Pharma COVID Roundup: News from J&J, CureVac, CSL, Roche, QiagenBy
The latest on manufacturing, potential treatments, and testing for COVID-19 with news from J&J, CureVac, CSL, Roche, LabCorp, Qiagen, Astellas, Celltrion, Sinovac, and others.
J&J Reports Results of COVID Vaccine in Preclinical Challenge Studies
Johnson & Johnson’s Janssen’s reported that its lead SARS-CoV-2 investigational vaccine candidate, Ad26.COV2.S, showed promising results in preclinical challenge studies. The studies showed that the vaccine prevented severe clinical disease in Syrian golden hamsters, upon challenge with SARS-CoV-2, the virus that causes COVID-19. The company reported that data, published in Nature Medicine, showed that the vaccine elicited an immune response as demonstrated by neutralizing antibodies and prevented severe clinical disease—including weight loss, pneumonia and mortality—in Syrian golden hamsters upon challenge.
Researchers first immunized Syrian golden hamsters with a single injection of the Ad26-based SARS-CoV-2 vaccine, which induced neutralizing antibodies in all the vaccinated animals. Four weeks later, the animals were exposed to a high dose of SARS-CoV-2 virus. These vaccinated animals lost less weight and had less virus in their lungs and other organs than unvaccinated control animals.
Ad26.COV2.S is currently being evaluated in clinical studies to establish the performance of the vaccine candidate in humans.
Source: Johnson & Johnson
CureVac To Get $297 M from German Gov’t for COVID Vaccine
CureVac, a Tubingen, Germany-based clinical-stage biopharmaceutical company developing messenger ribonucleic acid (mRNA) therapeutics, says it expects to receive up to EUR 252 million ($297 million) from the German Federal Ministry of Education and Research to support the development and manufacturing of its COVID-19 vaccine candidate.
In July 2020, CureVac had applied for a grant as part of a special program to accelerate the research and development of vaccines against SARS-CoV-2, the virus that causes COVID-19. In late July (July 2020), the Federal Minister of Education and Research, Anja Karliczek, announced that CureVac and other companies were eligible for funding according to the recommendation of a panel of experts.
In addition to the further development of CureVac’s COVID-19 vaccine candidate, the grant is expected to be used for the rapid expansion of production of the vaccine. Payments are contingent on reaching predefined milestones. CureVac expects funding of up to EUR 103 million ($122 million) in 2020 and up to EUR 149 million ($176 million) in 2021.
CSL to Manufacture, Supply Vaccines for Australian Gov’t
CSL, a Melbourne, Australia pharmaceutical company, has signed a heads of agreement (HoA) with the Australian government for the supply of 51 million doses of the University of Queensland’s (UQ) COVID-19 vaccine candidate, UQ-CSL V451, if proven successful. The company also signed a separate HoA with AstraZeneca to manufacture 30 million doses of AstraZeneca’s/Oxford University’s COVID vaccine candidate, AZD1222, should clinical trials prove successful.
The total number of the UQ COVID-19 vaccines ordered by the Australian government is based on a two-dose-per-person regime. Upon completion of successful clinical trials, CSL expects the first tranche of doses to be available by mid-2021.
The HoA is between CSL’s influenza vaccines company, Seqirus, which will hold regulatory responsibility as the marketing authorization holder, and the Australian government. Production of the vaccine to support late-stage clinical trials has commenced at CSL’s manufacturing facilities in Broadmeadows, Melbourne, Australia.
The University of Queensland is currently conducting a Phase I clinical study on UQ-CSL V451 to assess safety and immunogenicity in healthy volunteers. Should the Phase I study prove to be successful toward the end of this year (2020), CSL says it will take full responsibility for the subsequent Phase IIb/III clinical trial, which is expected to commence in late 2020.
Additionally, CSL has agreed with AstraZeneca to manufacture approximately 30 million doses of the AZD1222 vaccine candidate, with first doses planned for release to Australia early next year (2021). AZD1222 requires a two-dose-per-person regime. CSL will manufacture the vaccine from its Australian facilities and schedule production around the UQ-CSL V451 manufacture as well as manufacture its own core therapies.
