Avacta & Oncosec to Collaborate on Innovative Gene Delivery

Avacta & Oncosec to Collaborate on Innovative Gene Delivery

Avacta Group plc and OncoSec Medical Incorporated recently announced they have entered into a research collaboration to combine Avacta’s Affimer protein platform with OncoSec’s gene delivery technology ImmunoPulse. The research program will evaluate 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.

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. OncoSec’s prior Phase 2 OMS I-102 combination study of ImmunoPulse IL-12 and pembrolizumab 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. 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 aims to show 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 will demonstrate the potential of the combined technologies to create high-value immunotherapy combinations for clinical development and/or licensing.

“I am very pleased indeed that we have established this research partnership with OncoSec. Avacta is receiving a lot of interest in the Affimer platform for gene delivery and this is the third collaboration in this hugely important area following our partnerships with Moderna Therapeutics and FIT Biotech. 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,” said Dr. Alastair Smith, Avacta Group Chief Executive Officer.

“This important milestone in the evolution of our platform further solidifies OncoSec as a leader in gene delivery of intratumoral cancer immunotherapies,” added 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.”

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.

Avacta’s principal focus is on its proprietary Affimer® technology which is a novel engineered alternative to antibodies that has wide application in Life Sciences for diagnostics, therapeutics and general research and development. Antibodies dominate markets worth in excess of $100bn despite their shortcomings. Affimer technology has been designed to address many of these negative performance issues, principally; the time taken to generate new antibodies, the reliance on an animal’s immune response, poor specificity in many cases, and batch to batch variability. Affimer technology is based on a small protein that can be quickly generated to bind with high specificity and affinity to a wide range of protein targets. Avacta has a pre-clinical biotech development programme with an in-house focus on immuno-oncology and bleeding disorders as well as partnered development programmes. Avacta is commercialising non-therapeutic Affimer reagents through licensing to developers of life sciences research tools and diagnostics. For more information, visit www.avacta.com.

OncoSec is a biotechnology company developing DNA-based intratumoral immunotherapies with an investigational technology, ImmunoPulse, for the treatment of cancer. ImmunoPulse is designed to enhance the local delivery and uptake of DNA-based immune-targeting agents, such as plasmid encoded IL-12 (tavokinogene telseplasmid or “tavo”). In Phase 1 and 2 clinical trials, ImmunoPulse IL-12 has demonstrated a favorable safety profile, evidence of anti-tumor activity in the treatment of various solid tumors, and the potential to reach beyond the site of local treatment to initiate a systemic immune response. OncoSec’s lead program, ImmunoPulse IL-12, is currently in clinical development for metastatic melanoma and triple-negative breast cancer. The program’s current focus is on the significant unmet medical need in patients with melanoma who are refractory or have relapsed on anti-PD-1 therapies. In addition to tavo, the Company is also identifying and developing new immune-targeting agents for use with the ImmunoPulse platform. For more information, please visit www.oncosec.com.

Protein drugs such as antibodies and Affimers can be delivered to a patient by injection of the protein itself or, cells in the patient’s body can be made to make the protein if the DNA blue-print of the protein (the “gene”) can be placed into the cells.

There are multiple benefits of gene delivery, most notably that the expensive and difficult step of making a therapeutic protein to stringent quality standards is no longer required because the patient makes the protein inside his or her own body. The development time for gene delivered protein therapeutics is also shorter because the manufacturing development time is reduced. Gene delivery into specific tumor tissues also means that a high local dose is achieved with reduced systemic effects, especially if a small protein like an Affimer is used that will be rapidly cleared from the body if it leaves the tumor environment.

If gene delivery is to be effective and a clinically relevant dose achieved, then the protein drug must be easy for the patient’s body to make, and small proteins with simple structures, such as Affimers, are ideal for this. The gene may be delivered as DNA or RNA and methods of delivery include injection by electroporation or targeting using oncolytic virus particles which are packed with the DNA. Affimer proteins are suitable for all gene delivery methods.