Docetaxel

RESEARCH TRIANGLE PARK, N.C.--( BUSINESS WIRE )--Despite a drop in venture funding for digital health companies over the last two-and-a-half years, digital health products and solutions are expanding in scope and function to aid patient diagnosis, treatment, and monitoring. More solutions are now focused on specific diseases, and their commercial appeal has grown as developers build solutions that bring value back to providers, are more easily integrated with health systems, and embrace innovation such as AI to personalize care and reduce provider workload. Product types have also expanded, with health assessment tools such as digital diagnostics, sensor-based digital measures, and remote patient monitoring solutions joining digital therapeutics and consumer health apps to offer value for personal health and clinical care. These findings are based on a new report from the IQVIA Institute for Human Data Science: Digital Health Trends 2024: Implications for Research and Patient Care . There are currently 337,000 digital health apps along with more than 360 software-based digital therapies and 103 digital diagnostics commercially available. Simultaneously, the number of AI/ML enabled mobile and point-of-care devices is growing. “The landscape of digital health has evolved over the past two years, yielding new products that are more commercially viable and meet the needs of stakeholders across a broadening set of uses,” said Murray Aitken, executive director, IQVIA Institute for Human Data Science. “Digital health tools now support both patients and providers as they move from diagnosis to treatment and disease monitoring, with their scope expanding as new health assessment tools such as digital diagnostics have joined more mature digital therapies, accelerating care and closing gaps to improve health outcomes. Ultimately, these solutions will better fit into existing care pathways and bring benefits to more segments of patients and health systems.” A few key highlights of the report include: Digital health apps: Among the 337,000 digital health apps currently available, disease-specific apps continue to grow in number. While many continue to support mental health and patients with diabetes and cardiovascular diseases, recently-launched apps also help those with visual impairments, auditory issues and dermatologic conditions. Since app stores first emerged in 2008, over 1 million digital health apps have been created. However, two-thirds of these are no longer marketed, reflecting a high level of churn as many developers failed to differentiate their apps, consumer/patient uptake is relatively slow and financial returns have been meager. Apps with stronger clinical evidence have seen higher rates of use and more rapid uptake, indicating it is a key driver of consumer adoption and commercial success, as increased stakeholder focus is placed on evidence generation. Digital therapeutics: Approvals and adoption of DTx, which treat or alleviate disease by delivering a medical intervention, have proliferated as opportunities to gain regulatory approval and reimbursement grow; 140 have received approval in one or more countries and are intended for patient use at home and more than 220 software-based digital therapies are being used by providers within digital care programs or in their clinics, totaling more than 360 commercially-available digital therapies. The most progress has been seen in Germany, which has led the regulatory process and reimburses for 56 DTx, followed by the U.S. with 46 approved and the UK with 20. Along with behavioral approaches to treat mental health and chronic diseases such as diabetes and hypertension, recently approved DTx use biofeedback and virtual reality to reduce various types of pain, treat visual impairments, support respiratory and post-stroke neurological rehabilitation, and treat PTSD and phobias. Sensor-based digital measures: Through the use of digital sensors and wearables, nuanced aspects of health and patient experience are becoming traceable and measurable in daily life. In patient care and in clinical development programs for innovative medicines, sensor-based measures, including digital biomarkers and clinical outcome assessments, are proving valuable to remotely monitor patients, demonstrate the effects of therapeutic interventions and track outcomes. Life sciences companies have invested in the creation and validation of new digital endpoints, with some even building molecule-to-market digital strategies that overlay their drug development programs. By offering higher quality of data capture, more consistent measurements and increased sensitivity than traditional methods, some digital endpoints have optimized clinical development, allowing trial sponsors to reduce clinical trial enrollment and further