On May 29, 2025 Estrella Immunopharma, Inc. (NASDAQ: ESLA) ("Estrella" or the "Company"), a clinical stage biopharmaceutical company developing CD19 and CD22-targeted ARTEMIS T-cell therapies to treat cancer and autoimmune diseases, reported that the first patient has been dosed in the second cohort of its dose escalation study of Phase I/II STARLIGHT-1 trial for EB103, a CD19-redirected ARTEMIS T-cell therapy to treat patients with Advanced B-Cell Non-Hodgkin’s Lymphomas (NHL) (Press release, Estrella Biopharma, MAY 29, 2025, View Source [SID1234653505]).

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The second cohort will evaluate EB103 at a higher dose level following a review of safety data from the first dose cohort. As previously announced, no dose-limiting toxicities (DLTs) or treatment-related serious adverse events (SAEs) were observed in the first cohort. The initiation of dosing in the second cohort reflects steady progress in Estrella’s mission to complete Phase I of STARLIGHT-1.

"We are excited to announce another important milestone in our STARLIGHT-1 trial and are encouraged by the favorable safety profile and the complete response observed in the first cohort," said Cheng Liu, Chief Executive Officer of Estrella. "EB103 has a significant potential to address key limitations of traditional CAR-T therapies by mitigating safety risks and expanding accessibility to high-risk patient groups, including those with HIV-associated lymphoma and central nervous system (CNS) lymphoma – conditions that are excluded from existing CAR-T options. We look forward to evaluating EB103 at higher doses and delivering the treatments to patients soon."

About EB103

EB103, a T-cell therapy, also referred to as Estrella’s "CD19-Redirected ARTEMIS T-Cell Therapy," utilizes ARTEMIS technology licensed from Eureka Therapeutics, Inc. ("Eureka"), Estrella’s parent company. Unlike a traditional CAR-T cell, the unique design of an ARTEMIS T-Cell, like EB103 T-cell, allows it to be activated and regulated upon engagement with cancer targets that use a cellular mechanism more closely resembling the one from an endogenous T-cell receptor. Once infused, EB103 T-cells seek out CD19-positive cancer cells, bind to these cells, and destroy them.

On May 29, 2025 Debiopharm (www.debiopharm.com), a privately-owned, Swiss-based biopharmaceutical company aiming to establish tomorrow’s standard-of-care to cure cancer and infectious diseases, reported its upcoming contributions to the 2025 Annual American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Meeting in Chicago, Illinois (Press release, Debiopharm, MAY 29, 2025, View Source [SID1234653504]).

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The contributions feature three clinical poster presentations and one translational research abstract publication, highlighting Debio 0123’s potential across solid tumors. Among them is new data from the Debio 0123-SCLC-104 trial in small-cell lung cancer, offering insights into the candidate’s therapeutic potential in this difficult-to-treat disease. A Trial in Progress (TiP) poster from the investigator-initiated MedSir study—co-authored by Debiopharm—will present the design and methodology of the study investigating the combination of Debio 0123 with Trodelvy in breast cancer patients. In parallel, a separate TiP poster for the Debio 0123-102 monotherapy study will outline the framework and objectives of the ongoing dose expansion phase.

"Presenting our latest data on Debio 0123 at ASCO (Free ASCO Whitepaper) 2025 is a proud milestone for our team," said Angela Zubel, Chief Development Officer at Debiopharm. "This research highlights the promise of WEE1 inhibition as a precision strategy to target the vulnerabilities of aggressive cancers. Our goal is to push the boundaries of innovation to bring transformative therapies to patients who urgently need new options."

Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology

ASCO 2025 Contribution

Title

Presenter/Author

Abstract #e15127

*Publication only

In silico evaluation of the interaction of P-gp and 3A4 substrates with the WEE1 inhibitor Debio 0123 and clinical application in the Debio 0123-104 combination trial with carboplatin and etoposide.

Anne Bellon, PhD, PharmD

Debiopharm

Abstract #TPS3172

Poster Bd #: 479b

Phase IB/II study to evaluate safety and preliminary efficacy of the WEE1 inhibitor Debio 0123 in combination with sacituzumab govitecan (SG) in triple-negative or hormone receptor–positive (HR+)/HER2-negative (HER2–) advanced breast cancer (ABC): The WIN-B study.

