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BITT Announces FDA Acceptance of IND for
TNFR2 Antibody
2023-08-18
·
BioSpace
免疫疗法
临床申请
临床1期
Phase I trial in patients with relapsed or refractory
Non-Hodgkin’s lymphomas
BOSTON--(BUSINESS WIRE)--
Boston Immune Technologies and Therapeutics, Inc.
(BITT), a clinical stage biotechnology company developing novel
tumor necrosis factor superfamily receptor (TNFSR)
antagonist antibodies, announced today that the
Food and Drug Administration (FDA)
has cleared BITT’s Investigational New Drug application (IND) for a Phase I trial of BITT2101 (anti-
TNFR2
) in patients with
relapsed or refractory Non-Hodgkin’s lymphomas
. “We are excited to have approval to bring our lead antibody into clinical trials,” said Russell LaMontagne, Co-Founder and Chief Executive Officer of BITT. “This is the first antibody from BITT’s TNF Superfamily platform to enter the clinic and the first opportunity to demonstrate the novelty and utility of our proprietary dominant antagonist antibodies.” BITT’s Phase I, first-in-human, multi-center trial will be an open-label study of escalating doses of BITT2101 in
Non-Hodgkin’s lymphoma
subgroups including
cutaneous T cell lymphoma (CTCL)
,
primary cutaneous peripheral T cell lymphoma (PTCL)
,
adult T cell leukemia/lymphoma (ATLL)
,
diffuse large B cell lymphoma (DLBCL)
,
mantle cell lymphoma (MCL)
, and
marginal zone lymphoma (MZL)
. “The elevated levels of soluble
TNFR2
(sTNFR2) in these
lymphoma
subtypes suggest that
TNFR2
may play a significant role in progression and response to first line therapy. As the escalation arm progresses, we are actively exploring validation of sTNFR2 in multiple
cancers
including
solid tumors
for potential expansion arms,” added LaMontagne. About
Boston Immune Technologies and Therapeutics
Boston Immune Technologies and Therapeutics, Inc.
(BITT) is a clinical stage biotechnology company based in Boston, MA. BITT is developing a novel class of antagonist antibodies targeting TNF superfamily receptors for applications in
oncology
,
inflammation
,
autoimmunity
, and
infectious disease
based on the company’s DOMab platform. BITT is initiating clinical trials for
BIR2101
, its lead candidate, which is a monoclonal antibody that targets
tumor necrosis factor receptor 2 (TNFR2)
. BITT is also developing additional antibodies targeting TNF superfamily receptors for indications in
inflammation
,
oncology
and
infectious disease
including a
CD40 antagonist
that recently completed developability studies and is progressing toward an IND filing. Learn more at: .
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机构
Boston Immune Technologies & Therapeutics, Inc.
US Food & Drug Administration
适应症
成人T细胞白血病/淋巴瘤
难治性非霍奇金淋巴瘤
皮肤T细胞淋巴瘤
[+10]
靶点
TNFR
TNFR2
药物
Emunkitug
BITR-2101
anti-CD40 antibody (Jiangsu hengrui)
标准版
¥
16800
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