ImPact Biotech Announces Upcoming Data Presentations for Padeliporfin VTP at AUA and ASCO 2026

On April 21, 2026 ImPact Biotech, a clinical-stage biotechnology company focused on developing Padeliporfin vascular targeted photodynamic (VTP) therapy to treat a range of solid tumors, reported updated data from clinical trials of Padeliporfin VTP, including the Phase 3 ENLIGHTED trial in low-grade upper tract urothelial carcinoma (UTUC) and Phase 1 trial in unresectable locally advanced pancreatic ductal adenocarcinoma (LA-PDAC), will be presented at upcoming scientific conferences.

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The Company will share updated data from the ongoing ENLIGHTED trial at the American Urological Association (AUA) Annual Meeting taking place May 15-18, 2026, in Washington, D.C., and at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place May 29-June 2, 2026, in Chicago, IL. Updated preliminary data from the Company’s Phase 1 trial of Padeliporfin VTP in LA-PDAC will also be presented at ASCO (Free ASCO Whitepaper).

AUA Presentation Details:

Interactive Poster Title: The ENLIGHTED Phase 3 Trial: Advancing Treatment of Low-Grade Upper Tract Urothelial Carcinoma (LG UTUC) with Padeliporfin Vascular-Targeted Photodynamic Therapy (VTP)
Presenter: Vitaly Margulis, M.D., Professor of Urologic Oncology, University of Texas Southwestern Medical Center
Poster Number: IP30-04
Session Title: Bladder Cancer: Upper Tract Transitional Cell Carcinoma I
Session Date & Time: Saturday, May 16, 2026 at 7:00 AM ET

Podium Presentation Title: ENLIGHTED Phase 3 Trial of Non-Thermal, Drug-Activated Padeliporfin Vascular-Targeted Photodynamic Therapy (VTP) for Low-Grade Upper Tract Urothelial Carcinoma (LG-UTUC)
Presenter: Jonathan Coleman, M.D., Urologic Surgeon, Memorial Sloan Kettering Cancer Center
Session Title: Clinical Trials in Progress: Bladder Cancer
Session Date & Time: Sunday, May 17, 2026 at 10:44 AM ET

ASCO Presentation Details:

Poster Title: Phase I Light-Dose Escalation Study in Locally Advanced Pancreatic Ductal Adenocarcinoma: Intra-Arterial (IA) Padeliporfin Vascular-Targeted Photodynamic Therapy (VTP)
Presenter: Nadine Abi-Jaoudeh, M.D., Professor of Clinical Radiology, University of California Irvine
Poster Number: 236a
Session Title: Gastrointestinal Cancer: Gastroesophageal, Pancreatic, and Hepatobiliary
Session Date & Time: Saturday, May 30, 2026 at 9:00 AM CT

Poster Title: Advancing Treatment of Low-Grade Upper Tract Urothelial Carcinoma (LG UTUC) with Padeliporfin Vascular-Targeted Photodynamic Therapy (VTP): The ENLIGHTED Phase 3 Trial
Presenter: Vitaly Margulis, M.D., Professor of Urologic Oncology, University of Texas Southwestern Medical Center
Poster Number: 115a
Session Title: Genitourinary Cancer: Kidney and Bladder
Session Date & Time: Sunday, May 31, 2026 at 9:00 AM

ImPact recently presented updated safety and efficacy data from the ENLIGHTED trial at the European Association of Urology’s (EAU) 41st Annual Congress in March 2026. Padeliporfin VTP continues to demonstrate a potentially best-in-class profile for treatment of low-grade UTUC, supporting the opportunity to strategically partner the commercialization of the program. The Company expects topline data from the ENLIGHTED study in 2026 followed by an NDA submission.

In addition, ImPact recently presented positive preliminary data from the first cohort of the Phase 1 LA-PDAC study at the Society of Interventional Radiology (SIR) Annual Conference in April 2026. The Company is advancing Padeliporfin VTP in LA-PDAC representing a large market opportunity in highest unmet need patients, with potential for accelerated registrational pathway. Additional results from the ongoing Phase 1 study are expected through 2026.

