At the same time that it closed its first significant financing round - a $36 million Series A - Lux Biosciences Inc. gained worldwide rights to a late-stage immunosuppressant drug from Isotechnika Inc. to develop for ophthalmic diseases.

Jersey City, N.J.-based Lux paid a $3 million up-front fee to license ISA247, an oral, next-generation calcineurin inhibitor that Isotechnika was developing for psoriasis and transplant rejection. Total payments, though, to Isotechnika could reach $32.7 million based on development and commercialization of ISA247 in at least four ophthalmic indications, in addition to a double-digit royalty on a percentage of net sales.

Founded about a year ago, Lux (the Latin word for "light") has been working the last few months to nail down its Series A round and negotiate a licensing deal for ISA247, and "now we have these two important pieces coming together," said Ulrich Grau, president and CEO of Lux.

Each piece was "kind of contingent upon the other," Grau said, since having a promising licensing negotiation in the works helped entice investments, and Lux was able to provide Isotechnika with "assurance early on that there was a savvy group of investors behind us."

The financing included equal participation from funds managed by Zurich, Switzerland-based HBM Partners AG; Copenhagen, Denmark-based Novo A/S; and Boston-based SV Life Sciences, the same group of investors that provided a small amount of seed money to Lux when it first formed with the aim of investigating marketed or clinical-stage compounds for eye diseases.

ISA247, renamed LX-211 by Lux, is designed to work by targeting activated T cells in the immune system, and "by virtue of this mechanism has a great potential in several ophthalmic diseases," such as uveitis, dry-eye syndrome and maybe even age-related macular degeneration, Grau said.

"There's some very exciting evidence that AMD actually is an inflammatory disease," he added, and has a "clear immune component. There are a lot [of companies] focusing on VEGF and other growth factors, and while we watched this carefully, we think that the immune-mediated mechanism may be a bigger opportunity."

Lux will begin testing the compound in patients with uveitis and likely will look at dry-eye syndrome next. Additional indications have not yet been determined.

Funding from the Series A is expected to take the company through mid-2008, when pivotal trial data are anticipated from its first program of LX-211 in patients with uveitis.

Since Lux intends to use the same oral dosage form that Isotechnika has developed for psoriasis, it can skip the toxicology work and "piggyback" on earlier safety data, Grau said.

Lux's first step will be to meet with the FDA and the European Medicines Agency and "if that all goes well, as we believe it will," he told BioWorld Today, "we will be enrolling our first patient in the pivotal program in 2007."

By that timeline, the company could submit a new drug application for LX-211 as early as the latter part of 2008, which is about the same time frame Isotechnika has estimated for its NDA filing for ISA247 in psoriasis.

Lux's product will aim at treating "back-of-the-eye" forms of the uveitis - posterior, intermediate and panuveitis - which affects between 25 percent to 40 percent of the estimated 330,000 uveitis patients in the U.S., with similar numbers in Europe. It's a small enough market that Lux anticipates commercializing LX-211 itself.

"I anticipate that a sales force could cover both" U.S. and key European markets, Grau said.

In the meantime, Lux is preparing to expand its staff to 25 people, though still remaining "semi-virtual," and adding a European office in Frankfurt, Germany, headed by Manfred Zoltobrocki. He recently joined Lux's executive team of Grau; A. Clarke Atwell, chief operating officer; Eddy Anglade, chief medical officer; and Sidney Weiss, vice president of program management.

Axel Bolte, of HBM Partners, along with Thomas Dyrberg, of Novo A/S, and Lutz Giebel, of SV Life Sciences, were named to the company's board.

Expanding ISA247 Opportunity

While Lux makes plans for a pivotal trial in uveitis, Isotechnika is in an ongoing Phase III extension study of ISA247 in psoriasis and has completed a Phase IIa trial in kidney transplantation.

In the fall, the Edmonton, Alberta-based firm reported 24-week data from a Phase III trial in which ISA247 hit all primary and secondary endpoints in reducing patients' Psoriasis Area and Severity Index scores. Importantly, data also showed no increase in adverse events over the placebo arm and suggested minimal side effects. (See BioWorld Today, Nov. 8, 2005.)

The decision to partner the compound with Lux stemmed from the company's strategy to expand ISA247 development outside those two indications and "optimize the therapeutic and revenue potential" of the product, Isotechnika President and CEO Randall Yatscoff said during a conference call. "It represents another opportunity for us to capitalize on ISA247 as a multi-platform technology."

The company will remain involved throughout the collaboration, providing the manufactured product to Lux and participating in joint steering committee to oversee development of commercialization in ophthalmic indications.

In addition to ISA247, Isotechnika also is developing TAFA93, an immunosuppressant, in Phase I.

The company's shares (TSE:ISA) gained C25 cents Thursday, or 14.7 percent, to close at C$1.95 (US$1.76).