“Glioblastoma is the most common and aggressive cancerous brain tumour in adults due to its resistance to therapy. Treatment usually involves surgery, followed by chemotherapy and radiation therapy. Despite these intensive efforts, in most cases tumour cells regrow after treatment and the cancer recurs,” reports Science Daily. However, there may be a treatment option with the development of Berubicin, an anthracycline anticancer drug used for the treatment of malignant gliomas, as noted by Targeted Oncology.
As reported by Grand Review Research, “According to U.S. National Cancer Institute GBM is considered as the most aggressive form of brain cancer which represents 15.4% of all primary brain tumors and about 60% - 75% of all astrocytoma and shows rapid growth rate of benign cells in the organ. Currently unavailable therapies and prognosis for the treatment of GBM is expected to impact the market growth positively through to 2022.” That could open a world of opportunity for companies such as WPD Pharmaceuticals Inc. (CSE:WBIO)(OTC:WPDPF), Pfizer Inc. (NYSE:PFE), Moderna Inc. (NASDAQ:MRNA), BioNTech (NASDAQ:BNTX), and Novavax Inc. (NASDAQ:NVAX).
WPD Pharmaceuticals Inc. (CSE:WBIO)(OTC:WPDPF) BREAKING NEWS: WPD Pharmaceuticals Inc. a clinical-stage pharmaceutical company, is pleased to announce that it has engaged Image Analysis Group, a leading medical imaging company, to provide important critical imaging services during the Berubicin phase 2 clinical trials which are scheduled to start in February 2021.
IAG has deep expertise in partnering with global biotech companies to provide centralized reading and analysis of patient responses in real time. IAG’s scientific and clinical imaging expertise in the field of glioblastoma multiforme, coupled with IAG’s proprietary Artificial Intelligence (AI) powered platform DYNAMIKA will allow WPD and its partners to review efficacy assessments, objective responses, and to thoroughly explore Berubicin’s effect in patients with GBM.
Advanced cancer therapies often lead to pseudo-progression, a local tissue reaction resulting from immune cell infiltration, causing inflammation, tumor necrosis and oedema which are often misinterpreted as tumor growth on traditional MRIs. Under the arrangement, IAG will utilize its advanced AI-driven methodologies that provide reliable early efficacy readouts. Pseudo-progression is difficult to distinguish from disease progression using routine clinical MRI assessments, and having IAG’s advanced technology will be crucial for early detection and progression.
Mariusz Olejniczak, CEO of WPD commented, “We are very pleased to partner with IAG to collaborate on the upcoming Berubicin trials and other studies including WPD101, if possible in the future. IAG has a strong track record of working with leading biotech companies to provide critical imaging collection, analysis, and assessment which is a very important part of our Berubicin phase 2 trials. We look forward to working with them leading up to and in preparation of the commencement of these Trials.”
Olga Kubassova, CEO of IAG commented, “We are pleased that IAG’s unique focus on the use of quantitative imaging and AI will help accelerate WPD’s development programs while reducing R&D costs, timelines, and uncertainties. This work will support the field of advanced cancer drug development as a whole and provide much needed treatment options to patients with glioblastoma.”
Diana Dupont-Roettger, Chief Scientific Alliance Officer of IAG commented, “The integration of advanced imaging and AI driven image analysis will prevent a false response assessment in patients experiencing pseudo-progression and thereby enhance the efficacy read out of Berubicin, avoid early patient drop-out and save costs. IAG is excited to collaborate with WPD and to support the clinical development with optimal imaging trial design, efficient imaging data management and response assessment.”
Other related developments from around the markets include:
Pfizer Inc. (NYSE:PFE) and BioNTech SE announced they will supply an additional 100 million doses of COMIRNATY®, the companies’ COVID-19 Vaccine, to the 27 European Union (EU) member states in 2021. This announcement is a result of the European Commission’s decision to exercise its option to purchase an additional 100 million doses under its Advanced Purchase Agreement signed on November 11, 2020. This agreement brings the total number of doses to be delivered to the EU to 300 million. “We remain committed to moving as quickly and safely as possible to bring this vaccine to more people in Europe, as the deadly virus continues to spread at an alarming rate,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “In partnership with the European Commission, member states and healthcare providers, we will be able to reach a total of 150 million Europeans across the continent.”
Moderna Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, provided a supply update for the Moderna COVID-19 Vaccine , increasing its base-case global production estimate from 500 to 600 million doses for 2021. Moderna said it is continuing to invest and add staff to build up to potentially 1 billion doses for 2021. The Company said it expects about 100 million doses to be available in the United States by the end of the first quarter of 2021, with 200 million doses total available by the end of the second quarter. Moderna reported that approximately 18 million doses have been supplied to the U.S. Government to date. The vaccine received Emergency Use Authorization from the U.S. Food and Drug Administration (FDA) on December 18, 2020 and Moderna began supplying to the government shortly thereafter. Additional vaccine doses have also been supplied to the Canadian government following authorization by Health Canada's Interim Order on December 23, 2020.
BioNTech (NASDAQ:BNTX) wants to express its thanks and gratitude not only to its employees but also to the many partners who have assisted the company in successfully developing a vaccine for COVID-19. BioNTech acknowledges that without the tireless effort from its’ employees and partners, who have played a pivotal role in this effort, it would not have been able to achieve this historic company milestone, a journey which only began in early 2020. Data from its Phase 3 study have demonstrated that the vaccine is well-tolerated and 95% effective in preventing COVID-19. The vaccine has already received conditional marketing authorizations as well as emergency use authorizations in more than 45 countries around the world, including the United States and the European Union. BioNTech’s employees have made a significant contribution to this initiative, working around the clock to harness the power of mRNA and apply it to this effort of fighting against the devastating pandemic. In addition, our partner companies and organizations have provided the company with research expertise, critical supply support, and valuable insights and assistance throughout the development and trial process. Without them, achieving this result only 11 months after the initiation of Project Lightspeed would not have been possible.
Novavax Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, announced initiation of PREVENT-19 , its pivotal Phase 3 study in the United States and Mexico to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373, the Company’s COVID-19 vaccine candidate. The trial builds on research from Phase 1/2 studies demonstrating that the vaccine provoked a robust immune response, generated highly neutralizing antibodies against the virus and was generally well-tolerated. “With the COVID-19 pandemic raging around the globe, this trial is a critical step in building the global portfolio of safe and effective vaccines to protect the world’s population,” said Stanley C. Erck, president and chief executive officer, Novavax. “We thank our colleagues and partners who continue to work with us to urgently advance our commercial-scale manufacturing processes, and we are grateful for the hard work and assistance from Operation Warp Speed, the U.S. FDA and the government of Mexico on this program.”
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