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Sunday, September 25, 2022

The Fascinating Rise of DCVax®-L; Northwest Biotherapeutics, Inc (OTCMKTS: NWBO)

Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) has skyrocketed up the charts in recent days after the Company announced it is pursuing an intensive program of manufacturing preparations and planning as it approaches top line data from its Phase III trial of DCVax®-L. A cornerstone of this expanding program is completion of the Phase I buildout of the Sawston, UK manufacturing facility. With construction crews working double shifts to accelerate this completion, management anticipates the Phase I buildout will finish by mid-October of 2020.

NWBO was trading in the $0.15 to $0.25 range for years and never really did much but did attract a significant shareholder base along the way. This has all changed recently as NWBO stock has run northbound. The recent financing and buildout of its Sawston, UK manufacturing facility speak of significant confidence in the Company’s coming top line data from its 331-patient Phase 3 trial of DCVax®-L for Glioblastoma brain cancer.

Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) is a biotechnology company focused on developing personalized immune therapies for cancer. The Company has developed a platform technology, DCVax®, which uses activated dendritic cells to mobilize a patient’s own immune system to attack their cancer.

NW Bio lead product, 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. The Company 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.

NW Bio second product, DCVax®-Direct, is designed to treat inoperable solid tumors. A 40-patient Phase I trial has been completed, and included treatment of a diverse range of more than a dozen types of cancers. The Company is working on preparations for Phase II trials of DCVax-Direct.

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NWBO

Last week NW Bio reported it is pursuing an intensive program of manufacturing preparations and planning as it approaches top line data from its Phase III trial of DCVax®-L. A cornerstone of this expanding program is completion of the Phase I buildout of the Sawston, UK manufacturing facility. With construction crews working double shifts to accelerate this completion, management anticipates the Phase I buildout will finish by mid-October of 2020.

This buildout is the culmination of several years of design, development and preparatory activities, including 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).

This accelerated effort is being supported by the Company’s recent financings and by a special purpose competitive loan of £1.35 (~$1.77) million from the Department for Business, Energy & Industrial Strategy which is administered locally in the Cambridge/Sawston region by the Cambridgeshire & Peterborough Combined Authority. The project cost of this accelerated construction project, initiated in June of this year, is approximately £3.5 (~$4.6) million.

On September 1 NW Bio announced it has acquired Flaskworks for a consideration of $4.33 million, a company that has developed a breakthrough system to close and automate the manufacturing of cell therapy products such as DCVax®.  Flaskworks was previously owned by its technical founders and Corning Incorporated.  The technical team from Flaskworks has joined NW Bio as part of the acquisition. It is anticipated that the Flaskworks system will enable substantial scale-up of production volumes of DCVax products and substantial reduction of production costs.

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Currently running northbound 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. NWBO has been making a number of big moves in recent days  inclujding securing new financing as well as continuing the  buildout of its Sawston, UK manufacturing facility. Also NWBO just acquired Flaskworks; a company that has developed a breakthrough system to close and automate the manufacturing of cell therapy products such as DCVax® for $4.33 million in cash and stock. 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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