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Mirna Recommended for $10.3M Texas Grant, Poised to Close $25M Series B

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By Doug Macron

Mirna Therapeutics this week announced that it has been named as a likely recipient of a roughly $10.3 million award from the Cancer Prevention and Research Institute of Texas, a state-funded organization established to support cancer research and prevention programs.

While the money is expected to help the company advance its two lead microRNA mimics, Mirna is poised to receive a bigger shot in the arm from a pending private-equity financing round, President and CEO Paul Lammers told Gene Silencing News this week.

"We'd like to bring our lead compounds into the clinic and that's going to take quite a bit of money," he said. As such, "we're in the process of working on equity financing … [and have] signed a term sheet for a Series B equity round with a major corporate VC funding," worth around $25 million.

"On top of the $10 million from the state, [the Series B money] would be adequate for us to bring one or more of our lead compounds through phase I" testing, Lammers said. He added that upon the close of the Series B, which is expected this summer, the company anticipates having enough cash to fund its operations until approximately the first quarter of 2014.

According to CPRIT, Mirna was recommended to receive the award as part of an effort that saw the issuance of $142 million in grants to a variety of companies and institutions working in the cancer field. Mirna said that acceptance of the $10.3 million is subject to the completion of due diligence and contract negotiations.

"We're getting together with CPRIT … as soon as possible to talk about [what] the terms … of the contract will be and how we will … optimally apply the funds and make sure we get the most benefit out of [the funding]," Lammers explained.

Ideally, Mirna would like to be able to apply the money not only toward the advancement of its key drug candidates, but also for "moving the whole [product] portfolio forward because the more shots on goal, the better the chance to hit," he said. These negotiations will "hopefully conclude in the next few weeks."

Currently, Mirna has a pipeline of six drug candidates, but it is focusing on two in particular: miR-Rx34, a mimic of mir-34 for treating prostate and other solid tumors; and miR-Rx02, a mimic of an undisclosed miRNA for solid tumors including non-small cell lung cancer.

The former is the company's most advanced, and last year it announced preclinical data showing that it inhibited the proliferation and viability of a "variety of cultured cancer cells, including those derived from patients with melanoma, lung, prostate, liver, and colon cancers" (GSN 6/18/2009).

The data showed that miR-Rx34 inhibited the growth and metastasis of established human tumors when delivered systemically to mouse models of lung and prostate cancer.

Mirna continues to expect it will file an investigational new drug application to begin human testing of the agent in 2011, Lammers confirmed. The company also expects that miR-Rx34 will also be ready for an IND filing within that time frame.

"We are finalizing the chemistry of the mimics and evaluating the combination of the mimics with different delivery technologies," he said. Specifically, Mirna is working on a lipid emulsion technology that has been exclusively in-licensed from an undisclosed party and a nanoparticle originally developed for other non-miRNA applications by an undisclosed Japanese company.

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It is also working with "a number of other well-known delivery companies in the field" on other delivery approaches, Lammers noted.

In order to support its drug-development efforts, Mirna also continues to plan for expanding its staff, which currently includes eight employees.

The CPRIT funding and Series B "will obviously give us the opportunity to start growing the company a bit, which we need to do … because there is a lot of work ahead," Lammers said.

The company is currently looking to fill two scientist positions, and bring on a head of preclinical development and a business-development executive.

By Mirna's current projections, the company will have about 20 employees by the end of 2011 and 25 by the end of 2012, he said.

Meanwhile, it is looking to forge partnerships, not only around its two lead programs but also potentially new ones that have yet to be defined.

"Right now, [miRNAs are] a hot area of science," Lammers said. "A lot of major pharma and biotech companies have already … taken a position in microRNA or siRNA. The ones that have not may be concerned about missing the boat. Nowadays, they realize [the benefits of] getting involved at an early stage when you can help shape the preclinical and discovery efforts."

Because of this, there are "quite a few companies we're talking to that are interested in doing something now instead of waiting," he said.

"They realize that certain microRNA targets are very intriguing given the research and number of papers coming out … [and] miR-34 has gotten a lot of interest given its close relationship to p53 as a key tumor suppressor," Lammers noted. "At the same time, they know [Mirna has] a discovery engine … [and] we'd love to have the funding to use [it] to come up with more key functional microRNAs."

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