• 29 Aug 2023
• Admin
• News Article

ImmunoGen collaborates with Takeda to develop and commercialize Elahere in Japan

ImmunoGen, Inc., a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, announced it has entered into an exclusive collaboration with Takeda Pharmaceutical Company Limited to develop and commercialize Elahere (mirvetuximab soravtansine-gynx) in Japan.

"As a leader in the development and commercialization of novel products in oncology for more than two decades and with a deep heritage and presence in Japan, Takeda is the ideal partner to help us deliver Elahere to eligible patients in this important market," said Mark Enyedy, ImmunoGen's president and chief executive officer. "Building upon our strong commercial launch in the US, this partnership reinforces the continued excitement around Elahere's practice-changing potential and our commitment to bringing this biomarker-directed ADC to patients globally."

Under the terms of the collaboration and license agreement, ImmunoGen will receive a one-time, upfront payment and an additional payment upon conversion of US Food and Drug Administration (FDA) accelerated approval of Elahere in platinum-resistant ovarian cancer (PROC) to full approval. The company is eligible to receive additional payments if Takeda achieves prespecified regulatory and commercial milestones, as well as double-digit royalties on future net sales of Elahere in Japan. Per the agreement, ImmunoGen has retained exclusive production rights and will supply product for development and commercial use in Japan. In exchange, Takeda will receive an exclusive license to develop and commercialize Elahere in Japan and is responsible for all regulatory filings and obligations.

“We are pleased to bring Elahere to Japan, where there is a significant unmet need for patients with ovarian cancer, particularly for those whose disease has become resistant to platinum-based treatments,” said Teresa Bitetti, president of the global oncology business unit at Takeda. “The data from the phase 3 MIRASOL study demonstrate the potential for Elahere to become the new standard of care for this devastating disease, and we are confident this collaboration with ImmunoGen will bring significant value to patients in Japan. This investment is reflective of Takeda’s commitment to partnering with organizations that share our passion for developing new medicines for cancers with limited or ineffective treatment options and brings us one step closer to achieving our aspiration to cure cancer.”

Elahere (mirvetuximab soravtansine-gynx) is a first-in-class ADC comprising a folate receptor alpha-binding antibody, cleavable linker, and the maytansinoid payload DM4, a potent tubulin inhibitor designed to kill the targeted cancer cells.

Elahere is indicated for the treatment of adult patients with folate receptor-alpha (FRa) 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.

Eye problems are common with Elahere and can be severe. Elahere also can cause severe or life-threatening inflammation of the lungs that may lead to death and patients may develop nerve problems called peripheral neuropathy during treatment.

ImmunoGen is developing the next generation of antibody-drug conjugates (ADCs) to improve outcomes for cancer patients. By generating targeted therapies with enhanced anti-tumour activity and favourable tolerability profiles, the company aim to disrupt the progression of cancer and offer our patients more good days.