daleuton oral (DS107 oral) / DS Biopharma - LARVOL DELTA

[VIRTUAL] DSP107, a Novel Bi-Functional Fusion Protein That Combines Inhibition of CD47 with Targeted Activation of 4-1BB to Trigger Innate and Adaptive Anticancer Immune Responses (ASH 2020) - "The mainstay of treatment for Diffuse Large B cell Lymphoma (DLBCL) is conventional chemotherapy combined with anti-CD20 monoclonal antibody rituximab (RTX). Moreover, binding of DSP107 to CD47 enables the 4-1BBL-mediated costimulation of antitumor T cell cytotoxicity. Thus, DSP107 activates both innate and adaptive anticancer immunity and may be of use for the treatment of DLBCL alone or in combination with RTX."

IO Biomarker • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Immune Modulation • Inflammation • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Efficacy and Safety of Orally Administered DS107 in Adult Patients With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=219 | Terminated | Sponsor: DS Biopharma | Completed ➔ Terminated; Based on Interim Analysis results

Trial termination • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Efficacy and Safety of Orally Administered DS107 in Adult Patients With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P2; N=219; Completed; Sponsor: DS Biopharma; Recruiting ➔ Completed

Clinical • Trial completion • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Efficacy and Safety of Orally Administered DS107 in Adult Patients With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P2; N=200; Recruiting; Sponsor: DS Biopharma; Trial completion date: Aug 2020 ➔ Dec 2020; Trial primary completion date: Jul 2020 ➔ Nov 2020

Clinical • Trial completion date • Trial primary completion date • Atopic Dermatitis • Dermatitis • Dermatology • Dermatopathology • Immunology

Efficacy and Safety Study of Orally Administered DS107 in Moderate to Severe Atopic Dermatitis Patients (clinicaltrials.gov) - P2b; N=300; Active, not recruiting; Sponsor: DS Biopharma; Recruiting ➔ Active, not recruiting

Enrollment closed • Atopic Dermatitis • Biosimilar • Dermatitis • Dermatology • Immunology • Inflammation

Efficacy and Safety Study of Orally Administered DS107 in Moderate to Severe Atopic Dermatitis Patients (clinicaltrials.gov) - P2b; N=300; Recruiting; Sponsor: DS Biopharma; Trial primary completion date: Jun 2017 ➔ Feb 2018

Trial primary completion date • Atopic Dermatitis • Biosimilar • Dermatitis • Dermatology • Eczema • Immunology • Inflammation

A novel orally available delta-5 desaturase inhibitor prevents atherosclerotic lesions accompanied with changes of fatty acid composition and eicosanoid production in ApoE knockout mice. (PubMed, J Pharmacol Exp Ther) - "Delta-5 desaturase (D5D), encoded by fatty acid desaturase 1 (Fads1), is the rate-limiting enzyme for the conversion from dihomo-γ-linolenic acid (DGLA) to arachidonic acid (AA) in the ω-6 polyunsaturated fatty acid pathway...We conclude that compound-326 prevented the progression of atherosclerosis in Western-diet fed ApoE KO mice via anti-inflammatory effects, suggesting that D5D inhibitors can be a novel remedy for preventing CV events. SIGNIFICANCE STATEMENT: This study shows a D5D specific and orally available potent inhibitor provided the first evidence to support the concept that D5D inhibitors will be a novel remedy for preventing atherosclerosis and subsequent CV events through a novel anti-inflammatory mechanism."

Journal • Preclinical

Oral administration of whole dihomo-γ-linolenic acid-producing yeast suppresses allergic contact dermatitis in mice. (PubMed, Biosci Biotechnol Biochem) - "Taking advantage of well-known safety of S. cerevisiae, we previously investigated the efficacy of heat-killed whole DGLA-producing yeast cells on irritant contact dermatitis, and showed that oral intake of this yeast significantly suppressed inflammatory reactions, whereas no such suppression was observed by the intake of 25 times the amount of purified DGLA. Since this method is considered to be a simple and efficient way to suppress inflammation, we examined its effectiveness against allergic contact dermatitis (ACD) in this study and showed that this method was also effective against ACD."

Journal • Preclinical

Efficacy and Safety of Orally Administered DS107 in Adult Patients With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P2; N=200; Recruiting; Sponsor: DS Biopharma; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

Efficacy and Safety of Orally Administered DS107 in Adult Patients With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P2; N=200; Not yet recruiting; Sponsor: DS Biopharma; Initiation date: Jun 2019 ➔ Sep 2019

Clinical • Trial initiation date

A liposome-based formulation containing equol, dihomo-γ-linolenic acid (DGLA), and propionyl-L-carnitine to prevent and treat hair loss: a prospective investigation. (PubMed, Dermatol Ther) - "In the present study, the lotions TRINOV Lozione Anticaduta Uomo and TRINOV Lozione Anticaduta Donna, containing dihomo-γ-linolenic acid (DGLA), S-equol, and propionyl-l-carnitine, were tested on 30 men and 30 women (mean age of men was 46.6 ± 6.4 years; mean age of women was 49.5 ± 9.0) with signs of androgenic alopecia, respectively. Furthermore, significant increase in anagen hair and a significant decrease in telogen hair were observed starting from 3 months in male and 1 month in female patients. Thus, the formulations under investigation were effective in attenuating androgenic alopecia-related hair loss in men and women ."

Clinical • Journal

Fatty acid profile during lactation of Chinese women: a pooled data analysis (ESPGHAN 2019) - "...Concentrations of polyunsaturated FA such as linoleic (C18:2 n6), gamma-linolenic (C18:3 n6), arachidonic (C20:4 n6) and (ALA, C18:3 n3) acids were highly variable among individual studies as characterized by larger 95% CIs, whereas variation for other FA such as lignoceric (C24:0), dihomo-gamma linolenic (DGLA, C20:3 n6), eicosatrienoic (C20:3 n3), and docosapentaenoic (C22:5 n3) acids was very low... Our analysis provides for the first time an overview of representative FA concentration means across lactational stages from a variety of geographies within China. We observed temporal patterns in the course of lactation for several FA means and confirm the complexity, high variation, and diversity of different HMFA. Insights in the HMFA profile is important to advance our understanding in the function and interplay of the different FA in the growth and development of infants, an understanding that is currently lacking for many FA."

Clinical

Efficacy and Safety of Orally Administered DS107 in Adult Patients With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P2; N=200; Not yet recruiting; Sponsor: DS Biopharma

Clinical • New P2 trial