Sanofi, Debiopharm Deals Buy ImmunoGen Extra Time
Executive Summary
ImmunoGen has turned around two cash-generation deals in a week as it seeks to extend its funding and narrow its focus. It has sold one asset to Debiopharm and foregone future royalties on five products licensed to Sanofi in exchange for an upfront lump sum.
Antibody drug conjugate technology specialist ImmunoGen Inc. has added $60m to its balance sheet via the divestiture of one asset to Debiopharm International SA and the amendment of a multi-product licensing agreement with Sanofi.
The company had been looking to sign co-development/co-commercialization deals for development-stage candidates, monetize future royalty streams and out-license its two B-cell lymphoma programs, in order to get upfront cash, given that its current cash would only fund activities into the second quarter of 2018. ImmunoGen has several big pharma partners for its ADC technology, but not enough cash coming in to secure the future of its various in-house development programs, including a lead program in Phase III ovarian cancer trials that it is hoping to get approved by 2020.
IMGN529 Sold
The first of the recent deals sees one of the company's B-cell lymphoma programs disposed of. Switzerland's Debiopharm paid $25m up front for IMGN529 with a further $5m to be transferred upon the completion of the transfer of the related ImmunoGen technologies, which is scheduled to occur by the end of 2017. ImmunoGen also stands to receive a $25m milestone should this ADC, which is designed to treat patients with CD-37-positive B-cell malignancies such as non-Hodgkin lymphoma, enter a Phase III trial.
IMGN529 has shown anticancer activity in a Phase I monotherapy trial and completed a safety run-in study in combination rituximab; it is now set to progress into a Phase II trial combination with rituximab in patients with diffuse large B-Cell lymphoma and other forms of non-Hodgkin's lymphoma.
Sanofi Royalties Monetized
The amended arrangements with Sanofi will see the French major paying $30m up front to ImmunoGen to take exclusive development, manufacturing and commercialization rights to four named pipeline compounds and a fifth undisclosed candidate. The deal will remove ImmunoGen's future milestone and royalty rights laid out in the original agreements, signed in 2003 and 2013. It will also forego a limited US co-promotion option it had on four of the compounds.
The compounds in question are:
- Isatuximab, an unconjugated anti-CD38 antibody in Phase III development for relapsed and refractory multiple myeloma
- SAR566658, and ADC targeting CA6 in Phase II development for triple-negative breast cancer
- SAR408701, an anti-CEACAM5 ADC being studied in solid tumors
- SAR428926, an anti-LAMP1 ADC also being studied in solid tumors
- One more ADC directed to an undisclosed target
FORWARD Focus
ImmunoGen's lead product is mirvetuximab soravtansine, in Phase III as a single agent for folate receptor alpha-positive platinum-resistant ovarian cancer (the FORWARD 1 trial) and in Phase Ib/II in combination regimens for platinum-resistant and platinum-sensitive disease (the FORWARD II trial). The company believes it has potential to replace chemotherapy and become a preferred agent in combination regimens including with immunotherapies and PARP inhibitors. It is hoping to gain initial approval for the compound as a monotherapy in platinum-resistant ovarian cancer in 2020, and believes it has potential in other folate receptor alpha positive diseases including non-small cell lung cancer, endometrial cancer and triple-negative breast cancer.
Analysts at Leerink wrote in a May 30 research note that ImmunoGen had "other BD [business development] opportunities… to generate value in the near term, such as the divestiture of coltuximab (SAR3419) which was highlighted "best of ASCO" in 2015 [sic – it was actually 2014 – ed]." Sanofi handed back rights to coltuximab ravtansine in April 2015; the candidate had shown evidence of anticancer activity in relapsed/refractory diffuse large B-cell lymphoma in the Phase II STARLYTE trial.
The Leerink analysts also highlighted the company's other in-house clinical assets, IMGN779 and IMGN632, saying they "could represent attractive partnering assets".
ImmunoGen is scheduled to present Phase I dose-escalation data on IMGN779, an anti-CD33 ADC, in relapsed/refractory acute myeloid leukemia at EHA in June, with efficacy data expected to be ready for ASH in December. IMGN632 is an anti-CD123 ADC for hematological cancers expected to enter Phase I in the second half of 2017.
This is not the company's first monetization deal: in 2015 it notably converted a chunk of the future royalties on Roche's Kadcyla (ado-trastuzumab emtansine), which uses ImmunoGen's toxin and linker technology, into $200m of ready money. The company was put on the back foot when Kadcyla failed to show superiority to Roche's earlier generation breast cancer best-seller Herceptin (trastuzumab), reducing peak sales expectations for the drug – and royalty prospects for ImmunoGen. (Also see "ImmunoGen sucks up the cost of novelty value " - Scrip, 1 Apr, 2015.) Kadcyla remains the only marketed drug that uses ImmunoGen's ADC technology.
Another partnered program with a future milestone and royalty stream at a relatively advanced stage is anetumab ravtansine, which Bayer AG testing in a Phase II trial for mesothelioma.
ImmunoGen cut 17% of its workforce in September 2016 as part of its drive to extend its cash runway.