Agalimmune Receives $2-Million) Milestone Payment

Agalimmune Ltd recently announced it has received a milestone payment from Loxbridge Research LLP and Animatrix Finance Ltd following successful completion of two Phase I trials of its Alphaject technology in late-stage cancer patients. The investment will be used to fund Agalimmune’s research into combination therapy with immune checkpoint inhibitors, such as the CTLA-4, PD-1, and PD-L1 classes of compounds, as part of its supportive preclinical work packages.

The milestone payment represents continued investment into the company, and is being made in response to the promising early clinical data from two separate Phase I trials involving 20 patients. The more recent trial, funded by the US National Institutes of Health, and performed at University of Wisconsin in Madison, WI, focused on late-stage melanoma patients. The results were reported in a poster presented at AACR, the American Association for Cancer Research conference, with a second poster presented this past month at ASCO, the American Society for Clinical Oncology conference.

Agalimmune is focused on the development of an anti-tumor injectable technology that harnesses pre-existing immunity present in all humans. Agalimmune’s Alphaject technology includes methods for treating solid tumors in such a way that the immune system actively rejects them, akin to a non-matched graft or transplant. Tumors are directly injected with the Alphaject compound, to which humans naturally have a high antibody titer. Alphaject coats the tumor cells in alpha-Gal, thereby presenting a foreign antigen to the immune system. This is thought to bring about a hyper-acute rejection of the tumor, and breaks the immune tolerance, shielding it from attack, allowing the immune system to both begin to destroy the tumor immediately and also over time, to confer a long-lasting protection in the form of enhanced immune surveillance. The effect is analogous to a personalized cancer vaccine, acting continuously to prevent both metastasis and recurrence. A short animation to show the mechanism of action of Alphaject can be viewed at http://youtu.be/pIiWgQRa66o.

Key findings presented in the AACR and ASCO posters were that in two of the nine patients, new melanoma-associated antigen specific T-Cells were found following treatment with Alphaject. Most significantly, also in two of nine patients, new necrosis of non-injected lesions was observed, suggesting effective systemic action of activated specific killer T-Cells, a key marker of likelihood of immune effect on survival. The posters can be viewed at http://www.agalimmune.com/images/ZulegerCindy_AACR_2014.pdf, and http://www.agalimmune.com/images/ASCO_AlphaGal_Poster_2014.pdf

“We are delighted to see the Alphaject program advance. We believe that Alphaject has the potential to become an important addition to the oncologist’s arsenal in treating patients with potentially fatal solid tumors. The technology is perfectly suited to symbiotic activity with immune checkpoint blockade agents, and we are already seeing interest from a number of the developers of these drugs. I anticipate a combination trial in future with checkpoint blockade, and hope to see the synergies proven clinically,” said Dr. Charles Roberts, CEO of Loxbridge.

“We are encouraged by the results of the Wisconsin trial, in which repeated Alphaject injections were safe and induced promising immune responses in a subset of these advanced patients. Immune priming is an important component of inducing a protective anti-tumor response. Alphaject is designed to induce a personalized immune priming against the patient’s own tumor; we believe therefore it can become an important component of effective immunotherapeutic combination regimens,” added Mike Westby, CEO of Agalimmune.