AFM13 – Hodgkin Lymphoma
Affimed’s lead product AFM13 – designed as an Orphan Drug for Hodgkin Lymphoma – shows encouraging data after completing Phase 1 clinical trial.
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||100% completed||30 % 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 Lymphoma patients, and in 1st/2nd line therapy in combination with chemotherapy. This is highly feasible as AFM13 has shown an attractive safety profile in Phase 1 clinical trials. 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 > $500 million.
Orphan Drug Designations has been granted by both FDA and the EMA.
AFM13 is Affimed’s lead program that has completed successfully its Phase 1 study in relapsed / refractory Hodgkin Lymphoma patients. In the dose escalation part AFM13 was dosed up to 7mg/kg in a weekly dosing schedule for four weeks and up to 4.5mg/kg twice a week for four weeks.
AFM13 appears to be well tolerated with evidence of meaningful anti-tumor activity including partial responses and stable diseases.
The fact that an increaseing number of diseases have been reported in which CD30 is expressed on malignanct cells and the encouraging data warrant the further development of AFM13 in Hodgkin Lymphoma and other CD30 positive malignancies.
Hodgkin Lymphona is an indication with a high unmet medical need that requires new therapeutic approaches involving significantly improved treatments and a selective mechanism of action that will prolong patient lifespan and improve quality of life. To date, no immunotherapeutic targeted therapy has been approved, and there is no other immunotherapy currently in development.
Hodgkin Lymphoma is a very attractive market opportunity, with a projected market size of over 1 Billion US$ 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.