M1231 / EMD Serono, Sutro Biopharma - LARVOL DELTA

Sex-Related Variations in Platelet Reactivity in Presence or Absence of Antiplatelet Therapy. (PubMed, Eur Heart J Cardiovasc Pharmacother) - "Females exhibit heightened baseline ADP-dependent platelet reactivity and a diminished response to aspirin and clopidogrel monotherapy compared to males."

Journal

M1231 in Participants With Solid Tumors (clinicaltrials.gov) - P1 | N=23 | Completed | Sponsor: EMD Serono Research & Development Institute, Inc. | Active, not recruiting ➔ Completed | N=84 ➔ 23 | Trial completion date: Mar 2024 ➔ Jun 2023

Enrollment change • Metastases • Trial completion • Trial completion date • Breast Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • EGFR • MSI • MUC1

Translational PK/PD/efficacy modeling and efficacious human dose prediction for a first-in-class MUC1-EGFR (M1231) bispecific antibody drug conjugate (AACR 2022) - P1 | "The quantitative systems pharmacology model-based efficacious dose prediction range of 2.4 mg/kg to 4.3 mg/kg dosed Q3W informed the design of the ongoing M1231 first-in-human trial (NCT04695847)."

Clinical • PK/PD data • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • MUC1

M1231 in Participants With Solid Tumors (clinicaltrials.gov) - P1 | N=84 | Active, not recruiting | Sponsor: EMD Serono Research & Development Institute, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Breast Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • EGFR • MSI • MUC1

Preclinical studies of the bispecific MUC1xEGFR antibody drug conjugate M1231 in EGFR mutant NSCLC (AACR-NCI-EORTC 2022) - "In addition, cell viability was evaluated after the combination of M1231 with the EGFR-TKIs afatinib or osimertinib. MUC1 and EGFR were consistently expressed in NSCLC tumors after EGFR-TKI relapse. These findings indicate that NSCLC patients developing EGFR-TKI resistance under treatment may benefit from a bispecific MUC1xEGFR ADC like M1231."

Preclinical • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MUC1

M1231 is a bispecific anti-MUC1xEGFR antibody-drug conjugate designed to treat solid tumors with MUC1 and EGFR co-expression (AACR 2022) - "M1231 antitumor activity was associated with high target expression in NSCLC PDX models and was observed across a range of target expression levels in ESCC models. In summary, efficient payload delivery to tumor cells and strong antitumor activity of M1231 indicate that M1231 may have the potential to deliver an efficacy benefit to patients with tumors co-expressing MUC1 and EGFR."

Breast Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • MUC1

Antibody-Drug Conjugates Targeting the Human Epidermal Growth Factor Receptor Family in Cancers. (PubMed, Front Mol Biosci) - "A third HER2-directed ADC, disitamab vedotin (RC48), has been approved for locally advanced or metastatic gastric or gastroesophageal junction cancer by the NMPA (National Medical Products Administration) of China in 2021. In this review article, we summarize the three approved ADCs (T-DM1, DS-8201a and RC48), together with the investigational EGFR-directed ADCs (ABT-414, MRG003 and M1231), HER2-directed ADCs (SYD985, ARX-788, A166, MRG002, ALT-P7, GQ1001 and SBT6050) and HER3-directed ADC (U3-1402). Lastly, we discuss the major challenges associated with the development of ADCs, and highlight the possible future directions to tackle these challenges."

Journal • Review • Breast Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • ERBB3 • ERBB4 • HER-2

Merck Highlights Novel Mechanisms with the Potential to Transform Standards of Care in Several Cancers, MS, and Lupus (Businesswire) - "Advancing Assets with Transformational Potential: (i) Berzosertib (ATR inhibitor): Study planned for indication expansion in ovarian cancer and potentially in refractory GI cancers; (ii) M1231 (MUC1/EGFR bi-specific ADC): Phase I clinical study to characterize the safety and preliminary activity is well underway, and efficacy expansions into late-stage non-small cell lung cancer and esophageal squamous cell carcinoma are expected to begin in 2022."

New trial • Trial status • Esophageal Cancer • Gastrointestinal Cancer • Gynecologic Cancers • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer

[VIRTUAL] M1231, a Novel Bispecific Anti-MUC1xEGFR ADC (ADC-USA 2021) - "M1231 is a bispecific ADC for the treatment of solid tumors coexpressing MUC1 and EGFR Discuss the advantages of a bispecific ADC approach Review mechanism of action andpreclinical profile of M1231"

Oncology • Solid Tumor • EGFR • MUC1

Sutro Biopharma Earns Milestone Payment from Bispecific Antibody-Drug Conjugate Collaboration with Merck KGaA, Darmstadt, Germany (PRNewswire) - “Sutro Biopharma, Inc…announced that it has received a milestone payment under its collaboration and license agreement with the healthcare division of Merck KGaA, Darmstadt, Germany, related to a patient enrollment achievement in the Phase 1 dose escalation and expansion study of M1231 in adult patients with metastatic solid tumors, including non-small cell lung cancer (NSCLC) and esophageal squamous cell carcinoma.”

Financing • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

M1231 in Participants With Solid Tumors (clinicaltrials.gov) - P1; N=84; Recruiting; Sponsor: EMD Serono Research & Development Institute, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Breast Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • EGFR • MSI • MUC1

M1231 in Participants With Solid Tumors (clinicaltrials.gov) - P1; N=84; Not yet recruiting; Sponsor: EMD Serono Research & Development Institute, Inc.

Clinical • New P1 trial • Breast Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • EGFR • MSI • MUC1

Sutro Biopharma Reports Third Quarter 2020 Financial Results and Provides Business Highlights and Developments (PRNewswire) - “STRO-002: Continued progress on our program in STRO-002, folate receptor-alpha (FolRα) targeting ADC for development in ovarian cancer: The dose-expansion portion of the Phase 1 trial is expected to enroll patients in the fourth quarter of 2020. STRO-001: Dose escalation continues in STRO-001, a CD74 targeting ADC for development in B-cell malignancies: A dose-expansion portion of the Phase 1 is expected to begin enrolling patients in first half of 2021…Additional Phase 1 dose-escalation data for STRO-001 will be presented at ASH…in Patients with B-cell Non-Hodgkin Lymphoma; IND for M1231, MUC1-EGFR bispecific ADC, is on track in 2021 for the treatment of solid tumors. EMD Serono is projected to commence first-in-human studies of M1231 in non-small cell lung cancer (NSCLC) and esophageal squamous cell carcinoma in the first quarter of 2021.”

Enrollment status • IND • New trial • P1 data • Esophageal Squamous Cell Carcinoma • Gynecologic Cancers • Hematological Malignancies • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Oncology • Ovarian Cancer