Brisbane's Implicit announces debut deal

By Renate Krelle
Tuesday, 19 April, 2005

After a year scouting for its first deal, private Brisbane biotech Implicit Biosciences is hoping to raise a phoenix from the ashes of a dead US company, Cytran, which went bankrupt in 2002 after the Phase III failure of its lead candidate IM862.

The drug - a naturally occurring dipeptide - had sailed through earlier clinical trials as a monotherapy in AIDS-related Kaposi's sarcoma, showing an excellent safety and side effect profile. But in 2001 it failed to meet the Phase III trial's endpoints for that indication.

At the time IM862 was well advanced in a number of anti-cancer Phase II studies in the US for melanoma, breast, prostate and ovarian cancer. Orphan drug status is still held for ovarian cancer. Shortly afterwards the company toppled.

"All trials were immediately halted, which flabbergasted a lot of patients and researchers," said Implicit's chief executive, former Peplin CEO, Garry Redlich.

The IM862 patents were sold to private US biotech Melmotte, owned by Dr Ernest Mario - a former Glaxo chief executive who also headed up biopharma Alza, before it was sold to J&J in 2001.

Implicit, meanwhile is funded entirely by sophisticated investors plus its founders - a set of scientific luminaries including Prof Peter Andrews, QIMR's Michael Good, Ian Frazer of HPV vaccine fame, UQ's Istvan Toth, Alchemia's Tracie Ramsdale, US lawyer Dan Syrdal and Annette Maluish who pioneered clinical studies of interleukin at the NIH.

"This deal became available in November last year," said Redlich. It was not the first deal on Implicit's list -- chief operating officer Jane Andrews and Redlich had done due diligence on a number of technologies which were scotched at the eleventh hour because they discovered patent issues and potential royalty stacking.

Redlich said Implicit had acquired 100 per cent of the shares of IM862 assets from Melmotte for an undisclosed cash sum. Royalties on future earnings "commensurate with the risk associated with the project" will go back to the liquidators of Cytran.

"The mechanism is not known, and we believe that we have a good chance of teasing that out, and optimising the molecule by delivery and dosing," said Redlich.

The company's game plan is to fund research into IM862 anti-infective applications of through grants, and to pursue a new cancer indication. The safety profile for cancer patients is good, but reproductive toxicity must be investigated for anti-infective indications as IM862 is known to be anti-angiogenic in high doses.

"We're hoping to be in the clinic by the end of the year," said Redlich.

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