On March 26, 2025 ImCheck Therapeuticsannounced reported updated results from its ongoing open-label, randomized Phase I/II study EVICTION at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025 in Chicago, Illinois, USA (Press release, ImCheck Therapeutics, MAR 26, 2025, View Source [SID1234651473]). The poster presentation will provide efficacy, safety, pharmacodynamics and dose selection data on the novel γ9δ2 T-cell activator, ICT01, in combination with azacitidine and venetoclax for the treatment of patients with newly diagnosed AML.

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!

Details of the poster presentation at AACR (Free AACR Whitepaper) 2025 are:

Late-breaking abstract title: "γ9δ2 T-cell (γδTC) activation and azacitidine-venetoclax (AV) for older/unfit adults with newly diagnosed (ND) acute myeloid leukemia (AML) induces high rates of complete remission (CR): Preliminary efficacy, safety, pharmacodynamics (PD) and dose selection of ICT01 in the phase 1 study EVICTION"

Session: Phase 0 and Phase I Clinical Trials

Abstract number: CT024

Presenter: Abhishek Maiti, University of Texas MD Anderson Cancer Center

Authors:Abhishek Maiti, Pierre Peterlin, Daniel Morillo, Jose-Miguel Torregrosa-Diaz, Matthew Ulrickson, Agustin Penedo, Aude De Gassart, Elisabeth Wieduwild, Emmanuel Valentin, Maelle Mairesse, Patrick Brune, Katrien Lemmens, Stephan Braun, Daniel Olive, Naval G. Daver, Sylvain Garciaz, Pierre-Yves Dumas

Date: Monday, April 28, 2025

Time: 9:00 am- 12:00 pm EST

Location: Poster Section 49 / Poster Board Number: 3

The AACR (Free AACR Whitepaper) poster presentation will provide an update on the data in AML patients most recently presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting 2024 showing that ICT01 administered in combination with azacitidine and venetoclax demonstrated promising efficacy without compromising safety.

The AACR (Free AACR Whitepaper) poster will be available on ImCheck’s corporate website after the poster sessions have been opened.

On March 26, 2025 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, reported its 2024 annual results, including major business updates, financial performance and the strategy and outlook for 2025 and beyond (Press release, Innovent Biologics, MAR 26, 2025, View Source [SID1234651489]).

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!

Dr. Michael Yu, Founder, Chairman and CEO of Innovent, stated: "2024 marked a year of historic milestones—Innovent’s Non-IFRS net profit and EBITDA both turned positive for the first time, underscoring our strategic excellence and execution as a pioneer in sustainable biopharmaceutical operations. Meanwhile, we achieved record revenue, expanded our robust product portfolio to 15 approved products and delivered all late-stage development milestones to secure sustained growth momentum. We are also advancing breakthrough innovations in our early-stage pipeline for global opportunities while strengthening both global and local partnerships to accelerate innovation and growth.

With a clear strategy outlined above and a strong track record of execution, we are laying a solid foundation to enter a new phase of growth and global innovation. In the coming years, we aim to achieve RMB20bn product revenue in 2027 and advance five pipeline assets to the global MRCT Phase 3 stage by 2030. Through these efforts, we will evolve into a premier global biopharmaceutical company, delivering long-term value for patients, employees, shareholders and society."

Pioneering profitability with RMB20bn sales target in 2027

First-ever Non-IFRS Positive Profit and EBITDA*
Non-IFRS profit was RMB331.6 million and Non-IFRS EBITDA was RMB411.6 million
The gross profit margin was 84.9%, a year-over-year increase of 2.1 percentage points
The S,G&A expenses ratio was 50.9%, a year-over-year decrease of 7.1 percentage points
R&D expenses were RMB2,499.8million; Cash and short-term financial assets were RMB10,221.1 million, or approximately over USD1.4 billion, providing a solid foundation to our long-term ambitions
Revenue reached new height with solidified oncology leadership
Total revenue reached RMB9,421.9 million, growing by 51.8% year-over-year.
Product sales revenue reached RMB8,227.9 million, growing by 43.6% year-over-year.
Expansion of oncology product portfolio with new indications and broader NRDL coverage and patient access
Building CVM commercialization as another core capability
* Note: The financial numbers mentioned above, unless stated, were based on non-IFRS measure. Detailed disclosure can be found at the Company’s 2024 annual results announcement.

