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Ultimovacs finalize topline data for ph2 cancer vaccine trialUltimovacs is a norwegian clinical phase biotech with a universal cancer vaccine as its lead product. Today the company reported to the market that in march it will share topline data from its randomized phase 2 trial INITIUM for its lead product UV1 , a universal cancer vaccine to be used in combination with checkpoint inhibitors. The stock is at the moment testing the last major resistance level at around NOK 140, before the way is open to a retest of ATH.
OSL:ULTILong
by savepiginvest
Ultimovacs ASCO 2021 60% ORR 30% CR #cancervaccineUltimovacs’ UV1 in combination with pembrolizumab shows 60% Objective Response Rate in advanced melanoma Phase I data • UV1/pembrolizumab results in 30% complete responses plus 30% partial responses • Good safety and tolerability profile supports use of UV1 in combination treatments • Data to be presented at ASCO and abstract to be discussed in webcast on May 20, 2021 Oslo, 19 May 2021: Ultimovacs ASA ("Ultimovacs") (OSE ULTI), a clinical stage leader in immune stimulatory vaccines for cancer, today announced that its universal cancer vaccine, UV1, in combination with the checkpoint inhibitor pembrolizumab, demonstrated a 60% objective response rate (ORR) in metastatic malignant melanoma. All patients have been observed for at least 18 months and median observation time is 21 months. The results will be presented as an online poster at the American Society of Clinical Oncology (ASCO) 2021 Annual Meeting. The 60% ORR (6 complete responses (CR); 6 partial responses (PR) from a 20-patient cohort) with 30% CR, clearly exceeds the response rate for pembrolizumab alone in advanced melanoma (33-37% ORR and 5-12% CR)*. The median progression-free survival for the UV1/pembrolizumab combination in the study was 18.9 months compared with 5.5-11.6 months* for pembrolizumab alone in advanced melanoma. The overall survival was 80%, with the median overall survival yet to be reached after 21-months of follow-up. “These very strong and exciting data further strengthen the foundation for our broad Phase II clinical program for UV1,” said Jens Bjørheim, Chief Medical Officer at Ultimovacs. “To show this level of beneficial clinical response while being safe and well-tolerated in combination with pembrolizumab underscores our development strategy to show that UV1 can provide a significant increase in therapeutic effect in a broad range of indications and combinations.” The rationale for the use of UV1 is that patients with advanced malignant melanoma often lack the relevant T cells to obtain durable benefits from the use of pembrolizumab alone. UV1 expands T cells that have the potential to increase the breadth and diversity of the immune response towards all parts of the tumor. The data comes from Ultimovacs’ open-label Phase I study (NCT03538314) and will be shown as a poster presentation at ASCO, to be held virtually Friday, June 4, 2021 through Tuesday, June 8, 2021. The data also shows that the UV1/pembrolizumab combination is well tolerated, with adverse events largely restricted to low grade effects, mainly injection site reactions. “These data reinforce our conviction that UV1 can play a transformative role in the treatment of conditions such as malignant melanoma,” said Carlos de Sousa, CEO of Ultimovacs. “It suggests that UV1 in combination with checkpoint inhibitors like pembrolizumab can mobilize the immune system to fight cancer. This is very encouraging for melanoma patients and for those involved with the roll-out of Ultimovacs’ broader programs in solid cancers.” Webcast A corporate webcast will be held on Thursday 20 May 2021, 10:00 CEST. Carlos de Sousa, CEO of Ultimovacs and Jens Bjørheim, CMO, will discuss the ASCO abstract. It will be possible to submit written questions during the presentation. The webcast will be available subsequently on the company website;
OSL:ULTILong
by savepiginvest
#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.”
OSL:ULTILong
by savepiginvest
Ultimovacs Announces Updated Positive Results from Phase I TrialOslo, 19 October 2020: Ultimovacs ASA ("Ultimovacs", ticker ULTIMO), today announced five-year overall survival data from the Phase I trial evaluating UV1 as maintenance therapy in patients with non-small cell lung cancer. The results confirm achievement of the primary endpoints of safety and tolerability and indicate encouraging initial signals of long-term survival benefit. "Ultimovacs has established a growing body of clinical data demonstrating a strong safety and tolerability profile for UV1 and a range of preliminary efficacy signals in several cancer indications, all of which supports the further development of our proprietary cancer vaccine candidate," stated Carlos de Sousa, Chief Executive Officer at Ultimovacs. "The long-term follow-up results announced today demonstrate that treatment with UV1 is safe both at the time of administration and throughout the follow-up period of at least 5 years. Non-small cell lung cancer highly expresses telomerase and remains an indication in great need of new treatment options for patients." In the study, a total of 18 non-small cell lung cancer patients whose disease had not progressed after receiving at least 2nd line treatment with chemotherapy were enrolled to receive UV1 monotherapy as maintenance treatment. Outcomes of the study included the safety and tolerability of UV1 as well as initial signs of clinical response. As per the cut-off date of June 2020, every patient in the trial reached at least 60-months of follow-up post treatment with UV1. At the five-years landmark, the Overall Survival (OS) rate was 33% and median Progression Free Survival (mPFS) was 10.7 months. Throughout the follow-up period, none of the patients experienced unexpected safety issues related to UV1. Further, none of the patients alive after 5 years have received other immunotherapy after the vaccination with UV1. "At the time of the study initiation, there were no checkpoint inhibitors available for treatment of this patient population. For patients that received a second-line of chemotherapy the expected 5-year survival rate was less than 5 percent," stated Jens Bjørheim, Chief Medical Officer at Ultimovacs. "While our Phase I study is non-randomized and conducted in a small population, it is promising to see that UV1 was safe and well-tolerated and that using UV1 as a maintenance therapy could potentially provide benefit to patients in need of novel approaches." Ultimovacs presented 48-months of follow-up data at the Society for Immunotherapy of Cancer's (SITC) 34th Annual Meeting in November of last year.
OSL:ULTILong
by savepiginvest