(Press release, ImPact Biotech, APR 21, 2026, View Source [SID1234664665])

NextCure and Simcere’s SIM0505 (CDH6 ADC) Phase 1 Data to be Presented at ASCO 2026

On April 21, 2026 NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class, and best-in-class therapies to treat cancer and Simcere Zaiming Pharmaceutical Co., Ltd., (Simcere) an oncology-focused biopharmaceutical company and a subsidiary of Simcere Pharmaceutical Group Ltd (HKEX: 2096), reported a poster will be presented at ASCO (Free ASCO Whitepaper) 2026 highlighting Phase 1 data for SIM0505 in the treatment of solid tumors. ASCO (Free ASCO Whitepaper) 2026 is being held May 29 – June 2 in Chicago, Illinois. SIM0505 is an investigational antibody drug conjugate (ADC) targeting Cadherin-6 (CDH6) with a proprietary topoisomerase 1 inhibitor (TOPOi) payload.

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"We are very pleased to announce that the Phase 1 results for SIM0505 have been accepted as a poster presentation at ASCO (Free ASCO Whitepaper) 2026. This important milestone validates our collaborative clinical approach and highlights our mission of advancing innovative medicines to treat cancer patients," said Michael Richman, President and CEO of NextCure.

Presentation Details:

Title: Phase 1, multicenter, first-in-human (FIH) global study of SIM0505, an anti-CDH6 (CDH6) antibody-drug-conjugate (ADC) in patients with advanced solid tumors
Poster Abstract #: 5580
Poster Board: 246
Presenter: Xiaohua Wu, MD, PhD, Chief Physician and Chairman of the Multidisciplinary Team in Gynecologic Oncology at Fudan University Shanghai Cancer Center, Shanghai, China
Session: Gynecologic Cancer
Session Date: Monday June 1, 2026
Session Time: 9:00 AM CST to 12:00 PM CDT
A full copy of the poster will be available on the NextCure website under the Investor Relations "Events & Presentations" tab following the presentation.

About SIM0505

SIM0505 is a novel antibody drug conjugate (ADC) directed to cadherin-6 (CDH6 ADC), featuring a proprietary topoisomerase 1 inhibitor (TOPOi) payload. The ADC is designed for broad anti-tumor activity, fast systemic clearance and an improved potential therapeutic window. SIM0505 is being evaluated in an open-label, Phase 1 study (NCT06792552) for the potential treatment of advanced solid tumors, including ovarian cancer, with an emphasis on platinum resistant ovarian cancer. NextCure holds exclusive global rights for SIM0505, excluding China, Hong Kong, Macau, and Taiwan which are retained by Simcere Zaiming Pharmaceutical Co., Ltd.

(Press release, NextCure, APR 21, 2026, View Source [SID1234664664])

Zentalis Pharmaceuticals Announces Abstract Acceptance at ASCO 2026 Featuring Azenosertib in Combination with Paclitaxel for Platinum-Resistant Ovarian Cancer

On April 21, 2026 Zentalis Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical oncology innovator advancing late-stage development of investigational first-in-class WEE1 inhibitor azenosertib as a biomarker-driven treatment approach for ovarian cancer, reported that the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) has accepted an abstract for presentation at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting, which will be held June 1-5, 2026, in Chicago, IL.

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"We are pleased that data from Part 1 of the MUIR trial focusing on azenosertib in combination with paclitaxel in platinum-resistant ovarian cancer (PROC) have been accepted for presentation at ASCO (Free ASCO Whitepaper)," said Julie Eastland, Chief Executive Officer of Zentalis. "Paclitaxel is a commonly used agent across multiple tumor types, including in ovarian cancer. The azenosertib-paclitaxel data from MUIR Part 1 will showcase combinability and activity in an all-comer setting, which we believe indicates the broad potential for azenosertib in multiple lines of ovarian cancer and other tumor types. With our core strategic focus on advancing azenosertib in registration-intended trials as a monotherapy in the biomarker-selected Cyclin E1-positive PROC population through our DENALI and ASPENOVA trials, the MUIR trial represents an important part of our broader pipeline strategy."