Six new product launches in 2025 with growth momentum anticipated
Three additional approved precision therapies to strengthen lung and hematological cancer franchises:
Dovbleron (taletrectinib) : Potentially best-in-class ROS1 inhibitor
Limertinib: Third-generation EGFR TKI
Jaypirca(pirtobrutinib) : First non-covalent BTK inhibitor launched in China
Build chronic disease as another growth engine:
SINTBILO (tafolecimab injection): First PCSK-9 inhibitor successfully included in the NRDL
SYCUME (Teprotumumab N01 injection): First approved anti-IGF-1R monoclonal antibody, ending a 70-year drought of no new treatment options for thyroid eye disease in China；new studies for front-line treatment and inactive thyroid eye disease in plan
Mazdutide (GCG/GLP-1) : Global first GCG/GLP-1 dual receptor agonist, with two NDAs under NMPA review — first NDA for weight management in obese or overweight populations and second NDA for glycemic control of T2D adults. In addition, new Phase 3 studies are in plan for adolescent obesity, obstructive sleep apnea (OSA) and obesity with metabolic dysfunction-associated fatty liver disease (MAFLD, head-to-head with semaglutide 2.4mg). New clinical studies are also in plan for metabolic dysfunction-associated steatohepatitis (MASH), heart failure with preserved ejection fraction (HFpEF), and higher dose of mazdutide for obesity.
Picankibart (IL-23p19): Potentially best-in-class YTE IL-23p19 monoclonal antibody, with an NDA for moderate-to-severe plaque psoriasis under NMPA review. New studies for psoriasis with prior inadequate response to IL-17, adolescent psoriasis, and psoriatic arthritis(PsA) in plan.
2027 RMB20bn sales target with clear growth trajectory
With ever-growing innovative pipeline, sustainable growth is anticipated to continue even beyond 2027
Embarking on a new era of global innovation

Innovent Academy powers core technology platforms
Robust High-potential Pipeline Targeting 5 Assets in MRCT Phase 3 by 2030
Encouraging data readouts of key pipeline in support of next-step pivotal development
IBI363 (PD-1/IL-2α-bias): Unleashing potential as a next-generation IO therapy with global first-in-class design
Promising Phase 1 results reported in NSCLC, CRC and melanoma, aiming to address some of the most challenge cancer types including IO-failed, PD-L1 low expression and cold tumors;
Two Fast-track Designations from U.S. FDA for IO-treated melanoma and IO-treated squamous NSCLC;
First pivotal clinical trial has been initiated, in head-to-head comparison with pembrolizumab in IO-naïve mucosal and acral melanoma.
IBI343 (CLDN18.2 ADC): Novel Site-specific TOPO1i CLDN18.2 ADC
First MRCT Phase 3 of GC has been initiated in China and Japan
MRCT Phase 1 of PDAC is underway in China and U.S.
NMPA CDE Breakthrough Therapy Designation (BTD) and FDA Fast-track Designation (FTD) granted.
Nearly 10 next-generation programs aiming for global development
Oncology: IBI3009 (DLL3 ADC), IBI3001 (EGFR/B7H3 ADC), and IBI3020 (CEACAM5 dual-payload ADC)
CVM: IBI3016（AGT siRNA）, IBI3032（GLP-1 oral）, IBI3012 (GGG Antibody-peptide conjugate, APC), IBI3030（GGG-PCSK9 APC）
Autoimmune: IBI356 (OX40L) and IBI3002 (IL-4Rα/TSLP)
Hybrid models to accelerate innovation
IBI3009 (DLL3 ADC): global rights granted to Roche, to benefit SCLC patients worldwide
Research innovation showcased at medical conferences, including:
AACR, ASCO (Free ASCO Whitepaper), ESMO (Free ESMO Whitepaper) GI, ESMO (Free ESMO Whitepaper) plenary, ESMO (Free ESMO Whitepaper), WCLC, SITC (Free SITC Whitepaper), ESMO (Free ESMO Whitepaper) Asia for oncology pipeline innovation
ADA, APAO, ICE, CSE for general biomedicine pipeline material progress
Facilities and manufacturing capacity adhering to high-quality standards

