- FDA granted Breakthrough Therapy Designation for felzartamab
in PMN upon positive clinical data from M-PLACE, a Phase 2 study
led by I-Mab partner HI-Bio
- I-Mab has full development and commercialization rights of
felzartamab in Greater China for
all indications, with Phase 3 multiple myeloma data expected in
2024, followed by a planned BLA submission
ROCKVILLE, Md. and SHANGHAI, Nov. 2, 2023
/PRNewswire/ -- I-Mab (Nasdaq: IMAB) (the "Company"), a global
biotechnology company focused on bringing highly differentiated
medicines to patients around the world through the discovery,
development, and commercialization of novel immunotherapies and
biologics, and HI-Bio, a clinical-stage biotechnology company
developing targeted therapies for patients with severe
immune-mediated diseases (IMDs), today announced that the U.S. Food
and Drug Administration (FDA) has granted Breakthrough Therapy
Designation (BTD) for felzartamab, an investigational CD38
antibody, for the treatment of primary membranous nephropathy
(PMN).
"The FDA's decision to grant felzartamab Breakthrough Therapy
designation is recognition of the promising data we have collected
to date, as well as an acknowledgement of the need for major
advances over available therapies in the treatment of patients with
PMN," said Dr. Uptal Patel, Chief
Medical Officer of HI-Bio. "We believe that the cellular depletion
strategy with felzartamab in PMN is applicable to many more
immune-mediated diseases driven by antibodies produced in CD38+
plasma cells. For that reason, we are currently developing
felzartamab in multiple diseases including PMN, IgA nephropathy,
antibody-mediated rejection and lupus nephritis."
The FDA selectively grants Breakthrough Therapy Designation to
expedite the development and review of drugs that are intended to
treat a serious or life-threatening condition, and preliminary
clinical evidence indicates the drug may demonstrate substantial
improvement over available therapy on a clinically significant
endpoint(s).
The designation for felzartamab was based on clinical data
submitted to the FDA, including results from M-PLACE, a Phase
1b/2a proof-of-concept, open-label
study. The final analysis of the M-PLACE study has been accepted as
an oral presentation at the American Society of Nephrology (ASN)
Kidney Week 2023 Annual Meeting (Abstract TH-OR27), taking place
November 1–5, 2023, by Brad Rovin,
M.D., Director of the Division of Nephrology at Ohio State University.
I-Mab has the full rights to develop and commercialize
felzartamab for all indications in Greater China which encompasses Mainland
China, Hong Kong, Macau, and Taiwan. I-Mab is evaluating felzartamab in
oncology and autoimmune diseases. I-Mab is currently
conducting a Phase 3 registrational study of felzartamab in
combination with lenalidomide and dexamethasone as a second-line
treatment for multiple myeloma (MM) in China with progression-free survival (PFS) as
the primary endpoint, with a projected read-out in 2024, followed
by a planned BLA submission.
"We are excited about the potential therapeutic benefit of
felzartamab through this Breakthrough Therapy Designation by the
FDA, following the Orphan Drug Designation received in May," said
Dr. Andrew Zhu, President of I-Mab.
"This designation represents an important milestone for I-Mab, our
partner HI-Bio, and the PMN community as we continue to evaluate
felzartamab as an innovative immunotherapy for multiple
indications, including cancers and autoimmune diseases."
About Primary Membranous Nephropathy (PMN)
PMN is a rare autoantibody-mediated autoimmune kidney disease
and a leading cause of nephrotic syndrome (NS) in adults worldwide.
Disease onset and diagnosis typically occurs between 40 and 50
years of age, with 80% of patients presenting with nephrotic
syndrome (i.e., edema, >3.5 g/day proteinuria, hypoalbuminemia).
PMN is characterized by a thickening of the glomerular basement
membrane (GBM) due to the formation and deposition of immune
complexes in this space between podocytes and the glomerular
endothelium of the kidney.
Approximately 80% of PMN cases arise due to autoantibodies that
recognize the phospholipase A2 receptor (PLA2R) antigen expressed
on podocytes. Anti-PLA2R is both a diagnostic and prognostic
biomarker, and total aPLA2R antibody level has been shown to be a
biomarker for prognosis of outcome in patients with PMN. Other
autoantibodies have been identified in patients with PMN including
anti-THSD7A, NELL-1 and Sema3B, further supporting the role of
antibody-secreting plasma cells in the pathophysiology of PMN.
CD38+ long-lived plasma cells and plasmablasts are a main source of
autoantibodies.
There are no approved therapies for PMN. The current standard of
care comprises off-label use of supportive care measures (e.g.,
angiotensin-converting enzyme inhibitors or angiotensin receptor
blockers, statins, and diuretics), conventional immunosuppressive
treatments (ISTs) (e.g. cyclophosphamide combined with steroids and
calcineurin inhibitors) or B-cell depleting agents (e.g. anti-CD20
antibodies). However, these treatments are not effective in all
patients, with a significant proportion of patients not achieving
remission or relapsing. In addition, conventional immunosuppressive
treatments are associated with a high risk of toxicity.
About Felzartamab
Felzartamab is an investigational therapeutic human monoclonal
antibody directed against CD38, a protein expressed on mature
plasma cells. The antibody is directed against CD38 on the surface
of multiple myeloma cells, which has been characterized as one of
the most strongly and uniformly expressed antigens on the surface
of malignant plasma cells. According to its suggested mode of
action, the antibody recruits cells of the body's immune system to
kill the tumor through antibody-dependent cellular cytotoxicity
(ADCC) and antibody-dependent cellular phagocytosis (ADCP). The
antibody does not involve complement dependent cytotoxicity, or
CDC, an additional immune mechanism involved in tumor cell killing.
Scientific research suggests that an anti-CD38 antibody may have
therapeutic potential also in other cancers as well as autoimmune
diseases. Based on a licensing agreement between MorphoSys and
I-Mab signed in November 2017, I-Mab
owns the exclusive rights for development and commercialization of
felzartamab for all indications in Greater China, which encompasses Mainland
China, Hong Kong, Macao, and Taiwan. HI-Bio in-licensed felzartamab from
MorphoSys in June 2022, and holds
exclusive worldwide rights for felzartamab with the exception of
Greater China.
About I-Mab
I-Mab (Nasdaq: IMAB) is a global biotechnology
company focused on bringing highly differentiated medicines to
patients around the world through the discovery, development, and
commercialization of novel immunotherapies and
biologics. I-Mab's innovative pipeline is driven by
internal R&D's Fast-to-Proof-of-Concept, Fast-to-Market
development strategies, and through global partnerships. For
more information, please
visit https://www.i-mabbiopharma.com and follow us
on LinkedIn, Twitter, and WeChat.
I-Mab Forward Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
and other federal securities laws, including statements regarding
data from clinical studies of felzartamab, the potential
implications of clinical data for patients, and I-Mab's advancement
of, and anticipated clinical development, regulatory milestones,
and commercialization of felzartmab. Actual results may differ
materially from those indicated in the forward-looking statements
as a result of various important factors, including but not limited
to I-Mab's ability to demonstrate the safety and efficacy of its
drug candidates; the clinical results for its drug candidates,
which may not support further development or NDA/BLA approval; the
content and timing of decisions made by the relevant regulatory
authorities regarding regulatory approval of I-Mab's drug
candidates; I-Mab's ability to achieve commercial success for its
drug candidates, if approved; I-Mab's ability to obtain and
maintain protection of intellectual property for its technology and
drugs; I-Mab's reliance on third parties to conduct drug
development, manufacturing and other services; I-Mab's limited
operating history and I-Mab's ability to obtain additional funding
for operations and to complete the development and
commercialization of its drug candidates; and the impact of the
COVID-19 pandemic on the Company's clinical development, commercial
and other operations, as well as those risks more fully discussed
in the "Risk Factors" section in I-Mab's most recent annual report
on Form 20-F, as well as discussions of potential risks,
uncertainties, and other important factors in I-Mab's subsequent
filings with the US Securities and Exchange Commission. All
forward-looking statements are based on information currently
available to I-Mab, and I-Mab undertakes no obligation to publicly
update or revise any forward-looking statements, whether as a
result of new information, future events or otherwise, except as
may be required by law.
I-Mab Contacts
Investors
|
Media
|
Tyler Ehler
|
Gigi Feng
|
Senior Director,
Investor Relations
|
Chief Communications
Officer
|
IR@i-mabbiopharma.com
|
PR@i-mabbiopharma.com
|
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