Labs Partner with Pharma Companies to Develop New CDx Tests

There is often a significant lag between the launch of novel drugs and treatments and their adoption for actual clinical use. After all, it takes time for new products to gain the recognition of providers, patients, and payors. Pharmaceutical companies have sought to speed up the cycle by forming strategic alliances with diagnostics companies. The objective of these companion diagnostics (CDx) collaborations is for the lab company to develop and commercialize new lab tests that can identify individuals who may benefit from the use of the novel therapeutic drugs and treatments created by the pharma company partner.

The CDx model appears to be a win-win, with pharma companies seeing a return of at least $30 in therapeutics revenues for every dollar invested in diagnostics, according to a study from precision medicine analysis firm Diaceutics (cited in Diagnostic Testing and Emerging Technologies, August 17, 2017).¹ Pharma firms actively involved in precision medicine CDx collaborations include AstraZeneca, Amgen, Novartis, Roche/Genentech, Pfizer, Bristol Myers Squibb, and Merck.

Meanwhile, the diagnostics companies are responsible for discovering, validating, commercializing, and supplying the CDx test. They typically have little to no business stake in the drug but instead receive hefty payments from the pharma company, which may be in the form of front-loaded payments for development, royalties on each drug sold as a result of the CDx, or a combination of both.

There were three notable CDx alliances announced in January 2023.

Thermo Fisher Scientific + AstraZeneca for NSCLC Drug CDx

AstraZeneca’s keen interest in CDx partnerships isn’t hard to understand given that precision medicine treatments make up over 90 percent of its clinical pipeline—including drugs for cancer, cardiovascular, renal, metabolic, and respiratory diseases. In 2021, AstraZeneca enlisted Thermo Fisher Scientific to codevelop next-generation sequencing-based (NGS) companion diagnostics for its personalized medicine drug products.

As part of that long-term agreement, the firms announced on January 24, 2023, a new partnership to develop a CDx test for AstraZeneca’s non-small cell lung cancer (NSCLC) drug Tagrisso (osimertinib). The plan calls for leveraging Thermo Fisher’s Oncomine Dx Express Test on the Genexus Dx System, a fully integrated NGS platform to create a solid tissue, blood-based test to screen for NSCLC patients who may be eligible for Tagrisso treatment by identifying tumors that exhibit epidermal growth factor receptor (EGFR) alterations.

“By leveraging the Genexus Dx System’s unprecedented turnaround time, we can help ensure molecular testing results are more readily available to inform vital treatment decisions,” noted Garret Hampton, Thermo Fisher’s president of clinical next-generation sequencing and oncology in a statement.²

Foundation Medicine + Boehringer Ingelheim for Biliary Tract Cancer Drug CDx

Having secured FDA approval for a pair of CDx tests for all solid tumors—FoundationOneCDx and FoundationOneLiquid CDx—Roche subsidiary Foundation Medicine has been a go-to for pharma companies seeking to commercialize new cancer therapies. On Jan. 19, Foundation Medicine unveiled its latest CDx venture, a collaboration with Boehringer Ingelheim (BI) to develop the tissue-based FoundationOne CDx test as a companion diagnostic to BI’s biliary tract cancer drug BI 907828. The investigational oral drug is currently being evaluated for treatment of patients with certain forms of advanced or metastatic biliary tract cancer marked by amplifications of small molecule MDM2 antagonists in a Phase IIa/IIb multicenter clinical trial.

“High quality, well-validated genomic testing is critical to identify biliary tract cancer patients with complex alterations like MDM2 amplifications,” according to Foundation Medicine chief biopharma business officer, Sanket Agrawal, in the press statement announcing the deal.³

Foundation Medicine + Karyopharm for Endometrial Cancer Drug CDx

Earlier in the month, Foundation Medicine announced that it was partnering with fellow Massachusetts firm Karyopharm Therapeutics to turn FoundationOneCDx into an NGS-based CDx test to identify patients who would be eligible to enroll in a Phase III clinical trial evaluating Xpovio (selinexor), the pharma firm’s experimental drug for treating advanced or recurrent TP53 wild-type endometrial cancer. The companies pointed out that endometrial cancer is the most common female reproductive cancer in the US, and that about 50 percent of patients who have advanced or recurrent forms of the disease have p53 wild-type tumors. Xpovio is an exportin 1 (XPO1) inhibitor that would be used as a maintenance therapy after systemic therapy for the cancer.⁴

References:

1. https://www.g2intelligence.com/companion-diagnostics-driving-new-model-for-pharma-dx-partnerships/
2. https://www.businesswire.com/news/home/20230124005356/en/Thermo-Fisher-Scientific-Partners-with-AstraZeneca-to-Develop-Solid-Tissue-and-Blood-Based-Companion-Diagnostic-Test-for-Tagrisso
3. https://www.businesswire.com/news/home/20230118006003/en/Foundation-Medicine-Announces-Global-Collaboration-with-Boehringer-Ingelheim-to-Advance-Biliary-Tract-Cancer-Care
4. https://www.businesswire.com/news/home/20230110005421/en/Foundation-Medicine-Announces-Collaboration-with-Karyopharm-Therapeutics-to-Develop-FoundationOne%C2%AECDx-as-a-Companion-Diagnostic-for-XPOVIO%C2%AE-selinexor

****

Here’s a summary of key strategic diagnostic deals announced in January 2023: