AbbVie and ImmunoGen have signed a definitive agreement under which AbbVie will acquire ImmunoGen, including the company’s flagship cancer therapy mirvetuximab soravtansine-gynx (Elahere®)*[1][2] first-in-class antibody-drug conjugate (ADC) approved for platinum-resistant ovarian cancer (PROC).

The acquisition accelerates AbbVie’s commercial and clinical presence in the solid tumor space. Additionally, ImmunoGen’s follow-on pipeline of promising next-generation ADCs further complements AbbVie’s ADC platform and existing programs.

Under the terms of the transaction, AbbVie will acquire all outstanding shares of ImmunoGen for $31.26 per share in cash. The transaction values ImmunoGen at a total equity value of approximately $10.1 billion. The boards of directors of both companies have approved the transaction. This transaction is expected to close in the middle of 2024, subject to ImmunoGen shareholder approval, regulatory approvals, and other customary closing conditions.

“The acquisition of ImmunoGen demonstrates our commitment to deliver on our long-term growth strategy and enables AbbVie to further diversify our oncology pipeline across solid tumors and hematologic malignancies,” explained Richard A. Gonzalez, chairman and chief executive officer, AbbVie.

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“Together, AbbVie and ImmunoGen have the potential to transform the standard of care for people living with cancer,” Gonzalez said.

Driving long term revenue growth
ImmunoGen’s oncology portfolio has the potential to help drive long-term revenue growth for AbbVie’s oncology franchise, which itself has a dynamic pipeline of investigational therapies across a range of tumor types.

The company’s late-stage development programs for mirvetuximab soravtansine provide opportunity to expand into earlier lines of therapy and additional patient populations

Meaningful survival
Ovarian cancer is the leading cause of death from gynecological cancers in the U.S. mirvetuximab soravtansine is the first targeted medicine to show meaningful survival benefit in PROC. As a fast-growing solid tumor therapy, mirvetuximab soravtansine provides AbbVie with a potential multi-billion-dollar on-market medicine with expansion opportunities in earlier lines of therapy and larger segments of the ovarian cancer market.

Mark Enyedy Mr. Enyedy joined ImmunoGen as President and Chief Executive Officer in 2016, bringing over twenty-five years of combined general management, business development, and legal experience in the biotechnology industry. Prior to ImmunoGen, he served as Executive Vice President and Head of Corporate Development for Shire plc leading the company’s Strategy, M&A, and Corporate Planning functions and providing commercial oversight for the company’s pre-Phase 3 portfolio. Previously, Mr. Enyedy served as CEO of Proteostasis Therapeutics, Inc., following 15 years at Genzyme Corporation in diverse roles, most recently as President of the Transplant, Oncology, and Multiple Sclerosis divisions. Before joining Genzyme, Mr. Enyedy was an associate with the law firm Palmer & Dodge. He holds a J.D. from Harvard Law School and a B.S. from Northeastern University. Mr. Enyedy also serves on the Board of Directors of Akebia Therapeutics, Inc. and The American Cancer Society of Eastern New England. He previously served on the Board of Directors of Fate Therapeutics, Inc. and Keryx Biopharmaceuticals, Inc.
Mark Enyedy
Mr. Enyedy joined ImmunoGen as President and Chief Executive Officer in 2016, bringing over twenty-five years of combined general management, business development, and legal experience in the biotechnology industry. Prior to ImmunoGen, he served as Executive Vice President and Head of Corporate Development for Shire plc leading the company’s Strategy, M&A, and Corporate Planning functions and providing commercial oversight for the company’s pre-Phase 3 portfolio. Previously, Mr. Enyedy served as CEO of Proteostasis Therapeutics, Inc., following 15 years at Genzyme Corporation in diverse roles, most recently as President of the Transplant, Oncology, and Multiple Sclerosis divisions. Before joining Genzyme, Mr. Enyedy was an associate with the law firm Palmer & Dodge. He holds a J.D. from Harvard Law School and a B.S. from Northeastern University. Mr. Enyedy also serves on the Board of Directors of Akebia Therapeutics, Inc. and The American Cancer Society of Eastern New England. He previously served on the Board of Directors of Fate Therapeutics, Inc. and Keryx Biopharmaceuticals, Inc.

“With global commercial infrastructure and deep clinical and regulatory expertise, AbbVie is the right company to accelerate geographic and label expansion, and realize the full potential of mirvetuximab soravtansine as the first and only ADC approved in ovarian cancer,” said Mark Enyedy, president and chief executive officer, ImmunoGen. “The addition of ImmunoGen’s pipeline, platform, and expertise to AbbVie’s oncology portfolio is an exciting opportunity for the combined companies to advance innovation in ADCs. This transaction is the culmination of our 40-year commitment to develop and deliver the next-generation of ADCs and more good days for people living with cancer.”

Mirvetuximab soravtansine is a first-in-class ADC targeting folate receptor alpha (FRα) with a maytansinoid payload DM4, a potent tubulin inhibitor designed to kill the targeted cancer cells. The drug links DM4 via a cleavable linker to a folate receptor alpha-binding antibody.

Mirvetuximab soravtansine received U.S. Food and Drug Administration (FDA) accelerated approval in 2022 for the treatment of adult patients with FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. The positive Phase 3 results from the MIRASOL confirmatory trial will support a Marketing Authorization Application (MAA) to the European Union and a supplemental Biologic License Application (sBLA) submission to the U.S. FDA in order to gain full approval. Ongoing clinical development programs are underway to expand into earlier lines of therapy and enter other large patient segments of the ovarian market over the next 5-10 years.

