FM November2020 Digital P

Therapy designation for
IMGN632 for the treatment
of patients with relapsed or
refractory blastic plasmacytoid
dendritic cell neoplasm
(BPDCN).
IMGN632 is a CD123-
targeting ADC in clinical
development for hematological
malignancies, including
BPDCN, acute myeloid
leukaemia (AML), and acute
lymphocytic leukaemia (ALL).
The drug is currently being
evaluated in multiple cohorts,
including monotherapy for
patients with BPDCN and
minimal residual disease
positive (MRD+) AML following
frontline induction therapy
and in combinations with
azacitidine and venetoclax
for patients with relapsed/
refractory AML.
IMGN632 uses one of
ImmunoGen’s novel indolinobenzodiazepine
(IGN)
payloads, which alkylate
DNA without crosslinking.
IGNs have been designed to
have high potency against
AML blasts while
demonstrating less toxicity to
normal marrow progenitors
than other DNA-targeting
payloads.
BPDCN is a rare form of
blood cancer that has features
of both leukaemia and
lymphoma, with characteristic
skin lesions, lymph node
involvement, and frequent
spread to the bone marrow.
ODD to CAR-T
cells therapy for
gastric cancers
CARsgen Therapeutics
Co Ltd said that the US
FDA has granted orphan
drug designation to one of
CARsgen’s first-in-class drug
candidates, CT041, for the
treatment of gastric and
gastroesophageal junction
adenocarcinoma.
CT041 is a humanised
anti-claudin18.2 autologous
chimeric antigen receptor
(CAR) T-cell product and is
targeted to treat patients with
claudin18.2-positive tumours.
CT041 is the first
claudin18.2-targeted CAR
T-cell therapy that has
received Investigational New
Drug (IND) clearance by
the US FDA and the first to
receive IND clearance by the
National Medical Products
Administration (NMPA) in
China.
The initiation of an openlabel,
multicentre, phase 1b
clinical trial (NCT04404595)
to evaluate the safety and
efficacy of autologous
Dapagliflozin receives
breakthrough therapy
designation for CKD
AstraZeneca’s
dapagliflozin (Farxiga)
has been granted
Breakthrough Therapy
Designation (BTD) in
the US for patients with
chronic kidney disease
(CKD), with and without
type-2 diabetes (T2D).
The FDA granted
BTD based on clinical
evidence from the DAPA-
CKD trial. The detailed
results presented in
August demonstrated
that dapagliflozin on
top of standard of care
reduced the composite
measure of worsening of
renal function or risk of
cardiovascular (CV) or renal
death by 39% compared
to placebo (absolute risk
reduction [ARR] = 5.3%,
p