, 2024, Danma Biotech’s clinical trial application for DM919 injection was accepted by the NMPA. DM919 is a humanized monoclonal antibody independently developed by D2M that targets MICA/B protein and is expected to become a global NK/T cell checkpoint inhibitor FIC drug....DM919 is a MIC A/B monoclonal antibody and is also Danma Biotech’s first pipeline."

New trial • Oncology • Solid Tumor

DM919, an IND-ready MICA/B-specific antibody, reinforces NKG2D-MICA/B axis and promotes anti-tumor activities (SITC 2023) - "DM919 has shown significant antitumor activities in multiple mouse tumor models. Good safety profile in NHP and well-demonstrated manufacturability of DM919 have warranted an IND submission and further investigation in clinical trials."

IO biomarker • Oncology • CD8 • NKG2D

Co-production of l-Lysine and Heterologous Squalene in CRISPR/dCas9-Assisted Corynebacterium glutamicum. (PubMed, J Agric Food Chem) - "Repressing pyc encoding for pyruvate carboxylase in the l-lysine producer (DM1919) and its derivatives resulted in 99.24 ± 7.63 mg/L total squalene and 6.25 ± 0.20 g/L extracellular lysine at 120 h. Furthermore, various oil overlays were tested for efficient co-productions. In situ extraction with corn oil (10%, v/v) exhibited a separation of 99.75% (w/v) of total squalene (intra- and extracellular squalene), while l-lysine can be secreted in the medium. This co-production strategy will help a potential bioprocess of amino acid production with various terpenes."

Journal

DM919, a potent anti-MICA/B antibody, reinforces NKG2D-MICA/B axis and promotes anti-tumor activities in preclinical models (SITC 2022) - "Consent Written informed consent was obtained from the patient for publication of this abstract and any accompanying images. A copy of the written consent is available for review by the Editor of this journal."

IO biomarker • Preclinical • Oncology • Solid Tumor • CD8 • MICA • MICB • NKG2D