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According to a report published by Progressive Markets, the cancer immunotherapy market was valued at USD 57.2 Billion in 2017 and is expected to reach USD 166.7 Billion by 2025 while growing at a compound annual growth (CAGR) of 14.42%. The increasing spending on R&D activities for cancer immunotherapy, growing occurrence of cancer and the rise in approvals for the clinical trials are the main drivers of the market. Additionally, the number of people who have cancer is rising rapidly. According to a report released by the World’s Health Organization’s International Agency for Research on Cancer, cancer is estimated to cause 9.6 Million deaths and have 18.1 Million new cases in 2018. Cancer immunotherapy is one of the treatment types for cancer and has gained widespread importance in recent years. Regen BioPharma, Inc. (OTC: RGBP), Palatin Technologies, Inc. (NYSE : PTN ), Agenus Inc. (NASDAQ : AGEN ), BioLineRx Ltd. (NASDAQ : BLRX ), Ziopharm Oncology, Inc. (NASDAQ : ZIOP )
Based on application, the cancer immunotherapy market is divided into breast cancer, lung cancer, colorectal cancer, prostate cancer, melanoma, head and neck cancer and others. The lung cancer and breast cancer segments are expected to have market size of USD 22.3 Billion and USD 18.9 Billion respectively by 2025. Based on end-user, the market is segmented into hospitals, cancer research centers, and clinics.
Regen BioPharma, Inc. (OTCQB: RGBP) earlier this week announced breaking news that it, “has identified a series of small molecule drugs that inhibit NR2F6. Regen’s screening process demonstrated that its recently-identified, novel chemical compounds appear to inhibit NR2F6 and thus can potentially be developed for treating cancer.
The NR2F6 nuclear receptor has been identified as a potentially important immune cell inhibitor (an immune checkpoint), which may lead to developing therapies for treating cancers. Therapies that manipulate NR2F6 also show potential to act as cancer stem cell differentiators, transforming cancer stem cells into normal cells.
The NR2F6 program at Regen aims to identify antagonists of NR2F6 in order to unleash the cancer-killing potential of a patient’s own immune system as well as identify agonists which should suppress the immune system in diseases where the immune system is over-activated, such as autoimmunity.
‘We have identified a handful of compounds, representing three different structural classes, that inhibit NR2F6 in our primary screening assay,’ says Harry Lander, Ph.D., MBA, President and Chief Scientific Officer of Regen. ‘They exhibited a dose-dependent inhibitory effect on NR2F6 without cytotoxicity. Our next steps will focus on determining what effect they have on human immune cells.’
David Koos, Ph.D., Chairman & CEO of Regen BioPharma Inc. added, ‘This is exciting for Regen to reach this point in its goal for developing therapies that treat cancer. These compounds should provide us the basis to further refine our screening for successful antagonists in the development of immunologically-based cancer therapies. ‘
Correction: Regen BioPharma previously disclosed, in error, that ‘inhibiting NR2F6 is believed to provide potential therapies for treating autoimmunity.’ The statement should read: Activating NR2F6 potentially leads to inhibiting the immune system and should lead to therapies for treating autoimmunity diseases such as lupus.”
Palatin Technologies, Inc. (NYSE : PTN ) is a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases and conditions with significant unmet medical need and commercial potential. The Company recently announced that the U.S. Food and Drug Administration (FDA) has accepted the bremelanotide New Drug Application (NDA) for filing. The NDA was filed on March 23rd, 2018 by AMAG Pharmaceuticals, the Company’s exclusive North American licensee. Bremelanotide, an investigational melanocortin agonist, is being developed for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women. “We are very pleased with the FDA’s acceptance of the NDA filing for bremelanotide,” said Carl Spana, Ph.D., Chief Executive Officer and President of Palatin. “This is an important milestone for Palatin and reflects our drive and commitment to the development of novel therapies to treat conditions with significant unmet medical need and commercial potential. We look forward to assisting AMAG during the FDA review process. HSDD is an underserved medical condition and, if approved, bremelanotide has significant potential as an as-desired treatment of HSDD in premenopausal women.”
Agenus Inc. (NASDAQ : AGEN ) is a clinical-stage immuno-oncology company focused on the discovery and development of therapies that engage the body’s immune system to fight cancer. Recently, a study published in Cancer Cell reports on a novel discovery made by Agenus Inc. that may enhance the immune activity of cancer-fighting antibodies, including those targeting CTLA-4. Agenus has applied this discovery to its proprietary next-generation anti-CTLA-4 antibody (AGEN1181) on track for IND filing in 2H2018. Specifically, the research team demonstrated that a change in the Fc region can significantly improve the cross-talk between two immune cell types, such as antigen presenting cells (APCs) and T cells. This modification in the Fc region increases the duration and strength of interaction between the immune cells. In cancer immunotherapy, such an interaction is necessary to mount a potent immune response against cancer. “We have discovered a new mechanism involving a key portion of antibodies that modulates biological function and cancer-fighting abilities,” said Dr. Jeremy Waight, Principal Scientist at Agenus and lead author of the study. “Based on our discovery, we can modify this region, known as the Fc region, to significantly improve an antibody’s biological activity, by improving its immunological activity. We have already applied this discovery to our next generation anti-CTLA-4 antibody as well as other monospecific and bispecific antibodies in our pre-clinical pipeline and observed dramatic improvement in immune responses and anti-tumor activity.”
BioLineRx Ltd. (NASDAQ : BLRX ) is a clinical-stage biopharmaceutical company focused on oncology and immunology. BioLineRx Ltd. recently announced positive results from the lead-in period of the GENESIS trial, a double-blind, placebo-controlled Phase 3 trial comparing BL-8040 in combination with granulocyte colony-stimulating factor (G-CSF), to G-CSF alone, for the mobilization of hematopoietic stem cells (HSCs) used for autologous transplantation in multiple myeloma patients. “We are extremely encouraged by these results. Based on the robust data received from the first 11 patients, the DMC issued a positive recommendation to stop the lead-in part of the study and move immediately to the randomized placebo-controlled part of the study,” stated Philip Serlin, Chief Executive Officer of BioLineRx. “This is the first Phase 3 trial for our lead BL-8040 program, and as such, it is an important milestone in BL-8040’s comprehensive development plan. We look forward to the top-line results from the randomized, double-blind, placebo-controlled part of the study, which are expected in 2020.”
Ziopharm Oncology, Inc. (NASDAQ : ZIOP ) is a Boston-based biotechnology company focused on the development of next-generation immunotherapies utilizing gene- and cell-based therapies to treat patients with cancer. Ziopharm Oncology, Inc. recently announced that it has enrolled the first patient in its Phase 1 clinical trial to evaluate Ad-RTS-hIL-12 plus veledimex in combination with OPDIVO® (nivolumab), an immune checkpoint, or PD-1, inhibitor, in adult patients with recurrent glioblastoma (rGBM). “We are excited about the first-ever dosing of this combination and its potential to bring a potent and controlled anti-tumor immune response to glioblastoma,” said Francois Lebel, M.D., Executive Vice President, Research and Development, Chief Medical Officer at Ziopharm. “By controlling interleukin 12, Ad-RTS-hIL-12 plus veledimex already has shown it can recruit killer T cells into the tumor and increase expression of checkpoints in this microenvironment. The combination with an anti-PD-1 has the potential to further improve anti-cancer effects of IL-12 and provide a much-needed new therapeutic option for patients with brain cancer.”
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