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BioNTech Diagnostics Looks to Expand Market for Expression-Based Breast Cancer Subtyping Test


NEW YORK (GenomeWeb) – Fresh off a distribution deal with China's Shuwen Biotech, BioNTech Diagnostics of Germany is now looking to globally commercialize its PCR-based breast cancer stratification test, MammaTyper, which it has so far marketed mainly in Europe.

In addition, BioNTech Diagnostics, one of six subsidiaries of holding company Biopharmaceutical New Technologies (BioNTech), is developing a number of other cancer IVD tests, as well as companion diagnostics for cancer therapeutics developed in house and by others. 

Privately owned BioNTech was founded in 2008 by Ugur Sahin, a researcher and entrepreneur, and Christoph Huber, former head of the Department of Hematology and Oncology at the Mainz University Medical Center. The company, a spin off from Johannes Gutenberg University in Mainz, focuses on the development of immunotherapeutics and diagnostics for solid tumors.

In its first financing round in 2008, the company raised €150 million from a number of private investors, according to Sean Marett, BioNTech's chief operating officer, who added that this was the largest funding round of its kind at the time. Investors include billionaire twin brothers Andreas and Thomas Strüngmann, who founded generic drug manufacturer Hexal, and MIG Fonds.  

The following year, BioNTech acquired two contract manufacturers, JPT Peptide Technologies and Eufets, and founded four subsidiaries. Three of these focus on cancer therapeutics, while one — initially called TheraCode but renamed BioNTech Diagnostics last year — concentrates on cancer diagnostics. BioNTech, which is headquartered in Mainz, has approximately 400 employees in total, spread over several locations in Germany.

The diagnostics subsidiary has two main missions, according to Marett: to develop companion diagnostics and stratifying assays for BioNTech's own cancer therapeutics, and to build companion diagnostics for partners and cancer diagnostics for the general market.

In 2013, the company developed its first IVD, an immunohistochemistry-based companion diagnostic, called Claudetect, for a gastric cancer therapeutic from Mainz-based drug company Ganymed Pharmaceuticals that is currently in clinical trials.

This summer, BioNTech Diagnostics commercially launched MammaTyper, a CE-IVD kit for breast cancer classification, and RNXtract, an IVD kit for total RNA extraction from formalin-fixed paraffin-embedded tissue that is used as part of MammaTyper.

"With MammaTyper, we saw an opportunity to leverage our expertise in messenger RNA together with high medical need in classifying breast cancer patients appropriately," Marett said.

MammaTyper, which is globally patented and which BioNTech Diagnostics developed in collaboration with Cologne-based Stratifyer Molecular Pathology, measures the expression of four breast cancer biomarker genes — ERBB2 (HER2), ESR1 (ER), PGR (PR), and MKI67 — in breast cancer tissue, using RT-qPCR.  

Based on validated cutoffs, each marker is then classified as either positive or negative, and the combination of the four results is used to subtype the breast cancer tissue into Luminal A-like, Luminal B-like (HER2 negative), Luminal B-like (HER2 positive), HER2 positive (non-luminal), or triple negative tumors, according to the St. Gallen recommendations. Each of these subtypes have treatment recommendations associated with them.

According to the company, MammaTyper can be used in all female breast cancer cases as a primary diagnostic, as a secondary test in cases of unclear immunohistochemistry results, as a fast test to determine HER2 status, or as an alternative to IHC and in situ hybridization.

The MammaTyper kit was validated in several retrospective clinical trials, data from which the company plans to make available over the next six to nine months, using two real-time PCR platforms, the Versant kPCR Molecular System from Siemens Healthcare and the LightCycler 480 Instrument II from Roche. The test is available for those two instruments, but the company is currently working on validating it for additional PCR platforms, Marett said.

MammaTyper competes with IHC-based breast cancer classification, he said, one of the main advantages being that it provides a quantitative result and avoids the variability of interpretation between users. "If you have 20 pathologists look at the same sample, you may not get exactly the same subtyping because it depends on what the pathologist thinks," he said. "We will provide a number, and the cutoffs have been designed to mimic the subtyping that you see under the St. Gallen guidelines, so you always get the same consistent results."

The test is also fast, with a turnaround time of a single day, and simple to use. "We see the rate of PCR in pathology laboratories increasing very rapidly," Marett said. "I think over the next few years, we will see a significant uptake, not only of our test but PCR-based molecular tests generally, as people move to this new and more precise technology."

Compared to other gene expression-based breast cancer classification tests, such as Genomic Health's Oncotype DX, the advantage of MammaTyper is that it can be used to subtype all breast cancers according to the St. Gallen guidelines, and that pathologists can perform the test in their own lab rather than having to send it out, and obtain same-day results. The test also has "some predictive and prognostic capabilities," he said.

Currently, MammaTyper is used by an undisclosed number of customers throughout Europe. BioNTech Diagnostic's strategy is to sell the test to pathologists and hospitals through distributors, except in Germany, where it has established relationships with "key opinion leaders" in breast cancer and sells it to these directly, Marett said.

Pricing for the test varies between countries and customers but is generally higher than for an IHC-based test, he said, to account for the innovation it provides.

Reimbursement by health insurance is "a work in progress," he said, and the company is in talks with insurance providers in Europe and elsewhere about coverage. "We priced it such that it would be attractive to healthcare providers," he added.

The recent agreement with Shuwen Biotech in China represents BioNTech Diagnostics' first effort to market MammaTyper outside of Europe. The test is not approved as an IVD in China yet, and Shuwen plans to run clinical trials to get it certified while offering it as a service to Chinese customers. China is already the second-largest pharmaceutical market in the world, Marett said, as well as a large diagnostic market. "We see the convergence of diagnostics and therapeutics over the long term, so it makes sense for us to get our product approved and have it distributed in this very large and growing market," he said.

Over the next six to 12 months, BioNTest Diagnostics plans to roll out MammaTyper worldwide, including in the US, where it will probably seek a partner to take it through FDA approval.

In addition to MammaTyper, the company is working on several molecular diagnostic tests for classifying other, undisclosed types of cancer.

It is also developing a research-use-only test, called PCRTyper, to monitor T cells in the immune system over the course of therapy. That test is in late-stage development and the company is looking for distribution partners, Marett said.