Adaptimmune Therapeutics (ADAP) H.C. Wainwright 26th Annual Global Investment Conference 2024 summary

Pipeline overview and recent approvals

• Received first FDA approval for Tecelra, an engineered T cell therapy for synovial sarcoma.

• Pipeline includes lete-cel, expected to seek approval in 2026, and advanced programs in ovarian cancer, PRAME, and CD70.

• Tecelra launch supported by two approved biomarker tests and six authorized treatment centers, with plans to expand to 30 centers next year.

• Lete-cel targets NY-ESO-1 and expands reach to MRCLS, offering synergy with Tecelra for broader sarcoma coverage.

• Advanced pipeline assets include ADP-600 (PRAME TCR) and ADP-520 (CD70), both moving toward IND filings.

Differentiation and commercial strategy

• TCR therapies recognize both cell surface and intracellular antigens, unlike CAR-Ts, enabling broader targeting.

• Commercial launch metrics focus on number of treatment centers and apheresis patients, with dosing expected late in the year.

• Biomarker screening is nationwide, with sponsored testing and patient navigation support to streamline access.

• No REMS required for Tecelra due to favorable safety profile, with manageable CRS rates.

• Commercial infrastructure for Tecelra will be leveraged for lete-cel, maximizing operational efficiency.

Regulatory and development milestones

• Full approval for Tecelra depends on confirmatory data from a second cohort in the SPEARHEAD-1 study.

• Lete-cel regulatory pathway mirrors Tecelra, with data transfer and application preparation underway.

• Uza-cel, an advanced MAGE-A4 TCR, is in phase II for ovarian cancer and partnered with Galapagos for head and neck cancer using decentralized manufacturing.

• No current plans to pursue autoimmune indications; focus remains on solid tumors.

• Upcoming catalysts include commercial execution, lete-cel data at CTOS, ovarian trial progress, and INDs for PRAME and CD70 programs.