cretostimogene grenadenorepvec (CG0070) / Kissei, CG Oncology - LARVOL DELTA

CORE-008 COHORT B: EVALUATING INTRAVESICAL CRETOSTIMOGENE GRENADENOREPVEC IN PATIENTS WITH HIGH-RISK, BCG-EXPOSED NON-MUSCLE INVASIVE BLADDER CANCER (SUO 2025) - P2 | "Cohort B is now open for enrollment in collaboration with the Society of Urologic Oncology Clinical Trials Consortium (SUO-CTC). "

Clinical • IO biomarker • Bladder Cancer • Eye Cancer • Genito-urinary Cancer • Oncology • Retinal Disorders • Retinoblastoma • Solid Tumor • CSF2

DESIGN AND IMPLEMENTATION OF A PATIENT-CENTRIC EXPANDED ACCESS PROGRAM WITH CRETOSTIMOGENE GRENADENOREPVEC IN NON-MUSCLE INVASIVE BLADDER CANCER UNRESPONSIVE TO BACILLUS CALMETTE-GUERIN (SUO 2025) - P | "The study is actively enrolling, with initial patients treated. "

Clinical • IO biomarker • Bladder Cancer • Eye Cancer • Genito-urinary Cancer • Oncology • Retinal Disorders • Retinoblastoma • Solid Tumor • CSF2

FIRST RESULTS FROM CORE-008 COHORT A- PHASE 2 STUDY OF INTRAVESICAL CRETOSTIMOGENE GRENADENOREPVEC IN PATIENTS WITH HIGH-RISK BCG-NAÏVE NON-MUSCLE INVASIVE BLADDER CANCER (SUO 2025) - P2 | "The first results from CORE-008 Cohort A demonstrate that cretostimogene has promising clinical efficacy and safety in patients with high-risk, BCG-naïve NMIBC. These findings support the further evaluation of cretostimogene in the early, HR NMIBC disease continuum. Additional analyses are planned in patients with high-grade BCG-naïve Ta/T1 papillary-only NMIBC, within CORE-008, Cohort A."

Clinical • IO biomarker • P2 data • Bladder Cancer • Eye Cancer • Genito-urinary Cancer • Oncology • Retinal Disorders • Retinoblastoma • Solid Tumor • CSF2

TOPLINE RESULTS FROM BOND-003 COHORT P- A MULTI-NATIONAL, SINGLE-ARM STUDY OF INTRAVESICAL CRETOSTIMOGENE GRENADENOREPVEC FOR TREATMENT OF HIGH-RISK, PAPILLARY ONLY, BCG-UNRESPONSIVE NON-MUSCLE INVASIVE BLADDER CANCER (SUO 2025) - P3 | "Results from the BOND-003 Cohort P clinical trial of cretostimogene monotherapy in patients with BCG-UR papillary-only NMIBC demonstrate encouraging HG-RFS and a consistent, well-tolerated safety profile. Mature data with longer term follow-up will build upon these promising findings and will inform future treatment approaches with cretostimogene in High-Risk papillary-only BCG-UR NMIBC."

IO biomarker • Bladder Cancer • Eye Cancer • Genito-urinary Cancer • Oncology • Retinal Disorders • Retinoblastoma • Solid Tumor • CSF2

Current use of pre-clinical models for evaluation of human adenovirus-based cancer therapeutics. (PubMed, Mol Ther Oncol) - "Human adenoviruses (HAdVs) are enjoying a renaissance in interest for the development of cancer therapies following the approval of Adstiladrin (Ferring Pharmaceuticals) for the treatment of bladder cancer, strong phase 3 data from CG Oncology's cretostimogene grenadenorepvec, and many other products in late-stage clinical development. These modifications, and the highly complex interactions that occur between oHAdVs and the host, make it particularly challenging to develop relevant animal models to investigate acute toxicity, immunity, efficacy, and pharmacodynamics for pre-clinical development of these agents. Here, the experimental options for pre-clinical evaluation of therapeutic oHAdV-based vectors for cancer therapy are reviewed, with a focus on Ad serotype 5 (Ad5), the most common serotype for therapeutic oHAdV-based vector development."

