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DCVax®-L; Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) The Bull Has Awoken

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Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) has gone into full beast mode skyrocketing up the charts and emerging as the new darling of small caps making longs rich and slaying shorts along the way. Microcapdaily has been reporting on NWBO for years including when it was $0.15 not too long ago.

There could not be a more exciting time to be a NW Bio Investor; CEO Linda Powers recently made a presentation at the American Brain Tumor Association 2020 National Conference. She stated: “later this month of September, we will be expecting to UNBLIND, UNVEIL, and ANNOUNCE, **finally,** the results of our THIRTEEN YEAR LONG PHASE THREE TRIAL OF DCVAX FOR GLIOBLASTOMA BRAIN CANCER. And we think this study is going to be a major contribution to the field in terms of data, and we certainly hope to be able to bring a new treatment option to patients. So please stay tuned to see those clinical trial results in just a few weeks.  Brain and other nervous system cancers are the 10th leading cause of death for men and women. The global Glioblastoma multiforme (GBM) drugs market to reach nearly $1.4 billion by 2025, expanding at a CAGR of 12.6% during the forecast period, driven by rising geriatric population, growing incidence cases and rich clinical pipeline of new products.

Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) 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. NW Bio’s proprietary manufacturing technology enables the Company to produce its personalized vaccine in an efficient, cost-effective manner. NW Bio has a broad platform technology for DCVax dendritic cell-based vaccines. The Company’s lead product, DCVax-L, is currently in a 348-patient Phase III trial for patients with newly diagnosed Glioblastoma multiforme (GBM), the most aggressive and lethal brain cancer. The Company’s second product, DCVax-Direct, is currently in a 60-patient Phase I/II trial for direct injection into all types of inoperable solid tumor cancers. NW Bio has also conducted a Phase I/II trial with DCVax for late stage ovarian cancer together with the University of Pennsylvania. The Company previously received clearance from the FDA for a 612-patient Phase III trial with its third product, DCVax-Prostate, for late stage prostate cancer.

https://nwbio.com/wp-content/uploads/2014/04/NWBO-Pipeline2.jpgNW Bio has developed 3 product lines based on the DCVax technology, to address multiple different cancers. There are two main components to each DCVax product: the immune cells (dendritic cells) and the cancer biomarkers (antigens). All DCVax product lines are made from the patient’s own dendritic cells. The dendritic cells are freshly isolated, and newly matured and activated. NW Bio believes the existing dendritic cells in a cancer patient have already been compromised by the cancer, and this is the reason other vaccines have largely failed. However, the patient’s body continues to produce new precursors of dendritic cells, and these precursors (called “monocytes”) circulate in the patient’s blood stream. For all DCVax products, these precursors are obtained through a blood draw, and then (through NW Bio proprietary manufacturing processes), the precursors are matured into a fresh, uncompromised batch of new dendritic cells. The biomarker targets (“antigens”) component of the DCVax product, which is combined with the fresh, personalized dendritic cells, varies among the DCVax product lines.

DCVax-L — is made with cancer antigens from tumor lysate (a protein extract from processed tumor cells) from the patient’s own tumor tissue. As such, DCVax-L incorporates the full set of tumor antigens, making it difficult for tumors to find ways around it. This is the DCVax product that has been used in NW Bio GBM brain cancer and ovarian cancer clinical trials, and is currently in its Phase III trial. DCVax-L is expected to be used for any solid tumor cancers in situations in which the patient has their tumor surgically removed as part of standard of care. DCVax®-L, is designed to treat solid tumor cancers in which the tumor can be surgically removed. This product is in a 331-patient Phase III trial for newly diagnosed Glioblastome multiforme (GBM) which is in the process of moving towards data lock. On May 29, 2018, interim blinded data from the Phase III trial collected in March 2017 were published in a peer reviewed scientific journal. On November 17, 2018, updated interim blinded data from the Phase III trial collected in October 2018 were presented at the Society for Neuro-Oncology annual meeting. As the Company noted in its announcement of the publication and in subsequent reports, the data could get either better or worse as it continues to mature. NW Bio has been consulting with its Scientific Advisory Board, the Steering Committee of the trial and other independent experts about the ongoing handling of the trial and the preparations for data lock, unblinding and analyses. Investors are currently awaiting results from top line data from its 331-patient Phase 3 trial of DCVax®-L.

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Expectations are very high and NW Bio is working hard behind the scenes pursuing an intensive program of manufacturing preparations and planning. A cornerstone of this expanding program is completion of the Phase I buildout of the Sawston, UK manufacturing facility. With construction crews working around the clock to accelerate completion, management anticipates the Phase I buildout will be completed in October 2020. The facility includes clean room suites, quarantined storage, quality control testing suites, controlled cryostorage (freezing) facilities for the finished products, as well as specialized systems (for example, for full air changes every 60 seconds in the clean room suites, and precise monitoring of particle counts in the clean room air). The buildout is being financed by NW Bio as well as a special purpose competitive loan of  $1,770,000 from the Department for Business, Energy & Industrial Strategy which is administered locally in the Cambridge/Sawston region by the Cambridgeshire & Peterborough Combined Authority. The entire project is expected to cost $4.6 million.

DCVax®-Direct, is designed for situations in which the tumors are inoperable. A 40-patient Phase I trial has been completed, and included treatment of a diverse range of more than a dozen types of cancers. NW Bio is working on preparations for Phase II trials of DCVax-Direct. 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.

NW Bio is led by Linda Francis Powers who has been CEO since June 8, 2011. Ms. Powers is a serious go getter who earned a J.D., magna cum laude, from Harvard Law School. She has worked in Venture Captial as well as corporate finance and restructurings, mergers and acquisitions and intellectual property licensing. Ms. Powers is a Board member of M2GEN, the Trudeau Institute, the Chinese Biopharmaceutical Association, and the Rosalind Franklin Society.

On September 14 NWBO filed a form D related to the Flaskworks acquisition here. The acquisition of Flaskworks was executed and closed on August 28, 2020. The total purchase price was approximately $4.33 million, of which $1.65 million was paid in cash at closing, up to $2.01 million will be paid in stock subject to milestone-based vesting, and $0.67 million will be paid in either cash or stock, or a combination thereof, within 120 days after the closing. Flaskworks has developed a breakthrough system to close and automate the manufacturing of cell therapy products such as DCVax®.  It is anticipated that the Flaskworks system will enable substantial scale-up of production volumes of DCVax products and substantial reduction of production costs. Flashworks technical team has joined NW Bio as part of the acquisition.

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NWBO is quickly emerging as the new darling of small caps making longs rich and slaying shorts along the way. NW Bio is sitting on drugs in advanced clinical trials that could potentially turn several multi-billion-dollar cancer 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. Linda Powers recently stated:  “later this month of September, we will be expecting to UNBLIND, UNVEIL, and ANNOUNCE, **finally,** the results of our THIRTEEN YEAR LONG PHASE THREE TRIAL OF DCVAX FOR GLIOBLASTOMA BRAIN CANCER. And we think this study is going to be a major contribution to the field in terms of data, and we certainly hope to be able to bring a new treatment option to patients.” Brain and other nervous system cancers are the 10th leading cause of death for men and women. The global Glioblastoma multiforme (GBM) drugs market to reach nearly $1.4 billion by 2025, expanding at a CAGR of 12.6% We will be updating on NWBO when more details emerge so make sure you are subscribed to Microcapdaily so you know what’s going on with NWBO.

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

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