On May 22, 2025 Caris Life Sciences (Caris), a leading next-generation AI TechBio company and precision medicine pioneer, reported that the company and collaborators within the Caris Precision Oncology Alliance (Caris POA) will collectively present 37 abstracts across 16 tumor types at the upcoming 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, from May 30 – June 3, in Chicago, IL (Press release, Caris Life Sciences, MAY 22, 2025, View Source [SID1234653339]).

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"This year’s ASCO (Free ASCO Whitepaper) abstracts highlight the growing clinical value of integrated molecular profiling and real world data, particularly as AI tools transform how we diagnose and treat cancer," said Caris EVP and Chief Medical Officer George W. Sledge, Jr., MD. "The data from our internal and collaborative studies show that we are entering a new era of precision oncology, where every data point can support smarter, more personalized decision-making."

"Caris’ strong presence at ASCO (Free ASCO Whitepaper) demonstrates our ongoing commitment to revolutionizing healthcare and improving patient outcomes," said James Hamrick, MD, MPH, Chairman of the Caris Precision Oncology Alliance. "Caris’ comprehensive clinicogenomic database helps enable novel insights into cancer and, together with our network of Caris POA researchers, is truly making an impact on patients’ diagnosis, prognosis, care plans and responses to treatment."

Oral presentation:

CLONEVO: Preoperative abemaciclib for cisplatin-ineligible muscle-invasive bladder cancer (MIBC) with molecular response assessment. (Abstract 4520)
May 31, 2:15 – 2:21 PM CDT: Arie Crown Theater

Poster presentations:

Assessment of age in the clinical risk stratification of patients with IDH-mutant gliomas.
Abstract: 2058 Poster Board: 104 May 31, 9:00 AM CDT: Hall A

Comparing ERK signaling and tumor microenvironment in BRAF-altered gliomas.
Abstract: 2063 Poster Board: 109 May 31, 9:00 AM CDT: Hall A

Association of MGMT status with survival in low and high-grade IDH-mutant astrocytomas.
Abstract: 2065 Poster Board: 111 May 31, 9:00 AM CDT: Hall A

Prognostic impact of DDR mutations (mt) in IDH mutant high-grade gliomas (HGG).
Abstract: 2066 Poster Board: 112 May 31, 9:00 AM CDT: Hall A

Immune checkpoint inhibition in EBV-associated gastric cancer: A multi-center international retrospective analysis.
Abstract: 4043 Poster Board: 333 May 31, 9:00 AM CDT: Hall A

Molecular profile of hepatocellular carcinoma (HCC) in older (OA) versus younger adults (YA) receiving tyrosine kinase inhibitors: Does age matter?
Abstract: 4124 Poster Board: 414 May 31, 9:00 AM CDT: Hall A

The differential effect of stromal genes on gemcitabine/nab-paclitaxel (GN) and GN/cisplatin (GCN) outcomes in advanced pancreatic adenocarcinoma (aPDAC).
Abstract: 4166 Poster Board: 456 May 31, 9:00 AM CDT: Hall A

Biomarkers of response to immunotherapy in pancreatic ductal adenocarcinoma (PDAC) with homologous recombination deficiency (HRD).
Abstract: 4176 Poster Board: 466 May 31, 9:00 AM CDT: Hall A

Gamma secretase inhibitors and desmoid fibromatosis: Lessons from a real world, comprehensive genomic study of desmoids and CTNNB1/APC mutated soft tissue tumors.
Abstract: 11547 Poster Board: 30 May 31, 9:00 AM CDT: Hall A

Unveiling drivers of MHC repression and therapeutic strategies to counter immune evasion in small cell lung cancer.
Abstract: 8091 Poster Board: 212 May 31, 1:30 PM CDT: Hall A

Clinical outcomes and characterization of HER2 alterations in non-small cell lung cancer (NSCLC).
Abstract: 8538 Poster Board: 18 May 31, 1:30 PM CDT: Hall A

PRESCIENTai, an AI-based digital histopathological image signature for risk of late distant recurrence and extended endocrine therapy (EET) benefit in hormone-receptor-positive breast cancer.
Abstract: 1556 Poster Board: 322 June 1, 9:00 AM CDT: Hall A

Interferon signaling and outcomes in triple-negative breast cancer (TNBC) in FinXX, CALGB 40603 (Alliance) and real-world clinico-genomic data.
Abstract: 569 Poster Board: 162 June 2, 9:00 AM CDT: Hall A

