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Acerand Therapeutics Initiates First-in-Human Phase I Clinical Trial of ACE-232, a Novel CYP11A1 Inhibitor for Advanced Prostate Cancer
Acerand Therapeutics Initiates First-in-Human Phase I Clinical Trial of ACE-232, a Novel CYP11A1 Inhibitor for Advanced Prostate Cancer

Yahoo

time4 days ago

  • Business
  • Yahoo

Acerand Therapeutics Initiates First-in-Human Phase I Clinical Trial of ACE-232, a Novel CYP11A1 Inhibitor for Advanced Prostate Cancer

SHANGHAI & INDIANAPOLIS, June 05, 2025--(BUSINESS WIRE)--Acerand Therapeutics, a clinical-stage biotech company focusing on the discovery and development of innovative small-molecule therapies in oncology, today announced the dosing of the first patient in its first-in-human Phase I clinical trial (NCT06801236) of ACE-232, a novel oral inhibitor of CYP11A1. The trial is being conducted in patients with metastatic castration-resistant prostate cancer (mCRPC). This multicenter Phase I study is being conducted in both the United States and China. The study comprises two parts: a dose-escalation phase (Phase IA) and a dose-optimization phase (Phase IB). The primary objectives are to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), as well as preliminary clinical activity of ACE-232, and to determine the recommended Phase II dose (RP2D). Professor Emmanuel Antonarakis, Director of Genitourinary Oncology at Masonic Cancer Center, University of Minnesota, is serving as the global coordinating Principal Investigator for the study. "I would like to congratulate the Acerand team, the research staff, and the first patient for helping us to reach this important milestone," says Dr. Antonarakis. Preclinical data demonstrated that ACE-232 possesses superior potency, efficacy, and pharmacokinetic properties (flat PK curve and long half-life profile) compared to other investigational CYP11A1 inhibitors, including MK-5684 (Opevesostat, formerly known as ODM-208). ACE-232 showed excellent tolerability in preclinical models, presenting a wide therapeutic window for clinical development. The initiation of this trial marks a significant milestone for Acerand, representing its first clinical study in the United States and highlighting its strategic commitment to the global development of innovative cancer therapies that address major unmet medical needs. About ACE-232 ACE-232 is a highly potent and selective small-molecule inhibitor of CYP11A1, a key adrenal enzyme involved in the first and rate-limiting step of steroid hormone biosynthesis. By targeting CYP11A1, ACE-232 aims to suppress the production of androgens and other steroid hormones, offering a novel therapeutic mechanism for the treatment of androgen-dependent (including enzalutamide or abiraterone-resistant) prostate cancer. About Acerand Therapeutics Acerand Therapeutics is a biotech company dedicated to discovering and developing novel small-molecule therapies for oncology and metabolic diseases. With research and development hubs in Shanghai, China, and Indianapolis, USA, ACE-232 leverages its proprietary innovation platform and operational efficiency to deliver a highly differentiated pipeline of drug candidates from discovery to clinical trials. View source version on Contacts Acerand Therapeuticsinfo@ 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

Acerand Therapeutics Initiates First-in-Human Phase I Clinical Trial of ACE-232, a Novel CYP11A1 Inhibitor for Advanced Prostate Cancer
Acerand Therapeutics Initiates First-in-Human Phase I Clinical Trial of ACE-232, a Novel CYP11A1 Inhibitor for Advanced Prostate Cancer

Yahoo

time4 days ago

  • Business
  • Yahoo

Acerand Therapeutics Initiates First-in-Human Phase I Clinical Trial of ACE-232, a Novel CYP11A1 Inhibitor for Advanced Prostate Cancer