promise to reduce trial duration and the need for patients to travel to trial sites. The first sensor-based digital endpoints using wearables have also been formally approved for ongoing use in clinical trials by regulators in the U.S. and Europe. Digital diagnostics : Software-based devices that process signals from sensors have rapidly opened new routes to assess disease risk, accelerate diagnosis, monitor patient health and assess patient prognosis; and at least 103 such digital diagnostics are now commercially available. Notably, these digital health assessment tools are bringing new options to screen undiagnosed patients for diseases and enable providers to monitor patients remotely. Conditions now detectable using these tools include autism and autism spectrum disorders, sleep apnea, atrial fibrillation, skin cancers, epilepsy and sepsis, among others. Use of AI/ML : Many health assessment devices are enabled by AI/ML, and in the U.S., around 75 of these mobile and point-of-care tools have been approved by the FDA. This fits within a broader trend toward using AI to improve diagnostic equipment, and as of June 2024, 801 distinct AI/ML-enabled devices have received approval from the FDA. Remote patient monitoring: Digital tools such as wearables and symptom-tracking apps are being combined into broader clinical platform solutions for providers to monitor disease progression or response to therapy, detect recurrence and even predict future health changes to triage patients in greatest need of care. This has enabled the creation of hospital-at-home solutions that continuously detect and predict adverse events, thereby speeding patient discharge from hospital settings and improving quality of life for patients being treated with advanced therapies and medicines with higher risk profiles. Growth in this area has also spurred the creation of accelerated approval and reimbursement pathways for remote monitoring technologies. The uptake of digital health technologies: While the overall uptake of digital health technologies is rising, over the past two years it has been relatively limited and less than required to sustain high levels of investment, leading to multiple exits and restructuring by developers. Stakeholders in the digital health ecosystem are working through the regulatory and reimbursement challenges to attain sustainable investment and scaling of use that will provide maximum benefits to patients and health systems. The long-term potential for technology-supported and AI/ML-driven digital health interventions remains high despite near-term challenges. About the IQVIA Institute for Human Data Science The IQVIA Institute for Human Data Science contributes to the advancement of human health globally through timely research, insightful analysis and scientific expertise applied to granular non-identified patient-level data. Fulfilling an essential need within healthcare, the Institute delivers objective, relevant insights and research that accelerate understanding and innovation critical to sound decision making and improved human outcomes. With access to IQVIA’s institutional knowledge, advanced analytics, technology and unparalleled data, the Institute works in tandem with a broad set of healthcare stakeholders to drive a research agenda focused on Human Data Science, including government agencies, academic institutions, the life sciences industry, and payers. More information about the IQVIA Institute can be found at www.IQVIAInstitute.org . About IQVIA IQVIA (NYSE:IQV) is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. IQVIA’s portfolio of solutions are powered by IQVIA Connected Intelligence™ to deliver actionable insights and services built on high-quality health data, Healthcare-grade AI™ , advanced analytics, the latest technologies and extensive domain expertise. With approximately 88,000 employees in over 100 countries, including experts in healthcare, life sciences, data science, technology and operational excellence, IQVIA is dedicated to accelerating the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. IQVIA is a global leader in protecting individual patient privacy. The company uses a wide variety of privacy-enhancing technologies and safeguards to protect individual privacy while generating and analyzing information on a scale that helps healthcare stakeholders identify disease patterns and correlate with the precise treatment path and therapy needed for better outcomes. IQVIA’s insights and execution capabilities help biotech, medical device and pharmaceutical companies, medical researchers, government agencies, payers and other healthcare stakeholders tap into a deeper understanding of diseases, human behavior and scientific advances, in an effort to advance their path toward cures. To learn more, visit www.iqvia.com .