Shanghai R&D Center (medical) is newly operational in August 2024
Building U.S. lab in San Francisco
First manufacturing site: 60,000L antibody production capacity and ADC production lines in operation
Second manufacturing site: first phase of 80,000L completed construction
Committed to responsible business practices and enhancing ESG management practices

Innovent has been graded ‘AAA’ rating in MSCI ESG rankings, positioning us at the forefront of the biotechnology industry.
We recently launched our ESG website to further strengthen commitment to sustainability, corporate responsibility and ethical business conduct.
We initiated the "Warmth Stations" program to support frontline urban workers (e.g., sanitation workers, delivery personnel), by providing rest areas and essential supplies. Additionally, we launched the third annual "Children’s Book Donation" campaign, bringing hope and support to underprivileged children through book donations.
We have supported over 200,000 patients through our dedicated patient assistance programs, with drug donations totaling RMB 3.6 billion.
Our commitment to medical philanthropy has been recognized through prestigious awards, including the "Medical Philanthropy Promoter" title and designation as a "China Philanthropic Enterprise".
We were recognized on the "2024 China’s Most Attractive Employers List," with a workforce of 7,000 employees.

On March 26, 2025 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that its research collaborators will present at the upcoming 2025 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting being held April 25-30, 2025 in Chicago, Illinois (Press release, Genprex, MAR 26, 2025, View Source [SID1234651458]). The collaborators will present positive preclinical data from a study of its lead drug candidate, Reqorsa Gene Therapy (quaratusugene ozeplasmid), for the treatment of KRASG12C mutant non-small cell lung cancer (NSCLC).

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 delighted to have our academic partners present positive preclinical data on our lead drug candidate, REQORSA, as a potential therapeutic treatment for Ras inhibitor resistant lung cancer," said Ryan Confer, President and Chief Executive Officer at Genprex. "These preclinical data further validate REQORSA as a potential treatment for many types of cancer, including another subset of lung cancer. We remain highly encouraged by the role that TUSC2 plays in the treatment of lung cancer and by our preclinical programs expanding on the potential use of REQORSA to treat many types of cancer where patient populations continue to have unmet medical needs."

The featured Genprex-supported poster to be presented at AACR (Free AACR Whitepaper) 2025:

Title: Overcoming sotorasib acquired resistance in KRASG12C mutant NSCLC by TUSC2 gene therapy

Session Category: Experimental and Molecular Therapeutics

Session Title: Drug Resistance in Molecular Targeted Therapies 3

Session Date and Time: Tuesday, April 29 from 2-5 p.m. CT

Location: Poster Section 17

Poster Board Number: 12

Abstract Presentation Number: 5517

The featured Genprex-supported abstract to be presented at AACR (Free AACR Whitepaper) 2025:

Acquired resistance (AR) to Lumakras (sotorasib), the first FDA-approved KRASi, poses a significant challenge in the treatment of KRASG12C mutant NSCLC. Despite initial responses, patients invariably develop resistance, necessitating alternative therapeutic strategies. The mechanisms underlying AR include the emergence of additional mutations in the KRAS gene, reactivation of the KRAS pathway, or activation of alternative signaling pathways. TUSC2, a potent tumor suppressor gene with immunogenic properties, exhibits multifunctional activity by inhibiting downstream signaling pathways, including MAPK and mTOR; arresting the growth and proliferation of cancer cells; inducing tumor cell death; and activating innate and adaptive immune responses. In this study, researchers demonstrated that TUSC2 gene therapy (REQORSA) effectively overcomes sotorasib AR in KRASG12C mutant NSCLC mouse xenografts.

