MacroGenics Provides Update on Corporate Progress and 2024 Financial Results

   -- Fully enrolled LORIKEET, a randomized 150-patient Phase 2 study of 
      lorigerlimab in combination with docetaxel in patients with mCRPC 
 
   -- Initiating new LINNET Phase 2 study of lorigerlimab in ovarian cancer 
 
   -- Advancing multiple novel topoisomerase 1 inhibitor-based ADCs, including 
      MGC026, MGC028 and MGC030 
 
   -- Discontinuing further internal clinical development of vobra duo; 
      exploring potential partnering 
 
   -- Cash, cash equivalents and marketable securities of $201.7 million as of 
      December 31, 2024; cash runway extended into the second half of 2026 
 
   -- Conference call scheduled for today at 4:30 p.m. ET 

ROCKVILLE, Md., March 20, 2025 (GLOBE NEWSWIRE) -- MacroGenics, Inc. $(MGNX)$, a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing innovative antibody-based therapeutics for the treatment of cancer, today provided an update on its recent corporate progress and reported financial results for the year ended December 31, 2024.

"We concluded 2024 with the achievement of multiple clinical development milestones, including the completion of enrollment in the LORIKEET Phase 2 study evaluating lorigerlimab in combination with docetaxel in patients with mCRPC. We look forward to building upon this momentum in 2025 as we work to advance our novel pipeline of clinical product candidates, including lorigerlimab, MGC026 and MGC028," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "Finally, we have determined that the results of the TAMARACK Phase 2 study of vobra duo in mCRPC do not support additional financial investment by MacroGenics. We believe the B7-H3 target continues to have potential and are pleased with the progress being made with our alternate anti-B7-H3 ADC, MGC026."

Updates on Proprietary Investigational Programs

Lorigerlimab is a bispecific, tetravalent PD-1 × CTLA-4 DART$(R)$ molecule designed to enhance CTLA-4 blockade on dual-expressing, tumor-infiltrating lymphocytes compared to a PD-1/CTLA-4 monoclonal antibody (mAb) combination therapy, while maintaining maximal PD-1 blockade on all PD-1-expressing cells.

   -- Enrollment is now complete in the ongoing LORIKEET Phase 2 trial, a 150 
      patient randomized study of lorigerlimab in combination with docetaxel 
      vs. docetaxel alone in second-line, chemotherapy-naïve patients with 
      metastatic castration-resistant prostate cancer (mCRPC). The Company 
      expects to provide a clinical update in the second half of 2025. 
 
   -- Based on MacroGenics' cumulative experience to date from its Phase 1 and 
      Phase 2 studies of lorigerlimab, including in mCRPC -- a tumor setting 
      historically insensitive to checkpoint inhibition -- the Company plans to 
      conduct the LINNET Phase 2 study. This clinical trial will evaluate 
      lorigerlimab as monotherapy in patients with either platinum-resistant 
      ovarian cancer $(PROC)$ or clear cell gynecologic cancer (CCGC); both 
      represent areas of unmet need and historically have been relatively 
      insensitive to checkpoint inhibitor therapy. The study's primary endpoint 
      is ORR, with multiple secondary endpoints to be explored. The Company 
      anticipates enrolling up to 40 patients with PROC and up to 20 patients 
      with CCGC in LINNET, which is expected to commence by mid-2025. 

Emerging ADC Pipeline. MacroGenics is developing two clinical and one preclinical antibody-drug conjugate $(ADC)$ molecules that each incorporate a novel, glycan-linked topoisomerase I inhibitor (TOP1i)-based payload developed by the Company's collaboration partner, Synaffix (a Lonza company). These three candidates are described below.

   -- MGC026 is a TOP1i-based ADC that targets B7-H3, an antigen with broad 
      expression across multiple solid tumors and a member of the B7 family of 
      molecules involved in immune regulation. MGC026 shares the same variable 
      domain as that of vobra duo. MGC026 is currently being evaluated in a 
      Phase 1 dose escalation study in patients with advanced solid tumors, 
      with dose expansion in selected indications expected to initiate in 2025. 
 
   -- MGC028 is a TOP1i-based ADC that targets ADAM9, a member of the ADAM 
      family of multifunctional type 1 transmembrane proteins that play a role 
      in tumorigenesis and cancer progression and is overexpressed in multiple 
      cancers. The Company previously presented preclinical data showing 
      antitumor activity of MGC028 in in vivo models. Also, in a non-human 
      primate study, MGC028 was well tolerated at high dose levels with mild, 
      reversible side effects and no ocular toxicity, which is often a concern 
      with tubulin-inhibitor-based ADCs. The first patient was recently dosed 
      in a Phase 1 study of MGC028 in patients with advanced solid tumors. 
 
