AFM13 – Hodgkin Lymphoma
Affimed’s lead product AFM13-designed as an Orphan Drug for Hodgkin Lymphoma-entered clinical trials in 2010.
AFM13 - Hodgkin Lymphoma
| Compound | Target | Indication | Discovery | Preclinical | Phase I | Phase II |
|---|---|---|---|---|---|---|
| blue = current development status - green = planned development | ||||||
| AFM13 | CD30xCD16 | Hodgkin Lymphoma | 100% completed | 100% completed | 70 % 100% | |
Description
The TandAb® antibody, AFM13, is a bispecific, tetravalent human antibody specifically designed to treat Hodgkin Lymphoma. AFM13 is a RECRUIT-TandAb® targeting CD30 on the tumor target cells and CD16A on NK-cells as immune effector cells. Preclinical data indicate a specific and very effective engagement of NK-cells, inducing fast and strong ADCC in combination with good safety and tolerability.
Development status
A very robust GMP production process has been established for AFM13 in mammalian cells. The excellent stability predicts a long shelf life for the AFM13 product. After IND and CTA approval in August 2010 AFM13 entered a dose escalation phase I clinical trial in order to assess its safety and tolerability in Hodgkin Lymphoma patients. Orphan Drug Designations has been granted by both FDA and the EMA.
Hodgkin Lymphoma
Hodgkin Lymphona is an indication with a high unmet medical need that requires new therapeutic approaches involving significantly improved treatments and a selective mechanism of action that will prolong patient lifespan and improve quality of life. To date, no immunotherapeutic targeted therapy has been approved, and there are only a small number of targeted therapies in development.
Hodgkin Lymphoma is a very attractive market opportunity, with a projected market size of over 500 Million US$ by 2020 in the US and the EU. It seems quite likely that a few targeted therapies will have been approved by this time. The RECRUIT-TandAb® constructions position AFM13 as a product for targeted therapy designed to achieve higher efficacy and a better safety profile than the competing products in development. AFM13 could therefore gain a major market share in this indication.
There is a further, real upside potential for the RECRUIT-TandAb® AFM13 in anaplastic large cell lymphoma (ALCL), which constitutes about 10% of Hodgkin Lymphoma cases. Based on current knowledge and practice, the use of CD30 as a target in oncology is limited to HL and ALCL. However, the potential for CD30 to be used not only against allergic processes (asthma, atopic dermatitis) but also against transplantation, autoimmune and inflammatory diseases has been discussed in recently published scientific literature. (e.g.; Oflazoglu et al: Targeting CD30/CD30L in Oncology and autoimmune and inflammatory diseases. Adv Exp Med Biol 2009; 647: 174-185).
