BriaCell CEO: Building Offerings for the $30-billion Immunotherapy Market

According to BriaCell (TSXV:BCT, OCTQB:BCTXF) CEO Dr. William Williams, BriaCell is developing the first personalized off-the-shelf immunotherapy targeting advanced-stage breast cancer.

In the interview below, Dr. Williams discussed each of the company’s therapies and how the company fits into an immunotherapy market that is expected to see over $ 100 billion in yearly sales by 2021. He also provided insight into strategic partnerships the company is engaged in with other immunotherapy developers for the purpose of designing combined therapies.

Below is a transcript of our interview with BriaCell CEO Dr. William Williams. It has been edited for clarity and brevity.

Investing News Network: Please give our investor audience an overview of BriaCell and its innovative technology.

BriaCell CEO Dr. William Williams: BriaCell is developing the first personalized off-the-shelf immunotherapy for advanced breast cancer, the second leading cancer-related cause of death for women. Breast cancer has spurred significant development in new therapies including drugs like IBRANCE® and Herceptin®. Despite these advancements, about 41000 patients are expected to die of breast cancer in 2018, so there is clearly a huge unmet need for therapies for breast cancer.

As a growing market in drug development, immunotherapy drugs saw between $ 20 billion and $ 30 billion in sales in 2017. That number is expected to grow to over $ 100 billion in yearly sales by 2021. Immunotherapies are exciting because they use a patient’s own immune system to target and destroy cancer cells.

What have emerged are therapies that can tailor the immune response to the patient such as CAR-T cell therapy and PROVENGE®. However, each dose of these therapies has to be individually manufactured, which takes a lot of time and is extremely expensive. As such, there is a need for an off-the-shelf personalized immunotherapy.

BriaCell is developing an off-the-shelf personalized treatment for advanced breast cancer, which can be obtained readily following a simple diagnostic test to select the appropriate individualized treatment for each patient, and thus avoids the time, cost, and manufacturing complexities associated with other personalized immunotherapy approaches.  In proof of concept studies, we have seen evidence of tumor shrinkage in multiple sites including those in the lung and brain in patients whose tumors have migrated to other sites of their body. Impressively, these treatments had an excellent safety and tolerability profile. The treatment showed intense anti-tumor activity in  the patients who shared certain key HLA (human leukocyte antigen) genes with Bria-IMT.

Based on these findings, BriaCell is developing BriaDX, a diagnostic test, to be able to select the patients for whom these treatments would work best.

INN: What stage of development is BriaCell at with its technologies?

WW: We have two primary technologies that use our targeted immunotherapy approach.

For Bria-IMT, we have recently announced positive proof of concept in a Phase IIa study of advanced breast cancer with outstanding safety and excellent, predictable efficacy in patients with HLA matches with Bria-IMT™. Impressively, the safety and efficacy data appeared superior to that of the other advanced or approved drugs for breast cancer when they were at a similar clinical stage of development.

We analyzed the blood samples of the patients and learned that they contained circulating cancer-associated cells which expressed molecules known as immune checkpoints (PD-L1). We expect Bria-IMT to work even better when used in combination with a check point inhibitor such as Anti-PD-1 or anti-CTLA-4.  We have initiated a Phase IIa combination study of Bria- IMT™ with pembrolizumab [Keytruda®; manufactured by Merck & Co., Inc.] or ipilimumab [Yervoy®; manufactured by Bristol-Myers Squibb Company] in advanced breast cancer. The combination study is listed in ClinicalTrials.gov as NCT03328026.

These checkpoint inhibitors, pembrolizumab (anti-PD-1) and ipilimumab (anti-CTLA-4), have come to the forefront in the fight against cancer with substantial benefits for some patients. Most recently, the significance of immune checkpoints was recognized by the Nobel committee by awarding Drs. Honjo (PD-1) and Allison (CTLA-4) with the 2018 Nobel Prize in Physiology or Medicine, so we are very pleased with our choices of checkpoint inhibitors for the clinical study.

Based on our findings, we are working on developing Bria-OTS™, an off-the-shelf personalized treatment to be able to effectively treat over 90% of the patient population. Bria-OTS™ is expected to enter the clinic in 2019.

We are also working on developing Protein Kinase C delta inhibitors, small molecules that also have some immunotherapy activity. They have the potential to treat up to 30 percent of all cancers. They are expected to enter the clinics in 2021.

INN: How does your approach compare to other cancer therapies when they were at the same stage of development?

WW: If you look at approved therapies for breast cancer, including IBRANCE® and other CDK4/6 inhibitors, they all had safety issues with bone marrow suppression in early clinical studies. They also had relatively low response rates of between zero and five percent. As these drugs were being developed, it was learned that these drugs were effective only in patients with hormone-receptor-positive types of breast cancer.

With Bria-IMT™, when we looked at ‘all comers’, we observed response rates in the same range as other therapies at the same stage of development. However, when we narrowed it down to patients with HLA matches for Bria-IMT™, our response rates were far superior to those of the other treatments of the same stage of development, giving us a great deal of confidence as to the viability of our immunotherapy.

INN: How does BriaCell plan to attract interest from large pharmaceutical companies?

WW: BriaCell is actively engaging in a partnership discussion with a number of large pharmaceutical companies. Some of these companies are interested in BriaCell from a business standpoint, and are showing interest in licensing the company’s assets or engaging in another type of deal.

In our view, a check point inhibitor would work well with Bria-IMT™ or Bria-OTS™ since it would use a different, but synergistic mechanism of action. We believe that there could be a positive combination therapy strategy that implements both approaches. In fact, we have just dosed our first patient in a combination study with KEYTRUDA®, which is made by Merck Oncology.

We will continue to engage with these companies at upcoming oncology meetings to discuss potential partnerships.

INN: What is next for BriaCell and how does that fit into the company’s long-term plans?

WW: For Bria-IMT™ we are on track to begin a registration study in 2020 with agreement from the FDA and hope to get marketing approval by 2023. BriaCell’s management has notable experience getting drugs through the FDA, having been involved in over 10 drug approvals.

We are also on target to start the clinical trials for Bria-OTS, BriaCell’s off-the-shelf personalized immunotherapy, in 2019. This could also draw attention from pharmaceutical companies but also from the investment world as they see the first personalized off-the-shelf immunotherapy in the clinic.

Finally, we hope to have our Protein Kinase C delta inhibitor in the clinic within a couple of years. This will be another important inflection point for the company. Ultimately, we plan to move the company forward with minimal investment for the maximal value.

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