SHANGHAI & INDIANAPOLIS, June 05, 2025--(BUSINESS WIRE)--Acerand Therapeutics, a clinical-stage biotech company focusing on the discovery and development of innovative small-molecule therapies in oncology, today announced the dosing of the first patient in its first-in-human Phase I clinical trial (NCT06801236) of ACE-232, a novel oral inhibitor of CYP11A1. The trial is being conducted in patients with metastatic castration-resistant prostate cancer (mCRPC). This multicenter Phase I study is being conducted in both the United States and China. The study comprises two parts: a dose-escalation phase (Phase IA) and a dose-optimization phase (Phase IB). The primary objectives are to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), as well as preliminary clinical activity of ACE-232, and to determine the recommended Phase II dose (RP2D). Professor Emmanuel Antonarakis, Director of Genitourinary Oncology at Masonic Cancer Center, University of Minnesota, is serving as the global coordinating Principal Investigator for the study. "I would like to congratulate the Acerand team, the research staff, and the first patient for helping us to reach this important milestone," says Dr. Antonarakis. Preclinical data demonstrated that ACE-232 possesses superior potency, efficacy, and pharmacokinetic properties (flat PK curve and long half-life profile) compared to other investigational CYP11A1 inhibitors, including MK-5684 (Opevesostat, formerly known as ODM-208). ACE-232 showed excellent tolerability in preclinical models, presenting a wide therapeutic window for clinical development. The initiation of this trial marks a significant milestone for Acerand, representing its first clinical study in the United States and highlighting its strategic commitment to the global development of innovative cancer therapies that address major unmet medical needs. About ACE-232 ACE-232 is a highly potent and selective small-molecule inhibitor of CYP11A1, a key adrenal enzyme involved in the first and rate-limiting step of steroid hormone biosynthesis. By targeting CYP11A1, ACE-232 aims to suppress the production of androgens and other steroid hormones, offering a novel therapeutic mechanism for the treatment of androgen-dependent (including enzalutamide or abiraterone-resistant) prostate cancer. About Acerand Therapeutics Acerand Therapeutics is a biotech company dedicated to discovering and developing novel small-molecule therapies for oncology and metabolic diseases. With research and development hubs in Shanghai, China, and Indianapolis, USA, ACE-232 leverages its proprietary innovation platform and operational efficiency to deliver a highly differentiated pipeline of drug candidates from discovery to clinical trials. View source version on Contacts Acerand Therapeuticsinfo@

Acerand Therapeutics Initiates First-in-Human Phase I Clinical Trial of ACE-232, a Novel CYP11A1 Inhibitor for Advanced Prostate Cancer
Acerand Therapeutics Initiates First-in-Human Phase I Clinical Trial of ACE-232, a Novel CYP11A1 Inhibitor for Advanced Prostate Cancer

Business Wire

time4 days ago

  • Business
  • Business Wire

Acerand Therapeutics Initiates First-in-Human Phase I Clinical Trial of ACE-232, a Novel CYP11A1 Inhibitor for Advanced Prostate Cancer

SHANGHAI & INDIANAPOLIS--(BUSINESS WIRE)--Acerand Therapeutics, a clinical-stage biotech company focusing on the discovery and development of innovative small-molecule therapies in oncology, today announced the dosing of the first patient in its first-in-human Phase I clinical trial (NCT06801236) of ACE-232, a novel oral inhibitor of CYP11A1. The trial is being conducted in patients with metastatic castration-resistant prostate cancer (mCRPC). 'I would like to congratulate the Acerand team, the research staff, and the first patient for helping us to reach this important milestone,' says Dr. Antonarakis. This multicenter Phase I study is being conducted in both the United States and China. The study comprises two parts: a dose-escalation phase (Phase IA) and a dose-optimization phase (Phase IB). The primary objectives are to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), as well as preliminary clinical activity of ACE-232, and to determine the recommended Phase II dose (RP2D). Professor Emmanuel Antonarakis, Director of Genitourinary Oncology at Masonic Cancer Center, University of Minnesota, is serving as the global coordinating Principal Investigator for the study. 'I would like to congratulate the Acerand team, the research staff, and the first patient for helping us to reach this important milestone,' says Dr. Antonarakis. Preclinical data demonstrated that ACE-232 possesses superior potency, efficacy, and pharmacokinetic properties (flat PK curve and long half-life profile) compared to other investigational CYP11A1 inhibitors, including MK-5684 (Opevesostat, formerly known as ODM-208). ACE-232 showed excellent tolerability in preclinical models, presenting a wide therapeutic window for clinical development. The initiation of this trial marks a significant milestone for Acerand, representing its first clinical study in the United States and highlighting its strategic commitment to the global development of innovative cancer therapies that address major unmet medical needs. About ACE-232 ACE-232 is a highly potent and selective small-molecule inhibitor of CYP11A1, a key adrenal enzyme involved in the first and rate-limiting step of steroid hormone biosynthesis. By targeting CYP11A1, ACE-232 aims to suppress the production of androgens and other steroid hormones, offering a novel therapeutic mechanism for the treatment of androgen-dependent (including enzalutamide or abiraterone-resistant) prostate cancer. About Acerand Therapeutics Acerand Therapeutics is a biotech company dedicated to discovering and developing novel small-molecule therapies for oncology and metabolic diseases. With research and development hubs in Shanghai, China, and Indianapolis, USA, ACE-232 leverages its proprietary innovation platform and operational efficiency to deliver a highly differentiated pipeline of drug candidates from discovery to clinical trials.

