Domantis Ltd. raised US$33 million in a Series B financing that could take the company into clinical trials with its lead domain antibody (dAb) therapeutics.

The first antibody is expected to enter the clinic in the second half of 2005, following continued preclinical work this year. The $33 million (£17.5 million) funding is the largest financing round for the three-year-old company, which has research and development operations in Cambridge, England, and administrative operations in Cambridge, Mass.

"This funding, along with revenue that should come in from our existing partners, should get the company to the real significant milestone of having human efficacy data," said Bob Connelly, CEO of Domantis. "If you take this with money we have in the bank, and other money coming in, it should give us three years of run time, and hopefully more depending on how many deals we do."

Before completing the latest round, the company had about US$9 million in cash. It has raised a total of $54 million since its inception in December 2000, including $20 million through its partnership with Peptech Ltd.

Domantis will use the funds raised to fast-track its lead dAb programs into the clinic, as well as to build a preclinical and clinical pipeline.

"It's for R&D, with the D' part of it eating up a lot more cash than what it has to date," Connelly said.

The company's dAb programs show broad therapeutic potential in respiratory disease, inflammation, cancer and cardiac disorders. The technology can be used in a variety of formulation and delivery options, including oral and pulmonary administration. Domantis has eight therapeutic programs and three partner programs, with Sydney, Australia-based Peptech Ltd., New York-based ImClone Systems Inc., and Abbott Laboratories, of Abbott Park, Ill.

Connelly told BioWorld Today that Domantis will have a number of programs at the preclinical stage this year. He also expects the company to enter into more research and development or technology partnerships, and to expand its existing partnerships. It also could enter into some co-development partnerships in the near term.

"I don't think we'll license out any leads this year, but that's likely to start in 2005," he said.

Domantis formed its US$17 million collaboration with Peptech in April 2001, shortly after the company came into existence. As part of the Peptech collaboration, London-based MVM Ltd. invested US$3 million in Domantis. Domantis agreed to develop single-domain antibody drug candidates against four Peptech targets using technology developed at the UK Medical Research Council's Laboratory of Molecular Biology.

In November, Domantis received the final payment in the $20 million investment from Peptech and MVM as an anti-tumor necrosis factor-alpha dAb entered preclinical testing. The compound is expected to enter clinical testing in the second half of 2005.

Domantis completed the lead generation and optimization for the compound in less than 11 months. It reached preclinical efficacy at 14 months, when the dAb completely prevented the onset of rheumatoid arthritis in a clinically predictive model of human disease.

Connelly said its efficiency is one of the things that attracts investors. Domantis is able to conduct 10 to 12 programs a year, pushing them through from discovery to animal studies, all with only a 40-person organization.

"The chance of creating a really deep pipeline with fairly low capital needs is really a unique part of the story," he said.

Domantis would receive royalties on any product sales resulting from its collaboration with Peptech. And Peptech has the option to negotiate the co-development of dAbs against three additional targets.

Aside from its deal with Peptech, Domantis formed a research and license agreement with Abbott in November 2002 to discover therapeutics based on the dAb technology. And in March 2003, Domantis entered a nonexclusive licensing agreement with ImClone, allowing ImClone to select dAbs for therapeutic and research use.

Domantis also signed agreements with the Medical Research Council last April giving the company an exclusive commercial license to use a polymerase technology to search therapeutic polypeptides, including dAbs.

Domain antibodies, or dAbs, are the smallest functional binding units of antibodies, consisting of the variable regions of the human heavy or light chain.

Investors in the latest financing round were led by 3i Group plc, of the UK. Other new investors that participated included Gray Ghost LLC, of Baltimore; Albany Ventures, of the UK; and an undisclosed institutional investor in the U.S. Existing shareholders that participated were MVM and Peptech.

In connection with the financing, Nigel Pitchford, an associate director at 3i, joined Domantis' board.

The company changed its name in May 2002 from Diversys to Domantis, in order to reflect its core domain antibody technology.