Updated Data Demonstrating Favorable Safety Profile and
Encouraging Monotherapy Activity in BPDCN Presented During Oral
Session
Preclinical Combination Data in Relapsed/Refractory AML Support
Further Evaluation of Triplet; Trial in Progress Poster for Phase
1b/2 Study Presented
Conference Call to be Held on Monday, December 7 at 8:00 a.m.
ET
ImmunoGen Inc. (Nasdaq: IMGN), a leader in the expanding field
of antibody-drug conjugates (ADCs) for the treatment of cancer,
today announced that new safety and efficacy findings from the
expansion phase of the Phase 1/2 study of IMGN632 in patients with
relapsed/refractory blastic plasmacytoid dendritic cell neoplasm
(BPDCN) were presented during an oral session at the 62nd American
Society of Hematology (ASH) Annual Meeting.
“Comprising the largest prospective study with a single agent in
patients with relapsed/refractory BPDCN, the results presented at
ASH build on the previous data reported for IMGN632 and reinforce
the potential of this CD123-targeting ADC as a best-in-class
treatment option for BPDCN,” said Anna Berkenblit, MD, Senior Vice
President and Chief Medical Officer of ImmunoGen. “Given IMGN632’s
favorable safety profile, demonstrated anti-tumor activity, and
ease of administration via short infusion in an outpatient setting,
we continue to enroll both frontline and relapsed/refractory BPDCN
patients in this trial. In addition, the preclinical data presented
by our partners at MD Anderson Cancer Center in relapsed/refractory
AML further support the combination of IMGN632 with azacitidine and
venetoclax, which we are actively enrolling in a Phase 1b/2
clinical trial.”
“BPDCN is a rare, aggressive hematologic malignancy that is
characterized by historically low overall survival rates,” said
Naveen Pemmaraju, MD, Associate Professor in the Department of
Leukemia at MD Anderson Cancer Center. “Despite currently available
therapies, outcomes for relapsed/refractory patients remain poor
and there is an urgent need to develop better-tolerated treatment
options in the frontline setting. These updated safety and efficacy
findings for IMGN632 in patients with relapsed/refractory BPDCN are
encouraging, and I look forward to advancing IMGN632 into pivotal
development.”
IMGN632 MONOTHERAPY DATA IN BPDCN
Title: “Clinical Profile of IMGN632, a Novel CD123-Targeting
Antibody-Drug Conjugate, in Patients with Relapsed/Refractory
Blastic Plasmacytoid Dendritic Cell Neoplasm” (Abstract #167)
Oral Presentation Session: 616 Date: Saturday, December 5, 2020
Time: 12:30pm PT/3:30pm ET Updated key findings include:
Safety
- IMGN632 demonstrated a favorable safety profile in 29 patients
who received 0.045 mg/kg once every 3 weeks via a short (under 30
minutes) intravenous infusion, with limited grade ≥3
treatment-related adverse events (AEs) and no treatment-related
deaths.
- The most common grade ≥3 AEs were febrile neutropenia,
hyperglycemia, and thrombocytopenia (10% each).
- Grade ≥3 liver function test elevations were seen in one
patient (3%).
- No capillary leak syndrome was reported.
Efficacy
- In all relapsed/refractory BPDCN patients, the overall response
rate (ORR) was 29% (8/28) with a composite complete remission (CCR)
rate of 18% (5/28).
- In patients with prior SL-401 exposure (tagraxofusp-erzs), the
ORR was 31% (4/13) with a CCR of 15% (2/13).
- Among patients with bone marrow response assessment, 60% (9/15)
achieved a bone marrow complete response (blasts <5%).
- Durable responses were seen in multiple patients, up to 9.2
months without hematopoietic stem cell transplant.
- Two patients have been successfully bridged to hematopoietic
stem cell transplant.
TRIAL IN PROGRESS POSTER
Title: “A Phase 1b/2 Study of IMGN632, a CD123-Targeting
Antibody-Drug Conjugate, As Monotherapy or in Combination with
Venetoclax and/or Azacitidine for Patients with CD123-Positive
Acute Myeloid Leukemia” (Abstract 1047) Poster Session: 616 Date:
Saturday, December 5, 2020 Time: 7:00am – 3:30pm PT/10:00am –
6:30pm ET
PRECLINICAL POSTER
In addition, our partners at MD Anderson Cancer Center will
present preclinical data from their study combining IMGN632,
venetoclax, and azacitidine in in vitro and in vivo AML models.
Title: “Combining IMGN632, a Novel CD123-Targeting Antibody Drug
Conjugate with Azacitidine and Venetoclax Facilitates Apoptosis in
Vitro and Prolongs Survival In Vivo in AML Models” (Abstract 2886)
Poster Session: 617 Date: Monday, December 7, 2020 Time: 7:00am –
3:30pm PT/10:00am – 6:30pm ET
Additional information can be found at www.hematology.org,
including abstracts.
