AF122 : anti-cancer drug against Acute Myelogenous Leukemia.

Leukemia grows up in bone marrow and is characterized by an abnormal and excessive proliferation of white blood cell-precursors, blocked at a stage of differentiation, which finally invade the entire bone marrow and cause medullary insufficiency with insufficient production of red blood cells, and white blood cells, mainly polynuclear ones, and platelets. The leukemic cells can also invade other organs like lymph nodes, spleen, liver, testis or the central nervous system.

These phenomena result in classifying leukemia in two main families, Acute Lymphoblastic Leukemia (ALL) and Acute Myeloid Leukemia (AML).
In terms of segmentation of market, Affichem has focused on AML which are much more frequent than ALL, particularly in patients over 60. Indeed, the average age of patients suffering from AML is approximately 67 years. The incidence of AML is relatively low before the age of 40, 1 case for 100.000 people but increases dramatically with the age to 15 cases for 100.000 people over 75.
AML are the most frequent leukemia in adults, with around 200,000 new cases a year, representing between 15 to 20% of the leukemia market in Europe and in the United States.

AF122 has a dual mechanism of action, acting directly on cancer cells but also on immune system.
Indeed, AF122 induces cell differentiation followed by active immunogenic death (apoptosis and cytotoxic autophagy) on cancer cells. It also stimulates maturation of dendritic cells, antigen presentation and T lymphocyte infiltration in tumors.
Interestingly, it is very efficient on leukemic progenitor cells which are responsible for resistance and relapses. In addition, it has a very good toxicological profile. Altogether, these characteristics represent a main advantage compared to gold standard therapies.

AF122 has its own biomarker of efficacy, validated in vivo, which will be a great support for clinical development.


AF122 : other indications.

AF122 showed in vitro and in vivo efficacy on robust models of breast cancer and metastatic melanoma.
In accordance to the mechanism of action of AF122 and the drugs marketed or close to, AF122 may be evaluated on hormonoresistant (innate or acquired) and triple negative subtypes of breast cancers and melanoma with native BRaf protein, representing around 500,000 and 80,000 new cases per year respectively.


AF122 : market strategy.

Acute myeloid leukemia are considered an orphan disease.
Thus AF122 could benefit of the orphan drug status to facilitate and accelerate its access to the market.
This also will increase its commercial interest thank to the 7 (USA) or 10 (Europe) year-marketing exclusivity.

 
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