AMG 340 / Amgen - LARVOL DELTA

TNB585.001: A Study of AMG 340 in Subjects With Metastatic Castrate-Resistant Prostate Carcinoma (clinicaltrials.gov) - P1 | N=42 | Completed | Sponsor: Amgen | Active, not recruiting ➔ Completed | Trial completion date: Sep 2024 ➔ Jun 2024 | Trial primary completion date: Sep 2024 ➔ Jun 2024

Metastases • Trial completion • Trial completion date • Trial primary completion date • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Phase 1 clinical trial of AMG 340, a prostate-specific membrane antigen (PSMA)-targeted T-cell engager with a novel low-affinity CD3 binding domain designed to mitigate toxicity for the treatment of metastatic castration-resistant prostate cancer (mCRPC). (ASCO 2024) - P1 | "Despite reaching high doses, no dose response was observed, and AMG 340 did not generate sufficient clinical activity to warrant further exploration. However, AMG 340 demonstrated manageable CRS toxicity showing that decreased CD3-binding strength mitigates CRS, the main toxicity of TCEs. Clinical studies are ongoing evaluating the PSMA protein as a molecular target for prostate cancer."

Clinical • Metastases • P1 data • Endocrine Disorders • Fatigue • Genito-urinary Cancer • Hematological Disorders • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor • Thrombocytopenia

TNB585.001: A Study of AMG 340 in Subjects With Metastatic Castrate-Resistant Prostate Carcinoma (clinicaltrials.gov) - P1 | N=42 | Active, not recruiting | Sponsor: Amgen | N=100 ➔ 42

Enrollment change • Metastases • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

TNB585.001: A Study of AMG 340 in Subjects With Metastatic Castrate-Resistant Prostate Carcinoma (clinicaltrials.gov) - P1 | N=100 | Active, not recruiting | Sponsor: Amgen | Recruiting ➔ Active, not recruiting

Enrollment closed • Metastases • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

AMGEN REPORTS THIRD QUARTER FINANCIAL RESULTS (PRNewswire) - "FORTITUDE-201, a Phase 1b study of bemarituzumab monotherapy and in combination with standard of care therapy, in squamous NSCLC with FGFR2b overexpression, will be discontinued. AMG 340: A Phase 1 dose-escalation study of AMG 340, a lower T-cell affinity BiTE molecule targeting prostate-specific membrane antigen (PSMA), in mCRPC will be discontinued."

Trial termination • Genito-urinary Cancer • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Prostate Cancer • Solid Tumor

TNB585.001: A Study of AMG 340 in Subjects With Metastatic Castrate-Resistant Prostate Carcinoma (clinicaltrials.gov) - P1 | N=130 | Recruiting | Sponsor: Amgen | N=72 ➔ 130

Enrollment change • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

AMGEN REPORTS FOURTH QUARTER AND FULL YEAR 2021 FINANCIAL RESULTS (PRNewswire) - "Fourth Quarter Product and Pipeline Update: (i) Bemarituzumab: A Phase 1b study (FORTITUDE-201) of bemarituzumab for the treatment of squamous NSCLC is expected to initiate in Q1 2022; (ii) Acapatamab (AMG 160): Enrollment of acapatamab is ongoing in cohorts to explore outpatient administration. Decision-enabling data are expected in H1 2022. A master protocol evaluating combinations with acapatamab continues to enroll patients with earlier-line mCRPC; (iii) AMG 340 (formerly TNB-585): A Phase 1 dose-escalation study of AMG 340, a bispecific T-cell engager targeting PSMA, is enrolling patients with mCRPC; decision enabling data are expected in mid-2022."

Enrollment status • New P1 trial • P1 data • Genito-urinary Cancer • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Prostate Cancer • Solid Tumor • Urothelial Cancer

TNB585.001: A Study of TNB-585 in Subjects With Metastatic Castrate-Resistant Prostate Carcinoma (clinicaltrials.gov) - P1 | N=72 | Recruiting | Sponsor: Amgen | Trial completion date: Mar 2023 ➔ Sep 2024 | Trial primary completion date: Mar 2022 ➔ Sep 2024

Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Amgen Successfully Completes Acquisition Of Teneobio, Inc. (PRNewswire) - "Effective as of Oct. 19, 2021, Amgen has acquired all outstanding equity of Teneobio in exchange for a $900 million upfront cash payment, as well as future contingent milestone payments, to former Teneobio equity holders potentially worth up to an additional $1.6 billion in cash...The acquisition will also add TNB-585, a Phase 1 bispecific T cell engager for the treatment of metastatic castrate-resistant prostate cancer (mCRPC), and several preclinical oncology pipeline assets with the potential for near-term Investigational New Drug (IND) filings...Prior to the consummation of the acquisition, Teneobio distributed to its equity holders all equity held by Teneobio in (i) TeneoTwo, Inc., which develops TNB-486, a bispecific antibody targeting CD19 on tumor cells and CD3 on T-cells..."

