PIPELINE
Anti-Id Drugs The Company’s first priority is to identify small molecules that block blood vessel formation into tumors in the mouse (angiogenesis) by binding and inhibiting the Id proteins or inhibiting the expression of the Id genes. One of the anti-Id molecules discovered and patented by the Company (AGX51) diminishes both tumor formation and spread (metastasis) in mice by blocking the actions of the Id proteins. AGX51 inhibits both tumor associated angiogenesis as well as restorating the body’s normal controls block replication of tumor cells. These findings suggest the possibility that these drugs have a dual mechanism of action, anti-angiogenesis and anti-growth. A second drug (AGX1053) is a different type of molecule (an antisense-type fusion molecule) that prevents angiogenesis by inhibiting Id gene expression; this compound blocks both tumor formation and metastasis in mice. The Company is currently conducting additional studies on the anti-tumor activity of these molecules in animal tumor models. The Company intends to initiate clinical testing after submitting and IND application to the FDA for AGX51
Diagnostic/Prognostic/Surrogate Marker Test.
In collaboration with the diagnostic firm BioCheck, Inc., the Company is investigating the Id technology for its potential for the diagnosis and prognosis of various types of cancers. This collaboration is defined by a formal license agreement whereby AngioGenex, Inc. will receive milestones and royalties. Pilot measurements of serum Id proteins of breast cancer patients have been completed following the development of an assay. These results suggest the possibility of developing a highly sensitive test that will allow both early detection and the ability to monitor the progress of the disease during and after therapy. The detection of Id proteins in blood would indicate the presence of a tumor. The ability to detect breast cancer at a very early stage would allow early treatment and a much better opportunity to treat the disease successfully. It is expected that this test would also provide early detection of re-emergence of the disease signaling the need to reinstitute therapy. Currently, there is collaboration between AngioGenex, MSKCC and BioCheck to determine the tumor types that express the Id proteins thereby determining which tumors are likely to respond to anti-Id drugs. Early results suggest that all solid tumors express the Id proteins. Additional studies will be conducted to confirm these clinical findings. A diagnostic test of this type may offer the opportunity to provide selective therapy to patients, a major goal of cancer treatment. Providing evidence of the existence in the body of an Id containing tumor would suggest therapy include an anti-Id drug.
Potential for Non-Cancer Use of Anti-Id Drugs. Another Company strategy is to determine what other medical conditions are likely to benefit from the use of anti-Id drugs. There are many diseases in which the abnormal growth of blood vessels is thought to contribute to the underlying pathology. Important human diseases that are likely to benefit by Id inhibition include diabetic retinopathy, age related macular degeneration (ARMD), severe rheumatoid arthritis and endometriosis. Relevant mouse models of these conditions mimic the disease in humans and are available for testing purposes. Partnering possibilities would be enhanced if data were available in animal models of these diseases demonstrating the usefulness of anti-Id therapy.
Company Pipeline. The current AngioGenex product pipeline is given in the following Table.
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Product
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Class
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Stage
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Expected Regulatory Filing
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Indication
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AGX51: Small Molecule Inhibitor
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Therapeutic
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Preclinical
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IND 15-18 months from funding
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Cancer
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AGX1053: Peptide-AS Construct
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Therapeutic
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Preclinical
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IND 18-24 months from funding
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Cancer
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AGX1053: Peptide-AS Construct
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Therapeutic
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Preclinical
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IND 24-30 months from funding
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Ocular
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mAbs to Id1 & Id3 (done), mAbs to Id2 & Id4 (ongoing)
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Diagnostic Prognostic Surrogate
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Preclinical
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PMA/510k with Biocheck 30-36 months from funding
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In vitro test for Various Cancers
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Timeline and Estimated Activity Costs for Development AGX51 Through Phase 1:
