ArsciCor (arsenic trioxide oral) / BioSenic - LARVOL DELTA

BioSenic provides third quarter 2024 Business Update (GlobeNewswire) - "A Phase III study with oral arsenic trioxide in the first-line treatment of cGvHD, for which Medsenic received positive pre-IND response from the FDA, is currently anticipated to start in 2024....Phase IIb clinical trials for SLE and SSc are in the planning stage with the protocols for both studies being ready....The start of SLE and SSc Phase II clinical trials is therefore not envisioned before 2025."

New P2b trial • New P3 trial • Chronic Graft versus Host Disease • Systemic Lupus Erythematosus • Systemic Sclerosis

Medsenic/BioSenic patent granted in Japan for more protection of its therapeutic platform (GlobeNewswire) - "BioSenic...today announces the granting of a key patent by the Japan Patent Office to expand protection of the arsenic trioxide (ATO) platform. The patent, titled 'Use of metal ions to potentiate the therapeutic effects of arsenic,' covers the use of ATO platform in combination with metal ions such as copper....The new patent, granted to BioSenic’s subsidiary company Medsenic, involves two main immediate areas of application. The first one is in immune- and autoimmune-related diseases – specifically, the BioSenic’s lead project in 2024, chronic GvHD and, later, systemic sclerosis and systemic lupus erythematosus."

Patent • Chronic Graft versus Host Disease • Systemic Lupus Erythematosus • Systemic Sclerosis

BioSenic releases new in-depth analysis of its positive phase 2 clinical data for optimal administration scheme for its next late-stage trial of arsenic trioxide (ATO) targeting cGvHD (GlobeNewswire) - P2 | N=21 | GvHD-ATO (NCT02966301) | Sponsor: Medsenic | "BIOSENIC...today announced the final results of a new, detailed post-hoc analysis of the Company's previous Phase 2 clinical trial of ATO for the first-line curative treatment of cGvHD...At 6 months, the ORR was 75.0%, with a CR rate of 35% and a PR rate of 40%. BioSenic's new in-depth post-hoc clinical analysis of the Phase 2 clinical data now shows that in the group of patients who did not respond after first so-called induction cycle, more patients (20%) responded after a consolidation cycle of treatment. As a result, BioSenic will continue to use this 2-cycle, time-limited regimen...In addition, BioSenic has determined that an increase in the number of weekly injections over a four-week course could significantly increase the positive effect of the treatment on the biological and cellular parameters of the disease, consistent with a full effect of the drugat levels determined to be very safe for patients."

P2 data • Chronic Graft versus Host Disease • Graft versus Host Disease • Immunology

Medsenic, BioSenic’s subsidiary, signed a new set of licensing and commercialization agreements with Phebra PTY Ltd. (GlobeNewswire) - "BIOSENIC...today announce the signature of global licensing, supply and commercialization agreements with Phebra Pty Ltd. related to the adaptation of the License Agreement and the MDA signed earlier in May 2021, when Phebra became a minority shareholder in Medsenic SAS....The improved terms will make it more attractive for investors to participate in the financing of the upcoming Phase 3 trial of oral arsenic trioxide (OATO/ ArsciCor). This new licensing agreements between Medsenic SAS and Phebra Pty Ltd should facilitate the final steps of manufacturing, clinical confirmation of efficacy and subsequent commercialization of our oral arsenic drug in the field of chronic Graft versus Host Disease (cGvHD)....In addition, under the license agreement, Phebra Pty Ltd. agrees that Medsenic SAS will have exclusive worldwide territorial rights for the use of OATO in GvHD."

Licensing / partnership • Chronic Graft versus Host Disease

BioSenic reports half year 2023 results (GlobeNewswire) - "The Medsenic Phase 2 clinical study with arsenic trioxide in the first-line treatment of cGvHD has been completed and provided positive results. A Phase 3 study with oral arsenic trioxide in the first-line treatment of cGvHD, for which Medsenic received positive pre-IND response from the FDA, is currently anticipated to start in 2024."

