BioSpace Global Roundup, Aug. 27
Orchard Therapeutics – London-based Orchard Therapeutics will present new interim data from a study of OTL-203, an investigational gene therapy for the treatment of mucopolysaccharidosis type I (MPS-I) at the upcoming 46th Annual Meeting of the European Society for Blood and Marrow Transplantation.
ASLAN Pharmaceuticals – Singapore-based ASLAN announced the resumption of patient recruitment into its randomized, double-blind, placebo-controlled multiple ascending doses (MAD) study of ASLAN004 in moderate to severe atopic dermatitis. ASLAN paused recruitment of new patients in April in line with government restrictions enforced in Singapore to contain the spread of the coronavirus disease (COVID-19). Patients are now being recruited into the second of three dose cohorts at all screening sites in Singapore. To accelerate recruitment, ASLAN is in the process of opening additional study sites in Australia and the U.S., the company said. ASLAN expects to report interim, unblinded data from all dose cohorts in the fourth quarter of this year.
MC2 Therapeutics – Denmark’s MC2 struck a collaborative agreement with EPI Health, LLC on the commercialization of Wynzora Cream (calcipotriene and betamethasone dipropionate, w/w 0.005%/0.064%) in the U.S. Wynzora Cream was approved by the U.S. Food and Drug Administration (FDA) in July for the topical treatment of plaque psoriasis in adults, 18 years of age or older. MC2 Therapeutics retains full ownership of Wynzora Cream under the agreement and MC2 Therapeutics and EPI Health will utilize their combined resources to make the medication a leading patient preferred topical treatment of psoriasis in the U.S.
Pilloxa –Digital health company Pilloxa, based in Sweden, received €580,000 in funding from the EU’s EUROSTARS program The funds will also be used for further development of a complete digital system that facilitates the process both for the patients included in the study and for the investigator. The company is developing digital patient-centric solutions and, with the University of Oslo, will validate an innovation that supports the patient to take their medication as prescribed and further develop the solution to increase the quality and effectiveness of drug treatment in both the healthcare setting and during clinical trials. The study is the first of its kind in the field and the hope is that the results will lay the foundation for the next step in patient-centered drug development and treatment.
MetP Pharma AG – Switzerland-based MetP announced its nasal gel Nascum-VIREX will be evaluated for its protective effect against viral infection. The aim of the study is to test the effect of acute dose apical exposure of Nascum-VIREX upon viral infection with Human Rhinovirus 16 (HRV-A16) using fully differentiated human nasal epithelial cells. The nasal gel is highly bio-adhesive and forms a physical barrier in the nasal cavity to significantly trap airborne particles by a mechanical effect. The results of the study are expected at the end of October 2020. Nascum-VIREX is an antiviral-modified version of Nascum-Plus gel whose robust activity against the transmission noxious particles has already been proved.
Cynata Therapeutics – Australia’s Cynata Therapeutics Limited announced that the MEND (MEseNchymal coviD-19) Trial is now open for patient enrolment. The MEND Trial will investigate early efficacy of Cynata’s proprietary Cymerus mesenchymal stem cells (MSCs) in adults admitted to intensive care with COVID-19.
Byondis BV – Netherlands-based Byondis announced that the first patients have started treatment in a Phase I study of its investigational antibody-drug conjugate (ADC) [vic-]trastuzumab duocarmazine (SYD985) in combination with niraparib in patients with a HER2-expressing locally advanced or metastatic solid tumor. The study will enroll up to 120 patients who progressed on standard therapy or for whom no standard therapy of proven benefit exists. The first part of the study is taking place in leading European oncology centers in Belgium, United Kingdom and the Netherlands. Leading centers in France, Spain and Poland will join this trial at a later stage. SYD985 is Byondis’ most advanced ADC, in development for the treatment of a range of HER2-expressing tumor types including breast and endometrial cancer. Previously, the U.S. Food & Drug Administration granted SYD985 fast track designation based on promising data from heavily pre-treated last-line HER2-positive metastatic breast cancer patients participating in a two-part Phase I clinical study.
MediWound – Israel’s MediWound and its U.S. commercial partner Vericel Corporation announced that the Biomedical Advanced Research and Development Authority (BARDA), accepted the first shipment of NexoBrid (concentrate of proteolytic enzymes enriched in Bromelain) as part of its mission to build national preparedness for public health emergencies. The initial BARDA procurement of NexoBrid is valued at $16.5 million, which includes additional quarterly deliveries planned through the end of 2021. In addition, BARDA holds an option to procure additional quantities of NexoBrid through funding of up to $50 million.
Ipsen – France-based Ipsen announced results from the MOVE trial, the first and only multicenter Phase III study in fibrodysplasia ossificans progressiva (FOP), will be presented during an oral presentation at the American Society for Bone and Mineral Research 2020 annual meeting on Sept. 12. Dosing of palovarotene in the MOVE clinical trial was paused when futility criteria were met at a prespecified interim analysis. However, subsequent post hoc analyses showed the RARy agonist oral investigational therapy palovarotene reduced mean annualized new heterotopic ossification (HO) volume in pediatric and adult participants with FOP. This was compared with untreated patients from a natural history study over 24 months. Results from the MOVE trial demonstrated a 62% reduction in mean annualized new HO volume in participants treated with palovarotene versus untreated patients.
Rafarma Pharmaceuticals – Slovenia-based Rafarma Pharmaceuticals established a new corporate entity in Thailand, Rafarma (Thailand) Co. Ltd. The company intends to use the business entity for entering into new association agreements with Thai universities. New association agreements are currently under negotiations and are expected to cover research and joint projects in production of cannabis-based products.