Samsung Biologics signs Covid-19 therapy manufacturing deal with Eli Lilly

17 November | Covid-19

South Korean pharma firm Samsung Biologics has entered a long-term agreement with Eli Lilly and Company to manufacture its investigational Covid-19 virus neutralising antibody, bamlanivimab.

Bamlanivimab is an investigational antibody that targets the spike protein of SARS-CoV-2 and is designed to inhibit the virus’ attachment and entry into human cells.

According to the contract manufacturing organisation (CMO) agreement, Samsung Biologics will be mass-producing the therapy developed by Lilly for treating Covid-19 patients.

Last week, the US Food and Drug Administration granted emergency use authorisation (EUA) for bamlanivimab to treat patients aged 12 years or above with mild to moderate Covid-19, who are at high risk for progressing to severe disease and/or hospitalisation.

The EUA aids in distribution and emergency use of the antibody therapy administered via a single intravenous infusion.

A single dose of bamlanivimab should be administered within ten days of developing Covid-19 symptoms and a positive test.

Apart from the CMO, Samsung Biologics is engaged in the sectors including contract development organisation and contract research organisation.

With its three plants in Incheon, the company can deliver 362,000l of biosimilars every year.

17 november | covid-19

INDIAN FIRM BIOLOGICAL E INITIATES CLINICAL TRIAL OF COVID-19 VACCINE CANDIDATE

Indian pharma firm Biological E has initiated a Phase I/II clinical trial to evaluate the safety and immunogenicity of its Covid-19 subunit vaccine candidate.

The move comes after the company obtained approval from the Drugs Controller General of India.

The vaccine candidate has an antigen in-licensed from US-based Baylor College of Medicine’s integrated commercialisation team, BCM Ventures. It also contains an advanced adjuvant CpG 1018 from Dynavax Technologies.

Adjuvant is a pharmacological or immunological agent and boosts the immune response of a vaccine.

Biological E managing director Mahima Datla said: “We are very happy indeed to transition our potential vaccine candidate to clinical trials and offer one more potential option for the prophylaxis of Covid-19.”

The trial will also analyse the ability to induce an immune response, of the vaccine candidate, which has the Receptor Binding Domain of the Spike Protein of SARS-CoV-2 at three dose levels adjuvanted with CpG 1018 plus alum.

16 november | Clinical trials

UK STUDY SHOWS SNG001 AIDS IN FASTER COVID-19 RECOVERY

The University of Southampton in the UK has published the results from a clinical trial of an inhaled form of interferon beta-1a, SNG001, which reduced chances of hospitalised Covid-19 patients developing severe disease or death due to infection.

The naturally occurring protein, interferon beta, coordinates the immune response of the body to viral infections.

Studies in the laboratories have shown that the SARS CoV-2 virus directly suppresses the release of interferon beta. Decreased activity of the protein was also observed in Covid-19 patients during clinical trials.

The trial enrolled 101 hospitalised Covid-19 patients who were randomly given Synairgen’s SNG001 or placebo.

Results showed that patients who received SNG001 were twice as likely to show an improvement in their clinical condition at day 15 or 16 as compared with the placebo arm.

In the placebo group, 11 out of 50 patients developed severe disease needing mechanical ventilation or died between the first dose and day 15 or 16. All patients in the SNG001 group survived while three deaths were recorded in the placebo group.

16 november | Covid-19

JANSSEN BEGINS SECOND PHASE III COVID-19 VACCINE TRIAL

The Janssen Pharmaceutical Companies of Johnson & Johnson has initiated enrolment and dosing of participants in the Phase III ENSEMBLE 2 trial of a two-dose regimen of JNJ-78436735, an investigational vaccine candidate for preventing Covid-19 infection.

The ENSEMBLE 2 (NCT04614948) study, which is being conducted in collaboration with the UK National Institute for Health Research (NIHR), will enrol up to 30,000 participants globally.

This trial will run in parallel with the Phase III ENSEMBLE study of the single-dose regimen of JNJ-78436735, which is proceeding to enrol up to 60,000 participants across the globe. For the study, participants will be enrolled in Belgium, Colombia, France, Germany, the Philippines, South Africa, Spain, the UK and US.

The randomised, double-blind, placebo-controlled ENSEMBLE 2 trial will analyse the safety and efficacy of a two-dose vaccine regimen versus placebo in adults with and without comorbidities associated with an increased risk for severe Covid-19.

It will analyse efficacy of the vaccine candidate after the first and second dose to evaluate the protection provided against the virus and possible incremental benefits for duration of protection with a second dose.

11 november | funding

ADAGIO THERAPEUTICS RAISES FUNDING TO ADVANCE COVID-19 ANTIBODIES

Adagio Therapeutics has raised $80m in funding to further advance best-in-class antibodies to both treat and protect against Covid-19.

The company plans to use the proceeds to advance its lead antibody candidate, ADG20, into clinical development early next year for the treatment of the disease.

ADG20 offers potential best-in-class treatment and durable protection against the SARS-CoV-2 virus that causes Covid-19 and future coronaviruses.

Previously known as Google Ventures, GV led the Series B funding round that involved participation from existing investors such as Polaris Partners, Mithril Capital, Fidelity Management & Research Company.

Other participants included OrbiMed, new investors, Population Health Partners and Omega Funds.

11 november | vaccines

INDIAN RESEARCHERS DEVELOP VACCINE STRATEGIES FOR SARS-COV-2, HIV VIRUSES

Researchers at Indian Institute of Science’s (IISc) Molecular Biophysics Unit have announced the development of effective vaccine strategies against the SARS-CoV-2 and HIV viruses that cause Covid-19 and AIDS, respectively.