Maria Gion, MD, PhD

Medical Oncologist at Ramón y Cajal University Hospital

*Medsir and Debiopharm

Session Title: Gynecologic Cancer

ASCO 2025 Contribution

Title

Presenter/Author

Abstract #TPS5634

Poster Bd #: 524a

Debio 0123, a highly selective WEE1 inhibitor in adult patients with advanced solid tumors: A phase 1 dose escalation and expansion monotherapy study.

Maria M. Rubinstein, MD

Memorial Sloan Kettering Cancer Center, New York, NY

Session Title: Lung Cancer—Non–Small Cell Local-Regional/Small Cell/Other Thoracic Cancers

ASCO 2025 Contribution

Title

Presenter/Author

Abstract #8098

Poster Bd #: 219

Debio 0123, a highly selective WEE1 inhibitor, in combination with carboplatin (C) and etoposide (E), in patients (pts) with recurrent small cell lung cancer (SCLC): Determination of recommended dose (RD) from a phase 1 escalation.

Valentina Gambardella, MD, PhD

Department of Medical Oncology, Hospital Clínico Universitario, INCLIVA Biomedical Research Institute, University of Valencia, Valencia, Spain

About DNA-Damage Repair (DDR)

When cells have damaged DNA, they need to undergo a repair process called DDR to be able to survive. Cancer cells rely heavily on DDR as they divide and grow uncontrollably. Inhibition of DDR, particularly in combination with other anticancer agents, prevents cancer cells from repairing their DNA, which ultimately activates a self-destruction program in cancer cells. DDR inhibitors such as Debiopharm’s WEE1 inhibitor Debio 0123 are being tested in clinical and preclinical studies.

Debiopharm’s commitment to patients

Debiopharm aims to develop innovative therapies that target high unmet medical needs primarily in oncology and bacterial infections. Bridging the gap between disruptive discovery products and real-world patient reach, we identify high-potential compounds and technologies for in-licensing, clinically demonstrate their safety and efficacy, and then hand stewardship to large pharmaceutical commercialization partners to maximize patient access globally.

On May 29, 2025 Sarah Cannon Research Institute (SCRI), one of the world’s leading oncology research organizations conducting community-based clinical trials, reported that it will showcase its latest research highlights through more than 155 accepted abstracts and presentations at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, held in Chicago from May 30-June 3, 2025 (Press release, Sarah Cannon Research Institute, MAY 29, 2025, View Source [SID1234653503]). Over 75 investigators from more than 20 research sites in SCRI’s network are first authors and co-authors on the clinical trial updates featured at the Annual Meeting, including findings from 55 early-phase clinical trials.

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"We are excited to join our colleagues from around the world at ASCO (Free ASCO Whitepaper)’s Annual Meeting to share the latest developments in research that are advancing therapies for patients," says Howard A. "Skip" Burris, III, MD, President, SCRI. "From developments in novel agents to findings in a variety of cancers, the research presented by SCRI leaders not only highlights how our work is accelerating drug development, but also our dedication to ensuring people facing cancer have access to innovative treatments closer to home."

For a comprehensive list of SCRI abstracts and presentations, visit SCRI’s ASCO (Free ASCO Whitepaper) Site. To learn more about our research experts, visit our Leadership Page.

Noteworthy Presentations

Blood Cancer

David Andorsky, MD, SCRI at Rocky Mountain Cancer Centers I The US Oncology Network, will present "Efficacy and Safety of Asciminib in Patients with Chronic-Phase Chronic Myeloid Leukemia after 1 Tyrosine Kinase Inhibitor: Interim Analysis of the Phase 2 ASC2ESCALATE Trial" in the Rapid Oral Abstract Session, Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant on Friday, May 30 at 2:06 p.m. CDT in E450a.
Breast Cancer

Erika Hamilton, MD, SCRI, will deliver two oral presentations, including "Vepdegestrant, a PROTAC Estrogen Receptor Degrader, vs Fulvestrant in ER-Positive/Human Epidermal Growth Factor Receptor 2 –Negative Advanced Breast Cancer: Results of the Global, Randomized, Phase 3 VERITAC-2 Study" in the Oral Abstract Session, Breast Cancer—Metastatic on Saturday, May 31 at 1:15 p.m. CDT in Hall B1 and "Initial Phase 1 Dose Escalation Data for Emiltatug Ledadotin, a Novel B7-H4-Directed Dolasynthen Antibody-Drug Conjugate" during the Rapid Oral Abstract Session, Development Therapeutics—Molecularly Targeted Agents and Tumor Biology on Monday, June 2 at 8:00 a.m. CDT in S406.
Cancer Detection

Dax Kurbegov, MD, HCA Healthcare Sarah Cannon Cancer Network, will present "Performance Evaluation of a Reflex Blood-Based Methylated ctDNA Multi-Cancer Early Detection Test in Individuals with Obesity" in the Clinical Science Symposium, The Future of Cancer Detection is Coming on Saturday, May 31 at 8:24 a.m. CDT in Hall D1.
Lung Cancer

David Spigel, MD, SCRI, will present "An International, Multicenter, Prospective Randomized Trial of Adjuvant Chemotherapy for Stage Ia-IIa Non-Small Cell Lung Cancer Identified as High-Risk by a 14-Gene Molecular Assay" in the Poster Session, Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers on Saturday, May 31 from 1:30 – 4:30 p.m. CDT in Hall A.
Solid Tumors

Judy Wang, MD, SCRI at Florida Cancer Specialists & Research Institute, will deliver "An Open-Label, Phase I Trial of The SIRPα Monoclonal Antibody, BI 770371, Alone and in Combination with The PD-1 Inhibitor Ezabenlimab in Patients with Advanced Solid Tumors" as part of the Rapid Oral Abstract Session, Development Therapeutics—Immunotherapy on Sunday, June 1 at 11:45 a.m. CDT in S406.
In addition to the above, Dr. Erika Hamilton and Dr. David Spigel will serve in two prestigious leadership roles, as 2025 ASCO (Free ASCO Whitepaper) Annual Meeting Scientific Program Committee Chair and Cancer Communications Committee Chair, respectively.

In addition to scientific presentations, SCRI leadership will participate in and lead ASCO (Free ASCO Whitepaper) sessions, including:

Jason Henry, MD, SCRI at HCA HealthONE, will chair the Oral Abstract Session, Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology, on Friday, May 30 from 2:45 – 5:45 p.m. CDT in Hall D1.
Elisa Fontana, MD, PhD, SCRI at HCA Healthcare UK, will serve as panelist and present "KRAS G12C: From First to Next Generation" as part of the Gastrointestinal Cancer—Colorectal and Anal Oral Abstract Session on Friday, May 30 at 5:21 p.m. CDT in Arie Crown Theater.
Dr. Dax Kurbegov will serve as panelist in The Future of Cancer Detection Is Coming on Saturday, May 31 from 8:00 – 9:30 a.m. CDT in Hall D1.
Dr. Howard Burris will deliver the "Top Donor Recognition Ceremony" during the Opening Session on Saturday, May 31 at 10:50 a.m. CDT in Hall B1.
Haydar Frangoul, MD, MS, SCRI at TriStar Centennial Children’s Hospital, will present "Established Gene Therapy Options in the Clinic" during the ASCO (Free ASCO Whitepaper)/AACR Joint Session: Lessons From Gene Therapy in Practice: Successes, Challenges, and How to Have Access for All on Saturday, May 31 at 1:19 p.m. CDT in E450a.
Dr. Erika Hamilton will serve as a panelist in the Oral Abstract Session, Breast Cancer—Metastatic on Saturday, May 31 from 1:15 – 4:15 p.m. in Hall B1.
Meredith Pelster, MD, MSCI, SCRI, will chair the Oral Abstract Session, Development Therapeutics—Immunotherapy on Saturday, May 31 from 3:00 – 6:00 p.m. CDT in Hall D2.
Abdul Rafeh Naqash, MD, SCRI at OU Health Stephenson Cancer Center, will present "Dual-Edged: The Promise and Perils of Bispecific T-Cell Engagers in Lung Cancer and Beyond" during BiTES and Beyond: BiTES, Amivantimab, and the Multidimensional Impact of Toxicity Management on Sunday, June 1 at 11:42 a.m. CDT in Arie Crown Theater.
Melissa Johnson, MD, SCRI, will present "Gizmos and Gadgets! How Can Community Oncology Practices Hurdle the Obstacles to Administering Lung Cancer’s Newest Therapies" during BiTES and Beyond: BiTES, Amivantimab, and the Multidimensional Impact of Toxicity Management on Sunday, June 1 at 12:06 p.m. CDT in Arie Crown Theater.
Dr. Erika Hamilton will chair the Plenary Session on June 1 from 1:00 – 4:00 p.m. CDT in Hall B1.
Dr. Erika Hamilton will serve as a panelist in the Rapid Oral Abstract Session, Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology on Monday, June 2 from 8:00 – 9:30 a.m. CDT in S406.
Meredith McKean, MD, MPH, SCRI, will present "Novel Targets in Melanoma Treatment" during State of the Art: Melanoma 3.0T—Tech Innovations, New Targeted Therapies, and T-Cell Breakthroughs on Tuesday, June 3 at 8:15 a.m. CDT in S100a.
Dr. Abdul Rafeh Naqash will chair the Oral Abstract Session, Lung Cancer—Non–Small Cell Local-Regional/Small Cell/Other Thoracic Cancers on Monday, June 2 from 3:00 – 6:00 p.m. CDT in Arie Crown Theater.
Additional Poster Presentations with SCRI First Authors

