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Biovica Eyes 2020 Commercial Launch for DiviTum Metastatic Breast Cancer Assay


NEW YORK (360Dx) – Biovica, a Swedish biotechnology company, aims to launch an assay for predicting and monitoring treatment response in cancer patients by 2020.

CEO Anders Rylander said the company will initially market its DiviTum assay for use in breast cancer, though it could be used to monitor cell proliferation in all cancer types. Biovica will seek regulatory clearance for its test in the US as well as in Europe, and is currently engaged in nearly a dozen studies aimed at assessing the test's performance in both regions, he said.

"Our objective is to become a standard tool for evaluating treatment in metastatic cancer," Rylander said.

Biovica's approach relies on using enzyme-linked immunosorbent assays or real-time PCR to measure the level of the enzyme thymidine kinase (TK) in blood. As increases in TK levels are correlated to cell proliferation, the DiviTum assay can therefore show whether a specific treatment is slowing or stopping cancer cell proliferation, or if it is having any effect at all.

"The faster the cancer grows, the worse the prognosis for the patient," said Rylander. Offering clinicians data on cell proliferation is therefore important when it comes to formulating a prognosis and selecting appropriate treatments. "If the patient responds, we should see a reduction in proliferation," he said.

According to Rylander, the approach has advantages over current methods for monitoring response to treatment, such as imaging. "Typically with imaging, you take a picture of the tumor before and after treatment and compare," he said. "We have a huge advantage in that we are not measuring volume, we are measuring growth rate."

Changes in TK levels are also detectable in a few weeks following treatment, he noted, versus the amount of time it could take for tumor growth to be detectable by imaging, making Biovica's approach potentially faster than conventional methods. As such, the company believes DiviTum could improve treatment response, and, perhaps, survival rates.

Biovica also believes that DiviTum has advantages over other cell-proliferation assays in the market — sold by Thermo Fisher Scientific, Bio-Rad Laboratories, and Sigma-Aldrich, to name a few — because its approach can measure TK in blood, rather than cells cultured from biopsies.

The company's technology was developed by researchers at Uppsala University over the past 30 years, and Biovica was founded to commercialize it in 2009. Rylander said its activity has increased in recent years as it moves toward its goal of launching DiviTum by decade's end. Last year, the company raised $3.6 million to support its efforts, and acquired fellow Swedish biotech cSens and its RT-PCR-based platform for measuring TK. Biovica currently employs around 15 people, Rylander said. Since March, the company has traded on Nasdaq's First North exchange in Stockholm, where it has a market capitalization of SEK 223 million ($25 million). At the time of its IPO, Biovica raised another SEK 60 million, Rylander said.

While Rylander maintained that Biovica's method is "applicable for all cancers," he said the company chose to focus on metastatic cancer, as these kinds of patients typically receive multiple lines of treatment, meaning there is a need to quickly evaluate the efficacy of those therapies.

"There are also more treatments available, they are getting better, and the patients are getting more lines of treatment," Rylander said. "This creates new problems as all treatments are not efficient for all patients and, over time, the patient becomes resistant," he said. "But if you determine the patient is resistant, you can give an alternative treatment."

Biovica is therefore positioning DiviTum as an assay that can not only be used to flag the right treatment for cancer patients, but will also serve oncologists in making treatment decisions, while decreasing healthcare spend on cancer treatments that don't work.

To deliver the test to the market, Biovica is currently taking part in 10 trials, including institutes in the US and Europe, nine of which are related to breast cancer. It discussed the first clinical results on DiviTum and CDK4/6 inhibitors (in this case, palbociclib, sold by Pfizer as Ibrance) at the San Antonio Breast Cancer Symposium in December 2016.

That study, carried out with researchers at Washington University School of Medicine and Baylor College of Medicine, demonstrated a "significant correlation" between the effect of palbociclib and TK activity as measured by DiviTum, as well as the correlation between DiviTum and Ki-67, a proliferation marker typically measured in tumor biopsies, the company said at the time, positing that DiviTum has the potential to "replace biopsy and Ki-67 to measure cell proliferation."

At the American Association for Cancer Research conference held in Washington DC in April, the company also showcased the first results from a clinical trial of 20 metastatic or inoperable lung cancer patients with Dana-Farber Cancer Institute and the Karolinska Institute. According to the firm, DiviTum again had a "significant correlation with the antiproliferative effect of palbociclib." The study is ongoing.

This year, Biovica also initiated a number of new trials to vet its test in various clinical contexts. The company is now working with partners at Lund University in Sweden to compare the use of DiviTum versus standard methods in 150 breast cancer patients. The results of the study are expected in 2018. Another new study is with researchers at the University of Kansas, where Biovica will analyze patients with locally advanced breast cancer treated with CDK 4/6 inhibitors in combination with endocrine therapy. Other ongoing studies include collaborators at the University of Pennsylvania, City of Hope in Los Angeles, and Prato Hospital in Italy.

In addition, DiviTum is being evaluated in two studies funded through the EU's Horizon 2020 program. The first, called Pythia, is being run by the International Breast Cancer Study Group and the Breast International Group, and follows 120 postmenopausal women with advanced hormone receptor positive breast cancer treated with fulvestrant (sold as Faslodex by AstraZeneca) as well as palbociclib. The second, called Predix, is being carried out with partners at Karolinska as well as Radiumhemmet, an oncology clinic in Stockholm, to evaluate response-controlled treatment. The study will include 200 women with hormone-dependent breast cancer treated with endocrine therapy in combination with palbociclib.

Rylander said that in total, DiviTum is currently being used to assess about 1,500 breast cancer patients in various studies or trials, the majority of which will produce results by the end of 2018 and the beginning of 2019.

"These collaborations will generate important data, and the oncologists we work with are the leaders in this field," said Rylander. "It's also important to have this data to gain access to the market," he added, noting that data generated from the trials will be used to achieve future regulatory clearances, as well as to eventually obtain reimbursement for the test.

As both the US and Europe will be Biovica's core markets, Rylander said the firm is keen to identify partners with existing sales and distribution channels in place to commercialize the test.

"We will need at least one partner in the US and one in Europe," he said.

As it pursues that goal, Biovica is also interested in partnering with pharmaceutical companies that might pair the DiviTum assay with their own biomarkers to tailor new treatments. The company earlier this year began a partnership with UbiQ, a Dutch pharma, to evaluate a UbiQ drug for diffuse large B-cell lymphoma. Backed with EU funding of 210,000 ($244,000), the assay will be used in preclinical models to detect early signs of cell growth inhibition.

"If we can offer tailored companion diagnostic assays, it will be a major step for us in terms of product development," Rylander said.