stenoparib (2X-121) / Allarity Therap, Oncoheroes, Eisai - LARVOL DELTA

2X-121/ stenoparib - a novel, dual inhibitor of PARP and tankyrase in phase 2 clinical trials in advanced ovarian cancer- blocks the WNT signaling pathway and inhibits growth of human colorectal cancer cell lines at clinically relevant drug concentrations (AACR 2026) - "Importantly, these effects are evident at clinically relevant drug concentrations for 2X-121. Collectively, these data provide the foundation to explore the clinical potential of 2X-121 in colorectal cancers as well as other cancers where WNT pathway activation is prevalent."

Metastases • P2 data • Preclinical • Colorectal Cancer • Oncology • Ovarian Cancer • Refractory Ovarian Cancer • Solid Tumor • AXIN1 • BRCA

A Drug Response Predictor (DRP®) is associated with enhanced overall survival in the phase 2 trial in advanced, recurrent ovarian cancer patients treated twice daily with 2X-121/ Stenoparib (NCT03878849) (AACR 2026) - P2 | "Prior treatment included PARP inhibitors, mirvetuxumab, bevacizumab and immunotherapy. These results indicate that the 2X-121 DRP may be a predictive- rather than prognostic- biomarker, highlighting extended OS in patients treated twice daily with 2X-121. A new ph2 clinical trial protocol is currently enrolling platinum-resistant Ovarian Cancer patients to further explore and delineate the relationship between 2X-121 DRP® score and clinical benefit."

Clinical • IO biomarker • Metastases • P2 data • High Grade Serous Ovarian Cancer • Oncology • Ovarian Cancer • Solid Tumor • BRCA

Biomarker Directed Trial of Temozolomide and Stenoparib in Relapsed SCLC (clinicaltrials.gov) - P1/2 | N=166 | Recruiting | Sponsor: VA Office of Research and Development | Not yet recruiting ➔ Recruiting

Biomarker • Enrollment open • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Allarity Therapeutics Closes $20 Million Financing to Accelerate the Advance of Stenoparib Toward FDA Approval and Commercialization (GlobeNewswire) - "The financing is expected to extend the Company’s cash runway into the summer of 2028. The Company intends to use the proceeds primarily to support key initiatives designed to accelerate the advance of stenoparib toward pivotal development, FDA approval and commercialization....Stenoparib has demonstrated durable clinical benefit in heavily pre-treated ovarian cancer patients, including previously reported extended overall survival."

Financing • Ovarian Cancer

Allarity Therapeutics Doses First Patients in VA-Funded Phase 2 Trial Focused on Small Cell Lung Cancer with High Unmet Need (GlobeNewswire) - "This trial is being conducted in collaboration with the U.S. Department of Veterans Affairs (VA) and is fully funded through the VA’s Special Emphasis Panel on Precision Oncology. Patient recruitment is ongoing across 11 VA medical centers throughout the United States."

Trial status • Small Cell Lung Cancer

Allarity Therapeutics announces that its collaborative Phase 2 trial with the United States Veteran’s Administration Combining Stenoparib with Temozolomide in Relapsed Small Cell Lung Cancer is Now Open for Enrollment (GlobeNewswire) - "The trial is being conducted in collaboration with the U.S. Department of Veterans Affairs (VA) and is fully funded through the VA’s Special Emphasis Panel on Precision Oncology."

Enrollment open • Small Cell Lung Cancer

Anticipated Clinical Milestones in 2025–2026 (GlobeNewswire) - "Enrollment continued in the new Phase 2 trial protocol evaluating stenoparib in recurrent, platinum-resistant or platinum-ineligible advanced ovarian cancer. The study has maintained steady investigator engagement and is expected to generate critical data by end of 2026....SCLC combination trial launch: U.S. Veterans Administration–funded Phase 2 trial of stenoparib plus temozolomide in recurrent small cell lung cancer expected to be open for enrollment by year-end 2025."

Enrollment status • P2 data • Platinum resistant • Ovarian Cancer • Small Cell Lung Cancer

Performance Comparison of the Illumina MiSeq i100 with Established Instruments for Amplicon-Based Somatic and Liquid Biopsy Sequencing Panels (AMP 2025) - "Libraries were sequenced across 6 MiSeq i100 runs in 2x121 to 2x251 bp configurations and benchmarked against MiSeq and NextSeq 550 runs using matched inputs... The MiSeq i100 supports rapid and accurate detection of somatic and liquid biopsy variants with comparable sensitivity and specificity to established Illumina platforms. Although slight differences in on-target efficiency and coverage depth for longer amplicons were observed, all panels performed as expected with no impact on variant detection. The MiSeq i100's ease of use, shorter runtimes, and reagent handling improvements make it an attractive option for clinical and translational NGS workflows."

