EP0031 / Sichuan Kelun Pharma, Ellipses Pharma - LARVOL DELTA

Final results of a phase 1 study of EP0031, a next generation selective RET inhibitor (SRI) in patients with SRI naïve or pretreated advanced RET-altered tumors. (ASCO 2025) - P1/2 | "Clinical Trial Registration Number: NCT05443126 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • Metastases • P1 data • Oncology

Kelun-Biotech to Present Results of Six Clinical Studies at 2025 ASCO Annual Meeting (PRNewswire) - "Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd...announced that it will present results from six Kelun-led clinical studies at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, held in Chicago from May 30 to June 3. Results include data from its TROP2 antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT), anti-PD-L1 mAb tagitanlimab, and RET inhibitor KL590586 (A400/EP0031). The abstracts for these studies will be published on the ASCO's official website on May 22, 2025, local time."

Clinical data • Lung Non-Squamous Non-Small Cell Cancer • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Thyroid Gland Carcinoma • Triple Negative Breast Cancer

Ellipses Launches Pioneering Clinical Trial Programme in Middle East (Businesswire) - "Ellipses Pharma Limited...announced today it has inaugurated the first large-scale Phase 1/2 oncology clinical study of its kind in the United Arab Emirates, marking a significant milestone in the region’s healthcare landscape. Following approval by the UAE regulators and the Ministry and Department of Health, this study will be conducted initially at two major healthcare centres in Abu Dhabi - the Cleveland Clinic and Tawam Hospital. The inclusion of a third study centre is pending. Patient recruitment has commenced. The trial will focus on Ellipses' next generation selective RET inhibitor (SRI), EP0031/A400, a potential treatment of RET-altered tumours, most prevalent in non-small cell lung cancer and thyroid cancer."

Trial status • Non Small Cell Lung Cancer

EP0031 a next-generation selective RET inhibitor (SRI): Correlation of molecular and clinical responses in patients with RET alteration positive solid tumours naïve to or following prior SRI (ESMO 2024) - P1/2 | "There was encouraging evidence of clinical responses across the pt population, including pts naïve to or who had received prior SRI. Methylation-based ctDNA MR appears to show a strong correlation with the best clinical response. MR appears to be an early indicator of clinical response."

Clinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • RET

Kelun Biotech-B (06990), a leading biotech in the ADC field, joins hands with Merck to expand its global presence [Google translation] (Sina Corp) - "Kelun Biotech is a world-leading ADC Biotech, and joins hands with Merck to expand its global presence...A167 (PD-L1 monoclonal antibody) is expected to be approved for nasopharyngeal carcinoma in the second half of 2024. A400 (RET inhibitor) is expected to submit a marketing application in 2024."

Approval • Filing • Licensing / partnership • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

A Study of KL590586 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=414 | Active, not recruiting | Sponsor: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. | Enrolling by invitation ➔ Active, not recruiting

Enrollment closed • Metastases • Biliary Tract Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A phase-1 dose escalation and expansion study of EP0031, a next-generation selective RET inhibitor (SRI), in patients with SRI-naïve or pretreated advanced RET-altered NSCLC and other tumors. (ASCO 2024) - P1/2 | "These data add significantly to the large clinical data set reported for EP0031 from a trial of over 130 patients in China, most with advanced RET fusion +ve NSCLC. EP0031 has a manageable toxicity profile with promising activity in advanced NSCLC previously treated with or naïve to SRI, including those with brain metastases. This study is continuing at pace with Phase 2 expansion cohorts in SRI pre-treated and naïve patients."

Clinical • Metastases • P1 data • Anemia • Cardiovascular • Constipation • Endocrine Cancer • Gastroenterology • Gastrointestinal Disorder • Heart Failure • Hematological Disorders • Hypertension • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pain • Pancreatic Cancer • Solid Tumor • Thyroid Gland Carcinoma • Thyroid Gland Medullary Carcinoma • Thyroid Gland Papillary Carcinoma • RET

Ellipses' next generation selective RET inhibitor EP0031/A400 cleared to start Phase 2 (PRNewswire) - "Ellipses Pharma Limited...announced today the U.S. Food and Drug Administration (FDA) has confirmed the company's next generation selective RET inhibitor (SRI), EP0031/A400, is clear to progress into Phase 2 clinical development...The latest clinical data from the Ellipses Phase 1 study will be presented at ASCO in Chicago on June 3rd 2024."

P1 data • Trial status • Non Small Cell Lung Cancer • Solid Tumor • Thoracic Cancer

Ellipses' next generation selective RET inhibitor EP0031/A400 granted Fast Track designation by US Food and Drug Administration (Yahoo Finance) - "Ellipses Pharma...announced today that it has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for its next generation selective RET inhibitor EP0031/A400 for the potential treatment of RET-fusion positive Non-Small Cell Lung Cancer (NSCLC)....Data from the ongoing modular interventional phase 1/2 trial, which aims to assess the safety, side effects and effectiveness of EP0031/A400 in patients with advanced RET-altered malignancies, were submitted in support of the application, where for the first time EP0031/A400 showed tumour responses in NSCLC patients who were previously treated with first-generation SRIs."

