Palm Beach, FL –March 24, 2020 – Oncolytic viruses are becoming a new class of cancer immunotherapy weapons to combat cancer. These naturally occurring or modified viruses are a potent new weapon against cancer, according to recent reports on this growing market. The reports actually reveal that: “… since the late 1800s, doctors have observed that some patients with cancer go into remission, if only temporarily, after a viral infection. Although the notion of using viruses in cancer therapy is old, the science only began to move forward in the 1990s with advances in genetic engineering technology with another shift around 2005, as people began to realize the true value of viruses in cancer therapy is in immunotherapy. When an oncolytic virus infects a tumor cell, it makes copies of itself until the cell bursts. The dying cancer cell releases tumor antigens and/or danger signals, which can change the tumor microenvironment to change an immunologically “cold” tumor (lacking T cells) into a “hot” tumor (influx of a multitude of immune cells and cytokines). Oncolytic viruses are alerting the immune system that something is wrong. This can lead to an immune response against nearby tumor cells (a local response) or tumor cells in other parts of the body (a systemic response).” Active biotech and pharma companies in the markets this week include Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), Hoth Therapeutics, Inc. (NASDAQ: HOTH), ADMA Biologics, Inc. (NASDAQ: ADMA), Pfizer Inc. (NYSE:PFE), Aytu BioScience, Inc. (NASDAQ: AYTU).
Oncolytic viruses are naturally occurring or genetically modified to target specific types of cancer cells. They selectively replicate within the cancer cell via a tumor-specific promoter element that is incorporated into the viral genome or in deletions in key portions of the viral genome. The oncolytic viruses must be genetically stable and be incapable of reverting back to its wild-type form while replicating inside cancer cells. In addition, transgenes encoding interferon alpha, granulocyte macrophage colony stimulating factor (GM-CSF), and multiple cytokines have been inserted into oncolytic viruses to achieve a variety of immunomodulatory effect. The size of the oncolytic viral genome affects the transgene capacity, which makes certain oncolytic virus with larger genome more desirable.
Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) BREAKING NEWS: Oncolytics Biotech® Announces Favourable AWARE-1 Safety Update – Oncolytics Biotech® currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced a favourable assessment from the Safety Committee following review of data from the window of opportunity study in early-stage breast cancer, known as AWARE-1. Consistent with the safety run-in with patients receiving pelareorep and Tecentriq®, Cohort 1 demonstrated widespread viral replication in the majority of tumors with the creation of a pro-inflammatory effect in the tumor microenvironment. No negative effects to healthy tissue were noted.
The Committee evaluated safety parameters from patients participating in the safety run-in phase of the trial, consisting of select patients from cohorts 2 and 3, along with the fully enrolled cohort 1, and determined there were no safety concerns. The Committee also approved an amendment of the study to reduce the dose of Tecentriq to be consistent with the currently approved breast cancer dose of 840mg. The study will continue to enroll patients and the Safety Committee will meet again for an additional pre-planned meeting. Cohorts 1 and 2 represent our target tumor type of HR+ / HER2- and data from these patients will inform the design of the planned phase 3.
“After reviewing the totality of safety data, including patients receiving pelareorep plus the standard of care and those also receiving Tecentriq, the Safety Committee for AWARE-1 confirmed no significant toxicity resulting from treatment,” said Dr. Rita Laeufle, Chief Medical Officer at Oncolytics Biotech. “The study is continuing as planned, recruiting additional patients and examining the combination of pelareorep, plus the standard of care plus Tecentriq. We look forward to presenting updated data at the ESMO Breast Cancer conference in May, which will describe meaningful changes to the tumor microenvironment, evidence of tumor infection, and of course, our biomarker correlated to immunogenic response and viral replication.” Read this full press release and more news for ONCY at: https://financialnewsmedia.com/news-oncy/
Other recent developments in the biotech industry include:
Hoth Therapeutics, Inc. (NASDAQ: HOTH) recently announced it has reached an agreement with Voltron Therapeutics, Inc. (Voltron) to form a joint venture entity, to be named HaloVax, to commence preclinical studies for the development of vaccine prospects to prevent the Coronavirus (COVID-19) based upon VaxCelerate, a self-assembling vaccine (SAV) platform exclusively licensed by Voltron from the Vaccine and Immunotherapy Center (VIC) at MassachusettsGeneral Hospital (MGH).
Hoth and Voltron, with the support of MGH, will work jointly on exploring and developing this SAV technology as a means to aid patients at risk of being infected with COVID-19. The VaxCelerate vaccine platform was developed as a means of rapidly generating and pre-clinically testing a new vaccine against specific pathogen targets. The technology which received Department of Defense (DoD) funding has demonstrated proof of concept in Lassa Fever, an emerging infectious disease. HaloVax intends to use these same SAV principles to assist in the development of a potential vaccine against the COVID-19 pandemic.
ADMA Biologics, Inc. (NASDAQ: ADMA) a commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics for the treatment of immunodeficient patients at risk for infection and the prevention of certain infectious diseases, recently announced financial results for the third quarter and nine months ended September 30, 2019, and provided an overview of its recent corporate achievements.
“To date, 2019 has been a transformational year for ADMA, marked most importantly by the recent re-launch and launch, respectively, and first commercial sales of our lead assets BIVIGAM and ASCENIV, both indicated for the treatment of patients with primary humoral immunodeficiency (PI),” said Adam Grossman, ADMA’s President and Chief Executive Officer. “Our commercial rollouts are off to an encouraging early start for our IVIG brands. As we look ahead to the remainder of 2019 and into 2020, we remain focused on maximizing these initial product launches and executing on several strategic corporate initiatives aimed at growing our overall revenues, including potentially expanding the capacity at our manufacturing facility, opening new plasma collection centers, as well as growing our commercial team and hiring additional staff to support the anticipated production ramp up for 2020 and beyond.”
Pfizer Inc. (NYSE:PFE) announced recently that JADE COMPARE (B7451029) met its co-primary efficacy endpoints. The Phase 3 study evaluated the safety and efficacy of abrocitinib, an investigational oral once-daily Janus kinase 1 (JAK1) inhibitor, in adults with moderate to severe atopic dermatitis who were also on background topical therapy. The study also included an active control arm, dupilumab, a biologic treatment administered by subcutaneous injection, compared with placebo.
“It was helpful to study abrocitinib in combination with topical therapies to provide data relevant to the real-world setting,” said Michael Corbo, PhD, Chief Development Officer, Inflammation & Immunology, Pfizer Global Product Development. “The addition of an active control was also important to better understand the significance of this potential new medicine and we’re encouraged by the positive data from this trial.”
Aytu BioScience, Inc. (NASDAQ: AYTU) announced yesterday that it has received confirmation from the U.S. Food and Drug Administration (FDA) that the company may begin distribution of its Coronavirus Disease 2019 (“COVID-2019”) IgG/IgM Rapid Test throughout the United States. The COVID-19 IgG/IgM Rapid Test is intended for professional use and delivers results between 2 and 10 minutes at the point-of-care.
Aytu expects delivery of its first shipment of 100,000 tests this week. The Company has been in discussions with healthcare distributors, healthcare institutions, medical practices, and government agencies and is working quickly to begin distribution into the U.S. healthcare supply chain.
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