BioSpace Global Roundup, Sept. 3

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Biopharma and life science companies from across the globe provide updates on their pipelines and businesses. Let's take a look!

Polyphor - Polyphor AG and Fosun Pharmaceutical AG entered into an exclusive licensing agreement for balixafortide in China. Under the terms of the agreement, Polyphor and Fosun Pharma will develop and commercialize balixafortide for the Chinese market with an initial focus on metastatic breast cancer. China is projected to be the second-largest market globally for breast cancer treatments. Additional cancer indications and combination therapies will be evaluated jointly by the companies. Polyphor retains all rights to balixafortide outside of China. Balixafortide is a potent and highly selective blocker of CXCR4 and is currently the only CXCR4 antagonist in Phase III development for a solid tumor. CXCR4 plays a key role in tumor growth, invasion, angiogenesis, metastasis and resistance to therapeutics.

MaaT Pharma – France-based MaaT Pharma announced clinical data on the compassionate use of its lead full-ecosystem microbiome restoration biotherapeutic, MaaT013. The data included eleven patients that developed gastrointestinal, acute Graft-versus-Host-Disease (GI aGvHD), a severe condition where the transplant donor’s immune cells attack the patient’s tissues after receiving an allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT) to treat their hematologic malignancies. All patients showed some response to MaaT013, with five patients achieving a complete response and two having a very good partial response 28 days after first dosing.

SOTIO – Czech Republic-based SOTIO acquired the rights to Unum Therapeutics’ BOXR cell therapy platform and BOXR lead programs to develop novel T cell therapies for the treatment of solid tumors. The proprietary Bolt-on Chimeric Receptor technology incorporates novel transgenes to enhance T cell function in the solid tumor microenvironment. SOTIO will build on Unum’s R&D data, its team and a portion of its laboratory and manufacturing facility to create an R&D Center of Excellence for T cell therapies in Cambridge, Mass. SOTIO aims to develop multiple enhanced Chimeric Antigen Receptor (CAR)-T cell therapies for the treatment of solid tumors based on the BOXR technology. The lead program, BOXR1030 for the treatment of hepatocellular carcinoma and other solid tumors, is expected to initiate first clinical studies in 2021.

Immutep Limited – Based in Australia, Immutep Limited announced the Australian Research Council awarded the company and its research partner Monash University a grant to support a research collaboration into Lymphocyte Activation Gene-3 (LAG-3). This new funding will allow further investigation and provide insights into the way LAG-3 controls T cell function, and may ultimately lead to the development of a new generation of innovative medicines for the treatment of cancer, autoimmune diseases or infectious diseases.

Aequus – Vancouver’s Aequus Pharmaceuticals and its partner, Medicom Healthcare received the final certificate for the Canadian Medical Device Single Audit Program required to complete the Health Canada regulatory submission for the Evolve dry eye products in Canada. Within the next 10 days, Aequus expects to be filing for regulatory approval of the first three dry eye products in the Evolve line. These dry eye drops will be filed as New Class II medical devices with Health Canada, with an anticipated review time of up to 30 days following the submission.

Oncopeptides AB – Based in Stockholm, Oncopeptides AB received priority review from the U.S. Food and Drug Administration for the company’s New Drug Application seeking approval of melflufen (INN melphalan flufenamide), in combination with dexamethasone for the treatment of adult patients with multiple myeloma whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent and one anti-CD-38 monoclonal antibody. The FDA has set a PDUFA-date of Feb. 28, 2021. The submission is based on the results from the pivotal Phase II study HORIZON, evaluating intravenous melflufen in combination with dexamethasone in patients with relapsed refractory multiple myeloma.

Biophytis SA – The first patient was dosed in France-based Biophytis’ Phase II/III trial assessing Sarconeos (BIO101) for the treatment of patients with COVID-19-related respiratory failure. The COVA clinical program is a Phase II/III designed to evaluate the efficacy and the safety of Sarconeos (BIO101) as a treatment to prevent further respiratory deterioration in COVID-19 patients with severe respiratory failure. The second part of the study will investigate the efficacy of Sarconeos (BIO101) on the respiratory function of an additional 260 COVID-19 patients. The trial expects to recruit a total of about 310 patients. The primary endpoint is the proportion of all-cause mortality and respiratory deterioration within up to a 28-day period.

Biocartis Group – Belgium-based Biocartis Group NV expanded its collaboration with U.K.-based LifeArc to develop highly innovative prototype assays in the field of infectious and immune-related diseases on Biocartis’ fully automated molecular diagnostics platform Idylla.

BioVersys AG – Switzerland’s BioVersys secured a CHF 19 million Series B financing round to advance its two lead assets of infectious disease candidates into first in human clinical trials. BioVersys AG focuses on developing small molecules for multidrug-resistant bacterial infections with applications in Anti-Microbial Resistance (AMR) and targeted microbiome modulation. Both candidates are expected to enter Phase I this year.

Mursla – Liquid biopsy company Mursla, based in the U.K., raised £410K from the UK Government’s Future Fund and existing investors. The funding will enable Mursla to finalize its work on its novel exosome-based liquid biopsy platform, ExoPheno, with the aim of demonstrating how the platform can detect cancer signatures in plasma from solid tumors via exosomes. Mursla recently relocated from its roots at the Cavendish Laboratory at the University of Cambridge to its own laboratory and office space at the Cambridge Science Park.

Ilya Pharma – Sweden’s Ilya Pharma received a patent from the U.S. Patent and Trademark Office that cover a plasmid capable of expressing the protein CXCL12 in lactic acid bacteria, transformed lactic acid bacterial strains comprising the plasmid, and a number of products comprising the transformed bacteria. The patent provides protection for any use of the plasmid or transformed bacteria, such as in the healing of cutaneous or mucosal wounds, or elsewhere in other applications.

Relation Therapeutics - Project RE will apply London-based Relation Therapeutics’ and its partners’ technology to the identification of repurposed drug combinations as potential therapeutic candidates for COVID-19. Project RE will focus on finding therapies to tackle viral entry and replication and is co-led between Mila (Quebec AI Institute) and Relation Therapeutics.

Orchard Therapeutics – Gene therapy company Orchard Therapeutics announced additional interim data from an ongoing proof-of-concept clinical trial evaluating the safety and efficacy of OTL-203, an investigational ex vivo autologous hematopoietic stem cell (HSC) gene therapy in development for the treatment of mucopolysaccharidosis type I (MPS-I). The readout from the primary endpoint at one year of follow-up is expected in 2021.

Recce Pharmaceuticals – Australia’s Recce Pharmaceuticals received a grant from the Australian Government’s Entreprenuers’ Programme. RECCE 327 was recently accepted into the SARS-CoV-2 Antiviral Screening Program, a fee-for-service research program being conducted at the Doherty Institute and CSIRO’s Australian Centre for Disease Preparedness.

Poxel SA – France’s POXEL SA announced the initiation of DESTINY 1 (Deuterium-stabilized R-pioglitazone (PXL065) Efficacy and Safety Trial In NASH), the single dose-ranging Phase II trial evaluating PXL065 for the treatment of NASH. PXL065 is a novel, proprietary deuterium-stabilized R-stereoisomer of pioglitazone.

Exact Therapeutics – Norway-based Exact Therapeutics announced The Phase I ACTIVATE study evaluating ACT in patients with metastatic colorectal cancer has successfully enrolled the first patient following temporary suspension due to the Covid-19 pandemic. To date, six patients have been enrolled in the study.

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