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.”
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.
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.
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.
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.
The latest news, approvals and clinical trials you need to know about this month
Four pharma industry heavyweights: AstraZeneca, Merck, Pfizer and Teva Pharmaceutical are joining forces with an AI-focused initiative called AION Labs that aims to help fund drug research start-ups.
Moderna is set to build a $500m vaccine manufacturing facility in Africa capable of producing up to 500 million vaccine doses in the continent each year.
The price that Merck is charging for the US Government for a five-day course of its Covid-19 treatment molnupiravir – a reported 40 times the cost it takes to produce the medication.
Deaths from tuberculosis have increased for the first time in more than a decade, totalling more than 1.5 million people in 2020, according to a new report from the World Health Organization.
Supernus Pharmaceuticals has signed an agreement for the acquisition of Adamas Pharmaceuticals for nearly $450m.
Tecentriq (atezolizumab)
The US Food and Drug Administration (FDA) has approved Roche’s Tecentriq (atezolizumab) as adjuvant therapy for treating Stage II-IIIA non-small cell lung cancer adult patients whose tumours express PD-L1≥1%.
Source: Pharmaceutical Technology
Ofev (nintedanib)
The National Institute for Health and Care Excellence (NICE) has recommended Boehringer Ingelheim’s Ofev (nintedanib) for the treatment of adult patients with chronic fibrosing interstitial lung diseases with a progressive phenotype (PF-ILD).
Source: Pharma Times
Dupixent (dupilumab)
NICE has issued a final appraisal determination recommending Dupixent (dupilumab), as an add-on maintenance treatment for severe asthma.
Source: Pharmafield
TYRVAYA (varenicline solution)
The US FDA has approved Oyster Point Pharma Inc's treatment for dry eye disease, TYRVAYA (varenicline solution) Nasal Spray 0.03 mg, making it the first US-approved nasal spray for the chronic condition.
Source: Reuters
Covaxin
An expert panel on India’s Central Drugs Standard Control Organisation has recommended granting emergency use authorisation to Bharat Biotech’s Covid-19 vaccine, Covaxin, for use in children aged two to 18 years.
Source: Pharmaceutical Technology
Clinical Trials
Positive trial results for Valneva Covid-19 vaccine
The Valneva Covid vaccine that the UK cancelled a 100 million dose order for last month, works well at priming the immune system to fight coronavirus, phase III trial results suggest.
Source: BBC
Emergent commences Phase III trial of single-dose chikungunya vaccine
Emergent BioSolutions has dosed the first subject in the Phase III trial of its single dose investigational chikungunya virus (CHIKV) vaccine candidate, CHIKV VLP.
Source: Clinical Trials Arena
Biogen drug for rare form of ALS fails pivotal study
In the phase III VALOR study, the primary endpoint as measured by the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) did not reach statistical significance.
Source: Biogen
Immune-Onc doses first patient in Phase I solid tumour treatment trial
The trial will analyse the TTX-080’s safety and efficacy as a single agent and in combination with pembrolizumab or cetuximab.
Source: Clinical Trials Arena
FDA halts Allogene CAR-T trial after safety scare
A phase I trial of Allogene’s of-the-shelf CAR-T for lymphoma has been placed on hold by the FDA, after a “chromosomal abnormality” was seen in a patient receiving the cell therapy.
Source: Pharmaphorum
Roche’s Enspryng lowers disease relapses in phase III NMOSD trials
Roche has reported the latest longer-term efficacy and safety results from two Phase III trials of Enspryng (satralizumab) for the treatment of neuromyelitis optica spectrum disorder (NMOSD).
Source: Clinical Trials Arena
covid-19
Clinical trial disruption eases post-pandemic
After a lengthy period of uncertainty, trial disruption is levelling off, with 1,058 trials still disrupted