On June 01, 2020 Processa Pharmaceuticals reported that it has signed an agreement with Aposense to license in the patent rights and the know-how to develop and commercialize their next generation irinotecan cancer drug, ATT-11T (Press release, Aposense, JUN 1, 2020, View Source [SID1234583953]).
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Irinotecan metabolizes to SN-38, the active anti-cancer moiety, and is used as first and second line therapy in many types of cancer (e.g., metastatic colorectal, small cell lung, pancreatic). Although irinotecan has a narrow therapeutic window and dose limiting adverse effects, including a FDA "Black Box" warning for both neutropenia and severe diarrhea, irinotecan achieved peak annual sales of US$1.1 billion.
ATT-11T is a novel lipophilic anti-cancer pro-drug that is being developed for the treatment of the same solid tumors as prescribed for irinotecan. This pro-drug is a conjugate of a specific proprietary Aposense molecule connected to SN-38, the active metabolite of irinotecan. The proprietary Aposense molecule on ATT-11T allows ATT-11T to bind to cell membranes to form an inactive pro-drug depot on the cell with SN-38 preferentially accumulating in the membrane of tumors cells and the tumor core. This unique characteristic is expected to make the therapeutic window of ATT-11T wider than irinotecan such that the anti-tumor effect of ATT-11T will occur at a much lower dose than irinotecan with a milder adverse effect profile than irinotecan. The wider therapeutic window will likely lead to more patients responding with less side effects when on ATT-11T compared to irinotecan.
"The licensing of this product from Aposense fits with our strategy to continue to bring innovative products to patients with an unmet medical need condition. With the addition of this product to our pipeline, the Processa team is excited about moving into the cancer arena," said Dr. David Young, Chief Executive Officer of Processa.
The licensing agreement is a Condition Precedent License Agreement conditioned upon: (i) Processa’s closing of the Satisfactory Financing Round and the listing of the Company’s shares on the NASDAQ or NYSE and (ii) Aposense obtaining the approval of the Israel Innovation Authority for the consummation of the transactions set forth in the agreement. Subject to the terms of the Agreement and upon satisfaction of the conditions, Aposense will grant Processa a worldwide (excluding China), royalty-bearing right and license, including the right to sublicense. Under the terms of the License Agreement, Aposense will receive shares in Processa with an aggregate value of $2.5 M and could receive up to $125 M in potential development and sales milestones, as well as royalties of 7% based on net sales.