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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