Pharma COVID Roundup: News from AstraZeneca, CanSino, CelltrionBy
The latest on manufacturing and potential treatments for COVID-19 with news from AstraZeneca, CanSino Biologics, CGT Catapult, Bharat Biotech, and Celltrion.
AstraZeneca Reports Promising Early-Trial Results of COVID-19 Vaccine
AstraZeneca reports positive interim results from an ongoing Phase I/II trial of AZD1222, its COVID-19 vaccine candidate being developed with Oxford University.
The results showed that AZD1222 was tolerated and generated immune responses against SARS-CoV-2, the virus that causes COVID-19, in all evaluated participants. The results published in The Lancet confirmed a single dose of AZD1222 resulted in a four-fold increase in antibodies to the SARS-CoV-2 virus spike protein in 95% of participants one month after injection. In all participants, a T-cell response was induced, peaking by day 14, and maintained two months after injection.
Late-stage Phase II/III trials are currently underway in the UK, Brazil, and South Africa and are due to start in the US.
In parallel, AstraZeneca continues to fulfil its commitment for equitable access to the vaccine, should late-stage clinical trials prove successful. So far, commitments to supply more than two billion doses of the vaccine have been agreed with the UK, US, Europe’s Inclusive Vaccines Alliance (led by Germany, France, Italy and the Netherlands), the Coalition for Epidemic Preparedness Innovations (CEPI), a public–private partnership focused on vaccine development against emerging infectious diseases, Gavi, a global public health partnership, and the Serum Institute of India, a vaccines company based in Pune, India.
CanSino Biologics Reports Early-Phase Results of COVID-19 Vaccine
CanSino Biologics, a Tianjin, China-based biopharmaceutical company, reports that its COVID-19 vaccine candidate, Ad5-nCOV, has shown promising results in early human testing. Results of published in the medical journal, The Lancet.
The vaccine used an adenoviral vector and achieved humoral response to the SARS-CoV-2 spike glycoprotein receptor binding domain by Day 28 as well as T-cell responses.
Source: The Lancet
UK Gov’t Awards $128 M to CGT Catapult for COVID-19 Vaccine Mfg
Cell and Gene Therapy Catapult (CGT Catapult), a center of excellence funded by Innovate UK, the UK government’s innovation agency, has received £100 million ($128 million) to fund a Cell and Gene Therapy Catapult Manufacturing Innovation Center to accelerate the mass production of a COVID-19 vaccine in the UK.
The government initiative will upgrade an existing facility in Braintree, Essex to create a fully licensed manufacturing center. Due to open in December 2021, the center will have the capacity to produce millions of doses each month to ensure the UK has the capabilities to manufacture vaccines, including for emerging diseases, into the future.
While the center is under construction, the UK government has invested an additional £38 million ($48 million) to establish a rapid deployment facility, scheduled to open later this summer (summer 2020), which will support efforts to ensure a successful vaccine is available as soon as possible.
The new center will complement the UK’s Vaccines Manufacturing and Innovation Center a not-for-profit organization established to provide the UK vaccine development and advanced manufacturing capability, currently under construction in Oxfordshire and funded by £93 million ($119 million) from the UK government. Once completed next year (2021), the facility will have the capacity to produce enough vaccine doses to serve the entire UK population at scale.
To support these enhanced vaccine-manufacturing capabilities, the UK government will invest an additional £4.7 million ($6 million) to support CGT Catapult through the development of virtual and physical national Centers for Advanced Therapies Training and Skills in partnership with industry.
Source: Cell and Gene Therapy Catapult
Baharat Biotech Gets OK for COVID-19 Vaccine Trials in India
Bharat Biotech, a Hyderabad, India-based biopharmaceutical company, has received approval from the Drug Controller General of India to initiate Phase I and II clinical trials for its COVID-19 vaccine candidate, Covaxin. Clinical trials are scheduled to start across India this month (July 2020).
Bharat Biotech developed Covaxin in collaboration with the Indian Council of Medical Research at the National Institute of Virology (NIV). The SARS-CoV-2 strain was isolated at the NIV in Pune, India and transferred to Bharat Biotech. The indigenous, inactivated vaccine was developed and manufactured in Bharat Biotech’s BSL-3 (Bio-Safety Level 3) high-containment facility located in Genome Valley, Hyderabad, India.
