ImmunoGen Announces Recent Product Program Advancements & Anticipated 2016 Events in Advance of J.P. Morgan Healthcare Confer...
January 10 2016 - 3:00PM
Business Wire
ImmunoGen, Inc. (Nasdaq: IMGN), a biotechnology company that
develops targeted anticancer therapeutics using its antibody-drug
conjugate (ADC) technology, today announced recent product program
advancements and anticipated 2016 events in advance of the
34th Annual J.P. Morgan Healthcare Conference.
“ImmunoGen made significant progress in 2015 that is anticipated
to lead to a number of meaningful events in 2016 and beyond,"
commented Daniel Junius, President and CEO. “For mirvetuximab
soravtansine, our lead program, these include completing patient
enrollment in three disease-specific cohorts that can provide
informative data in 2016. They also include putting in place the
FORWARD I trial intended to support an Accelerated Approval pathway
as well as the FORWARD II combination trial. Additionally, we put
in place a trial to assess our IMGN529 in combination with
rituximab, established a development strategy for coltuximab
ravtansine, and submitted an IND for IMGN779, the first ADC to
utilize one of our new DNA-acting cancer-killing agents.”
Mr. Junius continued, “Our partners, too, made important
progress, with Roche reporting global growth in Kadcyla®sales,
encouraging initial clinical findings reported with Bayer’s
anetumab ravtansine, Novartis, Lilly, Sanofi, and Amgen all
advancing ADCs with ImmunoGen technology into the clinic, and a new
collaboration established with Takeda. We expect several key
partner events in 2016, including the advancement of two programs
into trials designed to support product registration.”
Mirvetuximab soravtansine – the first folate receptor α
(FRα)-targeting ADC.
2015 accomplishments include:
- Presentation of the first clinical data
from assessment in a disease-specific patient population that
demonstrated the potential of mirvetuximab soravtansine, used
alone, to make a meaningful difference for patients with heavily
pretreated FRα-positive ovarian cancer.
- Activity was most notable among
patients with high or medium amounts of FRα on their cancer cells,
the majority of the patients.
- Completion of patient enrollment in
three disease-specific Phase I cohorts (enrollment target):
- Patients with platinum-resistant
FRα-positive ovarian cancer (40 patients);
- Patients with platinum-resistant
FRα-positive ovarian cancer consenting to the required biopsies (20
patients); and
- Patients with relapsed/refractory
FRα-positive endometrial cancer (20 patients).
- Establishment of a development strategy
that includes:
- Assessment as single-agent therapy for
patients with FRα-positive ovarian cancer treated with 3-4 prior
regimens. This Phase 2 trial, FORWARD I, is intended to support an
Accelerated Approval pathway.In December, ImmunoGen and the GOG
Foundation, Inc. entered into a partnership designed to help
patients with ovarian cancer learn about FORWARD I and, if
appropriate, enroll in the study. Patient dosing in trial is poised
to start.
- Assessment for FRα-positive ovarian
cancer in three doublet combinations – with either pegylated
liposomal doxorubicin (Doxil®), bevacizumab (Avastin®), or
carboplatin; additional cohorts are possible. ImmunoGen is
conducting this Phase 1b/2 trial, FORWARD II, to
potentially expand the number of patients able to benefit from
mirvetuximab soravtansine. Patient dosing is underway.
- Preclinical evaluation of additional
types of cancers for potential clinical assessment.
Events anticipated in 2016
include:
- Meeting with regulators in 1H2016 on
the mirvetuximab soravtansine development program, including the
design of the second stage of the FORWARD I trial.
- Presentation of clinical data from the
40-patient ovarian cancer cohort at a medical meeting in
2Q2016.
- Presentation of clinical data from
additional expansion cohorts.
- Advancing FORWARD I and FORWARD II.
ImmunoGen plans to ultimately have more than 50 centers open in the
US, Canada, and Western Europe for FORWARD I patient
enrollment.
IMGN529 – CD37-targeting ADC for diffuse-large B-cell
lymphoma (DLBCL) and potentially other non-Hodgkin lymphoma (NHL)
subtypes.
