Pharma COVID Roundup: News from Lilly, Gilead, Daiichi Sankyo

The latest on manufacturing and potential treatments for COVID-19 with news from Lilly, Gilead, Dr. Reddy’s, Daiichi Sankyo, BioNTech, CureVac, Novavax and others.

News from Lilly, Dr. Reddy’s, Gilead, Daiichi Sankyo

Lilly Begins Phase III Trial of Arthritis Drug Baricitinib for COVID-19
Eli Lilly and Company has enrolled the first patient in a Phase III randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of baricitinib, an oral JAK1/JAK2 inhibitor licensed from Incyte, a Wilmington, Delaware-based biopharmaceutical company, in hospitalized adults with COVID-19.

Baricitinib, marketed as Olumiant, is approved for treating adults with moderately to severely active rheumatoid arthritis. Lilly says it expects to enroll 400 patients in the trial, with data expected in the next few months (as reported on June 15, 2020). The study will be conducted in the US, Europe, and Latin America, and includes patients hospitalized with SARS-CoV-2 infection who have at least one elevated marker of inflammation but do not require invasive mechanical ventilation at study entry.

In COVID-19 infection, increased disease severity can be associated with a hyperinflammatory state. It is hypothesized that through JAK1 and JAK2 inhibition, baricitinib may reduce the cytokine storm associated with the complications of this infection. In addition, baricitinib may have a role in inhibiting the host-cell proteins that assist in viral reproduction, thereby reducing the ability of infected cells to make more virus.

Should research efforts for baricitinib in COVID-19 prove successful, Lilly says it will continue to create adequate supply to support both appropriate clinical and investigational use.

Source: Eli Lilly and Company

Dr. Reddy’s, Gilead in Pact for Antiviral Remdesivir for COVID-19
Dr. Reddy’s Laboratories has entered into a non-exclusive licensing agreement with Gilead Sciences that will grant Dr. Reddy’s the right to register, manufacture, and sell Gilead’s investigational drug, remdesivir, a potential treatment for COVID-19, in 127 countries, including India.

Dr. Reddy’s will receive technology transfer from Gilead for manufacturing remdesivir and will conduct manufacturing scale-up and obtain regulatory approval for marketing of the drug in respective countries.

Remdesivir is an investigational antiviral therapy developed by Gilead that received emergency use authorization by the US Food and Drug Administration to treat COVID-19.

Source: Dr. Reddy’s Laboratories

Daiichi Sankyo To Develop mRNA Vaccine for COVID-19
Daiichi Sankyo reports it plans to develop a genetic mRNA vaccine for COVID-19.

Earlier this year (April, 2020), Daiichi Sankyo established a task force for company-wide R&D on vaccines and therapeutic agents for COVID-19.

The company is participating in the Fundamental Research on the Control of a Novel Coronavirus (2019-nCoV), a vaccine-development initiative supported by the Japanese government through the Japan Agency for Medical Research and Development. The company is also participating in a basic research project on a genetic mRNA vaccine for COVID-19 that uses nucleic-acid delivery technology developed by the company.

Daiichi Sankyo reports that in a recent pharmacological evaluation of a prototype mRNA vaccine using animal models, it achieved an increase in antibody titers to the novel coronavirus. The company says it is considering an increase in scale toward establishing a supply system with the aim to proceed to clinical studies around March 2021.

Source: Daiichi Sankyo

News from CureVac, BioNTech, Novavax, PTC Therapeutics

CureVac Gets OK for Phase I Trial of COVID-19 Vaccine
CureVac, a Tubingen, Germany-based clinical-stage biopharmaceutical company developing a mRNA therapeutics, reports that the Paul-Ehrlich-Institut (PEI), the Federal Institute for Vaccines and Biomedicines, a federal authority reporting to Germany’s Federal Ministry of Health, and the Belgian Federal Agency for Medicines and Health Products, the national pharmaceutical regulatory agency of Belgium, have approved a Phase I clinical trial for CureVac’s vaccine program to prevent SARS-CoV-2 infection.

The trial will be conducted in Germany and Belgium. First subjects will be vaccinated at the Institute for Tropical Medicine (Tübingen, Germany), Ghent University Hospital (Belgium), the Tropical Institute of the University Hospital Munich (Germany), Ludwig Maximilian University of Munich (Germany), and the Hannover Medical School (Germany).

CureVac´s mRNA vaccine candidate uses nucleotides without chemical modifications in the mRNA that encodes the full-length spike protein of SARS-CoV-2 and is formulated with lipid nanoparticles.

In a separate development, the German government plans to provide direct equity financing of EUR 300 million ($337 million) in CureVac. Details of the investment, which will be made by the Kreditanstalt für Wiederaufbau (KfW), a German state-owned development bank, have been laid out in a definitive draft agreement. The funds from the capital increase will be used by CureVac for further development of the company’s proprietary pipeline and mRNA platform technology and expansion of business activities. Under the agreement, the KfW will hold a stake of around 23% in CureVac.

