ImmunoGen Stock

ImmunoGen, Inc. operates as a commercial-stage biotechnology company.

The company focuses on developing and commercializing the next generation of antibody-drug conjugates (ADCs) to improve outcomes for cancer patients.

The company has established a leadership position in ADCs with a portfolio of differentiated product candidates to address both solid tumors and hematologic malignancies.

The company has set four strategic priorities for the business: executing the commercial launch for ELAHERE (mirvetuximab soravtansine-gynx) (ELAHERE); expanding the ELAHERE label by moving into platinum-sensitive ovarian cancer; advancing its clinical pipeline of novel ADCs for hematologic and solid tumors; and strengthening and expanding its pipeline through both internal discovery and external partnerships.

ELAHERE (Mirvetuximab Soravtansine)

Approval and Launch

ELAHERE is a first-in-class ADC targeting folate receptor alpha, a cell-surface protein over-expressed in a number of epithelial tumors, including ovarian, endometrial, and non-small-cell lung cancers. On November 14, 2022, the U.S. Food and Drug Administration (FDA) granted accelerated approval for ELAHERE for the treatment of adult patients with folate receptor alpha positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. The accelerated approval of ELAHERE was based on efficacy and safety outcomes from SORAYA, a single-arm trial of ELAHERE in patients with platinum-resistant ovarian cancer whose tumors express high levels of folate receptor alpha. Continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial. Patients eligible for treatment with ELAHERE are selected by the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay developed by Roche Tissue Diagnostics (RTD), which was also approved by the FDA on November 14, 2022. The company completed the build out of its U.S. commercial infrastructure in 2022 and initiated sales in the U.S. in November 2022.

Ongoing Development

In addition to SORAYA, the company is conducting MIRASOL, a randomized Phase 3 clinical trial designed to support full approval of ELAHERE. In July of 2022, the company completed enrollment in MIRASOL and expect to report top-line data from this trial in the second quarter of 2023. If MIRASOL is successful, the company plans to submit a marketing authorisation application, or MAA, for the approval of ELAHERE for the treatment of adult patients with folate receptor alpha positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens with the European Medicines Agency, or EMA, in the second half of 2023. Additionally, the company’s partner, Huadong Medicine, expects to submit a biologics license application to the National Medical Products Administration (NMPA) of China for ELAHERE in the same indication in the second half of 2023 to support potential approval and launch of ELAHERE in Greater China in 2024.

Beyond platinum-resistant ovarian cancer, the company’s strategy is to move ELAHERE into platinum- sensitive disease, and to position the product as the combination agent of choice in ovarian cancer. To this end, in January 2023, the company completed patient enrollment in PICCOLO, a single-arm trial of ELAHERE monotherapy in later-line folate receptor alpha positive platinum-sensitive patients, and plan to report on the primary endpoint before the end of 2023. The company has also generated encouraging data in recurrent platinum-sensitive disease with the combination of ELAHERE plus carboplatin and is supporting investigator sponsored trials (ISTs) with this combination in a single arm trial in the neoadjuvant setting and in a randomized trial comparing ELAHERE combined with carboplatin to standard of care in patients with recurrent platinum-sensitive disease. The company also initiated a single-arm Phase 2 trial (0420) of this combination followed by ELAHERE continuation in folate receptor alpha-low, medium, and high patients with platinum-sensitive disease. Results from this trial and the company’s ongoing ISTs will inform a path to the potential registration for ELAHERE plus carboplatin and, in parallel, could support compendia listing for this combination. Finally, the company has initiated GLORIOSA, a randomized Phase 3 trial of ELAHERE plus bevacizumab maintenance in folate receptor alpha-high recurrent platinum-sensitive disease that could support label expansion.

