Two companies started the new year on a high note. Nereus Pharmaceuticals Inc. and newly named Vitae Pharmaceuticals announced they had raised funds to push their products into clinical trials in 2005.

Marking its fourth financing round, San Diego-based Nereus will be receiving a $42.6 million private placement in two tranches. The first, already closed, amounted to $24.3 million.

The second tranche will be $18.3 million upon completion of development milestones, said Nereus President and CEO Kobi Sethna.

"We'll draw down the rest once we reach our milestones, which are investigational new drug applications for our two lead compounds," he told BioWorld Today. "Then we'll have funding in place for conducting clinical trials."

In its first three rounds, Nereus raised $38 million, Sethna said.

New investors HBM BioVentures Ltd., of Baar, Switzerland, and HBM BioCapital LP, of Research Triangle Park, N.C., led the fourth round, along with returning investors Alta Partners, of San Francisco; Forward Ventures, of San Diego; GIMV, of Antwerp, Belgium; Novartis Bioventure Fund, of Basel, Switzerland; Pacific Venture Group, of San Francisco; and Lotus BioScience Ventures, of Hong Kong.

Sethna estimated that the $42.6 million will sustain the company for the next two to three years.

"It depends on how the clinical trials go and whether we partner the compounds," Sethna said. "We've been talking to pharmaceutical companies about possible joint development projects, so that could change the picture."

He said Nereus hopes the funds will get its first compound, NPI-2358, a vascular disrupting agent, into Phase II trials and its second compound, NPI-0052, a proteasome inhibitor, into Phase I studies.

"Then we'll see what the market looks like and decide whether to go public or seek additional private funds or partner with pharmaceutical companies," Sethna said. "In two or three years, I think, if all goes well with the clinical trials, there's a good chance we'll probably seek some public funds."

NPI-2358, a cancer product that works as a targeted compound rather than a cytotoxic drug, is a selective tumor vascular disrupting agent (VDA) designed to treat solid tumors. The parent molecule of the compound was isolated from a marine fungus that provided the chemistry.

"The compound works on its own and synergistically with chemotherapy and radiotherapy," Sethna said, adding that the company plans to begin human trials in a few months.

The compound initially will be tested by itself, but Sethna said later "it will be tried in combination as we move along in the process."

He added that while VDA is a scientifically proven treatment, a VDA compound has yet to be approved by the FDA.

"So we're on the cutting edge here," he said.

Nereus' second targeted compound, NPI-0052 (salinosporamide), is derived from a marine-obligate actinomycete and is designed as a second-generation proteasome inhibitor to treat multiple myeloma. The concept of looking for treatments by inhibiting proteasomes has been a popular concept since the FDA approved Cambridge, Mass.-based Millennium Pharmaceuticals' Velcade in 2003, Sethna said.

In vitro data presented at the American Society of Hematology meeting in December by Nereus and Harvard Medical School's Dana-Farber Cancer Institute showed that the compound was active in multiple myeloma cells resistant to Velcade, as well as desamethasone and doxorubicin, though exact mechanisms still were under investigation. (See BioWorld Today, Dec. 10, 2004.)

"This is a very exciting compound for us," Sethna said of NPI-0052. "Also, on a preclinical basis, it shows more safety and does not have the same kind of toxic effects of other chemotherapy treatments."

Nereus has filed an accelerated investigational new drug application for NPI-0052, and Sethna said the company hopes to begin Phase I trials by the latter part of the year.

Using its marine microbial drug discovery platform, Nereus has "a host of other compounds in the wings that will be studied for potential use as anti-cancer, anti-inflammatory and anti-infectious agents," he said. "We'll be making selections of compounds to begin development in 2006 and 2007."

Created in 1998, Nereus began work in late 2001 isolating marine microbes. Sethna said in the last two years, the company "has grown exponentially."

Nereus also recently named three new directors to its board: incoming Director Gary Shearman, of HBM Advisors USA; Jason Fisherman, of Advent; and Nina Kjellson, of Interwest Partners.

Vitae's $34M Part Of Rapid Evolution'

Fort Washington, Pa.-based Vitae Pharmaceuticals, formerly Concurrent Pharmaceuticals, introduced its new name and secured $34 million in equity financing to accelerate the company's product programs.

Tuesday's announcements encapsulate "the rapid evolution of our company," said Vitae CEO Jeff Hatfield. "The name change emblemizes that revolution."

Vitae, a Latin word meaning "life," reflects the company's efforts to mark itself as a product-focused drug development company, Hatfield said.

He described Vitae as being "at the forefront of the trend of rapid product creation," with plans for four products to begin clinical trials in 2005.

"What's really important about all our efforts is the trend to rapidly create valuable products," he said.

Vitae has raised $75 million to date, including the $34 million in funding from two new investors - Atlas Venture, of Boston, and Wellcome Trust, of London - and existing investors Prospect Venture Partners, of Palo Alto, Calif.; Venrock Associates, of New York; and New Enterprise Associates, of Menlo Park, Calif.

The money will be used to accelerate product candidates as they begin human trials and, later, to help expand research and commercialization, Hatfield said.

"I hope this will sustain the company for a two- to three-year horizon," he said, adding that funds will be used to pay for upcoming clinical trials for four of Vitae's products.

The company's lead cancer program is set to start human trials in the first half of this year. Initial studies will focus on lymphoma, though the compound might also be tested for additional cancer indications.

Also in the pipeline is a compound aimed at treating myeloid leukemia. The company is developing a selective modulator of a nuclear receptor subtype thought to play a role in neutrophil differentiation and, based on preclinical studies, might be applied to treat and prevent chemo-radiotherapy-inducted neutropenia and to enhance peripheral blood progenitor-cell mobilization in transplantation.

A third product, a topical agent designed to treat psoriasis, eventually might be extended to the treatment of acne and photo-aging, based on results from clinical trials to begin this year.

The fourth product in preclinical development is an orally available renin inhibitor to manage hypertension and end-organ protection. Renin, an aspartyl protease, is the rate-limiting enzyme in the renin-angiotensin system that plays a key role in regulating blood volume, arterial pressure and vascular function.

Clinical studies have shown that inhibition of renin can control blood pressure, though most programs have not been successful in finding orally available small-molecule compounds suitable for development. Hatfield said Vitae is using its technology to generate non-peptidic renin inhibitors and has discovered multiple series of small-molecule inhibitors of the enzyme.

"Vitae selected this as our target challenge," he said. "We believe in a unique approach that combines the talent of drug discovery skills to achieve innovative products."

In May, the company bought a portfolio of near-clinical compounds from Allergan Inc.'s retinoid and rexinoid nuclear receptor drug program. Vitae, then known as Concurrent, gave Allergan undisclosed equity plus potential future milestone payments and royalties in exchange for exclusive license rights to compounds for diabetes and cancer. (See BioWorld Today, May 27, 2004.)

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