18 August 2020

Gilead and Tango Therapeutics partner for targeted cancer therapies

Gilead Sciences has collaborated with Tango Therapeutics to discover, develop and commercialise targeted immune evasion therapies for cancer patients.

This multi-year alliance builds on an agreement signed by the parties in 2018.

Under the latest deal, Tango will continue to use its CRISPR-enabled functional genomics target discovery platform to detect new immune evasion targets.

The number of targets will be expanded from five to 15. Gilead will have an option for global rights to programmes related to these targets over the coming seven years.

In addition, Gilead will have the right to pay option extension fees to Tango for activities through early clinical development. Tango will have an option to participate in the development and promotion of the lead products for up to five programmes in the US.

Gilead Sciences Research executive vice-president William Lee said: “Since we signed the original agreement two years ago, we have been very pleased with the productivity of the collaboration and with the quality of scientific discovery that has come from this partnership.

“We are looking forward to working with Tango to run additional cancer context-dependent screens to identify a broader set of targets based on our immuno-oncology strategy.”

The agreement does not include lead programmes of Tango, which retains the rights to find targets outside the immune evasion area.

Gilead will make an upfront payment of $125m to Tango, along with a $20m equity investment in the company. Gilead can option up to 15 programmes over the next seven years for up to $410m per programme.

Last month, Gilead entered into an agreement to acquire a 49.9% equity interest in cancer immunotherapies maker Tizona Therapeutics through an investment of $300m.

18 August 2020

OSE’s Covid-19 vaccine shows promise in preclinical studies

OSE Immunotherapeutics has reported positive data from preclinical and human ex-vivo studies of its Covid-19 vaccine candidate, CoVepiT.

The company published the findings online on BioRxiv.

Based on optimised peptides improved with artificial intelligence algorithms, CoVepiT elicits a lasting sentinel T lymphocyte immune response against Covid-19.

It is a neoepitope vaccine meant for prophylactic protection against the disease, generated using OSE’s Memopi technology.

According to preclinical data, the candidate led to strong trigger of memory CD8 T lymphocytes against various SARS-CoV-2 proteins in vaccinated humanised mice.

In humanised mouse model studies, CoVepiT vaccination resulted in an encouraging phenotype of Tissue-resident memory T-cells (Trm).

These Trm cells protect barrier tissues such as the respiratory tract and the lung, and remove infected cells prior to significant virus replication, noted the company.

OSE added that patients with asymptomatic, moderate and severe Covid-19 showed strong memory T-cell responses against the company’s multi-target peptides.

OSE Immunotherapeutics chief scientific officer Nicolas Poirier said: “The CoVepiT programme is based on a clinically-validated technology now shown to induce tissue-resident memory T lymphocytes (Trm) sentinel response against multiple parts of SARS-CoV-2, suggesting it provides a long-term protective immunity, as opposed to transient protection provided by neutralising antibodies.

“In addition, this vaccine is designed to anticipate ongoing recurrent virus mutation and evolution, further adding to its long-term protective potential. T-cell epitopes were also selected based on the natural immunity observed against our peptides in convalescent Covid-19 patients.”

Funding from Nantes Metropole supported the preclinical programme of CoVepiT.

Based on these positive findings, OSE intends to launch a Phase I clinical trial by the end of this year or early next year to assess the vaccine candidate’s efficacy in humans.

17 August 2020

EC and UK sign agreements for Covid-19 vaccines supply

The European Commission (EC) and the UK Government have entered into separate agreements for the supply of potential Covid-19 vaccines.

The EC concluded an agreement with AstraZeneca for up to 400 million doses of the Covid-19 vaccine candidate AZD1222. This marks the first deal signed by the EC for a Covid-19 vaccine.

The deal builds on an existing agreement with Europe’s Inclusive Vaccines Alliance led by Germany, France, Italy and the Netherlands. The latest agreement will provide European Union (EU) member states the option to access AstraZeneca’s vaccine equally at zero profit during the pandemic.

In addition, EU member states will be able to redirect doses to other European countries.

AstraZeneca CEO Pascal Soriot said: “This first vaccine agreement with the European Commission will ensure that millions of Europeans have access to the AZD1222 vaccine following its approval.

“With production in our European supply chain soon to be started, we hope to make the vaccine available widely and rapidly, with the first doses to be delivered by the end of 2020.”

Meanwhile, the UK Government has signed two different agreements for 60 million doses of Novavax’s and 30 million doses of Janssen Pharmaceutical’s Covid-19 vaccine candidate.

The government also agreed to co-fund a global clinical trial of the Janssen vaccine. The next phase of trials is planned for later this year to assess the ability of two doses of Janssen’s candidate to deliver long-term protection against Covid-19.

