detalimogene voraplasmid (EG-70) / enGene - LARVOL DELTA

P2s: Practice-changing, Paradigm-shifting Clinical Trials in Urology: A non-viral intravesical gene therapy for BCG-unresponsive NMIBC with CIS, with or without papillary disease: pivotal phase 2 interim results of detalimogene voraplasmid (AUA 2026) - P1/2 | "Source of Funding: enGene Inc INTRODUCTION AND OBJECTIVES: Detalimogene voraplasmid (EG-70) is a novel, non-viral investigational intravesical gene therapy, designed to induce local innate and adaptive immunity via sustained interleukin-12 expression and retinoic acid-inducible gene I pathway stimulation... Interim results of LEGEND Cohort 1 demonstrate encouraging activity of detalimogene in a heavily pre-treated BCG-unresponsive NMIBC population. The rapid onset of response, non-viral platform, and favorable safety profile support detalimogene voraplasmid as a promising bladder-sparing option in this setting."

Clinical • Gene therapy • P2 data • Bladder Cancer • Gene Therapies • Urology • IL12A

Preliminary results from LEGEND: A phase 2 study of detalimogene voraplasmid (EG-70), a novel, non-viral intravesical gene therapy for patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS). (ASCO-GU 2025) - P1/2 | "Preliminary data from the pivotal Phase 2 portion of the LEGEND study suggest a promising safety/tolerability profile, with TRAEs that were largely consistent with instrumentation/intravesical administration. Overall, 71% of patients dosed with detalimogene voraplasmid achieved a CR, with 67% achieving a CR at 3 months and 47% achieving a CR at 6 months. Cohort 1 (BCG-refractory patients with CIS) continues to enroll, with a target accrual of 100 patients."

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

Detalimogene plus Surfactant Key Opinion Leader (KOL) Webinar (Businesswire) - "The Company is currently enrolling high-risk, BCG-unresponsive NMIBC patients with CIS in an additional LEGEND cohort incorporating a brief surfactant bladder rinse with an FDA-approved surfactant solution (generic name: polidocanol)....On October 15, 2026, at 10:00 a.m. ET, the Company will host a webinar to provide greater detail on the preclinical data supporting the incorporation of its surfactant bladder rinse into clinical development. In addition, the Company will be joined by two KOLs from Colorado Urology, David Cahn, MD, and Suzanne Merrill, MD, FACS, to review clinical case studies and discuss various treatment considerations."

Preclinical • Trial status • Bladder Cancer

A phase 1/2 study of EG-70 (detalimogene voraplasmid) intravesical monotherapy for patients with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ. (ASCO 2024) - P1/2 | "All patients provide written informed consent. The ongoing, registration-enabling phase 2 portion of the LEGEND study is anticipated to recruit approximately 100 patients from sites in North America, Europe, and the Asia-Pacific region."

Clinical • Monotherapy • P1/2 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

A phase I/II study of EG-70 (detalimogene voraplasmid) intravesical monotherapy for patients (pts) with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) (ESMO 2024) - P1/2 | "All pts provide written informed consent. The phase 2 portion of the study will recruit ∼100 pts from sites in North America, Europe, and the Asia-Pacific region."

Clinical • Monotherapy • P1/2 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Polidocanol Bladder Rinse Increases Gene Transfer Efficiency of Locally Administered Detalimogene for Bladder Cancer Treatment (ESMO 2026) - No abstract available

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

A Substudy of the Ongoing Phase 1/2 LEGEND Study of Detalimogene Voraplasmid for the Treatment of HR-NMIBC with CIS with or without Papillary Disease Incorporating a Bladder Pre-Rinse (ESMO 2026) - No abstract available

P1/2 data • Bladder Cancer • Oncology

Anticipated Milestones (Businesswire) - "Data update on key regulatory endpoints, complete response (CR) at any time and maturing durability, as well as landmark CR rates from LEGEND's pivotal cohort planned for 4Q 2026; Pre-BLA meeting with the FDA in 4Q 2026; Initiation of BLA filing for detalimogene in 4Q 2026; Potential FDA approval decision for detalimogene and platform designation in 2027."

