INOVIO said today that its DNA vaccine for COVID-19 was on track for a Phase II/III trial this summer after generating positive interim Phase I results—though not positive enough to wow investors—and will also be studied as part of President Donald Trump’s “Operation Warp Speed” program.

According to INOVIO, preliminary analyses of its Phase I results showed that 34 out of 36 trial participants completing the study (94%) “demonstrated overall immune responses” six weeks after receiving two doses of INO-4800 in the study. Participants were enrolled into 1.0 mg or 2.0 mg dose cohorts, with each participant receiving two doses of INO-4800 four weeks apart.

The Phase I study (NCT04336410) was an open-label trial designed to evaluate the safety, tolerability and immunological profile of INO-4800 administered by intradermal injection followed by electroporation using the company’s CELLECTRA® 2000 device.

The trial initially enrolled 40 healthy adult volunteers 18 to 50 years of age at two U.S. sites with funding from the Coalition for Epidemic Preparedness Innovations (CEPI), which has awarded INOVIO a total $17.2 million in support toward development of INO-4800.

However, one participant in the 1.0 mg dose cohort and two participants in the 2.0 mg dose cohort were excluded in the immune analyses because they tested positive for COVID-19 immune responses at entry into the study, indicating prior infection. Another participant in the 2.0 mg dose cohort ended involvement in the trial “for reasons unrelated to safety or tolerability,” according to INOVIO.

INO-4800 was found to be generally safe and well-tolerated in all participants in both cohorts through week 8, following a review by the trial’s independent Data Safety Monitoring Board. Ten adverse events (AEs) were reported, but all were grade 1 in severity, and most were local injection site redness. There were no reported serious adverse events (SAEs), according to INOVIO.

Trials heat up, investors respond coolly

INOVIO also said it expanded its Phase I trial to add older participants in additional cohorts, and was still on track to begin a planned Phase II/III efficacy trial this summer upon regulatory approval.

“We look forward to urgently advancing INO-4800, as it is the only nucleic-acid based vaccine that is stable at room temperature for more than a year and does not require to be frozen in transport or for years of storage, which are important factors when implementing mass immunizations to battle the current pandemic,” INOVIO president and CEO J. Joseph Kim, PhD, said in a statement.

Despite the good clinical news, investors responded by sending the company’s shares down 15% to $26.95 a share at the close of trading, from yesterday’s close of $29.98.

The selloff followed what reports said was disappointment among investors that INOVIO had not offered further details of the Phase I results, saying that a full dataset will be published in a peer-reviewed medical journal.

“This Inovio press release is about as good of an example there is where a PR might sound awesome to the common person (Robinhood trader) but anyone who knows what they are talking about is like ‘where’s the data?’” Brad Loncar, CEO of Loncar Investments, tweeted this morning.

INOVIO also said that INO-4800 has been selected for a non-human primate (NHP) challenge study organized and funded by Operation Warp Speed, the program through which President Donald Trump’s administration has committed to delivering 300 million vaccine doses protecting against SARS-CoV-2 by January 2021.

INOVIO’s inclusion in the program comes days after Vaxart announced that its room temperature stable tablet vaccine for COVID-19 will be evaluated by Operation Warp Speed as well, in the name NHP study.

INOVIO’s INO-4800 is a DNA vaccine targeting the major surface antigen Spike protein of SARS-CoV-2. INO-4800 is among 28 “Definitely Maybe” COVID-19 therapeutic candidates within GEN’s COVID-19 DRUG & VACCINE CANDIDATE TRACKER, which has grown to 255 candidates.

Antibody, T cell immune responses

One key feature of INO-4800 and other DNA vaccines by INOVIO, according to the company, is the ability to generate balanced antibody and T cell immune responses. INOVIO said preliminary studies showed vaccination with INO-4800 was able to prevent viral replication in the lungs of mice challenged with SARS-CoV-2, and is currently being tested in a ferret challenge model

In May, INOVIO trumpeted the publication In May, INOVIO trumpeted the publication of preclinical data in Nature Communications reporting that INO-4800 showed robust neutralizing antibody and T cell immune responses against SARS-CoV-2 in mice and guinea pigs. INOVIO investigators collaborated on the study with researchers from Advaccine, Fudan University, Public Health England, the University of Texas, and The Wistar Institute.

“While the pathophysiologic profile of SARS-CoV-2 is not completely understood, research and clinical studies suggest that both T cell and antibody immune responses will be important for protection in both mild and serious infections,” stated Kate Broderick, PhD, senior vice president of R&D at INOVIO.

INO-4800 emerged as an early front runner among COVID-19 vaccine candidates; it was among developers of drug and vaccine candidates against the virus that were highlighted March 22 on CBS’ “60 Minutes.”

But in recent weeks, news for INO-4800 has been mixed.

On June 3, INOVIO filed a lawsuit against VGXI and its parent company GeneOne Life Science in the Court of Common Pleas of Montgomery County, PA, seeking unspecified monetary damages against the contract manufacturing organization. INOVIO accused VGXI and GeneOne of breaching a contract, then terminating the agreement and treating it as expired after refusing to transfer manufacturing methods, using VGXI’s technology, to two other contract manufacturers, Ology Bioservices and Richter-Helm BioLogics.

However, last week, INOVIO was awarded up to $71 million from the U.S. Department of Defense (DoD) toward manufacturing of two devices designed for injection of INO-4800. The DoD awarded approximately $54.5 million toward development and large-scale manufacturing of the company’s CELLECTRA® 3PSP smart device, and $16.6 million toward the purchase of INOVIO’s intradermal CELLECTRA® 2000 device and accessories, to be used for injecting INO-4800 in later-stage clinical trials.

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