Brazil’s SENAI CIMATEC Doses First Healthy Volunteers in Phase 1 trial of HDT Bio’s RNA COVID-19 Vaccine

HDT Bio Corp. | January 17, 2022

HDT Bio Corp., a U.S. developer of immunotherapies for oncology and infectious diseases and SENAI CIMATEC, an important Brazilian education, research, and innovation institute, have dosed the first healthy volunteers in Brazil in a Phase 1 trial of HDT Bio’s RNA COVID-19 vaccine, HDT-301. SENAI CIMATEC will conduct the clinical trial under the name Vaccine RNA MCTI-CIMATEC-HDT. The vaccine uses HDT Bio’s proprietary lipid nanoparticle RNA-delivery technology.

This clinical trial in Brazil is the second international study to get under way in our efforts to help partners in historically underserved nations fight this pandemic by transferring our unique technology to provide them local control over development, manufacturing and distribution of a COVID-19 RNA vaccine. The first was in India with our partner Gennova Biopharmaceuticals which has moved the vaccine into Phase 2 and Phase 3 trials.”

 HDT Bio CEO Steve Reed

HDT Bio has other partnerships for its RNA COVID-19 vaccine, including in South Korea and China. “These partnerships are part of our company’s mission and business strategy aimed at bringing our advanced immunotherapies to underserved nations to help address global health inequities,” Reed explained.

"Through the partnership with HDT Bio Corp., SENAI CIMATEC is incorporating in Brazil the development and qualification for a state-of-the-art technology in an exclusive way, as well as the first clinical study involving an RNA self-amplifying vaccine. This moment can be considered as an important demonstration of the potential of Brazilian science, represented in this study by SENAI CIMATEC,” said President of Federation of Industries of the State of Bahia Ricardo Alban “We also highlight the important funding received through the Ministry of Science, Technology and Innovations which has supported the execution of the initial clinical phases, “Alban added.

“From the clinical studies of the Vaccine RNA MCTI CIMATEC HDT we expect to obtain sufficient data to demonstrate the efficacy and safety of this product to the population. In this way, the development of the Vaccine RNA MCTI CIMATEC HDT represents a crucial milestone for the modernization of the national health system, since it can later be produced in the country itself,” said infectious disease doctor and Principal Investigator of the clinical studies in Brazil Roberto Badaró.

SENAI CIMATEC’s double-blind, placebo-controlled, dose-ranging Phase 1 clinical trial will enroll 90 healthy adult volunteers. The trial will assess the safety, tolerability, and immunogenicity of the vaccine at three dose levels, 1 µg, 5 µg and 25 µg. Safety and tolerability will be the primary endpoints assessed by incidence of adverse events for each dose through 12 months after the vaccination. Scheduled interim evaluations to measure immunogenicity also will be conducted.

HDT Bio’s innovative vaccine, which also will undergo a Phase 1 trial in the U.S., uses its proprietary lipid nanoparticle carrier system for delivery of RNA. The vaccine is significantly different from existing 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 nanoparticle delivery system rather than being encapsulated within it, providing for enhanced stability.

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. 

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 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, health and biotechnology, with the main objective to support industries, including the Brazilian Industrial Health Complex.


LSC-Montgomery is leading the way with some cutting edge Biotechnology research. Check out this video and then check out www.LoneStar.edu to find a career.