The Australian government will provide funding to support CSL’s readiness to manufacture AZD1222. This funding will be used to establish at-risk components required to produce the commercial manufacture of a recombinant vector-based COVID-19 vaccine, including the acquisition of specialized equipment, recruitment, training and redeployment of personnel, and retooling and reconfiguration of existing manufacturing facilities to cGMP.
AstraZeneca has established a separate commercial arrangement with the Australian government to supply the AZD1222 vaccine to Australia once it successfully completes clinical trials. Successful manufacture and supply of AZD1222 under contract to AstraZeneca is subject to Australian regulatory approval.
Roche, LabCorp Both Launch Combined COVID, Influenza Tests
Roche and LabCorp have both advanced a combined diagnostic test for SARS-CoV-2, the virus that causes COVID-19, and influenza A and Influenza B.
Roche has received emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for its cobas SARS-CoV-2 & Influenza A/B Test, intended for the simultaneous qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B in patients suspected of having respiratory viral infection consistent with COVID-19. Additionally, it is available in markets accepting the CE Mark, which is a certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area.
Under the FDA’s EUA, the test can be taken by individuals suspected of a respiratory viral infection, such as COVID-19, by their healthcare provider. The test is a multiplex reverse transcription polymerase chain reaction assay intended for the simultaneous qualitative detection and differentiation of SARS-CoV-2, influenza A virus, and influenza B virus in nasal or nasopharyngeal swab samples collected from individuals suspected of a respiratory infection, and is not intended for the detection of Influenza C virus.
In a separate development, LabCorp has launched a testing method to simultaneously detect COVID-19, influenza A/B, and respiratory syncytial virus (RSV) and has also submitted an application to the US Food and Drug Administration (FDA) to offer the combined single-panel test through its Pixel by LabCorp at-home test collection kit.
Pending authorization by the FDA, the Pixel by LabCorp at-home test will be another option for individuals to determine if they have the flu, COVID-19, or RSV. The Pixel by LabCorp at-home test uses a short swab that is easily inserted into the individual’s lower nostril.
Qiagen To Launch Rapid SARS-CoV-2 Antigen Test
Qiagen, a provider of molecular diagnostics and sample preparation technologies, has announced plans to launch a rapid, portable test that can detect antigens of SARS-CoV-2, the virus that causes COVID-19. The test, which is used with people with active infections, can process on average around 30 swab samples per hour using a small digital detection system and report results in less than 15 minutes.
The test, the Access Anti-SARS-CoV-2 Antigen Test, is expected to become available in the fourth quarter of 2020. Two versions of the antigen test are scheduled for US launch in the fourth quarter of 2020, one for labs and one for point-of-care (POC) use. Qiagen says it will apply for US Food and Drug Administration emergency use authorization and seek CE-IVD registration in Europe. A waiver of CLIA (Clinical Laboratory Improvement Amendments) certification in the US would allow the POC version to be used in settings such as airports or stadiums.
Astellas To Provide $2 M to Support COVID-19 Relief Efforts in Africa
The Astellas Global Health Foundation has announced it will provide $2 million in emergency relief focused on improved healthcare infrastructure and COVID-19 training and education in Kenya, the Dominican Republic, South Sudan, Democratic Republic of the Congo Ghana, Ethiopia and Nigeria. The funding addresses needs of partners seeking to prevent the immediate spread and combat the long-term effects of COVID-19.
Celltrion Gets OK in Korea for Phase I Trial of COVID-19 Drug
Celltrion, an Incheon, South Korea-based biopharmaceutical company developing innovator drugs and biosimilars, has received approval from the Korean Ministry of Food and Drug Safety for its investigational new drug (IND) application for a Phase I clinical trial of CT-P59, a COVID-19 antiviral antibody treatment candidate.
Celltrion has initiated enrollment of patients with mild symptoms of SARS-CoV-2, the virus that causes COVID-19, and the clinical trial is set to evaluate the safety, tolerability, efficacy, pharmacokinetics and immunogenicity of CT-P59.
