ImmunoGen Announces Completion of Operational Review
Cash Runway Extended Through Readout of Mirvetuximab Soravtansine Pivotal Trial in Ovarian Cancer
Conference Call to be Held at
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
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
Advance two additional assets that demonstrate ImmunoGen’s continued innovation in ADCs: IMGC936, which is in co-development with
MacroGenicswith 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
“I thank the employees separating from the business for their significant contributions to ImmunoGen and to the advancement of the ADC field,” said
“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
CONFERENCE CALL INFORMATION
ImmunoGen will hold a conference call today at
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
ImmunoGen partnered with the
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.
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.
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