ImmunoGen’s Big Internal Changes
ImmunoGen (IMGN) announced a radical impacting decision following the completion of an in-depth operational review aimed at extending the Company’s cash runway; delivering on its promises to continue developing a promising antibody drug conjugate (ADC) product and moving into the clinic what it believes will be next-generation ADCs.
Based on the outcomes of its review, ImmunoGen prioritized continuing the development of mirvetuximab and select portfolios of three earlier-stage product candidates, targeting solid tumors and hematological malignancies, to move forward towards clinical trials.
The Company unveiled that it will end the current quarter with $240 million on its balance sheet. It expects that with expense reductions, resulting from the operational changes announced today and anticipated cash to be received from partners, the cash will be sufficient to fund its operations through the release of top-line results from the upcoming irvetuximab Phase 3 study in platinum-resistant ovarian cancer. Which is expected to be announced in the first half of 2022.
The operational review was decided upon following the negative results from the FORWARD I, Phase 3 clinical trial evaluating mirvetuximab compared to chemotherapy in women with folate receptor alpha (FRα)-positive, platinum-resistant ovarian cancer. The results did not meet the primary endpoint.
Having said that, the firm also stated that the data from FORWARD I has positive news that demonstrates 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), Immunogen decided to pursue a new Phase 3 study in this patient population.
Strategic Priorites for ImmunoGen
In light of these developments, and the goal of extending the existing cash runway, ImmunoGen has established three strategic priorities for the business:
- Executing a registration study for mirvetuximab in platinum-resistant ovarian cancer,
- Advancing a select portfolio of earlier-stage product candidates and
- Strengthening the balance sheet through partnering.
ImmunGen’s New Focus:
- Initiating the registration study for mirvetuximab as a monotherapy for women with FRα-high, platinum-resistant ovarian cancer by the end of this year,
- Completing enrollment and continuing to follow up in the ongoing FORWARD II mirvetuximab combination cohorts,
- Continuing 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,
- Advancing two additional assets that demonstrate ImmunoGen’s continued innovation in ADCs: IMGC936, in co-development with MacroGenics with an IND expected by the end of 2019, and the Company’s next generation anti-FRα ADC, expected to enter development in mid-2020 and
- Licensing transactions or asset sales.
ImmunoGen Reducing Expenses
- Discontinuing the development of IMGN779 in adults with relapsed/refractory CD33-positive AML,
- Suspending all other research activities,
- Reducing its workforce by approximately 220 employees. A majority of these employees will separate from the business by mid-July 2019 and
- Seeking to sublease excess office and lab space.
The savings 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 its second quarter operating results on August 2, 2019.
Commenting on these decisions is Steve McCluski, ImmunoGen’s Chairman of the Board. He 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. 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
An ImmunoGen conference call was made this morning at 8am, discussing these results. Following the live webcast a replay of the call will be available at the same location through July 9, 2019.
Mirvetuximab soravtansine (IMGN853) is the 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.
FORWARD I Trial
The FORWARD I trial 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 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.
FORWARD II Trial
The FORWARD II trial is a Phase 1b/2 of mirvetuximab in combination with Avastin®, 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.
We believe that the time has come for ImmunoGen to focus on its promising ADC products and limit its spending, until these products reach the market. ImmunoGen and Seattle Genetics (SGEN) were equal leaders of the antibody-drug conjugates which has proven itself, and was validated, through the approvals of ADC drugs created by both firms. While Seattle Genetics flourished and the stock price multiplied several fold in the past five years, ImmunoGen continued deteriorating with the stock price falling like a rock, devastating its shareholders. All the damage was made as a result of previous managements’ bad decisions.
We have always believed in the ADC products advantages and our opinion was proven right through the approval of the ADC products and the thriving of Seattle Genetics. We now hope that, as painful as the new decisions by the firm’s current management are, they have the chance to resurrect this firm.
ADC technology and products are the golden tickets to fulfilling the wishes for ImmunoGen’s resurrection.
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