Industry news

South Africa rejects Sputnik V Covid-19 vaccine due to HIV concerns

19 october | vaccines

South African Health Products Regulatory Authority (SAHPRA) has decided not to approve Russia’s Sputnik V Covid-19 vaccine due to human immunodeficiency virus (HIV) concerns.

Developed by the Gamaleya Research Institute of Epidemiology and Microbiology, the vaccine merges two dissimilar adenovirus-vectored constructs based on Adenovirus Type 26 (Ad26) and Adenovirus Type 5 (Ad5).

The initial application for the vaccine was submitted on 23 February and since then, the vaccine data was analysed by SAHPRA under a rolling review process.

SAHPRA noted that there were concerns about the safety of Ad5-vectored shots in people who are at the risk for HIV infection.

The presence of already existing Ad-specific neutralising antibodies in people is a challenge faced by such types of vaccines.

The latest decision is based on clinical trials which analysed the safety of Ad5-vectored vaccines and those contained in the Russian vaccine.

Data from the STEP and PHAMBILI trials was taken into consideration. These trials assessed three doses of an Ad5-vectored vaccine that encodes the HIV gag, pol and nef proteins.

19 october | approvals

FDA EXPANDS APPROVAL TO GILEAD’S BIKTARVY FOR PAEDIATRIC HIV-1 TREATMENT

The US Food and Drug Administration (FDA) has approved an expanded indication for Gilead Sciences’ Biktarvy for paediatric subjects to treat human immunodeficiency virus 1 (HIV-1) infection.

The low-dose tablet form of the drug is indicated for kids weighing a minimum of 14kg to under 25kg and are virologically suppressed or new to antiretroviral treatment.

A comprehensive three-drug therapy for HIV-1, Biktarvy comprises bictegravir and emtricitabine/tenofovir alafenamide (Descovy).

To be used once a day, Biktarvy is said to be the smallest, integrase strand transfer inhibitor-based single-tablet regime for HIV-1.

With the latest approval of the supplemental new drug application, Biktarvy is now intended for younger HIV-1 patients.

19 october | clinical trials

UMEÅ UNIVERSITY STUDY FINDS MIX-AND-MATCH OF COVID-19 VACCINES REDUCES RISK

Scientists at Umeå University in Sweden have found that individuals who received AstraZeneca’s Covid-19 vaccine as a first dose and the messenger ribonucleic acid (mRNA) vaccine as a second shot had a reduced infection risk in a study.

Co-created by the University of Oxford and Vaccitech, AstraZeneca’s vaccine utilises a replication-deficient chimpanzee viral vector based on an adenovirus.

This shot also comprises the SARS-CoV-2 virus spike protein genetic material.

Various countries had earlier stopped the usage of AstraZeneca’s shot for individuals aged below 65 years.

In this regard, people who were given the first dose of this vaccine were advised to receive an mRNA vaccine as their second shot in the study.

18 october | deals

SILENCE AND HANSOH PARTNER TO DEVELOP SIRNA-BASED TREATMENTS

Silence Therapeutics and Hansoh Pharmaceutical have entered a partnership to develop small-interfering ribonucleic acid (siRNAs) drugs for three undisclosed targets using the former’s mRNAi GOLD platform.

Following the conclusion of the Phase I clinical trial, Hansoh will hold an exclusive option to licence rights to the first two targets in Hong Kong, Macau, Greater China and Taiwan.

For all the other territories, Silence will maintain exclusive rights for the two targets.

18 october | drug development

PFIZER AND BIONTECH SUBMIT DATA TO EMA FOR COVID-19 SHOT IN YOUNG CHILDREN

Pfizer and BioNTech have submitted data to the European Medicines Agency (EMA), backing the use of their Covid-19 vaccine, Comirnaty, in children aged five to less than 12 years.

The latest submission to the EMA is intended to modify the Conditional Marketing Authorization (CMA) for the vaccine in the EU.

The messenger ribonucleic acid vaccine is currently authorised for use under CMA from the European Commission to prevent Covid-19 in individuals aged 12 years or above.

Comirnaty is given in a two-dose regimen at a gap of three weeks.

Furthermore, the vaccine has also been authorised under an expanded CMA as a booster shot to be administered a minimum of six months after the second shot in people aged 18 years and above.

15 october | funding

BIOTECHNOLOGY STARTUP RECTIFY RAISES $100M THROUGH SERIES A FUNDING ROUND

Biotechnology firm Rectify Pharmaceuticals has raised $100m through a Series A funding round, which was co-led by Omega Funds, Atlas Venture, Forbion, and Longwood Fund.

Rectify plans to use the proceeds obtained from the financing round for its first human proof-of-concept studies.

The company, headquartered in Cambridge, Massachusetts, US, was founded last year by Jonathan Moore, a founding scientist at Vertex Pharmaceuticals, with Atlas Venture, a biotech venture capital firm.

The new start-up is developing a pipeline of positive functional modulators, disease-modifying precision therapies for patients with genetic diseases caused by mutations in adenosine triphosphate-binding cassette transporters.

In brief

Poseida and Takeda to develop non-viral in vivo gene therapy programmes

Poseida Therapeutics and Takeda Pharmaceutical have entered a research collaboration and license agreement to develop non-viral in vivo gene therapy programmes, including the former’s Hemophilia A programme.

Under the deal, the companies will research and develop up to eight in vivo gene therapy programmes.

CureVac to focus on second-generation mRNA vaccine candidates

German biopharmaceutical company CureVac has decided to abandon its Covid-19 vaccine development and focus on its collaboration with GlaxoSmithKline to develop second-generation messenger RNA (mRNA) vaccine candidates.

Pacira to acquire Flexion Therapeutics to boost non-opioid pain portfolio

Pacira BioSciences has entered a definitive agreement to acquire biopharmaceutical firm Flexion Therapeutics to boost its non-opioid pain portfolio. The company will acquire Flexion for an equity value of nearly $450m or $630m, which includes debt.

Merck seeks EUA for molnupiravir to treat Covid-19 in the US

Merck has submitted an EUA application to the US FDA for its investigational oral antiviral medicine, molnupiravir (MK-4482/EIDD-2801), to treat Covid-19.

Humanigen and Clinigen partner to implement lenzilumab

Humanigen has signed a contract with Clinigen Group to implement a managed access programme for investigational product lenzilumab (LenzMAP).

The first-in-class antibody Lenzilumabbinds to and neutralises granulocyte-macrophage colony-stimulating factor.

14 october | technology

IMMUSOFT AND TAKEDA TO DEVELOP CELL THERAPIES FOR RARE METABOLIC DISORDERS

Immusoft has signed a research and licensing agreement with Takeda Pharmaceutical for cell therapies in rare inherited metabolic disorders that lead to complications in the central nervous system.

The collaboration will see the discovery, development and commercialisation of cell therapies.

The cell therapies will be developed using Immusoft’s Immune System Programming technology platform.

14 october | vaccines

WHO KEEPS SPUTNIK V’S EUL PROCESS ON HOLD OVER MISSING DATA

The World Health Organization (WHO) has put Russia’s Covid-19 vaccine Sputnik V’s, Emergency Use Listing (EUL) process on hold, citing pending legal procedures and missing data.

In February, Russia had first sought WHO approval for Sputnik V.

It expects these issues to be resolved soon for the EUL process, reported Reuters.

WHO assistant director-general for access to medicines and health products Mariangela Simao said: “We are working almost on a daily basis with the ministry of health in Russia to address the remaining issues to be fulfilled by the Russian Direct Investment Fund.”