A Phase 2 Multi-arm, Open Label Study to Assess the Safety and Efficacy of EP0057 in Combination With Olaparib in Defined Populations of Patients With Relapsed Advanced Gastric Cancer and Small Cell Lung Cancer

The aim of EP0057 - 202 is to assess the safety and efficacy of EP0057 in combination with Olaparib (a PARP inhibitor) in two cancers where there is a high unmet need: extensive stage small cell lung cancer (SCLC) and ATM-negative gastric cancer (GC).
EP0057-202 is a non-comparative, multi-arm, multi-centre, open label, Phase 2 study to determine the efficacy, safety, and tolerability of EP0057 in combination with olaparib (an approved PARP inhibitor) in defined patient populations with relapsed* GC and SCLC.
*(see Eligibility Criteria for definition of "relapse" for each tumour type/population) The treatment cohorts will open sequentially at the Sponsor's discretion and patients may be enrolled into each cohort concurrently.
EP0057 is an investigational nanoparticle-drug conjugate administered intravenously. The rationale for developing EP0057 is to enable selective entry of EP0057 into tumour tissue and as a result create preferential accumulation of EP0057, and therefore of the payload Camptothecin, to translate into maximum tumour cell killing.

Start Date01 Apr 2023

Sponsor / Collaborator

Ellipses Pharma Ltd.

NCT05573126 / RecruitingPhase 1/2

A Modular, Open-Label, Multi-Centre Phase 1/2 Dose-Finding, Optimisation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of EP0062 in Patients With Relapsed Locally Advanced or Metastatic AR+/HER2-/ER+ Breast Cancer

The aim of this study is to identify the optimal dose for EP0062 as monotherapy and to assess its Safety, Tolerability, Pharmacokinetics, and Efficacy in Patients with Relapsed Locally Advanced or Metastatic AR+/HER2-/ER+ Breast Cancer

Start Date11 Jan 2023

Sponsor / Collaborator

Ellipses Pharma Ltd.

NCT05443126 / RecruitingPhase 1/2

A Modular, Open-label, Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of EP0031 in Patients With Advanced RET-altered Malignancies

The aim of this study is to assess the safety, side effects and effectiveness of EP0031 in patients with advanced RET-altered malignancies

Start Date30 Sep 2022

Sponsor / Collaborator

Ellipses Pharma Ltd.

100 Clinical Results associated with Ellipses Pharma Ltd.

0 Patents (Medical) associated with Ellipses Pharma Ltd.

Literatures (Medical) associated with Ellipses Pharma Ltd.

01 Jun 2024·Journal of Clinical Oncology

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.

Author: Krebs, Matthew G ; Piha-Paul, Sarina A. ; Italiano, Antoine ; Fisher, Geoff ; Morgensztern, Daniel ; Serrano, Sonia ; García-Pardo, Miguel ; Arkenau, Hendrik-Tobias ; García-Corbacho, Javier ; Spigel, David R. ; Gianoukakis, Andrew G. ; Forster, Martin ; Arnold, Susanne M. ; Garralda, Elena ; Alonso, Guzman ; Garrido, Pilar ; Subbiah, Vivek ; Brook, Sue ; Taylor, Matthew H. ; Wang, Judy S.

8556 Background: EP0031 (A400/KL590586) is a next generation SRI with greater potency against common RET alterations including resistance mutations, greater brain penetration, and produces deeper responses compared to 1st gen SRIs in preclinical NSCLC models (EORTC-NCI-AACR 2023 :B043). A Phase 1/2 study in China reported responses in RET fusion +ve NSCLC with prior SRI treatment, activity against brain metastases, a high ORR in SRI naïve RET fusion +ve NSCLC and encouraging tolerability. We report dose finding and optimization data from the first study of EP0031 in patients in the US and Europe. Methods: This Phase 1/2 study (NCT05443126) is recruiting patients with RET-altered NSCLC, medullary thyroid cancer (MTC) or other solid tumors and includes patients ≥ 18 years of age, PS 0 or 1, with/without asymptomatic, stable brain met. Results: As of 13th Dec '23, a total of 27 patients (16 F, 11 M, median age 58 years), 14 NSCLC (12 SRI pre-treated), 8 MTC (5 SRI pretreated) and 5 patients with other tumors (3 SRI pre-treated) were enrolled across 4 cohorts: 20mg (n=3), 60mg (n=9), 90mg (n=9) and 120mg (n=6) QD. The 60 and 90mg cohorts were expanded for dose optimization. SRI pre-treated patients received 1-7 prior lines of therapy. 6 patients had stable brain metastases at enrollment. No DLTs were observed. Most frequent G1/2 TEAEs (≥15%) were constipation, headache, ALT/AST, anemia, blurred vision, and dizziness. G3 TEAEs were rare and included (≥5%): hyponatremia, anemia, hypertension and diarrhea. Dose interruptions, reductions and discontinuations were seen in 8, 3 and 1 patient, respectively. In 8 response evaluable NSCLC patients, 4 confirmed PRs (cPR) were observed in 7 SRI pre-treated patients, of which 2 patients had complete responses (cCR) in the brain, and 1 SRI naive pt had a cCR. In 8 response-evaluable MTC patients, 2 cPRs and 1 SD were observed in 3 SRI naïve patients, and 2 of 5 SRI pre-treated patients achieved SD. In 5 response evaluable patients with other tumors, 2 SDs were observed in patients with pancreatic and papillary thyroid cancer, both SRI pre-treated. Plasma exposures increased proportionately with doses up to 120mg QD. 90mg QD was selected as the RP2D, with plasma levels >IC90 for all relevant RET fusions/mutations, including resistance mutations. This is consistent with the findings from the Phase 1/2 study in China. Expanded efficacy, safety, PK/PD and ctDNA data will be presented. Conclusions: 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 trial information: NCT05443126 .

20 Apr 2024·British Journal of Cancer

A phase I study of ATR inhibitor gartisertib (M4344) as a single agent and in combination with carboplatin in patients with advanced solid tumours

Article

Author: Bolleddula, Jayaprakasam ; Kalapur, Anup ; Gounaris, Ioannis ; Locatelli, Giuseppe ; Berlin, Jordan ; Ferrer-Playan, Jordi ; Cote, Gregory M ; Arkenau, Tobias ; Lolkema, Martijn P ; Burris, Howard A ; Goddemeier, Thomas ; de Bono, Johann

AbstractBackgroundGartisertib is an oral inhibitor of ataxia telangiectasia and Rad3-related protein (ATR), a key kinase of the DNA damage response. We aimed to determine the safety and tolerability of gartisertib ± carboplatin in patients with advanced solid tumours.MethodsThis phase I open-label, multicenter, first-in-human study comprised four gartisertib cohorts: A (dose escalation [DE]; Q2W); A2 (DE; QD/BID); B1 (DE+carboplatin); and C (biomarker-selected patients).ResultsOverall, 97 patients were enroled into cohorts A (n = 42), A2 (n = 26), B1 (n = 16) and C (n = 13). The maximum tolerated dose and recommended phase II dose (RP2D) were not declared for cohorts A or B1. In cohort A2, the RP2D for gartisertib was determined as 250 mg QD. Gartisertib was generally well-tolerated; however, unexpected increased blood bilirubin in all study cohorts precluded further DE. Investigations showed that gartisertib and its metabolite M26 inhibit UGT1A1-mediated bilirubin glucuronidation in human but not dog or rat liver microsomes. Prolonged partial response (n = 1 [cohort B1]) and stable disease >6 months (n = 3) did not appear to be associated with biomarker status. Exposure generally increased dose-dependently without accumulation.ConclusionGartisertib was generally well-tolerated at lower doses; however, unexpected liver toxicity prevented further DE, potentially limiting antitumour activity. Gartisertib development was subsequently discontinued.ClinicalTrials.govNCT02278250.

01 Dec 2023·Molecular Cancer Therapeutics

Abstract B043: 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

Author: Krebs, Matthew G ; Piha-Paul, Sarina ; Garralda, Elena ; Italiano, Antoine ; Guzman, Alonso ; Gianoukakis, Andrew G ; Fisher, Geoff ; Subbiah, Vivek ; Clark, Liz ; Arkenau, Tobi ; Garrido, Pilar ; Taylor, Matthew

AbstractBACKGROUND Emergence of resistance to 1st generation (gen) selective RET inhibitors (SRIs, selpercatinib/pralsetinib) is an area of high unmet need. EP0031 (A400/KL590586) has promise as a next gen SRI. Clinical data was recently reported from an ongoing Phase I/II study in China that included 109 patients (pts) with RET-altered tumours (NCT05265091, Zhou et al. JCO 2023, 41:16, suppl. 3007). ORR was 80.8 and 69.7%, across 40-120 mg QD doses, in treatment-naïve or pre-treated metastatic NSCLC, respectively. Responses durable with longest 14.5 mo ongoing, median DoR not reached. Responses, including in the CNS, observed in 5/7 pts that previously received 1st gen SRI. EP0031 had an encouraging safety and tolerability profile. 90mg QD was selected as RP2D. Here we report initial data from the dose ranging and optimisation module of a parallel Phase I/II study in the US and Europe. EXPERIMENTAL PROCEDURES This study (NCT05443126) is recruiting pts with RET-altered NSCLC, thyroid cancer or other solid tumours. Study includes male or female pts ≥ 18 years of age, PS 0 or 1 with/without asymptomatic, stable brain metastases. The first module is a dose escalation to investigate safety, tolerability, PK/PD and define the MTD and/or RP2D. This is based on rolling 6 design and is expected to recruit up to 40 pts.RESULTS As of 10th July 2023, a total of 15 pts, 5 medullary thyroid cancer (MTC), 2 CRC and 8 NSCLC, have been included across dose cohorts of 20mg (N=3), 60mg (N=6) and 90mg (N=6). PK profile is comparable with Chinese pts and consistent with QD dosing. 60mg QD predicted to achieve IC50 for inhibition of RET fusions/mutations. No DLTs and no serious adverse events reported. No dose reductions, interruptions or discontinuations have been required. AEs have been mainly Grade 1 or 2. No neutropenia, hypertension, neurotoxicity or QTc prolongation observed. Three pts (all MTC) that received 20 mg QD had their dose escalated to 60mg (after 5-7 cycles at 20mg). 2 of those pts, both SRI naïve, have ongoing stable disease for >23 weeks. 1 pt (prior SRI) with a new target lesion continues to derive clinical benefit and remains on treatment. Of 4 evaluable pts at 60 mg, 2 pts with NSCLC (prior SRI) have achieved a PR, treatment is ongoing and 2 pts with MTC (prior SRI) had PD, one of whom continues to derive clinical benefit and remains on treatment. The remaining pts at 60 or 90mg (potential RP2D) are not yet evaluable for efficacy. Genomic analyses for RET/non-RET resistance mechanisms are ongoing. Expansion of the 60mg and 90mg cohorts is planned for dose optimization. Expanded efficacy, safety and PK/PD data from dose ranging and optimization cohorts will be presented.CONCLUSIONS These preliminary data are encouraging, consistent with that reported from a larger cohort of Chinese patients, with early evidence that EP0031 is active in pts that received prior 1st gen SRI. Once RP2D confirmed, the study will expand cohorts of both SRI-naïve and pre-treated pts with RET-altered NSCLC, thyroid and other solid tumours.Citation Format: Elena Garralda, Alonso Guzman, Pilar Garrido, Andrew G Gianoukakis, Matthew Taylor, Sarina Piha-Paul, Matthew G Krebs, Antoine Italiano, Liz Clark, Geoff Fisher, Tobi Arkenau, Vivek Subbiah. 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 [abstract]. In: Proceedings of the AACR-NCI-EORTC Virtual International Conference on Molecular Targets and Cancer Therapeutics; 2023 Oct 11-15; Boston, MA. Philadelphia (PA): AACR; Mol Cancer Ther 2023;22(12 Suppl):Abstract nr B043.

News (Medical) associated with Ellipses Pharma Ltd.

23 Aug 2024

·www.echemi.com

Kelun Biotech's Net Profit Soars 1068% in H1, But Hidden Crisis?

In the first half of 2024, the Biotech company Kelun Biotech delivered a remarkable report card. The company has been able to achieve such remarkable results, mainly thanks to a number of partnerships with pharmaceutical giant Merck. These collaborations enabled Kelun Biotech to successfully turn a profit, with net income up 1,068% year-over-year. Specifically, Kelun Biotech's total revenue for the period amounted to $1.382 billion, an increase of 32.2% year-over-year. This significant increase was primarily driven by a number of milestone payments with Merck. At the same time, Kelun Biotech has also entered into a number of BD (Business Development) partnerships with companies such as Harbour Biomed and Ellipses Pharma, further enriching the company's cash flow. As of the end of June, the company's cash and financial assets reached 2.885 billion yuan, providing a solid financial foundation for the company's sustainable development. It is worth noting that Kelun Biotech has four products in the pipeline. These products include SKB264, the core product for the treatment of advanced solid tumors, and A166 for the treatment of advanced HER2-positive breast cancer of third line and above. Among them, SKB264 is expected to be approved for the treatment of triple-negative breast cancer within this year, becoming the first TROP2 ADC (Antibody Drug Conjugate) produced in China. This will fill the gap in this field of TROP2 ADCs produced in China, which has important clinical significance. In addition, SKB264 has also obtained the second indication application accepted by the National Medical Products Administration (NMPA). For the treatment of patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer who have failed EGFR-TKI and platinum-containing chemotherapy. If this indication can be approved, it will fill this clinical gap and bring new treatment options to patients. Currently, SKB264 has been initiated in 10 global Phase III clinical studies that will evaluate the efficacy of SKB264 as a monotherapy or in combination with other drugs for multiple indications. The development of these clinical studies has added more chips to the future commercialization of SKB264, and has also injected a strong impetus to the development of the company. With a rich product pipeline, strong research and development capabilities, and extensive cooperation with multinational pharmaceutical companies, Kelun Biotech is in a golden period of rapid development. In the future, with the continuous launch of the company's products and the approval of new indications, Kelun Biotech is sure to become a shining star in the Chinese biomedical industry, bringing more hope and choices to patients.

Phase 3Phase 1ADCFinancial StatementDrug Approval

01 May 2024

·www.prnewswire.com

Ellipses' next generation selective RET inhibitor EP0031/A400 cleared to start Phase 2

Drug has successfully completed US Food and Drug Administration's End of Phase 1 data review LONDON, May 1, 2024 /PRNewswire/ -- Ellipses Pharma Limited ("Ellipses"), a global drug development company focused on accelerating the development of cancer treatments through an innovative drug development model, 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. EP0031/A400 is a potential treatment of RET-altered tumours and clinical data in studies to date has shown promising efficacy in patients with NSCLC, thyroid and other solid tumours. Durable responses have been seen in patients who were naive to, or who had been pre-treated with, 1st generation SRIs including in patients with brain metastases1. The latest clinical data from the Ellipses Phase 1 study will be presented at ASCO in Chicago on June 3rd 2024. EP0031 is being developed jointly by Ellipses in a global clinical phase 1/2 trial under the name EP0031 (NCT05443126) and Sichuan-Kelun Biotech in China under the names KL590586/A400 (NCT05265091). Modular Phase 1 studies have been conducted in the US, Europe and China and a registrational Phase 2 trial in China is ongoing. The FDA granted Orphan Drug Designation to EP0031/A400 in November 2023 and in March of this year granted it Fast Track Designation, which facilitates the expedited development and review of new drugs intended to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs. Professor Sir Christopher Evans, Chairman, Ellipses, said: "We are greatly encouraged with the progress to date of EP0031/A400 and look forward to rapidly generating Phase 2 data, which will be another key step towards bringing this treatment to patients." Dr Rajan Jethwa, Chief Executive Officer, Ellipses, commented: "We are excited to announce another important clinical milestone as we continue to drive the development of EP0031 towards an NDA as a potential next-generation treatment for people living with RET-altered NSCLC and other cancers." Professor Tobias Arkenau, Global Head of Drug Development and Chief Medical Officer, Ellipses commented: "At every stage our belief has been reinforced that EP0031/A400 can be a transformational treatment for patients with RET fusion-positive NSCLC, which remains a progressive and fatal condition for hundreds of thousands of patients worldwide, despite available treatment options." About EP0031 In March 2021, Kelun-Biotech granted Ellipses an exclusive licence for EP0031 (A400) in certain territories including the US and Europe, with Kelun-Biotech retaining certain rights in Greater China. An Investigational New Drug Application (IND) application for EP0031 (A400) was approved by China's National Medicinal Products Administration in June 2021 and a registrational Phase 2 trial is ongoing in China. In June 2022, the U.S. Food and Drug Administration approved the EP0031 Phase 1/2 study IND application in the US. About RET altered malignancies Activating RET mutations and rearrangements have been identified as actionable drivers of oncogenesis in numerous tumour types and are most prevalent in non-small cell lung and thyroid cancer. It is estimated that RET mutations and rearrangements may be responsible for ~2% of all solid tumours. After the successful development of first generation SRIs and an increasing understanding of escape mechanisms to these agents, there is an unmet need to develop new treatments that can address acquired resistance, including the development of next-generation SRIs. About Ellipses Pharma Limited Ellipses is a global drug development company based in London, focused on accelerating the development of cancer treatments through an innovative drug development model that combines unbiased vetting to de-risk initial asset selection with an uninterrupted funding flow to minimise the time it takes to advance lead products through clinical trials and reach patients. About Kelun-Biotech Kelun-Biotech（6990.HK）is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialisation and global collaboration of innovative drugs. The company focuses on major disease areas such as solid tumours, autoimmune, inflammatory and metabolic diseases. At present, the company has 33 on-going innovative projects for medical needs in selected major disease areas such as solid tumours, autoimmune, inflammatory, and metabolic diseases, including 14 projects in the clinical stage and multiple global trials conducted in several regions such as China, Europe, and the United States. For more information, please visit . Logo - SOURCE Ellipses Pharma

