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Startup Microlin Aims for microRNA Drugs, Diagnostics with OSU IP in Hand

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Having secured the rights to a portfolio of nearly 100 issued and pending microRNA-related patents from Ohio State University, startup Microlin Bio has set its sights on developing both diagnostics and therapeutics based on the non-coding RNAs, with its first product on track to hit the market next year.

Late last month, Microlin announced that it had picked up access to the OSU intellectual property, which relates to miRNAs and their role in cancers including prostate, ovarian, colon, and lung, in addition to a novel lipid nanoparticle delivery technology.

Financial terms of the arrangement were not made public, but Microlin said that the university was given an undisclosed equity stake in the company.

According to Microlin Founder and Chairman Joseph Hernandez, the company was formed specifically to commercialize products based on OSU's technology. Now that a deal for the IP has been finalized, the company is advancing its various research and development programs in earnest.

Though still in its infancy, Microlin is charting an ambitious course that includes developing companion diagnostics for a line of miRNA-inhibiting drugs. And while the two initiatives are running in parallel, Hernandez told Gene Silencing News that the firm would likely move at least one diagnostic to the market before any therapeutic given the lower regulatory hurdles.

According to Hernandez, the company's most advanced diagnostic program involves a blood-based test for identifying patients with ovarian cancer.

Called Omira, it is "able to deduce with a very high level of accuracy whether a patient has markers that are indicative of ovarian cancer and would [warrant] more invasive diagnoses from there," he said. Once a diagnosis is confirmed by biopsy, the test can then be used to determine a tumor's chemosensitivity.

Specific details about the test are not available, but in 2009 OSU researcher and Microlin scientific advisor Carlo Croce published a paper showing that a panel of eight miRNAs are "significantly differentially expressed" in the serum of ovarian cancer patients versus normal individuals.

Specifically, that study found that miR-21, miR-92, miR-93, miR-126 and miR-29a were significantly overexpressed in cancer patients' blood, while miR-155, miR-127, and miR-99b were underexpressed.

Hernandez said that Microlin is preparing to conduct a validation study of the test in a CLIA lab environment using a "large patient set." Assuming a positive outcome, the company aims to begin marking Omira as early as the second quarter of 2014, he said.

Also in the company's diagnostics pipeline is Lumira, which is being developed to use a miRNA signature to determine a patient's risk of lung cancer, as well as the aggressiveness of the tumor.

Croce and his colleagues have published extensively on the role of miRNAs in lung cancer, most recently reporting that miR-486 is highly downregulated in lung tumors versus normal adjacent tissue, and that the miRNA effects cellular proliferation and survival by regulating insulin growth factor (GSN 9/19/2013).

Alongside this test is Colomira, which is designed to diagnose colon cancer and determine its aggressiveness, and to confirm a tumor's sensitivity to the chemotherapeutic fluorouracil. The company is also developing Promira to identify prostate cancer patients who require aggressive surgical intervention and those who simply need to be monitored.

On the therapeutics side, Microlin is developing four drugs to combat the cancers addressed by its suite of diagnostics.

Lumiralin is designed to inhibit miR-21, which the company said is commonly upregulated in non-small cell lung cancer cell lines and tissues; and Omiralin inhibits miR-484, which has been found to be involved in ovarian tumor angiogenesis. Microlin said that both of these drugs are in the discovery and optimization phase.

Meanwhile, the firm is in the discovery phase with Colomiralin, which targets miR-17-5p — a miRNA whose suppression has been associated with slowed tumor growth, reduced spontaneous apoptosis, and an increase in sensitivity to gemcitabine in colon cancer cells.

The company's least advanced drug, Promiralin, focuses on prostate cancer. No details about this agent's target have been released.

All four drug candidates incorporate Microlin's so-called QTsome delivery technology, which the company said combines cationic lipids with tertiary and quarternary amine headgroups.

"Tertiary amino-cationic lipids are conditionally ionizable and facilitate disruption of the lipid bilayer and oligonucleotide endosomal release under the acidic conditions of the endosome," the company said. Meanwhile, the quarternary amino-cationic lipids are "permanently charged, ensuring strong interaction between the lipids and the oligonucleotide, which ensures particle stability."

Henandez noted that the QTsome technology can enable both local and systemic drug delivery, but declined to comment in detail on how the approach targets specific cancer cells, citing "intellectual property reasons."

Earlier this year OSU's Robert Lee, who developed the QTsome technology and is a Microlin scientific advisor, published a paper describing cationic lipid nanoparticles that could deliver siRNAs and miRNAs selectively into hepatocytes and liver cancer cells in animal models.

Also this year, Lee and colleagues published data showing that cationic lipoplexes developed at OSU could deliver a specific miRNA — miR-29b — into tumor sites of a xenograft lung cancer mouse model.

Hernandez said that a paper specifically describing the QTsome technology is being prepared for publication.

As Microlin undertakes its R&D initiatives, Hernandez said that the company is funded well enough to advance its drugs through preclinical testing and to get at least one diagnostic onto the market without additional financing.

"Long term, we will seek partners, both strategic and financial," he told Gene Silencing News. "We're always open to having discussions with potential partners on all levels.

"But the intent right now is to move full throttle forward" on our own, he said.

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