MHC class I expression and outcomes in breast cancer in the real-world clinico-genomic data and the FinXX trial.
Abstract: 570 Poster Board: 163 June 2, 9:00 AM CDT: Hall A

Evaluation of tumor immune microenvironment in Hispanic and African American breast cancer.
Abstract: 1051 Poster Board: 30 June 2, 9:00 AM CDT: Hall A

Comparing clinical benefit of trastuzumab deruxtecan (T-DXd) and sacituzumab govitecan (SG) in a large cohort of HER2-negative metastatic breast cancer (MBC).
Abstract: 1076 Poster Board: 55 June 2, 9:00 AM CDT: Hall A

Steroid receptor expression and overall survival in breast cancer patients with ER+ bone metastasis: A retrospective review.
Abstract: 1077 Poster Board: 56 June 2, 9:00 AM CDT: Hall A

Multiomic Profiling of LRRC15 in Triple Negative Breast Cancer (TNBC).
Abstract: 1098 Poster Board: 77 June 2, 9:00 AM CDT: Hall A

Chemokines as predictive biomarkers for immune checkpoint inhibitor (ICI) benefit in triple negative breast cancer (TNBC).
Abstract: 1106 Poster Board: 85 June 2, 9:00 AM CDT: Hall A

Comprehensive molecular and immune characterization of adrenergic stress-signaling receptor ADRB2 in triple negative breast cancer (TNBC).
Abstract: 1107 Poster Board: 86 June 2, 9:00 AM CDT: Hall A

Comprehensive characterization of interleukin-enhanced factor 2 (ILF2) in triple-negative breast cancer (TNBC).
Abstract: 1114 Poster Board: 93 June 2, 9:00 AM CDT: Hall A

HIF family transcription factor expression in a cohort of 4362 patients with renal cell carcinoma (RCC).
Abstract: 4543 Poster Board: 343 June 2, 9:00 AM CDT: Hall A

Real-world analysis of 2IR immune response score in histologic subtype urothelial carcinoma (hsUC).
Abstract: 4568 Poster Board: 368 June 2, 9:00 AM CDT: Hall A

Prevalence of histology-agnostic biomarkers in pure squamous cell carcinomas of the genitourinary tract.
Abstract: 4609 Poster Board: 409 June 2, 9:00 AM CDT: Hall A

Comprehensive genomic profiling of Black and non-Hispanic White (NHW) men with prostate cancer (PCa).
Abstract: 5022 Poster Board: 221 June 2, 9:00 AM CDT: Hall A

Effect of HLA class I expression on the tumor immune microenvironment and prognosis in prostate cancer.
Abstract: 5044 Poster Board: 243 June 2, 9:00 AM CDT: Hall A

Molecular and clinical characterization of KLK2 mRNA expression in prostate cancer (PC).
Abstract: 5050 Poster Board: 249 June 2, 9:00 AM CDT: Hall A

Prognostic relevance of Aurora kinase A (AURKA) expression in prostate cancer (PCa).
Abstract: 5061 Poster Board: 260 June 2, 9:00 AM CDT: Hall A

Molecular characterization of STEAP1 and -2 in advanced prostate cancer.
Abstract: 5072 Poster Board: 271 June 2, 9:00 AM CDT: Hall A

Characterization and impact of B7-H3 (CD276) expression across disease states and racial groups in prostate cancer.
Abstract: 5073 Poster Board: 272 June 2, 9:00 AM CDT: Hall A

Survival association of PIK3CA in HPV-driven head and neck squamous cell carcinoma (HNSCC).
Abstract: 6056 Poster Board: 464 June 2, 9:00 AM CDT: Hall A

Comparative transcriptomic analysis to identify similarities and therapeutic vulnerabilities in olfactory neuroblastoma (ONB), sinonasal neuroendocrine carcinoma (SNEC) and sinonasal undifferentiated carcinoma (SNUC).
Abstract: 6095 Poster Board: 503 June 2, 9:00 AM CDT: Hall A

BRAF-V600E papillary thyroid cancer: Updated analysis of real-world patient data.
Abstract: 6099 Poster Board: 507 June 2, 9:00 AM CDT: Hall A

Clinical significance of the CGRP pathway gene expression in advanced solid tumors: A sub-analysis of MONSTAR-SCREEN-2.
Abstract: 2629 Poster Board: 276 June 2, 1:30 PM CDT: Hall A

Effect of elevated expression of LILRB4 and TSC22D3 on survival in lung cancer.
Abstract: 2633 Poster Board: 280 June 2, 1:30 PM CDT: Hall A

Regorafenib response prediction in metastatic colorectal cancer by a novel genomic and transcriptomic model.
Abstract: 3135 Poster Board: 450 June 2, 1:30 PM CDT: Hall A

Poster and abstract summaries highlighting this research will be available onsite at Caris’ booth #23093. The full abstracts will be available on the Caris website following the presentation.