Pivekimab Sunirine

Pivekimab sunirine (PVEK) is an ADC consisted of a high-affinity antibody designed to target CD123 with site-specific conjugation to a DNA-alkylating payload of the novel IGN (indolinobenzodiazepine pseudodimer) class. The company’s IGNs are designed to alkylate DNA without cross-linking, which has provided a broad therapeutic index in preclinical models. The company is advancing PVEK in clinical trials for patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN) and acute myeloid leukemia (AML).

In October 2020, the FDA granted Breakthrough Therapy designation for PVEK for the treatment of patients with relapsed or refractory BPDCN. Based on feedback from the FDA, the company amended its ongoing 801 Phase 2 trial, known as CADENZA, to include a new cohort of up to 20 frontline BPDCN patients.

A Type B meeting was held in August 2022 regarding these initial data from the CADENZA trial. Based on FDA feedback on trial design provided in this meeting, the efficacy analysis will be conducted in de novo BPDCN patients with CR/CRc as the primary endpoint and the key secondary endpoint of duration of CR/CRc. The company will enroll up to 20 de novo patients for purposes of the efficacy analysis. The company will also continue to enroll PCHM patients in CADENZA to further evaluate PVEK in this population. The company expects to report top-line data on the primary and key secondary endpoints in 2024.

The company is also conducting its 802 trial for PVEK, which is a Phase 1b/2 trial designed to determine the safety, tolerability, and preliminary antileukemia activity of PVEK when administered in combination with azacytidine and venetoclax to patients with relapsed and frontline CD123-positive AML. Having identified the recommended Phase 2 dose for the triplet, patients are accruing in both expansion cohorts. Based upon these results, the company will continue enrollment in two frontline AML expansion cohorts to optimize the duration of venetoclax therapy. In addition, in December 2022, the company announced a clinical collaboration with Gilead Sciences, Inc. to study PVEK in combination with magrolimab in relapsed refractory AML and expects to initiate this cohort under the 802 trial in the second half of 2023.

Other Pipeline Programs

The company continues to advance its earlier-stage pipeline programs. IMGC936 is an ADC in development with MacroGenics, Inc. that is designed to target ADAM9, an enzyme over-expressed in a range of solid tumors and implicated in tumor progression and metastasis. IMGC936 incorporates a number of innovations, including antibody engineering to extend half-life, site-specific conjugation with a fixed drug-antibody ratio to enable higher dosing, and a next-generation linker and payload designed for improved stability and bystander activity. Phase 1 dose escalation was completed and expansion cohorts in non–small cell lung cancer and triple-negative breast cancer initiated in the second half of 2022. The company expects to provide initial data from these cohorts in the second quarter of 2023.

IMGN151 is the company’s next generation anti-folate receptor alpha product candidate in development. This ADC integrates innovation in each of its components, which may enable IMGN151 to address patient populations with lower levels of folate receptor alpha expression, including tumor types outside of ovarian cancer. The company began enrollment in a Phase I clinical trial evaluating IMGN151 in patients with recurrent endometrial cancer and recurrent, high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancers in January 2023.

Collaborations and Out-Licenses

Huadong

In October 2020, the company entered into a collaboration and license agreement with Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. (Huadong) a subsidiary of Huadong Medicine Co., Ltd., under which Huadong will exclusively develop and commercialize ELAHERE in the People’s Republic of China, Hong Kong, Macau, and Taiwan, which the company refers to as Greater China. The company is also eligible to receive tiered low double digit to high teen royalties as a percentage of ELAHERE commercial sales by Huadong in Greater China. Although the company holds the MAA, Huadong is responsible for the development and commercialization of ELAHERE in Greater China except in limited circumstances.

Lilly

In February 2022, the company entered into a license agreement with Eli Lilly and Company (Lilly), pursuant to which the company granted Lilly worldwide exclusive rights to research, develop, and commercialize antibody-drug conjugates based on the company’s novel camptothecin technology.

Patents, Trademarks and Trade Secrets

The company has a substantial and robust intellectual property portfolio comprising over 1,800 issued patents and over 700 pending patent applications on a worldwide basis.