In addition, the company outlined the status of other clinical programs for the drug candidate. The company anticipates global pivotal study results from Phase II and III trials in patients with mild symptoms, a Phase III trial in patients with moderate-to-severe COVID-19, and a prevention clinical trial, by the end of 2021 (as reported on August 26, 2020). Celltrion says it plans to enroll people that are in close contact with COVID-19 patients and those with no symptoms as part of a prevention clinical trial to evaluate whether CT-P59 can elicit a neutralizing antibody response to prevent the virus from infecting human cells.
In July (July 2020), Celltrion initiated a Phase I trial of CT-P59 in the UK following the approval of the clinical trial authorization application from the UK Medicines and Healthcare products Regulatory Agency. Celltrion has also completed an infusion and initial safety assessment for the Phase I study in healthy volunteers in Korea, and the study is set for completion by the third quarter of this year (2020) as originally planned.
Source: Celltrion Healthcare
Sinovac Reports Preliminary Phase I/II Results of COVID-19 Vaccine
Sinovac Biotech, a Beijing, China-based biopharmaceutical company, reports positive results from a Phase I/II study in China of CoronaVac, its inactivated COVID-19 vaccine candidate, in healthy adults aged 60 and above. The company said that vaccine showed good safety and immunogenicity in healthy adults aged 60, which was comparable to the result in healthy adults aged from 18 to 59 in the earlier studies.
The Phase I/II clinical trial on elderly volunteers were randomized, double-blinded and placebo-controlled trials with two-dose immunization scheduled at 28-day intervals. CoronaVac was tested on a total of 421 healthy adults aged between 60 to 89 years old in the Phase I/II clinical trial. The company said that the vaccine candidate appeared to be well tolerated for low-dose, medium-dose, and high-dose groups. According to the results, the medium dose was selected to enter into a Phase III trial.
AnGes, Brickell Form Pact for COVID-19 DNA Vaccine
AnGes, an Ibaraki City, Osaka, Japan-headquartered company focused on gene medicines, has formed a collaboration with Brickell Biotech, a Boulder, Colorado-based clinical-stage pharmaceutical company developing products for skin diseases, for development of AnGes’ COVID-19 vaccine candidate.
Under the agreement, Brickell has the right to develop and if approved, commercialize AnGes’ proprietary investigational adjuvanted plasmid DNA vaccine intended to prevent SARS-CoV-2, the virus that causes COVID-19, in the US, South America, and certain emerging markets. AnGes will continue to lead the development of the vaccine in Japan.
AnGes is currently conducting Phase I/II clinical studies of its vaccine candidate in Japan, with data readouts expected through the first quarter of 2021. The results from these studies will guide AnGes’ and Brickell’s global development efforts of the vaccine candidate.
Source: AnGes and Bricknell Biotech
JanOne Prepares Production of COVID-19 Drug Candidate
JanOne, a Las Vegas, Nevada-based pharmaceutical company developing pain-management products, has confirmed stability of its developmental batch run of JAN101, its drug candidate for peripheral artery disease (PAD) and potential treatment for COVID-19 vascular complications.
Working with its bottling and labeling partner, Eurofins CDMO, JanOne says it is currently on track to initiate production of JAN101 to support planned Phase IIb trials to treat PAD. Required clinical batches of properly bottled and labeled product will be available to support immediate start of clinical research to use JAN101 as a potential treatment for COVID-19 vascular complications should JanOne gain US Food and Drug Application (FDA) investigational new drug (IND) approval. The company is currently finalizing its COVID-19 vascular treatment IND for submission to the FDA.
Eurofins CDMO’s Canadian facility, Alphora Research Inc., will work with the JanOne clinical teams and manufacturing partner to ensure the integrity of all active and placebo bottles of JAN101.
JanOne says it is expected that the IND for JAN101 as a COVID-19 vascular complication treatment will be submitted to the FDA in the coming weeks (as reported on September 3, 2020). Bottling and labeling of clinical trial batches are expected to begin in early October (October 2020) led by Eurofins CDMO. The company remains on track for its PAD Phase IIb clinical trials expected to begin in early 2021.