New P3 trial • Chronic Graft versus Host Disease

BioSenic releases details of optimized administration approach ahead of planned Phase 3 trial of OATO for chronic graft-versus-host disease (GlobeNewswire) - P2 | N=21 | GvHD-ATO (NCT02966301) | Sponsor: Medsenic | "BIOSENIC...announces the publication of an open-access article describing an optimized schedule for administration of oral arsenic trioxide (OATO) treatment for chronic graft-versus-host disease (cGvHD), based on an earlier post-hoc analysis of Phase 2 data. The schedule will play an important role in the protocol for BioSenic’s forthcoming pivotal Phase 3 clinical trial....It shows that the risk of loss of overall response over time is greater in patients who received only one cycle of ATO since they are in partial or complete remission at week 6 post-treatment compared to patients who received two cycles of second-line treatment. The use of 2 cycles of 4 weeks each, separated by a rest period of 4 weeks on ATO at 0.15mg/kg/day, should be optimal for the future treatment of cGvHD patients."

New P3 trial • P2 data • Chronic Graft versus Host Disease

BioSenic reaches agreement on a binding term sheet with Phebra PTY Ltd. with respect to the development of the first oral formulation of arsenic troxide for cGvHD treatment (GlobeNewswire) - "BIOSENIC...today announce the signature of a binding term sheet with Phebra PTY Ltd. related to the adaptation of the License Agreement and the MDA signed in May 2021....The initial License Agreement provided a commercialization agreement of 100% net profits for Medsenic SAS mainly in Europe and 55 % net sales profit for Phebra PTY Ltd. in the rest of the world (including major markets such as the US, Canada, South America, Japan, South East Asia, China and Australia)....In addition, under the license agreement, Phebra PTY Ltd. agrees that Medsenic SAS will have exclusive worldwide territorial rights for the use of OATO in GvHD."

Licensing / partnership • Chronic Graft versus Host Disease

BioSenic on its way to find the necessary funds to perform its key clinical trial on chronic Graft-versus-Host Disease (GlobeNewswire) - "BIOSENIC...today announces that it has signed a term sheet with Singapore based fund TrialCap Pte. Ltd. (the 'Term Sheet') and/or other lenders (the 'Lender') for a proposed debt and equity financing. BioSenic is seeking the funds to continue its clinical development, backed by previous highly promising Phase 2 and pre-clinical results of arsenic trioxide (ATO)....In accordance with the Term Sheet, the Lender will provide two term loan facilities of each up to USD 4,000,000. The facilities will be structured as a loan note facility agreement, with each loan to be advanced in cash directly to the relevant trial service provided or to BioSenic for relevant expenditures under the Phase 3 clinical study with oral arsenic trioxide (OATO) in first-line treatment of chronic Graft-versus-Host Disease (cGvHD)....In addition, under the Term Sheet, the Lender intends to make an equity investment of USD 800,000 in new shares of BioSenic."

Financing • Chronic Graft versus Host Disease

BioSenic performs further analysis of its phase 2 clinical trial data, leading to an optimal administration scheme for its next late-stage trial of arsenic trioxide in cGvHD (GlobeNewswire) - P2 | N=21 | NCT02966301 | Sponsor: Medsenic | "BIOSENIC...today announces the completion of a post-hoc analysis of its phase 2 clinical trial of ATO, finding the best scheme for administration of an efficient treatment of cGvHD. The analysis will be used to decide on the best oral ATO’s posology for BioSenic’s forthcoming phase 3 clinical trial....The primary endpoint of the phase 2 trial was preliminary efficacy based on the overall response rate (ORR; complete response [CR] or partial response [PR]) at 6 months, after 1 or 2 cycles of intravenous (IV) ATO treatment. At 6 months, the ORR was 75.0%, with a CR rate of 35% and PR of 40%....We are now focused on the finalizing preparations for our phase 3 trial of a new oral formulation of ATO targeting chronic graft-versus-host disease..."

New P3 trial • P2 data • Chronic Graft versus Host Disease • Graft versus Host Disease • Immunology

BioSenic receives a Chinese patent with broad claims, protecting the combined use of metal ions and arsenic salts to treat a wide range of serious diseases (GlobeNewswire) - "BioSenic...today announces the issuance of a key new patent entitled ‘Use of metal ions to potentiate the therapeutic effects of arsenic’ to its subsidiary company Medsenic by the China National Intellectual Property Administration (CNIPA). This patent (ZL202080040613.1)....The European Patent Office (EPO) granted similar protection (EP3972613) in April 2023....The patent involves two main immediate areas of application. The first is in immune and autoimmune related diseases such as chronic Graft-versus-Host Diseases (cGvHD), systemic sclerosis and systemic lupus erythematosus."

Patent • Chronic Graft versus Host Disease • Graft versus Host Disease • Immunology • Lupus • Systemic Lupus Erythematosus • Systemic Sclerosis

BioSenic provides financial update (GlobeNewswire) - "BioSenic today also enters into an agreement with the ABO Securities subsidiary, Global Tech Opportunities 15, to secure short term financing on the basis of the existing convertible bond program. Subject to the terms and conditions of the agreement, BioSenic shall be entitled to draw down three tranches of each EUR 0.3 million in June, July and August under the existing convertible bond program, for an aggregate principal amount of EUR 0.9 million. The parties will discuss how to draw down the remaining EUR 600,000 of the existing program and have initiated discussions with a view to a possible renewal of the program. BioSenic is currently preparing a fundraising to be organized in Q3/Q4 2023 to initiate the Phase III clinical trial in chronic graft versus host disease (cGVHD) in Q1 2024."

Licensing / partnership • New P3 trial • Chronic Graft versus Host Disease • Graft versus Host Disease • Immunology

BioSenic puts Phase IIb ALLOB trial on hold (GlobeNewswire) - "BioSenic's clinical activities will now focus on its Phase III cGVHD trial with oral arsenic trioxide (OATO). BioSenic, through the Medsenic company autoimmune disease platform had completed a successful phase II trial targeting cGVHD (chronic Graft vs Host Disease), with a demonstrated efficacy of more than 75% on the Full Study Population and 84% on the Per Protocol Population. A phase III study is now in the starting blocks to reach the market as quickly as possible, through the framework of an expedite 505(b)(2) FDA regulatory pathway."

New P3 trial • Chronic Graft versus Host Disease • Graft versus Host Disease • Immunology

BioSenic presents data on its new copper-arsenic trioxide combination for immunological disorders at the 25th International Conference on Redox Medicine (GlobeNewswire) - "BioSenic...will present the latest data on its arsenic trioxide (ATO) platform at the 25th International Conference on Redox Medicine 2023, held by Redox Medicine Society on June 21-23 in Paris, France...The presentation will focus on recent data for ATO...BioSenic is already evaluating an oral version of ATO (OATO) for systemic autoimmune indications, including an upcoming Phase III study in patients with chronic graft-versus-host disease following allogeneic hematopoietic stem cell transplant."

Clinical data • Chronic Graft versus Host Disease • Graft versus Host Disease • Immunology • Systemic Lupus Erythematosus • Systemic Sclerosis

BioSenic provides update regarding current license agreement with Phebra (GlobeNewswire) - "BioSenic...announces the amendment of the license agreement between its affiliate Medsenic SAS and Phebra Pty Ltd...Medsenic and Phebra entered into a license agreement and a marketing and supply agreement for the oral formulation of arsenic trioxide ('OATO') in the following indications: Graft Versus Host Disease ('GvHD')...Under the license agreement, Medsenic agreed to commence a clinical study using Phebra OATO. If such study would not start before 31 May 2023, Phebra could terminate the license agreement unless the parties agree to postpone such date. The license agreement grant is now subject to Medsenic’s ability to commence a clinical study using OATO before 31 May 2024."