The UK will also support Novavax’s Phase III study of its vaccine candidate, conducted in alliance with the National Institute for Health Research (NIHR).

Novavax intends to produce some of the vaccine using Fujifilm Diosynth Biotechnologies’s facilities in Billingham, Stockton-on-Tees.

If successful in trials, both the vaccines should be delivered to the UK mid next year.

These two agreements provide the UK with access to a total of six Covid-19 vaccine candidates, including Oxford/AstraZeneca’s AZD1222.

17 August 2020

Roche receives FDA approval for Enspryng to treat NMOSD

Roche has received approval from the US Food and Drug Administration (FDA) for Enspryng (satralizumab-mwge) to treat adults with anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD).

Enspryng is a humanised monoclonal antibody that targets and inhibits interleukin-6 (IL-6) receptor activity associated with the inflammation in NMOSD patients.

It is the first and only subcutaneous treatment approved for this indication, designed by Roche unit Chugai using recycling antibody technology.

NMOSD is a rare, debilitating autoimmune disease that impacts the central nervous system. It causes damages the optic nerve(s) and spinal cord, resulting in blindness, muscle weakness and paralysis.

Roche chief medical officer and Global Product Development head Levi Garraway said: “Today’s FDA approval of Enspryng, the first subcutaneous NMOSD treatment using novel recycling antibody technology, builds upon the work we’ve done in multiple sclerosis with OCREVUS to develop first-in-class medicines and further the scientific understanding of neuroimmunological diseases.”

FDA approval comes from data of Phase III SAkuraStar and SAkuraSky clinical trials, where the drug demonstrated efficacy and a favourable safety profile in AQP4 antibody positive NMOSD.

Data proved sustained for 96 weeks, with a significant decrease in the risk of relapse compared to placebo as a monotherapy and when used in combination with baseline immunosuppressant therapy (IST).

In the SAkuraStar trial, 76.5% of participants treated with Roche’s drug as monotherapy were relapse-free at 96 weeks, compared to 41.1% of those on placebo.

The SAkuraSky study data showed that use of Enspryng concurrently with baseline IST led to 91.1% of patients being relapse-free at 96 weeks, compared to 56.8% on placebo.

The primary endpoint of both the studies was time to first protocol-defined relapse.

An NMOSD patient or a caregiver can administer the medication at home after receiving training from a healthcare provider. It will be available in the US in two weeks.

Earlier this month, Roche obtained conditional marketing approval from the European Commission (EC) for Rozlytrek (entrectinib) to treat solid tumours in patients aged 12 years and above.

13 August 2020

Brazil’s Parana state to produce Russia’s Covid-19 vaccine

The Russian Direct Investment Fund (RDIF) and the Brazilian state of Parana are set to collaborate to produce and distribute Russia’s registered Covid-19 vaccine, Sputnik V.

Under the strategic cooperation agreement, RDIF will work with pharmaceutical companies in the state to help organise the production and distribution of the vaccine in Brazil and other Latin American countries.

RDIF and the Gamaleya National Research Institute of Epidemiology and Microbiology also agreed to provide the vaccine’s clinical trials results and production technological protocols to the Paraná State Institute of Technology (Tecpar) in the future.

Developed by the Gamaleya National Research Institute, the Sputnik V vaccine was registered by the Ministry of Health of Russia on 11 August.

RDIF CEO Kirill Dmitriev said: “We are seeing strong interest from our Brazilian partners in learning from Russia’s experience in the fight against coronavirus, including information related to the first registered coronavirus vaccine in the world.

“Brazil is one of five key countries ready to support the production of the Russian Sputnik V vaccine. We are confident in the high safety and efficacy of the Sputnik V vaccine and look forward to the approval of the vaccine by the Brazilian authorities soon.”

Meanwhile, Argentina and Mexico have agreed to produce AstraZeneca’s Covid-19 vaccine candidate for Latin American countries, except Brazil, reported Reuters citing Argentine President Alberto Fernandez.

AstraZeneca entered an agreement with biotechnology company mAbxience for the transfer of technology to initially manufacture 150 million vaccine doses.

Fernandez was quoted as saying: “Latin American production will be handled in Argentina and Mexico and that will allow timely and efficient access for all countries in the region.”

In a statement on Twitter, Mexican Foreign Minister Marcelo Ebrard said that the vaccine output may increase to 250 million doses.

AstraZeneca also signed a deal with non-profit organisation The Carlos Slim Foundation for the vaccine candidate production. It is expected that the vaccine will be delivered in the first half of next year.

12 August 2020

Samsung Biologics to build fourth manufacturing plant

South Korea-based biomedicine maker Samsung Biologics has unveiled plans to build its fourth plant this year to boost its manufacturing capabilities.