The Caris POA, a community of investigators, includes 97 cancer centers, academic institutions, research consortia and healthcare systems, including 45 NCI-designated cancer centers, collaborating to advance precision oncology and biomarker-driven research. Caris and POA members work together to establish and optimize standards of care for molecular testing through innovative research to improve clinical outcomes for cancer patients.

On May 22, 2025 Enliven Therapeutics, Inc. (Enliven or the Company) (Nasdaq: ELVN), a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics, reported that management will present at the following investor conferences (Press release, Enliven Therapeutics, MAY 22, 2025, View Source [SID1234653338]):

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TD Cowen’s 6th Annual Oncology Innovation Summit: Insights from ASCO (Free ASCO Whitepaper) & EHA (Free EHA Whitepaper)
Format: Fireside Chat
Date: Tuesday, May 27, 2025
Time: 1:00 p.m. ET

Jefferies Global Healthcare Conference
Format: Fireside Chat
Date: Wednesday, June 4, 2025
Time: 4:20 p.m. ET

Goldman Sachs Annual Global Healthcare Conference
Format: Fireside Chat
Date: Tuesday, June 10, 2025
Time: 4:00 p.m. ET

The fireside chats will be webcast live and can be accessed by visiting the investor relations section of the Company’s website at View Source Each webcast will be archived for a period of 90 days following the conclusion of the live event.

On May 22, 2025 Novita Pharmaceuticals, Inc. ("Novita"), a privately held, clinical-stage pharmaceutical company dedicated to developing novel cancer drugs through its proprietary fascin inhibitor technology, reported additional results from its Phase 2 study (NCT05023486) evaluating NP-G2-044 in combination with SOC anti-PD-1 therapy in patients with advanced solid tumors resistant to prior anti-PD-1 therapy at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Novita Pharmaceuticals, MAY 22, 2025, View Source [SID1234653337]). The oral presentation, titled "Durable responses in ICI-refractory or acquired resistance: Phase 2 study of NP-G2-044 combined with anti-PD-1 therapy", further supports the potential therapeutic benefit of NP-G2-044 in combination with immune checkpoint inhibitors (ICIs) to block metastasis and enhance immune response.

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"We are encouraged by the continued positive data from our Phase 2 trial of NP=G2-044, which highlight the therapeutic opportunity of our first-in-class fascin inhibitor for patients with advanced and metastatic solid tumors," said Jillian Zhang, Ph.D., President & Chief Scientific Officer of Novita. "Continued safety and durable efficacy findings across multiple tumor types speak to the impact of our novel therapy, as we see favorable response rates and no new metastases from more than half of patients. These data set the foundation for our Phase 3 study of NP-G2-044 + PLD in platinum resistant ovarian cancer, which we plan to start enrolling later this year."

Among the 45 patients treated with NP-G2-044 as of the most recent data cutoff (April 23, 2025), all had progressed on prior anti-PD-(L)1 therapies, with a median number of 2 prior lines, and with 20% of patients having at least 4 prior lines. The anti-PD-1 Combination RP2D for NP-G2-044 was 1600 mg QD with 4-week cycles. The primary endpoint was objective response rate (ORR), and secondary endpoints included progression-free survival (PFS), metastasis-free interval (MFI), overall survival (OS), safety, and tolerability.

Key highlights include:

