Bispecific Antibodies

Search documents
Xencor (XNCR) 2019 Earnings Call Presentation
2025-07-03 13:58
XmAb® Fc Domain Technology - Xencor's XmAb® Fc domains augment native immune functions, preserve half-life, stability and production of antibodies[4] - XmAb® Fc domains are 99.5% identical to natural antibodies and can be easily substituted into any antibody[9] - Xencor has over 500 issued and pending patents worldwide related to XmAb® Fc domains[4] Bispecific Antibody Pipeline - Xencor has 6 XmAb bispecific antibodies in Phase 1 clinical studies[4] - XmAb23104 (PD-1 x ICOS) entered Phase 1 in May 2019, and XmAb22841 (CTLA-4 x LAG-3) initiation was anticipated in Q2 2019[4,39] - Novartis has a co-development and ex-U.S license for XmAb14045 (CD123 x CD3)[4] - Amgen's AMG 424 (CD38 x CD3) is in Phase 1 study in myeloma, and AMG 509 (Undisclosed x CD3) is advancing in prostate cancer[4,11,44] IL-15 Cytokine Program - Genentech has a co-development collaboration with Xencor for novel IL-15 cytokines[4] - The collaboration includes $120 million upfront and up to $160 million in XmAb24306 development milestone payments, and up to $180 million for each new IL-15 program[42] - The first IND submission for XmAb24306 is planned for H2 2019[4,42] Clinical Programs and Partnerships - Xencor has 13 XmAb clinical programs ongoing internally or with partners, including tafasitamab/MOR208 (Morphosys) in Phase 3 and Ultomiris™ (Alexion) approved in the U.S for the treatment of adult patients with PNH[4,11] - In a Phase 1 study of XmAb14045 in relapsed/refractory AML, 28% of evaluable patients achieved either complete remission (CR) or CR with incomplete hematologic recovery (CRi) at 2 highest initial doses (1.3 and 2.3 mcg/kg weekly)[29,34] Financial Status - Xencor had $650.5 million in cash at March 31, 2019, providing runway beyond 2024[46]
Zura Bio (ZURA) 2025 Conference Transcript
2025-06-04 20:10
Summary of Zura Bio Conference Call Company Overview - Zura Bio was formed as a private company in 2022 and went public in 2023 [2][3] - The company has in-licensed three novel bispecific antibodies [3] Key Objectives and Achievements - The CEO outlined three objectives: secure two new INDs, initiate two phase two trials, and raise sufficient funds for these trials [3] - Successfully secured IND for systemic sclerosis and initiated the study in December 2024 [4] - IND cleared for hidradenitis suppurativa in March 2025, with the study activated [4] Lead Asset: Tipalizumab - Tipalizumab is a quadrivalent bispecific antibody that inhibits IL-17 and BAF [5] - The unique quadrivalent structure allows binding to IL-17, BAF, or both without requiring dual engagement [7] Phase Two Programs Systemic Sclerosis - Affects approximately 300,000 individuals globally with a ten-year mortality rate of 50% [8] - No advanced line agent approved for the disease; existing therapies provide modest effects [9] - Phase two trial will measure the change in modified Rodnan Skin Score and explore lung function [10] - Previous studies (e.g., Brodalumab) showed robust responses in skin scores, indicating potential for Tipalizumab [12] Hidradenitis Suppurativa - A challenging disease with around 300,000 patients in the US; existing treatments have modest benefits [17][18] - The need for higher efficacy therapies remains unmet [21] - Emerging data suggests a combinatory approach using IL-17 and B cell inhibition could improve outcomes [23] Clinical Trial Design and Expectations - Phase two trial for systemic sclerosis will have 80 participants and is expected to complete enrollment by Q1 2026, with top-line data by Q4 2026 [15] - The trial for hidradenitis suppurativa is expected to provide top-line data in Q3 2026 [29] - Both trials include a loading dose to achieve therapeutic levels quickly [30] Financial Position - The company has a strong cash position, expected to last through 2027, providing a buffer for post-data catalyst activities [32] Conclusion - Zura Bio is positioned uniquely in the biotech landscape with promising drug candidates and a solid financial foundation, aiming to validate its hypotheses in systemic sclerosis and hidradenitis suppurativa [33]