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A ‘Barrier’ to Better Health

Dave Jackson Dave Jackson, Stockhouse
0 Comments| September 30, 2020

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The blood-brain barrier plays an essential role in protecting the brain from blood-borne disease. But is also one of medicine’s great paradoxes – a system designed to protect the most sensitive region of the body but, in turn, ends up actively inhibiting the ability to treat disease within that sensitive region.

Bioasis Technologies Inc. (TSX-V.BTI, OTC:BIOAF, Forum) is a biopharmaceutical company focused on revolutionizing science by transporting therapeutic payloads across the blood-brain barrier and into the brain. The Company’s goal is to generate shareholder value by developing and commercializing its proprietary brain delivery technology – XB3 – to make life-saving drugs brain-penetrant and deliver those drugs at a therapeutically relevant dose.

In this intriguing podcast, Stockhouse Media’s Dave Jackson was joined by CEO Dr. Deborah Rathjen to talk more about the Company’s amazing XB3 platform, its landmark partnership with the Chiesi Global Rare Diseases Group, and all the things Bioasis shareholders and investors should be watching for in the upcoming months.

SH: So, let’s talk about all the buzz surrounding the XB3 platform. What exactly is it, and where does Bioasis hope to take it?

DR: There is certainly a new level of interest around the xB3 platform, particularly since we announced our partnership with Chiesi. XB3 is a technology for transporting life-saving drugs across the blood-brain barrier and into the brain. Bioasis’ xB3 Platform enables delivery of a variety of therapeutics including enzymes, siRNA, antibodies, other biologics and small molecules. Through the xB3 Platform, the Company has developed an internal pipeline of 10+ product candidates with a focus on three distinct therapeutic areas: (1) CNS oncology; (2) lysosomal storage disorders; and (3) neurodegeneration / inflammatory CNS disorders.

Our lead asset, xB3 -001, consists of a xB3 carrier peptide conjugated to Herceptin. It is currently in IND enabling studies and we received positive responses to our pre-IND filing in June 2019, potential for accelerated approval after Phase 1b/2a. xB3-001has a large addressable market of $3.7bn in HER2+ breast cancer metastasis to the brain, potential upside for use within HER2+ gastric cancer and brain cancer

xB3 -007, consists of a xB3 carrier peptide conjugated to β-glucocerebrosidase for Gaucher disease, Parkinson’s, and Lewy Body Dementia

xB3 -004 targets inflammation in the brain with potential in non-opioid pain relief, treatment of epilepsy and Multiple Sclerosis through a common mechanism based on inhibition of the cytokine IL-1

SH: Can you update us on the progress of your relationship with Chiesi Global Rare Diseases Group? This looks like a partnership that’s really working and making strong headway into treating neurodegenerative diseases.

Click to enlargeDR: The focus of our partnership with Chiesi is on a group of rare genetic diseases called Lysosomal Storage Disorders. Although the different types of LSDs are rare individually, taken together they affect roughly 1 in 7,700 births, making them a relatively common health problem. LSDs affect mostly children and they often die at a young age.

Lysosomes are sacs of enzymes within cells that digest large molecules and pass the fragments on to other parts of the cell for recycling. This process requires several critical enzymes and if these do not function the large molecules accumulate within the cell killing it. Some LSDs can be treated with enzyme replacement therapy however these enzymes do not cross the blood brain barrier without the help of xB3 technology. We believe that xB3 can play a very important role in reducing the brain symptoms of LSDs…. And although it is still early days in our collaboration we are really pleased to be working with Chiesi on treatments that could significantly improve the lives of patients with LSDs.

SH: Your deck states, “Bioasis’ XB3 patented platform provides researchers with a solution to one of medicine’s most stubborn challenges – how to transport medicines across the blood-brain barrier at doses sufficient to have a therapeutic effect.” Can you break down how the science works in layman’s terminology?

DR: Yes, I can. The blood-brain barrier performs an important function – keeping nasties out of the brain – and it does this very effectively, it is super-efficient. However, there are times when we would like selected molecules “good guys”” to enter the brain. Bioasis’ technology makes use of a natural process to make this happen. A receptor on the BBB, called LRP1 functions as a kind of shuttle, moving things across the BBB in a process that is called receptor-mediated transcytosis. Bioasis has designed a peptide – called xB3 – that attaches to LRP1. Once it binds or attaches to LRP1, xB3 is shuttled into the brain. We can attach many different kinds of molecules to xB3 – small or large – and these are also shuttled across the BBB and into the brain along with with xB3. This proprietary technology does not interfere with the normal function of the BBB. It is pretty simple really!

SH: Another important component of XB3 therapy its applications in non-opioid pain management. This sounds like a real game-changer.

DR: I think that we are all aware of the need to develop non-addictive treatments for pain, particularly for the treatment of the more chronic pain conditions, including neuropathic pain. Pain is an enormous problem globally. Estimates suggest that 20% of adults suffer from pain globally and 10% are newly diagnosed with chronic pain each year. Our approach has been to focus on the inflammatory basis of pain and the outcomes of Bioasis’ collaboration with MedImmune indicating that xB3-004, which is an xB3 version of a marketed antibody that inhibits binding to the IL-1 receptor, reduced pain in an industry-standard model. We are investigating the potential of xB3-004 in conditions where chronic pain is a symptom and where we may also have an effect on the underlying cause of the disease such as in Multiple Sclerosis. This is an exciting program and I feel that it is a somewhat overlooked part of our pipeline.

SH: The recent news of the passing of baseball Hall-of-Fame pitcher Tom Seaver was very sad new indeed. He suffered from the long-term degenerative effects of something called Lewy body dementia. Please tell how XB3 can ultimately effectively treat these kinds of devastating neurodegenerative diseases?

DR: Lewy body dementia is the second most common type of progressive dementia after Alzheimer's disease dementia. Protein deposits, called Lewy bodies, develop in nerve cells in the brain regions involved in thinking, memory and movement. These deposits are also observed in Parkinson’s disease and the associated dementia. Our approach to potential treatments for both Lewy Body Dementia and Parkinson’s disease utilizes xB3 delivery of the enzyme β-glucocerebrosidase into the brain to overcome the enzyme deficiency that results from mutations in the GBA gene that reduce enzyme function. This is the basis of our product xB3-007. We believe this product has potential for the treatment of Gaucher Disease, Parkinsons disease and Lewy body dementia where there is a common link to mutations in the GBA gene.

SH: In a recent Stockhouse article, you were quoted as saying Bioasis is focused on concluding additional strategic partnerships for its XB3 drug delivery platform and you’re making significant progress in discussions with potential partners, along with anticipated additional licensing agreements. Can you elaborate on these developments?

DR: We have been working in a purposeful way for some time now to ensure that our xB3 technology is widely adopted where there is a need for important life-saving medicines to be effective in treating brain conditions. Some research reports have estimated that the CNS Therapeutics market could be worth $128.9 billion by 2025. Imagine its value if peripherally administered biologics were able to be effective in the brain! The market research has also indicated that the cancer component is the fastest growing CNS therapeutics market segment which is of course of great interest to Bioasis. It is premature to speculate on potential future transactions however it is fair to say that we have seen strong interest in our platform since our deal with Chiesi was announced.

SH: I would be remiss if I didn’t mention that your share value has more than doubled since the beginning of June. To what do you attribute this significant stock jump?

DR: That is a very interesting question – I hope that it reflects a greater appreciation by investors of Bioasis technology and the potential of our rich pipeline. This period of course has seen the successful completion of our deal with Chiesi and a concerted effort to communicate with investors through a variety of channels. The initiation of research coverage by Edison Research has been helpful in this regard as was the joint Bioasis – Chiesi webcast in July. The Chiesi partnership has provided additional validation for our drug delivery technology which is an important consideration for investors.

SH: Finally, looking six months to a year down the road for Bioasis’ business, is there anything coming up investors should be keeping an eye out for?

DR: I think it is going to be a great 6 to 12 months for Bioasis’ investors. We are anticipating new preclinical data from our xB3-007 and xB3-004 programs where we are exploring new indications, including Lewy Body Dementia and Multiple Sclerosis respectively. We also anticipate data from a new program which is targeting a treatment for Frontal Temporal Dementia. With success from our business development activities we will intensify our efforts on getting to IND and first clinical trial of xB3-001 in women with HER2+ metastatic breast cancer that has spread to the brain.

To download episode, click here.

FULL DISCLOSURE: This is a paid article produced by Stockhouse Publishing.

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