Journal • Preclinical • Review • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

P2s: Practice-changing, Paradigm-shifting Clinical Trials in Urology (P2): FINAL RESULTS: BOND-003 COHORT C- PHASE 3, SINGLE-ARM STUDY OF INTRAVESICAL CRETOSTIMOGENE GRENADENOREPVEC FOR HIGH-RISK BCG-UNRESPONSIVE NON-MUSCLE INVASIVE BLADDER CANCER WITH CARCINOMA IN SITU (AUA 2025) - "The compelling efficacy, durability, freedom from progression, and tolerability of cretostimogene offer distinct advantages over existing therapies for the treatment of HR BCG-UR NMIBC. Ongoing investigations of this promising monotherapy, as well as future combinations, have the potential to address a considerable unmet need for bladder cancer patients."

Clinical • IO biomarker • P3 data • Bladder Cancer • Eye Cancer • Genito-urinary Cancer • Oncology • Retinal Disorders • Retinoblastoma • Solid Tumor • Urology • CSF2

DURABLE 24-MONTH OUTCOMES FROM BOND-003 COHORT C: PHASE 3 STUDY OF INTRAVESICAL CRETOSTIMOGENE GRENADENOREPVEC FOR HIGH-RISK BCG-UNRESPONSIVE NON-MUSCLE INVASIVE BLADDER CANCER WITH CARCINOMA IN SITU (SUO 2025) - P3 | "Cretostimogene offers distinct advantages with its efficacy, durability and safety profile for the treatment of HR BCG-UR NMIBC. Ongoing and future investigations of this promising therapy, as monotherapy and in rational combinations, may address the considerable unmet need for patients with bladder cancer."

IO biomarker • P3 data • Bladder Cancer • Eye Cancer • Genito-urinary Cancer • Oncology • Retinal Disorders • Retinoblastoma • Solid Tumor • CSF2

Design and implementation of a patient-centric expanded access program with cretostimogene grenadenorepvec in non-muscle invasive bladder cancer unresponsive to bacillus Calmette-Guerin. (ASCO-GU 2026) - P | "Clinical Trial Registry Number: NCT06443944. The full, final text of this abstract will be available on Feb 23 at 05:00 PM EST."

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

CORE-008 cohort B: Evaluating intravesical cretostimogene grenadenorepvec in patients with high-risk, BCG-exposed non-muscle invasive bladder cancer. (ASCO-GU 2026) - P2 | "Clinical Trial Registry Number: NCT06567743. The full, final text of this abstract will be available on Feb 23 at 05:00 PM EST."

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

First results from CORE-008 cohort A: Phase 2 study of intravesical cretostimogene grenadenorepvec in patients with high-risk BCG-naïve non-muscle invasive bladder cancer. (ASCO-GU 2026) - P2 | "Clinical Trial Registry Number: NCT06567743. The full, final text of this abstract will be available on Feb 23 at 05:00 PM EST."

Clinical • P2 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Topline results from BOND-003 cohort P: A multi-national, single-arm study of intravesical cretostimogene grenadenorepvec for treatment of high-risk, papillary only, BCG-unresponsive non-muscle invasive bladder cancer. (ASCO-GU 2026) - P3 | "Clinical Trial Registry Number: NCT04452591. The full, final text of this abstract will be available on Feb 23 at 05:00 PM EST."

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

Cystectomy-free survival following cretostimogene grenadenorepvec in high-risk BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ: Results from the phase 3 BOND-003 trial (Cohort C). (ASCO-GU 2026) - P3 | "Clinical Trial Registry Number: NCT04452591. The full, final text of this abstract will be available on Feb 23 at 05:00 PM EST."

