Northwest Biotherapeutics Inc - NWBO stock
OTC Symbol: NWBO | OTC Tier: OTCQB
Introduction[edit]
Northwest Biotherapeutics, Inc. (OTC: NWBO), is a development-stage biotechnology company that develops personalized immune therapies for cancer. The company is focused on producing more effective immunotherapy products that treat cancer better than the existing portfolio. The firm is keen to eliminate toxicities in those products associated with chemotherapies cost-effectively. Northwest therapeutics serves the U.S., Europe, and the international markets. The firm develops its products on the backbone of its DCVax technology, a platform that employs activated dendritic cells to marshal a patient’s immune system to counter cancer. DCVax-L, the company’s lead product, has completed a 331-patient international Phase III trial to treat Glioblastoma multiforme (GBM), the most aggressive and deadly brain cancer. It develops DCVax-Direct, undergoing Phase I/II clinical trials to treat inoperable solid tumors. The company has FDA clearance for a 612-patient Phase III trial in prostate cancer and clearance for Phase I/II trials for several other cancers. Northwest Biotherapeutics’ wholly owned subsidiaries include Aracaris Ltd, Aracaris Capital, Ltd, Flaskworks, Northwest Biotherapeutics B.V., and N.W. Bio GmbH. The company was incorporated in 1996. Its tocks publicly trade on OTC markets under the NWBO ticker symbol. The firm is headquartered in Bethesda, Maryland.[1]
Operations[edit]
The company is focused on the discovery, development, and commercialization of its immunotherapy products which trigger and reinforce the immune system's response to cancer treatment. The company is committed to developing products free of side effects and marginal clinical results, as portrayed by some of the current products in the market. The firm uses its expertise science of dendritic cells, a type of white blood cell that triggers the immune system, to professionally develop its products. Its cancer therapies have displayed the significant ability to extend the time to recurrence and survival while advancing the superior quality of life with zero negative side effects compared to existing therapies. Its DCVax technology uses the patient’s dendritic cells to activate the immune system. The cells are extracted from the body and loaded with antigens to create a personalized therapeutic vaccine. When injected back into the patient's body, it instigates a potent immune response against cells, slowing the progression and prolonging survival.[2]
Pipeline[edit]
DCVax-L
The product is made with cancer antigens from the patient’s tumor lysate. DCVax-L thus contains the full set of tumor antigens, making it more resilient to attacks by cancer pathogens. The Drax product has been used to engineer the company's GBM brain cancer and ovarian cancer clinical trials. It is expected to be applied to any solid tumor cancer patients whose tumors have been surgically removed. Following trials on DCVax-L, the company anticipates tabling a biologics license application for DCVax®-Brain with the FDA.[3]
DCVax-Direct
It is designed for application in situations where a patient’s tumor cannot be surgically removed. DCVax-Direct is also made up of a full set of tumor antigens in the patient's body. It allows the fresh, new dendritic cells to partially mature in a special manner and directly identifies antigens from tumor tissues within the patient’s body. A 40-patient Phase I trial on the product has been completed and included treatment of a wide range of cancers.[3]
DCVax-Prostate
This product is designed to cure late-stage prostate cancer. DCVax-Prostate has been developed using PSMA (Prostate Specific Membrane Antigen), essentially found in all late-stage prostate cancers. PSM is combined with fresh, personalized dendritic cells to develop DCVax-Prostate. The company has FDA clearance to begin Phase III clinical trial.[3]
Critical Company and Industry Developments[edit]
On Nov. 17, 2022, the company announced significant increases in median survival and the "long tail" of extended survival on recurrent and newly diagnosed glioblastoma brain cancer patients administered with DCVax-L during Phase 3 clinical testing of the product. The trial was communicated to have adhered to all the primary and secondary requirements under the Statistical Analysis Plan for the underlying trial. The company expressed its excitement given that it might be the first time in nearly 20 that such a trial has manifested robust survival extension in newly diagnosed glioblastoma of the sort.[4]
Acquisitions[edit]
Flaskworks, LLC[edit]
Northwest Biotherapeutics, on Aug. 28, 2022, closed a 100% acquisition of Flaskworks, LLC, a company with a system designed to wrap and automate the manufacture of cell therapy products like DCVax. Flaskwork’s technical team also joined Northwest Biotherapeutics as part of the acquisition agreement. The company believed the acquisition would simplify and streamline certain phases of its buildout.[5]
License Agreements[edit]
Roswell Park[edit]
Northwest Biotherapeutics has an exclusive license for a suite of dendritic cell technologies and intellectual property from Roswell Park Comprehensive Cancer Center. The licensed technologies include five newly filed patent families from 2023, offering significant patent life. These technologies encompass improved dendritic cell therapies, including methods for loading tumor antigens into dendritic cells and direct administration into tumors. There are also conditioning treatments aimed at enhancing patient responses and altering the tumor environment to improve the effectiveness of immune therapies, particularly in overcoming resistance to checkpoint inhibitors.[6]
- ↑ seekingalpha.com/symbol/NWBO - Company Profile. Accessed on 12/20/2022.
- ↑ Northwest Biotherapeutics Overview- Northwest Biotherapeutics’ Linkedin Page. Accessed on 12/20/2022.
- ↑ 3.0 3.1 3.2 Northwest Biotherapeutics, Inc., Product Candidates- Northwest Biotherapeutics website.
- ↑ Northwest Biotherapeutics Reports Positive Top-Line Results From Phase 3 Trial of DCVax®-L for Glioblastoma - Northwest Biotherapeutics press releases.
- ↑ NORTHWEST BIOTHERAPEUTICS INC Management's Discussion and Analysis of Financial Condition and Results of Operations (form 10-Q), page 22. Retrieved on 12/21/2022.
- ↑ PHARMABIZ.com. NW Bio announces exclusive in-license of portfolio of dendritic cell technology and intellectual property. June 18, 2024. Archive link.
