Affimed Reports First Quarter 2024 Updates

As part of its Q1 reporting, Affimed revealed the first data from its LuminICE-203 AFM-13 study and its AFM28 study in AML (Acute Myeloid Leukemia). These results highlight the strong potential of addressing innate immunity for cancer treatment and further validate Affimed’s bispecific approach.  

Importantly, Affimed could replicate the encouraging results of the initial MD Anderson study in its ongoing LuminICE-203 study, achieving an overall response rate (ORR) of 85.7% in the first 7 treatment-refractory Hodgkin lymphoma patients treated with Acimtamig (AFM13) in combination with AlloNK, Artiva’s allogeneic NK.  

The results include 4 complete remissions (CRs) and 2 partial responses (PRs). These results confirm the promising approach with a now viable commercial NK cell product.  

The first results from the AFM28 study establish a clinically active dose with a good safety profile for patients with CD123-positive relapsed/refractory acute myeloid leukemia.  

 Affimed is looking to also develop AFM28 in combination with an allogeneic, off-the-shelf NK cell product to further enhance efficacy as evidenced in the case of Acimtamig.  

With the recent AFM24 data presented at ASCO, the company has been able to achieve clinical validation across its pipeline within 6 months after its strategic refocus on the clinical development of its three core programs.  

Key facts and data highlights: 

Acimtamig (AFM13; CD30 / CD16A) 

• All patients were heavily pretreated with a median of 4 lines of prior treatment including combination chemotherapy, brentuximab vedotin and checkpoint inhibitors; 71 % (5/7) had also failed after prior autologous stem cell transplantation (ASCT). 

• Treatment-related adverse events were consistent with previous experience and were mainly mild to moderate. All side effects were well manageable with standard of care treatment and there were no treatment discontinuations due to acimtamig or AlloNK related adverse events. 

• Enrollment in cohorts 1 and 2 is completed; Cohorts 3 and 4 are now open and enrolling. 

AFM28 (CD123 / CD16A) 

• Completed enrollment of the sixth and final cohort in the multi-center Phase 1 open-label, dose-escalation study (AFM28-101), of AFM28 monotherapy in CD123-positive relapsed/refractory AML. 

• Of 6 patients treated at dose level 6 at 300mg, 1 patient showed a CR, 1 patient a CRi and 3 patients achieved SD, a CR/CRi rate of 33%. 

• Of 6 patients treated at dose level 5 at 250 mg, 1 patient showed a CR, ongoing after 5 months; 5 patients achieved a stable disease as best response. 

• No dose-limiting toxicities were reported in dose levels 5 and 6 

AFM24 (EGFR / CD16A) 

All responses reported in the last data update at ASCO were now confirmed by follow-up scan and are still ongoing