The data indicate that TUSC2 transfection significantly reduced colony formation in two AR cell lines. Transfection of TUSC2 also markedly increased apoptosis in AR cells. Re-expression of TUSC2 into AR PDXOs significantly decreased the viability of organoids compared with the empty vector. The H23AR tumors exhibited significantly lower sensitivity to sotorasib than their parental counterparts. However, treatment with REQORSA was highly effective in controlling tumor growth compared to treatment with sotorasib alone or the control groups. REQORSA alone also exhibited a strong antitumor effect on TC314AR PDXs. Sotorasib alone showed no significant antitumor activity in these models. However, a synergistic antitumor effect was observed when TC314AR PDX tumors were treated with the combination of REQORSA and sotorasib.

In conclusion, researchers demonstrated that REQORSA, alone or in combination with sotorasib, induced apoptosis, inhibited colony formation, and showed significant antitumor efficacy in KRASG12C mutant sotorasib-acquired resistant xenograft and PDX tumors.

About Reqorsa Gene Therapy

REQORSA (quaratusugene ozeplasmid) consists of a plasmid containing the TUSC2 gene encapsulated in non-viral lipid-based nanoparticles in a lipoplex form (the Company’s Oncoprex Delivery System), which has a positive charge. REQORSA is injected intravenously and specifically targets cancer cells. REQORSA is designed to deliver the functioning TUSC2 gene to negatively charged cancer cells while minimizing uptake by normal tissue. Laboratory studies conducted at MD Anderson show that the uptake of TUSC2 in tumor cells in vitro after REQORSA treatment was 10 to 33 times the uptake in normal cells.

On March 26, 2025 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a pioneer in the development of targeted radiotherapies, reported it will be presenting a business update today at Trump Mar-a-Lago Club, Florida (Press release, Actinium Pharmaceuticals, MAR 26, 2025, View Source [SID1234651474]). This presentation follows an Investor KOL Call and Company Update hosted by Actinium on Tuesday, March 25th highlighting its revitalized clinical programs and expanded market opportunities.

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!

Sandesh Seth, Actinium’s Chairman and CEO, said, "We are honored to have this opportunity to present Actinium Pharmaceuticals and highlight the significant progress we have made in the last several months at the Mar-a-Lago Club. We have great enthusiasm for our revamped clinical programs and expect to achieve significant milestones in 2025. If successful, we will have the opportunity to address multiple potential blockbuster market opportunities with Actimab-A in myeloid malignancies and solid tumors and with Iomab-ACT for cell and gene therapy conditioning."

Actinium has outlined its expanded market opportunities and expected 2025 milestones for each of its clinical programs as well as its R&D and radiopharmaceutical manufacturing capabilities as follows:

Actimab-A as a mutation agnostic, backbone therapy for myeloid malignancies including acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) across multiple treatment settings

Initiate Phase 2/3 trial in combination with CLAG-M in relapsed or refractory AML and seek potential partners or collaborators
Generate initial clinical data in frontline AML in first trial under CRADA with NCI
Initiate additional clinical trials in myeloid malignancies
Actimab-A as a pan solid tumor therapy in combination with PD-1 inhibitors including KEYTRUDA and OPDIVO by depleting myeloid derived suppressor cells (MDSCs)

Generate clinical proof of concept data in head and neck squamous cell carcinoma and non-small cell lung cancer
Explore additional solid tumor indications for future trials
Iomab-ACT as a universal targeted conditioning agent to increase patients access to cell & gene therapies and improve patient outcomes