ImmunoGen’s Pipeline
ImmunoGen’s follow-on pipeline of promising next-generation ADCs is expected to expands AbbVie’s growing oncology pipeline of potentially transformative programs across multiple different solid tumors and hematologic malignancies.

ImmunoGen’s pipleine includes IMGN-151, is a next-generation anti-FRα ADC for ovarian cancer with the potential for expansion into other solid tumor indications.  Pivekimab sunirine (previously known as IMGN-632), currently in Phase 2, is an anti-CD123 ADC targeting blastic plasmacytoid dendritic cell neoplasm (BPDCN), a rare blood cancer, which was granted FDA breakthrough therapy designation for the treatment of relapsed/refractory BPDCN.

Solid Tumors
ImmunoGen’s pipeline also includes IMGC936, a first-in-class ADAM9-targeting ADC that is comprised of a high-affinity humanized antibody site-specifically conjugated to DM21, a next-generation maytansinoid microtubule-disrupting payload, and combined with a stable peptide linker.

ADAM9 is a cell surface protein that belongs to the ADAM (a disintegrin and metalloproteinase) family of proteases, which have been implicated in cytokine and growth factor shedding and cell migration. Dysregulation of ADAM9 has been implicated in tumor progression and metastasis, as well as pathological neovascularization. It has been shown that ADAM9 is overexpressed in multiple solid tumor types (e.g., non-small cell lung cancer, gastric, pancreatic, triple-negative breast, and colorectal) and minimally expressed on normal tissue, making ADAM9 an attractive target for ADC development.

IMGC936 is being co-developed with MacroGenics and is currently in Phase 1 study.

AbbVie’s Pipeline
AbbVie’s ADC Pipeline includes:

  • Telisotuzumab vedotin (ABBV-399), an antibody drug conjugate (ADC) targeting cMet that is being investigated to treat non-small cell lung cancer (NSCLC).
  • ABBV-319, a novel oncology first-in-class steroid-based ADC targeting CD19 that is anticipated to have robust single-agent activity and provide significant clinical benefit as combination therapy in a variety of B-cell malignancies.
  • ABBV-400 is an antibody drug conjugate (ADC) targeting cMet that is being investigated to treat non-small cell lung cancer (NSCLC), colorectal cancer (CRC) and gastroesophageal adenocarcinoma (GEA).
  • ABBV-706 is an antibody-drug conjugate being investigated for the treatment of small cell lung cancer, central nervous system tumors and neuroendocrine carcinomas.

Partnership
In addition to ImmunoGen own, proprietary pipeline of ADC candidates, the company has created strategic partnerships and collaborations that help the company leverage their  technology to address unmet medical needs. These partnerships are primarily designed to advancing science, and gain access to complimentary capabilities. Today, ImmunoGen partnerships include a strategic cross-licensing agreement with CytomX Therapeutics to develop Probody™ drug conjugate (PDC) therapies and a co-development and co-promotion collaboration with MacroGenics to develop a first-in-class ADAM9-targeting ADC.

ImmunoGen technology platform has been the basis for a number of high-value partnerships resulting the development of ado-trastuzumab emtansine (Kadcyla®; Genentech/Roche), the first-ever ADC approved as a treatment option for HER2-positive breast cancer.

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Note: *  Mirvetuximab soravtansine is indicated for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Select patients for therapy based on an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Clinical trials
First in Human Study of IMGN151 in Recurrent Endometrial Cancer and Recurrent, High-grade Serous Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers – ClinicalTrials.gov Identifier: NCT05527184
Combination Chemotherapy (FLAG-Ida) With Pivekimab Sunirine (PVEK [IMGN632]) for the Treatment of Newly Diagnosed Adverse Risk Acute Myeloid Leukemia and Other High-Grade Myeloid Neoplasms – ClinicalTrials.gov Identifier: NCT06034470
Study of IMGN632 in Patients With Untreated BPDCN and Relapsed/Refractory BPDCN – ClinicalTrials.gov Identifier: NCT03386513
A Study of the Drug IMGN632 in Children With Leukemia That Has Come Back After Treatment or is Difficult to Treat – ClinicalTrials.gov Identifier: NCT05320380
IMGN632 as Monotherapy or With Venetoclax and/or Azacitidine for Participants With CD123-Positive Acute Myeloid Leukemia – ClinicalTrials.gov Identifier: NCT04086264
First-in-Human Study of IMGC936 in Patients With Advanced Solid Tumors – ClinicalTrials.gov Identifier: NCT04622774

Highlights of prescription information
Mirvetuximab soravtansine-gynx (Elahere®) [Prescribing Information]
Ado-trastuzumab emtansine (Kadcyla®; Genentech/Roche) [Prescribing Information]

References
[1] Heo YA. Mirvetuximab Soravtansine: First Approval. Drugs. 2023 Feb;83(3):265-273. doi: 10.1007/s40265-023-01834-3. PMID: 36656533.
[2] Mirvetuximab Soravtansine-gynx. Am J Health Syst Pharm. 2023 Mar 21;80(7):395-397. doi: 10.1093/ajhp/zxad001. PMID: 36807473.

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