National Editor

Epimmune Inc. reduced its staff by 23 percent and implemented other cost-cutting measures that the company said would give it enough operating funds to pull results from ongoing clinical trials in HIV and cancer.

Separately, the company entered a deal with Amgen Inc. around its PADRE technology, which also was reported after the market closed Wednesday.

Wall Street liked the news, boosting Epimmune's shares (NASDAQ:EPMN) by 31.5 percent Thursday, or 40 cents, to close at $1.67 after climbing as high as $1.95.

"It's not the first time we licensed it," said Epimmune President and CEO Emile Loria, nor will it likely be the last. "I'm sure we have other parties who are interested," he said.

Thousand Oaks, Calif.-based Amgen is buying a nonexclusive, worldwide license to Epimmune's PADRE technology, which is used in discovery research and consists of a family of molecules to enhance the immune response against an antigen. Financial terms were not disclosed.

Others that have signed up for PADRE include Elan Corp. plc, of Dublin, Ireland, and Biosite Inc., of San Diego.

Epimmune is cutting its research and administrative staff by 11, resulting in a one-time restructuring charge of about $350,000 in the third quarter, and said it will provide severance pay as well as help with outplacement.

The restructuring and other cost-cutting measures are expected to result in an annualized cost savings of about $1.7 million, so the company can forge ahead with its clinical trials. Every product in clinical development also came out of PADRE, Loria said.

In HIV, with sponsorship from the National Institutes of Health, Epimmune has the multi-epitope vaccine candidate EP HIV-1090 in a Phase I/II trial at the University of Colorado Health Sciences Center in Denver. It's a double-blind, placebo-controlled, dose-escalation study with four dose groups, two of which are enrolled and a third is undergoing testing.

Primary endpoints of the HIV trial are safety and immunogenicity as measured by cytotoxic T cells generated. Interim data are expected in the second quarter of next year. The NIH, along with the HIV Vaccine Trials Network, is testing the same drug in a Phase I prophylactic trial.

Phase I/II trials also are being conducted in lung cancer and in colorectal cancer with the vaccine candidate EP-2101, which includes proprietary native epitopes as well as modified, or analogue, epitopes designed to enhance the potency of T-cell response.

Patients enrolled in those trials will have had surgery to remove all detectable cancer cells, so they are generally expected to have normal immune system function. Each will get six injections of the vaccine.

Target enrollment for each trial is 12 patients. Three are enrolled so far in the lung cancer trial and six in the colorectal cancer study, with the primary endpoints of both being safety and immunogenicity. Data are expected in the second quarter of 2004.

Which of the drug candidates might advance fastest is difficult to say at this point, Loria told BioWorld Today.

"I would say it's more [about] portfolio management and different approaches," he said. "We have another task to be able to fulfill, which is the expression of these vaccines."

Last month, Epimmune's planned merger with Menlo Park, Calif.-based Anosys Inc. fizzled, but the company still has a potential $60 million vaccines partnership with Genencor International Inc., of Palo Alto, Calif., entered two years ago, plus NIH grants and contracts covering infectious diseases and cancer. (See BioWorld Today, Aug. 14, 2003, and July 11, 2001.)

Earlier this year, Epimmune entered a deal with Whitehouse Station, N.J.-based Merck & Co., under which the latter will determine activity within modified Epimmune epitopes. Epimmune got an evaluation license fee but further terms were not disclosed. (See BioWorld Today, May 2, 2003.)

Separately, Epimmune said Thursday that Michael Ross resigned from the board of directors, leaving the board with six directors, five of whom are independent.