In an interview with PharmaShots, Garret Hampton, President of Clinical Next-Generation Sequencing and Oncology at Thermo Fisher Scientific share his views on multiyear agreement with AstraZeneca to co-develop NGS-based CDx for targeted therapies

Shots:

• The collaboration will expand AstraZeneca’s portfolio of targeted therapies for cancer & other diseases. Thermo Fisher currently offers the NGS CDx solution which is approved and reimbursed by government & commercial insurers in 15+ countries, including the US, EU, Japan, South Korea & Middle East
• The agreement also provides the technology, expertise & ability to decentralize CDx tests to healthcare providers which will help to identify patients globally who may benefit from treatments
• Thermo Fisher’s Ion Torrent Genexus System can be used to expand patient access to precision therapies which was launched in 2019. The system is the fully integrated NGS platform with an automated specimen workflow that delivers results in a single day

Tuba: Discuss the collaboration of Thermo Fisher with AstraZeneca to co-develop NGS-based CDx (deal terms, milestones, royalties, etc.)

Garret: Thermo Fisher Scientific and AstraZeneca have signed a global, multi-year agreement to co-develop companion diagnostics to support AstraZeneca's expanding portfolio of targeted therapies. Having companion diagnostics available as these therapies come to market will help enable access for more patients around the world. 

Tuba: What makes AstraZeneca an ideal partner to work with?

Garret: AstraZeneca has already transformed countless patient lives through its leading oncology portfolio.

With more than 90 percent of AstraZeneca's clinical pipeline made up of targeted precision medicine therapies, they are helping drive the introduction of these therapies to the market. As we look to support broader genomic testing for patients, it makes sense for us to partner with a company that is equally committed to making these therapies available to patients. 

Tuba: Which therapy areas Thermo Fisher and AZ plans to target first & what the basis of the selection (such as unmet need, market size, pricing, etc)?

Garret: This partnership will cover multiple diseases across AstraZeneca's growing global portfolio of targeted precision medicines including oncology, cardiovascular disease, and renal disease, as well as metabolic and respiratory diseases. The first area we are exploring is oncology. 

Tuba: Are you planning to form an alliance with other global pharmaceuticals? Can we get insight into a few of them (if not in detail, but a glimpse)?

Garret: We are continuing to explore opportunities to partner with other global pharmaceutical companies to help ensure more patients can access new targeted therapies. 

In addition to our partnership with AstraZeneca, this year we announced FDA approvals for companion diagnostics developed with Servier for cholangiocarcinoma and Eli Lilly and Takeda for non-small cell lung cancer (NSCLC). Since announcing our first FDA-approved CDx for the Oncomine Dx Target Test in NSCLC in 2017, we have secured approval globally for 11 targeted NSCLC therapies and one targeted cholangiocarcinoma therapy. 

Tuba: How is Thermo Fisher planning to harness the use of Precision medicine today and tomorrow?

Garret: In the era of personalized medicine, molecular profiling has become essential for the treatment of cancer patients. With more genomic variations proving to be clinically relevant for matching patients with emerging targeted therapies, next-generation sequencing allows clinical labs to test for multiple alterations at once from a single, small amount of tissue.

We believe that everyone everywhere should have equal access to life-saving therapies. When available right away, genomic testing for disease helps unlock a broad array of targeted therapies. To realize this vision, we introduced the Ion Torrent Genexus System to simplify genomic testing so any hospital can provide clinically relevant next-generation sequencing (NGS) results in-house. It is the first automated NGS solution that delivers results economically in a single day, bringing us one step closer to a future where all cancer patients have access to precision medicine. 

It's not hard to imagine how treatment for cancer, rare disease, and other conditions will change when the timing and precision of the diagnosis are no longer determined by where one lives, but instead by whether their unique cancer be it a gene mutation, deletion or variation in their cancer  makes them a candidate for an existing therapy at the time when a biopsy is being tested with another standard of care technologies such immunohistochemistry.

In 2020 alone, the FDA approved 20 new personalized drugs and biologics. As the industry continues to increase the numbers of newly available targeted therapies CDx development will be become a standard part of the development process As the pipeline for targeted therapies becomes larger, and countries establish new regulatory pathways to ensure access to these therapies, it is becoming increasingly important for pharmaceutical and diagnostics companies to work hand-in-hand to ensure access to precision medicine. Equity and early access can improve outcomes at a population level, and that's what we're driving toward.

Tuba: Can you put some light on your globally distributed NGS CDx solution, the Oncomine Dx Target Test?

Garret: The Oncomine Dx Target Test (ODxTT) is the first globally distributable NGS-based CDx and was the first targeted NGS-based in vitro diagnostic test for NSCLC. Since it was first introduced in 2015, Thermo Fisher has partnered with pharmaceutical companies leveraging the Oncomine Dx Target Test, receiving 12 approvals and registrations across 17 countries. This test has 12 targeted therapies on its label, helping identify patients who may benefit from pharmaceutical drug launches around the world. We are continuing to work with our pharmaceutical partners to the expanded clinical utility of the test; for example, we recently announced that it received FDA approval as a CDx for cholangiocarcinoma. 

We are also working with pharmaceutical partners to develop new CDx tests using the Oncomine Precision Assay, which runs on the Genexus System. The Oncomine Precision Assay is used to detect key biomarkers from formalin-fixed paraffin-embedded (FFPE) tissue or liquid biopsy specimen. The assay contains more than 50 cancer-related biomarkers and, when run on the Genexus System, features an automated workflow with a one-day turnaround time and the lowest sample requirements on the market for detection of both DNA and RNA variants. 

In 2020, the FDA granted Breakthrough Device Designation to the Oncomine Precision Assay to identify low-grade glioma (LGG) patients with isocitrate dehydrogenase 1 and 2 (IDH1 and IDH2) mutations who may be eligible for (AG-881) from Agios Pharmaceuticals (now Servier). Over time, we will work to receive premarket approval for the Oncomine Precision Assay as a companion diagnostic for multiple therapies, as well as approval for liquid biopsy tumor profiling in lung cancer and solid tissue tumor profiling in multiple cancer types. 

Source: Nanostring

About Author: Garret Hampton is the president of Clinical Next-Generation Sequencing and Oncology at Thermo Fisher Scientific. He brings over 25 years of industry experience. Dr. Hampton holds a BA in natural sciences and genetics and an MA in natural sciences from Trinity College in Dublin, Ireland, and a Ph.D. in cancer genetics from Imperial Cancer Research Fund and University College London

Related Post: PharmaShots Interview: Dr. Trevor Feinstein and BeyondSpring Pharmaceuticals Dr. Lan Huang Shares Insight on the Data of Plinabulin + Docetaxel for NSCLC with EGFR Wild Type