FDA approval • FDA filing • P1/2 data • Bladder Cancer

Preliminary Results From Legend: a Phase 2 Study of Detalimogene Voraplasmid, a Novel, Investigational, Non-Viral Genetic Medicine for High-Risk Non-Muscle Invasive Bladder Cancer (NMIBC) (SIU 2025) - No abstract available

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

Mechanism of action and translation to the clinic of detalimogene voraplasmid (EG-70): A novel, investigational, non-viral immunotherapy for non-muscle-invasive bladder cancer (NMIBC). (ASCO-GU 2025) - P1/2 | "These preclinical findings demonstrate that detalimogene voraplasmid delivers genetically encoded immunostimulatory payloads locally to the bladder. The mechanism of action described preclinically has been translated into the clinic in the Phase 1 part of the LEGEND study."

IO biomarker • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • IL12A

A phase 1/2 study of detalimogene voraplasmid (EG-70) intravesical monotherapy for patients with high-risk non-muscle invasive bladder cancer (NMIBC). (ASCO-GU 2025) - P1/2 | "All patients provide written informed consent. The Phase 2 portion of the study is enrolling and will recruit up to 300 patients from sites in the USA, Canada, Europe, and the Asia-Pacific region."

Clinical • Monotherapy • P1/2 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

LEGEND: A phase 1/2 study of detalimogene voraplasmid (EG-70), an intravesical monotherapy for patients with high-risk non–muscle-invasive bladder cancer (NMIBC). (ASCO 2025) - P1/2 | "All patients provide written informed consent. The Phase 2 portion of the study is enrolling and will recruit approximately 300 patients across all cohorts, from sites in the USA, Canada, Europe, and the Asia-Pacific region."

Clinical • Monotherapy • P1/2 data • Bladder Cancer • Gene Therapies • Genito-urinary Cancer • Oncology • Solid Tumor

enGene plans to engage the FDA and begin its biologics license application by year-end, targeting potential approval and platform designation for detalimogene in 2027. (Yahoo Finance)

FDA approval • Bladder Cancer

LEGEND Study: EG-70 in NMIBC Patients BCG-Unresponsive and High-Risk NMIBC Incompletely Treated With BCG or BCG-Nave (clinicaltrials.gov) - P1/2 | N=350 | Recruiting | Sponsor: enGene, Inc. | Trial completion date: Nov 2028 ➔ Oct 2030 | Trial primary completion date: Jun 2026 ➔ Apr 2028

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

Pre-Biologics License Application (BLA) meeting with the FDA planned for 2H 2026 (Businesswire) - "Initiation of BLA submission for detalimogene planned for 2H 2026...Potential FDA approval of detalimogene in 2027...LEGEND's pivotal cohort (Cohort 1) consists of 125 patients with high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive NMIBC with carcinoma in situ (CIS)...LEGEND's pivotal cohort (Cohort 1) is designed to serve as the basis of the Company's planned Biologics License Application (BLA) filing."

FDA approval • FDA event • FDA filing • Bladder Cancer

enGene Reports Second Quarter 2026 Financial Results and Provides Business Update (Businesswire) - "Detalimogene plus Surfactant Cohort: In tandem with its pivotal update in May, the Company announced the initiation of an additional LEGEND cohort, which incorporates a short surfactant bladder rinse using diluted polidocanol solution...The first patients have been enrolled in the surfactant cohort, and the Company may enroll up to 80 patients in this global cohort...LEGEND Cohorts 2a, 2b and 3: As part of cash conservation efforts, the Company has stopped enrollment in these additional cohorts and plans to reevaluate its strategy for them following discussion with the FDA in 2H 2026."

Trial status • Bladder Cancer

Anticipated Milestones (Businesswire) - "12-month complete response data for all of Cohort 1 and pre-BLA meeting in 2H 2026; Initiation of BLA filing for detalimogene in 2H 2026; Potential detalimogene FDA approval decision and platform designation in 2027."

