Enesi Pharma and Sementis Sign R&D Collaboration Focused on Needle-free Solid Dose Vaccines for Peanut Allergy and Chikungunya/Zika Infection

OXFORD, England and MELBOURNE, Australia, November 5, 2018 /PRNewswire/ --

Enesi Pharma, an innovative pharmaceutical company developing unique injectable solid dose drug-device vaccine products, and Sementis, a biotechnology company developing innovative vaccine candidates for the prevention of allergies and infectious diseases, announce they have entered into a collaborative agreement. 

The collaboration is focused on the development and evaluation of solid dose versions of Sementis' lead peanut hypoallergy vaccine and their single vectored chikungunya/Zika vaccine candidates for administration via Enesi Pharma's ImplaVax® technology. ImplaVax is an innovative and proprietary needle-free solid dose implant and device technology for subcutaneous vaccination. Data to date demonstrate that ImplaVax-enabled vaccines can deliver superior immune responses compared to standard injection protocols among other benefits such as safety, ease of use, reliability and stability.

Sementis' investigational peanut hypoallergy vaccine, based on its SCV vector platform, has completed proof-of-concept studies, providing compelling evidence that it offers the possibility of a permanent cure for peanut allergy. It is estimated that over seven million individuals suffer with serious allergy to peanut, including many children, in the major markets of the U.S., Europe and Japan. This represents an estimated cost to healthcare systems in the tens of billions of US dollars annually. An ImplaVax-enabled vaccine could provide a simple and effective means to address peanut allergy on a large scale, particularly for younger sufferers who may have an aversion to needles and traditional injections.

Sementis' single vectored vaccine for chikungunya/Zika virus infection is equally promising with extensive proof-of-concept studies in mice demonstrating the effectiveness of the vaccine in protecting against Zika and chikungunya from a single vaccination shot. An ImplaVax-enabled product using the Sementis SCV chikungunya/Zika vaccine offers the potential to provide long-lasting immunity and retain potency across a wide range of storage conditions for prolonged periods. These represent high-priority objectives for governments and health authorities around the world.

David Hipkiss, CEO of Enesi Pharma, said:  

"We are delighted to enter into this new R&D collaboration. Sementis has developed a novel vaccine platform that has demonstrated exciting results in proof-of-concept studies in allergy and infectious diseases. The collaboration to develop a solid dose version of these vaccines for use with our ImplaVax needle-free device offers the potential to deliver a robust and effective product addressing significant global health challenges. We are seeing increasing interest from all areas of the vaccine and public health industries based on the potential benefits that ImplaVax could provide to improve vaccination. We look forward to advancing multiple collaborations, including this exciting project with Sementis." 

Dr Paul Howley, CEO of Sementis, added:  

"We are excited with this collaboration as we are very confident that the ImplaVax technology will work extremely well with our vaccine vector technology to reduce, or even eliminate, the reliance on maintaining a cold-chain environment from manufacture to point-of-care, and possibly providing long-term stability to our vaccines. Also, Enesi's technology may eliminate the need for highly trained healthcare workers to administer our vaccine as no injection is required. We will be evaluating this technology with one of our infectious disease vaccines and one of our hypoallergy vaccine candidates and if proven to expectations the ImplaVax technology will be applicable to all of Sementis vaccines covering infectious disease, allergies and cancers." 

Under the terms of the agreement, Enesi Pharma will formulate solid dose implants based on SCV vaccine provided by Sementis, and Sementis will undertake safety and immunogenicity testing, and preclinical development. Pending positive outcomes, this agreement would set the foundation of future commercial opportunities.

NOTES TO EDITORS 

About Peanut Allergy 

Peanut allergy is a disorder where an individual suffers from a potentially life-threatening allergic reaction upon ingesting even the smallest amount of peanut. There is no cure for peanut allergy available at this time; meaning sufferers must exercise strict dietary scrutiny and restrictions, imposing significant lifestyle constraints as the only means of avoiding a reaction.

Peanut allergy is one of the most severe food allergies; rarely remitting compared with milk and egg allergy and is frequently associated with life threatening allergic reactions (anaphylaxis). Peanut allergy in this way can be seen as a life sentence to the sufferer.

Current treatments are not preventative, a sufferer must be experiencing symptoms before self-diagnosis is made and treatment can occur (usually self-administration of adrenalin through an Epipen) and admission to hospital.

It is not difficult to imagine the fear and frustration felt by sufferers and the parents of suffering children given the seriousness of this allergy, and the public's often blasé use of a nut that is potentially deadly to more than one in one hundred people.

Sementis is developing a safe vaccine that it believes could be a permanent cure for peanut allergy.

There are estimated to be over 7 million peanut suffers in the major markets of the U.S., Europe and Japan. This figure is expected to rise to well over 8 million by 2025. One third of these are estimated to have severe peanut allergy.

The prevalence of food allergy in children in the emerging Asian economies (including China) has been rising and it is estimated that it is now comparable to that in Europe.

About Chikungunya and Zika 

Chikungunya is a debilitating disease that causes severe joint pain and can lead to long-lasting arthritis.

Zika is a virus currently circulating in the Americas and Asia and has recently received a lot of attention because of its association with microcephaly in children and Guillain-Barré syndrome in adults.

Both chikungunya and Zika can be transmitted from the bite of Aedes mosquitos, which are prevalent in tropical and temperate regions, and therefore both diseases have the potential to spread more widely.

Not surprisingly there is an overlap of regions where both viruses co-exist and where in a single bite can transmit both viruses at the same time. Current hotspots for both are the Americas particularly the Caribbean countries and territories. Chikungunya is also endemic in Africa and Asia, with concerns that Zika will also become endemic in these regions as the occurrence of chikungunya keeps on rising.

To combat both these diseases, Sementis aims to develop a dual acting vaccine to prevent both Chikungunya and Zika infection, making it a potential highly cost-effective public health outcome.

About Enesi Pharma 

Enesi Pharma is an innovative pharmaceutical company developing new products with potential to transform performance and delivery of vaccines and make a material impact on global healthcare.

The company's primary focus is the development of novel solid dose vaccines against a range of infectious and other select diseases, working in partnership with global companies, government agencies and non-governmental organisations.

Enesi's ImplaVax® formulation and device technologies offer significant potential benefits for patients, care givers, healthcare professionals and payers through enhanced effectiveness, safety, ease of use, reliability and stability, and are supported by a strong patient preference over a standard needle and syringe.

Enesi's experienced leadership team has a proven track record in the successful development and commercialisation of innovative products delivering high value outcomes for all stakeholders. For more information visit http://www.enesipharma.com or follow Enesi on Twitter at http://www.twitter.com/enesi_pharma

About Sementis 

Sementis is an Australian unlisted public biotechnology company that is using its proprietary Sementis Copenhagen Vector (SCV) platform technology to generate a portfolio of innovative vaccine candidates for the prevention of infectious diseases and treatment of allergies and cancers. SCV is a novel vector platform that uses a replication-incompetent vaccinia virus to stimulate both B-cell and T-cell immune responses. The genes for disease antigens are added to the SCV, which upon vaccination elicits a potent immune response to the disease state. Unlike other poxvirus vectored vaccines, SCV vectored vaccines can be manufactured in a CHO cell substrate thus enabling superior upscaling abilities in bioreactors and manufacturing using a protein free production process. For more information visit http://www.sementis.com.au