MT-101

CAMBRIDGE, Mass., April 17, 2023 /PRNewswire/ -- Myeloid Therapeutics, Inc. ("Myeloid"), a clinical stage mRNA-immunotherapy company, today announced its presentation of two posters at the American Association for Cancer Research (AACR) Annual Meeting, being held in Orlando, Florida. "At AACR 2023, we are pleased to present late-breaking research on our in vivo engineering capabilities and clinical data from our Phase I IMAGINE study of MT-101 in PTCL patients," said Daniel Getts, Ph.D., Chief Executive Officer of Myeloid. "These data demonstrate the power of myeloid cells to orchestrate broad immune responses. We look forward to advancing our platform and expanding our clinical portfolio of in vivo programming candidates and ATAK™ CAR cell therapy candidates." Details of the poster presentations are below: Title: "In vivo delivery of novel CD89 fusion receptor to myeloid cells by mRNA activates anti-tumor immunity " Session: Late-Breaking Research: Experimental and Molecular Therapeutics 1 Session Date and Time: Sunday April 16, 2023, 1:30 PM - 5:00 PM Location: Poster Section 35 Poster Board Number: 19 Abstract Presentation Number: LB027 Abstract Highlights: Myeloid illustrates with this poster its ability to engineer circulating and tumor-penetrating myeloid cells so that these cells are activated within the tumor setting and elicit anti-tumor adaptive immunity. This approach is an attractive, novel manner to harness systemic anti-tumor immunity. Myeloid has applied its engineering insights to overcome challenges of specifically targeting and activating myeloid cells in vivo. Myeloid has developed a novel in vivo myeloid cell engineering platform, in which a chimeric antigen receptor (CAR) is generated by fusing a tumor recognition scFv with the alpha chain of human Fc receptors (CD89). The stable expression and function of these receptors requires the endogenously expressed common Fc receptor gamma chain (FcRg), which expression is mostly restricted to myeloid cells. For in vivo engineering, the construct is encapsulated and delivered in lipid nanoparticles (LNP). Myeloid's most-advanced in vivo programming candidate is a candidate referred to as MT-302, targeting trophoblast cell surface antigen 2 (TROP2) on cancer cells. TROP2 is overexpressed in most human solid epithelial cancers, as compared to low expression in corresponding normal tissue. Increased TROP2 expression has been linked to increased tumor growth and has been implicated as a prognostic marker in these cancers, supporting the development of earlier therapies targeting TROP2. Within immunodeficient xenograft models of hepatocellular carcinoma and triple negative breast cancer, delivery of LNP mRNA encoding GPC3-CD89 or TROP2-CD89 fusion proteins resulted in anti-tumor efficacy, confirming the ability of this approach to program myeloid cells. Repeat dosing studies showed significant anti-tumor efficacy following bi-weekly administration of TROP2-CD89. These studies highlight the potential of in vivo delivery of CD89 fusion proteins to program myeloid cells to recognize and kill cancer, thus providing a novel, promising approach to treating cancer. Title: "Initial Preclinical and Clinical Experience of Autologous Engineered Monocytes in T cell Lymphoma Patients" Session Category: Clinical Trials Session: Phase I Clinical Trials in Progress Session Date and Time: Monday April 17, 2023, 1:30 PM - 5:00 PM Location: Poster Section 46 Poster Board Number: 19 Published Abstract Number: CT131 Abstract Highlights: Myeloid developed the first engineered monocyte cell product, by engineering autologous monocytes to express a novel chimeric antigen receptor (CAR). This CAR contains a tumor recognition domain that is fused to a CD8 hinge domain, Fcγ and PI3K intracellular signaling domains. In addition to imparting tumor specificity, the Fcγ and PI3K signaling domains promote phagocytosis, cytokine production and antigen presentation upon activation. In a rodent model of melanoma (gp75+ B16/F10-OVA), Ly6C+ monocytes engineered with this receptor were able to phagocytose tumor cells and cross present antigen in vitro. In vivo infusion of engineered monocytes was associated with significant suppression of tumor growth. FACS analysis of tumor-infiltrates demonstrated that engineered monocytes preferentially infiltrated tumors and differentiated into antigen presenting cells. Based on these promising data, MT-101 is being assessed in humans in the Phase 1, open-label, first-in-human trial in patients with refractory or relapsed T cell lymphoma, IMAGINE trial (NCT05138458). The primary objective is the assessment of safety and tolerability at Day 28, following 3 weekly cycles of 2 infusions. Secondary objectives include assessment of correlative markers of response, pharmacokinetics, and efficacy. In the first 3 subjects, MT-101 was well-tolerated, with no evidence of CRS, ICANS, or infusion reactions. Examination of biomarkers by CyTOF in one subject showed changes in circulating leukocytes, including B cells. In this subject, survival has been greater than 10 months, while the median overall survival of patients with R/R PTCL is 5.5 months. Abstracts and full session details can be accessed through the AACR meeting planner: AACR Annual Meeting 2023 | Meetings | AACR. About Myeloid's ATAK™ CAR receptors and in vivo mRNA Programming Myeloid's novel class of CARs, known as ATAK™ Receptors, combine tumor recognition with multiple proprietary innate-immune signaling domains. Myeloid scientists have screened multiple unexplored combinations of innate-immune signals and uncovered optimal multi-signal pathways. The combination of cancer recognition binders with these novel intracellular signaling domains allows myeloid cells to be reprogrammed with previously unexplored combinations of immune signals, leading to tumor killing and broad systemic anti-tumor responses. Myeloid's novel in vivo engineering platform specifically targets and activates myeloid cells to elicit broader anti-tumor adaptive immunity. Through this approach, Myeloid demonstrates that delivery of lipid-nanoparticles (LNPs) encapsulating mRNA results in selective uptake and expression by myeloid cells in vivo, leading to potent tumor killing in multiple cold tumor models. These data demonstrate the potential for Myeloid's technology to program cells directly in vivo. About Myeloid Therapeutics Myeloid Therapeutics is a clinical stage mRNA-immunotherapy company developing novel therapies for cancer and autoimmune diseases. Integrating the fields of RNA, immunology and medicine, the Company's proprietary platform provides clinical solutions by matching therapeutic modalities to disease conditions, including use of autologous cell therapies, in vivo cell programming using mRNA, RNA-based gene-editing using RetroT™ and multi-targeted biologics. For more information, visit . Investor and Media Contact Amy Conrad Juniper Point [email protected] SOURCE Myeloid Therapeutics

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.