FDA approval • FDA filing • P2 data • Bladder Cancer

Decoding Immune Mechanisms in BCG-unresponsive Non-muscle Invasive Bladder Cancer. (PubMed, Front Biosci (Landmark Ed)) - "In parallel, we highlight emerging intravesical immunotherapies for BCG-unresponsive NMIBC with carcinoma in situ, including nadofaragene firadenovec (Adstiladrin), nogapendekin alfa inbakicept-pmln (Anktiva), cretostimogene grenadenorepvec (CG0070), and detalimogene voraplasmid (EG-70). The lack of comparative data, coupled with the absence of predictive biomarkers of response, complicates treatment selection. Our review underscores that developing effective therapies for BCG-unresponsive disease will require combination strategies targeting multiple immune escape mechanisms that shape immune dynamics within the TME."

IO biomarker • Journal • Review • Bladder Cancer • Gene Therapies • Genito-urinary Cancer • Oncology • Solid Tumor • HLA-E • KLRC1 • PD-1 • PD-L1

Detalimogene voraplasmid: “LEGEND Cohort 1 Interim Efficacy Data”; Non-muscle invasive bladder cancer (Engene) - Corporate Presentation: “Re-induction success rate of 14.0% (6/43 non-CRs at 3 months responded following re-induction)”

P2 data • Bladder Cancer • Genito-urinary Cancer • Oncology

Detalimogene voraplasmid shows promising activity in BCG-unresponsive NMIBC (Urology Times) - "Overall, the investigational intravesical gene therapy produced a complete response (CR) rate at any time of 54% (67 of 124 patients) and a 6-month CR rate of 43% (52 of 121 patients) among patients enrolled in the pivotal cohort of the study. The Kaplan-Meier estimate for 12-month duration of response was 25% (95% CI, 11 to 41), and the reported rate of progression to muscle-invasive or more advanced disease was 3.2%."

P1/2 data • Bladder Cancer

enGene Announces Updated Interim Results From LEGEND Pivotal Cohort (Businesswire) - "Efficacy overview: 54% (95% CI: 45%, 63%) CR at any time (67/124); 91% of responses occurred at first disease assessment; 43% (95% CI: 34%, 52%) CR rate at 6 months (52/121) with 14% (6/43) of patients having successfully converted from non-CR to CR post re-induction; Two re-induced patients have not yet had a 6-month assessment...The Kaplan-Meier (KM) estimate of the 12-month duration of response (DoR) is 25% (95% CI: 11%, 41%)...The Company plans further engagement with the FDA as it approaches a potential Biologics License Application (BLA) filing and plans to provide an update in the second half of 2026....The Company plans to share these data with the broader medical community at a Plenary Presentation at the upcoming American Urological Association meeting on May 15, 2026."

FDA filing • P2 data • Bladder Cancer

Intravesical detalimogene voraplasmid for the treatment of BCG-naive high-risk (HR) non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary disease: LEGEND cohorts 2A and 3 trial in progress (AUA 2026) - No abstract available

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

Detalimogene program drives enGene (ENGN) shift to Therapeutics focus (StockTitan.net) - "The company plans a Biologics License Application submission for detalimogene in the second half of 2026, targeting potential approval and a commercial organization in 2027."

FDA approval • FDA filing • Bladder Cancer

enGene Announces Name Change to enGene Therapeutics Inc. (Businesswire) - "Name change reflects transition towards potential commercial organization in 2027; Planned Biologics License Application (BLA) submission for detalimogene in 2H 2026."

Commercial • FDA filing • Bladder Cancer

Anticipated Milestones (Businesswire) - "'...potential launch in 2027.'...Update from LEGEND pivotal cohort planned for a spring 2026 medical conference; 12-month complete response data from LEGEND pivotal cohort expected in 2H 2026; Planned BLA filing for LEGEND’s pivotal cohort in the second half of 2026."

FDA filing • Launch US • P1/2 data • Trial status • Bladder Cancer