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HONG KONG, March 6, 2025 /PRNewswire/ -- Akeso, Inc. (9926. HK) ("Akeso" or the "Company") is pleased to announce the completion of patient enrollment for its Phase III registrational clinical trial (COMPASSION-22/AK104-306) evaluating cadonilimab, the world's first PD-1/CTLA-4 bispecific antibody independently developed by the company, as an adjuvant treatment for hepatocellular carcinoma (HCC) with high recurrence risk following curative resection or ablation. The completion of patient enrollment in the COMPASSION-22/AK104-306 trial marks a significant milestone in the clinical development of cadonilimab for HCC. In addition to this Phase III study, another Phase III trial investigating cadonilimab in combination with lenvatinib and transarterial chemoembolization (TACE) for the treatment of unresectable intermediate to advanced HCC is currently progressing on schedule. The extensive exploration of combination therapies involving cadonilimab for HCC is expected to offer more effective treatment options for both early-stage and advanced HCC patients. HCC is one of the most common malignant tumors globally. According to 2024 data, there are about 865,000 new cases of liver cancer worldwide, with 370,000 occurring in China. The recurrence rate after surgery is high, especially in patients with high-risk factors, with a five-year recurrence rate exceeding 70%. Currently, no standard adjuvant treatment exists for HCC in clinical practice. Identifying effective adjuvant therapies to reduce recurrence risk and extend survival is a critical unmet need in HCC treatment. Cadonilimab is the world's first approved bispecific immunotherapy for cancer. Previous studies have shown its significant efficacy and favorable safety profile in treating HCC. Research presented at the 2023 European Society for Medical Oncology (ESMO) Asia Annual Meeting demonstrated that cadonilimab combined with FOLFOX-HAIC as neoadjuvant therapy for resectable multinodular HCC achieved a 100% disease control rate (DCR) with manageable safety. Furthermore, data from the 2023 ESMO Congress highlighted that cadonilimab combined with lenvatinib as a first-line treatment for advanced HCC showed superior antitumor activity compared to approved therapies, effectively controlling tumor progression and offering long-term survival benefits over current treatment options. Akeso will continue to advance cadonilimab clinical development for multiple malignant tumors, with the aim to provide more therapeutic options for patients worldwide. Currently, cadonilimab is currently involved in over 23 clinical studies across 16 indications, including gastric cancer, lung cancer, liver cancer, cervical cancer, and pancreatic cancer. It has already received approval for the treatment of recurrent/metastatic cervical cancer and first-line gastric cancer. The sNDA for cadonilimab for the treatment of first-line cervical cancer is currently under review. Additionally, five Phase III trials for HCC, non-small cell lung cancer (NSCLC), and gastric cancer are underway. Studies across multiple indications, including cervical cancer, gastric cancer, and NSCLC, have shown that cadonilimab offers meaningful efficacy benefits in all patient populations, regardless of PD-L1 expression levels (high, low, or negative). These patient data indicates that cadonilimab can also significantly broadens the eligible patient population that can benefit from cancer immunotherapies. About AkesoAkeso (HKEX: 9926.HK) is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world's first or best-in-class innovative biological medicines. Founded in 2012, the company has created a unique integrated R&D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the core, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode, and has gradually developed into a globally competitive biopharmaceutical company focused on innovative solutions. With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them, 23 candidates have entered clinical trials (including 11 bispecific/multispecific antibodies and bispecific antibody-drug conjugates). Additionally, 5 new drugs are commercially available, and 5 new drugs across 7 indications are currently under regulatory review for approval. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise. For more information, please visit https://www.akesobio.com/en/about-us/corporate-profile/ and follow us on Linkedin.
Phase Ib trial to evaluate CS5001 in combination with R-CHOP as a first-line treatment for diffuse large B-cell lymphoma (DLBCL), aiming to reshape the standard-of-care landscape. CS5001 is also being investigated globally in a multi-center Phase Ib clinical trial for multiple solid tumor types. SUZHOU, China, March 6, 2025 /PRNewswire/ -- CStone Pharmaceuticals ("CStone", HKEX: 2616), a biopharmaceutical company dedicated to developing innovative cancer therapies, today announced the submission of a Phase Ib clinical trial application in Australia for CS5001, its ROR1-targeting antibody-drug conjugate (ADC), in combination with first-line standard-of-care (SoC) for DLBCL. CS5001 is also being evaluated as both a monotherapy and in combination with a PD-L1 inhibitor for advanced solid tumors in an ongoing global multi-center clinical trial. Building on promising data from CS5001 monotherapy in later-line aggressive and indolent lymphomas, this Phase Ib trial aims to expand the therapeutic potential of CS5001 across all DLBCL stages and solid tumors. The study will explore: CS5001 + R-CHOP: First-line treatment for DLBCL patients who have not received prior systemic therapy. CS5001 + SoC: For patients with relapsed or refractory DLBCL. CS5001 Monotherapy: Targeting ROR1-expressing solid tumors. CS5001 + Sugemalimab: Combination therapy for advanced solid tumors. Dr. Jason Yang, CEO, President of R&D, and Executive Director at CStone, stated: "We are thrilled to reach another key clinical milestone for CS5001. The existing data underscore its broad potential in both lymphomas and solid tumors. Notably, a ROR1 ADC combined with R-CHP has demonstrated an impressive complete response (CR) rate in a Phase II trial for first-line DLBCL. As we advance from late-line monotherapy to frontline combination therapy, we are optimistic that CS5001 will provide significant clinical benefits to DLBCL patients and establish itself as a first-line treatment option. Meanwhile, we continue to explore CS5001's potential in solid tumors and eagerly anticipate further positive outcomes." The global multi-center Phase Ib trial for CS5001 is actively enrolling patients across the United States, Australia, and China. Recruitment is ongoing for monotherapy cohorts targeting aggressive and indolent advanced lymphomas, which could potentially expand into a Phase II single-arm registrational study. Additional cohorts, including the first-line DLBCL combination therapy and solid tumor monotherapy and combination therapy arms, will be initiated soon. About CS5001 (ROR1 ADC) CS5001 is a clinical-stage antibody-drug conjugate ("ADC") targeting ROR1 (receptor tyrosine kinase-like orphan receptor 1). CS5001 has been uniquely designed with proprietary tumor-cleavable linker and pyrrolobenzodiazepine ("PBD") prodrug. Only after reaching the tumor, the linker and prodrug are cleaved to release the PBD toxin, resulting in lethal DNA cross-links in cancer cells. The use of the linker plus PBD prodrug effectively helps address the toxicity associated with traditional PBD payloads, leading to a better safety profile. CS5001 has demonstrated complete tumor suppression in several preclinical cancer models and demonstrated favorable serum half-life and pharmacokinetic characteristics. CS5001 is a promising candidate drug with precision treatment potential in both hematologic tumors and malignant solid tumors. Additionally, CS5001 utilizes site-specific conjugation for a precise drug antibody ratio of which enables homogeneous production and large-scale manufacturing. In October 2020, CStone signed a licensing agreement with LigaChem Biosciences, Inc. (LCB) for the development and commercialization of CS5001 which was originally generated by collaboration of LCB and ABL Bio, both South Korea-based leading biotech companies. Under the agreement, CStone obtains the exclusive global right to develop and commercialize CS5001 outside the Republic of Korea. The first-in-human data for CS5001 in patients with advanced solid tumors and lymphomas was presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. Additionally, the latest clinical data on CS5001 as a monotherapy in patients with advanced lymphomas has recently been presented at the 66th American Society of Hematology (ASH) Annual Meeting. CS5001 has demonstrated encouraging safety and robust anti-tumor activity in the Phase 1a dose escalation trials across 10 dose levels. At the tentative recommended Phase 2 dose (RP2D) of DL8 (125 μg/kg), CS5001 achieved objective response rates (ORRs) of 70% in advanced B-cell lymphoma and 100% in Hodgkin lymphoma. Encouraging efficacy signals were also observed in advanced solid tumors, including non-small cell lung cancer and pancreatic cancer. CS5001 was well tolerated in heavily pre-treated patients with advanced B-cell lymphomas and solid tumors. About CStone CStone (HKEX: 2616), established in late 2015, is an innovation-driven biopharmaceutical company focused on the research and development of anti-cancer therapies. Dedicated to addressing patients' unmet medical needs in China and globally, the Company has made significant strides since its inception. To date, the Company has successfully launched 4 innovative drugs and secured approvals for 16 new drug applications (NDAs) covering 9 indications. The company's pipeline is balanced by 16 promising candidates, featuring potentially first-in-class or best-in-class antibody-drug conjugates (ADCs), multispecific antibodies, immunotherapies and precision medicines. CStone also prides itself on a management team with comprehensive experiences and capabilities that span the entire drug development spectrum, from preclinical and translational research to clinical development, drug manufacturing, business development, and commercialization. For more information about CStone, please visit www.cstonepharma.com. Forward-looking statements The forward-looking statements made in this article only relate to events or information as of the date when the statements are made in this article. Except as required by law, we undertake no obligation to update or publicly revise any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. All statements in this article are made on the date of publication of this article and may change due to future developments. Disclaimer: only for communication and scientific use by medical and health professionals, it is not intended for promotional purposes.
From many clicks to one query, drug supply managers can more quickly access, analyze, and visualize the trial supply data they need. PHILADELPHIA, March 6, 2025 /PRNewswire/ -- Suvoda LLC, a global clinical trial technology company that specializes in complex studies in therapeutic areas like oncology, central nervous system (CNS), and rare disease, today announced the early adopter launch of Sofia, an artificial intelligence assistant designed to simplify how study teams access and review clinical trial information. Sofia is available on the Suvoda Platform and can be enabled by sponsors looking to provide drug supply managers with efficient access to vital information through an intuitive chat interface, reducing what were once multi-screen, multi-click processes to simple conversations. "When creating Sofia, we asked ourselves: What if clinical trial staff had an AI assistant that could alleviate their administrative burdens?" said E.K. Koh, Chief Product Officer at Suvoda. "Sofia became our answer. It's an exciting opportunity to streamline the management of clinical trials." Built with Suvoda's commitment to reliability and security, Sofia brings greater efficiency to clinical trial operations, while adhering to data privacy and other regulatory requirements in clinical research. Sofia's key capabilities include: Streamlines Information Retrieval: Users access trial information through natural language queries that simplify navigation. They can now easily find answers that otherwise would span multiple screens, putting information they need at their fingertips. Improves Productivity in Drug Supply Management: Drug supply managers can more quickly complete tasks like compare depot inventories, review drug lot releases for specific countries, check shipment details, and look over participant visit schedules, helping reduce workload and support operational efficiency. Provides Reliable Responses: Sofia answers questions using expert instructions developed by subject matter experts with deep industry experience. It will "show its work" to users who wish to verify the results and will only answer questions that it has been trained on, helping avoid hallucinations in the answers that plague typical AI tools. Includes Privacy Controls: Built specifically for clinical trials, Sofia operates with safeguards, including restrictions to study data based on user role which keeps customer data accessible to only authorized users and helps to maintain the study blind. Sofia also has guardrails to protect customer and patient data from exposure to public domain AI models. Creates Visualizations: Sofia can create charts, graphs, and tables to help users more easily digest data. Supports Global Operations: Individuals can converse with Sofia in their preferred language. Sofia is currently optimized for drug supply managers using Suvoda Interactive Response Technology (IRT), with plans to expand to other users and products across the Suvoda Platform. This strategic rollout demonstrates Suvoda's dedication to thoughtful innovation that prioritizes reliability and user experience in clinical trial technology. "There is a lot of hype around AI, but there is also a lot of promise," said Koh. "We've approached our work with Sofia with extreme diligence because in clinical trials there is no room for error." Named after a Greek word for "wisdom," Sofia embodies Suvoda's guiding principle to enable clinical trial sponsors, sites, and patients to Trial Wisely. It is one more example of Suvoda's determination to smooth clinical trial complexity and give sponsors and sites the control over their trials to more efficiently bring life-saving therapies to those who need them most. About Suvoda Suvoda is a global clinical trial technology company specializing in complex, life-sustaining studies in therapeutic areas like oncology, central nervous system (CNS), and rare diseases. Founded in 2013 by experts in eClinical technologies, Suvoda empowers clinical trial professionals to manage the most urgent moments in the most urgent trials through advanced software solutions delivered on a single platform. Headquartered outside Philadelphia, Suvoda also maintains offices in Portland, OR, Barcelona, Spain, Bucharest and Iasi, Romania, and Tokyo, Japan. The company's Net Promoter Score (NPS) consistently exceeds the technology industry average, contributing to the company being selected by trial sponsors and CROs to support more than 1,800 trials across 95 countries. To learn more, visit suvoda.com. Follow Suvoda on LinkedIn. For additional information please contact: Robin Abadia, Director External Communications, Suvodamarketing@suvoda.com Logo - https://mma.prnasia.com/media2/1759317/Suvoda_Logo.jpg?p=medium600
PALMA DE MALLORCA, Spain, March 5, 2025 /PRNewswire/ -- Laminar Pharma, a leader in the development of innovative cancer therapy based on membrane lipid therapy, announced today optimistic results from its ongoing clinical trial evaluating LAM561 for the treatment of newly diagnosed glioblastoma (ndGBM), the most aggressive form of brain cancer, that has seen limited clinical improvement in the last 20 years. The trial, partially funded with an EU H2020 Grant (ClinGlio), has shown an improvement trend in progression-free survival (PFS) in MGMT-methylated patients receiving LAM561 in combination with chemoradiotherapy (radiotherapy plus temozolomide) as the standard of care (SoC) compared to placebo plus SoC treatment. LAM561 is available for in-license for all territories. Laminar's current fund raising round is still open, for a limited time, to additional investors. The pivotal phase 2b/3 trial, "A randomized, double-blind, placebo-controlled adjuvant trial in newly diagnosed primary glioblastoma subjects to assess the efficacy and safety of LAM561 in combination with radiotherapy and temozolomide standard of care treatment" (NCT04250922), enrolled 144 patients with newly diagnosed glioblastoma. In November 2024, After reaching 66 PFS events the independent data monitoring committee (IDMC) recommended: (1) Continue the trial without modifications until 90 OS events (overall survival), when the final analysis will be carried out, estimated for Q4 2026; (2) that the trial should not be stopped for reasons of safety or futility and (3) opening the study, that is, removing the blind. From that moment, patients, doctors and Laminar as sponsor are able to know if any patient received placebo or LAM561. Although the main primary outcome of the interim analysis (Hazard Ratio of 0.5 for PFS) was not reached for the whole trial population, the unblinding of the trial has allowed Laminar to conduct an ongoing evaluation (non-statistically assessed and with data under monitoring review) considering the per protocol predefined stratification: methylation status of the MGMT promoter and RTOG score (3, 4 or 5), a scale describing the side effects caused by radiation therapy and the higher the RTOG score the worse the clinical position. By revising the data stratified by MGMT promoter methylation status and RTOG, and using data available on 18th February 2025, the median PFS for methylated patients RTOG3 was 56,7 weeks on the LAM561 treatment arm against 19 weeks on the placebo arm (n=9). Moreover, the median PFS for methylated patients RTOG4 was 86,4 weeks on the LAM561 treatment arm against 54,7 weeks on the placebo arm (n=39). With currently available data, methylated patients treated with LAM561 + SoC seem to experience a potentially clinically relevantimprovement in PFS (Hazard-ratio estimation of 0.53) compared to control group (placebo+SoC). PFS was not improved by LAM561 in unmethylated patients. This interim perspective should be taken with caution since the study is still ongoing and providing new information and the final interpretation will only be apparent once the study has completed after reaching 90 OS events; and, although progression of the disease is a relevant clinical event, overall survival is the primary outcome of the trial and conclusions on the final effect of the drug need to wait until the final analysis is performed and data is reviewed by the IDMC. Laminar intends to perform an in-depth independent objective assessment of the findings. The methylation status of the MGMT promoter is highly relevant in the prognosis of glioblastoma [Leske et al., 2023]. MGMT-methylated patients represent 35-50% of the total glioblastoma patients. "We are encouraged by the progression-free survival results from this trial in MGMT-methylated patients, which, if reflected by positive overall survival results, may represent a significant advance in the treatment of glioblastoma, a condition with poor prognosis that affects more than 100,000 people every year", said Dr. Pablo Escribà, CEO of Laminar Pharma. "Glioblastoma remains one of the most challenging cancers to treat, and these findings highlight the potential of LAM561 to improve outcomes for methylated patients, a considerable portion of the total glioblastoma population. Our team is committed to continuing the development of this promising therapy." The combination of LAM561 and SoC was well-tolerated. The safety data in the trial is consistent with the known safety profile of LAM561 studied in previous clinical trials, with no new safety signals observed in the combination arm. Trial Details and Key Findings: The study enrolled 144 patients with newly diagnosed, IDH-wildtype, glioblastoma. MGMT-methylated patients treated with LAM561 and SoC currently show a trend towards longer progression-free survival (86,4 weeks) compared to placebo control SoC group (54,7 weeks, HR 0.53). The study will continue until 90 OS events when final analysis will be conducted, estimated by late 2026. Safety data showed that the treatment was well-tolerated, with adverse events consistent with previous trials and a well-known safety profile. These results built on earlier preclinical and clinical data, which indicated that LAM561 could effectively target, through modification of the membrane lipid, the molecular pathways associated with glioblastoma growth. Further analysis and longer follow-up periods are underway to assess overall survival and other secondary endpoints. About Glioblastoma: Glioblastoma (GBM) is the most common primary malignant brain tumor and accounts for nearly 50 percent of all gliomas and approximately 25 percent of all primary brain and CNS malignant tumors. The incidence of GBM in Europe is currently above 25,000 new cases each year, rising to over 100,000 cases per year worldwide. The prognosis for GBM patients is very poor, with a median survival time of about 14.5 months despite optimum chemo-radiation treatment. About 15% of patients survive two years after diagnosis and ca. 4% survive for five or more years. In this scenario, there is a desperate need for novel treatment alternatives that provide safe and more efficacious clinical outcomes. About LAM561: LAM561 (2-hydroxyoleic acid (2-OHOA); idroxioleic acid, sodium) is a synthetic derivative of oleic acid and the most advanced Laminar's R&D product which is taken orally. This drug alters the composition of the plasma membrane in cancer cells, reducing the activity of membrane-associated signaling proteins that are known to promote tumor growth and affecting tumors in the brain. LAM561 is in the process of completing its last clinical development phase and has shown promising preliminary clinical activity in the treatment of aggressive brain tumors, glioblastoma. About Laminar Pharma: Laminar Pharmaceuticals S.A. (Laminar) is a Spanish biotechnological company created in 2006, committed to translational health research, for the rational design and development of drugs to treat oncological and other pathologies in the form of synthetic fatty acids considered "First-in-class Health Solutions" and based on a novel technology, the Melitherapy (MLT or Membrane Lipid Therapy). Laminar controls all the processes, from the rational design of the molecules to the clinical trials that lead to the launch of a new drug, with constant investment in R&D and high-quality standards. It is currently headquartered in Mallorca (Spain) with a subsidiary in Massachusetts (USA). The development and commercialization of medicines involves a high degree of risk, and only a small number of research and development programs result in the commercialization of a product. This document contains forward-looking statements. These statements do not relate strictly to historical or current facts and may be accompanied by words such as "anticipate," "believe," "conceivably" , "could," "estimate," "expect," "may", "potential," "possible," "will," and other words of similar meaning. The results of clinical trials may not be indicative of the full results or the results of later-stage clinical trials and do not guarantee regulatory approval. Media Contact: Javier Fernández Díazj.fernandez@laminarpharma.com References: Leske, H., Camenisch Gross, U., Hofer, S., Neidert, M. C., Leske, S., Weller, M., ... & Rushing, E. J. (2023). MGMT methylation pattern of long-term and short-term survivors of glioblastoma reveals CpGs of the enhancer region to be of high prognostic value. Acta Neuropathologica Communications, 11(1), 139
HIGHLIGHTS Safety Review Committee (SRC) meeting confirms end of the Dose Escalation Phase and commencement of the Cohort Expansion Phase (Phase II stage) of the SECuRE study. Based on the efficacy and safety assessment of all cohorts and the focus on earlier stages of treatment, the SRC confirmed expansion at 8 GBq dose level and recommended to increase the number of cycles from up to 4 to up to 6. Cohort 4 of the Dose Escalation Phase of the SECuRE trial, assessing multiple administrations of 67Cu-SAR-bisPSMA, is complete. Prostate-specific antigen (PSA) levels are continuing to drop in 3 participants, with reductions ≥80% observed in 3 cases so far. A complete response was achieved in a participant in cohort 4 following 2 doses of 12 GBq of 67Cu-SAR-bisPSMA to date, based on the Response Evaluation Criteria in Solid Tumors v1.1 (RECIST). Across all cohorts, 68% of participants have shown reductions in PSA levels, despite the vast majority of the participants (77%) only receiving a single dose of 67Cu-SAR-bisPSMA. The majority of participants that did not respond to the treatment had received chemotherapy in the metastatic castration-resistant prostate cancer (mCRPC) stage, were part of the lowest dose cohort (cohort 1) and had some of the highest PSA levels at study entry. 67Cu-SAR-bisPSMA has shown a favourable safety profile across all cohorts. The majority of reported adverse events (AEs) were Grade 1-2, with anaemia and thrombocytopenia being the most prevalent among the haematological events. Most AEs have now resolved. One Dose Limiting Toxicity (DLT) in 1 participant occurred at the highest dose in cohort 4, a transient Grade 4 thrombocytopenia, which improved to Grade 3 after 2 weeks. This participant had bone metastases, a high baseline PSA [1503.12 ng/mL] and had previously been treated with chemotherapy and multiple lines of 177Lu-PSMA-617. A PSA drop of 10.7% was observed following the administration of 1 cycle of 67Cu-SAR-bisPSMA. In the group of 13 participants who had not received chemotherapy in the mCRPC setting, all but 1 participant had PSA drops of 35% or more, predominantly with single doses of 67Cu-SAR-bisPSMA. PSA reductions of 80% or more were achieved in almost half of these patients. The majority of participants had received ≥3 lines of therapy prior to enrollment in the study (63.6%). Disease control based on radiographic assessment (RECIST) was achieved in 11 of the 12 (92%) pre-chemotherapy participants who had evaluable disease at baseline. The SECuRE trial protocol has been amended to bring 67Cu-SAR-bisPSMA to participants at earlier stages of their disease, in the pre-chemotherapy setting. The amendment incorporates an increase in the number of participants in the Cohort Expansion Phase of the trial from 14 to 24, with a subset of participants planned to receive the combination of 67Cu-SAR-bisPSMA with enzalutamide, an ARPi. SYDNEY, March 5, 2025 /PRNewswire/ -- Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, is pleased to announce the completion of the Dose Escalation Phase of the SECuRE trial (NCT04868604)[1]. The SRC recommended the trial progress to the Cohort Expansion Phase (Phase II) at the 8 GBq of 67Cu-SAR-bisPSMA dose level based on the safety and efficacy data demonstrated in every cohort of the study. Across cohorts 1-4 of the SECuRE study, 68% of participants have shown reductions in PSA levels, despite the vast majority of the participants (77%) only receiving a single dose of 67Cu-SAR-bisPSMA. Most of these participants had a high level of bone metastases at study entry (77.3%), a high median PSA of 112.86 ng/mL (range 0.1-1503.1) and were heavily pre-treated with ≥3 lines of therapy (63.6%). Disease control based on radiographic assessment (complete response + partial response + stable disease) was achieved in 78% of the participants so far (including 2 partial responses and 1 complete response observed to date based on the RECIST assessment). The complete response was seen in a patient dosed twice at 12 GBq. This is the second complete response recorded following 67Cu-SAR-bisPSMA treatment, first being the patient previously reported to have a complete response following 2 doses at 8 GBq (first dose administered through the SECuRE trial, and a second dose administered under the the United States [US] Food and Drug Administration [FDA] Expanded Access Program [EAP]). Safety profile of 67Cu-SAR-bisPSMA is favourable across cohorts 1-4 with the majority of AEs being Grade 1-2. Anaemia and thrombocytopenia were the most prevalent AEs among the haematological events. No overall trends in other haematological parameters or renal safety were observed in any of the cohorts. Only 1 DLT has been reported in the trial (transient Grade 4 thrombocytopenia, which improved to Grade 3 after 2 weeks) in a patient in the highest dose cohort (cohort 4). This participant had a baseline PSA of 1503.12 ng/mL, had been treated with multiple lines of therapy, including chemotherapy in the mCRPC setting and multiple doses of 177Lu-PSMA-617, and had bone metastases prior to entering the study. The participant's baseline characteristics may have contributed to the lowering of the platelet levels. Despite the unfavourable prognosis of this participant, which included a very high PSA and being heavily pre-treated, 1 cycle of 67Cu-SAR-bisPSMA was still able to reduce his PSA by 10.7% (to 1341.80 ng/mL). Pre-chemotherapy participants Thirteen participants across cohorts 1-4 in the SECuRE trial were naïve to taxanes in the mCRPC setting (pre-chemotherapy), including 2 in cohort 1 and 3 in cohort 2. The majority of pre-chemotherapy participants had bone metastases (69.2%) with a median PSA of 42.41 ng/mL (range 0.1-182.4) at study entry. Almost half of these participants received ≥3 lines of therapy prior to trial enrolment (46.2%). Despite the heavy disease burden and the majority of participants only receiving single doses of 67Cu-SAR-bisPSMA, there was an outstanding result observed in the pre-chemotherapy setting. Out of the total of 13 pre-chemotherapy participants across all cohorts, 12 had PSA drops greater than 35%. PSA reductions greater than 50% were reached in 61.5% (8/13) of participants, and reductions of 80% or more were achieved in 46.2% (6/13) of participants. Disease control based on the RECIST assessment was also observed in 11 out of 12 pre-chemotherapy participants (92%) who had measurable disease at baseline. One participant reached a complete response with 2 doses of 12 GBq in cohort 4, 2 participants had partial responses (cohort 2 and cohort 4), and 8 participants achieved stable disease at this time. Three participants in the pre-chemotherapy setting of the SECuRE trial had previously been treated with actinium-225 based radioligand therapies (RLT) and, in 1 case, in combination with lutetium-177 based therapy. All 3 participants showed reductions in PSA levels following treatment with 67Cu-SAR-bisPSMA in the trial. Notably, 1 of these 3 participants showed a PSA reduction of 83.4% following the administration of 2 doses of 12 GBq of 67Cu-SAR-bisPSMA in cohort 4, despite being heavily pre-treated. The lines of therapy administered to the patient prior to the SECuRE trial enrollment included androgen deprivation therapy (ADT), 2 androgen receptor pathway inhibitors (ARPIs), autologous cellular immunotherapy, and investigational agents (immunotherapy and 177Lu-PSMA-I&T plus 225Ac-J591). Safety assessment in pre-chemotherapy participants was comparable to the overall patient population with most AEs being Grade 1 and Grade 2. Cohort Expansion Phase Based on the data from cohorts 1-4, the SRC recommends the SECuRE trial progress to Cohort Expansion (Phase II) at an 8 GBq dose level, with an increase in the total number of cycles from up to 4 to up to 6. This recommendation is based on the favourable safety profile of 67Cu-SAR-bisPSMA observed to date. Cohort 2 (single dose of 8 GBq of 67Cu-SAR-bisPSMA) with 3 participants had the highest rate of PSA response in the trial, and all participants in the cohort had disease control based on the RECIST assessment (including one partial response). The PSA reductions were 81.4%, 95.2% and 99.4%. Only 1 participant in this cohort developed 67Cu-SAR-bisPSMA-related AEs (Grade 1 dry mouth and altered taste, both improved, and Grade 2 fatigue, resolved). No haematological toxicity was reported in the cohort. The first patient to receive 2 doses of 67Cu-SAR-bisPSMA at 8 GBq (first dose through the SECuRE trial and second dose under the US EAP) achieved a complete anatomical, molecular and biochemical response (assessed by the RECIST criteria, positron emission tomography [PET] and PSA, respectively). He had been heavily pre-treated (chemotherapy in the neoadjuvant setting, ADT, 2 ARPIs and an investigational agent) prior to entering the SECuRE study. The patient's recent follow up showed that he remains with undetectable PSA for almost 16 months, having received his first dose of 67Cu-SAR-bisPSMA over 20 months ago (June 2023). A recent PSMA PET showed no signs of recurrent or metastatic disease. Most AEs related to 67Cu-SAR-bisPSMA were mild or moderate, with the majority having either improved or resolved over time. Based on these safety and efficacy data, where exceptional efficacy signals were observed at lower radiation doses, 8 GBq was chosen as an optimal dose for the Cohort Expansion Phase. The SECuRE trial protocol has been amended to include evaluation of mCRPC participants who have not received chemotherapy in the metastatic (pre-chemotherapy) setting. This amendment is aligned with Clarity's strategy of bringing 67Cu-SAR-bisPSMA to participants with earlier stages of the disease and is based on the promising safety and efficacy data, especially in pre-chemotherapy participants of the SECuRE trial. The protocol amendment also incorporates an increase in the number of participants in the Cohort Expansion Phase of the trial from 14 to 24, in which a subset of participants will receive the combination of 67Cu-SAR-bisPSMA with enzalutamide, an ARPI. These changes are aimed at optimising the development of all of Clarity's products in prostate cancer, following ongoing discussions with and advice from many important global medical experts in the field of prostate cancer, including the Company's Clinical Advisory Board members, Prof Louise Emmett and Prof Oliver Sartor, as well as the SRC. Clarity's Executive Chairperson, Dr Alan Taylor, commented, "The SECuRE trial continues to generate extraordinary results, and we thank our team, Principal Investigators, members of the SRC, and especially the participants who have contributed to the study. Seeing the safety profile and already observing impressive signs of efficacy (despite the majority of participants only receiving a single cycle of 67Cu-SAR-bisPSMA and the primary focus of the Dose Escalation Phase being safety assessments), we are thrilled to progress to Phase II, the Cohort Expansion Phase, of our theranostic SECuRE trial. "Dose escalation trial design has not been routinely used in other RLT studies. By pioneering this approach with the SECuRE trial, Clarity was looking to systematically evaluate the safety of 67Cu-SAR-bisPSMA in the context of its therapeutic effect. By gradually increasing the dose from one cohort to the next, we have minimised the risk of AEs and established a favourable safety profile for patients, while also demonstrating that 67Cu-SAR-bisPSMA is effective. "We are looking forward to executing our strategy of bringing 67Cu-SAR-bisPSMA to earlier lines of prostate cancer therapy with the recent protocol amendment, given the exciting data in pre-chemotherapy participants. We are also increasing the number of participants in the Cohort Expansion Phase. This decision is partly motivated by the increased demand from oncologists to include their participants into the trial, but it is also led by our decision to explore potential benefits of using a combination of 67Cu-SAR-bisPSMA with enzalutamide, following consultation with world-leading prostate cancer oncologists and nuclear medicine physicians. "With our focus on treating earlier stage disease (pre-chemotherapy in the mCRPC setting), it is an incredible outcome to have 12 out of 13 pre-chemotherapy participants in the trial experiencing greater than 35% reductions in PSA and almost half of the 13 experiencing drops of 80% or greater. PSA reductions were seen across all cohorts, including the lowest 4 GBq cohort where all pre-chemotherapy participants exhibited greater than 50% drops in PSA from a single dose. Remarkably, one of those participants has had 4 additional doses under EAP and achieved disease control for over 2 years since first treatment. The results from 3 pre-chemotherapy participants who received 8 GBq of 67Cu-SAR-bisPSMA have been outstanding with a favourable safety profile and excellent efficacy, where PSA reductions were greater than 80% for all participants and above 95% for 2 out of the 3 participants, with all of them achieving radiographic disease control and 1 showing a complete response to date. "The very compelling safety and efficacy data for SAR-bisPSMA that we continue generating stems from Clarity's strong adherence to the highest level of scientific and clinical research. At the heart of this rigorous approach is the dimer "bis" molecule developed at the benchtop of Australian science and translated into the clinic. When optimising the PSMA molecule, the goal was to create an ideal candidate for both therapy and diagnosis of prostate cancer. We wanted to overcome the shortfalls of the current generation of PSMA-targeting products, increasing not only the amount of product in the lesions, but also how long the product is retained in the lesions over time. We are now seeing these results in the clinic with 67Cu-SAR-bisPSMA in the SECuRE trial and with 64Cu-SAR-bisPSMA in our diagnostic trials. "The recent receipt of 3 Fast Track Designations from the US FDA for our optimised SAR-bisPSMA molecule, one of which was based off the data presented here, is testament to the high quality of this data, but also reflects a critical need for novel solutions in prostate cancer management. With an estimated combined market value of approximately US$10-15 billion by 2030 for PSMA-targeted products, we are hoping to address the evident high unmet need in this segment, from first diagnosis to the treatment of metastatic disease, and improve treatment outcomes for men with prostate cancer around the world. "We look forward to swiftly recruiting into the next phase of the SECuRE trial, moving towards a Phase III pivotal trial. We are very excited about what the future holds for this promising product and are working tirelessly to bring it to people who need it most in a timely manner, whilst adhering to the highest standards of clinical research." About the SECuRE trial The SECuRE trial (NCT04868604)[1] is a Phase I/IIa theranostic trial for identification and treatment of participants with PSMA-expressing mCRPC using 64Cu/67Cu-SAR-bisPSMA. 64Cu-SAR-bisPSMA is used to visualise PSMA-expressing lesions and select candidates for subsequent 67Cu-SAR-bisPSMA therapy. The trial is a multi-centre, single arm, dose escalation study with a cohort expansion involving approximately 54 participants in the US and Australia. The overall aim of the trial is to determine the safety and efficacy of 67Cu-SAR-bisPSMA for the treatment of prostate cancer. About SAR-bisPSMA SAR-bisPSMA derives its name from the word "bis", which reflects a novel approach of connecting two PSMA-targeting agents to Clarity's proprietary sarcophagine (SAR) technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-bisPSMA is a Targeted Copper Theranostic (TCT) that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu) for therapy. 67Cu-SAR-bisPSMA and 64Cu-SAR-bisPSMA are unregistered products. The safety and efficacy of 67Cu-SAR-bisPSMA and 64Cu-SAR-bisPSMA have not been assessed by health authorities such as the US FDA or the Therapeutic Goods Administration (TGA). There is no guarantee that these products will become commercially available. About Prostate Cancer Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death in men worldwide[2]. Prostate cancer is the second-leading causes of cancer death in American men. The American Cancer Institute estimates in 2025 there will be about 313,780 new cases of prostate cancer in the US and around 35,770 deaths from the disease[3]. About Clarity Pharmaceuticals Clarity is a clinical stage radiopharmaceutical company focused on the treatment of serious diseases. The Company is a leader in innovative radiopharmaceuticals, developing Targeted Copper Theranostics based on its SAR Technology Platform for the treatment of cancers in children and adults. www.claritypharmaceuticals.com For more information, please contact: Clarity Pharmaceuticals Dr Alan Taylor Catherine Strong Executive Chairperson Investor/Media Relations ataylor@claritypharm.com c.strong@morrowsodali.com +61 406 759 268 References ClinicalTrials.gov Identifier: NCT04868604, https://clinicaltrials.gov/ct2/show/NCT04868604 Global Cancer Statistics 2022: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries, https://acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21834 American Cancer Society: Key Statistics for Prostate Cancer, https://www.cancer.org/cancer/prostate-cancer/about/key-statistics.html This announcement has been authorised for release by the Executive Chairperson.
BOSTON, March 5, 2025 /PRNewswire/ -- Bioheng Therapeutics US LLC ("Bioheng"), a clinical-stage biotech company dedicated to developing innovative universal CAR-T cell therapies, today announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for CTD402, a CD7-targeted universal CAR-T (UCAR-T) cell therapy, for the treatment of pediatric and adult patients with relapsed/refractory T-cell acute lymphoblastic leukemia/lymphoma (R/R T-ALL/LBL). The study approved by the FDA is a single-arm, open-label Phase Ib/II trial with a simplified dose-finding design, designed to optimize dosing and accelerate clinical development. "We are delighted that CTD402 has received IND clearance from the U.S. FDA for a Phase Ib/II trial with a simplified dose-finding design, accelerating our clinical development timeline in the United States," stated Jiangtao Ren, Ph.D., President & Chief Scientific Officer (CSO) of Bioheng. "IIT study results showed an impressive ORR, alongside a favorable safety profile. These results validate our ANSWER® platform's ability to deliver both rapid therapeutic impact and reduced patient risk, positioning CTD402 as a potential best-in-class therapy for T-cell malignancies." About CTD402 CTD402 is a universal CAR-T cell product targeting CD7 derived from healthy donors and intended for the treatment of T-ALL/LBL. It is genetically modified to avoid fratricide, graft-versus-host disease (GvHD), and host-versus-graft rejection (HvG) while enhancing anti-tumor activity. CTD402 can be prepared in a single batch for multiple people, achieving an "off-the-shelf" capability for patients in need of CAR-T cell therapy. About T-ALL/LBL T-ALL/LBL are distinct clinical presentations of the same malignancy, originating from immature T-cell lineage lymphoid cells and classified based on the degree of bone marrow involvement. [1] While frontline therapy achieves high complete remission (CR) rates, the majority of patients ultimately experience relapse. Relapsed or refractory (R/R) disease is associated with poor outcomes, with a 5-year overall survival (OS) rate of less than 20%.[2] About Bioheng Bioheng Therapeutics is a clinical-stage company focused on allogeneic "off-the-shelf " universal CAR-T therapies. Founded in 2017, we aim to develop the world's leading allogeneic cell therapy platforms and products to address some of the most challenging unmet needs. References: [1] Swerdlow S H, Campo E, Pileri S A, et al. The 2016 revision of the World Health Organization classification of lymphoid neoplasms[J]. Blood, The Journal of the American Society of Hematology, 2016, 127(20): 2375-2390. [2] Marks D I, Rowntree C. Management of adults with T-cell lymphoblastic leukemia[J]. Blood, The Journal of the American Society of Hematology, 2017, 129(9): 1134-1142.
Clinical Trials/Medical Discoveries
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