TAK-186 / Takeda - LARVOL DELTA

A Study of TAK-186 (Also Known as MVC-101) in Adults With Advanced or Metastatic Cancer (clinicaltrials.gov) - P1/2 | N=95 | Terminated | Sponsor: Takeda | Trial completion date: Nov 2026 ➔ Jun 2025 | Active, not recruiting ➔ Terminated | Trial primary completion date: Sep 2025 ➔ Jun 2025; Sponsor decision based on limited anti-cancer activity of TAK-186.

First-in-human • Trial completion date • Trial primary completion date • Trial termination • Colorectal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • KRAS • MSI • PD-L1

Heterogeneous and evolving epitope landscape of clinical anti-drug antibodies against multidomain biotherapeutic: a case study of TAK-186. (PubMed, MAbs) - "Several potential linear epitopes were identified subsequently through experimental and computational approaches. Overall, we presented in this study a practical strategy to elucidate and potentially mitigate the immunogenicity liabilities of complex biotherapeutics."

Heterogeneity • Journal

A Study of TAK-186 (Also Known as MVC-101) in Adults With Advanced or Metastatic Cancer (clinicaltrials.gov) - P1/2 | N=97 | Active, not recruiting | Sponsor: Takeda | Recruiting ➔ Active, not recruiting | N=258 ➔ 97

Enrollment change • Enrollment closed • Colorectal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • KRAS • MSI • PD-L1

A phase I/II, first-in-human, open-label, dose-escalation study of TAK-186, an EGFR × CD3ε COBRA T cell engager, in adult patients with unresectable, locally advanced, or metastatic solid tumors (ESMO 2023) - P1/2 | "Cytokine release syndrome will be reported by ASTCT consensus grading. Recruitment is ongoing."

Clinical • Metastases • P1/2 data • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • EGFR

A Study of TAK-186 (Also Known as MVC-101) in Adults With Advanced or Metastatic Cancer (clinicaltrials.gov) - P1/2 | N=228 | Recruiting | Sponsor: Takeda | N=123 ➔ 228 | Trial completion date: Oct 2024 ➔ Nov 2026 | Trial primary completion date: Nov 2023 ➔ Sep 2025

Enrollment change • Metastases • Trial completion date • Trial primary completion date • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • KRAS • MSI • PD-L1

CIVO Intratumoural Microdosing of Anti-Cancer Therapies in Australia (clinicaltrials.gov) - P1 | N=0 | Withdrawn | Sponsor: Presage Biosciences | N=12 ➔ 0 | Trial completion date: Jul 2031 ➔ Jun 2022 | Not yet recruiting ➔ Withdrawn | Trial primary completion date: Jul 2031 ➔ Jun 2022

Enrollment change • Trial completion date • Trial primary completion date • Trial withdrawal • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • CASP3 • CD163 • CD4 • CD68 • CD8 • CD86 • GZMB • NCAM1

A Study of MCV-101 (Also Known as TAK-186) in Adults With Advanced or Metastatic Cancer (clinicaltrials.gov) - P1/2 | N=123 | Recruiting | Sponsor: Takeda | N=68 ➔ 123

Enrollment change • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • ALK • EGFR • PD-L1

Regression of EGFR positive established solid tumors in mice with the conditionally active T cell engager TAK-186. (PubMed, J Immunother Cancer) - "The studies shown support the advancement of TAK-186, and the pursuit of additional COBRA TCEs for the treatment of solid tumors."

Journal • Preclinical • Hematological Disorders • Hematological Malignancies • Oncology • Solid Tumor • EGFR

CIVO Intratumoural Microdosing of Anti-Cancer Therapies in Australia (clinicaltrials.gov) - P1; N=12; Not yet recruiting; Sponsor: Presage Biosciences; Initiation date: Jul 2021 ➔ Oct 2021

Clinical • Trial initiation date • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • CASP3 • CD163 • CD4 • CD68 • CD8 • CD86 • GZMB • NCAM1

Phase 0 Australia Master Protocol for CIVO Intratumoural Microdosing of Anti-Cancer Therapies (clinicaltrials.gov) - P1; N=12; Not yet recruiting; Sponsor: Presage Biosciences

Clinical • New P1 trial • Oncology • Solid Tumor • CASP3 • CD163 • CD4 • CD68 • CD8 • CD86 • GZMB • NCAM1

A Dose Escalation and Expansion Study of MVC-101 in Patients With Advanced Cancer (clinicaltrials.gov) - P1/2; N=68; Recruiting; Sponsor: Maverick Therapeutics, Inc

New P1/2 trial • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • ALK • EGFR • PD-L1

Takeda to Acquire Maverick Therapeutics to Advance T-Cell Engager Therapies for Solid Tumors and Expand Novel Immuno-Oncology Portfolio (Businesswire) - “Takeda Pharmaceutical Company Limited…announced the exercise of its option to acquire Maverick Therapeutics, Inc…Under the agreement, Takeda will obtain Maverick’s T-cell engager COBRA™ platform and a broad development portfolio, including Maverick’s lead development candidate TAK-186 (MVC-101) currently in a Phase 1/2 study for the treatment of EGFR-expressing solid tumors, and TAK-280 (MVC-280), which is anticipated to enter the clinic in the second half of Takeda’s fiscal year 2021 for the treatment of patients with B7H3-expressing solid tumors…Takeda exercised its option to acquire Maverick for a pre-negotiated upfront payment as well as potential development and regulatory milestones totaling up to $525 million…The deal is expected to be finalized in Q1 of Takeda’s fiscal year 2021.”

M&A • Oncology • Solid Tumor