Three analysts initiate coverage on CureVac

BofA securities starts CureVac (CVAC -10.5%) coverage with buy and sets price target of $70 (23% upside).

Jefferies Financial initiates CureVac with hold, and price target of $58.

Credit Suisse initiates CureVac with neutral and sets PT of $68 (20% upside).

“CureVac has strong development pipeline. The company’s product candidates are in different stages of development. Its lead drug candidate is mRNA based vaccine against COVID-19” writes Avisol Capital Partners on SA.

https://seekingalpha.com/news/3612262-three-analysts-initiate-coverage-on-curevac

Qiagen readies launch of rapid portable coronavirus test

Qiagen (NYSE:QGEN) announces plans to launch the Access Anti-SARS-CoV-2 Antigen Test designed to generate ~30 tests per hour from swab specimens using a small digital detection system.

The test, developed in collaboration with Australian digital diagnostics company Ellume, can generate a result in less than 15 minutes and is suited for high volume environments requiring fast accurate results.

Two versions of the Antigen Test, one for labs and one for point-of-care use, will be commercially available next quarter.

Feasibility tests showed sensitivity of at least 90% and specificity of 100%.

https://seekingalpha.com/news/3612278-qiagen-readies-launch-of-rapid-portable-coronavirus-test

Pfizer/BioNTech add Germany to large-scale study of COVID-19 vaccine

Pfizer (NYSE:PFE) development partner BioNTech (NASDAQ:BNTX) announces regulatory sign-off in Germany for its Phase 2/3 clinical trial evaluating COVID-19 vaccine candidate BNT162b2.

The companies say more than 25K participants have been enrolled thus far, 83% of the target of 30K across 120 sites globally.

https://seekingalpha.com/news/3612059-pfizer-biontech-add-germany-to-large-scale-study-of-covidminus-19-vaccine

Kamada up on positive interim data from Phase 1/2 IgG trial in COVID-19

Kamada (NASDAQ:KMDA) jumps 17% premarket in reaction to completing enrollment and announcing initial interim results from its ongoing Phase 1/2 open-label trial in Israel of its anti-SARS-CoV-2 plasma-derived hyperimmune immunoglobulin (IgG) product as a potential treatment for COVID-19.

The trial is designed to assess the safety, pharmacokinetics, and pharmacodynamics of Kamada’s plasma-derived IgG product in hospitalized, non-ventilated COVID-19 patients with pneumonia.

A total of 12 eligible patients (age 34-69) were enrolled in the trial. Patient follow-up will occur for 84 days.

Symptoms improvement was observed in 11 of the 12 patients within 24 to 48 hours from treatment. All 11 patients were subsequently discharged from the hospital within a median hospital stay of 4.5 days from treatment.

One patient had a serious adverse event four days after treatment, which was categorized by the investigator as unrelated to the Company’s IgG product.

“We expect that these initial interim results, and the final trial results, to be available by January 2021, will support our clinical plan to advance our IgG product as a potential treatment for hospitalized COVID-19 patients,” said Amir London, CEO.

FDA response on submitted pre-IND information package expected next Month; U.S. clinical development anticipated to commence in early 2021.

https://seekingalpha.com/news/3612068-kamadaplus-17-on-positive-interim-data-from-phase-1-2-igg-trial-in-covidminus-19

Vaxart’s COVID-19 vaccine shows encouraging action in preclinical study

Vaxart (NASDAQ:VXRT) announces pre-publication of a manuscript titled “Preclinical studies of a recombinant adenoviral mucosal vaccine to prevent SARS-CoV-2 infection.”

The study was designed to assess the relative immunogenicity of four candidate vaccines expressing multiple combinations of the spike (S) and nucleocapsid (N) proteins of the SARS-CoV-2 virus in a standard mouse model. Key findings are as follows:

IgA response in the lungs of animals was induced, which is indicative of a mucosal immune response. Particularly, neutralizing antibodies in the lungs were observed at a very high percentage of the total antibody response.

Immunization with our vaccine candidate expressing full length S and N proteins induced IgG responses in a dose-dependent manner.

Antigen-specific CD4+ and CD8+ T cells were induced at both low and high doses.

Vaccine administration induced only low levels of IL-4 production, suggesting little risk of vaccine- dependent disease enhancement.

Vaxart stock has sunk in recent weeks, from $17 to ~$5, but this is still a huge premium to early 2020 low of $0.35. VXRT YTD growth is around 1,300%.  

https://seekingalpha.com/news/3612106-vaxart-s-covidminus-19-vaccine-shows-encouraging-action-in-preclinical-study

RedHill’s opaganib shows encouraging action against SARS-CoV-2 in preclinical

RedHill Biopharma (RDHL +12.0%) announces encouraging results from a preclinical study assessing protease inhibitor opaganib in an in vitromodel of human lung bronchial tissue. Opaganib completely inhibited SARS-CoV-2 replication.

Opaganib is currently being evaluated in a global Phase 2/3 trial and a U.S. Phase 2 study in severely ill COVID-19 patients with pneumonia.

Opaganib demonstrated the most potent activity compared to all compounds tested, including the positive control, Gilead Sciences’ (GILD -2.4%) remdesivir.

In addition to Opaganib, RedHill’s in-vitro study evaluated the antiviral activity of its Phase-2 stage investigational drug, RHB-107.

A U.S. Phase 2/3 study with RHB-107 in an outpatient setting should launch later this year.

https://seekingalpha.com/news/3612131-redhills-opaganib-shows-encouraging-action-against-sars-covminus-2-in-preclinical-study

Inovio adds Thermo Fisher to list of COVID-19 vaccine makers

Inovio Pharmaceuticals (INO +0.2%) announces that Thermo Fisher Scientific (TMO -0.8%) has signed a letter of intent to produce its COVID-19 vaccine candidate INO-4800.

TMO is the latest addition to a consortium of third-party manufacturers that INO is counting on to make 100M doses next year, if approved.

https://seekingalpha.com/news/3612134-inovio-adds-thermo-fisher-to-list-of-covidminus-19-vaccine-makers