Licensing / partnership • Chronic Graft versus Host Disease • Graft versus Host Disease • Immunology

BioSenic provides First Quarter 2023 Business Update (GlobeNewswire) - "In May 2023, BioSenic identified key biomarkers for cGvHD and submitted patent to EPO. The technology covered by the patent applies to a method and kit for diagnosing and monitoring cGvHD in an individual who has undergone an allogeneic hematopoietic stem cell transplantation....A Phase III study with oral arsenic trioxide in the first-line treatment of cGvHD, for which Medsenic received positive pre-IND response from the FDA, is currently anticipated to start in 2023."

New P3 trial • Patent • Chronic Graft versus Host Disease • Graft versus Host Disease • Immunology

Medsenic Publishes an Article in Transplantation and Cellular Therapy, Unveiling High Response Rate and Corticosteroid Sparing With Arsenic Trioxide-based First-line Therapy in cGvHD after allo-HSCT (Businesswire) - P2 | N=21 | NCT02966301 | Sponsor: Medsenic | "First-line combination of arsenic trioxide and prednisone in cGvHD showed an Overall Response Rate (ORR) at 6 months of 75%, allowing rapid corticosteroid tapering....Medsenic...announced today a new publication in Transplantation and Cellular Therapy, - the official Journal of ASTCT (American Society for Transplantation and Cellular Therapy) - that provides insights from its drug Arscimed...in patients with Chronic Graft Versus Host Disease (cGvHD)....We look forward to confirming its efficacy in a Phase III study as well as its significant impact on improving the quality of life of cGvHD patients'...Medsenic received positive pre-IND response from FDA to initiate a Phase III Clinical Study in cGvHD, with an oral formulation of ATO (OATO, chosen commercial name: ArsciCor)."

FDA event • P2 data • Chronic Graft versus Host Disease • Graft versus Host Disease • Transplantation

BioSenic publishes new data on the mechanism of action of arsenic trioxide (ATO) (GlobeNewswire) - "BIOSENIC...announces that data providing additional details about the mechanism of action of its lead API arsenic trioxide (ATO) to prevent autoimmune diseases has now been published in a peer-reviewed paper. The article entitled 'Optimal combination of arsenic trioxide and copper ions to prevent autoimmunity in a murine HOCl-induced model of systemic sclerosis' also details an original ATO formula to maximize efficacy in fighting autoimmunity and reducing side effects. The peer-reviewed paper is published in Frontiers in Immunology. This new formulation data has been completed following pre-clinical activities and does not constitute data validated through clinical trial."

Preclinical • Chronic Graft versus Host Disease • Graft versus Host Disease • Immunology • Systemic Sclerosis

BioSenic SA provides an update on the developments of its TOA (Arsenic Trioxide) platform dedicated to autoimmune diseases (GlobeNewswire) - P2b | N=21 | NCT02966301 | Sponsor: Medsenic | The platform dedicated to autoimmune diseases using TOA has completed a phase IIb trial showing positive results on the safety and efficacy of the product in 20 patients suffering from cGVHD (the chronic form of graft versus host disease ). Of note, in this corticosteroid-controlled trial, patients' corticosteroid levels declined as early as six weeks after starting TOA treatment, reaching minimal levels....The cGvHD autoimmune disease platform's Phase III study was designed to reach market as quickly as possible, including through the US Food and Drug Administration's 505b2 fast-track regulatory pathway....As a result, BioSenic expects the passage of key, value-creating milestones during the first half of 2023, in particular the interim results of phase IIb of ALLOB and the start of the phase III study of TOA in cGvHD."

P2b data • Chronic Graft versus Host Disease • Graft versus Host Disease • Immunology

BioSenic SA provides update on its autoimmune disease platform based on ATO (arsenic trioxide) (GlobeNewswire) - "The autoimmune disease platform using ATO has completed a phase IIb trial with positive results on safety and efficacy in 20 patients for cGVHD (chronic Graft vs Host Disease)....As a result, BioSenic expects key value creation milestones in H1 2023 with...the start of the phase III study with ATO in cGvHD."

New P3 trial • Trial completion • Chronic Graft versus Host Disease • Graft versus Host Disease • Immunology