Image Source: BriaCell.com

BriaCell Therapeutics Corp (Nasdaq: BCTX, BCTXW) (TSX:BCT) is a clinical stage biotechnology company based in Canada that develops novel immunotherapies for cancer.

The Company’s lead candidate is Bria-IMT™ is a whole-cell cancer immunotherapy in Phase I/II clinical trials, combined with Incyte’s retifanlimab, for advanced breast cancer. Incyte has a collaboration with BriaCell here, so we wanted to ask BriaCell’s management, including CEO William Williams, about the rationale for the combination.  Here's what they had to say:

Immune checkpoint inhibitors, such as Incyte’s retifanlimab, are designed to overcome immune suppression in cancer patients, and is revolutionizing the fight against cancer.

Quite simply, anti-PD-1 immune checkpoint inhibitors work by taking the foot off the brake of the immune system while targeted immunotherapies like our Bria-IMT^TM put the foot on the gas, resulting in synergistic effects. Immune checkpoint inhibitors have come to the forefront in the fight against cancer, the significance most recently recognized by the 2018 Nobel Prize in Physiology or Medicine (Scientists behind game-changing cancer immunotherapies win Nobel medicine prize), which has further validated our decision to launch a combination therapy with the immune checkpoint inhibitors.

Bria-IMT™ has been shown to directly and indirectly stimulate T cells, and hence boost the immune system.  It is important to note that immune checkpoint inhibitors have NOT been shown to work on their own in breast cancer, which further explains the synergistic action we’ve so far seen in our combination approach.

Could you please compare the data seen in this early phase trial to similar trials in metastatic breast cancer, ideally with similar baseline characteristics? Please comment on the survival benefits of BriaCell’s treatment, given that such sick women with late stage cancer qualify for your study.

We are treating patients who have failed all available therapies.  Their life expectance is very limited.  In spite of that, we are still seeing remarkable responses in some subsets of patients – and we are able to identify these subsets during screening with a simple saliva test.  We have seen encouraging results in patients both on the Bria-IMT™ treatment regimen alone and especially in combination with immune checkpoint inhibitors (as outlined above).  This includes a patient who had failed 12 prior treatment attempts who had a tumor metastasized behind her left eye causing the eye to bulge out as well as tumors on the outside lining of the brain.  After our treatment, she had complete 100% resolution of the tumor behind her eye and marked improvements elsewhere.  She went on to survive for almost 2 years when her life expectancy was only a few weeks when we first began her treatment. Overall, we believe we are seeing a benefit in prolonging the lives of these patients with advanced breast cancer and have seen marked clinical benefit in patients with limited to no treatment options.

Please discuss the clinical and regulatory schedule for Bria-IMT™. How long is the registration trial going to be? What sort of patent protection does the asset have? 

To note up front, because we’re treating such sick women, our pivotal registration study to begin marketing/selling the drug is the Phase IIb (rather than full Phase III).  And we have been awarded a Fast Track designation by the FDA which has and will speed up regulatory communication turnaround.

We are expecting to hold an end of Phase IIa meeting with the FDA before the end of the year to discuss and negotiate the number of patients required to obtain the drug approval for advance breast cancer indication. Based on FDA’s requirements and the study costs, we will be able to evaluate our options regarding the continuation of the study by ourselves and/or seek a partner. We will also be in a better position to estimate the timeline it will take for the approval of our immunotherapy.  

And yes, our technology has been patented and it would also be very difficult to render generic as it is a cellular therapy.  Additional info here.

Please discuss your other programs. What is the value add with your Off The Shelf immunotherapy program? 

As we treated our patients, we noticed that some patients responded to the immunotherapy treatments much better than the others. We studied these patients further and discovered that their HLA type was a key determinant – and simple to identify via a simple saliva test. This makes sense immunologically as HLA molecules start immune responses, and we believe that Bria-IMT™ directly stimulates T cells. If the patient has the same HLA type as the Bria-IMT™ treatment cells, her immune system would show a stronger ability to recognize and attack their cancer, what we refer to as “HLA matching”.  Our top responders have been “HLA matches”.

We, then, sat back and thought of the ways that we could treat the other patients and turn them into top responders, and our novel off-the-shelf personalized immunotherapy approach was developed. This approach allows us to essentially “HLA match” each patient by identifying her HLA type prior to dosing. We would then treat her with pre-manufactured cells that correspond to her HLA type.  We call this matching approach Bria-OTS™ or Off-The-Shelf.  Quite simple! 

The power of this novel technology can be extraordinary, noting that we could use only a few cell lines to be able to make HLA specific immunotherapies. This will limit manufacturing costs while allowing us to personalize our therapy.

Imagine that a patient comes to her physician/oncologist. She will have her HLA type determined using a simple, inexpensive, and fast saliva test. Based on her HLA type, she will be given an off-the-shelf treatment (i.e. premade treatments) in few days. This treatment will be personalized because it is a match with the HLA type of the patient, but the patient does not need to wait to receive her personalized treatment because the treatments are pre-manufactured. This is a novel concept; and unlike other personalized cell therapies, like CAR-T, that may take weeks to prepare. Unfortunately, weeks are precious and fleeting for patients with advanced stage of breast cancer, so our product will kill two birds with one stone by providing personalized immunotherapies for patients quickly.

We are expecting to have the IND for our Bria-OTS™ advanced breast cancer program and begin clinical studies by the end of the year. This year indeed is a very exciting year for us.

Please discuss your cash position. When do you expect a PDUFA? Do you have adequate cash to last until then? If not, how do you plan to fund your programs?

As of April 30, 2022, BriaCell had US$44.5million in cash. 

We are expecting to hold an end of Phase IIa meeting with the FDA before the end of the year to discuss and negotiate the number of patients required to obtain the drug approval for advance breast cancer indication. Based on FDA’s requirements and the study costs, we will be able to drive this program forward with or without a big pharma partner.  We have cash runway through the next 2 years, which advances us well-through these key value-creating clinical milestones.

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