Accepted Abstract Title: Azenosertib Plus Paclitaxel for Platinum-Resistant Ovarian Cancer: Results From a Phase 1b Study
Abstract Number: 5529
Session Type / Title: Poster Session – Gynecologic Cancer
Poster Board: 195
Date/Time: June 1, 2026; 9am-12pm CDT

About MUIR Clinical Trial
MUIR (ZN-c3-002) is a multi-part, open-label Phase 1b clinical trial (NCT04516447) evaluating the safety, efficacy, and preliminary clinical activity of azenosertib in combination in patients with ovarian cancer.

Part 1 enrolled patients with platinum-resistant ovarian cancer (PROC) treated with azenosertib in combination with one of four chemotherapy regimens: carboplatin, gemcitabine, pegylated liposomal doxorubicin, or paclitaxel. Primary objectives are safety and tolerability, with key secondary objectives including clinical activity assessed by objective response rate, duration of response, and progression-free survival per RECIST v1.1.

Part 2 is evaluating azenosertib plus bevacizumab as maintenance regimen (first [1L] or second line [2L]) in patients with advanced ovarian, peritoneal, or fallopian tube cancer following platinum-based chemotherapy. The dose expansion portion will evaluate azenosertib at the recommended dose in combination with bevacizumab in patients with platinum-sensitive ovarian cancer in 2L who progressed while on a PARP inhibitor for 1L maintenance. The primary objective is safety and tolerability; secondary objectives include preliminary clinical activity of the combination as assessed by progression-free survival for the dose expansion portion.

About Azenosertib
Azenosertib is an investigational, potentially first-in-class, selective, and orally bioavailable inhibitor of WEE1 currently being evaluated in clinical studies in ovarian cancer and additional tumor types. WEE1 acts as a master regulator of the G1-S and G2-M cell cycle checkpoints, through negative regulation of both CDK1 and CDK2, to prevent replication of cells with damaged DNA. By inhibiting WEE1, azenosertib enables cell cycle progression, despite high levels of DNA damage, thereby resulting in the accumulation of DNA damage and leading to mitotic catastrophe and cancer cell death.

Azenosertib is in late-stage development as a potential treatment for Cyclin E1-positive platinum-resistant ovarian cancer (PROC). There is currently no approved treatment option specifically for this biomarker-selected population which comprises approximately 50% of PROC patients. Cyclin E1 protein overexpression has been established as a sensitive and specific predictive biomarker for identifying patients who could potentially derive benefit from azenosertib treatment, based on retrospective analysis of azenosertib studies in PROC. Validation of the Cyclin E1 companion diagnostic assay is ongoing in the DENALI and ASPENOVA trials.

Azenosertib has been granted Fast Track Designation by the U.S. FDA for the treatment of patients with Cyclin E1-positive platinum-resistant ovarian cancer. Fast Track Designation is intended to facilitate the development and expedite the review of therapies that have the potential to treat serious conditions and address unmet medical needs.

(Press release, Zentalis Pharmaceuticals, APR 21, 2026, View Source [SID1234664663])

ITM to Announce Quality of Life Data from the Phase 3 COMPETE Trial in Patients with Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs) at ASCO 2026

On April 21, 2026 ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, reported that it will provide quality of life data from its Phase 3 COMPETE trial in a poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, held from May 29 – June 2, 2026 in Chicago, Illinois.

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Poster Presentation Details
Title: Quality of life in patients with gastroenteropancreatic neuroendocrine tumors receiving 177Lu-edotreotide or everolimus: Results from the COMPETE study
Abstract Number: 4171
Poster Board Number: 154
Poster Session: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary
Date and Time: May 30, 2026, 9:00 AM – 12:00 PM CDT
Location: McCormick Place Convention Center, Chicago, IL, USA
Presenter: Jaume Capdevila, MD, PhD, study investigator and senior medical oncologist at Vall d’Hebron University Hospital, Barcelona, Spain

About the COMPETE Trial
The COMPETE trial (NCT03049189) evaluated 177Lu-edotreotide (ITM-11), a proprietary, synthetic, targeted radiotherapeutic investigational agent compared to everolimus, a targeted molecular therapy, in patients with inoperable, progressive Grade 1 or Grade 2 gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This trial met its primary endpoint, with 177Lu-edotreotide demonstrating clinically and statistically significant improvement in progression-free survival (PFS) compared to everolimus. 177Lu-edotreotide is an investigational product pending review by the U.S. Food and Drug Administration (FDA) and is not approved by any regulatory authority for the safety and/or efficacy of any intended use. It is also being evaluated in COMPOSE, a Phase 3 study in patients with well-differentiated, aggressive Grade 2 or Grade 3, somatostatin receptor (SSTR)-positive GEP-NETs.

