Company Will Prioritize Continued Development of Mirvetuximab
Soravtansine and a Select Portfolio of Earlier-Stage Candidates
Cash Runway Extended Through Readout of Mirvetuximab
Soravtansine Pivotal Trial in Ovarian Cancer
Conference Call to be Held at 8 a.m. ET Today
ImmunoGen, Inc., (Nasdaq:IMGN), a leader in the expanding field
of antibody-drug conjugates (ADCs) for the treatment of cancer,
today announced the completion of an in-depth operational review
designed to extend the Company’s cash runway and deliver on its
commitment to develop next-generation ADCs to bring more good days
to patients and generate increased value for shareholders. Based on
the outcomes of this review, the Company will prioritize continued
development of mirvetuximab and a select portfolio of three
earlier-stage product candidates targeting solid tumors and
hematological malignancies. The Company will end the current
quarter with approximately $240 million on its balance sheet and
expects this cash, together with expense reductions resulting from
the operational changes announced today and anticipated cash
receipts from partners, will fund operations through the release of
top-line results from the upcoming mirvetuximab Phase 3 study in
platinum-resistant ovarian cancer, which are expected in the first
half of 2022.
The operational review commenced following the announcement that
FORWARD I, ImmunoGen’s Phase 3 clinical trial evaluating
mirvetuximab compared to chemotherapy in women with folate receptor
alpha (FRα)-positive, platinum-resistant ovarian cancer, did not
meet the primary endpoint. Data from FORWARD I did, however,
demonstrate a consistent efficacy signal across a range of
parameters in the pre-specified subset of patients with high FRα
expression. Following consultation with the U.S. Food and Drug
Administration (FDA), the Company will pursue a new Phase 3 study
in this patient population.
In light of these developments and with the goal of extending
the Company’s existing cash runway, ImmunoGen has established three
strategic priorities for the business: execute a registration study
for mirvetuximab in platinum-resistant ovarian cancer; advance a
select portfolio of earlier-stage product candidates; and further
strengthen its balance sheet through partnering. Consistent with
these priorities, ImmunoGen will focus on the following core
activities:
- Initiate the registration study for mirvetuximab as a
monotherapy for women with FRα-high, platinum-resistant ovarian
cancer by the end of this year;
- Complete enrollment and continue follow up in the ongoing
FORWARD II mirvetuximab combination cohorts;
- Continue IMGN632 development in patients with relapsed acute
myeloid leukemia (AML), blastic plasmacytoid dendritic cell
neoplasm (BPDCN), and other CD123-positive hematologic malignancies
in collaboration with Jazz Pharmaceuticals;
- Advance two additional assets that demonstrate ImmunoGen’s
continued innovation in ADCs: IMGC936, which is in co-development
with MacroGenics with an IND expected by the end of 2019; and the
Company’s next generation anti-FRα ADC, which is expected to enter
development in mid-2020; and
- Monetize its remaining portfolio and platform technologies
through out-licensing transactions or asset sales.
Correspondingly, the Company will reduce ongoing expenses
through the following portfolio prioritization and restructuring
initiatives:
- Discontinue the development of IMGN779 in adults with
relapsed/refractory CD33-positive AML;
- Suspend all other research activities;
- Reduce its workforce by approximately 220 employees, with a
majority of these employees separating from the business by
mid-July 2019; and
- Seek to sub-lease excess office and lab space.
Following a transition period, the savings generated by the
restructuring are expected to reduce ImmunoGen’s quarterly expenses
by more than 50%. As a result of the workforce reduction, the
Company expects to record a one-time charge totaling approximately
$16.4 million related to termination benefits and other related
expenses. This charge is expected to be recorded in the quarter
ending June 30, 2019, and the related cash payments will be
substantially paid out by June 30, 2020. In addition, an
anticipated charge of $3.7 million is expected to be incurred for
retention benefits in the same time period. Updated 2019 financial
guidance will be provided when ImmunoGen announces it second
quarter operating results on August 2, 2019.
