ImmunoGen & Merck Establish Collaboration for Clinical Evaluation of Mirvetuximab Soravtansine in Combination with Keytruda®...
05 February 2016 - 12:00AM
Business Wire
− ImmunoGen’s mirvetuximab soravtansine folate
receptor alpha (FRα)-targeting antibody-drug conjugate (ADC) to be
assessed in combination with Merck’s anti-PD-1 therapy −
ImmunoGen, Inc. (Nasdaq: IMGN), a biotechnology company that
develops novel anticancer therapeutics using its ADC technology,
and Merck, known as MSD outside the United States and Canada,
announced today that they have entered into a clinical research
collaboration for the assessment of ImmunoGen’s mirvetuximab
soravtansine in combination with Merck’s anti-PD-1 therapy,
Keytruda® (pembrolizumab), for the treatment of patients with
FRα-positive ovarian cancer.
Mirvetuximab soravtansine is an experimental ADC for
FRα-positive cancers that has shown notable activity for
FRα-positive ovarian cancer in early clinical testing. Mirvetuximab
soravtansine contains a monoclonal antibody that enables it to bind
to FRα-positive tumor cells with ImmunoGen’s DM4, a maytansinoid
cancer-killing agent, attached to kill these cells. In preclinical
research conducted by ImmunoGen and academics, ADCs with
maytansinoids have been found to enhance the maturation and
activation of the dendritic cells of the immune system that
stimulate antitumor responses.1,2 Keytruda is a humanized
monoclonal antibody that works by increasing the ability of the
body’s immune system to help detect and fight tumor cells. Keytruda
blocks the interaction between PD-1 and its ligands, PD-L1 and
PD-L2, thereby activating T-lymphocytes, which may affect both
tumor cells and healthy cells.
“We look forward to evaluating our mirvetuximab soravtansine ADC
in combination with Merck’s anti-PD-1 therapy, Keytruda,” said
Daniel Junius, ImmunoGen President and Chief Executive Officer. “In
early clinical testing, mirvetuximab soravtansine has demonstrated
notable activity as a single agent for FRα-positive ovarian cancer,
and we are aggressively advancing it for this use. At the same
time, we believe mirvetuximab soravtansine should be evaluated in
different combination regimens to potentially provide the greatest
benefit to the most patients. Keytruda has a different mechanism of
action than the other agents being assessed.”
“Fully realizing the potential for Keytruda to help patients
with cancer requires strategic collaborations, such as this
agreement with ImmunoGen, that explore how complementary approaches
might result in improved outcomes for patients,” said Dr. Eric
Rubin, vice president and therapeutic area head, oncology
early-stage development, Merck Research Laboratories. “We look
forward to evaluating the data from this combined approach in
patients with FRα-positive ovarian cancer.”
ImmunoGen is conducting a Phase 1b/2 clinical trial, FORWARD II,
that evaluates mirvetuximab soravtansine for FRα-positive ovarian
cancer used in doublet combination with other anticancer agents.
The assessment of mirvetuximab soravtansine with Keytruda will be
added to this trial, with Merck supplying the Keytruda. ImmunoGen
expects this cohort to open for patient enrollment in the second
half of 2016.
The agreement is between ImmunoGen and Merck, through a
subsidiary. The agreement includes a provision for potential
expansion of the collaboration to include a subsequent Phase 3
clinical trial. Additional details were not disclosed.
About Mirvetuximab Soravtansine
ImmunoGen developed mirvetuximab soravtansine as a potential
treatment for ovarian cancer and other FRα-positive solid tumors.
In early clinical testing, mirvetuximab soravtansine demonstrated
notable activity when used as a single agent to treat
platinum-resistant FRα-positive ovarian cancer.3 ImmunoGen is
assessing the ADC used as a single agent for pretreated
FRα-positive ovarian cancer in its Phase 2 trial, FORWARD I, which
is intended to support an Accelerated Approval pathway.
Mirvetuximab soravtansine is also now being assessed in separate
combinations with pegylated liposomal doxorubicin (Doxil®),
bevacizumab (Avastin®), and carboplatin in the Phase 1b/2 trial,
FORWARD II.
About Ovarian Cancer
Each year there are approximately 240,000 new cases of ovarian
cancer diagnosed and 140,000 deaths from the disease on a global
basis.4 Among all gynecologic cancers, ovarian cancer accounts for
the most deaths on an annual basis.
About ImmunoGen, Inc.
ImmunoGen is a clinical-stage biotechnology company that
develops targeted anticancer therapeutics using its proprietary ADC
technology. The Company's lead product candidate, mirvetuximab
soravtansine, is a potential treatment for folate receptor
α-positive ovarian cancer and other solid tumors. A number of major
healthcare companies have licensed limited rights to use
ImmunoGen's ADC technology to develop anticancer therapies; it is
used in Roche's marketed product, Kadcyla®. More information about
the Company can be found at www.immunogen.com.
1ImmunoGen internal research2Martin, Müller, et. al, Cancer
Immunol Immunother (2014) 63:925-9383ASCO 2015, abstract 5518 and
AACR-NCI-EORTC 2015, abstract C474WHO GLOBOCAN 2012
Doxil®, Avastin®, Kadcyla®, and Keytruda® are registered
trademarks of their respective owners.
ImmunoGen Forward-Looking Statement
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 mirvetuximab soravtansine,
including risks related to clinical studies and regulatory
processes, their timings and results. A review of these risks can
be found in ImmunoGen's Annual Report on Form 10-K for the fiscal
year ended June 30, 2015 and other reports filed with the
Securities and Exchange Commission.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20160204005187/en/
For Investors:ImmunoGen, Inc.Carol Hausner,
781-895-0600info@immunogen.comorFor Media:Michael Lampe,
484-575-5040michael@michaellampeconsulting.com
ImmunoGen (NASDAQ:IMGN)
Historical Stock Chart
From Apr 2024 to May 2024
ImmunoGen (NASDAQ:IMGN)
Historical Stock Chart
From May 2023 to May 2024