Giredestrant

BOSTON, Dec. 15, 2023 (GLOBE NEWSWIRE) -- Carrick Therapeutics, an oncology-focused biopharmaceutical company discovering and developing highly differentiated therapies, today announced that the first patient has been dosed in its Phase 2b clinical trial evaluating the combination of samuraciclib (CT7001), an oral and first-in-class inhibitor of CDK7, and fulvestrant, an intramuscular injected selective estrogen receptor degrader (SERD), in women with HR+, HER2- advanced breast cancer previously treated with a CDK4/6 inhibitor. “We continue to make great progress in evaluating the combination of samuraciclib and fulvestrant with the dosing of the first patient in the Phase 2b study,” said Tim Pearson, Chief Executive Officer of Carrick Therapeutics. “There is a large unmet need in treatment for women with HR+, HER2- breast cancer, which represents more than two thirds of all new female breast cancer cases. We previously announced data from a single-arm Ph2a study with this combination therapy that demonstrated both clinical activity and tolerability. As such, we are encouraged by the potential of samuraciclib to be a first and best-in-class treatment for women with advanced breast cancer.” The randomized Phase 2b clinical trial will evaluate the Progression Free Survival benefit of the novel combination of samuraciclib with fulvestrant in comparison to fulvestrant alone for patients with breast cancer that have progressed following treatment with a CDK4/6 inhibitor. The clinical trial is being conducted with support from Pfizer Ignite, a new end-to-end service for biotech companies with high potential science that leverages the company’s significant R&D capabilities, scale and expertise to accelerate the development of breakthrough therapies. Carrick maintains full economic ownership and control of samuraciclib and its pipeline. Clinical trial details can also be found on www.clinicaltrials.gov under study ID: NCT05963984. For additional information on the clinical trial, please contact hello@carricktherapeutics.com. About Samuraciclib (CT7001)Samuraciclib is the most advanced CDK7 inhibitor in clinical development. Inhibiting CDK7 is a promising therapeutic strategy in cancer as CDK7 regulates the transcription of cancer-causing genes, promotes uncontrolled cell cycle progression and promotes resistance to anti-hormone therapy. Samuraciclib has demonstrated a favorable safety profile and encouraging efficacy in early clinical studies. In addition to the above studies, samuraciclib has further potential in prostate, pancreatic, ovarian and colorectal cancers. Samuraciclib has been granted Fast Track designation from the U.S. Food and Drug Administration (FDA) for use in combination with fulvestrant for the treatment of CDK4/6i resistant HR+, HER2- advanced breast cancer. Carrick is collaborating with Roche, Menarini Group and Arvinas/Pfizer to evaluate novel combinations of samuraciclib with Roche’s oral SERD giredestrant, Menarini Group’s oral SERD elacestrant, and Arvinas/Pfizer’s proteolysis targeting chimera (PROTAC) Estrogen Receptor degrader vepdegestrant (ARV-471) in late-stage CDK4/6i resistant HR+, HER2- metastatic breast cancer. About Carrick TherapeuticsCarrick Therapeutics is an oncology-focused biopharmaceutical company developing highly differentiated novel therapies that address significant unmet needs. The Company’s lead program, samuraciclib, is a novel CDK7 inhibitor currently in Phase 2 clinical trials for HR+ breast cancer. Additionally, Carrick is developing CT7439, a novel CDK12/13 inhibitor / Cyclin-K glue-degrader, which is expected to enter a Phase 1 clinical trial in the first half of 2024. For more information about Carrick Therapeutics, please visit www.carricktherapeutics.com Carrick Contacts Carrick TherapeuticsJenny Horsfield, Chief Business Officerjenny.horsfield@carricktherapeutics.com Investors and MediaLuke Heagle, Real Chemistrylheagle@realchemistry.com

The MiRaDor trial, a proof-of-concept study, aims to evaluate the usefulness of ctDNA analysis to detect Minimal Residual Disease in early breast cancer patients who are at high risk of relapse This marks the first-time MEDSIR and Oncoclínicas will join forces to perform a trial together, with MEDSIR taking the lead in launching the advanced platform for patient monitoring and Oncoclínicas & Co contributing from multiple recruiting centers In 2022, MEDSIR and Oncoclínicas forged a strategic partnership, uniting their efforts to advance independent clinical research throughout Latin America and drive global independent oncological investigations SAN ANTONIO, Dec. 6, 2023 /PRNewswire/ -- MEDSIR presented today the design of the MiRaDor trial, a proof-of-concept study, conducted in collaboration with Oncoclínicas & Co, which aims to evaluate the usefulness of ctDNA analysis to detect minimal residual disease in patients who had hormone receptor positive/HER2 negative early breast cancer and are at high risk of relapse. The study will evaluate if serial blood sample analysis (with a periodicity of 3 months during the first year, and every 6 months afterwards) is able to identify early if cancer has returned, even before this can be detected by commonly used imaging tests. Additionally, it will evaluate if serial blood sample analysis can early identify if the patients are responding to a specific breast cancer treatment. The study will also assess patients with 90% decreases in baseline ctDNA at 6, 9, and 12 months, along with those with 70% and 50% decreases at corresponding intervals. This momentous partnership marks the