P3 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Evolving Pharmacotherapy for Bladder Cancer-From Non-Muscle-Invasive to Metastatic Disease-Development of Novel Therapies for BCG-Unresponsive NMIBC (PubMed, Gan To Kagaku Ryoho) - "Bladder cancer is a common malignancy in the elderly, with approximately 75% of cases diagnosed as non-muscle-invasive bladder cancer(NMIBC).Although transurethral resection of bladder tumor(TURBT)is the standard initial treatment, recurrence rates remain high, and intravesical Bacillus Calmette-Guérin(BCG)instillation has long been used as an adjuvant therapy.However, about 30% of patients develop BCG-unresponsive disease despite adequate BCG administration.Radical cystectomy is recommended in such cases, but its invasiveness and impact on quality of life(QOL)often make it impractical in real-world settings.Thus, the development of novel bladder-preserving treatments is urgently needed.In recent years, diverse approaches including immune checkpoint inhibitors(ICI), gene therapy, drug delivery systems(DDS), and oncolytic virus-based therapies have been actively investigated, with numerous clinical trials ongoing worldwide.Importantly, pembrolizumab, nadofaragene..."

Journal • Bladder Cancer • Gene Therapies • Genito-urinary Cancer • Oncology • Solid Tumor

Final results of CORE-001: A phase-2, single arm study of cretostimogene grenadenorepvec in combination with pembrolizumab in patients with BCG-unresponsive, non-muscle invasive bladder cancer with carcinoma in situ. (ASCO 2024) - P2 | "The efficacy and safety of cretostimogene plus pembrolizumab for treatment of BCG-UR, HR NMIBC with CIS demonstrates best-in-class CR and DOR compared to current FDA-approved therapies, with an acceptable AE profile. Further investigation of this promising combination therapy is warranted and may serve to address a considerable unmet need."

Clinical • Combination therapy • IO biomarker • P2 data • Bladder Cancer • Eye Cancer • Genito-urinary Cancer • Oncology • Retinal Disorders • Solid Tumor • CSF2 • PD-L1

Mk3475 Keynote 935: Study of CG0070 Given in Combination With Pembrolizumab, in Non-Muscle Invasive Bladder Cancer, Unresponsive to Bacillus Calmette-Guerin (clinicaltrials.gov) - P2 | N=37 | Recruiting | Sponsor: CG Oncology, Inc. | Trial completion date: Jun 2022 ➔ Jun 2023 | Trial primary completion date: Dec 2021 ➔ Jun 2023

Combination therapy • Trial completion date • Trial primary completion date • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

Phase 2, Single Arm Study of CG0070 Combined with Pembrolizumab in Patients with Non Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG) (SITC 2022) - P2 | "Data on efficacy and safety for all enrolled patients, N=35, as well as biomarker (CAR, E2F, and PDL1) assessment will be presented at the time of the conference. Trial Registration NCT04387461 Ethics Approval CENTRAL IRB Castle: Protocol Number: CORE-001 (CG2003C) Sponsor CG Oncology, Inc Study Title A Phase 2, Single Arm Study of CG0070 Combined with Pembrolizumab in Patients with Non- Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG) Study Materials Reviewed and Approved by Castle IRB: • Clinical Study Protocol CORE-001 (CG2003C) Summary of Changes, Version: Amendment 4, 24JAN 2022 • Clinical Study Protocol CORE-001 (CG2003C), Version: Amendment 4, 24 JAN 2022 • Investigator’s Brochure Pembrolizumab Risk Language, Version: Edition 03 SEP 2021 • Investigator’s Brochure Pembrolizumab, Version: Edition 21, 02 SEP 2021 • Master Informed Consent Form Template, Version: 5, 04 FEB 2022 • Patient Educational Slide Deck Sites Approved..."

Clinical • IO biomarker • P2 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer • CSF2 • PD-L1

CORE1: Phase 2 Single Arm Study of CG0070 Combined with Pembrolizumab in Patients with Non Muscle Invasive Bladder Cancer Unresponsive to Bacillus Calmette-Guerin (BCG) (AUA 2023) - "This initial data on the efficacy and safety of CG0070 plus pembrolizumab for the treatment of BCG unresponsive NMIBC is encouraging. Data on efficacy and safety for all enrolled patients, N=35, as well as biomarker (CAR, E2F, and PDL1) assessment will be presented at the time of the conference."

