Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) is an exciting little biotech that has managed to attract legions of shareholders who continue to accumulate. The stock does have a history of big moves up recently seeing another significant pop.

There is a lot to get excited about on NWBO, the Company is developing cancer vaccines designed to treat a broad range of solid tumor cancers more effectively than current treatments, and without the side effects of chemotherapy drugs.

Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) is a clinical stage biotechnology company focused on the development of personalized immunotherapy for a broad range of solid tumor cancers. The company has over 190 issued patents and more than 65 pending patent applications worldwide, grouped into 12 patent families. The Company is led by Linda Powers, a successful entrepreneur who worked for many years in corporate finance and restructurings, mergers and acquisitions, joint ventures and intellectual property licensing. Ms. Powers has served as the Chairman of NW Bio since 2007, and as CEO since 2011. NWBO platform technology is DCVax, which uses activated dendritic cells to mobilize a patients own immune system to attack their cancer.

Northwest lead product is DCVax-L for Glioblastoma multiforme (GBM), the most lethal form of primary brain cancer. The Company has completed two Phase I/II trials and are now well under way with a large Phase III trial, as described below. Northwest is currently conducting a 348-patient double blind, randomized, placebo controlled Phase III clinical trial with DCVax-L for newly diagnosed GBM. The primary endpoint of the trial is Progression Free Survival, meaning the length of time that a patient continues without disease progression (i.e., recurrence of the tumor). Secondary endpoints include overall survival and other measures. The trial is under way at 51 sites (medical centers) across the US. The sites and the eligibility criteria are listed in the profile of the trial at ClinicalTrials.gov. The trial is also under way in Europe. The lead site is Kings College Hospital in London. Approximately 30 trial sites are also in varying stages of preparation in the U.K. and Germany.

DCVax Direct offers a potential new treatment option for the wide range of clinical situations in which patients tumors are considered inoperable because the patient has multiple tumors, or their tumor cannot be completely removed, or the surgery would cause undue damage to the patient and impair their quality of life. DCVax-Direct is administered by direct injection into a patients tumors. It can be injected into any number of tumors, enabling patients with locally advanced disease or with metastases to be treated. DCVax-Direct can also be injected into tumors in virtually any location in the body: not only tissues at or near the surface of the body but also, with ultra-sound guidance, into interior tissues. Northwest is currently conducting a 60-patient Phase I/II trial of DCVax-Direct for all types of inoperable solid tumors. The trial is under way at MD Anderson in Houston, TX and MD Anderson in Orlando, FL, with additional sites in varying stages of preparation. The Phase I stage of the trial involves dose escalation, testing 3 different dose levels of DCVax-Direct, and confirmation of the optimal dose.

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DCVax-Prostate is designed specifically for late stage, hormone independent prostate cancer. Such cancer involves the spread of micro-metastases beyond the prostate tissue. In most patients, there is no focal tumor which can be surgically removed and used to make lysate, or into which dendritic cells can be directly injected. Instead, the cancer cells are diffuse. We have developed a DCVax product line using a particular proprietary antigen PSMA (Prostate Specific Membrane Antigen) which is found on essentially all late stage (hormone independent) prostate cancer. The PSMA is produced through recombinant manufacturing methods, and is then combined with the fresh, personalized dendritic cells to make DCVax-Prostate.

Northwest is led by Linda Powers, her linkedin page describes her as: Ms. Powers served as Chairman of NW Bio for the last 4 years, and brings more than 25 years experience in corporate transactions and operations, including more than a decade specializing in building biotech companies through Toucan Capital. Ms. Powers is particularly well known for her experience in building biotech companies that are developing cell therapies, including both immune cell therapies (such as NWBios DCVax) and adult stem cell therapies. Such products consisting of living human cells require fundamentally different manufacturing, storage, distribution and handling than do pharmaceutical drugs (pills in bottles). Such living cell products also involve different clinical and regulatory requirements, and different business and cost/pricing models, than traditional drugs. The cell therapy companies which Ms. Powers has been involved in building over the last decade, both in the US and abroad (in Asia, Europe and Israel), are at the forefront of clinical trials and early commercialization. Ms. Powers has served for years on a number of related boards, including the M2Gen Board of the Moffitt Cancer Center, the Board of the Trudeau Institute (a world leader in immunology research) and others. As Chairman of NW Bio, she has brought her lengthy experience to bear in helping to shape NW Bios overall strategy and programs. As CEO, she will now undertake operational responsibilities in addition to continuing her duties as Chairman.

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Currently trading at a $129 million market valuation NWBO has $1.9 million in the treasury, manageable debt and fast growing sales reporting $593k in revenues for the 3 months ended September 30, 2019. NWBO is an exciting story developing in small caps; this little biotech is sitting on drugs in development that could potentially turn the multi-billion dollar drug-resistant cancers market upside down. NW Bio lead product, DCVax-L, is currently in a 331-patient Phase III trial for patients with newly diagnosed Glioblastoma multiforme (GBM), the most aggressive and lethal brain cancer. The stock has a significant shareholder base that continues to bid this one higher. We will be updating on NWBO when more details emerge so make sure you are subscribed to Microcapdaily so you know whats going on with NWBO.

Disclosure: we hold no position in NWBO either long or short and we have not been compensated for this article.

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The Inside Scoop on Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) - MicroCap Daily