A Disease Control Rate of 76% (includes patients with Stable Disease and Objective Responses).
An ORR of 21% including three patients with Partial Response (PR) and four patients with Complete Responses (CR) including two Pathologic Complete Responses.
Results indicate durable responses and tumor control in a significant proportion of patients across at least seven cancer types, including cases converted from ICI-non-responsive to ICI-responsive.
Long lasting objective responses have been observed across multiple tumor types, with four patients in ongoing treatment, two of which show duration lasting more than 80 weeks in pancreatic cancer and endometrial cancer.
55% of all patients show no new metastases.
Notable outcomes include continued CR in a cervical cancer patient, target lesion CR in an endometrial cancer patient, pathological CRs in a pancreatic cancer patient and a patient with gastroesophageal junction adenocarcinoma, clinical CR in a cutaneous squamous cell carcinoma patient, and PRs in non-small cell lung cancer and cholangiocarcinoma.
Increased T-cell infiltration and enhanced proliferation as well as expanded activated dendritic cells (DCs) in the tumor microenvironment were observed, supporting the therapeutic function of fascin inhibition and immune activation.
An amendment to the study is currently underway to open additional cohorts, which will aim to further evaluate the combination of NP-G2-044 with anti-PD-1 therapy across patient populations and solid tumor subtypes. Future analysis will also explore biomarkers for response prediction and mechanisms of resistance, guiding personalized approaches in treatment-resistant cancer. Novita plans to share additional data from the Phase 2 expansion cohort of NP-G2-044 in combination with ICI in the second half of 2025 with enrollment in its pivotal Phase 3 study of NP-G2-044 + PLD in platinum resistant ovarian cancer expected to begin in the third quarter of 2025.

On May 22, 2025 Foresight Diagnostics, Inc. ("Foresight"), a leading diagnostics company specializing in the development of ultra-sensitive minimal residual disease (MRD) detection, reported the presentation of independent validation data demonstrating the prognostic performance of its Foresight CLARITY MRD assay in patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL) (Press release, Foresight Diagnostics, MAY 22, 2025, View Source [SID1234653336]). The results will be shared in an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place from May 31 to June 3, 2025, in Chicago, Illinois.

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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

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The prospective, multi-center observational study, led by Amsterdam UMC in close collaboration with the Hemato-Oncology Foundation for Adults in the Netherlands (HOVON) and Netherlands Comprehensive Cancer Organization (IKNL), is the largest independent validation study of Foresight CLARITY to date, spanning more than 150 patients with frontline DLBCL treated uniformly with curative-intent therapy across 50 sites in the Netherlands and Belgium.

Key Findings:

ctDNA-MRD was detected at end of treatment (EOT) in 24% of patients; 76% were MRD-negative.
MRD-positive patients showed significantly lower progression-free survival (28% vs. 88%) and overall survival (50% vs. 97%) compared to MRD-negative patients.
Among patients who were MRD-negative and achieved PET complete response at EOT, 2-year progression-free survival (PFS) and overall survival (OS) were 91% and 99%, respectively.
All patients who failed to achieve complete response by PET and remained MRD-positive experienced relapse.
ctDNA-MRD remained a powerful independent predictor of outcomes across multiple clinical subgroups, even after adjusting for standard prognostic factors.
"These results provide important prospective validation of Foresight CLARITY’s clinical performance in frontline DLBCL across a large, real-world patient cohort," said David Kurtz, M.D., Chief Medical Officer of Foresight Diagnostics. "This study adds to a growing body of clinical evidence that we believe should strengthen the field’s confidence in our assay’s ability to accurately assess treatment response. We remain on track for a planned launch into the clinical market and look forward to integrating CLARITY into routine clinical practice."

Lead study authors Steven Wang, M.D. and Martine Chamuleau MD PhD, Amsterdam UMC, added: "Our findings confirm that ultra-sensitive ctDNA-MRD detection provides meaningful prognostic information beyond standard imaging and clinical factors. We believe this assay can support better risk stratification than imaging alone and inform post-treatment management decisions in DLBCL."

Oral presentation details:

Title: Prospective validation of end of treatment ctDNA-MRD by PhasED-Seq in DLBCL patients from a national trial
Presenter: Steven Wang, MD, PhD (Amsterdam UMC)
Session: Oral Abstract Session – Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Time: Friday, May 30 | 2:45 – 5:45 p.m. CT
Location: Room S100a or live stream for virtual attendees
Abstract number: 7000
In addition to the oral presentation, Foresight’s technology will be highlighted in other presentations, including:

"Sequencing-guided chemotherapy optimization using real-time evaluation in newly diagnosed DLBCL with circulating tumor DNA: SHORTEN-ctDNA" (NCT06693830) Presenter: Stephanie Meek, Ph.D. (Foresight) in collaboration with Columbia University
Type: Poster #272a
Session: Poster Session – Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Date/Time: Sunday, June 1 | 9:00 a.m. – 12:00 p.m. CT | Poster Hall A

