Affimed (AFMD) Leerink’s Global Healthcare Conference 2025 summary

Leadership and strategic direction

• New CEO with extensive experience in biotech fundraising, public offerings, and clinical development, having led multiple companies through significant financing and clinical milestones.

• Pipeline prioritization is a key focus, with decisions influenced by investor input and commercial potential of each asset.

• AFM24 and AFM28 are receiving the most attention from investors and partners due to promising data and large unmet needs.

• Acimtamig may be deprioritized due to its smaller commercial potential, though it remains a topic in partnering discussions.

• Investor and partner interests are aligned, with both groups seeking late-phase, differentiated programs.

Clinical program updates and data

• AFM24 in combination with atezolizumab shows a 21% ORR and 5.6 months PFS in EGFR wild type NSCLC, and 24% ORR with similar PFS in EGFR mutant patients.

• Higher exposure to AFM24 correlates with improved efficacy across ORR, PFS, and OS, prompting a move to a 720 mg dose cohort, pending regulatory approval.

• Next AFM24 cohort will exclude prior taxane exposure to potentially enrich for better PFS outcomes.

• AFM28 in AML has shown a 40% composite CR rate at 300 mg, with response durations of 2.5–6.5 months, outperforming recent regulatory benchmarks.

• Dose escalation for AFM28 continues, with further data expected 6–9 months after enrolling the next cohort.

Differentiation and competitive positioning

• NK cell engager approach enables a wider therapeutic index, reducing toxicity compared to T-cell engagers, CAR-Ts, and ADCs targeting CD123.

• AFM24 and AFM28 demonstrate lower on-target toxicity, with no typical EGFR-related skin or mucosal side effects.

• Both programs are seen as optimal for difficult targets with narrow therapeutic windows, validated by similar approaches from competitors.

• Acimtamig, in combination with Artiva’s NK cells, maintains high CR and ORR rates in double refractory Hodgkin’s lymphoma, with durability data pending.

• Commercial viability and scalability are prioritized in development decisions, especially regarding NK cell sourcing and dosing regimens.