On April 28, 2025 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of masked, conditionally activated biologics, reported new preclinical data in collaboration with Moderna on an mRNA encoded masked IL-12 molecule (Press release, CytomX Therapeutics, APR 28, 2025, View Source [SID1234652227]). The data will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, being held in Chicago, IL on April 25-30, 2025.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are excited to share new preclinical data at AACR (Free AACR Whitepaper), establishing proof of concept for an mRNA encoded masked molecule in the treatment of cancer," said Marcia Belvin, Ph.D. SVP, Chief Scientific Officer of CytomX Therapeutics. "IL-12 has shown promising anti-tumor activity, but its clinical use has been limited due to its inflammatory toxicity and narrow therapeutic window. By combining CytomX’s proprietary PROBODY masking technology and Moderna’s mRNA technology, we have created an mRNA therapeutic encoding a masked IL-12, designed to be selectively activated within the tumor microenvironment (TME), with limited systemic activity. The data presented at AACR (Free AACR Whitepaper) show proof of concept for this unique technology combination, a key initial goal of the CytomX-Moderna collaboration."

Details for the poster presentation are as follows:
Presentation Title: An mRNA-encoded masked IL-12 improves systemic tolerability while maintaining anti-tumor efficacy in preclinical studies
Poster Number: 3127/12
Section 24
Session Date and Time: April 28, 2025, 2:00 pm – 5:00 pm CT

On April 28, 2025 Plexium, Inc. (Plexium), a leading next-generation targeted protein degradation company, reported multiple presentations with the Company’s selective monovalent degrader programs for SMARCA2, IKZF2 and CDK2 at the 2025 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, taking place April 25-30, 2025, in Chicago, IL (Press release, Plexium, APR 28, 2025, View Source [SID1234652243]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"These data highlight the clinical and preclinical progress we’ve made across our portfolio, including the use of a novel E3 ligase DCAF16, in our SMARCA2 program—an industry first that reinforces the differentiated potential of our monovalent degrader platform," said Jorge F. DiMartino, MD, PhD, Chief Medical Officer at Plexium. "We are also excited to share initial clinical data from PLX-4545, which demonstrated clinical proof of mechanism and intended pharmacological immunophenotypic effects."

Oral Presentation Details:

Title: "Discovery and characterization of novel, potent and selective CDK2 molecular glue degrader against CCNE1-amplified tumors"
Session: MS.ET09.01 – Degraders and Glues
Abstract Number: 6375
Date and Time: April 29, 2:55 PM – 3:10 PM
Presenting Author: Leenus Martin, PhD

Title: "PLX-4545, a selective IKZF2 degrader, reprograms suppressive Tregs leading to tumor growth inhibition and combination benefit with immune checkpoint therapy"
Session: MS.ET09.01 – Degraders and Glues
Abstract Number: 6380
Date and Time: April 29, 4:10 PM – 4:25 PM
Presenting Author: Peggy Thompson, PhD

Poster Presentation Highlights:

Title: "Mechanistic characterization of selective monovalent direct degraders of SMARCA2″
Session: PO.ET09.04 – Degraders and Glues 1
Abstract Number: 404
Section: 18
Date and Time: April 27, 2025, 2:00 PM – 5:00 PM
Presenting Author: Julia Toth, PhD

Plexium’s SMARCA2 degraders function by bromodomain binding and covalent modification
A CRISPR knockout screen identified DCAF16 as being required for PLX-61639 mediated SMARCA2 degradation
MOA studies demonstrate PLX-61639-mediated SMARCA2:DCAF16 protein interactions and the requirement of covalent binding to a specific DCAF16 cysteine to support a stable ternary complex and subsequent SMARCA2 degradation
Title: "Preclinical characterization of PLX-61639, a potent and orally bioavailable SMARCA2-selective monovalent direct degrader"
Session: PO.ET09.10 – Degraders and Glues 2
Abstract Number: 1653
Section: 18
Date and Time: April 28, 2025, 9:00 AM – 12:00 PM
Presenting Author: Gregory Parker, PhD

Plexium has designed PLX-61639, a potent and selective direct degrader of SMARCA2, and nominated it as a development candidate
Daily oral dosing of PLX-61639 results in deep and sustained SMARCA2 degradation, eliciting robust tumor growth inhibition and regression in SM4mut CDX and PDX models, no tumor growth inhibition is observed in a control SM4wt CDX model
PLX-61639 is currently advancing through IND-enabling studies
Title: "A first in human trial of PLX-4545, a molecular glue degrader of IKZF2, in healthy volunteers, shows pharmacologic modulation of Tregs at well-tolerated doses"
Session Title: PO.CT01.02. First-in-Human Phase I Clinical Trials 2
Abstract Number: CT150
Section: 48
Date and Time: April 29, 2025, 9:00 AM – 12 PM
Presenting Author: Jorge DiMartino, MD, PhD

PLX-4545 an oral, CRBN molecular glue degrader of IKZF2, a lineage-defining transcription factor for Tregs was tested in healthy adult volunteers
With repeated daily dosing for 14 days, all dose levels achieved complete degradation of IKZF2 in PBMCs by Day 2 leading to conversion of Tregs into effector-like T cells and an increase in activated T effector cells
TEAEs were mostly Grade 1 or 2 (mild or moderate) in severity and no Dose Limiting Toxicities were encountered. All AEs were reversible with discontinuation of dosing
The AACR (Free AACR Whitepaper) 2025 posters will be made available on the Plexium website.

