MacroGenics Updates on Vobramitamab Duocarmazine

MacroGenics, Inc., a biopharmaceutical company focused on developing innovative antibody-based cancer therapeutics, has announced the presentation of clinical data from its TAMARACK Phase 2 study of vobramitamab duocarmazine (vobra duo) at the European Society for Medical Oncology (ESMO) Congress 2024. The event will be held in Barcelona, Spain, from September 13-17.

The abstract submitted to ESMO is based on data collected up to April 12, 2024, with additional information from a July 9 data cut-off, covering safety, efficacy, and the 6-month radiographic progression-free survival (rPFS) rate. The poster, titled "1654P; TAMARACK: Randomized Phase 2 trial of the B7-H3 targeting antibody-drug conjugate (ADC) vobramitamab duocarmazine (vobra duo) in metastatic castration-resistant prostate cancer (mCRPC)," will provide insights into the study's outcomes.

Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics, highlighted the significance of these findings in shaping future steps for the vobra duo program in mCRPC. To comply with ESMO's embargo policy, the detailed poster will be available on MacroGenics' website around September 15, 2024. The company has entered a quiet period, refraining from hosting a conference call for its quarterly financial results or corporate progress. Instead, an investor update call will be scheduled post-ESMO presentation to discuss TAMARACK data and future plans for the vobra duo program.

MacroGenics finished enrolling TAMARACK study participants in Q4 2023 and is set to present the primary endpoint of a 6-month rPFS rate at ESMO. Following a thorough data review in late July 2024, MacroGenics, in agreement with the Independent Data Monitoring Committee (IDMC), decided to stop treatment for remaining mCRPC study participants eligible for further dosing. Most participants had already completed 8-12 cycles of vobra duo. Continuous monitoring for adverse events, disease progression, and survival remains in place.

Dr. Koenig emphasized the priority of patient safety and the intent to determine next steps for vobra duo after reviewing mature median rPFS and overall survival (OS) data later this year. Final data from the TAMARACK trial will be presented at a future conference.

The TAMARACK Phase 2 study evaluates vobra duo, an ADC targeting B7-H3, an antigen on various solid tumors and part of the immune-regulating B7 family. The study involves mCRPC participants previously treated with one androgen receptor axis-targeted therapy (ARAT) and potentially one taxane-containing regimen. The study tests two vobra duo doses, 2.0 mg/kg and 2.7 mg/kg, administered every four weeks.

MacroGenics specializes in developing monoclonal antibody-based cancer therapies. Their pipeline stems from proprietary antibody technology platforms, leading to strategic collaborations with global pharmaceutical and biotechnology firms. As vobra duo advances, the company remains committed to evaluating its potential thoroughly.

Overall, the TAMARACK study's forthcoming data at ESMO 2024 will be crucial in guiding future clinical studies and potential approvals for vobra duo in treating mCRPC.

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