Saturday, May 31

"Phase 1 Expansion Study of FF-10832 Antitumor Activity in Patients with Advanced Biliary Carcinomas," Gerald Falchook, MD, SCRI at HCA HealthONE, 9:00 a.m. – 12:00 p.m. CDT, Hall A.
"Preliminary Safety, Pharmacokinetics, and Clinical Activity of RG6344 in Patients with BRAF V600E-Mutant Metastatic Colorectal Cancer," Dr. Elisa Fontana, 9:00 a.m. – 12:00 p.m. CDT, Hall A.
"Real-World Treatment Patterns and Outcomes with Trifluridine/Tipiracil Monotherapy or in Combination with Bevacizumab in Metastatic Colorectal Cancer," Donald Richards, MD, PhD, SCRI at Texas Oncology I The US Oncology Network, 9:00 a.m. – 12:00 p.m. CDT, Hall A.
"Interim Results of PDL1V, a Vedotin-Based ADC Targeting PD-L1, in Patients with NSCLC in a Phase 1 Trial," Dr. Elisa Fontana, 1:30 – 4:30 p.m. CDT, Hall A.
"Integration of a Virtual Personalized Medicine Review Board Integration into a Major Community Oncology Phase 1 Unit," Marilynn Hammer, PhD, SCRI, 1:30 – 4:30 p.m. CDT, Hall A.
"A Digital Intervention to Enhance Engagement with Oral Oncolytic Treatments and Assess Patient Experiences with Novel Therapies," David Waterhouse, MD, MPH, SCRI at OHC I The US Oncology Network, 1:30 – 4:30 p.m. CDT, Hall A.
Monday, June 2

"Efficacy and Safety of Larotrectinib in Patients with TRK Fusion Thyroid Carcinoma: An Updated Analysis," Marcia Brose, MD, PhD, SCRI at Sidney Kimmel Cancer Center at Jefferson Health, 9:00 a.m. – 12:00 p.m. CDT, Hall A.
"Imlunestrant with or without Abemaciclib in Advanced Breast Cancer: Safety Analyses from the Phase III EMBER-3 Trial," Joyce O’Shaughnessy, MD, SCRI at Texas Oncology I The US Oncology Network, 9:00 a.m. – 12:00 p.m. CDT, Hall A.
"Zanzalintinib + Nivolumab ± Relatlimab in Patients with Advanced Solid Tumors: Results from Two Dose-Escalation Cohorts of the Phase 1b STELLAR 002 Study," Benjamin Garmezy, MD, SCRI, 1:30 p.m. – 4:30 p.m. CDT, Hall A.
"First Report of ROR2 Directed Therapy with Conditionally Active Antibody Drug Conjugate in Advanced Melanoma," Jacob Keeling, MD, SCRI at HCA HealthONE, 1:30 p.m. – 4:30 p.m. CDT, Hall A.
"ZL-1310, a DLL3 ADC, in Patients with Extensive Stage Small Cell Lung Cancer: Ph1 Trial Update," Manish Patel, MD, SCRI at Florica Cancer Specialists & Research Institute, 1:30 p.m. – 4:30 p.m. CDT, Hall A.
"First-in-Human Phase 1 Study of CUSP06, a Cadherin-6-Directed Antibody-Drug Conjugate, in Patients with Platinum-Refractory/Resistant Ovarian Cancer and Other Advanced Solid Tumors," Dr. Manish Patel, 1:30 p.m. – 4:30 p.m. CDT, Hall A.
"First-in-Human Study of BG-C9074, a B7-H4-Targeting ADC in Patients with Advanced Solid Tumors: Preliminary Results of the Dose-Escalation Phase," Cesar Perez, MD, SCRI at Florida Cancer Specialists & Research Institute, 1:30 p.m. – 4:30 p.m. CDT, Hall A.
"Efficacy and Safety of Pralsetinib in RET Fusion-Positive Solid Tumors: Final Data from the ARROW Trial," Vivek Subbiah, MD, 1:30 p.m. – 4:30 p.m. CDT, Hall A.
"Efficacy and Safety Results of a Multi-Center Phase I Study of Utidelone Capsule, a Novel Oral Microtubule Inhibitor, in Advanced Solid Tumor Patients," Dr. Judy Wang, 1:30 p.m. – 4:30 p.m. CDT, Hall A.

On May 29, 2025 Lantern Pharma Inc. (NASDAQ: LTRN), a clinical-stage biopharmaceutical company leveraging advanced AI and machine learning to transform the cost, pace, and timeline of oncology drug development, reported promising preclinical data for LP-184 in atypical teratoid rhabdoid tumors (ATRT), a rare and aggressive pediatric brain cancer (Press release, Lantern Pharma, MAY 29, 2025, View Source [SID1234653502]). The results were presented by Dr. Eric Raabe of Johns Hopkins University School of Medicine at the Society for Neuro-Oncology’s 8th Biennial Pediatric Neuro-Oncology Conference held May 15-17, 2025, in San Diego, California.

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The data further validates the research that supported Lantern Pharma’s Rare Pediatric Disease Designation from the FDA for LP-184 in ATRT and strengthens the scientific foundation for the company’s planned pediatric clinical trial expected to begin in late 2025 or early 2026.

The data demonstrated that LP-184, a next-generation acylfulvene clinical-stage drug candidate, significantly extended survival in mouse models of ATRT. In the CHLA06 model, median survival increased from 20 days in the control group to 89 days in the LP-184 treatment group, representing a 345% improvement (p<0.0001). In the BT37 model, median survival increased from 68 days to 98 days (p=0.0422).

"The preclinical data presented by Dr. Raabe and his team at Johns Hopkins provides powerful confirmation of LP-184’s potential to address the significant unmet need in pediatric ATRT," said Panna Sharma, CEO and President of Lantern Pharma. "The substantial increase in survival time and the favorable tolerability profile observed in these models underscore the promise of LP-184 as a novel therapeutic option to evaluate clinically for this devastating pediatric cancer. This independent validation further supports our Rare Pediatric Disease Designation and reinforces our path toward initiating our planned pediatric clinical trial."

Key highlights from the presentation include:

LP-184 demonstrated potent anti-tumor activity across multiple ATRT cell lines representing different molecular subtypes (MYC, TYR, and SHH), with IC50 values ranging from 17.5 nM to 161 nM
Treatment with LP-184 significantly decreased cancer cell proliferation and increased apoptosis (programmed cell death) in ATRT cells
LP-184 showed strong blood-brain barrier penetrance, with reported Cmax of 730 nM in brain tissue
No apparent toxicity was observed in the mouse models, with stable weight maintained throughout the treatment period
Treatment with LP-184 resulted in statistically significant survival benefits in two different orthotopic xenograft ATRT models
ATRT is characterized by the deletion or inactivation of the SMARCB1 gene, an epigenetic regulator. LP-184’s mechanism of action may be particularly effective against tumors with epigenetic dysregulation, potentially explaining the strong preclinical anti-tumor activity observed in this tumor type.

