Sermonix Pharmaceuticals LLC
Sermonix Pharmaceuticals Inc is a privately held, Ohio-based biopharmaceutical company focused on developing and commercializing female-specific oncology products, particularly targeting breast cancer. The company is engaged in multiple Phase 2 clinical trials of its lead investigational drug, lasofoxifene, which shows promise as a treatment for ER-positive metastatic breast cancer, especially in cases with ESR1 mutations. Led by founder Dr. David Portman, the team has extensive experience in drug development, regulatory processes, and commercialization. Sermonix collaborates with global partners and is committed to addressing unmet medical needs in women's health and oncology, with a focus on overcoming resistance to hormonal therapies and improving quality of life for patients.
Industries
Nr. of Employees
small (1-50)
Sermonix Pharmaceuticals LLC
Columbus, Ohio, United States, North America
Products
Investigational oral selective estrogen receptor modulator (SERM)
An investigational oral endocrine therapy candidate developed for ER+/HER2- advanced breast cancer with ESR1 mutations; evaluated as monotherapy and in combination with CDK4/6 inhibitors in clinical studies.
Randomized clinical development program for ESR1-mutant ER+ breast cancer
A multi-study clinical program comprising randomized studies comparing an investigational endocrine therapy to standard-of-care fulvestrant-based regimens in patients with ESR1-mutant ER+/HER2- advanced breast cancer.
Patient survey program for ER+ metastatic breast cancer
A series of patient-focused surveys designed to capture knowledge, quality-of-life, sexual health, and symptom burden among people with ER+/HER2- metastatic breast cancer to inform clinicians and researchers.
Investigational oral selective estrogen receptor modulator (SERM)
An investigational oral endocrine therapy candidate developed for ER+/HER2- advanced breast cancer with ESR1 mutations; evaluated as monotherapy and in combination with CDK4/6 inhibitors in clinical studies.
Randomized clinical development program for ESR1-mutant ER+ breast cancer
A multi-study clinical program comprising randomized studies comparing an investigational endocrine therapy to standard-of-care fulvestrant-based regimens in patients with ESR1-mutant ER+/HER2- advanced breast cancer.
Patient survey program for ER+ metastatic breast cancer
A series of patient-focused surveys designed to capture knowledge, quality-of-life, sexual health, and symptom burden among people with ER+/HER2- metastatic breast cancer to inform clinicians and researchers.
Services
Clinical development and trial management
End-to-end design and execution of Phase 2 and Phase 3 oncology clinical trials, including multicenter enrollment, protocol implementation, and data dissemination.
Patient-reported outcomes and survey studies
Design and administration of patient surveys and quality-of-life studies to collect HRQoL, sexual health, and symptom data to inform clinical development and clinician education.
Strategic alliance and licensing support
Negotiation and execution of territorial licensing and strategic collaboration agreements to enable regional clinical development, regulatory filings, manufacturing and commercialization.
Access to partner GMP manufacturing and commercialization channels
Coordination with manufacturing partners that maintain GMP-certified facilities to support scale-up, quality-compliant production, and regional commercialization support.
Scientific communications and conference support
Preparation and dissemination of scientific posters, abstracts and conference presentations to communicate preclinical and clinical results.
Clinical development and trial management
End-to-end design and execution of Phase 2 and Phase 3 oncology clinical trials, including multicenter enrollment, protocol implementation, and data dissemination.
Patient-reported outcomes and survey studies
Design and administration of patient surveys and quality-of-life studies to collect HRQoL, sexual health, and symptom data to inform clinical development and clinician education.
Strategic alliance and licensing support
Negotiation and execution of territorial licensing and strategic collaboration agreements to enable regional clinical development, regulatory filings, manufacturing and commercialization.
Access to partner GMP manufacturing and commercialization channels
Coordination with manufacturing partners that maintain GMP-certified facilities to support scale-up, quality-compliant production, and regional commercialization support.
Scientific communications and conference support
Preparation and dissemination of scientific posters, abstracts and conference presentations to communicate preclinical and clinical results.
Expertise Areas
- Clinical trial management (Phase 2–3, randomized multicenter studies)
- Adaptive platform and neoadjuvant trial participation
- Precision oncology for ER+ metastatic breast cancer
- Translational and preclinical oncology research
Key Technologies
- Oral selective estrogen receptor modulators (SERMs)
- ESR1-mutation-targeted small-molecule therapy
- CDK4/6 inhibitor combination regimens
- Liquid biopsy and mutation detection assays