Fulvestrant

Partnership aims to develop efficacious and well-tolerated treatments for advanced metastatic breast cancer COLUMBUS, Ohio, and CAMBRIDGE, Mass., March 24, 2025 /PRNewswire/ -- Sermonix Pharmaceuticals, a privately held biopharmaceutical company developing innovative therapeutics to specifically treat metastatic breast cancers (mBC), and Regor Therapeutics Group, a clinical-stage global biopharmaceutical company, today announced a strategic collaboration to optimize Regor's proprietary, cutting-edge rCARD™ (Regor Computer Accelerated Rational Discovery) platform for identification of novel targets and therapeutics that fulfill unmet patient clinical needs and preferences in the breast oncology arena. The partnership will unite the key core competencies of both organizations to leverage expertise from early discovery through preclinical, clinical, and commercial launch, resulting in treatments that deliver on the promise of fulfilling on efficacy but also developing therapies with tolerability and quality of life profiles that are aligned with patient priorities and concerns. With a Phase 3 asset – oral lasofoxifene – in development for the treatment of ESR1-mutated ER+ HER2- mBC, the Sermonix team has expertise within the clinical drug development and commercialization arena and understands the landscape and value proposition of new treatments, which are requirements for launch success and adoption by both patients and health care providers. Patient insights and unmet needs within the arena of onco-sexuality and cardio oncology, in addition to patient concerns with respect to bone health, have been increasing in importance and are areas for which Sermonix also has expertise and interest in exploring. These areas are currently gaps within the breast cancer treatment patient arena and hold great concern for patients as breast cancer potentially evolves from a lethal to a chronic disease. Regor's leading rCARD™ platform empowers drug discovery and development from target identification and validation, molecular design and optimization, to translational research and clinical development with unprecedented speed, efficiency, and success rate. "Regor's translational to clinical approach – and then confirmation of clinical impact – is one we greatly admire and is producing molecules for development that will be best in class from both an efficacy and tolerability perspective," said Dr. David Portman, Sermonix founder and chief executive officer. "At Sermonix, we believe patients deserve not only highly efficacious treatments, but also ones that are well tolerated and potentially improve quality of life for breast cancer patients. Deep patient insights and the potential to develop targets that can ultimately provide efficacy while addressing areas of key concerns to patients such as vaginal, bone, and cardiovascular health would be fulfilling on the promise of optimized drug development. It is an honor to collaborate with Regor in that shared mission." Sermonix is currently enrolling its Evaluation of Lasofox ife ne in ESR1 Mutations (ELAINE-3) study, comparing targeted lasofoxifene in combination with the CDK 4/6 inhibitor abemaciclib versus fulvestrant plus abemaciclib in pre- and post-menopausal subjects with locally advanced or metastatic ER+/HER2- breast cancer with an ESR1 mutation. "After engaging in extensive discussions with Sermonix, closely watching its clinical and commercial market development efforts in the breast oncology segment, it is obvious the company shares the vision and dedication of our team at Regor," said Dr. Xiayang Qiu, founder and CEO of Regor. "The Sermonix team demonstrates both expertise and passion, and we are truly excited to embrace that as part of our work in identifying optimal drug candidates that can make a significant impact for patients with metastatic breast cancer." About Sermonix Sermonix Pharmaceuticals Inc. is a privately held biopharmaceutical company focused on the development of female-specific oncology products and is currently undertaking a Phase 3 clinical study of lasofoxifene, its lead investigational drug. The Sermonix management team, led by founder Dr. David Portman, has significant experience in all stages of the drug development, regulatory and commercialization processes. Paul Plourde, M.D., vice president of oncology clinical development, has many decades of experience at AstraZeneca in the breast cancer drug development arena. Barry Komm, Ph.D., chief scientific officer, is recognized for his expertise in nuclear receptor biology. Miriam