Pharma COVID Roundup: News from Moderna, Novavax, Pfizer, AstraZeneca

The latest on manufacturing and potential treatments and testing for COVID-19 with news from Moderna, Pfizer, Novavax, AstraZeneca, Gilead Sciences, Qiagen, and others.

Moderna Concludes Talks for EU Supply Pact for COVID-19 Vaccine
Moderna, a clinical-stage biopharmaceutical company developing messenger RNA (mRNA) therapeutics and vaccines, has concluded advanced exploratory talks with the European Commission (EC) to supply 80 million doses of its vaccine candidate against COVID-19, mRNA-1273, with an option for an additional 80 million doses.

The potential purchase agreement with the EC of 80 million doses provides for an option for European Union (EU) member states to purchase an additional 80 million doses for a total of up to 160 million doses. Moderna began a Phase III study of mRNA-1273 on July 27, 2020, and enrollment of approximately 30,000 participants is on track to be completed in September (September 2020).

Overall, Moderna is scaling up global manufacturing to be able to deliver approximately 500 million doses of its COVID vaccine annually and possibly up to 1 billion doses per year, beginning in 2021. In Europe, the company is working with its strategic manufacturing partners, Lonza, and Rovi, a Madrid-based pharmaceutical company and CDMO, for the manufacturing and fill–finish outside of the US. Moderna says that this forms a dedicated supply chain to support Europe and countries other than US that enter into purchase agreements with the company.

Moderna’s potential supply pact with the EU is in addition to the company’s supply pact with the US government. Earlier this month (August 2020), Moderna was awarded up to $1.525 billion, including incentive payments, by the US government under a US Department of Defense government to manufacture and deliver 100 million doses of mRNA-1273. The US supply agreement provides for the manufacturing and delivery of an initial 100 million doses of mRNA-1273 by the US government for $1.225 billion. Moderna is eligible to receive up to an additional $300 million upon acceptance of the initial 100 million doses if mRNA-1273 has achieved an emergency use authorization (EUA) or an approved biologics license application (BLA) by the US Food and Drug Administration (FDA) on or before January 31, 2021.

In addition, the US government has four additional and separate options to purchase 100 million doses per option of mRNA-1273. Each option is exercisable at the sole discretion of the US government following receipt of an EUA or BLA by the FDA at various times during the first half of 2021. Upon the exercise of each option, the US government will pay Moderna $1.65 billion for each option. If all four options are exercised, Moderna would receive $6.6 billion plus the initial funding of $1.525 billion to bring total US government funding for the supply of its COVID-19 vaccine to $8.125 billion. Moderna disclosed the additional details of its US supply agreement in a filing on August 11, 2020 with the US Securities and Exchange Commission. In addition, the company is also entitled to receive approximately $600 million upon the presentation of certain documentation regarding the production of mRNA-1273 and its regulatory filing.

The US government funding for the supply of Moderna’s COVID-19 vaccine is in addition to a previous award of up to $955 million for the clinical development of mRNA-1273 and associated manufacturing through the Biomedical Advanced Research and Development Authority (BARDA), part of the US Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response.

Source: Moderna (European Commission) and Moderna (US Securities and Exchange Commission)

Pfizer, BioNTech Move COVID Vaccine Candidate to Phase II/III Trials
Pfizer and BioNTech, a Mainz, Germany-based immunotherapy company, have moved their mRNA COVID-19 vaccine candidate, BNT162b2, into Phase II/III trials to evaluate safety and efficacy.

Pfizer and BioNTech are proceeding with a global (except for China) Phase II/III clinical study to evaluate BNT162b2. The study is actively enrolling in the US, Argentina, and Brazil. Additional enrollment is planned in Germany, Turkey, and South Africa. The study is an event-driven trial that is planned to enroll up to 30,000 participants between 18 and 85 years of age and has enrolled 11,000 participants to date (as reported on August 20, 2020).

Assuming clinical success, Pfizer and BioNTech are on track to seek regulatory review for BNT162b2 as early as October 2020 and, if regulatory authorization or approval is obtained, they currently plan to supply up to 100 million doses worldwide by the end of 2020 and approximately 1.3 billion doses by the end of 2021.

Source: Pfizer and BioNTech

BioNTech, Fosun Pharma in Supply Pact for COVID Vaccine
BioNTech, a Mainz, Germany-based immunotherapy company, and Fosun Pharma, a Shanghai-based pharmaceutical company, have announced an intended collaboration under which BioNTech will supply 10 million doses of its BNT162 mRNA-based vaccine candidate (subject to clinical success and regulatory approval) against SARS-CoV-2, the virus that causes COVID-19, to Fosun in Hong Kong and Macao, China.