   -- MGC030 is a preclinical TOP1i-based ADC that targets an undisclosed 
      antigen expressed across several solid tumors. There are currently no 
      approved therapeutics to this target. An Investigational New Drug $(IND.AU)$ 
      application to the U.S. Food and Drug Administration (FDA) for MGC030 is 
      planned for 2026. 

Updates on Selected Partnered Programs

   -- MGD024 is a next-generation CD123 × CD3 DART molecule. Under an 
      October 2022 exclusive option and collaboration agreement with Gilead 
      Sciences, Inc. (Gilead), MacroGenics continues to enroll patients in a 
      Phase 1 dose escalation study of MGD024 in patients with CD123-positive 
      neoplasms, including acute myeloid leukemia and myelodysplastic 
      syndromes. Gilead has the option to license MGD024 at predefined decision 
      points during the Phase 1 study. 
 
   -- ZYNYZ(R) (retifanlimab-dlwr) is a monoclonal antibody targeting PD-1 that 
      the Company licensed to Incyte Corporation (Incyte) in 2017. In July 
      2024, Incyte announced positive Phase 3 top-line results for its 
      registrational studies of retifanlimab in squamous cell carcinoma of the 
      anal canal (SCAC) and non-small cell lung cancer (NSCLC) and continues to 
      conduct global studies of retifanlimab across multiple indications. In 
      February 2025, Incyte disclosed that its supplemental Biologics License 
      Application (sBLA) for retifanlimab in advanced/metastatic SCAC was filed 
      with the FDA in December 2024, with approval anticipated in the second 
      half of 2025. To date, MacroGenics has received $365.0 million in upfront 
      and milestone payments from Incyte under the agreement and remains 
      eligible for up to $540.0 million in additional development, regulatory 
      and commercial milestones. 
 
   -- MARGENZA(R) (margetuximab-cmkb) global rights were sold to TerSera 
      Therapeutics LLC (TerSera), a privately-held biopharmaceutical company 
      with a focus on oncology and non-opioid pain management, pursuant to an 
      agreement previously announced. TerSera made a payment of $40.0 million 
      to MacroGenics at closing in November 2024 and MacroGenics may receive 
      additional sales milestone payments of up to an aggregate of $35.0 
      million. MacroGenics subsequently paid an $8.0 million amendment fee to 
      its former commercialization partner during the fourth quarter of 2024. 
      MacroGenics will manufacture MARGENZA drug substance on behalf of TerSera 
      going forward. 

Update on Vobramitamab Duocarmazine

Vobramitamab duocarmazine (vobra duo) is an ADC with a cleavable peptide linker designed to deliver a DNA-alkylating duocarmycin payload to solid tumors that express B7-H3.

   -- Results for the concluded TAMARACK Phase 2 study included, based on a 
      February 21, 2025 data cut-off, mature median radiographic 
      progression-free survival (rPFS) of 9.5 months for the 2.0 mg/kg cohort 
      (95% CI, 8.5-11.2) and 10.0 months for the 2.7 mg/kg cohort (95% CI, 
      7.4-11.4) in patients with mCRPC. Safety data from the study remained 
      consistent with prior data disclosures. 
 
   -- Based on its assessment of the vobra duo safety and efficacy profile and 
      an internal resource and portfolio review, MacroGenics has decided not to 
      pursue further internal development of vobra duo and will instead explore 
      potential alternatives for partnering this program. 

2024 Financial Results

   -- Cash Position: Cash, cash equivalents and marketable securities balance 
      as of December 31, 2024, was $201.7 million, compared to $229.8 million 
      as of December 31, 2023. 
 
   -- Revenue: Total revenue was $150.0 million for the year ended December 31, 
      2024, compared to total revenue of $58.7 million for the year ended 
      December 31, 2023. The increase was primarily due to a net increase of 
      $85.0 million in revenue recognized from milestones achieved under the 
      Incyte License Agreement. 
 
   -- R&D Expenses: Research and development expenses were $177.2 million for 
      the year ended December 31, 2024, compared to $166.6 million for the year 
      ended December 31, 2023. The increase was primarily due to increased 
      research, development, manufacturing and clinical costs related to 
      MGC028, the Company's preclinical ADC pipeline and lorigerlimab, offset 
      by decreased development and clinical trial costs related to the 
      Company's discontinued projects and margetuximab. 
 
   -- SG&A Expenses: Selling, general and administrative expenses were $71.0 
      million for the year ended December 31, 2024, compared to $52.2 million 
      for the year ended December 31, 2023. The increase was due to an 
      amendment fee paid by MacroGenics to its former commercial partner 
      pursuant to the sale of MARGENZA and increased non-cash stock-based 
      compensation and accrued severance expenses related to the separation 
      agreement with the Company's Chief Executive Officer. 
 

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