Biopsy • Liquid biopsy • BRCA1 • BRCA2

Allarity Therapeutics Presents New Phase 2 Clinical Data for Stenoparib/2X-121 Showing Landmark Median Overall Survival Has Now Surpassed 25 Months (GlobeNewswire) - "The presentation showcased the first Kaplan-Meier analysis for median Overall Survival (mOS) from the Company’s ongoing Phase 2 trial that enrolled patients with advanced ovarian cancer, all of whom had either platinum-resistant or refractory disease and had tumors showing a Stenoparib-specific Drug Response Predictor (DRP) score above 50. Notably, these data provide the first evidence that stenoparib, when given twice daily, may extend patient survival. The mOS has not been formally reached yet and now exceeds 25 months. Two patients actively remain on therapy now more than 24 months, with one of these two patients carrying a wild-type BRCA gene—a genetic background that typically precludes benefit from PARP inhibitors."

P2 data • Platinum resistant • Ovarian Cancer

Allarity Therapeutics CEO to Present at Biomarkers & Precision Medicine 2025 (GlobeNewswire) - "In addition to his presentation, Mr. Jensen will be interviewed by Oxford Global’s editorial team to provide further insights into Allarity’s research and its innovative DRP companion diagnostic platform. The interview will be featured on Oxford Global’s online content portal."

Clinical • Solid Tumor

Anticipated Clinical Milestones in 2025:…SCLC combination trial launch (GlobeNewswire) - "U.S. Veterans Administration–funded Phase 2 trial of stenoparib plus temozolomide in recurrent small cell lung cancer should open for enrollment in Q3, with patient recruitment expected to begin during H2 2025."

Trial status • Small Cell Lung Cancer

Anticipated Clinical Milestones in 2025: Ovarian cancer trial progress (GlobeNewswire) - "Continued enrollment in new Phase 2 ovarian cancer trial protocol, with initial data expected in 2026."

P2 data • Platinum resistant • Ovarian Cancer

Analysis of 35 liquid biopsy samples from stage 3 and 4 newly diagnosed lung cancer patients using Pillar Biosciences OncoRevealTM Core and Fusion Next Generation Sequencing panels (ECP 2025) - "Sequencing of libraries was performed using paired-end read length of 121bp (2x121) and two indexing reads of 8 cycles each... We show here that we successfully implemented a NGS panel for ctDNA analysis in routine practice. We are initiating the use for other tumour types such as advanced breast carcinomas as well."

Biomarker • Biopsy • Clinical • Liquid biopsy • Next-generation sequencing • Breast Cancer • Lung Cancer • Microsatellite Instability • Oncology • Solid Tumor • MSI

Allarity Therapeutics Granted FDA Fast Track Designation for Stenoparib for the Treatment of Advanced Ovarian Cancer (GlobeNewswire) - "Allarity recently began patient enrollment under a new Phase 2 clinical trial protocol evaluating stenoparib in advanced, recurrent, platinum-resistant or platinum-ineligible ovarian cancer."

Enrollment status • Fast track • Platinum resistant • Oncology • Ovarian Cancer

PREDICT 2X-121: Investigation of the Anti-tumor Effect of 2X-121 in Patients With Recurrent, Advanced Ovarian Cancer (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: Allarity Therapeutics | Active, not recruiting ➔ Recruiting

Enrollment open • Platinum resistant • Oncology • Ovarian Cancer • Solid Tumor

Allarity Therapeutics Receives Australian Patent Acceptance Notice for Stenoparib DRP Companion Diagnostic (GlobeNewswire) - "Allarity Therapeutics...announced that IP Australia...has formally accepted the Company’s patent application for its DRP companion diagnostic specific to stenoparib....The granted patent will be officially advertised in the Australian Official Journal of Patents on June 26, 2025, followed by a three-month opposition period. If unopposed, the patent is expected to be granted within 20 working days thereafter....Allarity previously secured a European patent for the Stenoparib DRP and holds 18 granted patents for drug-specific DRPs, including eight in the United States. Patent applications for the Stenoparib DRP remain pending in the U.S., Canada, Japan, China, and India."

Diagnostic • Patent • Oncology • Ovarian Cancer

Allarity Therapeutics Announces Dosing of Second Patient in New Phase 2 Trial of Stenoparib in Advanced Ovarian Cancer (GlobeNewswire) - "Allarity Therapeutics...announced that the second patient has been dosed in its new Phase 2 clinical trial protocol evaluating stenoparib in patients with advanced, recurrent, platinum-resistant or platinum-ineligible ovarian cancer."