first time these two entities will work together to recruit patients and conduct a trial, with MEDSIR being responsible for launching the advanced platform for patient monitoring and active participation from Oncoclínicas & Co across multiple recruiting centers. The genesis of this collaboration can be traced back to 2022 when MEDSIR — a global company specializing in the strategic design of independent clinical research — and Oncoclínicas & Co — considered one of the largest and most respected groups in oncology, hematology, and radiotherapy in Latin America — forged a strategic partnership, pooling their efforts to propel independent clinical research across Latin America and spearhead global investigations in oncology. The absence of an accurate test to determine relapse risks with standard-of-care treatment highlights the critical need for methods capable of swift identification and prediction of recurrence risk, as well as assessing treatment effectiveness in a more expedited manner. In response to this imperative, the innovative companies united forces for the first-time to launch this platform for enhanced patient monitoring, which will commence in December 2023 until June 2028. This pioneer platform systematically assesses how circulating tumor DNA (ctDNA) changes over time and in response to treatment, serving as a valuable tool in determining patients who are likely to experience disease recurrence. Moreover, it holds the potential to contribute significantly to the analysis of the efficacy of escalating new therapies for patients undergoing a relapse. Recent advancements in liquid biopsy methods, specifically circulating tumor DNA (ctDNA) analysis, have created a non-invasive alternative to traditional biopsies. ctDNA, small tumor DNA fragments present in the bloodstream, allows for the detection of minimal residual disease (MRD), often undetectable by standard tests. The MiRaDor trial integrates these innovative liquid biopsy methods into its two-phase structure: surveillance and treatment. The surveillance phase will involve 1,260 patients with HR[+]/HER2[-] early breast cancer undergoing endocrine therapy. Blood samples will be collected and ctDNA will be analyzed at multiple intervals to monitor changes over time. Patients with positive ctDNA results, without evidence of progression by imaging, will move to the treatment phase. In this subsequent phase, 40-60 patients will be assigned to one of four arms: (A) standard endocrine therapy (control group); (B) giredestrant (a selective estrogen degrader); (C) giredestrant + abemaciclib (a cyclin-dependent kinase 4/6 inhibitor); or (D) giredestrant + inavolisib (for patients with a PIK3CA mutation). Treatment and ctDNA assessments will continue until evidence of disease progression, physician's or patient's decision, or study completion. The MiRaDor clinical trial embodies a pivotal step towards advancing breast cancer patient care. Beyond its primary goal of early detection through the correlation of ctDNA changes with treatment efficacy, the study envisions itself as a transformative platform for heightened patient monitoring. This strategic approach not only facilitates the timely identification of patient progression but also enables swift therapeutic interventions, ultimately contributing to individualized and enhanced patient outcomes. Lastly, the significance of MiRaDor lies not only in its cutting-edge technology and strong strategic and scientific foundation but also in its role as the inaugural collaboration between MEDSIR and Oncoclínicas & Co in patient recruitment and trial execution. This milestone underscores MEDSIR's commitment to developing innovative clinical trials that have the potential to revolutionize the management of breast cancer patients, offering new ways for improved care and treatment strategies. ABOUT MEDSIR Founded in 2012, MEDSIR works closely with its partners to drive innovation in oncology research. Based in Spain and the United States, the company manages all aspects of clinical trials, from study design to publication, utilizing a global network of experts and integrated technology to streamline the process. The company offers proof-of-concept support and a strategic approach that helps research partners experience the best of both worlds from industry-based clinical research and investigator-driven trials. To promote independent cancer research worldwide, MEDSIR has a strategic alliance with Oncoclínicas, the leading oncology group in Brazil with the greatest research potential in South America. Learn how MEDSIR brings ideas to life: ABOUT Oncoclínicas & CO Oncoclínicas - the largest cancer care group in Latin America - has a specialized, innovative model that focuses on the entire oncology care process, combining operational efficiency, humanized service and high specialization, through a medical team made up of more than 2,600 professionals, who mainly specialize in oncology. With the mission of making cancer treatment accessible to everyone in the country, it offers a complete operational system made up of outpatient clinics integrated with highly complex oncology centers. It currently has 134 units in 35 Brazilian cities, providing access to cancer care in all regions where it operates, with the quality standards of the best cancer centers in the world. The Group also owns Boston Lighthouse Innovation, a bioinformatics company based in Cambridge, USA, and holds shares in MEDSIR, a Spanish company dedicated to the development and management of clinical trials for independent cancer research. ínicas.com SOURCE MEDSIR