May 2020
Vol 7 | Issue 303

Q&A with Bill Haack of Cadex Genomics

CEO and Co-Founder

Principle Series:

Cadex Genomics® has developed a technology platform that addresses many unmet medical needs in the management of cancer care. Our first product is a blood-based molecular diagnostic test named Alibrex® that will give our company a first mover advantage in the field of real-time therapy monitoring for patients with late-stage, solid-tumor cancers. Unlike most advances in the management and treatment of cancer which typically impact only a small subgroup of patients, Alibrex is effective in all solid tumor types and is therapy agnostic. Real time therapy monitoring with Alibrex is a major advancement for patients with cancer.

In addition to Alibrex, Cadex Genomics has identified four other novel applications of its technology:
• Radiation-free cancer recurrence monitoring (Recurbrex)
• Stage confirmation to ensure that a patient’s early-stage cancer disease has been properly diagnosed and is not, in fact, evidence of later-stage cancer
• Minimal residual disease (MRD) testing to determining if a patient’s cancer has been cured and unlikely to recur
• Screening of patients for early detection of cancer

 


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How will Cadex Genomics and its lead product, Alibrex, help patients with cancer?

In the U.S alone, there are over 700,000 stage IV cancer patients treated annually. Each year, these patients receive approximately 6.5M cycles of cancer therapy. About 25% of these therapies fail to arrest the growth of the patient’s tumor. This translates into 1.6M cycles of therapy that deliver all the toxic side-effects and little to none of the intended benefits. In those 25% of cases, the therapy is negatively impacting the patient's quality of life without delivering any clinical benefit.

Alibrex can greatly improve the quality of patient care by reducing the number of ineffective therapies delivered to patients. This will increase the quality of life and, likely, the survival times for these patients. The magnitude of impact is best expressed by one physician who said: “We have been waiting for a test like Alibrex for years. It can be a real game changer in the management of patients with stage IV cancer.” While most advances in cancer care impact only a small subset of cancer patients, Alibrex will improve care for all stage IV patients with solid tumors.

What also excites us is that while improving patients’ lives, Alibrex will also help control healthcare costs. The costs of cancer treatments are expensive, often costing $10s of thousands per cycle. Increasingly, patients are being asked to shoulder these costs. In less developed countries, patients typically face the full burden of the costs of their cancer treatment. By reducing the number of ineffective therapies, Alibrex will save billions of dollars of cancer care and make that care accessible to more patients.

What is the plan to complete the clinical development and launch of Alibrex?

Alibrex addresses a market with an annual revenue potential of $1.2B in the United States and $2.2B worldwide. Alibrex will be the first test of its kind, establishing Cadex Genomics as a major player in cancer diagnostics. Alibrex will be made available to patients in early Q2-2021 under a CLIA license; FDA approval is not required.

Two proof-of-concept studies have been completed for Alibrex, one of which has already been published. Results from these studies indicate that Alibrex is highly effective. We have an ongoing international, multicenter, prospective clinical trial underway at 16 study sites to clinically validate Alibrex. This study will be completed in Q1-2021 and will validate that Alibrex is ready for clinical use. A larger follow-up clinical validation study will be completed later in 2021. This study will help broaden adoption and reimbursement.

We plan to publish all results from our clinical studies in peer-reviewed medical journals.

Who is the team behind the vision of Cadex Genomics?

Cadex Genomics is a team of deeply experienced scientific, medical, and commercial professionals who have developed and commercialized numerous life science technologies including several leading-edge therapeutics and molecular diagnostic tests.

The team has medical experience at MD Anderson Cancer Center, Georgetown University, and Tulane University, along with highly successful commercial experience launching products at Genentech, Glaxo Smith Kline, Novartis, Castle Biosciences, Genomic Health (now Exact Sciences) and Veracyte.


Bill Haack of Cadex Genomics

Bill Haack has over 20 years of experience in life sciences. He started his career at Genentech where he led the Sales Operations team and the successful launch of Rituxan and Herceptin. He was an early employee at Genomic Health where he helped lead, and was instrumental in, the successful launch and commercial success of all three Oncotype DX products. Under Mr. Haack’s leadership, Genomic Health grew from a zero- revenue company to over $300M in annual revenues. Mr. Haack also led the launch of Genomic Health in Europe where he led the start-up of their headquarters in Geneva and the establishment of commercial teams in the United Kingdom, France, Italy and Germany. Mr. Haack holds an MA degree in Economics. Contact Bill bhaack@cadexgenomics.com