Platinum resistant • Trial status • Ovarian Cancer

Allarity Therapeutics Announces Research Collaboration with Indiana Biosciences Research Institute to Further Advance Understanding of Stenoparib’s Unique, Dual Therapeutic Mechanism of Action (GlobeNewswire) - "Allarity Therapeutics, Inc...announced a research collaboration with the Indiana Biosciences Research Institute (IBRI). The collaboration is aimed primarily at further deepening the Company’s mechanistic understanding of the dual mechanism of action of stenoparib....Under the agreement, IBRI will conduct advanced molecular and cellular studies to clarify the individual and combined contributions of PARP inhibition and WNT pathway modulation to stenoparib’s observed anticancer effects....The collaboration is also expected to support Allarity in potential future efforts to pursue marketing approval for stenoparib, and to further clarify its mechanism of action in both the Company’s ongoing Phase 2 trial in advanced ovarian cancer and its recently announced combination trial evaluating stenoparib with temozolomide in recurrent small cell lung cancer (SCLC)."

Commercial • Platinum resistant • Ovarian Cancer • Small Cell Lung Cancer

Allarity Therapeutics Announces First Patient Enrolled in New Phase 2 Clinical Trial Protocol of Stenoparib in Advanced Ovarian Cancer (GlobeNewswire) - "Allarity Therapeutics...announced that the first patient has been enrolled in its new Phase 2 clinical trial protocol of stenoparib for the treatment of advanced, platinum-resistant or platinum-ineligible ovarian cancer. The newly launched protocol will accelerate the clinical development of stenoparib and its drug-specific Drug Response Predictor (DRP) companion diagnostic (CDx) toward potential FDA approval....The trial is expected to generate significant clinical data by late summer 2026. Allarity plans to pursue multiple advantaged regulatory pathways to expedite potential approval of both stenoparib and its DRP companion diagnostic (CDx)."

P2 data • Platinum resistant • Trial status • Ovarian Cancer

Allarity Therapeutics Announces Participation in Pharma Partnering Summit US (GlobeNewswire) - "Allarity Therapeutics, Inc...today announced the Company’s CEO, Thomas Jensen, will deliver a company overview focused on stenoparib and the Company’s DRP companion diagnostic platform and conduct one-on-one meetings at the Pharma Partnering Summit US."

Clinical • Diagnostic • Oncology

Allarity Therapeutics Provides First Quarter 2025 Update, Highlighting Continued Stenoparib Benefit and Upcoming Trial Enrollment (GlobeNewswire) - "Anticipated Clinical Milestones in 2025:...New Small Cell Lung Cancer Trial-Combination Study: Patient enrollment will initiate in Q2-Q3 2025 in this new Phase 2 trial evaluating stenoparib in combination with temozolomide for recurrent small cell lung cancer (SCLC). The trial, fully funded by the U.S. Veterans Administration, will assess the potential of this novel combination to improve outcomes in recurrent SCLC patients with extremely limited therapeutic opportunities."

Trial status • Small Cell Lung Cancer

Allarity Therapeutics Provides First Quarter 2025 Update, Highlighting Continued Stenoparib Benefit and Upcoming Trial Enrollment (GlobeNewswire) - "Anticipated Clinical Milestones in 2025: New Ovarian Cancer Trial Protocol-New Protocol Enrollment: In the first half of 2025, Allarity expects to begin enrollment under a new protocol for stenoparib in advanced, recurrent, platinum-resistant or platinum-ineligible ovarian cancer. The updated protocol design reflects the compelling, durable clinical benefit observed to date in platinum resistant patients. The protocol aims to provide the definitive foundation for pivotal registration trials for stenoparib in ovarian cancer.​"

New trial • Platinum resistant • Ovarian Cancer

PREDICT 2X-121: Investigation of the Anti-tumor Effect of 2X-121 in Patients With Recurrent, Advanced Ovarian Cancer (clinicaltrials.gov) - P2 | N=40 | Active, not recruiting | Sponsor: Allarity Therapeutics | N=60 ➔ 40 | Trial completion date: Mar 2026 ➔ Sep 2027 | Trial primary completion date: Sep 2025 ➔ Mar 2027

Enrollment change • Trial completion date • Trial primary completion date • Oncology • Ovarian Cancer • Solid Tumor

Study to Determine the Maximum Tolerated Dose (MTD) of PARPi 2X-121 Monotherapy and the MTD of Dovitinib in Combination With 2X-121 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=40 | Suspended | Sponsor: Allarity Therapeutics | Trial completion date: Mar 2025 ➔ Dec 2025

Monotherapy • Trial completion date • Oncology • Solid Tumor

Biomarker Directed Trial of Temozolomide and Stenoparib in Relapsed SCLC (clinicaltrials.gov) - P1/2 | N=166 | Not yet recruiting | Sponsor: VA Office of Research and Development | Phase classification: P2 ➔ P1/2

Biomarker • Phase classification • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor