MacroGenics Updates on Corporate Progress, Q1 2024 Financials, and Interim TAMARACK Phase 2 Data

MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical enterprise devoted to the advancement of antibody-based cancer treatments, announced updates on its corporate progress and financial results for the quarter ending March 31, 2024. The company highlighted the encouraging interim findings from the Phase 2 TAMARACK study of vobra duo, an antibody-drug conjugate (ADC) targeting B7-H3, in treating metastatic castration-resistant prostate cancer (mCRPC).

Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics, expressed optimism regarding the updated safety and preliminary efficacy data from the study. He noted that the data validates the hypothesis that lowering doses and extending the dosing interval could enhance tolerability without compromising biological activity. This interim data has prompted MacroGenics to plan for a potential Phase 3 study, potentially commencing next year, with final data on safety, efficacy, and durability anticipated in the latter half of 2024.

Professor Johann DeBono from The Institute of Cancer Research, London, highlighted the significance of the promising interim results, suggesting that vobra duo could become the first therapy targeting B7-H3 in prostate cancer patients, offering a crucial new treatment option given the limited existing therapies.

Key updates on MacroGenics’ investigational programs include:

B7-H3-Directed Therapies:
- Vobramitamab duocarmazine (vobra duo): This ADC targets B7-H3, widely expressed in various solid tumors. The TAMARACK Phase 2 study enrolled patients with mCRPC who had prior androgen receptor-axis targeted therapy and possibly one taxane regimen. The study evaluates two doses, 2.0 mg/kg and 2.7 mg/kg, every four weeks. Interim data, based on an April 2024 cutoff, indicated promising PSA reductions and tumor response rates with manageable safety profiles.

- MGC026: Another B7-H3-targeting ADC, MGC026, employs a topoisomerase I inhibitor payload. Ongoing Phase 1 studies have shown MGC026’s greater potency and tolerance in preclinical models, supporting its potential utility in treating various advanced solid tumors.

- Enoblituzumab: This monoclonal antibody targets B7-H3 and is being evaluated in the HEAT study for high-risk localized prostate cancer. The trial is assessing its neoadjuvant use before radical prostatectomy.

Lorigerlimab:
Lorigerlimab is a bispecific PD-1 × CTLA-4 DART® molecule. It is currently being tested in combination with vobra duo, and in the LORIKEET Phase 2 study, which compares lorigerlimab plus docetaxel versus docetaxel alone in mCRPC patients. The study targets a primary endpoint of radiographic progression-free survival, with completion anticipated in 2024 and updates expected in early 2025.

Emerging ADC Pipeline:
- MGC028: This preclinical ADC targets ADAM9, implicated in various cancers. Preclinical studies have demonstrated MGC028’s effectiveness in models of multiple cancers, with good tolerance in non-human primate studies. An investigational new drug (IND) application is expected by late 2024.

Partnered Programs:
- MGD024: This humanized CD123 × CD3 DART molecule is designed to minimize cytokine-release syndrome while retaining anti-tumor activity. It is being tested in a Phase 1 dose-escalation study for CD123-positive neoplasms, including acute myeloid leukemia and myelodysplastic syndromes.

Financial Results for Q1 2024:
MacroGenics reported a cash balance of $184.2 million as of March 31, 2024, down from $229.8 million at the end of 2023. Revenue for the first quarter of 2024 totaled $9.1 million, a decrease from $24.5 million in the same period in 2023, primarily due to a drop in collaborative agreements revenue. Research and development expenses remained stable at $46.0 million, while selling, general, and administrative expenses rose slightly to $14.7 million. The net loss for the quarter was $52.2 million, compared to $38.0 million in the prior year’s quarter.

In summary, MacroGenics is making considerable advances in its cancer treatment pipeline, particularly with the promising interim data from the TAMARACK study of vobra duo. The company is poised for further clinical trials and potential new treatment options for various cancers, supported by its robust financial position and strategic planning.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!