JNJ-9401 / J&J, Xencor - LARVOL DELTA

Clinical Trials of Potentially ‘Game-Changing’ Immunotherapy Drug for Advanced Prostate Cancer Underway at CU Anschutz Cancer Center (University of Colorado Anschutz Medical Campus) - "Two clinical trials underway at the University of Colorado Anschutz Cancer Center may offer new hope to prostate cancer patients who have disease that has spread beyond the prostate gland and is no longer responding to hormone therapies....One of the clinical trials open at the CU Anschutz Cancer Center is a phase III trial testing the efficacy of pasritamig on its own compared to best supportive care; the other is a phase I trial investigating the combination of pasritamig with a second T-cell engager that targets a cancer cell protein called PSMA and T-cell protein CD28."

Trial status • Castration-Resistant Prostate Cancer

KLK2-comPAS: A Study of Pasritamig With or Without JNJ-87189401 Versus Placebo for Late Line Metastatic Castration-resistant Prostate Cancer (mCRPC) (clinicaltrials.gov) - P3 | N=1203 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial primary completion date: Dec 2027 ➔ Aug 2028

Trial primary completion date • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor • BRCA

A Study of JNJ-78278343 in Combination With JNJ-95298177 for Treatment of Prostate Cancer (clinicaltrials.gov) - P1 | N=140 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Mar 2027 ➔ Dec 2027 | Trial primary completion date: Jan 2027 ➔ Nov 2027

Trial completion date • Trial primary completion date • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor • AR

Business Highlights:…Pasritamig (GlobeNewswire) - "Johnson and Johnson Innovative Medicine (J&J) expect to present Phase 1b clinical data for pasritamig, a first-in-class bispecific antibody against KLK2, in combination with JNJ-9401 in patients with advanced prostate cancer who have progressed after multiple lines of therapy, during the second half of 2026."

P1 data • Prostate Cancer

A Study of JNJ-87189401 Combined With JNJ-78278343 for Advanced Prostate Cancer (clinicaltrials.gov) - P1 | N=355 | Recruiting | Sponsor: Janssen Research & Development, LLC | N=250 ➔ 355

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

A Study of JNJ-87189401 Plus JNJ-78278343 for Advanced Prostate Cancer (clinicaltrials.gov) - P1 | N=110 | Not yet recruiting | Sponsor: Janssen Research & Development, LLC

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

A Study of JNJ-87189401 Plus JNJ-78278343 for Advanced Prostate Cancer (clinicaltrials.gov) - P1 | N=130 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Jun 2027 ➔ Oct 2027

Trial completion date • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

A Study of JNJ-87189401 Plus JNJ-78278343 for Advanced Prostate Cancer (clinicaltrials.gov) - P1 | N=250 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Oct 2027 ➔ Jun 2028

Trial completion date • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

A Study of JNJ-87189401 Plus JNJ-78278343 for Advanced Prostate Cancer (clinicaltrials.gov) - P1 | N=250 | Recruiting | Sponsor: Janssen Research & Development, LLC | N=130 ➔ 250

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

A Study of JNJ-87189401 Plus JNJ-78278343 for Advanced Prostate Cancer (clinicaltrials.gov) - P1 | N=110 | Recruiting | Sponsor: Janssen Research & Development, LLC | Not yet recruiting ➔ Recruiting

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

A phase I, first-in-human, open-label, multicenter, trial-in-progress of the safety, tolerability, and preliminary efficacy of JNJ-87189401 (PSMA-CD28 bispecific antibody) combined with JNJ-78278343 (KLK2-CD3 bispecific antibody) for advanced prostate cancer (ESMO 2024) - P1 | "Secondary objectives: preliminary efficacy (objective response rate, duration of response, PSA response rate), pharmacokinetics, and immunogenicity. Enrollment (N≈110) is ongoing."

Clinical • Metastases • P1 data • Carcinoid Tumor • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor • KLK2

Johnson & Johnson is transforming solid tumor cancer outcomes with new data at the 2024 World Conference on Lung Cancer and European Society for Medical Oncology Congress (PRNewswire) - "Johnson & Johnson...announced today that 11 oral presentations from the Company's industry-leading solid tumor portfolio and pipeline will be featured at the 2024 World Conference on Lung Cancer (WCLC) and the European Society for Medical Oncology (ESMO) 2024 Congress. Twenty-seven studies (23 company-sponsored and four investigator-initiated), including four late-breaking abstracts, will feature new data in lung, bladder, prostate, and colorectal cancers."

Clinical data • Bladder Cancer • Colorectal Cancer • Non Small Cell Lung Cancer • Oncology • Prostate Cancer

Xencor Regains CD20 x CD3 Bispecific T-Cell Engager (Businesswire) - "Xencor, Inc...announced it will regain exclusive worldwide rights to plamotamab, a CD20 x CD3 bispecific T-cell engager, which Xencor advanced through Phase 1 clinical development in hematologic cancers. In 2021, Xencor entered a collaboration and license agreement with Janssen Biotech, Inc. to develop and commercialize plamotamab and novel B-cell targeting bispecific antibodies designed to conditionally activate T cells through the CD28 co-stimulatory receptor....Xencor has been notified that Janssen will terminate its rights to plamotamab under the collaboration and license agreement. Janssen has retained its rights to develop and commercialize B-cell targeting CD28 bispecific antibodies, including JNJ-9401 (PSMA x CD28) and JNJ-1493 (CD20 x CD28)."

Licensing / partnership • Hematological Malignancies • Leukemia • Lymphoma • Metastatic Castration-Resistant Prostate Cancer • Non-Hodgkin’s Lymphoma • Oncology • Prostate Cancer • Solid Tumor