Fast track designation • Non Small Cell Lung Cancer

A Study of EP0031-101 in Patients With Advanced RET-altered Malignancies (clinicaltrials.gov) - P1/2 | N=265 | Recruiting | Sponsor: Ellipses Pharma

Metastases • Trial completion date • Trial primary completion date • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Orphan Designation: Treatment of tissue-agnostic RET fusion-positive solid tumors (FDA) - Date Designated: 11/15/2023

Orphan drug • Oncology • Solid Tumor

Preliminary results from a phase I/II study evaluating the safety, tolerability, and efficacy of EP0031, a next generation selective RET inhibitor, in patients with advanced RET-altered malignancies. (AACR-NCI-EORTC 2023) - No abstract available

Clinical • Metastases • P1/2 data • Oncology

Kelun-Biotech Announces Interim Results for 2023 (Yahoo Finance) - "Today, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd...announced its interim results for the six months ended June 30, 2023....We have completed patient enrolment of A140 (Cetuximab biosimilar) in November 2022 with an anticipated NDA filing with NMPA for RAS wild-type mCRC in the second half of 2023. In July, the company commenced pivotal trial of A400 (RET inhibitor) for advanced RET+ NSCLC, a trial of A400 for advanced RET+ medullary thyroid carcinoma received IND approval from the NMPA."

Enrollment closed • Non-US regulatory • Trial status • Colorectal Cancer • Endocrine Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thyroid Gland Carcinoma • Thyroid Gland Medullary Carcinoma

A phase I study of KL590586, a next-generation selective RET inhibitor, in patients with RET-altered solid tumors. (ASCO 2023) - P1/2 | "KL590586 was well-tolerated, and associated with robust clinical activity in RET-altered tumors regardless of tumor type, including NSCLC pts with resistance to1st gen SRIs and with CNS mets. Pivotal studies are planned. Clinical trial information: NCT05265091."

Clinical • IO biomarker • P1 data • Cardiovascular • CNS Disorders • Constipation • Gastroenterology • Gastrointestinal Cancer • Gastrointestinal Disorder • Hepatology • Hypertension • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pain • Pancreatic Cancer • Solid Tumor

Ellipses Pharma Announces Intent to Accelerate Clinical Programme Following ‘Encouraging’ Data on Next Generation Selective RET Inhibitor (Businesswire) - P1/2 | N=414 | NCT05265091 | "Ellipses Pharma...today announces its intention to expedite further global clinical development of the next generation selective RET inhibitor (SRI) EP0031/A400 following the publication of ‘very encouraging’ clinical data....Trial data of the Phase 1 Study of KL590586 (EP0031/A400), presented at the American Society of Clinical Oncology (ASCO) conference in Chicago today, reported preliminary efficacy and safety for a total of 109 patients. A400/EP0031 was generally well tolerated with the majority of adverse events recorded as manageable grade 1 or 2. In the overall RET-altered tumour population, patients who received A400/EP0031 at doses between 40 and 120mg OD had an objective response rate of 60% with a disease control rate of 90%."

Commercial • P1 data • Oncology • Solid Tumor

A Study of EP0031-101 in Patients With Advanced RET-altered Malignancies (clinicaltrials.gov) - P1/2 | N=265 | Recruiting | Sponsor: Ellipses Pharma | Not yet recruiting ➔ Recruiting

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

A modular, open-label, phase I/II study to evaluate the safety, tolerability, pharmacokinetics and efficacy of EP0031, a next generation selective RET inhibitor, in patients with advanced RET-altered malignancies (AACR 2023) - P1/2 | "For expansion cohorts patients must have a solid tumor measurable by RECIST v1.1, with/without asymptomatic, stable brain metastasesRecruitment was initiated in the US in November 2022 and is expanding to centers across Europe and rest of world. A parallel Phase I/II trial is ongoing in China (A400, NCT05265091, Kelun Biotech).1Annals of Oncology 32(2) S66 (2021)2Journal Thoracic Oncol 15(4) 542 (2020)"

Clinical • Metastases • P1/2 data • PK/PD data • Endocrine Cancer • Lung Cancer • Neuroendocrine Tumor • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thyroid Gland Carcinoma • Thyroid Gland Medullary Carcinoma • RET

A modular, open-label, phase I/II study to evaluate the safety, tolerability, pharmacokinetics and efficacy of EP0031, a next generation selective RET inhibitor, in patients with advanced RET-altered malignancies (ELCC 2023) - P1/2 | "1 Annals of Oncology 32(2) 261 (2021). 2 Journal Thoracic Oncol 15(4) 542 (2020)."

Clinical • Metastases • P1/2 data • PK/PD data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • RET

Ellipses Announces First Patient Dosed with EP0031, a Next Generation Selective RET Inhibitor (Businesswire) - "Ellipses Pharma...announces the first dosing of a patient in EP0031-101, a trial investigating Ellipses’ next generation selective RET inhibitor (SRI) EP0031...This global, modular, Phase 1/2 trial will evaluate the safety, tolerability and efficacy of EP0031 in patients with advanced RET-altered tumours and is now open to enrolment at multiple US sites. Ellipses plans to open further trial sites in the UK and EU in 2023....Kelun will present clinical data for the first time at an international conference in 2023."

P1/2 data • Trial status • Oncology • Solid Tumor

A Study of EP0031-101 in Patients With Advanced RET-altered Malignancies (clinicaltrials.gov) - P1/2 | N=265 | Not yet recruiting | Sponsor: Ellipses Pharma

New P1/2 trial • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Ellipses Announces FDA Clearance of IND Application for EP0031 for Patients With Advanced RET-altered Malignancies (Businesswire) - "Ellipses Pharma...announces that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for EP0031, a next generation selective RET inhibitor (SRI)....Approval of the IND is a significant step in the initiation of a global, modular Phase 1/2 trial to evaluate the safety, tolerability and efficacy of EP0031 in patients with advanced RET-altered cancers including patients who have not received prior treatment with first generation SRIs. The trial will include sites across the US and Europe and the first patient is anticipated to enter the dose escalation part of the trial in Q3 2022."

IND • New P1/2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Thyroid Gland Carcinoma