Present initial data from commercial CAR-T trial at University of Texas Southwestern
Generate clinical data in first non-malignant indication from sickle cell disease allogeneic stem cell transplant trial at Columbia University
Pipeline Expansion Leveraging Targeted Radiotherapy R&D Capabilities

Present abstract at AACR (Free AACR Whitepaper) highlighting Actinium-225 targeted radiotherapy for novel radiotherapy cancer target
Establish In-house Radiopharmaceutical Manufacturing & Production

Advance build-out of manufacturing facility
Explore strategic partnerships leveraging proprietary Actinium-225 cyclotron manufacturing technology
Mr. Seth continued, "In addition to the multitude of milestones that lie ahead for our clinical programs, we are excited to highlight our expanding capabilities. As a pioneer in targeted radiotherapy, we are leveraging our robust know-how and intellectual property to develop new pipeline programs to address indications with high unmet needs. In addition, we are investing in our infrastructure and are thrilled to be moving ahead with the build-out of our manufacturing facility starting next quarter in anticipation of future clinical success. Finally, we look forward to fully leveraging our proprietary Actinium-225 cyclotron manufacturing technology to meet our projected demand given our expanding Actinium-225 programs as well as facilitate strategic partnerships. With our strong balance sheet providing runway into mid-2027, our team is focused and committed on execution and value creation."

On March 26, 2025 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for hematologic malignancies and solid tumors, reported that it will release results from four preclinical studies in poster presentations at the 2025 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (AACR 2025), taking place from April 25th to 30th at the McCormick Place Convention Center, Chicago, the United States (Press release, Antengene, MAR 26, 2025, View Source [SID1234651490]). These four posters will feature Antengene’s four highly differentiated and high-potential programs, including ATG-201 (CD19 x CD3 TCE) and ATG-042 (MTAPnull-selective PRMT5 Inhibitor), which are poised to enter clinical development in the second half of 2025; ATG-110 (LY6G6D x CD3 TCE), which was developed on the AnTenGagerTM TCE 2.0 platform for the treatment of microsatellite stable colorectal cancer; and a companion diagnostic antibody developed to assess CD24 expression and guide clinical studies of CD24-targeted therapies.

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!

Details of the Poster Presentation:
ATG-201 (CD19 x CD3 T cell engager)
Title: ATG-201, a novel T-cell engager (TCE) effectively depletes B cells with reduced risk of CRS for the treatment of B cell malignancies and B cell related autoimmune diseases
Abstract Number: 7326
Session Category: Immunology
Session Title: T Cell Engagers and Novel Antibody-Based Therapies
Date: April 30, 2025
Time: 9:00 AM – 12:00 PM (Central Time)
10:00 PM, April 30, 2025 – 1:00 AM, May 1, 2025 (Beijing Time)
Location: Poster Section 40

