Laboratory for Advanced Medicine (LAM) says its plans for this year include developing and commercializing more of its early cancer detection tests, expanding its portfolio beyond the four for which it has achieved validation, as well as growing its commercial staff and moving into its new headquarters.
Last year the company began commercializing its non-invasive, epigenetics-based IvyGene blood test, which is designed to detect and measure DNA methylation patterns that are consistent with actual cancer presence. IvyGene has been validated to detect breast, colon, liver, and lung cancers.
“We’re not stopping there. We're looking at brain cancer, pancreatic cancer, we're looking at prostate cancer,” Justin C. Li, CFA, LAM General Manager and VP of Finance, told Clinical OMICs in San Francisco, where company executives attended the recent J.P. Morgan Healthcare Conference. “LAM will continue to roll out these new products in the coming years, while focusing on the regulatory path and the commercial path for the existing cancer products.”
Over the next few years, LAM plans to increase its test portfolio to a dozen or so assays, then bundle those tests into a panel using biomarkers that are sensitive to multiple different cancer types.
LAM’s test measures the methylation status of cell-free DNA at target gene sites. The results are reported as a quantitative IvyGene Score. The IvyGene Score is calculated as a composite average of cell-free DNA that is methylated at the target sites as a fraction of the total cell-free DNA present. The test is intended for use in conjunction with other diagnostic and confirmatory tests, including mammograms, PET scans and biopsies.
“We're looking for CpG islands, which represent the methylation status of the ctDNA. Those are the biomarkers. Basically, we find ways to interrogate those CpG islands,” Li said. As noted in a 2017 study, the human genome contains ∼30,000 CpG islands, long stretches (0.5–2 kb) of DNA with unusually elevated levels of CpG dinucleotides.
‘Opportunity to Replace Ultrasound’
In 2019, one key area of focus for LAM will be its IvyGene Dx Liver Cancer Test. The company is planning clinical trials in China and in the U.S. (CLiMB, NCT03694600) designed to assess the test, both alone and in combination with ultrasound for the detection of hepatocellular carcinoma (HCC) within a population that is at high risk for the disease due to liver cirrhosis. For cirrhosis patients, current standard of care requires screening for HCC every six to 12 months.
The Chinese trial, LAM reasons, should give hospital administrators in China greater confidence in the liver cancer test. In the U.S., an estimated 1,578 participants are expected to be enrolled for the trial, which at deadline had yet to begin recruiting. The study’s estimated primary completion date is March 28, 2020.
“The only tool they have right now is the blunt tool of ultrasound, which is way inaccurate,” LAM CFO Richard Brand said. “Doctors are scratching their heads, saying, ‘We understand the objective, but why do this?’ We have a real clear opportunity to replace ultrasound and start to dominate that submarket, and help those patients first, and then move on to other categories.”
LAM is looking to roll out the liver cancer test first, both in the U.S. and in China, where the company has offices in Beijing, Bei Dai He—and Guangzhou, where it operates a CLIA-certified lab—and where it perceives a strong market for the test. According to World Health Organization data updated this month, 392,868 people were diagnosed with liver cancer in 2018, with 368,960 people having died of the disease. And while China has less than 20% of the world’s population, it accounts for nearly half of all new liver cancer cases, with HCC representing approximately 90% of all cases of primary liver cancer.
In October at the Society for Immunotherapy of Cancer's (SITC) 33rd Annual Meeting, LAM presented an abstract with positive data:
‘High Diagnostic Potential’
“These data demonstrate the high diagnostic potential of cfDNA methylation markers in the blood for the detection of hepatocellular carcinoma,” the researchers concluded.
And in December at the San Antonio Breast Cancer Symposium, LAM presented data in another abstract showing that its DNA methylation-based biomarkers detected the presence of breast cancer with 89% sensitivity and 96% specificity.
In that study, 53 of the 65 breast cancer samples were correctly identified for an overall calculated sensitivity of 89% with little difference between the sensitivity of detecting Stage I to Stage IV breast cancer (range 88% to 94%). Additionally, 28 of 32 samples drawn from healthy donor subjects (specificity 95%)—later revised to 37 of 39, with the same 95% specificity—and all 15 samples drawn from subjects diagnosed with benign breast disease (specificity 100%) were also correctly identified.
Another priority for LAM this year will be a test in nasopharyngeal cancer, where early detection can prevent cancer from spreading into the brain.
The company is also gearing up to open its expanded headquarters in Irvine, CA, near John Wayne Airport, with executives recently concluding a walkthrough and preparing to move in equipment. The expanded HQ will include a 10,000-square-foot sequencing lab for R&D, and additional labs designed to assist with clinical trials.
Besides Irvine, LAM’s U.S. operations are in West Lafayette, IN, and the Dallas suburb of Coppell, TX—where last year, LAM opened a support office for its sales and marketing team, with the goal of accommodating inquiries and orders for the IvyGene test. In conjunction with that expansion, LAM made available its IvyGene test to all firefighters in Bedford, TX, a city between Dallas and Fort Worth.
LAM has about 100 employees now, with plans to hire more people for its commercialization efforts.
“We have six sales people in China. Eventually, to cover the three main cities, we will need 30,” Brand said. “There's 100 key liver doctors in the U.S. We need 10 salespeople to cover that. after we establish that coverage, then there's another 3,000 liver doctors, so we will need another 20 salespeople after that. But we need some more C-suite people like head of sales, chief commercialization officer, people like that.”
Li said privately-funded LAM has raised “tens of millions” in financing since its founding—including $30 million in Series A financing completed in 2017. The company is raising another round now, and expects it will be “well oversubscribed” following initial plans to gather another $30 million from investors, Brand said.