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||CD30xCD16A||Hodgkin Lymphoma||100% completed||100% completed||90 % 100%|
The TandAb® AFM13 is specifically designed to treat Hodgkin Lymphoma. AFM13 is a RECRUIT-TandAb® targeting CD30 on malignant Reed-Sternberg cells and CD16A on NK-cells.
AFM13 has potential to be developed as salvage therapy in 3rd line Hodgkin’s Lymphoma patients, and in 1st/2nd line therapy in combination with chemotherapy. This is highly feasible as AFM13 has shown a benign safety profile. Therefore, AFM13 has a significant market potential for the therapy of Hodgkin’s Lymphoma patients and other CD30 positive tumors which could lead to annual sales of > $500 million.
Orphan Drug Designations has been granted by both FDA and the EMA.
AFM13 is our lead program that is currently investigated in a phase I/IIa study in Hodgkin’s Lymphoma patients. We have completed 7 dose escalations (up to 7mg/kg), and the product appeared to be safe and well tolerated. Furthermore, with several stable diseases and a partial response, the product shows clear signs of activity.
A very robust GMP production process has been established for AFM13 in mammalian cells. The excellent stability predicts a long shelf life for the AFM13 product. After IND and CTA approval in August 2010 AFM13 entered a dose escalation phase I clinical trial in order to assess its safety and tolerability in Hodgkin Lymphoma patients.
Hodgkin Lymphona is an indication with a high unmet medical need that requires new therapeutic approaches involving significantly improved treatments and a selective mechanism of action that will prolong patient lifespan and improve quality of life. To date, no immunotherapeutic targeted therapy has been approved, and there is no other immunotherapy currently in development.
Hodgkin Lymphoma is a very attractive market opportunity, with a projected market size of over 1 Billion US$ by 2020 in the US and the EU. The RECRUIT-TandAb® constructions position AFM13 as a product for targeted therapy designed to achieve high efficacy and a good safety profile. AFM13 could therefore gain a major market share in this indication.
There is a further upside potential for the RECRUIT-TandAb® AFM13 in anaplastic large cell lymphoma (ALCL), which constitutes about 20% 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).