Lupus Immunotherapeutic Vaccine Candidate Reports Positive Study Results

A French biopharma company announced results from a phase IIb clinical trial of the lupus vaccine candidate IFNalpha Kinoid induced neutralizing anti-IFN-α2b antibodies and significantly reduced the IFN gene signature with an acceptable safety profile.

Neovacs’s IFNα Kinoid (IFN-K) vaccine candidate is made of inactivated IFNα coupled to a carrier protein. This combination of proteins provokes an immune response from white blood cells and stimulates them to produce antibodies against IFNα in lupus patients.

This study’s results were published on December 23, 2019, showing at 36 weeks, 91 percent of the people receiving the IFN-K injection produced neutralizing antibodies against interferon-alpha, which is a pro-inflammatory molecule that activates autoimmune response and is overproduced in people with lupus.

Although the IFN-K vaccine did not significantly reduce people’s BILAG-Based Composite Lupus Assessment (BICLA) scores other encouraging clinical results were observed, said Lupus.org in a related press release on December 27, 2019.

Over 50 percent of those treated with IFN-K showed reduced Low Lupus Disease Activity State scores, versus 29.8 percent in the placebo group. 

Additionally, the treatment group also benefited from a notable decrease in corticosteroid intake and improved fatigue.

This study included 185 lupus patients with moderate to severe disease activity and positive interferon (IFN) gene signature was randomized to receive IFN-K or PBO intramuscular injections (days 0, 7 and 28 and W12 and W24).

During 2016, the U.S. Food and Drug Administration (FDA) granted fast-track status to Neovacs for its vaccine IFNα Kinoid.

This study’s results are good news since there is no cure for lupus today.

Lupus vaccine candidate news

• Lupus Vaccine Candidate Launches Phase 1b Study
• Lupus Vaccine Candidate Passes Phase 2b Study

Systemic lupus erythematosus (SLE) or lupus erythematosus is a debilitating, chronic autoimmune disease whose etiology remains unknown, and mostly affects women, says the US Centers for Disease Control and Prevention (CDC).

If you have lupus, your risk is higher for other health problems that are common in women, such as heart disease and osteoporosis.

Additionally, women with lupus who get pregnant are considered to have a “high-risk-pregnancy.” This means that problems during pregnancy may be more likely for women with lupus. It doesn’t mean there will definitely be problems, says the CDC.

There are several different types of lupus:

• SLE is the most common and most serious type of lupus. SLE affects all parts of the body.
• Cutaneous lupus erythematosus, which affects only the skin
• Drug-induced lupus, a short-term type of lupus caused by certain medicines
• Neonatal lupus, a rare type of lupus that affect newborn babies

SLE is characterized by a loss of tolerance of self-antigens, with the production of autoantibodies, especially antinuclear antibodies that attack healthy tissues and cause inflammatory reactions in different parts of the body. 

The disease can affect multiple organs and is characterized by heterogeneous clinical signs (skin rashes, arthritis, photosensitivity, nephritis, neurological disorders, anemia, thrombocytopenia, etc.), which vary from one person to another and change during the progression of the disease.

Treating SLE often requires a team approach because of the number of organs that can be affected.

SLE treatment consists primarily of immunosuppressive drugs that inhibit the activity of the immune system. Hydroxychloroquine and corticosteroids (e.g., prednisone) are often used to treat SLE. 

The FDA approved belimumab in 2011, the first new drug for SLE in more than 50 years.

SLE also may occur with other autoimmune conditions that require additional treatments, like Sjogren’s syndrome, antiphospholipid syndrome, thyroiditis, hemolytic anemia, and idiopathic thrombocytopenic purpura.

The CDC said in an online statement during October 2018, older national prevalence estimates vary widely due to differences in case definitions, small study populations, and study methods. 

A conservative estimate suggests a prevalence of 161,000 with definite SLE.

This study was funded by Neovacs S.A., and the researchers were related to the company.

Neovacs is a leading biotechnology company focused on an active immunotherapy technology platform (Kinoids) with applications in autoimmune diseases.

Lupus Vaccine News published by Precision Vaccinations