A new spin-out of an Indian company best known for making generic drugs aims to compete with top biotechs like Amgen and Regeneron in one of oncology's biggest research areas.
Officially launched Tuesday, Ichnos Sciences is an offshoot of Glenmark Pharmaceuticals, from which it will inherit five experimental medicines, two research laboratories and roughly 350 employees.
While its pipeline encompasses autoimmune diseases and pain, Ichnos will focus foremost on a type of cancer drugs known as bispecific antibodies.
For years a sideshow in oncology research, bispecifics are now at the center of efforts to find new ways to recruit the body's immune system in an attack on tumors.
Amgen's widely considered a leader in the field, having won U.S. approval five years ago for the first cancer bispecific in its leukemia drug Blincyto. The biotech is advancing nearly a dozen more through clinical testing.
Other large drugmakers, most notably Roche and Regeneron, are investing as well, aiming first at blood cancers like lymphoma, multiple myeloma and leukemia.
Ichnos is well aware of the competition it faces. Yet CEO Alessandro Riva, who left a high-profile post running Gilead's cancer business to join the new company, argues the science behind designing bispecifics has yet to be settled.
"This is a still evolving field," he said in an interview with BioPharma Dive. "No company has declared victory in terms of having identified the best composition of an immune cell engager. There is a lot to do and we're just at the beginning."
Unlike regular antibodies, bispecifics can bind to two cell targets rather than one. This characteristic allows drugmakers to design a therapy that brings immune cells into contact with tumor cells, potentially precipitating a potent immune response.
In theory, bispecifics could offer a simpler approach than CAR-T cell therapy, which also seeks to involve the immune system in an attack on cancer.
Practically, however, initial efforts to build a bispecific resulted in molecules with structural disadvantages. Amgen's Blincyto, for example, has a short half life in the blood and must be dosed continuously due to how the drug is constructed.
Bispecifics are newly in vogue, though, because some of those early challenges have been solved and a second generation of clinical candidates are yielding promising data.
To start, Ichnos will advance two bispecific drugs. One, in Phase 1 testing for breast cancer, targets the HER2 protein along with an immune cell protein called CD3. The other, also in Phase 1, binds to CD3 as well as a protein called CD38 that's often found on multiple myeloma cells.
While efforts by Amgen and others are better known, Ichnos' myeloma candidate actually entered human testing before a similar candidate from Amgen. Results won't be available for some time, though, with data readouts anticipated in 2021.
Glenmark will fund Ichnos' work for now, although the spin-out plans to eventually consider an initial public offering, Riva said.
"We're covered for a certain period of time," Riva said. "This time is precious for us to continue to build up Ichnos science and make sure we're fully independent and then able to go to the next step, which is a potential IPO."
Ichnos will operate two research centers, one in Switzerland and another in India, as well as a development site in New Jersey, out of which it will be based.
Advancing its bispecific platform in cancer will be a priority, but the company is also staked from Glenmark with an anti-OX40 antibody in Phase 2b testing for atopic dermatitis. Data for that program are expected in 2020.
Two Phase 2 candidates in pain will be seen through development, but Ichnos does not plan to invest in pain research more broadly, Riva said.
In spinning out Ichnos, Glenmark is betting new drug development will progress more quickly outside of its walls than alongside its generic and active ingredient businesses.
"The mindset is completely different," said Riva. "You need to be credible in front of the community with regard to what you're planning and the science you're implementing."