HDT Bio Partners with Brazil’s SENAI CIMATEC to Advance RNA COVID-19 Vaccine to Fight Pandemic

• Agreement extends HDT Bio’s international COVID 19 vaccine partnerships as part of its long-term goal of changing the global-health paradigm to address global-health inequity
• The company’s RNA-based vaccine offers simpler manufacturing, easier deployment without the need for ultra-low freezers, and requires vastly lower dosing than current RNA COVID-19 vaccines

SEATTLE & SALVADOR, Brazil–(BUSINESS WIRE)–HDT Bio Corp., a developer of immunotherapies for oncology and infectious diseases, and SENAI CIMATEC, an important education, research, and innovation institute, announced today that they will co-develop HDT Bio’s RNA COVID-19 vaccine, HDT-301, in Brazil. Brazil’s National Health Surveillance Agency (Anvisa) has authorized Phase 1 clinical trials of HDT-301. SENAI CIMATEC will conduct those clinical trials under the name Vaccine RNA MCTI-CIMATEC-HDT. This vaccine uses HDT Bio’s proprietary LION^TM RNA-delivery technology.

SENAI CIMATEC is a Brazilian developer of a full range of health technologies, including vaccines, adjuvants, biologics, cell and gene therapies, in vitro diagnostic products and medical devices. “This agreement with SENAI CIMATEC will help build Brazil’s own vaccine and drug manufacturing capabilities, and provide the country’s population with greater access to advanced medicines,” said HDT Bio CEO Steve Reed. “Our company’s unique mission is to initiate value-creating partnerships with drug manufacturers and developers in historically underserved countries as part of our sustainable global health and business strategy.”

HDT Bio has established similar development collaborations for HDT-301 in India with Gennova Biopharmaceuticals, with Quratis Inc. in South Korea, and with a third partner in China. Gennova has completed its Phase 1 trial of HDT Bio’s RNA vaccine technology and Indian regulatory authorities have approved the start of pivotal Phase 2/3 trials.

HDT Bio’s innovative vaccine uses its proprietary LION^TM, lipid-based carrier system for delivery of RNA. The vaccine is significantly different from currently commercially available RNA vaccines in two ways. First, its RNA payload is designed to amplify itself inside the body. As a result, the vaccine activates the immune system at a much lower dose than commercially available vaccines, enhancing safety and reducing manufacturing costs. Second, the RNA attaches to the outside of the LION^TM system rather than being encapsulated within it, providing for enhanced stability.

“Partnering with HDT Bio gives us a unique opportunity to bring the world’s most advanced RNA vaccine technology to Brazil to fight COVID-19,” said the Brazilian minister of science, technology and innovations, astronaut Marcos Pontes. The Ministry is supporting and following the development of vaccines in Brazil.

“The agreement enables us to drive clinical development, manufacturing, distribution and commercialization in Brazil,” said Antônio Ricardo Alban, President of Federation of Industries of the State of Bahia, which includes SENAI CIMATEC.

Through the technology transfer agreement, SENAI CIMATEC will incorporate HDT Bio’s technology not only to battle COVID-19, but also to support other technological and scientific advances in Brazil.

“Thanks to the technology transfer SENAI CIMATEC has already started production of HDT Bio’s RNA COVID-19 vaccine on a pilot scale, and is performing research related to new variants of SARS-CoV-2,” said Leone Andrade, Director of Technology and Innovation of SENAI CIMATEC.

Under the agreement, HDT Bio has granted SENAI CIMATEC a non-exclusive license to its technology for research, manufacture and sale of HDT-301 in Brazil. The Seattle biotech company will provide the vaccine for Phase 1, 2, and 3 studies. Additionally, the technology transfer agreement allows the entire production of the vaccine in Brazil, including the API, after the completion of clinical studies. These initiatives will help to increase the number of jobs and vaccines available for Brazilians.

ABOUT HDT BIO CORP.

HDT Bio is a biopharmaceutical company dedicated to providing immunotherapies to people around the world, including those in historically underserved areas. The company seeks to harness the body’s immune system to deliver therapies that narrowly target the specific areas of the body where they are needed. HDT Bio’s work focuses on oncological and infectious disease applications. HDT Bio’s founders are world leaders in the development of immune stimulants, including both therapeutics and therapy-enhancing adjuvants. One of the company’s core technologies, RNA/LION™, combines formulation and adjuvant ingredients to stabilize and deliver RNA to the immune system to stimulate responses for therapy or vaccination. http://hdt.bio

ABOUT SENAI CIMATEC

SENAI CIMATEC focuses on higher education, research and innovation for the development of industry. Its manufacturing and technology integrated campus is one of the most advanced centers for education (under graduation, master degree and PhD programs), specialized services, applied research and innovation projects in Brazil. CIMATEC operates in more than 40 different areas of competence, with emphasis on computer technology, engineering, healthy and biotechnology, with the main objective to support industries, including the Brazilian Industrial Health Complex.. For more information visit: http://www.senaicimatec.com.br/.

Contacts

Christopher M. Pirie, Ph.D.

(425) 241-4152

[email protected]