Both IMGN779 and IMGN632 use ImmunoGen's novel indolino-benzodiazepine payloads called IGNs, which alkylate DNA without crosslinking. IMGN779 is a CD33-targeted ADC for the treatment of acute myeloid leukemia (AML) currently in Phase 1 testing. IMGN632 is a CD123-targeted ADC for hematological malignancies, including AML and blastic plasmacytoid dendritic cell neoplasm (BPDCN). Last month, the Company announced that the Investigational New Drug application for IMGN632 is active and it expects to open a Phase 1 trial later this year.
"The clinical and preclinical data being presented at ASH demonstrate
the early potential of our novel IGN portfolio," said
In a poster presentation, the Company will report updated data evaluating the safety and anti-leukemia activity from the dose escalation phase of the IMGN779 first-in-human trial. In a separate presentation, preclinical data evaluating the mechanism, anti-leukemia efficacy, and tolerability of repeated dosing of IMGN779 and cytarabine in combination using in vitro and in vivo human AML preclinical models will be reported. Lastly, preclinical data reporting the prevalence of CD123 expression in acute lymphoblastic leukemia (ALL), and assessing the anti-leukemia activity of IMGN632 on ALL cells will be presented in a poster presentation.
Title (Abstract #1357): "IMGN779, a Next Generation
CD33-Targeting ADC, Combines Effectively With Cytarabine in Acute
Myeloid Leukemia (AML) Preclinical Models, Resulting in Increased DNA
Damage Response, Cell Cycle Arrest and Apoptosis In Vitro, and
Prolonged Survival In Vivo"
Poster session #616:
Saturday, December 9, 5:30 - 7:30 PM PST.
- Poster session #616:
Title (Abstract #1312): "IMGN779, a Next-Generation
CD33-Targeting Antibody-Drug Conjugate (ADC) Demonstrates Initial
Antileukemia Activity in Patients with Relapsed or Refractory Acute
Poster session #613:
Saturday, December 9, 5:30 - 7:30 PM PST.
- Poster session #613:
Title (Abstract #2718): "CD123 Expression Patterns and
Potential of IMGN632, a CD123-Targeted Antibody Drug Conjugate, in
Acute Lymphoblastic Leukemia"
Poster session #618:
Sunday, December 10, 6:00 - 8:00 PM PST.
- Poster session #618:
Additional information can be found at www.hematology.org, including abstracts.
IMGN779 is a novel ADC that combines a high-affinity, humanized anti-CD33 antibody, a cleavable disulfide linker, and one of ImmunoGen's novel indolino-benzodiazepine payloads, called IGNs, which alkylate DNA without crosslinking, resulting in potent preclinical anti-leukemia activity with relative sparing of normal hematopoietic progenitor cells.1,2 IMGN779 is in Phase 1 clinical testing for the treatment of AML.
IMGN632 is a humanized anti-CD123 antibody-drug conjugate that is a potential treatment for AML, BPDCN, myelodysplastic syndrome, B-cell acute lymphocytic leukemia, and other CD123-positive malignancies. IMGN632 uses a novel IGN payload, linker and antibody technology and in AML xenograft models has demonstrated a large therapeutic index.3
Indolino-benzodiazepine cancer-killing agents, or IGNs, are a new class of cancer-killing agent developed by ImmunoGen for use in ADCs. These ultra-potent, DNA-acting IGNs alkylate DNA without crosslinking, which preclinically has resulted in potent anti-leukemia activity with relative sparing of normal hematopoietic progenitor cells.4,5 IMGN779, a CD33-targeting ADC in Phase 1 testing for AML, was the first IGN ADC to enter clinical testing.
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
ImmunoGen is a clinical-stage biotechnology company that develops targeted cancer therapeutics using its proprietary ADC technology. The Company's lead product candidate, mirvetuximab soravtansine, is in a Phase 3 trial for FRα-positive platinum-resistant ovarian cancer, and is in a Phase 1b/2 trial in combination regimens for earlier-stage disease. ImmunoGen has three additional clinical-stage product candidates, two of which are being developed in collaboration with Jazz Pharmaceuticals. ImmunoGen's ADC technology is also used in Roche's marketed product, Kadcyla®, and in programs in development by Amgen, Bayer, Biotest, CytomX,
Kadcyla® is a registered trademark of
2 Y. Kotvun et al. (2016) Blood 128:768.
3 S. Adams et al, Abstract 2832, Presented at the American Society of Hematology, December 3-6, 2016.
5 Y. Kotvun, 2016.
This press release includes forward-looking statements. 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. It should be noted that there are risks and
uncertainties related to the development of novel anticancer products,
including IMGN779 and IMGN632, including risks related to preclinical
and clinical studies, their timings and results. A review of these risks
can be found in ImmunoGen's Transition Report on Form 10-KT for the
six-month transition period ended
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