LONDON - Human antibody specialist Cambridge Antibody Technology (CAT) Group plc has withdrawn from its joint venture with California-based Techniclone Inc. for development of tumor necrosis therapy (TNT) for treatment of cancer.

While this leaves CAT without a cancer program, David Chiswell, CEO, told BioWorld International, “I wouldn't say that as a company we are out of cancer.“ The decision to pull out of the joint venture was made as a result of a “conventional review of the portfolio“ and reflects the fact that, since the relationship was formed in 1996, several of CAT's other products have begun clinical trials.

The two companies planned to do a clinical trial of a chimeric antibody linked to a radioactive isotope, for local delivery in the treatment of glioma. Since the deal was initiated CAT has isolated human TNT antibodies that were able to identify necrotic tissue in human tumor xenografts in mice, and these were being evaluated in preclinical studies. The plan was to develop the human antibody for systemic delivery and in vivo imaging applications, with Phase I/II trials due to begin this year.

Chiswell said deciding which projects to take forward was “never quite just a question of money,“ but that the glioma trial (to be funded 50-50 by the two partners) was very expensive to do. He added CAT would still be entitled to royalties if Techniclone, of Tustin, Calif., succeeds in getting products to market, but at lower levels.

CAT, of Royston, U.K., disclosed termination of the joint venture as it released results for the six months ended March 31, 1998, which showed a loss of £2.97 million, compared with £6.41 million in 1997.

Turnover of £945,000, up from £265,000, came mainly from the second installment of a license fee from Eli Lilly and Co., of Indianapolis, under an agreement signed in December 1996. Expenditures were £3.85 million, up from £3.69 million in 1997, and at the end of the period there was £40.9 million cash, down from £48.1 million in March 1997.

Chiswell said the financial results were “absolutely OK.“

The highlight of CAT's clinical progress was the completion of patient enrollment in a European Phase I/IIa study of its human antitumor necrosis factor (TNF) alpha antibody, in the treatment of rheumatoid arthritis. To date 1,000 doses of the compound, which is being developed by BASF AG, of Ludwigshafen, Germany, have been given to patients. Phase II studies will start shortly in Europe and the U.S.

Chiswell was pleased with the progress of the trial, the first results of which will be disclosed at the American College of Rheumatism meeting in November 1998. He pointed out that the principle of using anti-TNF alpha to reduce inflammation in rheumatoid arthritis has already been proved. The expectation is that CAT's human antibody will not initiate any immune response and will therefore be suitable for chronic use.

Chiswell said there also is good progress with an anti-TGF beta 2 antibody for the treatment of ophthalmic fibrosis, where the Phase I/II study has completed its first dose level.

“This was the first time in the U.K. that anyone has injected antibodies into the eye: the independent safety panel review said there were no safety concerns at the first dose level, and we have now moved on to the next dose, which is great.“ *

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