Other News

Enveric Biosciences Announces Reverse Stock Split

Enveric Biosciences | July 15, 2022

Enveric Biosciences, Inc. a neuroscience-focused biotechnology company developing next-generation, psychedelic-inspired mental health medicines, announced that it intends to effect a reverse stock split of its common stock at a ratio of 1 post-split share for every 50 pre-split shares. The reverse stock split will become effective at 4:05 p.m., New York time, on Thursday, July 14, 2022. Enveric’s common stock will continue to be traded on the Nasdaq Capital Market under the symbol “ENVB” and will begin trading on a split-adjusted basis when the market opens on Friday, July 15, 2022. At a special meeting of stockholders held on July 14, 2022, Enveric’s stockholders granted the Company’s Board of Directors the discretion to effect a reverse stock split of Enveric’s common stock through an amendment to its Amended and Restated Certificate of Incorporation, as amended, at a ratio of not less than 1-for-10 and not more than 1-for-100, such ratio to be determined by the Company’s Board of Directors. At the effective time of the reverse stock split, every 50 shares of Enveric’s issued and outstanding common stock will be converted automatically into one issued and outstanding share of common stock without any change in the par value per share. Stockholders holding shares through a brokerage account will have their shares automatically adjusted to reflect the 1-for-50 reverse stock split. It is not necessary for stockholders holding shares of the Company’s common stock in certificated form to exchange their existing stock certificates for new stock certificates of the Company in connection with the reverse stock split, although stockholders may do so if they wish. The reverse stock split will affect all stockholders uniformly and will not alter any stockholder’s percentage interest in the Company’s equity, except to the extent that the reverse stock split would result in a stockholder owning a fractional share. Any fractional share of a stockholder resulting from the reverse stock split will be rounded up to the nearest whole number of shares. The reverse stock split will reduce the number of shares of Enveric’s common stock outstanding from 52,684,548 shares to approximately 1,053,691 shares. Proportional adjustments will be made to the number of shares of Enveric’s common stock issuable upon exercise or conversion of Enveric’s equity awards and warrants, as well as the applicable exercise price. Stockholders whose shares are held in brokerage accounts should direct any questions concerning the reverse stock split to their broker. All stockholders of record may direct questions to the Company’s transfer agent, American Stock Transfer & Trust Company, LLC, at 1-877-248-6417 or 1-718-921-8317. About Enveric Biosciences Enveric Biosciences, Inc. is a neuroscience-focused pharmaceutical company developing next-generation, psychedelic-inspired mental health medicines. Enveric’s robust pipeline supports drug development from the clinic to commercialization aimed to help millions of patients in need around the world suffering from conditions that include cancer-related distress, PTSD and more.

Read More


Celyad Oncology Announces FDA Lifts Clinical Hold of CYAD-101-002 Phase 1b Trial

Celyad Oncology | August 01, 2022

Celyad Oncology SA a clinical-stage biotechnology company focused on the discovery and development of chimeric antigen receptor T cell therapies for cancer, today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on the CYAD-101-002 Phase 1b trial after the Company made changes to the eligibility criteria for the trial. “We are pleased that the FDA lifted the clinical hold on this trial. We remain confident in the potential development of not only the candidate itself, but the continued development with our proprietary TIM technology. CYAD-101 is currently our only clinical candidate co-expressing NKG2D and TIM, and we hope to continue to showcase our expertise with our non-gene edited technologies and explore additional opportunities to utilize NKG2D in allogeneic CAR T,” Dr. Charles Morris, Chief Medical Officer of Celyad Oncology As previously disclosed, on February 28, 2022, the Company announced that it was voluntarily pausing the CYAD-101-002 trial to investigate reports of two fatalities in the study. The trial was subsequently put on clinical hold in March 2022 by the FDA. About Celyad Oncology Celyad Oncology is a clinical-stage biotechnology company focused on the discovery and development of chimeric antigen receptor T cell therapies for cancer. The Company is developing a pipeline of allogeneic (off-the-shelf) and autologous (personalized) CAR T cell therapy candidates for the treatment of both hematological malignancies and solid tumors. Celyad Oncology was founded in 2007 and is based in Mont-Saint-Guibert, Belgium and New York, NY. The Company has received funding from the Walloon Region to support the advancement of its CAR T cell therapy programs.