BioNTech will supply the vaccines from its mRNA manufacturing facilities in Europe. BioNTech and Fosun Pharma announced a strategic collaboration in March (March 2020) for the joint development and commercialization of potential COVID-19 vaccine products based on BioNTech’s mRNA technology platform in Mainland China, Hong Kong, Macau, and Taiwan.

A Phase I trial has been initiated in China and the first participants with one of the vaccine candidates from the BNT162 program, BNT162b1, was announced earlier this month (August 5, 2020. One hundred and forty-four participants have been fully enrolled in the Phase I study.

This week (August 27, 2020), Fosun Industrial, a wholly owned subsidiary of Fosun Pharma, entered into a letter of intent with Jacobson Pharma, a Hong Kong-based company engaged in manufacturing and trading of generic drugs and proprietary Chinese medicines, in relation to the contemplated distribution of 10 million doses of BioNTech’s vaccine candidate.

BioNTech is also partnered with Pfizer for the development, manufacturing, and commercialization for BioNTech’s COVID vaccine candidates globally, except in China.

Source: BioNTech and Fosun Pharma

Novavax Enrolls First Patients for Phase II Trial of COVID-19 Vaccine
Novavax, a Gaithersburg, Maryland-based clinical-stage vaccine company, has enrolled the first volunteers in the Phase II portion of its ongoing clinical trial to evaluate NVX-CoV2373, Novavax’s COVID-19 vaccine candidate.

The Phase II clinical trial expands on the age range of the Phase I portion by including older adults 60–84 years of age as approximately 50% of the trial’s population. In the Phase I portion of the Phase I/II clinical trial, conducted in Australia, Novavax reports that NVX-CoV2373 was generally well-tolerated and elicited antibody responses numerically improved to that seen in human convalescent sera.

The Phase II portion of the ongoing Phase I/II clinical trial will evaluate NVX-CoV2373 with the company’s adjuvant, Matrix-M, in subjects aged 18 to 84 years. The clinical trial will assess two dose sizes (5 µg and 25 µg), each with 50 µg of Matrix‑M. Although the trial was designed to confirm immunogenicity in adults, secondary objectives include preliminary evaluation of efficacy. The study is targeting enrollment of up to 1,500 healthy volunteers, with approximately 50% of participants ≥ 60 years of age, at up to 40 sites in the US and Australia.

Source: Novavax

AstraZeneca Initiates Phase I Trial for COVID-19 mAb Combo Therapy
AstraZeneca has dosed the first participants in a Phase I trial of AZD7442, a combination of two monoclonal antibodies (mAbs) in development for the prevention and treatment of COVID-19.

AZD7442 is a combination of two mAbs derived from convalescent patients with SARS-CoV-2 infection. Discovered by Vanderbilt University Medical Center and licensed to AstraZeneca in June 2020, the mAbs were optimized by AstraZeneca with half-life extension and reduced Fc receptor binding. The company says the treatment has the potential to be given as a preventative option for people exposed to the virus and to treat and prevent disease progression in patients already infected by the virus.

The Phase I trial will evaluate the safety, tolerability and pharmacokinetics of AZD7442 in healthy volunteers. The trial will include up to 48 healthy participants in the UK aged 18 to 55 years and is funded by the Defense Advanced Research Projects Agency, part of the US Department of Defense, and the Biomedical Advanced Research and Development Authority, part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services. Data readout is anticipated in the second half of 2020.

Should AZD7442 prove to be tolerated and have a favorable safety profile in the trial, AstraZeneca says it will progress it into larger late-stage Phase II and Phase III trials to evaluate its efficacy as a potential preventative and treatment approach against COVID-19.

Source: AstraZeneca

Gilead Issues Update on Mfg Plans for COVID-19 Drug Remdesivir
Gilead Sciences has provided an update on its manufacturing plans for its investigational COVID-19 treatment, Veklury (remdesivir). The company issued a statement on August 6, 2020.

In addition to process improvements that have shortened the manufacturing timeline to six months, Gilead says it has expanded its global network of internal manufacturing sites and external organizations to include more than 40 companies in North America, Europe, and Asia.

The company says it has increased supply more than 50-fold since January (January 2020) and anticipate being able to meet real-time global demand starting in October (October 2020). We plan to produce more than two million treatment courses by the end of the year, and we anticipate producing several million more in 2021, if needed. Gilead says it plans to produce more than two million treatment courses by the end of the year (2020), and anticipates producing several million more in 2021, if needed.

In addition, Gilead has entered into voluntary licensing agreements with nine generics manufacturers to further expand supply of remdesivir to 127 countries that represent nearly all low-income and lower-middle income countries. Gilead reports it has completed technology transfers with these companies, and they are beginning the manufacturing process.

