Tuvatexib

LONDON, UK I January 29, 2024 I Vidac Pharma Holdings Plc. (Hamburg and Stuttgart: T9G; ISIN:GB00BM9XQ619; WKN: A3DTUQ), a clinical-stage oncology biopharmaceutical company pioneering a groundbreaking new way of treating cancer, today announces favorable findings from a Phase 2a interim analysis of its lead drug candidate VDA-1102 in Mycosis Fungoides (MF), a form of Cutaneous T-Cell Lymphoma (CTCL) and a rare “orphan” disease which might command fast-track regulatory processing . The data provide further signs of the efficacy and safety of Vidac Pharma’s family of non-toxic small molecules in treating cancer. The interim analysis of 50% of subjects showed an Objective Response Rate (ORR) of 56%, with 22% complete response (CR), and 34% partial response. Responses were observed between 8 and 12 weeks. These results compare favorably to the standard of care of mechlorethamine, which has a 13% CR and a much longer median response time of 26 weeks. Side-effects were local and mild in severity, except in one case, which was moderate. All patients recovered, however, and the disease did not progress in any of the patients during the 4 months of the study. “These interim results are another important confirmation that Vidac Pharma’s approach of attacking cancer at its core has substantial therapeutic potential. Our drug candidates reverse the abnormal metabolism that is a characteristic of all cancer cells, halting tumor proliferation and immune-resistance. What we are seeing bears the promise of applying these drugs across a wide range of cancers,” said Vidac Pharma Chief Executive Officer Max Herzberg. The interim results come from more than 50% of planned patients - 9 out of 16 – in an open-label within-subject placebo-controlled study into the efficacy and safety of VDA-1102 as a topical ointment treatment for 12 weeks in adult subjects with relapsed stage-1 MF. Next milestones are full-population interim results, expected in the second quarter, and final results in Q4. Vidac Pharma is developing a breakthrough new technology which reverses the abnormal metabolism of cancer cells – known as the Warburg effect - by preventing the Hexokinase 2 (HK2) enzyme from blocking the VDAC mitochondrial relay channels. Clinical data have shown the powerful effects this can have in halting cancer cell proliferation and restoring programmed cell death. Vidac’s lead drug candidate VDA-1102 is also at the clinical development stage for patients with actinic keratosis (AK), for which the company will soon launch a second Phase 2b study. About Vidac Pharma Vidac Pharma is a clinical-stage biopharmaceutical company dedicated to discovering and developing first-in-class medicines to help people suffering from a range of oncologic and onco-dermatologic diseases. Vidac develops first-in-class anti-cancer drugs by modifying the hyper glycolytic tumor microenvironment, targeting the overexpression and wrong anchoring of the Hexokinase 2 metabolic checkpoint (HK2) in cancer cells, to renormalize tumor microenvironment and selectively provoke their programmed death without affecting surrounding normal tissue. VDA-1102, a first drug candidate of Vidac Pharma was proven effective against advanced Actinic Keratosis (AK) and Cutaneous T-cell Lymphoma (CTCL) in Phase 2 trials in humans. www.vidacpharma.com SOURCE: Vidac Pharma

DUBLIN--( BUSINESS WIRE )--The "Cutaneous T-Cell Lymphoma - Pipeline Insight, 2022" clinical trials has been added to ResearchAndMarkets.com's offering. This "Cutaneous T-Cell Lymphoma - Pipeline Insight, 2022" report provides comprehensive insights about 25+ companies and 27+ pipeline drugs in Cutaneous T-Cell Lymphoma pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. Geography Covered Global coverage Cutaneous T-Cell Lymphoma Understanding Cutaneous T-Cell Lymphoma: Overview Cutaneous T-cell lymphoma (CTCL) is a rare type of blood cancer. It begins in a type of white blood cell called the T-lymphocyte (T-cell). T-cells help prevent infections and other diseases. As odd as it sounds, most T-cells are found in our skin. That's because our skin is the first line of defense against disease. The surface of an adult's skin contains about 20 billion T-cells. That's nearly twice as many T-cells as found in other parts of the body. There are many types of CTCL. More than half the people who develop CTCL will have one of the following types: Mycosis fungoides or Sezary syndrome. Mycosis fungoides is the most common type of CTCL. This type tends to worsen very slowly. It can stay in its earliest stage, which often looks like rash, for years. In this stage, the cancer is often difficult to diagnose because it tends to looks like eczema or psoriasis. These conditions are much more common than CTCL. Sezary syndrome is more aggressive. It can also look like eczema. Some people develop red and swollen skin over much of their body. Their skin may feel hot, sore, and extremely itchy. Because CTCL is rare and often looks like eczema or another common skin disease, it can take time to get the diagnosis. Some people who have CTCL are referred to a dermatologist because it's thought that they have a stubborn case of eczema or psoriasis. This report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Cutaneous T-Cell Lymphoma pipeline landscape is provided which includes the disease overview and Cutaneous T-Cell Lymphoma treatment guidelines. The assessment part of the report embraces, in depth Cutaneous T-Cell Lymphoma commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Cutaneous T-Cell