- COVID-19 vaccine developer BioNTech has secured rights to a new cancer drug, announcing Monday it will pay $200 million to a private U.S. biotech called OncoC4 for an immunotherapy of the same class as Bristol Myers Squibb’s Yervoy and AstraZeneca’s Imjudo.
- OncoC4 developed the antibody drug to more selectively turn on immune cells involved in fighting tumors without affecting other parts of the body. Yervoy and Imjudo have high rates of immune-related side effects, including some that in rare instances can be fatal.
- BioNTech is best known for developing therapies that use messenger RNA to turn on immune responses to infectious diseases and cancer. However, it has quietly built an arsenal of experimental antibodies, some of which emerged from a collaboration with the Danish biotech Genmab, which first developed the Johnson & Johnson cancer drug Darzalex.
BioNTech held 13.4 billion euros, or about $14 billion, worth of cash at the end of the third quarter of 2022 due to revenue from the COVID-19 vaccine it developed with Pfizer. The company spent just over 1 billion euros on drug research and development over the first nine months of 2022, leaving plenty of room for its business development team to seek out candidates for licensing or smaller targets for acquisition.
Getting a next-generation drug from the same class as Yervoy and Imjudo, which are called CTLA-4 inhibitors, is an attractive idea. Launched in 2011, Yervoy was the first so-called “checkpoint inhibitor” that overwrote mechanisms tumors uses to turn off immune cells, preceding drugs like Merck’s Keytruda and Bristol Myers’ own Opdivo by a few years.
However, CTLA4 blockers are hampered by high rates of immune-related side effects, which have played a role in limiting their use. Yervoy, for example, resulted in medically significant immune-related side effects in more than one-third of melanoma patients included in one retrospective analysis.
In developing the drug that BioNTech has now licensed, OncoC4 is seeking to shut down the activity of certain white blood cells that suppress immune responses, but only inside the tumor. The idea is to limit the drug’s effect on those same white blood cells elsewhere in the body, potentially curbing unwanted side effects. In Phase 1/2 testing with Keytruda, OncoC4’s drug led to low rates of medically significant side effects. None were life-threatening, OncoC4 reported in November.
The drug, dubbed ONC-392, has received Fast Track designation from the Food and Drug Administration as a single-agent treatment for non-small cell lung cancer resistant to Keytruda and other immunotherapies. A 600-patient Phase 3 trial in this setting is being planned and would compare ONC-392 to a chemotherapy called docetaxel.
Another Phase 2 trial is testing ONC-392 in combination with Keytruda in ovarian cancer patients whose disease is resistant to chemotherapy.
BioNTech’s deal is expected to close in the first half of 2023 and includes milestone payments and double-digit tiered royalties for OncoC4.