M&A • Genito-urinary Cancer • Hematological Malignancies • Oncology • Prostate Cancer

[VIRTUAL] TNB585.001: A multicenter, phase 1, open-label, dose-escalation and expansion study of tnb-585, a bispecific T-cell engager targeting PSMA in subjects with metastatic castrate resistant prostate cancer. (ASCO 2021) - P1 | "The activity endpoints (per PCWG3/RECIST1.1) include overall response rate, PSA50, PSA30, CTC counts, progression free survival and overall survival . The relationship between PSMA expression (via PSMA-PET) and activity will be assessed."

Clinical • P1 data • Genito-urinary Cancer • Human Immunodeficiency Virus • Infectious Disease • Inflammation • Oncology • Prostate Cancer • Solid Tumor • EGFR • FOLH1

Amgen To Acquire Privately Held Teneobio For $900 Million In Cash With Future Contingent Milestone Payments (PRNewswire) - "Amgen...and Teneobio today announced an agreement under which Amgen will acquire Teneobio, a privately held, clinical stage biotechnology company developing a new class of biologics called Human Heavy-Chain Antibodies...The acquisition will also add TNB-585, a Phase 1 bispecific T cell-engager for the treatment of metastatic castrate-resistant prostate cancer (mCRPC), and several preclinical oncology pipeline assets with the potential for near-term IND filings."

M&A • Genito-urinary Cancer • Oncology • Prostate Cancer

Attenuating CD3 affinity in a PSMAxCD3 bispecific antibody enables killing of prostate tumor cells with reduced cytokine release. (PubMed, J Immunother Cancer) - "Our data suggest that TNB-585, with its low-affinity anti-CD3, may be efficacious while inducing a lower incidence and severity of CRS in patients with prostate cancer compared with TCEs that incorporate high-affinity anti-CD3 domains."

Journal • Genito-urinary Cancer • Inflammation • Oncology • Prostate Cancer • Solid Tumor

A Study of TNB-585 in Subjects With Metastatic Castrate-Resistant Prostate Carcinoma (clinicaltrials.gov) - P1; N=72; Recruiting; Sponsor: Teneobio, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A Study of TNB-585 in Subjects With Metastatic Castrate-Resistant Prostate Carcinoma (clinicaltrials.gov) - P1; N=72; Not yet recruiting; Sponsor: Teneobio, Inc.

Clinical • New P1 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Teneobio Announces FDA Clearance of IND for TNB-585 and Initiation of Phase I Clinical Studies for Metastatic Castrate Resistant Prostate Cancer (GlobeNewswire) - “Teneobio, Inc. and its affiliate TeneoThree, Inc. announced today that their investigational new drug application (IND) for TNB-585, a bispecific T-cell engaging antibody for the treatment of metastatic castrate resistant prostate cancer (mCRPC) was cleared for the initiation of Phase I clinical studies by the US Food and Drug Administration (FDA) on January 23, 2021.”

IND • Genito-urinary Cancer • Oncology • Prostate Cancer

[VIRTUAL] TNB-585: A CD3xPSMA Bispecific Antibody for T-Cell Mediated Killing of Prostate Tumor Cells with Minimal Cytokine Release (PCF 2020) - "Overall, our data suggest that TNB-585 may be efficacious whilst inducing a lower incidence and severity of cytokine release syndrome in prostate cancer patients compared to currently available bispecific antibodies that utilize strong binding/activating anti-CD3 domains. Funding Acknowledgments: Partially funded by NCI grant #1R43CA232972-01"

Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

[VIRTUAL] Effect of modulation of CD3 binding in a PSMAxCD3 T-cell engaging bispecific antibody on maintenance of efficient tumor cell kill and cytokine release. (ASCO 2020) - "We have developed a novel CD3xPSMA T-BsAb that mediates T-cell killing of PSMA+ tumor cells with minimal production of cytokines. This molecule may improve safety, efficacy, and offer opportunities for combination therapy to treat CRPC. A Phase 1 clinical trial of this compound in CRPC is scheduled to begin in Q1 2021."

Clinical • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor