Latest news with #DrDaveSimpson
Associated Press
11 hours ago
- Business
- Associated Press
Iksuda Therapeutics Receives FDA IND Clearance for IKS014
NEWCASTLE, England--(BUSINESS WIRE)--Jun 30, 2025-- Iksuda Therapeutics (Iksuda), the developer of class-leading antibody drug conjugates (ADCs) with clinically validated tumour-selective payload release formats, today announces that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for IKS014, a human epidermal growth factor receptor 2 (HER2) ADC targeting patients with advanced HER2+ solid tumours, enabling the expansion of ongoing clinical trials. IKS014 is currently being investigated in an open-label phase 1 dose-escalation study ( ) designed to evaluate the safety and tolerability of increasing dose levels of IKS014 and establish a recommended phase 2 dose. Preliminary data from this study has demonstrated promising clinical activity across multiple tumour types, including breast, ovarian, gallbladder, and oesophageal cancers, and including patients who have relapsed after prior treatment with Enhertu. Gaining access to U.S. centres for the dose expansion stage of this phase 1 trial will enable efficient confirmation of the role of IKS014 in this important patient sub-set. Dr Dave Simpson, Chief Executive Officer, Iksuda Therapeutics, said: 'The FDA clearance of our IND application for IKS014 represents a significant milestone in our mission to address the critical unmet needs of patients with HER2-positive cancers, particularly those who have exhausted current standard-of-care options. Early clinical data has been extremely encouraging, and we are excited to expand our program to reach more patients. 'The early efficacy signals that have been observed, particularly in patients that have relapsed after receiving prior treatments of Kadcyla and Enhertu, suggest IKS014 could potentially offer a new treatment option for patients who currently have limited alternatives. We look forward to working with our clinical partners to further evaluate the potential of IKS014.' The first stage of this phase 1 trial, to determine the recommended phase 2 dose for dose expansion, is nearing completion. The expansion phase will assess several patient cohorts including those with HER2-positive breast cancer who are refractory to or cannot tolerate Enhertu, patients with HER2-low breast cancer and patients with HER2-positive positive gastric cancer. The IND clearance will allow Iksuda to access patients across sites in the United States, alongside sites in Australia, New Zealand, and Singapore. The phase 1 trial is expected to complete in 2H 2026. About IKS014 IKS014 is a potential best-in-class antibody drug conjugate, benefiting from tumour selective activation and release of the cytotoxic agent monomethyl auristatin F (MMAF). In preclinical trials, it displayed impressive activity in high- and low-HER2 expressing tumours with a favourable Therapeutic Index vs other HER2-directed drugs. Iksuda gained exclusive world-wide rights (excluding Greater China and South Korea) to IKS014 from LigaChem Biosciences ( ). About Iksuda Therapeutics: Iksuda Therapeutics is a clinical stage, UK-based biotechnology company focussed on the development of class leading antibody drug conjugates (ADCs) targeting difficult-to-treat haematological and solid tumours. Iksuda's pipeline of ADCs is centred on a portfolio of prodrug DNA and protein alkylating payloads in combination with stable conjugation chemistries including its proprietary PermaLink ® platform. The Company's design concepts for ADCs are now clinically validated to significantly improve the therapeutic index of this important modality and improve the outcomes for patients living with cancer. View source version on CONTACT: For further information please contact: Iksuda Therapeutics Dave Simpson, Chief Executive Officer Tel: +44 (0) 191 6031680 [email protected] Consulting (Financial Media and IR) Simon Conway / Rob Winder / Amy Byrne Tel: +44 (0) 020 3727 1000 [email protected] KEYWORD: NORTH AMERICA UNITED STATES IRELAND UNITED KINGDOM EUROPE MASSACHUSETTS INDUSTRY KEYWORD: SCIENCE BIOTECHNOLOGY RESEARCH PHARMACEUTICAL ONCOLOGY HEALTH FDA CLINICAL TRIALS SOURCE: Iksuda Therapeutics Copyright Business Wire 2025. PUB: 06/30/2025 08:00 PM/DISC: 06/30/2025 08:00 PM
Yahoo
30-05-2025
- Business
- Yahoo
Iksuda Therapeutics announces first patient successfully dosed in phase 1 trial evaluating IKS03 in advanced B cell non-Hodgkin lymphomas
First-in-human trial is designed to determine recommended dose of IKS03, a CD19-directed antibody drug conjugate, for the subsequent dose-expansion IKS03 is Iksuda's second asset to begin clinical testing NEWCASTLE, England, May 30, 2025--(BUSINESS WIRE)--Iksuda Therapeutics (Iksuda), the developer of class-leading antibody drug conjugates (ADCs) with clinically validated tumour-selective payload release formats, today announces the completion of dosing of its first patient with IKS03, a CD19-directed ADC, in a phase 1, first-in-human, clinical trial in patients with advanced B cell non-Hodgkin lymphoma. This first-in-human study ( will evaluate the safety, tolerability, preliminary antineoplastic activity, pharmacokinetics and pharmacodynamics of increasing dose levels of IKS03, and determine the recommended dose for dose-expansion. Efficacy will be further evaluated in disease-specific expansion cohorts. The study is currently enrolling patients across clinical sites in Italy, Spain, Australia, United States and Canada. Dr Dave Simpson, Chief Executive Officer, Iksuda Therapeutics, said: "With the first patient successfully completing the safety evaluation period with IKS03, Iksuda demonstrates its continued commitment to drive its differentiated ADCs through clinical proof of concept, further solidifying our position as a clinical-stage ADC-focused company. Although there have been advances in the treatment of non-Hodgkin lymphoma in recent years, there remains a significant unmet patient need, and we hope that IKS03 will be able to build on the potential benefit-risk profile suggested by the data generated in preclinical studies." About IKS03 IKS03 is a best-in-class CD19-targeting ADC delivering a tumour-activated prodrug pyrrolobenzodiazepine (PBD) which was licensed from LigaChem Biosciences (formerly LegoChem Biosciences) ( Preclinical testing demonstrates best-in-class efficacy (vs in-clinic and marketed CD19-targeted therapies) in in vivo xenograft models and significantly raised maximum tolerated dose (MTD) in non-human primate disease models, demonstrating its potential to be the leading anti-CD19 therapy in B-cell cancers. About Iksuda Therapeutics: Iksuda Therapeutics is a clinical stage, UK-based biotechnology company focussed on the development of class leading antibody drug conjugates (ADCs) targeting difficult-to-treat haematological and solid tumours. Iksuda's pipeline of ADCs is centred on a portfolio of prodrug DNA and protein alkylating payloads in combination with stable conjugation chemistries including its proprietary PermaLink® platform. The Company's design concepts for ADCs are now clinically validated to significantly improve the therapeutic index of this important modality and improve the outcomes for patients living with cancer. View source version on Contacts For further information please contact: Iksuda Therapeutics Dave Simpson, Chief Executive OfficerTel: +44 (0) 191 6031680Email info@ FTI Consulting (Financial Media and IR) Simon Conway / Rob Winder / Amy ByrneTel: +44 (0) 020 3727 1000Iksuda@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
