AB2 Bio Ltd achieves a medical breakthrough in the treatment of systemic inflammation

PRESS RELEASE AB2 Bio Ltd achieves a medical breakthrough in the treatment of systemic inflammation • Drug candidate effective in treat ing a baby girl carrying a newly identified, potentially fatal, genetic mutation causing severe systemic inflammation • Case report to be presented at the Annual Meeting of the A merican College of Rheumatology (ACR) Lausanne (Switzerland), November 9, 2015 . The Swiss biotech company AB2 Bio Ltd today announced a medical breakthrough in the treatment of severe systemic inflammation with its experimental drug, Interleukin -18 Binding P rotein (IL -18BP). A critically ill baby girl with major systemic inflammation was successfully treated in summer 2015 with IL -18BP on a compassionate use basis. In September, it was reported that she has entered into full remission. This extraordinary case report will be presented at the Annual Meeting of the ACR in San Francisco, CA on November 9, 2015. AB2 Bio Ltd, located on the Innovation Park at the École polytechnique fédérale de Lausanne (EPFL), Switzerland, is specialised in the development of treatments against inflammatory diseases . The company is currently in a Series B financing round. Dr. Andrew Sleight, CEO of AB2 Bio Ltd, commented: “We are all delighted and proud that our Phase II drug candidate successfully treated this baby girl and that she could be discharged from hospital and return home with her parents . This is a major medical breakthrough confirming that our drug candidate is an effective and life-saving treatment for patients suffering from s evere inflammatory diseases.” Prof. Cem Gabay, Professor of Medicine at the University Hospital of Geneva added : “If you plot out her data over time with the start and stop dates of her medication, I think it is dramatically clear that IL-18BP made the difference for her.” In May 2015, a Physician, based at the Children’ s Hospital of Philadelphia, who was treating a critically ill baby girl, asked AB2 Bio Ltd to provide IL-18BP on a compassionate use basis. At that time the baby was 3 months old and had major systemic inflammation. Her chances of survival were considered small as she was suffering from severe entero colitis (inflammation of the colon). Genotyping of the baby demonstrated that she had a recently identified, potentially fatal, genetic mutation of the NOD-like receptor C4 (NLRC4) gene. This mutation is associated with extremely high levels of IL -18, the therapeutic target of AB2 Bio. With the help of the company, the treating physician submitted a Compassionate Use Investigational New Drug (IND) Application to the US Food and Drug Administration (FDA). The treatment was initiated in June 2015 and she rapidly responded with her symptoms resolv ing. Early August 2015 she was discharged from hospital. Although she is still being treated with IL -18BP, she is now at home with her parents and has entered into full remission. About Interleukin-18 Binding Protein (IL-18BP) and inflammatory diseases While the time-limited inflammatory response is a natural mechanism intended to limit harm to the body, dysregulated and persistent inflammatory processes are the basis of several chronic inflammatory and autoimmune dise ases. IL-18BP is a human protein with a high affinity for IL -18, a major inflammatory cytokine. In healthy people, there is a large excess of naturally occurring IL -18BP keeping levels of free IL -18 low. However, in patients with certain inflammatory diseases, the IL - 18/IL-18BP balance is disrupted, resulting in high levels of free and active IL-18, which in turn leads to pathological inflammation. Administration of AB2 Bio’s exogenous recombinant human IL -18BP restores the IL-18/IL-18BP balance, removing free IL-18 and thereby reducing inflammation. AB2 Bio has developed the first proprietary assay detecting free IL -18 allowing the identification of clinical entities that are driven by free IL -18. As patients with high levels of free IL -18 can be identif ied, the clinical impact of treatment with IL -18BP will be maximized. The patients unlikely to respond to the treatment will not be unnecessarily exposed to ineffective medicines. Extensive Phase I and Ib clinical trial results have demonstrated that IL-18BP is very well tolerated and has an excellent safety profile. AB2 Bio is currently conducting a Phase II clinical trial in patients with Adult onset Still’s disease. About the expanded access program Expanded access, sometimes called "compassionate use," is the use outside of a clinical trial of an investigational medical product (i.e., one that has not been approved by regulatory authorities). Wherever possible, use of an investigational treatment by a patient as part of a clinical trial is preferable because clinical trials can generate data that may lead to the approval of products and, consequently, to wider availability. However, when patient enrolment in a clinical trial is not possible (e.g., a patient is not eligible for any ongoing clinical trials , or there are no ongoing clinical trials), patients may be able to receive the treatment, when appropriate, through expanded access. About AB2 Bio Ltd AB2 Bio Ltd, located on the Innovation Park at the École polytechnique fédérale de Lausanne (EPFL), is specialised in the development of treatments against inflammatory diseases. The Swiss biotech company is developing drugs that will not only treat the sy mptoms but particularly target the underlying causes of inflammation -based diseases. Extensive Phase I and Ib clinical trial results with the company’s human IL-18BP demonstrated a high tolerance and an excellent safety profile. Please find further information on www.ab2bio.com. Media Contacts Daniel Piller, Partner IRF Communications AG, Phone +41 43 244 81 54, [email protected]

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