Introduction: By depleting autoreactive B cells, CD19-targeted CAR-T have shown early yet promising efficacy in treating patients with B cell-driven autoimmune diseases. However, the clinical application of TCE continues to be greatly hindered by the unfavorable pharmacokinetics and toxicity associated with cytokine release syndrome. To overcome these limitations, Antengene developed ATG-201, a "2+1" CD19 x CD3 TCE, which was evaluated in a series of in vitro studies for binding affinity, T cell dependent cytotoxicity (TDCC) cytokine release, and drug developability. The in vivo anti-lymphoma efficacy and pharmacodynamic effect were evaluated in Raji xenograft model. The tissue resident B cell depletion was assessed in CD34+ hematopoietic stem cells humanized mice. Pharmacokinetic parameters of ATG-201 were evaluated in normal Balb/c mice.
Results: Compared to benchmark TCEs, ATG-201 demonstrated stronger naïve B cell depletion activity with much lower cytokine release in vitro. ATG-201 showed potent anti-lymphoma activity in PBMC-humanized subcutaneous Raji xenograft model with significant augment of infiltrated CD8+ T cells in tumor microenvironment and limited proinflammatory cytokines detected in plasma. Single dose ATG-201 completely and deeply depleted B cells in blood, bone marrow and spleen of CD34+ cells humanized mice. ATG-201 demonstrated potent efficacy in mouse systemic lupus erythematosus model, inhibiting the lymph node swelling and auto-antibody producing.
Conclusions: ATG-201 demonstrated CD19-dependent CD3 binding and activation, inducing effective B cell depletion in vitro and in vivo with low cytokine release, which provides potential for the treatment of B cell malignancies and B cell related autoimmune diseases. ATG-201 is poised to enter clinical development in the second half of 2025.
ATG-042 (MTAPnull-selective PRMT5 Inhibitor)
Title: Preclinical characterization of ATG-042, a novel MTAPnull-selective PRMT5 inhibitor
Abstract Number: 4230
Session Category: Experimental and Molecular Therapeutics
Session Title: HDAC and Methyltransferase Inhibitors
Date: April 29, 2025
Time: 9:00 AM – 12:00 PM (Central Time)
10:00 PM, April 29, 2025 – 1:00 AM, April 30, 2025 (Beijing Time)
Location: Poster Section 16

Introduction: Targeting the PRMT5-MTA complex has become a promising strategy for treating MTAPnull cancer in a synthetically lethal manner, avoiding on-target off-tumor hematological toxicity when using first-generation, non-selective PRMT5 inhibitors. Herein, Antengene developed ATG-042, a novel MTAPnull-selective PRMT5 small molecule inhibitor with good brain penetration. In this study, the in vitro activity and MTAP selectivity of ATG-042 were profiled using HCT116 MTAP wild type (wt) cells, HCT116 MTAP knock out (ko) cells and multiple endogenous MTAPnull cell lines. The in vivo efficacy was tested in cell derived xenograft (CDX) mouse models with HCT116 MTAP wt cells, HCT116 MTAP ko cells, LU99 cells (MTAPnull) and U87MG-luc (MTAPnull). The pharmacokinetic and toxicological properties were assessed with corresponding assay methods.
Results: ATG-042 showed excellent anti-proliferative activities on multiple endogenous MTAPnull cell lines with IC50 values between 10nM and 100nM. ATG-042 demonstrated high permeability, good metabolic stability, and low risk of drug-drug interaction. In vivo PK study shows that ATG-042 is well absorbed, with a dose-dependent increase in plasma distribution and high oral bioavailability in mice, SD rats and beagle dogs. Furthermore, ATG-042 is brain-penetrable (B/P ratio=51% in mice; KPuubrain=0.73 in rats). ATG-042 showed robust in vivo efficacy in both subcutaneous CDX models (HCT116 -MTAP ko, LU99) and orthotopic CDX model (U87MG-luc) as a single agent. In addition, ATG-042 also exhibited potential synergy in combination with other drugs for antitumor therapy.
Conclusions: ATG-042 is an oral MTAPnull-selective PRMT5 inhibitor with potent efficacy against MTAPnull tumor. It also demonstrated good tolerability and brain penetrability. ATG-042 is poised to enter clinical development in the second half of 2025.
ATG-110 (LY6G6D x CD3 T cell engager)
Title: ATG-110, a novel "2+1" LY6G6D-targeted T-cell engager (TCE) for the treatment of MSS colorectal cancer
Abstract Number: 3509
Session Category: Immunology
Session Title: T Cell Engagers
Date: April 28, 2025
Time: 2:00 PM – 5:00 PM (Central Time)
3:00 AM – 6:00 AM, April 29, 2025 (Beijing Time)
Location: Poster Section 38

