I wrote the following in answer to a question on the "Agora" forum.
My understanding of the status of xB3-001 is that a lot of money is needed to continue the manufacturing by WuXi of sufficient clinical-grade (GMP - good manufacturing practices) xB3-001 for the remaining preclinical studies, toxicity study, for instance, and for Phase 1b/2. I believe that about $8 million is required.
If I recall correctly, sufficient drug quantities and manufacturing capacities are required by the FDA for continued treatment of patients after the clinical trials. Bioasis also has to prove that the drug can be manufactured in sufficient quantities to satisfy all commercial markets after approval. Because it is a biologic, the cell lines that produce the drug can evolve causing changes in the drug's structure. Bioasis must prove that the structure can be maintained and that the company has quality assurance programs in place to assure continued structural integrity. This all has to be done before the IND submission.
I also believe that this final push to the completion of preclinical manufacturing can't stop once started because some or all of the process would need to be restarted, resulting in substantial costs to restart it all.
There is another alternative, however. It's possible to restart the development and manufacturing processes with a new partner that has the ability to genetically design another xB3-001 fusion protein. The partner would also need to have the means of manufacturing the fusion protein. The partner could do the initial work under a Material Transfer Agreement, which are almost always kept secret. In other words, the work could be going on now. There could be no timeline for xB3-001 made available to the public because a timeline can only exist if work is planned or being done. If a relationship is secret then no timeline!
Bioasis has a relationship with such a biologic manufacturing company through the Chiesi deal. It's possible, maybe likely, that Chiesi will advance the 4 LSDs with Protalix, its partner with the Fabry disease drug (PRX-102). If so, it's highly likely that Bioasis's Dr. Mei Mei Tian would assist Chiesi and Protalix in advice and oversight capacities throughout the xB3-4LSD development program.
Protalix can manufacture monoclonal antibodies like xB3-001 with its plant cell manufacturing process that they call ProCellEx. ProCellEx is way cheaper than WuXi's mammalian cell line manufacturing processes. A discussion of ProCellEx can be a subject for another post.
Protalix, or another company with similar capabilities, could earn part of its way into a partnership with Bioasis by completing this preclinical work. I have no knowledge of such an arrangement but something like this wouldn't surprise me. (It appears that Protalix introduced Bioasis to Aposense for siRNA work which suggests that Protalix has knowledge of and respect for Bioasis.)
There is an interesting element to it all. Bioasis has made a deal with Oxyrane for the development of an unnamed drug. But Oxyrane has a highly touted version of the enzyme required for Gaucher disease. Oxyrane also has a highly regarded manufacturing capability using yeast. Oxyrane appears to have solved some of the manufacturing limitations with yeast and claim the capability of manufacturing a broader array of biologics than yeast has historically had.
What's interesting to me is that Bioasis stopped talking about Cerezyme some time before the Oxyrane deal was announced. It's gone from Bioasis literature. Is that because it would be false to discuss it because Bioasis has decided on another version of the enzyme, like Oxyrane's version?
And then, let me go even further with this (conspiracy?) theory. Protalix has a Gaucher drug partnership with Pfizer. It is the first and only drug manufactured with plant cells that has been approved by the FDA. That was back in 2012. Protalix sold most of its rights to this drug to Pfizer. So, what might that mean to Bioasis?
Let's say that Bioasis and Protalix are working more deeply than we think. Suppose that it's possible that xB3-004 and progranulin are on the table with Protalix. Could it be possible that there is a huge relationship under consideration between Bioasis, Protalix and maybe Chiesi, or an arm of Chiesi?And then suppose that Protalix has a non-compete clause for Gaucher in its agreements with Pfizer. That would mean that Gaucher disease could not be part of this big partnership. That would drive Bioasis to develop Gaucher disease with somebody else, maybe like Oxyrane, which, like Protalix, can manufacture drugs. That piece of the jigsaw puzzle would be a neat fit.
This is all rank speculation. I have absolutely no information other than what's in the public domain that can support this speculation. But once you go down this road a little, it looks plausible.
I guess my point is that it's not wise to be too pessimistic about Bioasis and xb3-001. The potential for deals, partnerships and mergers are huge. Mergers? Who said anything about mergers. A merger between Bioasis and Protalix, at least on equal terms using an all stock acquisition of Bioasis by Protalix, would result in Bioasis shareholders having an immediate win with huge share price potential on the NASDAQ.
Protalix's strategic plan of having an ownership of all drugs they produce appears to completely encompass such a deal. They can manufacture and Bioasis cannot. Protalix needs drugs to manufacture and Bioasis with xB3 can supply a new drug construct every day of the week and half dozen more on the weekend. Made in heaven.
It would be such a slick way of advancing both companies, doing so with stock at these generally low prices, and leaving shareholders, including Bioasis shareholders, with all the blue sky they can breathe.
But, ummm, this is all wild-eyed speculation on a slow day. But, wow, there's some stuff that has to be considered to be possibly going on, and if so, then the development of the whole scenario isn't too hard.
So, yeah, maybe xB3-001 is stalled because of money. I suspect that if Bioasis moved xB3-001 to somebody else like Protalix that a slightly different structure of the fusion protein would result. Would that have to be patented? Are there any real hurdles?
What's important is that xB3 is important, and as long as it continues to perform with efficacy and safety, then this type of scenario isn't only possible, it's highly likely, IMUNVHO (in my usual not very humble opinion).
Ok, at ease. Remember it's just speculation. Fun though...