(Press release, ITM Isotopen Technologien Munchen, APR 21, 2026, View Source [SID1234664662])

Remix Therapeutics Announces Oral Presentation of First-in-Class Small Molecule MYB mRNA Degrader REM-422 Phase 1/2 ARIA Trial Results at the 2026 American Society of Clinical Oncology Annual Meeting

On April 21, 2026 Remix Therapeutics (Remix), a clinical-stage biotechnology company developing small molecule therapies to modulate RNA processing and address the underlying drivers of disease, reported the final results of the Phase 1 dose-escalation cohort of the Phase 1/2 ARIA study evaluating MYB mRNA degrader, REM-422, in patients with recurrent or metastatic (R/M) adenoid cystic carcinoma (ACC), have been accepted for an oral presentation at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting, taking place on May 29 – June 2, 2026 in Chicago and online.

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The presentation will be delivered by Renata Ferrarotto, MD, from The University of Texas MD Anderson Cancer Center and will highlight results from the Phase 1 portion of the study evaluating the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of REM-42 in patients with R/M ACC, a disease driven by MYB dysregulation, for which there are no approved systemic therapies.

Oral Presentation Details:

Title: Clinical Activity of REM-422, a MYB mRNA Degrader, in Recurrent/Metastatic Adenoid Cystic Carcinoma: Final Results from the Phase 1/2 Dose-Escalation Cohort
Session Type/Title: Clinical Science Symposium – Small Glands, Big Challenges: Novel Therapeutics in Salivary Gland Cancer
Presenter: Renata Ferrarotto, MD, Professor in the Department of Head and Neck Medical Oncology at The University of Texas MD Anderson Cancer Center
Abstract Number: 6009
Date and Time: June 1, 2026, 8:00 AM – 9:30 AM CDT

About REM-422

REM-422 is a first-in-class, potent, selective, and oral small molecule mRNA degrader that induces the reduction of MYB mRNA and subsequent protein expression. REM-422 functions by facilitating the incorporation of a poison exon in the MYB mRNA transcript, leading to nonsense-mediated decay of the transcript. REM-422 is currently in Phase 1/2 clinical studies in both Adenoid Cystic Carcinoma (ACC) and Acute Myeloid Leukemia (AML) or high-risk myelodysplastic syndrome (HR-MDS). The U.S. Food and Drug Administration granted REM-422 Orphan Drug Designation for ACC and AML and Fast Track designation for ACC.

About the ARIA (A study of REM-422 In Adenoid cystic carcinoma) Clinical Trial
This Phase 1/2, open-label, non-randomized, multicenter study (NCT06118086) is investigating REM-422 in patients with recurrent, metastatic or unresectable Adenoid Cystic Carcinoma (ACC). The study includes a Dose Escalation Phase and a Dose Expansion Phase. The purpose of the Dose Escalation Phase is to determine the maximum tolerated dose and/or recommended Phase 2 dose (RP2D) of REM-422 in patients with recurrent, metastatic, or unresectable ACC. The purpose of Dose Expansion is to further evaluate the safety and anti-tumor activity of the REM-422 RP2D in biomarker positive patients.

About Adenoid Cystic Carcinoma
Adenoid cystic carcinoma (ACC) is a solid tumor that most commonly arises in the salivary glands characterized by frequent recurrent, perineural invasion and dysregulation of the MYB oncogene. Depending on the location of the tumor, symptoms may include numbness of the face, difficulties swallowing, changes in vision, or difficulty breathing, among others. Many therapeutic approaches, such as chemotherapy, kinase inhibitors, and immunotherapy have been studied in ACC with modest or disappointing results, and there remain no approved treatment options.

(Press release, Remix Therapeutics, APR 21, 2026, View Source [SID1234664661])