NorthWest Biotherapeutics Inc (NWBO)

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In 2016, Sanofi decided not to make BCG. A vaccine consisting of a weakened non-infective version of TB bacteria.

By 2017, that left Merck with a monopoly. Merck did not bother building a new manufacturing plant to increase production until a new one is to be completed a decade later by 2025/2026, perhaps even late 2026. (Then they will bring it online slowly)

The price of BCG tripled due to high demand and low supply. A decade long shortage ensued (through 2026 or later). It’s used for TB vaccines but mostly Bladder cancer treatment.

The current version of DCVax-Direct requires BCG for its manufacture. DCVax-Direct, particularly with future combinations is a potential disruptive technology in the field of cancer care. Many BP (Such as Merck and Sanofi) might stand to lose profit share unless said technology was brought to its proverbial knees.

DCVax-Direct has patents out to 2035/2036.

DCVax-direct’s phase I primary completion date was December 2016.

Yes that’s exactly in between the time that Sanofi announced their intent and then acted on their intent to stop making BCG and create a BCG shortage.

Knowing this shortage would and did occur, Merck waited a decade to finish its BCG manufacturing plant, in the still future, by possibly late 2026.

Also, one of Merck’s largest investors, Citadel, is being sued by NWBO for manipulating their stock price through an illegal technique known as spoofing when Citadel was and still is functioning as NWBO’s market maker role for NWBO.

Meanwhile, little NWBO’s direct program was attacked from many angles between 2013 and 2018. The same program that now needed available TICE BCG to start its next trial.

The first trial, not intended to prove efficacy, but amazingly did show signs of survival increase as a monotherapy in late stage cancer patients. https://pmc.ncbi.nlm.nih.gov/articles/PMC6449174/

DCVax-Direct’s potential was unlimited, but no large manufacturers helped make up the TICE BCG shortage, so NWBO placed its program on ice. It was literally one of two necessary ingredients.It was cash strapped.

By 2024, NWBO had encouraging progress with another cancer therapy called DCVax-l, which, by today’s date, stands a good chance at being approved for marketing in the U.K.

NWBO also signed some collaboration deals this past month or so, and one of them could help bankroll DCVax-Direct restart-up, if that collaboration has monetary terms such as cash up front.

NWBO is still being hounded day in and day out by ne’re-de-wells possibly backed by linked sources, although this has not been proven.

The lawsuit filed by NWBO discussed above also faces a decision on a second MTD filed by Citadel and other defendants, in days or weeks.

Patients in addition to long term investors have suffered for great periods of time, and I think it’s been only very recently that we learned the BCG shortage above is one reason why.