Aelix Therapeutics has raised €11.5 million ($12.6 million) to advance a therapeutic HIV candidate to clinical proof of concept. Ysios Capital, Johnson & Johnson ($JNJ) and others backed the round, having been persuaded that Aelix's immunotherapy has the potential to be a functional cure for HIV.
|Aelix CSO Christian Brander|
Barcelona, Spain-based Aelix, a spinout from the city's renowned HIV research center HIVACAT, has only has preclinical data to date. But with the preclinical data backing up the scientific hypothesis put forward by well-regarded researchers at HIVACAT, Aelix has managed to tap investors for the cash it needs to take the immunotherapy through to a Phase II efficacy data readout in 2019. The trial will go some way to demonstrating whether Aelix can realize its ambition to rewire the immune systems of HIV patients to make them more like a subpopulation that naturally fends off the virus.
"HIV infection makes a very strong immune response in everybody, but evidently that immune response is unable or inadequate to control the virus. In some people, you will find very little virus, in some people a lot of virus," Christian Brander, co-founder and CSO of Aelix, told FierceBiotech. To identify why some people naturally cope better with HIV infection than others, Brander and his team looked at the immune responses of 1,000 people who were living with the virus. The work led to the identification of certain immune responses that are unique to people with low viral loads.
Having picked out T cell targets associated with lower viral loads, the team incorporated them into a polypeptide sequence. The sequence was then integrated into DNA and modified ankara virus (MVA) vectors, resulting in a candidate Brander thinks can enable the immune systems of more patients to manage the viral load. "Our immunotherapy has the intention of increasing those immune responses to these more beneficial targets, and avoiding responses to the non-beneficial ones," Brander said. The DNA-MVA vector combination is intended to both prime and boost the immune response.
Patients will receive a few DNA shots, to prime the immune system, followed by a MVA injection to boost the response, a combination Brander thinks could keep HIV viral loads at undetectable levels without the daily treatment regimens needed today. A Phase I trial in 30 healthy volunteers to assess safety and immune responses is due to start later this year, after which Aelix plans to move into a Phase II efficacy study in patients. "We are going to look for any signs of viral reactivation. It could be considered unethical to let people go for a long time once they do not control the virus," he said.
A small team is in charge of making such decisions. Aelix is planning to limit itself to 6 employees, a lean model intended to give it the necessary expertise in clinical development to pull off its strategy. Jordi Naval, a prolific life science entrepreneur, is serving as CEO, with Brander taking on the role of CSO. The presence of Naval, who has founded a handful of companies, is indicative of the recycling of talent that has contributed to Spain's biotech sector entering an upbeat period, in which Sanifit, Minoryx Therapeutics and Oryzon Genomics (BME:ORY) have all raised money.
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