A company developing a bispecific antibody that already has clinical
data in blood cancers has raised more than $60 million in its latest
venture capital funding round that it plans to use to advance the drug
in solid tumors.
South San Francisco, California-based Amphivena Therapeutics said
Tuesday that it had raised $62 million in a Series C round, which
NanoDimension and Qiming Venture Partners co-led. New investors included
Clough Capital, Aju IB, Korys Merieux, Kaitai Capital, Industrial
Investors and Nawton Limited, along with insider investors MPM Capital
and funds managed by Tekla Capital Management and Franklin Berger.
The company is developing a
bispecific T-cell engager antibody called AMV564, which targets CD33 and
CD3. Such antibodies are immunotherapies designed to work by targeting
both cancer cell-surface proteins and proteins expressed on the surfaces
of T cells, enabling the latter to kill the former. The company has
been developing the drug for acute myeloid leukemia and myelodysplastic
syndromes, and it is currently in a Phase I study among relapsed or
refractory AML.
The drug is designed to eliminate myeloid-derived
suppressor cells, or MDSCs, while sparing normal neutrophils and
monocytes. In addition to MDS and AML, the drug is in a Phase I study
for solid tumors that the company said is open for enrollment, though
searches for the name of the company of the drug on ClinicalTrials.gov
only turned up the MDS and AML trials.
Updated data from the AML study presented
at the European Hematology Association’s 2019 annual meeting in July
from 33 patients across nine dose cohorts showed a complete response, a
complete response with incomplete hematological recovery and a partial
response. Grade 1 and 2 cytokine release syndrome – a side effect
sometimes observed with bispecific antibodies – also occurred.
Amgen’s Blincyto
(blinatumomab) is a bispecific T-cell engager currently on the market.
The drug targets the CD19 antigen in acute lymphoblastic leukemia. Amgen
is developing another bispecific antibody, AMG 420, that targets the
BCMA antigen in multiple myeloma and produced a 70 percent overall
response rate among patients who received the drug at 400 micrograms,
the dose recommended for further study. Another bispecific antibody on
the market is Roche’s Hemlibra (emicizumab-kxwh), used to treat hemophilia A.
In late June, the Food and Drug Administration issued
a draft guidance for companies developing bispecific antibodies, in
oncology as well as other disease areas. However, an expert said the
guidance was flawed because it did not distinguish between Blincyto and
Hemlibra’s very different mechanisms of action, despite both products
falling under the category of “bispecific.”
Source. Medcity News, September, 24, 2019, Alaric Dearment
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