On April 28, 2025 Lumicell, Inc., a leader in developing innovative fluorescence-guided imaging technologies for cancer detection, reported the release of early clinical trial findings from the ex vivo feasibility study for molecular imaging in gastric cancer (Press release, Lumicell Diagnostics, APR 28, 2025, View Source [SID1234652275]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Today, Andrew T. Chan, MD, MPH, and David A. Drew, Ph.D. of the Clinical and Translational Epidemiology Unit and Division of Gastroenterology at Massachusetts General Hospital, presented during the session "Advances in the Detection and Treatment of Gastrointestinal Cancers" as a part of the Stand Up To Cancer (SU2C) Gastric Cancer Open Scientific Session at this year’s American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting.

Dr. Drew presented compelling new findings highlighting the potential of cathepsin activity as a biomarker for gastric cancer, confirmed through single-cell analysis in patient samples and molecular profiling in genetically engineered mouse models. These findings support the use of pegulicianine-fluorescence imaging in detecting early-stage and neoadjuvant-treated gastric tumors.

In collaboration with Lumicell, Dr. Drew and Dr. Chan led the first clinical trial of pegulicianine in gastrointestinal cancer patients (NCT02584244). In this study, patients with diffuse and intestinal-type gastric cancers received intravenous pegulicianine prior to undergoing curative-intent surgical resection. Post-surgical specimens imaged ex vivo demonstrated strong, tumor-specific fluorescence signals, correlating with pathologically confirmed cancerous tissue. Importantly, pegulicianine was well tolerated by all study participants.

"Most gastric cancers are diagnosed at a locally advanced stage, with five-year survival rates below 30%," said Dr. Chan. "Current screening approaches, such as random biopsies during upper endoscopy, lack sensitivity. These findings represent a shift toward enabling early and more accurate detection."

Dr. Drew added, "We are thrilled to share these feasibility results. This work is propelling us toward real-time, in vivo endoscopic imaging, which could improve early detection strategies of gastric and gastroesophageal cancers in the at-risk patient population."

The next stage of this research is in progress, involving an in vivo clinical trial of pegulicianine and Lumicell’s newly developed endoscopic imaging system.

On April 28, 2025 enGene Holdings Inc. (Nasdaq: ENGN or "enGene" or the "Company"), a clinical-stage, non-viral genetic medicines company, reported that management will present at upcoming investor conferences in May 2025. Details of the conferences are below (Press release, enGene, APR 28, 2025, View Source [SID1234652291]):

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Conference: 2025 Bloom Burton & Co. Healthcare Investor Conference
Date: Monday, May 5, 2025
Time: 2:30 p.m. ET
Format: Corporate Presentation

Conference: The Citizens Life Sciences Conference
Date: Wednesday, May 7, 2025
Time: 11:30 a.m. ET
Format: Fireside Chat

A live webcast of these presentations can be accessed under the "Investors" section of the enGene website at www.engene.com and will be archived there for 90 days.

On April 28, 2025 Delcath Systems, Inc. (NASDAQ: DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, reported that the U.S. Food and Drug Administration (FDA) has completed its 30-day review of the Company’s Investigational New Drug (IND) application for a Phase 2 clinical trial evaluating HEPZATO in combination with standard of care (SOC) for liver-dominant metastatic breast cancer (mBC) (Press release, Delcath Systems, APR 28, 2025, View Source [SID1234652228]). With the FDA’s review complete, Delcath is now cleared to initiate patient enrollment in the U.S.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Phase 2 trial will evaluate the safety and efficacy of HEPZATO in combination with SOC versus SOC alone in patients with liver-dominant HER2-negative mBC following the failure of previous treatments. The SOC options will be the physician’s choice of eribulin, vinorelbine or capecitabine. Approximately 90 patients will be enrolled in this randomized, controlled trial. The study will take place at more than 20 sites across the United States and Europe, with patient enrollment expected to begin in the fourth quarter of 2025. The trial’s primary endpoint, hepatic progression-free survival, is anticipated to be announced by the end of 2028, while results for overall survival, a secondary endpoint, are expected in 2029.

Company management estimates that approximately 7,000 patients annually in the United States are affected by HER2-negative metastatic breast cancer with liver metastases and are candidates for third line treatment. This population includes patients with a significant burden of liver metastases, which are likely to be the primary cause of mortality. By focusing on this demographic, Delcath intends to offer a novel therapeutic option to those patients with limited treatment alternatives.

"This randomized Phase 2 trial marks an important milestone as we expand the clinical investigation of HEPZATO into patients with liver-dominant metastatic breast cancer," said Gerard Michel, Chief Executive Officer of Delcath Systems, Inc. "We are excited to bring new hope to patient populations in indications beyond metastatic uveal melanoma and to further demonstrate the potential of HEPZATO to address unmet needs in oncology. This study underscores our commitment to broadening the applications of HEPZATO and the underlying hepatic delivery system, positioning us as a platform technology that can offer directed treatment options for a variety of liver-dominant cancers."