Once complete, the 256kl plant in Incheon will increase the company’s total capacity to 620kl. Manufacturing operations are expected to start in the second half of 2022.

Samsung Biologics will design the plant by incorporating unique features of the three previous plants to enable multi-scale manufacturing services at the site.

Plant 4 will comprise a total floor area of 23.8 million square metres.

Samsung Biologics CEO Dr Tae Han Kim said: “In this continuously evolving climate, we are strategically positioning ourselves to respond to the needs of our global clients who are producing new medicines that are more complex and diverse and deliver superior client satisfaction.

“With the production of Plant 4, our ‘Super Plant,’ Samsung Biologics is investing in a total line refinement and addition of new mid-scale and small-scale facilities to ensure production efficiency and provide top-notch services to raise the bar even further to establish ourselves as the leading global standard.”

The company also announced that it entered negotiations with Incheon Free Economic Zone (IFEZ) authorities to acquire additional land for its second bio complex.

Samsung Biologics will develop a global R&D facility and an open innovation centre on a 330,000m² area near the company’s current complex.

Overall, Samsung Biologics could invest more than KRW2trn ($2bn) on the two initiatives.

In May, GlaxoSmithKline signed an agreement with Samsung Biologics to increase capacity to manufacture and supply its biopharmaceutical therapies.

12 August 2020

US to procure 100 million Covid-19 vaccine doses from Moderna

The US Government has signed an agreement with Moderna to procure 100 million doses of its potential Covid-19 vaccine, mRNA-1273.

As agreed, the US will pay up to $1.525bn for the manufacturing and delivery of the vaccine doses including incentive payments for a timely delivery.

The agreement also includes an option to enable the purchase of an additional 400 million doses of mRNA-1273.

MRNA-1273 is an mRNA vaccine against Covid-19 jointly developed by Moderna and investigators from the National Institute of Allergy and Infectious Disease’s (NIAID) Vaccine Research Center.

In May, the US Food and Drug Administration (FDA) granted mRNA-1273 Fast Track designation.

Currently, it is one of the few vaccine candidates to advance to the final stage of testing. The Phase III study began last month with enrolment expected to complete in September.

Moderna CEO Stéphane Bancel said: “We appreciate the confidence of the US government in our mRNA vaccine platform and the continued support.

“We are advancing the clinical development of mRNA-1273 with the ongoing Phase III study being conducted in collaboration with NIAID and BARDA.

“In parallel, we are scaling up our manufacturing capability with our strategic partners, Lonza, Catalent and Rovi, to address this global health emergency with a safe and effective vaccine.”

In recent weeks, the US government ramped up efforts to procure millions of doses of potential Covid-19 vaccines from different companies as part of Operation Warp Speed programme.

US Secretary of Health and Human Services Alex Azar said: “For Operation Warp Speed, we are assembling a broad portfolio of vaccines to increase the odds that we will have at least one safe, effective vaccine as soon as the end of this year.

“With this latest investment, we will have supported the vaccine candidate developed by Moderna in partnership with the NIH all the way from early development through clinical trials and now manufacturing, with the potential to bring millions of safe and effective doses to the American people.”

Last month, Moderna signed a deal to receive additional $472m to support the late-stage clinical development of mRNA-1273.

12 August 2020

Russia approves world’s first Covid-19 vaccine

Russia has awarded regulatory approval to a Covid-19 vaccine, becoming the first country in the world to register a coronavirus vaccine for use.

The vaccine, Sputnik V, reflects the former Soviet Union’s space race successes.

However, the international community expressed concerns over the move as the vaccine launched before it completed the final trials.

Russian President Vladimir Putin claimed that Sputnik V completed all necessary tests and provides effective immunity against the disease that has currently infected more than 20 million people globally, including 895,000 in Russia.

He also said that one of his daughters, who volunteered for vaccination, had been inoculated.

Administered in two doses, the vaccine is developed by Gamaleya Institute in Moscow. It comprises two serotypes of a human adenovirus with an S-antigen of the new coronavirus to trigger an immune response in the body.

The vaccine will initially be administered on medical personnel and followed by teachers voluntarily starting later this month, with expected distribution next month, reported Reuters.

Russian business conglomerate Sistema also plans to put in vaccine into mass production by the end of this year, the news agency added.

Sputnik V is yet to complete the Phase III trial that usually involves thousands of participants.

Earlier this week, the Association of Clinical Trials Organizations (ACTO), a local trade body in Russia, urged the government to postpone the launch until the Covid-19 vaccine candidate completes the trial process.

More than 100 potential Covid-19 vaccine candidates are currently under development across the world. Among them, around four are under Phase III trials.

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