Portman, M.D., is co-founder and chief operating officer, with expertise in clinical trial conduct and patient recruitment. Elizabeth Attias, M.M.Sc., Sc.D., chief strategy and development officer, has extensive experience in pharmaceutical drug commercialization. Simon Jenkins, Ph.D., vice president of operations, has over 30 years of experience in global drug development leadership. Sermonix non-executive chairman of the board is Anthony Wild, Ph.D., former president of both Parke-Davis Pharmaceuticals and Warner-Lambert's Pharmaceutical Division. Learn more at SermonixPharma.com. To learn more about the ELAINE studies, visit DiscoverElaine.com. Sermonix Contact: Elizabeth Attias, Sc.D. Chief Strategy and Development Officer [email protected] (973) 723-7832 About Regor Therapeutics Group Regor Therapeutics Group is a clinical-stage biotechnology company, headquartered in Cambridge, MA and with operations in Houston, TX, San Diego, CA, and Shanghai, China. Regor is developing innovative and clinically differentiated medicines to address large unmet needs in oncology, metabolism, and auto-immunity. Regor is powered by the highly efficient drug discovery engine rCARDTM (Regor Computer Accelerated Rational Discovery) that enables rapid prototyping and validation of candidate molecules. This rapid approach to developing small molecules against high-profile targets is the creation of the four cofounders who collectively brought decades of experience in leading US biopharma and were previously the named inventors of 4 FDA-approved medicines. The power of the rCARDTM platform and approach has been highlighted by out-licensing deals with top companies, including Roche/Genentech on next-gen CDK oncology agents RGT-419B and RGT-587 (now GDC-4198 and GDC-0587) in late 2024.To learn more about Regor, please visit us at . Regor Contact: Cece Wenqin Hu Communications & Corporate Affairs E: [email protected] SOURCE Sermonix Pharmaceuticals; Regor Therapeutics Group WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Pfizer and Arvinas have shared promising top-line results from a late-stage study of their investigational protein degrader vepdegestrant in a subset of breast cancer patients. The phase 3 VERITAC-2 trial has been evaluating the candidate against AstraZeneca’s endocrine therapy Faslodex (fulvestrant) in adults with oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. Patients enrolled to the trial had also experienced disease progression following prior treatment with cyclin-dependent kinase 4/6 inhibitors and endocrine therapy. VERITAC-2 met its primary endpoint in the cohort of patients with oestrogen receptor 1 (ESR1) mutations, a common cause of acquired resistance, with vepdegestrant demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to Faslodex. Statistical significance in PFS improvement was not reached in the intent-to-treat population. Overall survival was immature at the time of the analysis and will continue to be assessed as a key secondary endpoint, the companies said, adding that vepdegestrant was generally well tolerated and its safety profile was consistent with that observed in previous studies. Megan O’Meara, interim chief development officer at Pfizer Oncology, said: “Patients with advanced ER-positive/HER2-negative metastatic breast cancer face significant clinical challenges, with limited treatment options following disease progression and the development of resistance to available endocrine therapies. “This data from VERITAC-2 supports the potential of vepdegestrant to give patients whose tumours harbour ESR1 mutations additional time without disease progression, compared to [Faslodex].” It is estimated that nearly 320,000 people will be diagnosed with breast cancer in the US this year, with ER-positive/HER2-negative disease accounting for approximately 70% of all cases. Taken orally, vepdegestrant is designed to harness the body’s natural protein disposal system to specifically target and degrade the ER. The drug has already been granted fast track designation by the US Food and Drug Administration, and data from VERITAC-2 will now be shared with global regulatory authorities to potentially support regulatory filings. John Houston, chairperson, chief executive officer and president at Arvinas, said: “The first phase 3 data readout for a PROTAC degrader represents a significant achievement and this data shows that vepdegestrant has the potential to provide clinically meaningful outcomes for thousands of patients with metastatic breast cancer whose tumours harbour ESR1 mutations.”