With regard to the company’s tubulin-acting maytansinoid cytotoxic payload agents, the company owns 22 issued U.S. patents covering various embodiments of the company’s maytansinoid technology, including those with claims directed to certain maytansinoids, including DM4 and DM21, and methods of manufacturing DM1, DM4, and DM21, as well as methods of using the same. These issued patents are expected to remain in force until various times between 2023 and 2038. With regard to the company’s IGN payload agents, the company has 39 issued U.S. patents covering various aspects of the company’s DNA-acting cytotoxic payload agents, which will expire at various times between 2030 and 2038. With regard to the company’s camptothecin agents, the company has an issued U.S. patent covering various aspects of the company’s camptothecin cytotoxic payload agents, which expires in 2040. In addition, the company has received or is applying for comparable patent protection in other major commercial and manufacturing jurisdictions, including Europe, Japan, and China.

The company’s intellectual property strategy also includes pursuing patents directed to linkers, antibodies, conjugation methods, ADC formulations and the use of specific antibodies and ADCs to treat certain diseases. In this regard, the company has 22 issued patents related to many of the company’s linker technologies, as well as additional pending patent applications disclosing and claiming many other related and strategically important embodiments of these linker technologies, including methods of making the linkers and antibody maytansinoid conjugates comprising these linkers. These issued patents are expected to remain in force until various times between 2023 and 2034. The company also has 23 issued U.S. patents covering methods of assembling ADCs from their constituent antibody, linker, and cytotoxic payload agent moieties. These issued patents will expire between 2026 and 2039. In addition, the company has received or is applying for comparable patents in other major commercial and manufacturing jurisdictions, including Europe, Japan, and China.

The company has 21 issued U.S. patents and 15 pending U.S. applications covering various embodiments of the composition of matter and methods of treatment using ELAHERE, expiring at various times between 2031 and 2043. The company has filed 5 applications for patent term extension of patents covering various aspects of ELAHERE with the U.S. Patent and Trademark Office. The company expects the U.S. Patent and Trademark Office to deem one or more of these patent term extension applications allowable. With respect to PVEK, the company has 6 issued U.S. patents and 5 pending U.S. applications covering various embodiments of the composition of matter and methods of treatment using PVEK, expiring at various times between 2036 and 2043.

Regulatory Matters

For ELAHERE (and potentially other of the company’s product candidates), the company works with collaborators to develop or obtain access to in vitro companion diagnostic tests to identify appropriate patients for these targeted therapies. For example, the company partnered with RTD to develop a companion diagnostic device for ELAHERE. In conjunction with the FDA’s approval of ELAHERE, the agency also approved the VENTANA FOLR1 RxDx Assay as a companion diagnostic device to select patients eligible for treatment with ELAHERE.

Approved drug products, such as ELAHERE, are subject to continuing regulation by the FDA, including, among other things, record-keeping requirements, reporting of adverse experiences with the drug, providing the FDA with updated safety and efficacy information, drug sampling and distribution requirements, complying with certain electronic records and signature requirements, and complying with the FDA’s promotion and advertising requirements.

The company is subject to federal laws, including the Medicaid Drug Rebate Program, that require pharmaceutical manufacturers to report certain calculated product prices to the government or provide certain discounts or rebates to government authorities or private entities, often as a condition of reimbursement under government healthcare programs.

Suppliers

The company relies on a sole third-party supplier, Società Italiana Corticosteroidi S.r.l, to manufacture the DM4 used in ELAHERE.

Research and Development

The company’s research and development expense was $213.4 million for 2022.

Competition

The company’s competitors include research institutions, pharmaceutical companies, and biotechnology companies, such as Pfizer, Seattle Genetics, Roche, Astellas, AstraZeneca, Daiichi Sankyo, GlaxoSmithKline, AbbVie, Mersana Therapeutics, Eisai, Sutro BioPharma, and the Menarini Group.

History

ImmunoGen, Inc. was founded in 1980. The company was incorporated in Massachusetts in 1981.