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#Ultimovacs $ULTI announce FOURTH randomized phase 2 trial FOCUSNote that information about the third study is still expected before year end. Ultimovacs ASA – Initiates FOCUS Phase II Trial for Universal Cancer Vaccine, UV1, in Head and Neck Cancer Patients Receiving Pembrolizumab Oslo, 22 December 2020: Ultimovacs ASA (“Ultimovacs”, ticker ULTI), today announced the initiation of FOCUS, a Phase II randomized clinical trial that will evaluate the Company’s proprietary universal cancer vaccine, UV1, in 75 patients with recurrent or metastatic head and neck cancer who will be treated with standard of care therapy pembrolizumab. The trial will be conducted at 10 sites across Germany and led by principal investigator Prof. Mascha Binder, M.D., Medical Director and Head of the Immunological Tumor Group at University Medicine Halle, Germany, who is a renowned oncology clinician and researcher specializing in the analysis of immuno-oncology treatments and their interaction with tumor tissues. The FOCUS trial is Ultimovacs’ fourth Phase II clinical trial with UV1 and comes in addition to the collaboration Phase II trial announced in May 2020. “We continue to strategically expand our clinical development program for our proprietary cancer vaccine, not only by testing UV1 in additional cancer indications with critical need, such as head and neck cancer, but also by collaborating with clinicians like Professor Binder who can provide us with unique insights,” stated Jens Bjørheim, Chief Medical Officer at Ultimovacs. “Professor Binder and her team are well-recognized experts who will increase our understanding of UV1’s mechanism of action and contribute data on anti-tumor activity induced by UV1 vaccination.” The FOCUS (First-line metastatic Or recurrent HNSCC/Checkpoint inhibitor UV1 Study) Phase II trial is an investigator-sponsored, randomized Phase II clinical trial that will recruit patients with recurrent or metastatic PD-L1 positive head and neck squamous cell carcinoma across 10 clinical sites in Germany. The trial will evaluate the addition of UV1 to a standard of care treatment with PD-1 checkpoint inhibitor pembrolizumab as compared to pembrolizumab monotherapy. A total of 75 patients indicated for treatment with pembrolizumab will be enrolled in the FOCUS study, randomized 2-to-1 so that 50 patients will receive UV1 and pembrolizumab and 25 patients will receive pembrolizumab alone. The primary endpoint of the study is the progression-free survival rate at 6 months, and planned readout of topline results is expected in 2023. The FOCUS Phase II trial is partially supported through an innovation grant of up to NOK 16 million from the Norwegian Research Council and will not require Ultimovacs to secure additional financing at this stage. “This clinical trial is the extension of an earlier collaboration with Ultimovacs that introduced me to the therapeutic potential of the UV1 approach,” commented Professor Mascha Binder, M.D., Medical Director and Head of the Immunological Tumor Group at University Medicine Halle. “I am excited to apply my own insights as well as my team’s expertise to this trial with the goal of potentially providing head and neck cancer patients with better treatment options.” “We have continued to build momentum in our broad clinical development program with the start of the FOCUS study, representing the important opportunity to test UV1 in combination with pembrolizumab in a randomized setting for the first time,” said Carlos de Sousa, Chief Executive Officer at Ultimovacs. “We welcome the funding provided by the Norwegian Research Council, which supports our ability as a small biotechnology company to conduct four Phase II trials in parallel and evaluate UV1 in different indications with more than 450 patients and as part of various treatment combinations.” Dr. de Sousa added: “Although we have signed our agreement with the lead investigator for our previously announced third Phase II clinical trial, we will need to wait for the investigator and the pharmaceutical partner to finalize the signature process for their agreement before we can provide full details, which we expect to do before year end.”
ULong
by savepiginvest
AKERBP at major resistance. AKERBP has managed to fill the gap it left behind in March of this year at NOK 222,10. However, currently we've arrived at historical strong resistance, furthermore, we have the 200MA (weekly) just above as well. The most likely scenario is a retrace before an attempt to break this resistance. So where to look? I see a nice confluence of the top of the weekly cloud and the 0.382 fib on the latest impulse on the weekly chart around NOK 194,50). Of course a lot can happen, but I will be paying attention to signs of support once it reaches this area. This would mean a healthy retrace following traditional fib patterns and a retest of the Ichi cloud.
OSL:AKRBP
by duco1
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Targovax has the cheapest oncolytic virus on the marketONCOS-102 is one of the most promising oncolytic viruses with >200 patients treated. Targovax stock has been under pressure for years after equity offerings at fairly low pricing, but has been making a strong move recently, quite without many investors taking notice. Norwegian Biotech especially in the field of cancer immunotherapy may be ready for a new round of interest after the recent news about Vaccibody partnering with Genentech.
OSL:CRNALong
by savepiginvest
#Softox $SOFTX nordic #biofilm medtech with US defence grantSoftOx Solutions AS is a Scandinavian medtech company, founded in 2012, listed at Euronext Growth with new ticker OSL:SOFTX . After years of research and product development with leading Nordic research institutions, SoftOx has developed a non-toxic and highly efficient antiseptic technology, which eradicates and prevents biofilm infections and is fully virucidal. THESE PRODUCTS ARE CURRENTLY UNDER DEVELOPMENT Human Wound & Infection Treatments SoftOx is developing a range of products that can be classified as either medical devices or medicinal products (drugs) for human use. Collectively, the R&D efforts are focused on prevention and eradication of serious infections. Such infections are not limited to pathogenic bacteria, but may also include viral and fungal infections. The current product candidates are either in the clinical or late stage preclincal (animal testing) phase. SoftOx Wound Irrigation Solutions (medical device) for acute and chronic wounds, to both prevent and treat infections (including biofilms). SoftOx Anti-infectives are products aimed to actively treat and remove topical infections in wounded and mucosal tissues, such as those caused by biofilms, AMR microbes, viruses and fungi.
OSL:SOFTXLong
by savepiginvest