Affimed (AFMD) 2024 Cantor Fitzgerald Global Healthcare Conference summary

Program overviews and clinical progress

• Three NK cell engager programs in clinical development, all with clinical proof of concept as monotherapy or in combination.

• AFM13 (CD30 NK cell engager) showed 83% overall response and 50% CR rate in combination with allo-NK cells; more data expected in Q4.

• AFM24 (EGFR NK cell engager) demonstrated over 20% response rate and median PFS of 5+ months in NSCLC, both wild-type and mutant EGFR.

• AFM28 (CD123 NK cell engager) showed 50% CR/CRi rate in refractory AML patients.

Differentiation and advantages of NK cell engagers

• NK cell engagers offer tumor specificity and a wider therapeutic index compared to T cell engagers.

• No cross-resistance observed with other modalities; activity seen post-small molecules and post-CAR T.

• Both monotherapy and combination regimens show compelling activity and synergy.

AFM13 clinical data and regulatory strategy

• In a study with 36 refractory Hodgkin lymphoma patients, AFM13 plus allo-NK cells achieved 95%+ ORR and 70%+ CR rate.

• Durable responses observed, with one-third of patients in ongoing CR at 12 months, some at 18–24 months.

• Transitioned to a commercially suitable NK cell product and multicenter trial; 83% ORR and 50%+ CR in real-world setting.

• Four cohorts in phase II, testing two doses each of acimtamig and NK cells; aiming for ~80 evaluable patients for accelerated approval.

• FDA supports single-arm study for accelerated approval due to lack of standard of care.