Source: Gilead Sciences

NIH To Begin Preclinical Studies of Gilead’s Antiviral Drug for COVID-19
The National Center for Advancing Translational Sciences (NCATS), part of the National Institutes of Health, reports that it will conduct preclinical studies of GS-441524, an antiviral drug of Gilead Sciences, as a treatment for COVID-19. GS-441524 is an antiviral drug, separate from Gilead’s remdesivir, which is also being studied to treat COVID-19.

NCATS reported that it will study the drug in preclinical studies in a letter dated August 20, 2020 to Public Citizen, a Washington DC-based nonprofit consumer advocacy organization. Public Citizen and two researchers from the MD Anderson Cancer Center in Texas had sent a letter on August 4, 2020 to the heads of National Institutes of Health, the National Institute of Allergy and Infectious Diseases (NIAID), the US Food and Drug Administration, the Biomedical Advanced Research and Development Authority, and Gilead Sciences to study GS-441524 based on evidence that they presented that showed GS-441524 may offer advantages over Gilead’s remdesivir in treating COVID-19.

NCATS said in its letter that it has informed the NIAID about its plans for preclinical studies.

NCATS said it will share the preclinical data it generates for GS-441524 with the scientific community on its Open Data Portal soon after the studies are completed.

Source: Public Citizen

FDA Issues EUA for Convalescent Plasma for COVID-19
The US Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for convalescent plasma for treating COVID-19 in hospitalized patients.

The EUA authorizes the distribution of COVID-19 convalescent plasma (CCP) in the US and its administration by healthcare providers, as appropriate, to treat suspected or laboratory-confirmed COVID-19 in hospitalized patients with COVID-19.

In a clinical memorandum, the FDA specified that it examined four sources of information in evaluating the EUA: (1) the history of convalescent plasma for respiratory coronaviruses; (2) evidence of preclinical safety and efficacy in animal models; (3) published studies of the safety and efficacy of CCP; and (4) data on safety and efficacy from the National Expanded Access Treatment Protocol sponsored by the Mayo Clinic.

In issuing the EUA, the FDA said it “determined that it is reasonable to believe that COVID-19 convalescent plasma may be effective in lessening the severity or shortening the length of COVID-19 illness in some hospitalized patients,” in an August 23, 2020 statement. “The agency also determined that the known and potential benefits of the product, when used to treat COVID-19, outweigh the known and potential risks of the product and that that there are no adequate, approved, and available alternative treatments.”

In providing the EUA, the FDA said that the EUA does not replace the need for a randomized clinical trial of CCP. “The EUA is not intended to replace randomized clinical trials and facilitating the enrollment of patients into any of the ongoing randomized clinical trials is critically important for the definitive demonstration of safety and efficacy of COVID-19 convalescent plasma,” said the FDA in its statement.

The FDA initiated an expanded access program for CCP in early April (April 2020). The program was developed with funding from the US Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA), with the Mayo Clinic serving as the lead institution. To date (as reported on August 23, 2020), the program has facilitated the infusion of over 70,000 patients with convalescent plasma.

Source: US Food and Drug Administration

Qiagen To Launch a SARS-CoV-2 Antibody Detection Test in the US
Qiagen, a provider of molecular diagnostics and sample preparation technologies, has announced the US launch of a digital test done on a portable device to detect antibodies in people exposed to the SARS-CoV-2, the virus that causes COVID-19.

The antibody test, named the Access Anti-SARS-CoV-2 Total test, provides results in about 10 minutes. The launch of this antibody test, which was developed in partnership with Ellume, an East Brisbane, Queensland, Australia-based digital diagnostics company, comes after the submission by Qiagen of the test to the US Food and Drug Administration (FDA) for emergency use authorization.

The company says first shipments are planned for late August 2020. A CE-IVD marking for Europe and other markets is planned in the coming weeks (as reported on August 24, 2020).

Source: Qiagen

Sinovac in Supply Pact with PT Bio Farma for COVID-19 Vaccine
Sinovac Biotech, a Beijing, China-based biopharmaceutical company, has signed two agreements with PT Bio Farma, a Bandung, Indonesia-based biopharmaceutical company, for the supply, local production, and technology licensing of Sinovac’s inactivated vaccine candidate against COVID-19, CoronaVac.

Under the agreements, Sinovac will supply Bio Farma with bulk vaccine to enable the production of at least 40 million doses of CoronaVac in Indonesia before March 2021. After March 2021, Sinovac will continue to supply the required quantity of the bulk vaccine until the end of 2021. Sinovac recognizes Indonesia as one of the countries where it will provide the technology licensing of the CoronaVac to enable local production.

Currently, Bio Farma is conducting a Phase III clinical trial for Sinovac’s CoronaVac in Bandung, Indonesia.

Source: Sinovac

Scancell Consortium Awarded $2.6 M To Progress COVID-19 Vaccine
Scancell Holdings, an Oxford, UK-based developer of immunotherapies for cancer and infectious diseases, has secured £2 million ($2.6 million) in funding from Innovate UK, the UK government’s innovation agency, to initiate a Phase I clinical trial of Scancell’s COVID-19 vaccine candidate during 2021.