Source: Bharat Biotech
Celltrion Enters Clinical Trial of Potential COVID-19 Drug
Celltrion, an Incheon, South Korea-based biopharmaceutical company developing innovator drugs and biosimilars, has launched a Phase I clinical trial investigating a potential antiviral antibody treatment for patients with COVID-19.
The study follows positive preclinical results for the treatment candidate and subsequent approval of the investigational new drug application by the Korean Ministry of Food and Drug Safety. The company says the drug will also be investigated for use as a preventative measure.
The Phase I clinical trial aims to enroll 32 healthy volunteers in collaboration with Chungnam National University Hospital, in Daejeon, South Korea. The study will evaluate the antiviral antibody treatment candidate in healthy participants who have not been diagnosed with COVID-19. The trial’s completion is expected by the third quarter of this year (2020).
Celltrion is set to conduct a further Phase I clinical trial of the antiviral treatment candidate in mild COVID-19 patients across Europe, including the UK, which will be followed by global Phase II/III trials in patients with mild and moderate COVID-19. Celltrion anticipates preliminary results from pivotal studies by the end of the year (2020).
In addition, a clinical trial investigating the use of the potential antiviral antibody treatment as a preventative measure, by enrolling people in close contact with COVID-19 patients globally, is also planned. The top line data for this trial is anticipated in the first quarter of 2021.
Celltrion says it has previously demonstrated its antiviral antibody treatment to be effective in neutralizing the mutated G-variant strain of SARS-CoV-2 (D614G variant).
US Gov’t To Distribute $10 Bn in Funding to High-Impact COVID-19 Areas
The US Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), has announced plans to begin distributing $10 billion in a second round of COVID-19 funding to hospitals in high-impact areas.
The funding is provided through the Coronavirus Aid, Relief, and Economic Security (CARES) Act and the Paycheck Protection Program and Health Care Enhancement Act, which allocated $175 billion in relief funds to hospitals and other healthcare providers, including those disproportionately impacted by the pandemic.
Payments from the $10-billion distribution will be provided to more than 1,000 hospitals in the US and begin this week (July 2o, 2020). In May (May 2020), the HHS announced the first round of high-impact funding totaling $12 billion that was distributed to 395 hospitals. With that, the total committed payments for the two rounds of high impact area funding from the Provider Relief Fund program, to date, is over $20 billion, representing almost 12% of the entire $175 billion program.
Source: The US Department of Health and Human Services
Valneva to Participate in UK Gov’t COVID-19 Vaccine Response Program
Valneva, a Saint-Herblain, France-headquartered vaccine company, has reached agreement in principle with the UK government to provide up to 100 million doses of its SARS-CoV-2 vaccine candidate, to be manufactured at its facilities in Livingston, Scotland.
The UK government is expected to contribute to UK clinical studies costs and is negotiating funding to expand Valneva’s Scottish facility. As part of its broader COVID-19 response, Valneva says it plans to further invest in its manufacturing facilities in Livingston, Scotland and also in Solna, Sweden.
In April (April 2020), Valneva announced that it is developing VLA2001, an inactivated whole virus vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. VLA2001 uses a platform used in the company’s vaccine approved for active immunization for the prevention of Japanese encephalitis.
Valneva is also collaborating with Dynavax, a Berkeley, California-based vaccines company, to evaluate the potential use of its CpG 1018 adjuvant as part of the VLA2001 vaccine, expected to enter clinical studies by the end of 2020 and to potentially reach regulatory approval in the second half of 2021.
Synairgen Reports Positive Results for Interferon Beta in COVID-19 Trial
Synairgen, a Southampton, UK-based respiratory drug-discovery and development company, reports positive results from its clinical trial of SNG001, an inhaled formulation of interferon beta, in hospitalized COVID-19 patients.
The double-blind placebo-controlled trial recruited 101 patients from nine specialist hospital sites in the UK during March 30 to May 27, 2020. The company says patients who received SNG001 had a 79% lower risk of developing severe disease compared to the placebo, and patients who received SNG001 were more than twice as likely to recover from COVID-19 as those on the placebo.
Synairgen says further analysis will be conducted over the coming weeks (as reported on July 20, 2020) and reported in due course.