ImmunoGen President and CEO Mark Enyedy

ImmunoGen said today it was eliminating nearly three-quarters of its workforce—220 jobs—and doubling down on developing its lead antibody-drug conjugate (ADC), the ovarian cancer treatment mirvetuximab soravtansine (IMGN853), while shrinking its pipeline, led by an ovarian cancer ADC, and its facilities following a review of operations.

The layoffs would wipe out the jobs of approximately 220 employees, or 74% of the 296 employees that ImmunoGen reported as of December 31, 2018, according to its Form 10-K annual report for 2018, filed March 1.

“A majority of these employees [will be] separating from the business by mid-July 2019, and the remaining affected employees transitioning over varying periods of time of up to 12 months,” ImmunoGen stated in a regulatory filing.

ImmunoGen estimated that it will record a one-time charge against second-quarter 2019 earnings totaling approximately $16.4 million related to termination benefits and other related charges. The related cash payments will be substantially paid out by June 30, 2020. In addition, ImmunoGen expects to incur a $3.7 million charge for retention benefits in the same time period.

In addition to the job cuts, ImmunoGen said it will shrink its pipeline by ending development of Phase I candidate IMGN779 in adults with relapsed/refractory CD33-positive acute myeloid leukemia (AML), and suspend all research activities not connected to mirvetuximab soravtansine or three earlier-stage cancer candidates:

  • IMGN632, which is being developed for relapsed AML, blastic plasmacytoid dendritic cell neoplasm (BPDCN), and other CD123-positive hematologic malignancies in collaboration with Jazz Pharmaceuticals. Combination studies are expected to launch in the second half of this year.
  • IMGC936, an ADAM9-targeting ADC being co-developed with MacroGenics for solid tumor cancers. An IND is expected to be filed by the end of 2019.
  • A next-generation anti-FRα ADC that is expected to enter clinical development in mid-2020.

“Critical” to future

“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,” ImmunoGen president and CEO said in a statement.

ImmunoGen added that it will seek to monetize all other candidates and platform technologies through outlicensing transactions or asset sales, as well as sub-lease the majority of its 120,000 square feet of lab and office space at 830 Winter Street in Waltham, MA, and dispose of excess equipment. The lease expires on March 31, 2026, with an extension option for two additional five‑year terms.

The company said it could not estimate its expected loss on such transactions.

The job, pipeline, and facility cuts come nearly four months after mirvetuximab soravtansine failed the Phase III FORWARD I trial (NCT02631876) by missing its primary endpoint of progression-free survival (PFS) in either the entire study population or a pre-specified subset of patients with high FRα expression.

For the 218 patients in the pre-specified high FRα subgroup, ImmunoGen said, PFS was longer in patients who received mirvetuximab soravtansine compared with chemotherapy (HR 0.69, p-value 0.049). However, the study required the p-value in the high subset to be less than or equal to 0.025 to achieve statistical significance.

The company also met with FDA officials, seeking a path to registration. During the “Type C” meeting, the company sought accelerated approval of the drug based on secondary endpoints met during FORWARD I. The high FRα subset showed signs of encouraging overall response rate and overall survival, according to the company, which began evaluating the potential benefit of mirvetuximab soravtansine for FRα-positive platinum-resistant ovarian cancer.

Instead, the company acknowledged on May 15, the FDA recommended ImmunoGen conduct a new Phase III trial assessing mirvetuximab soravtansine in patients with high folate receptor alpha (FRα)-positive, platinum-resistant ovarian cancer.

New Phase III trial

ImmunoGen said today it will proceed with the new trial, with the registration study assessing mirvetuximab soravtansine as a monotherapy for women with FRα-high, platinum-resistant ovarian cancer to be launched by the end of this year.

Topline results from that study are expected in the first half of 2022. Until then, ImmunoGen expects to be able to operate using the approximately $240 million on its balance sheet expected at the end of the current quarter; money saved from the job, pipeline, and facility cuts; and cash expected from collaboration partners.

Additionally, ImmunoGen will complete enrollment and continue follow-up in the Phase Ib/II FORWARD II trial (NCT02606305), designed to assess mirvetuximab soravtansine in combination with Roche/Genentech’s vascular endothelial growth factor inhibitor Avastin® (bevacizumab), carboplatin, or Merck & Co.’s blockbuster cancer immunotherapy 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 soravtansine plus carboplatin and Avastin in patients with platinum-sensitive ovarian cancer.

ImmunoGen said it will provide investors with updated 2019 financial guidance when it announces second quarter results on August 2. Back on February 8, ImmunoGen published guidance that projected:

  • Cash and cash equivalents of between $135 million and $140 million by year’s end.
  • Revenues of between $40 million and $45 million.
  • Operating expenses of between $265 and $270 million.

“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,” added ImmunoGen chairman Steve McCluski. “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.”

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