CONFERENCE CALL INFORMATION
ImmunoGen will hold a conference call on Monday, December 7 at
8:00 a.m. ET to discuss the data presented at ASH, the pathway to
FDA approval in BPDCN, and an AML program progress update; Dr.
Naveen Pemmaraju, Associate Professor in the Department of Leukemia
at MD Anderson Cancer Center, will join the call to review the
BPDCN data presented at ASH. To access the live call by phone, dial
(877) 621-5803; the conference ID is 1795760. The call, along with
associated slides, may also be accessed through the Investors and
Media section of immunogen.com. Following the call, a replay will
be available at the same location.
ABOUT IMGN632
IMGN632 is a CD123-targeting ADC in clinical development for
hematological malignancies, including blastic plasmacytoid
dendritic cell neoplasm (BPDCN), acute myeloid leukemia (AML), and
acute lymphocytic leukemia (ALL). IMGN632 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
Vidaza® (azacitidine) and Venclexta® (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
tumor cells, while demonstrating less toxicity to normal marrow
progenitors than other DNA-targeting payloads. FDA has granted
IMGN632 Breakthrough Therapy Designation in relapsed/refractory
BPDCN.
ABOUT BLASTIC PLASMACYTOID DENDRITIC CELL NEOPLASM
(BPDCN)
BPDCN is a rare form of blood cancer that has features of both
leukemia and lymphoma, with characteristic skin lesions, lymph node
involvement, and frequent spread to the bone marrow. This
aggressive cancer requires intense treatment often followed by stem
cell transplant. Despite the approval of a CD123-targeting therapy,
the unmet need remains high for patients, both in the frontline and
in the relapsed/refractory setting.
ABOUT ACUTE MYELOID LEUKEMIA (AML)
AML is a cancer of the bone marrow cells that produce white
blood cells. It causes the marrow to increasingly generate
abnormal, immature white blood cells (blasts) that do not mature
into effective infection-fighting cells. The blasts quickly fill
the bone marrow, impacting the production of normal platelets and
red blood cells. The resulting deficiencies in normal blood cells
leave the patient vulnerable to infections, bleeding problems, and
anemia. It is estimated that, in the U.S. alone, 21,380 patients
will be diagnosed with AML this year and 10,590 patients will die
from the disease.
ABOUT CD123
CD123, the interleukin-3 alpha chain, is expressed on multiple
myeloid and lymphoid cancers including AML, BPDCN, ALL, chronic
myeloid leukemia, and myeloproliferative neoplasms. With limited
expression on normal hematopoietic cells, rapid internalization,
and expression on AML leukemia stem cells, CD123 is a validated
therapeutic target, with the approval of a CD123-targeting therapy
for BPDCN.
ABOUT IMMUNOGEN
ImmunoGen is developing the next generation of antibody-drug
conjugates (ADCs) to improve outcomes for cancer patients. By
generating targeted therapies with enhanced anti-tumor activity and
favorable tolerability profiles, we aim to disrupt the progression
of cancer and offer our patients more good days. We call this our
commitment to “target a better now.”
Learn more about who we are, what we do, and how we do it at
www.immunogen.com.
Vidaza® and Venclexta® are registered trademarks of their
respective owners.
This press release includes forward-looking statements based on
management's current expectations. These statements include, but
are not limited to, ImmunoGen’s expectations related to: the
occurrence, timing, and outcome of potential pre-clinical,
clinical, and regulatory events related to ImmunoGen’s product
candidates; and the presentation of pre-clinical and clinical data
on ImmunoGen’s product candidates. For these statements, ImmunoGen
claims the protection of the safe harbor for forward-looking
statements provided by the Private Securities Litigation Reform Act
of 1995. Various factors could cause ImmunoGen’s actual results to
differ materially from those discussed or implied in the
forward-looking statements, and you are cautioned not to place
undue reliance on these forward-looking statements, which are
current only as of the date of this release. Factors that could
cause future results to differ materially from such expectations
include, but are not limited to: the timing and outcome of
ImmunoGen’s pre-clinical and clinical development processes; the
difficulties inherent in the development of novel pharmaceuticals,
including uncertainties as to the timing, expense, and results of
pre-clinical studies, clinical trials, and regulatory processes;
ImmunoGen’s ability to financially support its product programs;
risks and uncertainties associated with the scale and duration of
the COVID-19 pandemic and resulting impact on ImmunoGen’s industry
and business; and other factors more fully described in ImmunoGen’s
Annual Report on Form 10-K for the year ended December 31, 2019 and
other reports filed with the Securities and Exchange
Commission.
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version on businesswire.com: https://www.businesswire.com/news/home/20201205005014/en/
INVESTOR RELATIONS AND MEDIA ImmunoGen Courtney O’Konek
781-895-0600 courtney.okonek@immunogen.com OR FTI Consulting
Robert Stanislaro 212-850-5657
robert.stanislaro@fticonsulting.com
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