Orion's collaborator, MSD, expands clinical development program for opevesostat to women's cancers
Orion's collaborator, MSD, expands clinical development program for opevesostat to women's cancers

Yahoo

time21-05-2025

  • Business
  • Yahoo

Orion's collaborator, MSD, expands clinical development program for opevesostat to women's cancers

ORION CORPORATION INVESTOR NEWS 21 MAY 2025 at 07.30 EEST Orion's collaborator, MSD, expands clinical development program for opevesostat to women's cancers Orion's collaborator, MSD, has expanded the development program for opevestostat (MK-5684) to now include women's cancers. A new Phase 2 clinical trial evaluating the safety and efficacy of opevesostat for the treatment of breast, endometrial and ovarian cancers has been posted to database. The study is not yet recruiting patients. Further information is available on A Study of MK-5684 in People With Certain Solid Tumors (study identifier: NCT06979596) MSD has global exclusive rights to opevesostat which is an oral, non-steroidal and selective inhibitor of CYP11A1 discovered and developed by Orion. MSD is currently evaluating opevesostat in several clinical trials, including two Phase 3 trials, for the treatment of metastatic castration-resistant prostate cancer. Contact person:Tuukka Hirvonen, Investor Relations, Orion Corporation tel. +358 10 426 2721 Publisher:Orion CorporationCommunicationsOrionintie 1A, FI-02200 Espoo, Orion is a globally operating Nordic pharmaceutical company – a builder of well-being for over a hundred years. We develop, manufacture and market human and veterinary pharmaceuticals and active pharmaceutical ingredients. Orion has an extensive portfolio of proprietary and generic medicines and consumer health products. The core therapy areas of our pharmaceutical R&D are oncology and pain. Proprietary products developed by Orion are used to treat cancer, neurological diseases and respiratory diseases, among others. In 2024 Orion's net sales amounted to EUR 1,542 million and the company employed about 3,700 professionals worldwide, dedicated to building well-being. Orion's A and B shares are listed on Nasdaq Helsinki.

Orion's collaborator, MSD, expands clinical development program for opevesostat to women's cancers
Orion's collaborator, MSD, expands clinical development program for opevesostat to women's cancers

Yahoo

time21-05-2025

  • Business
  • Yahoo

Orion's collaborator, MSD, expands clinical development program for opevesostat to women's cancers

ORION CORPORATION INVESTOR NEWS 21 MAY 2025 at 07.30 EEST Orion's collaborator, MSD, expands clinical development program for opevesostat to women's cancers Orion's collaborator, MSD, has expanded the development program for opevestostat (MK-5684) to now include women's cancers. A new Phase 2 clinical trial evaluating the safety and efficacy of opevesostat for the treatment of breast, endometrial and ovarian cancers has been posted to database. The study is not yet recruiting patients. Further information is available on A Study of MK-5684 in People With Certain Solid Tumors (study identifier: NCT06979596) MSD has global exclusive rights to opevesostat which is an oral, non-steroidal and selective inhibitor of CYP11A1 discovered and developed by Orion. MSD is currently evaluating opevesostat in several clinical trials, including two Phase 3 trials, for the treatment of metastatic castration-resistant prostate cancer. Contact person:Tuukka Hirvonen, Investor Relations, Orion Corporation tel. +358 10 426 2721 Publisher:Orion CorporationCommunicationsOrionintie 1A, FI-02200 Espoo, Orion is a globally operating Nordic pharmaceutical company – a builder of well-being for over a hundred years. We develop, manufacture and market human and veterinary pharmaceuticals and active pharmaceutical ingredients. Orion has an extensive portfolio of proprietary and generic medicines and consumer health products. The core therapy areas of our pharmaceutical R&D are oncology and pain. Proprietary products developed by Orion are used to treat cancer, neurological diseases and respiratory diseases, among others. In 2024 Orion's net sales amounted to EUR 1,542 million and the company employed about 3,700 professionals worldwide, dedicated to building well-being. Orion's A and B shares are listed on Nasdaq in to access your portfolio

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