AZD0754 / AstraZeneca - LARVOL DELTA

APOLLO: Study of AZD0754 in Participants With Metastatic Prostate Cancer (clinicaltrials.gov) - P1/2 | N=60 | Recruiting | Sponsor: AstraZeneca | Trial completion date: Mar 2027 ➔ Jul 2027 | Trial primary completion date: Mar 2027 ➔ Jul 2027

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

APOLLO: Study of AZD0754 in Participants With Metastatic Prostate Cancer (clinicaltrials.gov) - P1/2 | N=60 | Recruiting | Sponsor: AstraZeneca | Active, not recruiting ➔ Recruiting

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

APOLLO: Study of AZD0754 in Participants With Metastatic Prostate Cancer (clinicaltrials.gov) - P1/2 | N=56 | Active, not recruiting | Sponsor: AstraZeneca | Recruiting ➔ Active, not recruiting

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

LOCUS: LTFU for All Cell and Gene Therapy Studies (clinicaltrials.gov) - P=N/A | N=64 | Not yet recruiting | Sponsor: AstraZeneca | Initiation date: Jun 2024 ➔ Oct 2024

Gene therapy • Trial initiation date • Gastrointestinal Cancer • Gene Therapies • Genito-urinary Cancer • Hepatocellular Cancer • Oncology • Prostate Cancer • Solid Tumor

LOCUS: LTFU for All Cell and Gene Therapy Studies (clinicaltrials.gov) - P=N/A | N=64 | Not yet recruiting | Sponsor: AstraZeneca | N=30 ➔ 64 | Initiation date: Feb 2024 ➔ Jun 2024

Enrollment change • Gene therapy • Trial initiation date • Gastrointestinal Cancer • Gene Therapies • Genito-urinary Cancer • Hepatocellular Cancer • Oncology • Prostate Cancer • Solid Tumor

APOLLO: Study of AZD0754 in Participants With Metastatic Prostate Cancer (clinicaltrials.gov) - P1/2 | N=60 | Recruiting | Sponsor: AstraZeneca

Metastases • New P1/2 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Antitumor activity of AZD0754, a dnTGFβRII-armored, STEAP2-targeted CAR-T cell therapy, in prostate cancer. (PubMed, J Clin Invest) - "Further, AZD0754 enforced robust, dose-dependent in vivo efficacy in STEAP2-expressing cancer cell line-derived and patient-derived xenograft mouse models, and exhibited encouraging preclinical safety. Together, these data underscore the therapeutic tractability of STEAP2 in prostate cancer as well as build confidence in the specificity, potency, and tolerability of this potentially first-in-class CAR-T therapy."

CAR T-Cell Therapy • IO biomarker • Journal • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • STEAP2 • TGFB1

Armored STEAP2 CAR-T (AZD0754) alone and in combination with enzalutamide demonstrates anti-tumor activity across a range of STEAP2 expressing prostate cancer PDX models (SITC 2023) - "Conclusions Together, these data underscore the potential therapeutic tractability of STEAP2 in prostate cancer and build confidence in the STEAP2 expression threshold required for AZD0754 activity. Moreover, our study explores potential combination strategies involving standard-of-care therapies."

Combination therapy • IO biomarker • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • AR • IFNG • TGFB1

"Summary of $AZN Car-T projects AZD0754 (preclinical) & C-CAR031 (FIH). These were the posters #AACR23 didn't make available to virtual attendees." (@JacobPlieth)

Preclinical • Oncology

Antitumor activity of AZD0754, a dnTGFbRII armored STEAP2 targeted CAR-T therapy, in preclinical models of prostate cancer (AACR 2023) - "Armored STEAP2 CAR-T cells demonstrate favorable in vitro properties, robust dose dependent in vivo efficacy in STEAP2 expressing cell line- and patient derived- mouse xenograft models and encouraging preclinical safety. Taken together, this data builds confidence in the specificity and potency of this potential first in class STEAP2 targeted CAR-T therapy and supports future clinical development."

IO biomarker • Late-breaking abstract • Preclinical • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • TGFB1

AstraZeneca advances its pipeline and highlights progress in immuno-oncology, ADCs, cell therapy and epigenetics at AACR (AstraZeneca Press Release) - "In cell therapy, the first clinical data will be presented for C-CAR031, a novel transforming growth factor-beta (TGFβ) armoured Glypican 3 (GPC3) targeting chimeric antigen receptor T cell (CAR-T) therapy that is being investigated for liver cancer. Early results show it is well tolerated with promising anti-tumour activity seen with objective responses in several patients to date....In addition, the first preclinical data will be shared on AZD0754, a novel TGFβ armoured CAR-T targeting STEAP2, a protein commonly overexpressed in prostate cancer."

Clinical data • Preclinical • Gastrointestinal Cancer • Genito-urinary Cancer • Liver Cancer • Oncology • Prostate Cancer • Solid Tumor