Phyllodes Tumor

In collaboration with leading cancer centers, research results to be presented from four studies across a breadth of breast tumor types and genomic alterations demonstrating Caris' impact on precision medicine IRVING, Texas, Dec. 4, 2023 /PRNewswire/ -- Caris Life Sciences®(Caris), the leading next-generation AI TechBio company and precision medicine pioneer that is actively developing and delivering innovative solutions to revolutionize healthcare and improve the human condition using molecular science and AI, today announced that the company and collaborators within the Caris Precision Oncology Alliance™ (POA) will collectively present findings at the San Antonio Breast Cancer Symposium (SABCS) that illustrate the potential impact of molecular profiling on the treatment of breast cancer. The findings demonstrate the power of Caris' comprehensive clinico-genomic database that enables novel insights into cancer that could have profound effects on a patient's diagnosis, prognosis, care plan, and response to treatment. SABCS is being held December 5-9, 2023 (Booth #1433) in San Antonio, Texas. Continue Reading "The San Antonio Breast Cancer Symposium continues to be the premiere conference for breast cancer research," said George W. Sledge, Jr., MD, Executive Vice President and Chief Medical Officer of Caris. "As part of our continuing commitment to the breast cancer community, Caris is proud to share important clinical/translational research created with our academic partners on important breast cancer questions." The research findings demonstrate the power of Caris' comprehensive clinico-genomic database Post this Presentations and posters from Caris include: Milan Radovich, PhD, Senior Vice President and Chief Scientific Officer of Caris, will participate in a Concurrent Educational Session entitled "Genomics for Clinical Research and Cancer Care" from 3:10 – 5:00 p.m. CT on Thursday, December 7 in the Stars at Night Ballroom 1-2. Dr. Radovich will deliver a presentation on "Emerging approaches to targeting pathways using precision medicine in breast cancer" from 3:10 – 3:40 p.m. before participating in a panel discussion from 4:40 – 5:00 p.m. "Precision oncology in breast cancer is rapidly evolving with the recent approval of several targeted therapies that rely on the detection of molecular biomarkers to inform selection. On the horizon are novel genomic and AI based approaches that will further shape the future treatment of this disease," said Dr. Radovich. "This education session at SABCS will highlight advances in new drug modalities and targetable pathways; liquid biopsies and clonal hematopoiesis; emerging evidence on treatment resistance; and the forefront of AI-enabled digital pathology for biomarker detection." A Caris study will be featured in the Concurrent Poster Spotlight Sessions Block 5 in the "PS13 Special Populations: Pregnancy, Male and Geriatric Patients" section on Thursday, December 7, from 5:30 – 6:30 p.m. CT in the Stars at Night Ballroom 3-4. The spotlight poster is titled "Molecular and Immunological Landscape of Sex-Based Differences in Breast Cancer: A Distinct Disease in Men" (Presentation #PS13-09). The study was performed in collaboration with Caris Precision Oncology Alliance™ (POA) members Dana-Farber Cancer Institute and Legorreta Cancer Center at Brown University, as well as others including the Mayo Clinic. In the featured study, the molecular and immunological landscapes of male and female breast cancer were investigated across 10,728 breast cancer samples (male, n=137; female, n=10,591) using Caris' Next-Generation Sequencing (NGS) technology. The results of this analysis indicate that male breast cancer has differential molecular and immune features compared to female breast cancer. A better understanding of these sex-based differences may help inform disease outcomes, provide a rationale for tailored therapeutic approaches, and guide the design of future treatments. "The Caris Precision Oncology Alliance™ continues its contribution to advancing breast cancer research by presenting novel findings on the molecular and immunological features of male breast cancer at this year's SABCS," said Chadi Nabhan, MD, MBA, FACP, Chairman of the POA. "By leveraging Caris' expansive real-world clinico-genomic database, our partner academic institutions are able to uncover new insights into the underpinnings of breast cancer biology leading to better therapeutic interventions." The POA includes 90 cancer centers, academic institutions, research consortia and healthcare systems, including 42 NCI-designated cancer centers, collaborating to advance precision oncology and biomarker-driven research. POA members work together to establish and optimize standards of care for molecular testing through innovative research focused on predictive and prognostic markers that improve the clinical outcomes