Source: CureVac (funding) and CureVac (clinical trial)

BioNTech Gets $112 M in EU Financing for COVID-19 Vaccine
BioNTech, a Mainz, Germany-based immunotherapy company, has concluded a EUR 100-million ($112 million) debt-financing agreement with the European Investment Bank (EIB), the long-term lending institution of the European Union, to support the development of BNT162, the company’s COVID-19 vaccine program and to expand manufacturing capacity to supply the vaccine. The supply will be done at the company’s own risk while the clinical studies are ongoing.

In April (April 2020), Pfizer and BioNTech formed a collaboration, worth up to $748 million ($185 million upfront), to develop vaccine candidates against COVID-19. BioNTech began clinical testing of BNT162, in Germany in April (April 2020) and in the US at the beginning of May (May 2020).

Source: BioNTech

Novavax Hires Ex AstraZeneca Senior Executive; Plans To Raise $200 M
Novavax, a Gaithersburg, Maryland-based clinical-stage vaccine company, has appointed a new member to its senior leadership team and also entered into an agreement to sell stock in a private placement to raise $200 million. Both actions fall in line with the development of Novavax’s COVID-19 vaccine candidate, NVX-CoV2373.

In the first action, Novavax has appointed Filip Dubovsky, MD, MPH, FAAP, formerly a senior executive at AstraZeneca, as Senior Vice President and Chief Medical Officer, to oversee Novavax’s medical and clinical affairs and related activities. He has more than 20 years of infectious-disease experience. Most recently, he was Head of Clinical Engagement and Policy and Deputy Chief Medical Officer for clinical affairs at AstraZeneca. At MedImmune, the global biologics arm of AstraZeneca, he oversaw the clinical development of early- and late-stage infectious disease and vaccine assets. Previously, he created and managed a portfolio of 25 malaria vaccine candidates spanning early candidate optimization to Phase III clinical studies at PATH’s Malaria Vaccine Initiative.

In a separate development, Novavax agreed to sell 4,388,852 shares of common stock to an investment fund affiliated with RA Capital Management in a private placement; upon closing Novavax will receive gross proceeds of approximately $200 million.

Source: Novavax (senior executive appointment) and Novavax (RA Captial)

PTC Therapeutics Initiates Phase II/III Trials of COVID-19 Treatment
PTC Therapeutics, a South Plainfield, New Jersey-based biopharmaceutical company, announced that the US Food and Drug Administration has authorized the initiation of a Phase II/III trial to investigate the company’s PTC299, a dihydroorotate dehydrogenase (DHODH) inhibitor, as a potential treatment for COVID-19.

PTC299 is an oral investigational drug with a dual-mechanism of action that has the potential to address two elements of COVID-19: (1) high viral replication and (2) uncontrolled inflammatory response that ensues after infection. PTC will initiate an integrated Phase II/III study in the US in the coming days (as reported on June 17, 2020) with additional sites planned globally. The Phase II/III study will evaluate the efficacy and safety of PTC299 in two stages: the first stage consisting of 40 patients, followed by a larger cohort of approximately 340 patients.

PTC299 is an oral, small molecule tablet that inhibits the cellular enzyme, DHODH, which is used to produce the RNA building blocks for the production of SARS-CoV-2. The company says that PTC299 has shown inhibition of viral replication in SARS-CoV-2 cell-based assays, which has led to PTC moving the candidate into the clinic.

The primary objective is to evaluate the clinical efficacy of PTC299 compared with placebo assessed by time to respiratory improvement in adult individuals hospitalized with COVID-19.

PTC299 is also being developed for treatment in oncological indications and has been studied in nine clinical trials in over 300 individuals.

Source: PTC Therapeutics

UK Gov’t Funds Imperial College’s Phase I Trials of COVID-19 Vaccine
The UK government is providing £41 million ($51 million) in funding toward the development of Imperial College London’s COVID-19 vaccine and an additional £5 million ($6 million) of philanthropic gifts.

Clinical researchers will begin human trials of the COVID-19 vaccine candidate developed at Imperial College London that uses new self-amplifying RNA technology.

The vaccine has undergone preclinical safety tests and has been shown to be safe and produced encouraging signs of an effective immune response in animal studies, according to information from the UK government. Over the coming weeks (as reported on June 15, 2020), 300 healthy participants will receive two doses of the vaccine. If the vaccine is safe and shows a promising immune response in humans, then Imperial College says larger Phase III trials would be planned to begin later in the year (2020) with approximately 6,000 healthy volunteers to test its effectiveness.

Source: UK Government and Imperial College London

SAB Biotherapeutics Begins Mfg of COVID-19 Therapeutic Candidate
SAB Biotherapeutics, a Sioux Falls, South Dakota-based clinical-stage biopharmaceutical company, initiated manufacturing of SAB-185, its COVID-19 therapeutic candidate, on May 25, 2020 to support the next phase of clinical development for its potential COVID-19 therapeutic, still on track to begin human trials in early summer (summer 2020).

SAB uses genetically engineered cattle to produce the polyclonal antibody product.

Source: SAB Biotherapeutics

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