According to data compiled by Global Market Insights, the biotechnology market was valued at USD 330.3 Billion in 2015 and is projected to exceed USD 775.2 Billion while growing at a CAGR of 9.9% from the forecast period between 2016 to 2024. The growing demand for technology like DNA sequencing, fermentation, recombinant technology and tissue engineering is expected to drive the market. Other technologies that are dominant in the market are PCR, nano-biotechnology, chromatography, and cell-based assays, which are projected to rapidly expand and other applications such as immunotherapy are also quickly emerging. According to MarketsandMarkets, the global cancer immunotherapy market is expected to reach USD 119.39 Billion by 2021 from USD 61.9 Billion in 2016 and grow at a CAGR of 14% from 2016 to 2021. Regen BioPharma, Inc. (OTC:RGBP), ARCA Biopharma, Inc. (NASDAQ:ABIO), Onconova Therapeutics, Inc. (NASDAQ:ONTX), Celldex Therapeutics, Inc. (NASDAQ:CLDX), PharmaCyte Biotech, Inc. (OTC:PMCB)
In 2018, it is estimated that approximately 1.7 Million new cases of cancer will be diagnosed in the U.S, according to the National Cancer Institute. The immunotherapy market application segment is broken up into various forms of cancer such as lung cancer, breast cancer, and prostate cancer, which are among the most common forms. The market will see strong growth due to the prevalence of cancer and the rising demand for treatment options. “The potential of immunotherapies is huge. I would say that immunotherapies are the most important change in oncology treatment in the past 10 years, and now they are expanding into other disease areas,” said Etienne Drouet, Vice President of Strategic Development at SynteractHCR. “Immunotherapy is the new star in the life sciences. Compared to chemotherapy they have less adverse events, and also show positive long-term effects in overall survival rates.”
Regen BioPharma, Inc. (OTCQB:RGBP) announced yesterday 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 show potential for treating autoimmune diseases such as Lupus.
The NR2F6 nuclear receptor has been identified as a potentially very important immune cell inhibitor (an immune checkpoint) which may be important in developing therapies for treating autoimmune diseases like Lupus. Therapies that manipulate NR2F6 show potential to act as a cancer stem cell differentiators, potentially transforming cancer stem cells into normal cells.
The NR2F6 program at Regen aims to identify antagonists of NR2F6 in an effort to unleash the cancer-killing potential of a patient’s own immune system as well as identifying 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 autoimmune diseases. These compounds recently identified should provided us the basis to further refine our screening for successful antagonists in the development of immunologically based cancer therapies.”
ARCA Biopharma, Inc. (NASDAQ:ABIO) is dedicated to developing genetically-targeted therapies for cardiovascular diseases through a precision medicine approach to drug development. ARCA biopharma, Inc. recently announced that it has received guidance from the U.S. Food and Drug Administration (FDA) following an End-of-Phase 2 meeting regarding the Phase 3 program for ARCA’s pharmacologically unique beta-blocker, Gencaro, as a potential genetically-targeted treatment for atrial fibrillation (AF) patients with heart failure (HF). The FDA previously granted the Gencaro atrial fibrillation development program Fast Track Designation. As the Gencaro program is developing potentially the first genetically-targeted cardiovascular therapy, the FDA has suggested the Company submit an SPA application, which the Company anticipates submitting in the third quarter of 2018. “We are encouraged by the outcome of our End-of-Phase 2 meeting regarding the development path forward for Gencaro and the FDA’s response to the data from our completed Phase 2B GENETIC-AF study,” commented Dr. Michael Bristow, ARCA’s President and Chief Executive Officer. “FDA concurrence to proceed into Phase 3 is an important milestone for ARCA and for patients suffering from AF and HF, an indication for which there is a significant unmet medical need and currently no FDA approved therapeutics.”
Onconova Therapeutics, Inc. (NASDAQ:ONTX) is a Phase 3-stage biopharmaceutical company focused on discovering and developing novel small molecule drug candidates to treat cancer, with a primary focus on Myelodysplastic Syndromes (MDS). Onconova Therapeutics, Inc. recently announced that its commercial partner, Pint Pharma GmbH, will assist in expanding access to clinical trials studying rigosertib, a novel and targeted anti-cancer compound currently in a Phase 3 study for the treatment of MDS, to several selected sites across South America. Pint Pharma is a European-based pharmaceutical company focused on the development, registration and commercialization of specialty-based treatments for the Latin American market and has successfully participated in clinical trials for hematological cancers. “This assistance will help make rigosertib available to cancer patients on a fifth continent, following our ongoing clinical trials in North America, Europe, Asia and Australia. We are delighted to partner with Pint Pharma, which has a wide footprint in South and Central America, with first-hand experience in running clinical trials for malignant hematological disorders,” said Dr. Ramesh Kumar, Chief Executive Officer of Onconova Therapeutics, Inc.
Celldex Therapeutics, Inc. (NASDAQ:CLDX) is developing targeted therapeutics to address devastating diseases for which available treatments are inadequate. Celldex Therapeutics, Inc. recently presented two programs at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. Data from the Phase 1/2 study of Celldex’s varlilumab, a CD27 targeting investigational immune-activating antibody, and Bristol-Myers Squibb’s Opdivo® (nivolumab), an anti-PD1 immunotherapy, for patients with ovarian cancer and colorectal cancer, were presented in an oral session by Rachel E. Sanborn, M.D., Co-director of the Providence Thoracic Oncology Program and Phase 1 Clinical Trials Program, at the Earle A. Chiles Research Institute, Providence Cancer Institute, in Portland, Ore. In addition, an overview of the Phase 2 study of the anti-ErbB3 antibody CDX-3379 in combination with Erbitux®in advanced head and neck squamous cell cancer was presented in a “clinical trials in progress” poster session. “Moving forward, we believe more work needs to be done to identify synergistic combinations and patient populations that have the best chance of responding to varlilumab treatment,” said Tibor Keler, Ph.D., Executive Vice President and Chief Scientific Officer of Celldex Therapeutics. “We are continuing to explore these opportunities through inclusion in our ongoing Phase 1 study of CDX-1140, our CD40 agonist antibody, and several investigator-initiated studies.”
PharmaCyte Biotech, Inc. (OTCQB:PMCB) is a clinical stage biotechnology company developing cellular therapies for cancer and diabetes based upon a proprietary cellulose-based live cell encapsulation technology known as “Cell-in-a-Box®.” The Company recently announced that it has successfully completed a study on the stability after “hand thawing” syringes of the Cell-in-a Box® encapsulated cells that will be used, in combination with low doses of the cancer prodrug ifosfamide, for the treatment of locally advanced, non-metastatic, inoperable pancreatic cancer (LAPC). The data obtained from this “hand thawing” study is required by the U.S. Food and Drug Administration (FDA). At individual study sites, the frozen cells in the Cell-in-a Box® capsules within syringes will be hand-thawed and then kept at room temperature until they are implanted into a patient with LAPC. The results of the “hand thawing” study announced show that the viability of the cells remains essentially the same for at least 30 minutes at room temperature. This serves to define the time that the interventional radiologist has to implant the Cell-in-a-Box® capsules after thawing to ensure cellular viability within the patient. PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, explained the significance of the study saying, “This is yet another important study that PharmaCyte has completed to comply with the FDA’s requirements for our planned, upcoming clinical trial in LAPC. The Cell-in-a Box® encapsulated cells are in a frozen state before they are administered to the patient. This study was designed to determine how long after unfreezing the Cell-in-a Box® encapsulated cells can they be held at room temperature before being introduced into the patient without losing their effectiveness.
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