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Apr 24, 2015

Lytix Biopharma announces a proof of concept milestone for LTX-315, an intra-tumoral oncolytic peptide immunotherapy

By targeting the cancer cells, LTX-315 induces the release of potent immune stimulants and an extended range of patients` own tumor antigens - increasing patient specific immune response to attack cancer. A body of data has been generated on LTX-315 which confirms a modest and predictable clinical safety profile and emerging clinical evidence of anti-tumor and immune effects. In addition, preclinical data demonstrate strong synergy with LTX-315 and immune checkpoint inhibitors (ICIs). Based on this Lytix Biopharma intends to initiate the first combination trial in the second half of 2015.

There is a paradigm shift in cancer treatment with the introduction of cancer immunotherapy. Combinations of complementary immunotherapy treatments are expected to be an integral part of future cancer treatment delivering significant clinical benefit. ICIs “take off the brakes” imposed by the tumor on the immune system and they are expected to be an integral part of future cancer therapy. LTX-315 stimulates or “pushes the accelerator” of the immune system through release of potent immune stimulants. In addition, LTX-315 differentiates from many other immune stimulants by inducing the release of the broadest possible spectrum of patient specific tumor antigens. These antigens  enhance the effect of potent immune stimulants released by LTX 315 and  potentially the effect of standard of care treatment (including immune therapies such as ICIs).

The strong preclinical data in addition to evidence of anti-tumour effects (including immune effects) in the Phase I study have provided Proof of Concept for LTX-315. Lytix Biopharma intends to present the safety and efficacy data from the ongoing Phase I monotherapy study at an oncology conference in the second half of 2015.

Dr. James Spicer (King’s College London at Guys Hospital London, UK), principal investigator of the Phase I study commented:

“Emerging evidence of anti-tumour activity and immune effects have been observed with LTX-315 in the Phase I study. With a modest and predictable safety profile it is both attractive and appropriate to now explore combination therapy with Immune Checkpoint Inhibitors while continuing to evaluate the monotherapy activity of LTX-315.”

Professor Laurence Zitvogel (Institute Gustave Roussy, Paris, France) commented about LTX-315 MoA:

“The compelling pre-clinical anticancer activity obtained with LTX-315 alone and in combination with other anticancer drugs support the rationale to evaluate in patients LTX-315 in combination with immune checkpoint inhibitors.”

LTX-315 has a multi-indication potential, and malignant melanoma will be the 1st indication in which combinations with LTX-315 will be evaluated.

Unni Hjelmaas, CEO of Lytix Biopharma commented on this important milestone to initiate combination trials:

“We are very excited about having reached this important milestone for the drug candidate LTX-315. Cancer immunotherapy is our area of focus and we believe LTX-315 has the potential to deliver enhanced clinical benefit to cancer patients in combination with immune checkpoint inhibitors. The plan is to initiate the first combination trial the second half of 2015.”

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Read external articles about the milestone here (only in Norwegian):

Hegnar

Digitalis/LMI

nord24

Dagens medisin

iTromsø


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Further information:

Unni Hjelmaas CEO
Tel (+47) 915 19 651, e-mail: unni.hjelmaas@lytixbiopharma.com

Andrew Saunders, Chief Medical Officer
Tel +44 (0) 7900190331, e-mail: andrew.saunders@lytixbiopharma