BioLineRx Ltd., a clinical-stage biopharmaceutical company focused on oncology and immunology, has acquired Agalimmune Ltd., a private UK-based company with an innovative, anti-cancer immunotherapy platform. Acquisition consideration consisted of a $6 million upfront payment, of which $3 million is in cash and the remainder in BioLineRx shares. Additional future payments may be made based on development and commercial milestones.

Agalimmune’s lead compound is AGI-134, a synthetic alpha-Gal immunotherapy in development for solid tumors. AGI-134 harnesses the body’s pre-existing, highly abundant anti-alpha-Gal antibodies to induce a systemic, specific anti-tumor response to the patient’s own tumor neo-antigens. This response not only kills the tumor cells at the site of injection, but also brings about a durable, follow-on, anti-metastatic immune response.

AGI-134 has completed numerous pre-clinical studies, demonstrating robust protection against the development of secondary tumors in a model of melanoma with a single dose only. Synergy has also been demonstrated in additional pre-clinical studies when combined with a PD-1 immune checkpoint inhibitor, offering the potential to broaden the utility of such immunotherapies, and improve the rate and duration of responses in multiple cancer types. AGI-134 is in near-clinical development and is expected to commence a first-in-man study in patients with solid tumors in the first half of 2018.

Philip Serlin, chief executive officer of BioLineRx, stated, "Immuno-oncology is one of the most promising approaches for the treatment of cancer. Although a number of current immunotherapies are receiving widespread attention, many solid tumors are still able to evade the immune system’s surveillance. Most immunotherapies work best in highly mutated tumors that are infiltrated with immune cells, known as ‘hot’ tumors. Unfortunately, the overwhelming majority of tumors are ‘cold’ tumors, and thus transforming a ‘cold’ tumor into a ‘hot’ tumor is a major objective in cancer treatment.”

"In this regard, Agalimmune’s lead asset, AGI-134, harnesses naturally occurring, pre-existing antibodies to elicit a tumor-specific immune response that is unique to the treated individual and provides a universal, small-molecule approach to personalized immunotherapy. The subsequent stimulation and recruitment of T cells, which recognize the patient’s own neo-antigens, to the tumor site, has the potential of transforming ‘cold’ tumors into ‘hot’ ones. Through this important acquisition, we will also benefit from Agalimmune’s complementary immunology expertise and facilities in the UK, which support our strategic focus in this area. We are enthusiastic to incorporate into our pipeline this promising near-clinical asset, which substantially strengthens our position in the immuno-oncology space,” added Mr. Serlin.

"We are very excited that we found an ideal partner for our promising therapeutic pipeline. We are extremely impressed by BioLineRx’s proven drug development capabilities, as well as their meaningful collaborations with global pharmaceutical companies,” said Damian Marron, chief executive officer of Agalimmune. "We strongly believe in the value of our unique platform and we look forward to its accelerated clinical development by BioLineRx.”