Clinical • IO biomarker • P2 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer • CSF2 • PD-L1

P2s: Paradigm-shifting, Practice-changing Clinical Trials in Urology: Pivotal Results from BOND-003: A Phase 3, Single-arm Study of Intravesical Cretostimogene Grenadenorepvec for the Treatment of High Risk, BCG-Unresponsive Non-Muscle Invasive Bladder C (AUA 2024) - No abstract available

Clinical • P3 data • Urology

BOND-003- Cohort P: A Multi-national, Single-arm Study of Intravesical Cretostimogene Grenadenorepvec for the Treatment of High-Risk, Papillary Only, BCG-Unresponsive Non-Muscle Invasive Bladder Cancer (SUO 2024) - "Screening and patient selection have been initiated. NCT044552591 "

IO biomarker • Bladder Cancer • Eye Cancer • Genito-urinary Cancer • Oncology • Retinal Disorders • Retinoblastoma • Solid Tumor • Urology • CSF2

TRIAL IN PROGRESS: BOND-003 COHORT P- A MULTI-NATIONAL, SINGLE-ARM STUDY OF INTRAVESICAL CRETOSTIMOGENE GRENADENOREPVEC FOR THE TREATMENT OF HIGH-RISK, PAPILLARY ONLY, BCG-UNRESPONSIVE NON-MUSCLE INVASIVE BLADDER CANCER (AUA 2025) - "35+ clinical sites have been selected in the United States and Japan. The study has surpassed 50% enrollment, with interim results expected at the end of 2025."

IO biomarker • Bladder Cancer • Eye Cancer • Genito-urinary Cancer • Oncology • Retinal Disorders • Retinoblastoma • Solid Tumor • CSF2

UPDATES TO THE CORE-008 TRIAL PROTOCOL: A PHASE 2 MULTI-ARM, MULTI-COHORT STUDY TO EVALUATE INTRAVESICAL CRETOSTIMOGENE GRENADENOREPVEC IN PATIENTS WITH HIGH-RISK NON-MUSCLE INVASIVE BLADDER CANCER (AUA 2025) - P2 | "Cohort CX, recently added to the study, will evaluate safety and HG-EFS of cretostimogene in combination with intravesical gemcitabine, either concurrent (Arm 1) or sequential (Arm 2) in BCG-exposed and BCG-unresponsive patients. All cohorts in the CORE-008 study are currently open for recruitment, with approximately one-third of patients already enrolled in Cohort A at the time of abstract submission. Cohort B has received collaborative support from the Society of Urologic Oncology-Clinical Trials Consortium (SUO-CTC)."

Clinical • IO biomarker • P2 data • Bladder Cancer • Eye Cancer • Genito-urinary Cancer • Oncology • Retinal Disorders • Retinoblastoma • Solid Tumor • Urology • CSF2

PIVOT-006: A phase 3, randomized study of cretostimogene grenadenorepvec versus observation for the treatment of intermediate risk non-muscle invasive bladder cancer (IR-NMIBC) following transurethral resection of bladder tumor (TURBT). (ASCO-GU 2024) - "Exploratory outcome measures include patient-reported quality of life, biomarker analyses, coxsackie adenovirus receptor and E2F promoter expression, neutralizing antibodies, and markers of immunogenicity. Clinical trial information: Pending."

Clinical • P3 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • CSF2

PIVOT-006: A Study of Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate Risk NMIBC Following TURBT (clinicaltrials.gov) - P3 | N=367 | Active, not recruiting | Sponsor: CG Oncology, Inc. | Trial completion date: Jan 2030 ➔ Feb 2029 | Trial primary completion date: Jan 2028 ➔ Jun 2026

Trial completion date • Trial primary completion date • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urethral Cancer • Urothelial Cancer

CG Oncology Provides Updated Timeline for PIVOT-006 Phase 3 Topline Data in Intermediate-Risk NMIBC (GlobeNewswire) - "PIVOT-006 Phase 3 topline data evaluating cretostimogene monotherapy for intermediate-risk NMIBC now expected in 1H 2026, nearly one year ahead of schedule....This expedited timeline is due to the rapid study enrollment across over 90 sites."

P3 data: top line • Bladder Cancer

CORE-008 Cohort B: Evaluating Intravesical Cretostimogene Grenadenorepvec in Patients with High-Risk, BCG-Exposed Non-Muscle Invasive Bladder Cancer (EAU 2026) - No abstract available

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