The researchers reported the design of a ‘heat-tolerant’ vaccine candidate for Covid-19 which contains a part of the spike protein of the novel coronavirus called the receptor binding domain, with the help of which the virus adheres to the host’s cell.

Molecular Biophysics Unit professor Raghavan Varadarajan is developing the vaccine candidate in partnership with startup Mynvax and other institutes.

The candidate triggered a strong immune response when it was tested in guinea pig models and also remained stable for a month at 37°C, IISc reported.

In brief

Bangladesh signs Covid-19 vaccine deal with Serum Institute of India

Bangladesh has entered into a deal with the Serum Institute of India to acquire 30 million doses of a potential vaccine being developed by AstraZeneca for Covid-19. Under the deal, Beximco will purchase five million doses of vaccine per month.

EC approves AstraZeneca and Merck’s Lynparza for two cancer types

AstraZeneca and Merck’s Lynparza (olaparib) has secured approval from the European Commission for prostate cancer and ovarian cancer treatments in the European Union. A subgroup analysis of the PROfound Phase III trial of Lynparza backs the prostate cancer approval.

Australia to acquire 40 million doses of Novavax Covid-19 vaccine

Novavax has signed a non-binding heads of terms document with the Australian Government to supply 40 million doses of its Covid-19 vaccine candidate, NVX-CoV2373. The vaccine candidate is currently in Phase III clinical trial in the UK. 

AIIMS find ivermectin prophylaxis reduces infection in Covid-19 patients

A study by All India Institutes of Medical Sciences (AIIMS)-Bhubaneswar in the Indian state of Odisha found that two doses of potential drug ivermectin prophylaxis resulted in a 73% reduction in Covid-19 infection.

Regeneron to continue patient recruitment for Covid-19 trial

The independent data monitoring committee (DMC) has recommended the continuation of Regeneron’s UK-based RECOVERY trial analysing REGN-COV2 in hospitalised patients with Covid-19. Prior to this, DMC recommended holding enrolment for the REGN-COV2 antibody cocktail treatment trials for Covid-19 based on a potential safety signal and an unfavourable risk/benefit profile.

10 november | Deal

BRIDGE BIOTHERAPEUTICS TERMINATES COLLABORATION AGREEMENT WITH BOEHRINGER

Bridge Biotherapeutics and Boehringer Ingelheim have mutually agreed to terminate their previously signed collaboration and licence agreement to develop BBT-877.

In July 2019, Boehringer entered a deal with Bridge Biotherapeutics to develop the drug candidate, BBT-877, for the treatment of fibrosing interstitial lung diseases, including idiopathic pulmonary fibrosis (IPF).

According to the deal, Boehringer agreed to make upfront and near-term payments of €45m to Bridge Biotherapeutics. This deal included milestone payments of up to €1.1bn.

BBT-877 is an autotaxin inhibitor being trialled for the treatment of idiopathic pulmonary fibrosis and various fibrotic diseases.

Under the latest deal, Bridge Biotherapeutics will regain all rights to the drug candidate.

In the pre-clinical models for fibrosing interstitial lung diseases, the novel therapy yielded positive safety and efficacy data.

09 november | manufacturing

AUSTRALIA TO INITIATE MANUFACTURING OF VACCINE CANDIDATE FOR COVID-19

Australia is planning to commence the manufacturing of Covid-19 vaccine candidate, AZD1222, at biotech firm CSL’s advanced manufacturing facility in Broadmeadows, Victoria.

AstraZeneca and the University of Oxford are developing the vaccine. CSL signed separate deals with AstraZeneca and the Australian Government to produce approximately 30 million doses of AZD1222.

The company plans to make available the first set of vaccines in the first half of next year. The two-dose regimen can potentially vaccinate up to 15 million people.

Initially, the production process will begin with the thawing of vials containing vaccine cells, frozen under liquid nitrogen to preserve its integrity.

Thawing prepares for replication in the bioreactors. On growing in the bioreactors, the vaccine is filtered and purified, leaving just the antigen or vaccine product, which then gets formulated and filled into dosage vials.

In brief

Bangladesh signs Covid-19 vaccine deal with Serum Institute of India

Bangladesh has entered into a deal with the Serum Institute of India (SII) to acquire 30 million doses of a potential vaccine being developed by AstraZeneca for Covid-19. Under the deal, Beximco will purchase five million doses of vaccine per month.

EC approves AstraZeneca and Merck’s Lynparza for two cancer types

AstraZeneca and Merck’s Lynparza (olaparib) has secured approval from the European Commission for prostate cancer and ovarian cancer treatments in the European Union. A subgroup analysis of the PROfound Phase III trial of Lynparza backs the prostate cancer approval.

Australia to acquire 40 million doses of Novavax Covid-19 vaccine

Novavax has signed a non-binding heads of terms document with the Australian Government to supply 40 million doses of its Covid-19 vaccine candidate, NVX-CoV2373. The vaccine candidate is currently in Phase III clinical trial in the UK.

AIIMS find ivermectin prophylaxis reduces infection in Covid-19 patients

A study by All India Institutes of Medical Sciences (AIIMS)-Bhubaneswar in the Indian state of Odisha found that two doses of potential drug ivermectin prophylaxis resulted in a 73% reduction in Covid-19 infection.

Regeneron to continue patient recruitment for Covid-19 trial

The independent data monitoring committee (DMC) has recommended the continuation of Regeneron’s UK-based RECOVERY trial analysing REGN-COV2 in hospitalised patients with Covid-19. Prior to this, DMC recommended holding enrolment for the REGN-COV2 antibody cocktail treatment trials for Covid-19 based on a potential safety signal and an unfavourable risk/benefit profile.