The U.S. government is advertising for a company to undertaketotal development of one of its newest anti-AIDS drugs. Twoweeks ago, the NIH Office of Technology Transfer (OTT) put alicensing opportunity titled "Anti-viral Agent (F-ddA) Useful inthe Treatment of AIDS" into its fast-lane channel for imminentpublication in the Federal Register.
An exclusive, worldwide, royalty-bearing license is available toan entrepreneurial pharmaceutical or biotechnology companythat "can effectively pursue the preclinical, clinical andcommercial development of F-ddA as a drug for the treatmentof human immunodeficiency virus (HIV) infection." Thenucleoside analog's full name is 9- (2,3 dideoxy-2-fluoro-b-D-threopentofuranosyl) adenine.
Medical oncologist Wyndham Wilson, special assistant to thedirector of the National Cancer Institute's Division of CancerTherapy, will chair the committee to select the licensee.
Wilson told BioWorld that F-ddA "is a reverse-transcriptaseinhibitor, as are ddI and AZT. But as a fluorinated compound, F-ddA's binding site and pharmacokinetic profile are slightlydifferent."
He added: "Some preliminary in vitro data suggest that F-ddAmay be somewhat non-cross-resistant with ddI. Strains of HIVthat are resistant to ddI may still be sensitive to fluoro-ddAand might be handled differently by the body." If confirmed invivo, this means the new compound could prove effectiveagainst strains of the AIDS virus that ddI can no longer slowdown.
F-ddA, developed at NCI by researcher John Driscoll, "has asomewhat different metabolic pathway from AZT and ddI,"Wilson explained. "It differs somewhat in its binding to reversetranscriptase and has a different pharmacokinetic profile."
NIH filed to patent F-ddA in March (application No.07/762,082). "In view of the high priority for developing newdrugs for the treatment of HIV infection," reads its licensureannouncement, "all proposals must be received 90 days fromdate of publication in the Federal Register. Thus far, Wilsonsaid, nobody is under consideration for the award.
The agency will grant its license to the bidder with "the mostmeritorious plan for the development of F-ddA to a marketablestatus." This will involve, notably, the ability to synthesizeenough product to treat 500 to 1,000 AIDS patients in clinicaltrials and cooperation in conducting these studies with NCI andthe National Institute of Allergy and Infectious Diseases.
Wilson, NCI's scientific contact person for enquiries about theF-ddA license, may be reached at (301) 496-6404. StevenFerguson, OTT's licensing specialist for the drug, can be reachedat (301) 496-7735.
NON-EXCLUSIVE RIGHTS FOR HIV PROTEIN ASSAY
The Office of Technology Transfer (OTT) on Wednesday put intoits Federal Register hopper an offer to license non-exclusiverights to an "Assay for Inhibitors of HIV DNA Integration," onwhich it had filed a patent application (No. 07/762,092) inSeptember 1991.
The in vitro screening system identifies potential anti-retroviral drugs that target HIV integration and the virus'integrase protein.
Integrase, said the assay's developer, Robert Craigie of theNational Institute of Diabetes, Digestive and Kidney Diseases, isa 32kD core viral protein that recognizes the ends of the viralDNA, after reverse transcription, makes a break in the hostcell's DNA, and joins it to the viral end following infection toinitiate replication.
The assay now on the licensing block reproduces that reactionin a cell-free system, re-creating the same biochemical stepsthat normally insert HIV's DNA into the host DNA.
"It's a screening type, research-directed assay rather than aproduct," Craigie told BioWorld, "so the best way to get itcommercially used is by non-exclusive licenses, for not too higha fee."
He sees two opportunities for the assay for companies seekingHIV integrase inhibitors:
-- For pharmaceutical companies, which already have largecollections of compounds to screen, "the most rational way touse this assay would be running it in parallel with otherscreens."
-- For biotechnology companies, "there is a possible opening todevelop and market this kind of assay system in a form thatcan be sold to other companies for screening purposes."
In its present form, the assay uses a radioactive label. But, saidCraigie, "It can readily be converted to colorimetric, and itwould be easy for a biotechnology licensee to make that switch,then sell the system to pharmaceutical companies."
Craigie can be reached at (301) 496-4081 and Steven Fergusonof OTT, licensing specialist for this offer, at (301) 496-7735.
-- David N. Leff Science Editor
(c) 1997 American Health Consultants. All rights reserved.