PROHOST FILTER

APHTON (APHT)

IGN311 moved into Phase 1/2 trials  

 The first patient is already enrolled in a newly initiated open-label Phase 1/2 trial of Aphton’s compound IGN311.

Enthusiasm by investors was obvious when Aphton moved its monoclonal antibody drug IGN311 targeting Lewis Y tumor-associated antigen for the treatment of epithelial cancers. Lewis Y tumor-associated antigen - a blood group related oligosaccharide is a validated target. And yes, it expresses in up to 90% of all epithelial cancers including breast, colon, gastric and pancreatic cancers, but rarely in normal adult cells. Yet, the drug is not the first to target this antigen. Yttrium Y 90 monoclonal antibody, Hu3S193, is in clinical trials targeting the same antigen for the same cancers.

Aphton’s IGN311 is a humanized monoclonal antibody that has the potential to target all the aforementioned cancers. The endpoints of the Phase 1/2 study are the effective reduction the number of Lewis-Y positive tumor cells and to decrease the volume of pleural effusions or ascites in patients with epithelial cancers. In addition, the study will also evaluate safety, tolerability and pharmocokinetics of the IGN311 antibody. The study is intended to enroll up to 24 patients.

Data from Phase I trial reported earlier this month demonstrate that IGN311 has a favorable safety and tolerability profile, and a serum half-life of more than 20 days. In addition, data from the trial suggested that the antibody may be capable of significantly decreasing the number of disseminated tumor cells circulating in peripheral blood. This is good news. Good news also is the choice of the trial end points, especially the pleural effusion and ascitis, which are complications of cancers. These effusions occur due to the accumulation of excess fluid within the membranes covering the lung, and in the abdomen, respectively, which is caused by the invasion of disseminated tumor cells originating from breast, colon, gastric, pancreatic and other cancers into the pleural space or into the abdomen. These effusions are considered severe complications of cancer and a treatment dilemma. The current means of managing them are of limited efficacy.

As we mentioned above, the drug is not alone in clinical trials for epithelial tumors. Also, it is still in early stage, making it irrelevant developing an opinion on its efficacy and safety compared to competing   drugs at this stage. The results of this Phase 1/2 trials, though, might give us a hint and could enable observers to compare it with other drugs’ results from the same phase trials. The concept is great, but wait and see is our attitude at this stage. We cross our fingers.

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