Avacta Group, the developer of Affimer® biotherapeutics and reagents, and OncoSec Medical, a company developing intratumoral cancer immunotherapies, have entered into a research collaboration to combine Avacta’s Affimer protein platform with OncoSec’s gene delivery technology ImmunoPulse®.

The research program evaluates the benefits of delivering Affimer protein genes directly into tumors using the OncoSec technology with the long-term aim of developing gene delivered Affimer immunotherapies.

Affimer biotherapeutics are a novel engineered alternative to antibodies based on a fully human small protein that can be quickly engineered to bind with high specificity and affinity to a wide range of protein targets.  The size and biophysical characteristics of Affimer proteins make them an ideal candidate for gene delivery approaches.

Results from this research collaboration demonstrated the potential of the combined technologies to create high-value immunotherapy combinations for clinical development and/or licensing…

Gene delivery technology
OncoSec has developed a gene delivery technology called ImmunoPulse that has clinically demonstrated safe and efficient delivery of DNA encoded proteins directly into a patient’s tumor.  Prior Phase II OMS I-102 combination study of ImmunoPulse® IL-12 and pembrolizumab (Keytruda®; Merck Oncology), a humanized antibody designed to blocks a protective mechanism of cancer cells and allowing the immune system to destroy those cancer cells, successfully demonstrated the safety and efficacy of the platform with a 50% best overall response rate and a 41% complete response rate in 22 patients unlikely to respond to anti-PD-1 therapy.

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PD-L1 (Programmed Death-Ligand 1) is part of the ‘immune checkpoint’  target family. The normal function of immune checkpoints is to help regulate the immune system and to prevent its over-activation towards healthy cells. Tumor cells often can take advantage of this system to “switch-off” and evade the immune system. By specifically targeting certain proteins involved with these pathways, it is possible to reactivate the patients’ own immune system and so destroy the cancer cell.

OncoSec was also granted Orphan Drug and FastTrack Designation for pIL-12, otherwise known as tavokinogene telseplasmid or “tavo,” from the United States Food and Drug Administration (FDA).

The collaboration between the companies shows that, by using ImmunoPulse to deliver DNA encoding Avacta’s immuno-modulatory Affimers, including Avacta’s PD-L1 inhibitor (AVA04), into tumor cells and other tissues, a clinically relevant dose can be achieved.  The companies plan to then demonstrate efficacy of the Affimers in a relevant in vivo tumor model.

Results from the research collaboration demonstrated the potential of the combined technologies to create high-value immunotherapy combinations for clinical development and/or licensing.

“[…] we have established [a] research partnership with OncoSec.  […] this is the third collaboration in this hugely important area following our partnerships with Moderna Therapeutics and FIT Biotech,” noted Alastair Smith, Avacta Group Chief Executive Officer

“Gene delivery is a very exciting new area and one in which I believe we can establish Affimer technology as the protein platform of choice because of the technical benefits of using a small, simple protein for this application.  This is potentially a very large opportunity for Avacta and a successful outcome of the collaborative work with OncoSec would not only create the potential for the two companies to consider future co-developments but would also support Affimer licensing deals more widely in this rapidly growing field.  We look forward to updating the market on our progress,” Smith added.

“This important milestone in the evolution of our platform further solidifies OncoSec as a leader in gene delivery of intratumoral cancer immunotherapies,” noted Daniel J. O’Connor, Chief Executive Officer of OncoSec.

“We are delighted to be collaborating with Avacta on the innovative science that is set to transform the lives of patients living with cancer and other devastating diseases.  We look forward to the advancement of this collaboration and to sharing the broader clinical application of OncoSec’s ImmunoPulse platform in 2018,” O’Connor, concluded.

Each party will bear their own internal costs and will share any third-party costs associated to the partnership, which are estimated to be non-significant.

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