"Current treatment options for ATRT are limited to surgery, intensive chemotherapy, and radiation, with poor outcomes and significant treatment-related toxicity," said Dr. Marc Chamberlain, Chief Medical Officer of Starlight Therapeutics and Lantern Executive Director of Clinical Development. "The single-agent activity of LP-184 in these models suggests it could potentially transform the treatment landscape for children with these brain tumors."

The company highlighted that the pediatric Phase I trial for LP-184 in brain tumors is targeted to open in winter 2025 or early 2026, following completion of the ongoing Phase I trial in adult solid tumors (NCT05933265) and obtaining future funding and approvals from the pediatric consortium.

About Atypical Teratoid Rhabdoid Tumor (ATRT)

ATRT is a rare, fast-growing tumor of the brain and spinal cord that typically occurs in children aged three years and younger, though it can occur in older children and adults. These tumors are characterized by the loss of function of the SMARCB1 gene. ATRTs account for approximately 1-2% of all pediatric brain tumors but represent a disproportionately high percentage of brain tumors in infants. Current treatment involves a combination of surgery, intensive chemotherapy, and, in some cases, radiation therapy. Despite aggressive treatment, the prognosis remains poor, with a median survival of approximately 17 months, highlighting the urgent need for more effective therapies.

About LP-184

LP-184 is a next-generation acylfulvene drug candidate, a synthetic small molecule belonging to a class of naturally-derived anti-cancer agents. LP-184 works by preferentially damaging DNA in cancer cells that overexpress specific biomarkers or that harbor mutations in DNA damage repair pathways. LP-184 is the product of years of research, including insights from RADR, Lantern’s proprietary AI platform that leverages over 200 billion oncology-focused data points.

LP-184 is a prodrug that is converted to its bioactive form inside the cancer cell by PTGR1 (prostaglandin reductase 1), an enzyme that is overexpressed in certain cancers. Once activated, LP-184 creates cytotoxic metabolites that form adducts with DNA, leading to irreparable DNA damage and ultimately tumor cell death.

LP-184 has shown nanomolar preclinical potency across multiple cancer types, including several that are resistant to standard therapies, and has demonstrated particularly promising preclinical activity in CNS and brain cancers. The drug has received Orphan Drug Designation from the FDA for the treatment of malignant gliomas and pancreatic cancer, as well as Rare Pediatric Disease Designation for ATRT.

On May 29, 2025 Eikon Therapeutics, Inc., a late-stage clinical biopharmaceutical company dedicated to integrating advanced engineering with traditional biology research to accelerate drug discovery, reported that new data from its oncology programs will be presented in collaboration with independent investigators at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, to be held May 30 – June 3, 2025, in Chicago, Illinois (Press release, Eikon Therapeutics, MAY 29, 2025, View Source [SID1234653501]). Alongside these presentations, Eikon will also share additional milestone updates across its broad and diverse research and development pipeline.

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"We are encouraged by the progress we are seeing across our clinical-stage oncology programs, which reflect both the potential of these candidates and the capabilities of the fully integrated development organization that we are building at Eikon," said Roger M. Perlmutter, M.D., Ph.D., Chief Executive Officer of Eikon Therapeutics. "Our team brings deep experience in advancing therapies through clinical studies and regulatory review, and we are pleased to see that capability reflected in the progress of our lead programs. At the same time, we continue to advance a pipeline of internally derived candidates, informed by the insights of our novel technology platform and Single Molecule Tracking (SMT) system. We look forward to positioning our results in the context of what has been achieved by the broader ASCO (Free ASCO Whitepaper) community."

ASCO 2025 Presentations

The following posters will spotlight new first-in-human and combination data from Eikon’s two most advanced clinical programs.

