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Samtheo Biopharma Forms Subsidiary Lyndor Bioscience to Develop Moffitt Cancer Center Rx

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Samtheo Biopharma, a company formed last year to acquire and develop technology related to targeted therapeutics and personalized medicine, has licensed from Florida's H. Lee Moffitt Cancer Center a small molecule with the potential to treat cancer patients with chemotherapeutic and radiation resistance.

As part of the arrangement, Samtheo, which employs an "unusual" strategy combining venture investment with hands-on R&D, has formed and invested an undisclosed amount in a subsidiary called Lyndor Biosciences, which will collaborate with Moffitt and eventually seek a larger pharmaceutical partner to commercialize the treatment, a Samtheo executive said this week.

For Moffitt, which also has an undisclosed equity stake in Lyndor, the deal marks its first investment in a company, spinout or otherwise, and is an "exciting step" for its tech-transfer office, created in 2003, a Moffitt official said.

Samtheo, which is based in New York, has obtained from Moffitt exclusive worldwide rights to a small molecule that selectively inhibits the activation of all three isoforms of Akt, a family of proteins whose persistent activation is thought to play a role in oncogenesis, chemotherapeutic and radiation resistance, and cancer cell proliferation and invasiveness.

Under the license agreement, Lyndor has agreed to pay Moffitt undisclosed milestone payments and running royalties on the sales of licensed products. Lyndor plans to develop and commercialize the small molecule, called LD-101, for refractory and resistant tumors and metastatic malignancies.

Akt is also abnormally hyperactivated in many advanced malignancies and late-stage tumors, including breast, prostate, pancreatic, liver, ovarian, and colorectal. Jin Cheng, a professor of molecular oncology, and Said Sebti, professor and chair of drug discovery, both at Moffitt, co-discovered the inhibitor.

Samtheo was founded last year by Susan Rosenbaum, a former corporate lawyer, investment banker, and executive; and Lawrence Akinsamni, a medical doctor and pharmacologist who has conducted research at several drug companies.

Rosenbaum, now CEO of the company, told BTW this week that she and Akinsamni founded Samtheo "out of a lifelong desire to be involved with a life-sciences company developing innovative technology with integrity" in the personalized medicine and targeted therapeutics space.

To that end, the company decided to adopt what Rosenbaum called an unusual strategy of acquiring or investing in technology from universities, research institutions, medical foundations, unaffiliated scientists, and possibly even biotechnology and pharmaceutical companies.

The company said that it seeks to acquire technology in any stage of development for indications in any medical specialty, but particularly technology with applications in life-threatening illnesses with unmet medical needs. It then works to develop that technology further and eventually partner with a larger partner to take it to market.

"We are not a VC," Rosenbaum told BTW. "We're not Wall Streeters. We're entrepreneurs with a number of years of experience working with companies. We believe we're what scientists at universities [and] pharma companies need."

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In addition, as a small company itself, Samtheo intends to put a lot of sweat equity into its investments. "We don't have the budget to support [drug development], but we know how to roll up our sleeves and work 24-7. We're old fashioned in that way, but also ahead of our time, and really right for the time, because we decided on this model before the current financial crisis."

For its deal with Moffitt, Samtheo created the Lyndor Biosciences subsidiary, which will share management with Samtheo but operate as a separate entity. The reason for forming a separate company, Rosenbaum said, was to allow Lyndor to focus solely on developing LD-101 while Samtheo can continue to cull academic labs for other potentially unrelated technologies in which to invest.

"We're looking to help the universities have an advantage and get technologies to market more quickly," Rosenbaum said. "It's early-stage stuff that a lot of other companies are not looking at. To date this is the only thing we've found that we believed in."

Lyndor will continue to partner with Moffitt under a sponsored research deal, which is currently being negotiated, to develop the treatment; and then will attempt to partner with a larger pharmaceutical company to shepherd it through clinical trials. Rosenbaum said that Lyndor is currently in discussions with "several" interested potential pharma partners, although she declined to name them.

Equity Play

Lyndor may indeed be just what the doctor ordered for Moffitt Cancer Center's tech-transfer efforts.

According to the Association of University Technology Managers' most recent annual licensing activity survey, Moffitt spent about $79 million on research in 2006 but only executed one license or option agreement, and didn't spin out a single company.

However, Moffitt only formally established a tech-transfer office, now called the Office of Technology Management and Licensing, in 2003, Ray Carpenter, senior intellectual property associate of the OTML, told BTW this week.

Carpenter said that the arrangement of Samtheo forming a separate company to take the LD-101 drug candidate forward was amenable to Moffitt.

"We haven't been around that long," Carpenter said. "This deal was very exciting, and as our office continues to mature, we continue to gain a lot of experience with different tech-transfer options. We pride ourselves on being very flexible."

As part of the deal, Moffitt took an undisclosed equity stake in Lyndor, marking the first equity investment for the center.

"We have done deals where we had the option of equity or to take upfront payments, and we took the latter," Carpenter said. "We took equity in this case because we're sensitive to the fact that cash is king for a young company. We didn't want to saddle them with an upfront payment. But there are other royalties and milestones involved."

In addition, Carpenter said that Moffitt is currently negotiating with Lyndor and Samtheo on a separate sponsored research agreement for investigational new drug-related studies to be conducted in Cheng's lab.

"We don't just hand off a technology and have it be the last time we see it," he said. "We like to establish relationships where the company has access to the thought leaders here, and access to patients, clinical trials, et cetera. This benefits the company greatly to continue picking our brain, and Lyndor was very aware of that."

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