for cancer patients. Additional Presentations Reveal Potential Impact of Comprehensive Molecular Profiling Caris will present additional data from studies demonstrating the critical role of precision medicine and molecular profiling in the treatment of breast cancer. All presentations will be made available online through Caris' website beginning December 7. Comprehensive Molecular and Immunological Characterization of Invasive Ductal Triple-Negative Breast Cancer (Presentation Number: PO4-24-01) This investigation of the molecular and immune signatures of invasive ductal (ID) triple-negative breast cancer (TNBC) aimed to improve understanding of TNBC biology to facilitate future identification of novel targets for treatment of this heterogenous disease. The results of this retrospective study of more than 13,000 breast cancer samples indicate that ID TNBC is associated with a distinct mutational and immunological profile compared to ID non-TNBC. ID TNBC is also associated with worse overall survival compared to ID non-TNBC. However, ID TNBC patients have improved survival post-pembrolizumab treatment. Comprehensive Characterization of BCL2 Family Genes in Metaplastic Triple Negative Breast Cancer (Presentation Number: PO4-24-02) This study aimed to investigate the expression of BCL2 family genes in metastatic TNBC. Results of this molecular profiling study suggest a strong association between higher expression of PMAIP1 and worse patient survival in this cancer. This association may potentially be attributable to higher immune checkpoint and stem cell-related gene expression, in addition to higher frequency of PD-L1 positivity in PMAIP1-High tumors. Further investigation is needed to prospectively validate PMAIP1 as a potential prognostic biomarker candidate in metaplastic TNBC. Genomic Landscape of Malignant Phyllodes Tumors Identifies Subsets for Targeted Therapy (Presentation Number: PO4-24-08) Phyllodes tumors are rare tumors of the breast, a subset of which have considerable malignant potential. This study aimed to identify targetable alterations and enhance understanding of the mutational profiles of malignant phyllodes tumors (MPTs) to potentially enhance treatment options. NGS identified actionable genomic alterations, including an NTRK1 fusion and low HER2 transcriptional expression. These findings highlight the importance of NGS-based profiling, including RNA sequencing, in MPT research to uncover potential targeted treatment options for patients. About Caris Life Sciences Caris Life Sciences® (Caris) is the leading next-generation AI TechBio company and precision medicine pioneer that is actively developing and delivering innovative solutions to revolutionize healthcare and improve the human condition using molecular science and AI. Through comprehensive molecular profiling (Whole Exome and Whole Transcriptome Sequencing) and the application of advanced AI and machine learning algorithms, Caris has created the large-scale, clinico-genomic database and computing capability needed to analyze and unravel the molecular complexity of disease. This convergence of sequencing power, big data and AI technologies provides an unmatched platform to deliver the next-generation of precision medicine tools for early detection, diagnosis, monitoring, therapy selection and drug development. Headquartered in Irving, Texas, Caris has offices in Phoenix, New York, Tokyo, Japan and Basel, Switzerland. Caris or its distributor partners provide services in the U.S., Europe, Asia and other international markets. To learn more, please visit CarisLifeSciences.com. Caris Life Sciences Media Contact: Lisa Burgner [email protected] 214.294.5606 SOURCE Caris Life Sciences

VANCOUVER, BC, March 30, 2023 /PRNewswire/ - A Vancouver-based therapeutics company has begun a second Phase II trial of its novel long lasting non-opioid pain medication, with a specific focus on treating Chronic Scrotal Pain (CSP), a debilitating condition estimated to affect 1% of the male population. Sustained Therapeutics' first sustained release drug candidate, ST-01, is designed to slowly release over about 28 days from a single injection. The initial Phase I trial in CSP showed that the treatment was feasible with encouraging signals of activity. This Phase II trial will explore the possibility of repeated treatments, and will compare the reduction in pain to Standard of Care for this condition. "Many men suffering CSP are in the prime of their lives, and struggle with decreased quality of life, chronic and often debilitating pain," says Dr. Martin Gleave, Founder and Chief Medical Office of Sustained Therapeutics. "Our new therapeutic, specifically customized to treat CSP, could help reduce or eliminate CSP after a series of treatments, and improve quality of life for these men." This Phase II trial of ST-01 received regulatory clearance from Health Canada in December 2022, and