EIK1001-006 (Abstract: TPS9604)
Title: TeLuRide-006: An adaptive phase 2/3 study of EIK1001, a Toll-like receptor 7/8 (TLR7/8) agonist, in combination with pembrolizumab in patients with advanced melanoma
Date and time: June 1, 2025, from 9:00 AM – 12:00 PM CDT
Presenter: Jason J. Luke, M.D., UPMC, Hillman Cancer Center

EIK1003-001 (Abstract: 3122)
Title: Safety and efficacy of EIK1003, a selective PARP1 inhibitor, as monotherapy in participants with advanced solid tumors
Date and time: June 2, 2025, from 1:30 PM – 4:30 PM CDT
Presenter: Guru P. Sonpavde, M.D., AdventHealth Cancer Institute

Recent Program Milestones

In addition to its presentations at ASCO (Free ASCO Whitepaper), Eikon will be discussing recent program milestones including:

EIK1001-006 (TeLuRide-006, NCT06697301): The first patient has been enrolled in the TeLuRide-006 trial, which is investigating the potential role of EIK1001, a systemically administered co-agonist of toll-like receptors 7 and 8 that has been observed to exhibit clinical activity as a monotherapy and in combination with anti-PD-(L)1 agents across multiple solid tumor types in Phase 1 trials, as an addition to standard of care pembrolizumab (KEYTRUDA) for the treatment of patients with advanced metastatic melanoma. TeLuRide-006 is a global, multicenter, randomized, double-blind, active comparator-controlled, adaptive Phase 2/3 trial to evaluate the safety and efficacy of EIK1001 and pembrolizumab versus placebo and pembrolizumab as first-line therapy in participants with advanced melanoma. The trial includes dose optimization and dose expansion parts. Eikon has entered into a clinical trial collaboration and supply agreement with Merck (known as MSD outside of the United States and Canada). Under the terms of the Agreement, Merck will provide pembrolizumab to Eikon. Eikon will be the sponsor of the Phase 2/3 clinical trial.

EIK1001-005 (TeLuRide-005, NCT06246110): Enrollment continues as planned in this Phase 2 trial testing EIK1001 with pembrolizumab and chemotherapy in patients with squamous and nonsquamous non-small cell lung cancer. The trial’s primary objective is to evaluate the safety and tolerability of EIK1001. Eikon also hopes to learn whether the immunomodulatory mechanism of EIK1001 might improve standard therapy in this hard-to-treat setting.

EIK1003-001 (NCT06253130): Enrollment is proceeding in the trial of EIK1003, a highly selective PARP1 inhibitor, in adults with advanced solid tumors. Initial pharmacokinetic, safety, tolerability, and early efficacy findings from the monotherapy dose-escalation cohort will be reported in an ASCO (Free ASCO Whitepaper) 2025 poster (Abstract: 3122).

EIK1004-001 (NCT06907043): The first patient has been dosed in a Phase 1/2 trial of EIK1004, a CNS-penetrant selective PARP1 inhibitor. This trial is assessing safety, pharmacokinetics/pharmacodynamics, and preliminary antitumor activity in patients with advanced solid tumors, including those with brain metastases.

"The steady progress we are making as evidenced by the first safety and efficacy data from EIK1003, the initiation of our adaptive melanoma study with EIK1001, and the recent first-patient dosing of the CNS-penetrant selective PARP1 inhibitor EIK1004, underscores the momentum Eikon’s clinical team is building across our oncology portfolio," said Roy Baynes, M.D., Ph.D., Chief Medical Officer of Eikon Therapeutics. "Their deep experience in oncology is translating into real world progress, and we are pleased to share these advances with the oncology community at ASCO (Free ASCO Whitepaper) as we work to deliver new medicines to address serious illnesses."

Eikon at AACR (Free AACR Whitepaper) 2025

The Eikon Therapeutics team also recently presented program data at the 2025 American Association for Cancer Research (AACR) (Free AACR Whitepaper) conference. These presentations included:

EIK1004-001 (Abstract#5719): Identification of EIK1004: A CNS-penetrant, potent and selective PARP1 inhibitor poised for testing in patients with HRD mutant tumors. The poster presented data on methodologies to optimize early lead PARP1 inhibitors with novel structures for selectivity and CNS penetration leading to discovery of EIK1004.

EIK1003-001 (Abstract # CT197): A first-in-human, Phase 1/2 dose escalation, dose-optimization, and dose-expansion trial of PARP1-selective inhibitor EIK1003 in patients with advanced solid tumors.

The Eikon team will also welcome attendees at ASCO (Free ASCO Whitepaper) Booth #14143 to discuss these and its other pipeline programs.