Orphan DrugPhase 2Fast TrackPhase 1IND

06 Jun 2023

·www.pharmaceutical-technology.com

ASCO 2023: Ellipses Pharma advances plans for RET inhibitor following encouraging results

Aidan McNamee The audience at the 2-23 ASCO Annual Meeting. Positive results have motivated Eclipse to accelerate its RET inhibitor pipeline. Credit: Photo by © ASCO/Todd Buchanan 2023. Chicago, Illinois-based Ellipses Pharma has announced its intention to accelerate the global clinical development of its selective RET inhibitor EP0031/A400. Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. Access the report to: Benchmark the impact of major themes on the Biopharmaceutical industry. Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents. Evaluate the effects of COVID-19 on the sector. Download the full report to understand what to expect and how to align your strategies for success. 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Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. Thank you. Please check your email to download the Report. Following the publication of clinical data from its Phase I study of the inhibitor at the American Society of Clinical Oncology (ASCO) conference, Ellipses was motivated to accelerate clinical development due to what it believes are “very encouraging” results. The ASCO Annual Meeting is being held 2–6 June in Chicago. Recommended Reports Reports LOA and PTSR Model - Ensartinib Hydrochloride in Sarcomas GlobalData Reports LOA and PTSR Model - Ropidoxuridine in Sarcomas GlobalData View all Companies Intelligence Ellipses Pharma Ltd View all According to the company, RET mutations and fusions may be responsible for roughly 2% of all solid tumours. This includes 2% of non-small cell lung cancer (NSCLC) and 60-80% of medullary thyroid cancers. Ellipses reported preliminary efficacy and safety data for the 109 patients enrolled in the trial. For the RET-altered tumour population, patients receiving doses of 40-120mg had an objective response rate (ORR) of 60%, and a disease control rate of 90%. Two patient cohorts were highlighted in particular. The first, patients, with previously untreated RET-fusion positive advanced NSCLC, had an ORR of 80.8%. Another cohort of patients with RET-fusion positive NSCLC who had received treatment like chemo-immunotherapy, had an ORR of 69.7%. In both cases, DCR of over 96% were reported. Dr. Tobias Arkenau, Global Head of Drug Development & CMO at Ellipses, said the data gives Ellipses the backing to advance their pipeline. The company was also eager to highlight observed evidence of clinical activity in patients with brain metastases. It also saw similar for patients who had previously been treated with first-generation SRIs, who currently have limited available treatment options. The cohorts were part of a global, modular phase I/II trial in patients with advanced RET-altered tumours (add NCT). Data released at this point will be augmented by the results of ongoing trials in the US, EU, and UK Kelun-Biotech, Ellipses’ partner in developing the RET inhibitor, is conducting clinical investigations in China for patients with RET-altered cancers. Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. 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Phase 1ASCOClinical ResultImmunotherapy

100 Deals associated with Ellipses Pharma Ltd.

100 Translational Medicine associated with Ellipses Pharma Ltd.

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Pipeline

Pipeline Snapshot as of 07 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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Phase 2 Clinical

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

RAD-140 ( AR )	Metastatic breast cancer More	Phase 2 Clinical
Lunbotinib ( RET )	RET mutation Solid Tumors More	Phase 2 Clinical
EP-0042 ( AURK x FLT3 )	Acute Myeloid Leukemia More	Phase 2 Clinical
EP-0057 ( HIF-1α x TOP1 )	Platinum-Resistant Ovarian Carcinoma More	Phase 2
EP0017 ( DR4 x DR5 x HER3 x TRAIL )	Neoplasms More	Preclinical

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