No dose-limiting toxicities reported in two different weekly doses in heavily pre-treated patients Preliminary evidence of dose response includes significant tumor shrinkage and one patient with complete resolution of a liver lesion MONTREAL, Dec. 09, 2024 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Thera technologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, today announced data from Part 3 (dose optimization, weekly dosing schedule) of its ongoing Phase 1b trial of sudocetaxel zendusortide (TH1902) – the company’s lead investigational peptide drug conjugate (PDC) – in patients with advanced ovarian cancer. Based on results demonstrating favorable tolerability and signals of efficacy, the Medical Review Committee, which includes study investigators and external experts, has unanimously recommended continued evaluation and exploration of higher doses. “We are encouraged by the tolerability and preliminary efficacy data for sudocetaxel zendusortide seen thus far in this part of the Phase 1 study, which was designed to explore dose optimization utilizing a weekly dosing schedule in a population of heavily pre-treated ovarian cancer patients,” commented Christian Marsolais, Ph.D., Senior Vice President and Chief Medical Officer at Theratechnologies. “These latest results add to the growing body of evidence that our novel PDC technology can deliver a toxic payload into cancer cells with little impact on non-cancerous tissues and we believe there could be further clinical implications at a higher dose.” A total of 13 patients with advanced ovarian cancer who progressed despite prior platinum-based and taxane chemotherapy were enrolled in two Arms in Part 3 of the Phase 1b trial. Seven patients were enrolled in Arm A and received a 1.75-mg/kg/week dose of sudocetaxel zendusortide on a weekly infusion, three-weeks-on/one-week-off schedule every 28 days. The six patients enrolled in Arm B received a 2.5-mg/kg/week dose on the same schedule. Investigators observed no dose-limiting toxicities in either arm. Although there were no responses observed in the five Arm A participants that comprised the per-protocol (PP) set, there was encouraging evidence of activity observed in three of the six patients enrolled in the Arm B PP set, including one patient with a complete resolution of a liver lesion. Those three Arm B patients also experienced significant reductions in the CA-125 ovarian tumor marker as well as significant tumor shrinkage, including two patients with more than a 25% reduction in tumor size. Additionally, Arm B participants in the PP set received a mean of 10.25 weeks of treatment compared to a mean of 7.6 weeks of treatment in patients treated on Arm A. All patients in Arm B received at least two cycles of treatment, with some completing up to four cycles (on-treatment range: 4-18 weeks). The Company received permission from the U.S. Food and Drug Administration (FDA) in 2023 to amend the initial Phase 1b clinical trial protocol based on results from Parts 1 and 2, which utilized every-3-week dosing. For Part 3, the protocol was amended to explore dosing weekly for three weeks, followed by a one-week break and shifted the focus to patients with ovarian cancer. At the 2024 American Society of Clinical Oncology (ASCO) annual meeting earlier this year, Theratechnologies presented an updated analysis from Parts 1 and 2 of the study, in which sudocetaxel zendusortide induced durable disease stabilization (up to 45 weeks) lasting beyond treatment completion in several patients with a variety of solid tumors. The ASCO presentation also highlighted early signals of efficacy observed in female cancers (ovarian cancer, endometrial cancer, triple-negative breast cancer [TNBC]), as well as a manageable safety profile when sudocetaxel zendusortide was dosed at 300mg/m2 given once every 3 weeks with few Grade 3 adverse events (AEs). “The latest data from Part 3 of the Phase 1 trial build on a compelling body of preclinical and translational evidence of antitumor activity with sudocetaxel zendusortide,” said Ira Winer, M.D., Ph.D., FACOG, a member of the Gynecologic Oncology and Phase 1 Clinical Trials Multidisciplinary Teams at Karmanos Cancer Center and Professor of Oncology at Wayne State University School of Medicine in Detroit, MI. “While this is a small sample of patients, it is not often that we see promising signs of efficacy, combined with favorable safety and tolerability data, in this patient population with advanced disease. We therefore recommend and encourage continued investigation with further dose escalation for this agent.” In addition to the Phase 1b clinical trial results, there is also an extensive body of preclinical data demonstrating the flexibility of the Company’s SORT1+ Technology™ platform when conjugated with different toxic payloads. With a significant portion of the clinical trial data to date now available, Theratechnologies will accelerate its search for a partner to advance