2015 accomplishments include:
- Completion of dosing-finding Phase 1
evaluation of IMGN529 used as monotherapy. IMGN529 demonstrated
encouraging single-agent activity in patients with heavily
pretreated NHL, particularly ones with DLBCL.
- Establishment of strategy to evaluate
IMGN529 in combination with rituximab (Rituxan®) in a Phase 2 trial
based on distinctive synergy seen in preclinical models.
- Design and start of implementation of
this Phase 2 trial, with patient dosing expected to start
shortly.
Anticipated in 2016:
- Advancing Phase 2 combination
trial.
- Potentially other program updates.
Coltuximab ravtansine – CD19-targeting ADC for DLBCL and
potentially other NHL subtypes.
2015 accomplishments include:
- Regaining coltuximab ravtansine rights
from Sanofi.
- Establishment of strategy to advance in
a combination regimen.
- Preclinical evaluation of alternatives
for selection of regimen to be assessed clinically.
Events anticipated in 2016
include:
- Disclosure of combination regimen to be
assessed in 1H2016.
- Initiation of Phase 2 combination study
midyear.
IMGN779 – Novel CD33-targeting ADC for acute myeloid
leukemia (AML) and potentially other malignancies. IMGN779 is the
first ADC utilizing one of ImmunoGen’s new DNA-acting IGNs as the
cancer-killing agent.
2015 accomplishments include:
- IND submitted and active, ImmunoGen’s
fourth IND in four years.
Events anticipated in 2016
include:
- Initiation of Phase 1 testing for the
treatment of AML in 1H2016.
Partner Programs – ImmunoGen has a distinctive record of
successful partnerships.
There are now ten novel anticancer compounds, including
Kadcyla®, in the clinic for a broad range of solid and liquid
cancers through ImmunoGen partnerships with Amgen, Bayer, Biotest,
Lilly, Novartis, Roche and Sanofi.
2015 accomplishments include:
- Amgen, Lilly, Novartis and Sanofi each
advanced a novel ADC with ImmunoGen technology into clinical
testing.
- Study investigators presented
encouraging Phase 1 clinical findings with Bayer’s anetumab
ravtansine in pretreated mesothelioma.
- A collaboration was established with
Takeda in early 2015, and in December, Takeda took its first
license for the exclusive right to develop ADCs to an undisclosed
target using ImmunoGen technology. The taking of this license
triggers ImmunoGen recognition of approximately $8.6 million of
(non-cash) revenue in its quarter ending December 31, 2015.
- In December, CytomX announced it is
advancing a novel anticancer agent targeting CD166 using its
ProbodyTM technology and ImmunoGen’s ADC technology under a
strategic collaboration established between the companies in early
2014. This event does not impact ImmunoGen financial results.
Events anticipated in 2016
include:
- Two partner compounds begin testing in
trials designed to support product registration.
- At least one additional partner
compound disclosed and/or advances into clinical testing.
Cash Position
ImmunoGen will report the financial results for the quarter
ended December 31, 2015 on January 29, 2016. The Company
noted that it ended the quarter with approximately $212
million in cash and cash equivalents and had no debt.
About ImmunoGen, Inc.
ImmunoGen is a clinical-stage biotechnology company that
develops targeted anticancer therapeutics with its proprietary ADC
technology. The Company’s lead product candidate, mirvetuximab
soravtansine, is a potential treatment for folate receptor
α-positive ovarian cancers and other solid tumors. A number of
major healthcare companies have licensed limited rights to use
ImmunoGen’s ADC technology to develop novel anticancer therapies;
it is used in Roche’s marketed product, Kadcyla®. More information
about the Company can be found at www.immunogen.com.
Doxil®, Avastin®, Rituxan® and Kadcyla® are registered
trademarks of their respective owners.
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 risks related to clinical
studies, regulatory reviews, and product commercialization, 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20160110005008/en/
For Investors:ImmunoGen, Inc.Carol Hausner,
781-895-0600info@immunogen.comorFor Media:For ImmunoGen,
Inc.Michael Lampe,
484-575-5040michael@michaellampeconsulting.com
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