Allogene Therapeutics(ALLO)2023-03-01 02:40Financial Data and Key Metrics - The company ended the year with 350 million, including 75.4 million, with full-year expenses totaling 21 million, with full-year expenses at 332.6 million for 2022, or $2.32 per share [31] Business Line Data and Key Metrics - The CD19 program showed an overall response rate (ORR) of 57% and a complete response rate (CRR) of 58% in the Phase I trials [15] - The ongoing CR rate at 6 months was 50%, with all CRs at 6 months remaining durable at 12 months [15] - The BCMA program (ALLO-715) demonstrated an ORR of 67% and a very good partial response (VGPR) or better rate of 42% in the FCA60 cohort [18] - The median duration of response for ALLO-715 was 9.2 months, with the longest ongoing response at 24 months [18] - The CD70 program (ALLO-316) showed a 100% disease control rate in CD70-positive renal cell carcinoma patients, with 3 out of 9 patients achieving partial responses [22] Market Data and Key Metrics - The company is expanding its Phase II CD19 pivotal trial (ALPHA2) outside the U.S. into additional geographies [34] - The CD70 program is being evaluated for potential expansion into other CD70-expressing solid tumors and hematologic indications [24] - The company is preparing for a Phase III study in earlier-line large B-cell lymphoma, targeting trial initiation in the first half of 2024 [17] Company Strategy and Industry Competition - The company is focusing on executing its Phase II CD19 pivotal trials, evaluating the best path forward for multiple myeloma, and progressing the ALLO-316 trial in solid tumors [29] - The company is prioritizing the ALPHA2 study for ALLO-501A, with plans to potentially start an earlier-line study by 2024 [40] - The company is exploring the use of its Dagger platform, which may be deployed across additional CAR T products in both hematologic and solid tumors [50] Management Commentary on Operating Environment and Future Outlook - The company believes it has the operational capabilities, scientific insight, and capital resources needed to succeed in its endeavors [29] - The company is focused on improving manufacturing processes for its BCMA candidates (ALLO-715 and ALLO-605) to achieve optimal performance [19] - The company expects to present updated datasets on its CD19 and CD70 programs in 2023, with potential updates on the Alloy manufacturing process and BCMA program improvements [68] Other Important Information - The company has developed and validated a diagnostic assay for CD70 expression in renal cell carcinoma patients, which is being used for patient selection in the ALLO-316 study [86] - The company is not currently enrolling patients in the ALLO-605 Phase I study as it works on improving the manufacturing process [71] Q&A Session Summary Question: Enrollment and investigator feedback for the CD19 pivotal trial [32] - Enrollment in the ALPHA2 study is continuing according to plan, with expansion into additional geographies [34] - Investigators are enthusiastic about the trial and enrollment [34] Question: Rationale for prioritizing earlier-line large B-cell lymphoma trial [36] - The company sees an opportunity to advance the program to earlier lines, with discussions ongoing about the study design and population [37] Question: Regulatory discussions and pivotal trial status for multiple myeloma [39] - The potential pivotal study for multiple myeloma is likely to be pushed to 2024, with ongoing engagement with regulatory bodies and manufacturing process optimization [41] Question: Alloy process manufacturing and its role in the pivotal trials [43] - The Alloy process is being used in both pivotal trials for ALLO-501A, with all patients dosed using this manufacturing process [45] Question: Dagger platform and its potential deployment across the pipeline [47] - The Dagger platform may be expanded into additional CAR T products, with ongoing work to explore its use in both hematologic and solid tumors [50] Question: Ex-U.S. opportunity for ALLO-501A [52] - The company has the option to opt into ex-U.S. rights for ALLO-501A, with a decision based on financial and developmental factors [53] Question: Patient enrollment and outpatient treatment for pivotal studies [55] - Investigators are leveraging existing infrastructure for outpatient treatment, with patients selected based on their suitability for CAR T therapy [56][57] Question: Manufacturing tweaks for ALLO-605 and ALLO-715 [59] - The company is focusing on optimizing the manufacturing process for both ALLO-605 and ALLO-715, with potential reintroduction into the clinic in 2024 [60] Question: Timing of data readout for the CD19 pivotal trials [62] - The company targets data availability for both ALPHA2 and EXPAND trials at roughly the same time, following completion of enrollment in the first half of 2024 [63] Question: Manufacturing optimization for the BCMA program [65] - The company is reviewing the manufacturing process for both ALLO-715 and ALLO-605, with a decision on which product to take forward expected later [66] Question: 2023 catalysts and updates on the CD19 program and Alloy process [67] - The company plans to present updated datasets on its CD19 and CD70 programs, with potential updates on the Alloy manufacturing process and BCMA program improvements [68] Question: CD70 expression and potential expansion into liquid tumors [81] - CD70 is a target with wide distribution across malignancies, with potential expansion into additional solid tumors and hematologic indications [82][83] Question: Status of CD70 assay development and deployment [85] - The company has developed and validated a diagnostic assay for CD70 expression, which is being used for patient selection in the ALLO-316 study [86]