Mymetics, a pioneer and leader in the research and development of virosome-based vaccines against life threatening and life disabling diseases, announced today that the National Institutes of Health (NIH) has awarded Mymetics and Texas Biomedical Research Institute (Texas Biomed) a five-year grant for the project called “Cold Chain-independent, Needle-free Mucosal Virosomal Vaccine to Prevent HIV-1 Acquisition at Mucosal Levels”.

The project has the objective to prepare Mymetics’ promising HIV-1 vaccine candidate for clinical trials. The vaccine candidate is based upon Mymetics’ virosomes, enveloped virus-like particles that display on their surface rationally designed HIV-1 antigens. The vaccine is created to induce protective mucosal antibodies acting as a frontline defense against sexual HIV transmission.

An earlier formulation of the vaccine candidate has shown safety and immunogenicity in a Phase I clinical trial in healthy women. Two independent non-human primate studies demonstrated the safety and high efficacy of the virosome-based vaccine in Chinese and Indian-origin rhesus macaques against repeated low-dose intravaginal challenges with a monkey AIDS virus, a so-called tier 2 R5 SHIV that shares key biological features with human transmitted forms of HIV-1. Mymetics recently finished a European Horizon 2020 funded project where Mymetics developed adjuvanted new solid powder forms of the vaccine which can be directly administered to mucosal tissues (nose, sublingual or oral) without needles and that do not depend on refrigeration, which makes the new vaccine attractive for the developing world where AIDS is at epidemic levels.

“We are excited to collaborate with Mymetics and our partners on a promising AIDS vaccine candidate that seeks to induce protective immune defenses at mucosal barriers – where HIV-1 first enters the body during sexual transmission of HIV-1. The new joint project complements our basic research, where we demonstrated potent protection with mucosal antibodies administered to rhesus macaques” said Professor and Director of the Texas Biomed AIDS Program, Dr. Ruth Ruprecht, who serves as Principal Investigator together with Dr. Sylvain Fleury, CSO of Mymetics Corporation.

“We are extremely grateful for the trust and support from the NIH for our project, it will enable the continued progress of our cold chain, independent virosome based HIV vaccine candidate” Ronald Kempers, CEO of Mymetics, stated. “We will be able to prepare it for clinical trials in collaboration with world leading HIV scientists from the University of Louisiana at Lafayette and our longstanding partner Texas Biomed.

The project will start on May 1, 2019 and is planned for five years. It is co-led by Drs. Ruprecht and Fleury and includes subawards to Dr. François Villinger of the University of Louisiana at Lafayette, and Dr. Sarah Ratcliffe of the University of Virginia. First results are expected to be reported in 2020.

Source: Mymetics

Synaffix, a Dutch biotechnology company exclusively focused on continued advancement of its clinical-stage antibody-drug conjugate (ADC) technology for the development of best-in-class ADCs, announces that it has entered into a license agreement with Shanghai Miracogen Inc., a Chinese biotechnology company with a clinical-stage pipeline of ADCs.

Under the terms of the agreement, Miracogen has been granted non-exclusive rights to Synaffix’s proprietary  GlycoConnect™ and HydraSpace™ ADC technologies for use in its next clinical candidate. Synaffix is eligible to receive upfront and potential milestone payments that total $125 million, plus royalties­­.

Miracogen will be responsible for the research, development, manufacturing and commercial-ization of the ADC product while Synaffix will be responsible for the manufacturing of components that are specifically related to its proprietary GlycoConnect™ and HydraSpace™ technologies.

This agreement follows a research collaboration between the two companies which was centered around a specific drug candidate that has now been selected for clinical development.

Mary Hu, Chairman and CEO of Miracogen, said:

“We are very pleased to have reached this license agreement with Synaffix. We believe that their GlycoConnect™ and HydraSpace™ technologies will further differentiate our pipeline of ADCs by delivering valuable expansion of the therapeutic index. Our efficient and collaborative relationship during the research phase has provided us with a highly competitive new asset for the Miracogen pipeline in just a five-month timeframe. We look forward to continuing our collaboration as we advance this candidate into the clinic and beyond to benefit cancer patients.”

Peter van de Sande, CEO of Synaffix, said:

“Working with Miracogen has been a rewarding experience. As we transition into the development phase together, this license agreement with Miracogen provides additional validation of our GlycoConnect™ and HydraSpace™ technologies.”

“There is a clear trend in China towards developing innovative products and as such, ADCs have emerged as a strong area of growth within the field of oncology. Our proprietary technologies can address the current unmet need for clinical candidates with an enhanced therapeutic index, thereby driving further growth of our activities in China and other markets.”

Source: Synaffix