"ALPHA3: A pivotal phase 2 study of first-line (1L) consolidation with cemacabtagene ansegedleucel (cema-cel) in patients (pts) with large B-cell lymphoma (LBCL) and minimal residual disease (MRD) after response to standard therapy"
Sponsor: Allogene Therapeutics
Presenter: Jason Westin, M.D., M.S., FACP (The University of Texas MD Anderson Cancer Center)
Type: Poster #267a
Session: Poster Session – Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Date/Time: Sunday, June 1 | 9:00 a.m. – 12:00 p.m. CT | Poster Hall A
"Safety and Efficacy of AZD0486, a CD19xCD3 T-cell Engager, in Relapsed or Refractory Diffuse Large B-cell Lymphoma" (NCT04594642)
Sponsor: AstraZeneca
Presenter: Tae Min Kim, M.D. (Seoul National University Hospital)
Type: Poster #229
Session: Poster Session – Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Date/Time: Sunday, June 1 | 9:00 a.m. – 12:00 p.m. CT | Poster Hall A
"Circulating tumor DNA assessment in patients with early-stage classical Hodgkin lymphoma treated with combination of brentuximab vedotin and nivolumab" (NCT03646123)
Sponsor: Pfizer
Presenter: Ryan Lynch, M.D. (Fred Hutchinson Cancer Center)
Type: Poster #223
Session: Poster Session – Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Date/Time: Sunday, June 1 | 9:00 a.m. – 12:00 p.m. CT | Poster Hall A

On May 22, 2025 Accent Therapeutics, a clinical-stage biopharmaceutical company pioneering novel, targeted, small molecule cancer therapeutics, reported that a Trial in Progress poster for its first-in-human, Phase 1/2 study of its first-in-class oral DHX9 inhibitor, ATX-559, will be presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, held May 30-June 3 in Chicago, Illinois (Press release, Accent Therapeutics, MAY 22, 2025, View Source [SID1234653335]).

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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

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"As a novel inhibitor of DHX9, a previously undrugged RNA and DNA/RNA helicase, ATX-559 offers potential as a unique therapeutic approach for addressing cancers characterized by high replication stress," said Jason Sager, M.D., Chief Medical Officer of Accent Therapeutics. "We are encouraged by the robust suite of data that continue to support the clinical evaluation of ATX-559 in our ongoing Phase 1/2 study."

Initiated in late 2024, the first-in-human, Phase 1/2, open-label, dose-escalation and expansion study is designed to evaluate multiple doses of ATX-559 in solid tumor patients, with expansion cohorts of patients with advanced or metastatic BRCA-1 and/or BRCA-2-deficient breast cancer and microsatellite instability-high (MSI-H) and/or deficient mismatch repair (dMMR) solid tumors (NCT06625515). Primary endpoints include identification of the recommended Phase 2 dose (RP2D) and assessment of the safety and tolerability of ATX-559. The study additionally aims to characterize the pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity (as assessed per RECIST v1.1 criteria) of orally administered ATX-559. The study is currently open and enrolling. Additional undisclosed solid tumor indications undergoing replicative stress and representing significant patient populations may be explored either in parallel or in subsequent studies.

Details for the presentation are as follows:

Presentation Title: Trial in Progress: First-in-Human Study of ATX-559, an Oral Inhibitor of DHX9, in Patients with Advanced or Metastatic Solid Tumors, and Molecularly Defined Cancers

Abstract Number: TPS3181
Session Type: Poster Session
Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Session Date and Time: Monday, June 2, 1:30 pm – 4:30 pm CDT
Location: Hall A – Posters and Exhibits | On Demand
Presenter: Meredith Pelster, M.D., M.Sc.
The poster will be available on the Accent Therapeutics website following the meeting.

About ATX-559
ATX-559 is a first-in-class potent and selective inhibitor of DHX9, a novel and previously undrugged RNA and DNA/RNA helicase, shown to play a critical role in tumors with high levels of replication stress (including breast, ovarian, colorectal, endometrial, gastric, and others), representing large patient populations with significant unmet medical need. DHX9 has been reported to play important roles in replication, transcription, translation, RNA splicing, RNA processing, and maintenance of genomic stability, making it a compelling novel oncology target. In addition to exploiting key tumor vulnerabilities in DNA repair deficient backgrounds (e.g., BRCA) and hyper-mutated states (e.g., MSI-H/dMMR), Accent is exploring the sensitivity of other tumor types to DHX9 inhibition, and the potential to combine DHX9 inhibitors with other cancer treatments to maximize its full potential for helping patients. Accent retains full worldwide rights to ATX-559, currently being evaluated in a Phase 1/2 clinical trial (NCT06625515), and the DHX9 program.