its oncology program. About Sudocetaxel Zendusortide (TH1902) and SORT1+ Technology™ Sudocetaxel zendusortide is a first-of-its-kind sortilin receptor (SORT1)-targeting PDC, and the first compound to emerge from the Company’s broader licensed oncology platform. A new chemical entity, sudocetaxel zendusortide employs a cleavable linker to conjugate (attach) a proprietary peptide to docetaxel, a well-established cytotoxic chemotherapeutic agent used to treat many cancers. The FDA granted Fast Track designation to sudocetaxel zendusortide as a single agent for the treatment of all sortilin-positive recurrent advanced solid tumors that are refractory to standard therapy. Theratechnologies has established the SORT1+ Technology™ platform as an engine for the development of PDCs that target SORT1, which is expressed in multiple tumor types. SORT1 is a “scavenger” receptor that plays a significant role in protein internalization, sorting, and trafficking. Expression of SORT1 is associated with aggressive disease, poor prognosis, and decreased survival. It is estimated that SORT1 is expressed in 40% to 90% of endometrial, ovarian, colorectal, triple-negative breast (TNBC), and pancreatic cancers, making this receptor an attractive target for anticancer drug development. About Theratechnologies Theratechnologies (TSX: TH) (NASDAQ: THTX) is a biopharmaceutical company focused on the development and commercialization of innovative therapies addressing unmet medical needs. Further information about Theratechnologies is available on the Company's website at www.theratech.com, on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov. Follow Theratechnologies on LinkedIn and X (formerly Twitter). Forward-Looking Information This press release contains forward-looking statements and forward-looking information (collectively, the “Forward-Looking Statements”) within the meaning of applicable securities laws, that are based on management’s beliefs and assumptions and on information currently available to it. You can identify forward-looking statements by terms such as “may”, “will”, “should”, “could”, “promising”, “would”, “outlook”, “believe”, “plan”, “envisage”, “anticipate”, “expect” and “estimate”, or the negatives of these terms, or variations of them. The Forward-Looking Statements contained in this press release include, but are not limited to, statements regarding: (i) the conjugation of different toxic payloads to be directed into cancer cells; (ii) signs of efficacy, combined with safety and tolerability data of sudocetaxel zendusortide; (iii) the further development of the Company’s lead PDC, sudocetaxel zendusortide; and (iv) the search for a partner to advance the oncology program. Although the Forward-Looking Statements contained in this press release are based upon what the Company believes are reasonable assumptions in light of the information currently available, investors are cautioned against placing undue reliance on these statements since actual results may vary from the Forward-Looking Statements contained in this press release. These assumptions include, without limitation, that: (i) the technology stemming from the oncology platform will allow for the development and conjugation of various PDC and payloads to treat cancer; and (ii) the Company will be able to find a partner to pursue the development of the oncology platform. Forward-Looking Statements assumptions are subject to a number of risks and uncertainties, many of which are beyond the Company’s control, that could cause actual results to differ materially from those that are disclosed in or implied by such Forward-Looking Statements. These risks and uncertainties include, but are not limited to, (i) the lack of observation of signs of efficacy and safety results as sudocetaxel zendusortide may be further studied; (ii) difficulties in developing and conjugating payloads to peptides derived from the oncology platform; and (iii) the inability of the Company to find a partner to pursue the development of the oncology platform. We refer current and potential investors to the “Risk Factors” section of our annual information form filed under a Form 20-F dated February 21, 2024, available on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov under Theratechnologies’ public filings. The reader is cautioned to consider these and other risks and uncertainties carefully and not to put undue reliance on forward-looking statements. Forward-Looking Statements reflect current expectations regarding future events and speak only as of the date of this press release and represent our expectations as of that date. We undertake no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise, except as may be required by applicable law. Contacts: Media inquiries:Julie SchneidermanSenior Director, Communications & Corporate Affairscommunications@theratech.com1-514-336-7800 Investor Inquiries:Joanne Choi Senior Director, Investor Relationsjchoi@theratech.com551-261-0401