Scancell’s DNA vaccines target dendritic cells to stimulate high avidity T cells that identify and destroy diseased cells. This technology has been applied with Scancell’s ImmunoBody cancer vaccine, SCIB1, which was safely administered to patients with malignant melanoma in a Phase I/II clinical trial.

The company’s aim is to use this technology platform to produce a simple and scalable vaccine that induces both durable T cell responses and virus neutralizing antibodies (VNAbs) to provide long-lasting immunity against COVID-19. With Scancell set to receive approximately £2 million ($2.6 million) in funding the company expects it to cover the majority of the development and Phase I trial costs.

Scancell’s DNA vaccine will target the SARS-CoV-2 nucleocapsid (N) protein in addition to the key receptor-binding domain of the spike (S) protein to generate both T cell responses and VNAbs against the SARS-CoV2 virus. The N protein is highly conserved among coronaviruses; therefore, the company says this new vaccine has the potential to generate protection not only against SARS-CoV-2, the virus that causes COVID-19, but also against new strains of coronavirus that may arise, according to the company.

Source: Scancell Holdings

ReiThera’s COVID-19 Vaccine Candidate Enters Phase I Trials
ReiThera, a Rome-based biopharmaceutical company for advanced therapies, has dosed the first volunteer in a Phase I study of the company’s vaccine candidate, GRAd-COV2, against SARS-CoV-2, the virus that causes COVID-19.

The Phase I study is being conducted in Italy at the Lazzaro Spallanzani National Institute for Infectious Diseases (INMI) in Rome and at the GB Rossi University Hospital in Verona.

ReiThera’s vaccine candidate GRAd-COV2 encodes the full-length spike protein of the SARS-CoV-2. The vaccine technology is based on a proprietary replication-defective gorilla adenoviral (GRAd) vector, which the company says induced a strong humoral and cellular immune response in preclinical studies and demonstrated a good safety profile.

A larger international Phase II/III trial in countries where SARS-CoV-2 is still active is planned to commence by the end of 2020, pending positive interim safety and immunogenicity results of the Phase I trial.

The Phase I trial of GRAd-COV2 is being funded by the Italian Ministry of Scientific Research and the Lazio region in Italy. The study is being run jointly by ReiThera and Lazzaro Spallanzani INMI using initial vaccine material manufactured at ReiThera’s facility in Rome.

In parallel, ReiThera is working with Leukocare, a Martinsried/Munich, Germany-based drug-formulation company focused on protein therapeutics, to develop a thermostable GRAd-COV2

vaccine formulation and with Univercells, a Gosselies. Belgium technology company specializing in bioprocessing, to develop a manufacturing process for large-scale production of the vaccine.

Source: ReiThera

JanOne Plans IND for Drug To Treat COVID-19 Complications
JanOne, a Las Vegas, Nevada-based pharmaceutical company developing pain-management products, reports that it is preparing an investigational new drug (IND) application for JAN101, its drug candidate for peripheral artery disease (PAD), as a potential treatment for COVID-19 vascular complications.

The company is preparing IND packages for US Food and Drug Administration submission, which is expected to be completed in late August 2020, for JAN101 as a potential treatment to mitigate severe organ and tissue damage caused by COVID-19.

In addition, the company expects JAN101 to soon (as reported on August 11, 2020) to enter Phase IIb trials for PAD. The company has developed a sustained-release formulation of JAN-101 and is beginning its engineering run and manufacturing for multiple trials expected to begin in early 2021. The company expects to have an initial GMP batch of 250,000 doses by mid-September 2020 to provide enough tablets to carry out its proposed Phase IIb PAD trials and the COVID-19 treatment study IND.

The company says it will now focus on commercial production capability of JAN101, which uses sodium nitrite, and is currently negotiating to purchase 1,000 kilos of sodium nitrite from a multinational biopharmaceutical company to support GMP manufacturing batches of more than 20 million doses of JAN101

Source: JanOne

Romark Gets FDA OK for Mfg Facility; To Produce COVID Treatment
Romark, a pharmaceutical company focused on infectious diseases, has received approval by the US Food and Drug Administration (FDA) for its manufacturing facility in Manati, Puerto Rico for the production of its anti-parasite drugs, Alinia (nitazoxanide) tablets, 500 mg, and Alinia (nitazoxanide) for oral suspension, 100 mg/5mL in the US market.

The Puerto Rico facility is also in line with the company’s plans to manufacture and distribute its investigational new drug candidate, NT-300 (nitazoxanide extended-release tablets), which is currently undergoing Phase III clinical trials for both the prevention and treatment of COVID-19 and other viral respiratory illnesses.

Source: Romark

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