Last month, Lupe Duarte read an announcement from her colleagues that City of Hope was recruiting for a COVID-19 vaccine trial. The mother of three, who also cares for her infirm parents, volunteered immediately.
This afternoon the 48-year old project manager became the first patient to get a dose of the vaccine developed by a team of researchers at City of Hope.
She's part of the biotech institution's phase 1 trial, which tests a drug's safety typically over one to two years. The process is likely to last just three months as regulators speed up approval to deal with the pandemic. The next stage, expected to span about eight months, would test on more volunteers and further assess safety and efficacy.
Los Angeles biotech companies are in a race to create vaccines as the U.S. embarks on the largest public health initiative in generations.
On Friday, the FDA issued emergency authorization to Pfizer's COVID vaccine, paving the way for a massive mobilization effort across the country. Moderna has also submitted a vaccine, slated for review December 17.
But that won't bring an end to the need for vaccines.
"Let's face it, there are close to 7 billion people on this Earth, and most of them will need a vaccine," said City of Hope vaccine researcher Don J.Diamond. "No one company will want to devote the resources to vaccinating the world."
ImmunityBio<img lazy-loadable="true" data-runner-src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yNDk0ODQzMi9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTY2NTUwNTMzNH0.IyRvykxKTpGw9CnaNbUEUAWuYRKuMHlxSl9f14M2YqE/img.jpg?width=980" id="8c0ff" class="rm-shortcode" data-rm-shortcode-id="eff3564a2ca30e03d4f21a7efc0dbb94" data-rm-shortcode-name="rebelmouse-image" alt="ImmunityBio" data-width="343" data-height="112" /><p>The El Segundo-based biotech company ImmunityBio is the furthest along. It started phase one trials of its vaccine at Hoag Hospital in Newport Beach in October with 35 patients.</p><p>No adverse reactions have been reported in the 20 individuals that have received low doses of the vaccines, so far.</p><p>The vaccine, called hAd5, uses engineered adenovirus that targets "spike" and "nucleocapsid" COVID proteins to generate antibodies that the company hopes will provide long-term immunity.</p><p>The CEO of ImmunityBio, Patrick Soon-Shiong, a biotech leader and billionaire who owns the umbrella company NantQwest and the Los Angeles Times, told the news organization two months ago that the biggest challenge to using adenovirus is that it is a common cold virus. Many already have developed antibodies that could hurt its effectiveness.</p><p>His late-stage immunotherapy company had been working with adenovirus in its development of drugs for cancer and infectious diseases</p><p>The two-dose vaccine in development wouldn't require frigid temperatures that Pfizer's vaccine needs.</p><p>The company sees promise. Last month, it found that T cells gathered from previously infected patients showed indications that an immune response could be triggered by the vaccine.</p><p>"As the virus continues to spread at an alarming rate, it is important that we develop COVID-19 vaccines that not only provide the population with protection from new infection through antibodies that block viral entry into cells, but also establish a robust T cell immune response to clear the virus from infected cells," said Soon-Shiong said in a statement announcing the findings.</p>
City of Hope<img lazy-loadable="true" data-runner-src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yNDk0ODUxMC9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTY2NzY4ODg1Mn0.DWNeL5QBch1zA0Pk14uAWRbis0Duev3DWwnmRpnSZkg/img.jpg?width=980" id="1bff7" class="rm-shortcode" data-rm-shortcode-id="4ea24675c4e4c34021f717580d9f55e7" data-rm-shortcode-name="rebelmouse-image" data-width="1000" data-height="563" /><p>A team at City of Hope's clinical research center for cancer, diabetes and diseases announced last month it entered a phase one clinical trials. The vaccine aims to stimulate antibodies and T cells that can block the virus from entering susceptible cell types such as those in the lungs.</p><p>The first volunteer, a City of Hope employee, is scheduled to receive the first dose of the vaccine on Friday.</p><p>Researchers at the Duarte-based biomedical treatment and research facility developed a synthetic platform technology that hosts the SARS-CoV-2 spike and nucleocapsid proteins known as an MVA.</p><p>The MVA then replicates DNA within other cells that ultimately leads to the production of Sars-CoV-2 proteins that triggers an immune response.</p><p>According to City of Hope, synthetic MVA is a safely modified version of the poxvirus that's been approved by the Food and Drug Administration for the prevention of smallpox and monkeypox. It's also included in the federal government's Strategic National Stockpile for lifesaving use during a public health emergency.</p><p>Like many other vaccines, City of Hope's would require two doses. It would need to be stored at 60 degrees celsius, not as cold as Pfizer's, but researchers are investigating whether it can be freeze dried and stored at room temperature. The trial is estimated to finish by the end of March 2021.</p>
Capricor Therapeutics<img lazy-loadable="true" data-runner-src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yNDk0ODQ0NC9vcmlnaW4ucG5nIiwiZXhwaXJlc19hdCI6MTYzNTg3MzAxNX0.-joWdKw48GNWRi3LDel2WSQeBYux9oe-13EWcoDj8AE/img.png?width=980" id="ad9b0" class="rm-shortcode" data-rm-shortcode-id="2f92fd4767c268d7b522cf4d021a10a6" data-rm-shortcode-name="rebelmouse-image" alt="Capricor Therapeutics" data-width="1200" data-height="627" /><p>The Beverly Hills-based clinical stage biotech company is in the early stages of developing an exosome-RNA vaccine with Johns Hopkins University that uses tiny particles secreted by cells as a natural drug delivery vehicle in the body.</p><p>"As a cell-free substance, exosomes can be stored, handled, reconstituted and administered in a similar fashion to common biopharmaceutical products, such as antibodies and other recombinant protein drugs," the company said in a statement.</p><p>The 15-year-old company is known for developing exosome-based therapeutics to treat conditions including Duchenne muscular dystrophy.</p><p>Capricor said it has also begun phase two of a clinical trial of a therapeutic for patients at high-risk that are infected with the virus. The study is enrolling high-risk patients to examine the long-term cardiac consequences of the virus.</p><p><br></p><p><em>**This story has been updated.</em><br></p>
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