“I thank the employees separating from the business for their
significant contributions to ImmunoGen and to the advancement of
the ADC field,” said Mark Enyedy, ImmunoGen’s President and Chief
Executive Officer. “Reorganizing the business is critical to the
Company’s future, enabling us to extend our cash position and
continue the development of mirvetuximab and our portfolio of
promising ADCs in earlier stages of development. We look forward to
continued progress with the business, including the start of the
registration study for mirvetuximab by year-end and additional
monotherapy and combination data at ESMO in September, identifying
a recommended Phase 2 dose and initiating combination studies with
IMGN632 in the second half of the year, and filing an IND for
IMGC936 by the end of 2019.”
“This was an extremely difficult decision for the Board, as we
believe deeply in the therapeutic promise of ADCs, the Company’s
science, and its people,” said Steve McCluski, ImmunoGen’s Chairman
of the Board. “These are, however, the right steps to take to bring
mirvetuximab to patients and offer the best opportunity to capture
long-term value for our shareholders, whom we thank for their
support.”
CONFERENCE CALL INFORMATION
ImmunoGen will hold a conference call today at 8 a.m. ET to
discuss these results. To access the live call by phone, dial
1-786-789-4797; the conference ID is 6921368. The call may also be
accessed through the Investors section of the Company’s website,
www.immunogen.com. Following the live webcast, a replay of the call
will be available at the same location through July 9, 2019.
ABOUT MIRVETUXIMAB SORAVTANSINE
Mirvetuximab soravtansine (IMGN853) is the first folate receptor
alpha (FRα)-targeting ADC. It uses a humanized FRα-binding antibody
to target the ADC specifically to FRα-expressing cancer cells and a
potent anti-tumor agent, DM4, to kill the targeted cancer
cells.
ABOUT FORWARD I
FORWARD I is a Phase 3 trial in which 366 patients were
randomized 2:1 to receive either mirvetuximab soravtansine or the
physician's choice of single-agent chemotherapy (pegylated
liposomal doxorubicin, topotecan, or weekly paclitaxel). Eligible
patients were diagnosed with platinum-resistant ovarian cancer that
expresses medium or high levels of FRα and were treated with up to
three prior regimens. The primary endpoint of this study was
progression free survival (PFS), which was assessed in the entire
study population and in the subset of patients with high FRα
expression. ImmunoGen estimates that 12,000-14,000 patients per
year in the U.S. meet these criteria, with a comparable number in
the major markets in Europe.
ImmunoGen partnered with the GOG Foundation Inc., a leader in
clinical research in gynecologic malignancies, on FORWARD I, which
was conducted in North America and Europe.
ABOUT FORWARD II
FORWARD II is a Phase 1b/2 study of mirvetuximab in combination
with Avastin® (bevacizumab), carboplatin or Keytruda®
(pembrolizumab) in patients with FRα-positive platinum-resistant or
platinum-agnostic ovarian cancer, primary peritoneal, or fallopian
tube tumors, as well as a triplet combination of mirvetuximab plus
carboplatin and Avastin in patients with platinum-sensitive ovarian
cancer.
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.” The Company has built a
productive platform generating a broad pipeline of ADCs targeting
solid tumors and hematologic malignancies.
Learn more about who we are, what we do, and how we do it at
www.immunogen.com.
FORWARD-LOOKING STATEMENTS
This press release includes forward-looking statements based on
management's current expectations. 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 and uncertainties related to the execution of the
restructuring of the Company’s operations, including, without
limitation, unanticipated delays and costs in implementing the
workforce reduction and subleasing activities, the Company’s
ability to control future spending to enable it to fund its
remaining operations through the release of top-line results from
the upcoming mirvetuximab Phase 3 study, as well as the risks and
uncertainties inherent in the Company’s development programs,
including 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 year ended December 31, 2018 and
other reports filed with the Securities and Exchange
Commission.
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version on businesswire.com: https://www.businesswire.com/news/home/20190627005101/en/
INVESTORS ImmunoGen Sarah Kiely 781-895-0600
sarah.kiely@immunogen.com
MEDIA ImmunoGen Courtney O’Konek 781-895-0600
courtney.okonek@immunogen.com
OR
FTI Consulting Robert Stanislaro or Helen O’Gorman 212-850-5600
robert.stanislaro@fticonsulting.com
helen.o'gorman@fticonsulting.com
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