Lymphoma collaborations, licensing, mergers and acquisition, funding, designations and other product related details. Cutaneous T-Cell Lymphoma Emerging Drugs Chapters This segment of the Cutaneous T-Cell Lymphoma report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases. Cutaneous T-Cell Lymphoma Emerging Drugs SGX301: Soligenix SGX301 is a novel first-in-class photodynamic therapy utilizing safe, visible light for activation. The active ingredient in SGX301 is synthetic hypericin, a potent photosensitizer that is topically applied to skin lesions, is taken up by the malignant T-cells, and then activated by fluorescent light 16 to 24 hours later. HyBryte (synthetic hypericin or SGX301) may provide a safer, more convenient alternative. It is a topical ointment which is applied to the lesions and then activated by safe visible fluorescent light. HyBryte is being tested as a photodynamic light therapy with an enhanced safety profile and a treatment regimen that may be completed in as little as 6 weeks. Its pivotal Phase III clinical study (the "FLASH" study) for CTCL has completed enrollment showing a statistically significant outcome after 6 weeks treatment (p=0.04) with continued improvement to 40% response rate after 12 weeks treatment (p< 0.0001). Lacutamab : Innate Pharma Lacutamab (IPH4102) is a first-in-class anti-KIR3DL2 humanized cytotoxicity-inducing antibody, which is currently in clinical trials for treatment of cutaneous T-cell lymphoma (CTCL), an orphan disease. This group of rare cutaneous lymphomas of T lymphocytes has a poor prognosis with few efficacious and safe therapeutic options at advanced stages. KIR3DL2 is an inhibitory receptor of the KIR family, expressed by approximately 65% of patients across all CTCL subtypes and expressed by up to 90% of patients with certain aggressive CTCL subtypes, in particular, Sezary syndrome. It is currently being evaluated in Phase II stage of development. BNZ-1: Bioniz BNZ-1 is a selective inhibitor of three members of the IL-2 family: IL-2, IL-9, and IL-15. The profile of BNZ-1 is promising as a long-term therapy capable of transforming the standard of care in CTCL as data implicates the dysregulation of IL-2/IL-9/IL-15 as responsible for disease pathology. Bioniz conducted a Phase I/II study in CTCL, in which BNZ-1 exhibited a substantial improvement in safety and efficacy relative to standard of care. BNZ-1 has orphan drug designation in US and EU. In February 2022, Equillium, Inc. announced that it has acquired Bioniz Therapeutics, Inc., a privately held clinical-stage biotechnology company. Bioniz developed its novel structured-domain peptides, including BNZ-1 and BNZ-2, entirely in-house from its proprietary product discovery platform. BNZ-1 is Phase II/III ready in CTCL with open U.S. INDs for each indication and has orphan designation for CTCL in the U.S. and Europe. Cutaneous T-Cell Lymphoma: Therapeutic Assessment This segment of the report provides insights about the different Cutaneous T-Cell Lymphoma drugs segregated based on following parameters that define the scope of the report, such as: Major Players in Cutaneous T-Cell Lymphoma There are approx. 25+ key companies which are developing the therapies for Cutaneous T-Cell Lymphoma. The companies which have their Cutaneous T-Cell Lymphoma drug candidates in the most advanced stage, i.e. Phase III include, Soligenix Phases The report covers around 27+ products under different phases of clinical development like Late stage products (Phase III) Mid-stage products (Phase II) Early-stage product (Phase I) along with the details of Pre-clinical and Discovery stage candidates Discontinued & Inactive candidates Route of Administration Cutaneous T-Cell Lymphoma pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as Intra-articular Intraocular Intrathecal Intravenous Ophthalmic Oral Parenteral Subcutaneous Topical Transdermal Molecule Type Products have been categorized under various Molecule types such as Oligonucleotide Peptide Small molecule Product Type Drugs have been categorized under various product types like Mono, Combination and Mono/Combination. Cutaneous T-Cell Lymphoma: Pipeline Development Activities The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Cutaneous T-Cell Lymphoma therapeutic drugs key players involved in developing key drugs. Pipeline Development Activities The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Cutaneous T-Cell Lymphoma drugs. Cutaneous T-Cell Lymphoma Report Insights Cutaneous T-Cell Lymphoma Pipeline Analysis Therapeutic Assessment Unmet Needs Impact of Drugs Cutaneous T-Cell Lymphoma Report Assessment Pipeline Product Profiles Therapeutic Assessment Pipeline Assessment Inactive drugs assessment Unmet Needs Key Players Soligenix Elorac Innate Pharma Viridian Therapeutics Sorrento Therapeutics Bio-Path Holdings Legend Biotech Genzada Pharmaceuticals VidacPharma Bioniz Therapeutics Otsuka Pharmaceutical Hoffmann-La Roche BioInvent International AB Scopus BioPharma Codiak BioSciences Merck Sharp & Dohme LLC Otsuka Pharmaceutical Co., Ltd. Myeloid Therapeutics Jiangsu Simcere Pharmaceutical miRagen Therapeutics Kymera Therapeutics Citius Pharmaceuticals 4SC Equillium Key Products SGX301 BNZ-1 Lacutamab ExoIL-12 BP1002 MRG-106 BBI-3000 WP1220 Tucidinostat IPH4102 Resiquimod VDA-1102 Resminostat Pembrolizumab ASTX660 KT-333 MT-101 SIM1811-03 Cobomarsen LB1901 EQ101 For more information about this clinical trials report visit https://www.researchandmarkets.com/r/uspzvl About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.