the company moved quickly to begin screening and enrolling patients. Currently four sites across Canada are participating in the trial, and the first patient has been enrolled. The trial is planned to take about one year to recruit all the participants, with a further six months of follow-up. "One of the most important qualities of our drug is that it can be carefully tailored to treat a broad variety of conditions," says Dr. Gleave. "CSP is our main development focus, and we're already seeing promising results. Our researchers are focused on identifying more novel candidates to leverage this novel platform to deliver drugs and treat a wide variety of conditions." There is a high unmet medical need for an effective long-lasting treatment for CSP. An estimated 1 to 6 million men in the US suffer from CSP, with about 500,000 new cases occurring per year. Current treatments are either very mild, such as recommending NSAIDs, or invasive, including surgery. While about 15% of patients suffering from CSP do eventually have surgery, many others simply live with chronic, untreated pain. In severe cases some people cannot work, must go on disability, suffer depression and have reduced quality of life. A recent survey of urologists treating this type of condition found 80% feel Sustained Therapeutics' new drug meets an unmet need and would significantly increase their ability to help individuals suffering from CSP, providing them a "new tool" in their arsenal. The product is also easy to use, with no additional specialized training needed. Those interested in participating in the Canadian-based trial or learning more about it may contact Lesley Parker, VP Clinical Operations at Sustained Therapeutics, at lparker@sustainedtx.com This second trial complements Sustained Therapeutics' ongoing Phase II trial of ST-01 in the treatment of acute post-operative pain. Sustained has also added depth and experience to their leadership team with the appointment of William Annett as Chief Executive Officer, and Howard M. Glase to the Board of Directors. William brings a successful track record in the life sciences industry and Howard has over twenty-five years of Canadian and U.S. corporate pharmaceutical senior commercial management experience. About Sustained Therapeutics: Sustained Therapeutics is a clinical-stage company utilizing its advanced clinical and research expertise to develop non-opioid locally injected sustained-release therapeutics primarily for the treatment of pain. A spin-off from the University of British Columbia and the Vancouver Prostate Centre, their novel sustained-release drug delivery platform has the potential to provide effective, long-lasting solutions for managing both acute and chronic pain. The company also plans to develop the platform to enable sustained release treatments for cancer and inflammatory diseases. sustainedtherapeutics.com

CytoDyn (CYDY) and Biomm have signed an exclusive supply and distribution agreement that will enable the latter to market CCR5 antagonist leronlimab (PRO 140) in Brazil on receiving regulatory approval. An investigational humanised IgG4 mAb, leronlimab blocks CCR5, a cellular receptor vital in HIV infection, tumour metastases and other diseases, including Nonalcoholic Steatohepatitis (NASH). Currently, CytoDyn is carrying out clinical trials of leronlimab in Brazil for indications such as Long-Hauler Covid-19, NASH and cancer. Biomm CEO Heraldo Marchezini said: “We are very pleased with our recently executed exclusive supply and distribution agreement with CytoDyn. “Our urgent goal is to provide leronlimab to Brazilians critically ill with Covid-19.” Leronlimab has secured Fast Track designation from the US Food and Drug Administration (FDA) to assess two potential indications for treating the human immunodeficiency virus (HIV) and metastatic cancer. The first indication is combination treatment with HAART for HIV patients and the second is for metastatic triple-negative breast cancer (mTNBC). Meanwhile, CytoDyn is set to deliver the treatment to a Philippine hospital for administration to 28 critically ill Covid-19 patients under a new compassionate special permit (CSP). In this regard, the company’s commercial partner in the country, Chiral Pharma, is working with the Philippine FDA and the hospital. CytoDyn president and CEO Nader Pourhassan said: “Based upon the speedy recovery of the first Covid-19 CSP patient in the Philippines, we are coordinating very closely with Chiral and the regulators to ensure we are expediting as much leronlimab as needed. “We remain hopeful that all of these coordinated efforts will continue to expand the availability of leronlimab to the Philippines.” Prior to this, CytoDyn announced that the first CSP patient in the Philippines treated with a 700mg injection of Vyrologix (leronlimab-PRO 140) significantly improved 35 hours after receiving the medication.