Read More


Pharmactive Enters Strategic Partnership with Nutraconnect for APAC

Pharmactive | June 08, 2022

Pharmactive Biotech Products, S.L.U., announces a new strategic partnership with Singapore-based Nutraconnect Pte, Ltd. to bring innovative, scientifically backed nutraceutical ingredients to the Asia-Pacific marketplace (not including Australia and New Zealand). The partnership will combine the strengths of both companies into a greater whole. Pharmactive will provide its well-supported, clean-label botanical extract ingredients, while Nutraconnect will function as a growth engine for the region, connecting Pharmactive with local and regional nutraceutical players seeking high-quality, pure ingredients. Nutraconnect Pte., Ltd. is a start-up led by Rohit Noronha, co-founder and Chief Growth Officer, and Nikhil Prabhakar Sawant, co-founder and CEO. Both are highly experienced leaders in the nutraceutical industry. We are very fortunate to partner with Nutraconnect, as their team possesses a great deal of market and customer information and strategic insight, allowing for quick responses to potential customers in their local time-zone, Asia is a tremendous growth-hub for Pharmactive. We already have had successes in Korea, Japan, Vietnam, and Malaysia with Affron® pure saffron extract and Aged Black Garlic [ABG+®]. Many Asian industry players, formulators, and brand owners approach us about new compounding formats or innovative product concepts to cross the nutraceutical/functional food and beverage divide. Asia is clearly the frontrunner in terms of new ingredient concepts." Jean-Marie Raymond, CEO and Founder of Pharmactive. About Pharmactive Pharmactive Biotech Products, S.L.U., is a Madrid-based pioneering biotechnology company that develops and manufactures differentiated natural ingredients supported by science, such as pure saffron extract and aged black garlic. The company's mission is to make a daily positive and significant impact on people's health and well-being through premium botanical ingredients backed by scientific studies and approved by ethics committees. Pharmactive grows, cultivates, and produces farm-to-fork botanical ingredients with a minimal ecological footprint. About Nutraconnect Founded in 2022, Nutraconnect Pte., Ltd., is a nutraceutical business growth acceleration service headquartered in Singapore. The company provides end-to-end solutions for global nutraceutical ingredient manufacturers that are looking to establish a foundation for sustainable growth in the fragmented, but booming APAC market.

Read More


NEOGEN® and Gencove Launch InfiniSEEK™ -- The First Whole Genome and Genotyping Sequencing Solution for Cattle Breeders

NEOGEN | May 16, 2022

NEOGEN® Corporation (NASDAQ: NEOG) and Gencove, the leading low-pass whole genome sequencing and analysis software company, today announced the launch of InfiniSEEK™, an innovative, cost-effective solution for whole genome sequencing and targeted SNP analysis. Combining NEOGEN's world-class genomic solutions and services with Gencove's low-pass sequencing and analytics software, the solution can deliver genomic insights to help advance cattle breeding programs worldwide. NEOGEN offers innovative, high quality, value-added genomic technologies to the agrigenomics industry, With the launch of InfiniSEEK, our customers now have a data-rich, cost-efficient way to get genome-wide sequence data, specific genetic traits, and parentage markers simultaneously with excellent accuracy to characterize cattle across the world. We are excited to add this new solution to NEOGEN's portfolio." Dr. Jason Lilly, NEOGEN's Vice President of International Business. Gencove developed a process that simultaneously yields low-pass whole genome sequencing and high coverage genotyping at pre-selected loci in a single molecular reaction, InfiniSEEK is NEOGEN's first commercial product built on the Gencove software and analysis platform, and we are thrilled it will be deployed through NEOGEN's best in class genomics offering services." Dr. Joseph Pickrell, co-founder and CEO of Gencove. With InfiniSEEK, the industry now has a platform to: Minimize selection bias by sequencing more or all of a population Discover new traits impacting desired phenotypes Reliably manage more than 400 bovine genetic traits and conditions InfiniSEEK has been rigorously validated, and results demonstrate low-pass genome-wide sequencing to be greater than 99 percent concordant to deep whole-genome sequencing and can offer even higher, clinical-grade accuracy at specific regions of interest. About Gencove With additional opportunities to improve human health and the challenge of feeding the world's growing population, demand for genomic information has skyrocketed. To meet the need, Gencove combines low-pass whole genome sequencing (reading the DNA at shallower depths) with a proprietary software-as-a-service computation layer. The result is a high-throughput, cost-effective, accurate sequencing and analysis solution. As evidence of the technology's value, the company has hundreds of customers, and the largest genomics service providers in the world partner with Gencove. About NEOGEN NEOGEN Corporation develops and markets comprehensive solutions dedicated to food and animal safety, operating with the intention to "everyday, protect the people and animals we care about." The company's Food Safety segment markets dehydrated culture media and diagnostic test kits to detect foodborne bacteria, natural toxins, food allergens, drug residues, plant diseases, and sanitation concerns. NEOGEN's Animal Safety segment is a leader in the development of genomic solutions along with the manufacturing and distribution of a variety of animal healthcare products, including diagnostics, pharmaceuticals, veterinary instruments, wound care, and disinfectants, as well as rodent and insect control solutions.

Read More


LSC-Montgomery is leading the way with some cutting edge Biotechnology research. Check out this video and then check out www.LoneStar.edu to find a career.