Introduction: Colorectal cancer (CRC) is one of the most common cancers worldwide and requires more effective and safer therapies to improve the poor survival outcome, particularly in patients with microsatellite stable (MSS) colorectal cancer, who exhibit primary resistance to immune checkpoint inhibitors and lack effective treatment options. T cell engagers have shown encouraging efficacy in treating hematological malignancies, while exhibiting suboptimal clinical efficacies in solid tumors. The risk of cytokine release syndrome (CRS) remains as a significant challenge clinically. ATG-110 is a novel "2+1" LY6G6D x CD3 TCE developed by Antengene. In this study, ATG-110 was evaluated in a series of preclinical in vitro studies for binding affinity, T cell activation and cytokine release, T cell dependent cytotoxicity (TDCC), and drug developability. The in vivo anti-tumor efficacy was evaluated in PBMC-humanized immunodeficient NDG mice engrafted with LY6G6Dmedium-expression HT55 or LY6G6Dvery low-expression SW480 MSS CRC cells.
Results: ATG-110 binds to LY6G6D-positive cell lines, including LY6G6D-overexpression 293T, HT55, LS1034, with the nanomolar grade EC50. The CD3 binding site of ATG-110 is concealed by the LY6G6D Fab arm before binding to LY6G6D, due to the steric hindrance. Therefore, ATG-110 demonstrated limited binding capability to CD3+ cells before LY6G6D crosslinking. It activates T cells and induces cytokine release only in the presence of LY6G6D+ cells. In vitro, ATG-110 resulted in potent T cell dependent cytotoxicity with single-digit pM IC50 values on HT55 and SW480 cells. ATG-110 also showed potent anti-tumor activity in PBMC-humanized SW480 xenograft model and exhibited complete response (CR) in PBMC-humanized HT55 xenograft model. Furthermore, ATG-110 also demonstrated good drug developability.
Conclusions: ATG-110 demonstrated LY6G6D-dependent CD3 binding and activation with low risk of CRS. It showed powerful in vitro and in vivo anti-tumor efficacy against colorectal cancer, which warrants further clinical evaluation.
ATG1144 (CD24 CDx Antibody)
Title: Development of a diagnostic antibody for CD24 targeted therapy
Abstract Number: 671
Session Category: Clinical Research
Session Title: Diagnostic Biomarkers 2
Date: April 27, 2025
Time: 2:00 PM – 5:00 PM (Central Time)
3:00 AM – 6:00 AM, April 28, 2025 (Beijing Time)
Location: Poster Section 29

Introduction: CD24 has emerged as a promising therapeutic target for anti-cancer treatment. Several clinical trials are being conducted to evaluate the safety and efficacy of CD24-targeted therapies. Here, Antengene developed and characterized an anti-CD24 diagnostic antibody to enhance the screening and selection of patients based on CD24 expression. In this study, the authors described the discovery of the diagnostic antibody, and the evaluation of accuracy, sensitivity (selectivity), specificity, and assay precision of the antibody.
Results: Monoclonal antibody clone ATG1144 binds to the hCD24 core peptide in ELISA with an EC50 of 0.06 nM. Distinct membrane staining on human normal esophageal tissue FFPE specimens can also be observed with IHC staining using ATG1144. For accuracy assessment, six CDX and twenty human specimens, comprising both positive and negative specimens (including solid tumors and B-cell non-Hodgkin lymphomas), were validated. Samples exhibiting high, medium, and low CD24 expression levels were evaluated for sensitivity and specificity, and the interpreted results aligned with the reference outcomes. FFPE tissues from three distinct patients were evaluated for assay precision assessment. The TMA IHC staining result revealed that 50-80% of patients with lung, breast, bladder, ovarian, or liver cancer have CD24 expression on tumor cell surface with low expression in the para-cancerous normal tissue.
Conclusions: ATG1144 specifically binds to human CD24 with high sensitivity as demonstrated by IHC staining. The development and validation of the method have been finalized using Leica Bond III platforms. These data suggest a potential diagnostic use of ATG1144 for identifying CD24+ patients.