Busy week for Optimum’s clients as we head into March

Neuraxpharm launches RMS drug in Europe, calls for awareness of rare disease 

In another exciting week for Optimum’s clients, Neuraxpharm kicked off proceedings with the first launch of Briumvi (ublituximab) in Europe, for treatment of relapsing multiple sclerosis. 

Germany is the first country to see the launch of the drug following Neuraxpharm’s agreement with TG Therapeutics, announced in August 2023, to commercialise Briumvi outside the United States, Canada, Mexico and excluding certain Asian countries that have been previously partnered. 

Further launches are planned in Europe for the drug, which is the only B-cell depleting therapy approved for relapsing multipole sclerosis (RMS), that is administered in a 1-hour infusion, twice per year, following an induction period. 

Neuraxpharm and partner Minoryx followed the announcement with a call for greater awareness of X-linked adrenoleukodystrophy and cerebral adrenoleukodystrophy on Thursday 29th February – Rare Disease Day 2024. 

Düsseldorf – based Neuraxpharma and strategic alliance partner, Barcelona – based Minoryx, announced the publication of a special information film to draw attention to the disease. 

The film includes insights from world renowned expert Professor Fanny Mochel, the Director of the Reference Center for Leukodystrophies – La Pitié-Salpêtrière Hospital, Paris, and Karen Harrison, Support Services Manager of Alex, The Leukodystrophy Charity (Alex-TLC).  

In the film, Professor Mochel describes the disease and the need for regular screening to identify patients as early as possible, while Karen Harrison speaks powerfully about the patient experience and need for better treatments. 

Curve Therapeutics raises £40.5m to boost drug discovery and advance breakthrough pipeline 

Curve Therapeutics, a private biotechnology company pioneering a revolutionary intracellular screening platform addressing complex and challenging disease targets, on Tuesday announced the close of its successful £40.5 million Series A financing. 

Pfizer Ventures led the round with participation from Columbus Venture Partners and British Patient Capital, which join founding investor Advent Life Sciences and co-lead from the seed round, Epidarex Capital. 

Curve’s powerful Microcycle® platform enables the direct discovery of biologically active molecules against targets that have been difficult to address using conventional drug discovery methods.  

Based in state-of-the-art labs in Southampton Science Park, Curve’s platform allows functional screening and enrichment of highly diverse, gene-encoded, Microcycle libraries within the cytoplasm of mammalian cells to identify library members that have a desired biological activity against a therapeutic target. 

BII Welcomes 12 new companies to its Venture Lab Program 

BioInnovation Institute (BII), an international non-profit foundation incubating and accelerating world-class life science research, on Thursday announced that twelve new companies entered its Venture Lab acceleration program for early-stage companies.  

The cohort is strategically aligned with BII’s focus on supporting innovative early-stage start-ups that can improve human and planetary health. 

The 12-month Venture Lab program is designed to support start-up companies with business acceleration, scientific, and team development, and provides a founder-friendly convertible loan of EUR 500,000 (approximately 4M DKK) plus access to labs and offices at the BII in Copenhagen.  

In becoming a part of the Venture Lab program, the early-stage companies also get an exclusive opportunity to apply for EUR 1.3M in follow-up funding through BII’s Venture House program. For details of the 12 new companies in the fields of Planetary Health, Therapeutics, Women’s Health, Health Tech and Quantum, read the full release. 

Bionical Appoints Chief Technology Officer to create data products 

Bionical Solutions, a leading provider of technology enabled engagement and healthcare services to global pharmaceutical, biotech, healthcare companies and the NHS, on Thursday announced the appointment of Andrew Seward as Chief Technology Officer for the Digital business. 

Andrew has over 12 years of experience in technology and product management, and joins Willington-based Bionical after serving as Head of Data Product Development at Experian Consumer Services, which counts 25% of the UK’s adult population as its customers.   

Drawing on his expertise of delivering next-generation customer experiences and new AI features, he created and led the implementation of Experian’s new Data Strategy and delivered a pioneering machine learning platform as a founding member of Experian’s Machine Learning Council.  He has been Chief Technology Officer at prominent HR software company, Mitrefinch Ltd, and has led product strategy and development at UK fintech company, Quint Group, and tech start-up, Cronofy. 

Andrew is the founder of Tech Nottingham, an organisation with around 3,500 members and one of the largest tech communities in the UK, which works closely with technology businesses of all sizes, as well as local government and educational institutions, to promote Nottingham as a tech centre.  

Ariceum Therapeutics Granted UK authorisation to conduct Phase 1 clinical study of its first-in-class Iodine-123 labelled PARP inhibitor in patients with recurrent glioblastoma 

Ariceum Therapeutics (Ariceum), a private biotech company developing radiopharmaceutical products for the diagnosis and treatment of certain hard-to-treat cancers, on Thursday announced that it had received approval from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to undertake a Phase 1 clinical trial (CITADEL-123) of 123I-ATT001, its Iodine-123 labelled PARP inhibitor, in patients with recurrent glioblastoma. 

The authorisation follows Ariceum’s submission of a Clinical Trial Authorisation (CTA) application to the MHRA in December 2023 with the Phase 1 study expected to commence in the UK in June 2024. Ariceum is the first company to sponsor a clinical trial of Auger therapy for recurrent glioblastoma, an aggressive form of brain cancer and it will be exploring other solid tumour indications in the future. 

ATT001 delivers its radioisotope payload, Iodine-123, in a highly targeted way to cancer cells expressing PARP, an enzyme they use to repair its DNA. This radioisotope emits low energy Auger electrons, which deposit their energy over short distances, making them particularly useful for causing lethal damage to cancer cells while sparing healthy tissue. An additional benefit of using Iodine-123 is that this isotope is more widely available than others, being produced in a regular cyclotron. 

4SC Files Marketing Authorisation Application with EMA for Resminostat (Kinselby) 

4SC AG, a biotech company improving the lives of patients suffering with advanced-stage cutaneous T-cell lymphoma (CTCL), announced on Friday that it has filed its Marketing Authorisation Application (MAA) for resminostat (Kinselby) with the European Medicines Agency (EMA) and that its MAA has been accepted by the EMA as sufficient for examination. 

In September 2023, the Company announced data from its RESMAIN study on resminostat (Kinselby) that showed a statistically significant improvement in progression free survival compared with placebo. 

Lytix and Vicore announce Q4 2023 Results 

Lytix Biopharma and Vicore Pharma reported their year-end and Q4 2023 results. 

Oslo-based Lytix  highlighted important clinical progress through positive interim results from both its phase II studies on different types of skin cancer with its lead product candidate LTX-315.  

Early results from the partnership study on basal cell carcinoma (regular skin cancer) with Nasdaq-listed Verrica Pharmaceuticals were positive, with complete clearance of cancer cells in four out of six patients treated with the highest dose of Lytix’ LTX-315. The entire study is set to be completed in H1 2024. 

For Vicore highlights from Q4 included the ongoing Phase 2 development of C21 for idiopathic pulmonary fibrosis (IPF), which continues as planned and no blood pressure signal has been observed in its clinical trials. In December, Vicore appointed Dr. Bertil Lindmark MD, PhD, as new Chief Medical Officer.