ARUVANT PARTNERS WITH LONZA TO MANUFACTURE SICKLE CELL DISEASE TREATMENT

Clinical-stage biopharmaceutical firm Aruvant Sciences and Lonza have entered a strategic long-term manufacturing agreement for the former’s one-time investigational gene therapy for sickle cell disease (SCD), ARU-1801.

The gene therapy will be developed for Aruvant’s upcoming pivotal trial.

Designed to tackle the limitations of present curative treatment options, ARU-1801 has unique characteristics that permit it to be given with reduced intensity conditioning.

The investigational lentiviral gene therapy is currently under analysis as a one-time potentially curative treatment for SCD in the Phase I/II MOMENTUM study. The trial is now enrolling subjects.

According to preliminary clinical data, engraftment of ARU-1801 and amelioration of SCD is achievable with a single dose of low-intensity chemotherapy.

Aruvant chief technology officer Palani Palaniappan said: “We are partnering with Lonza, one of the world’s leading cell and gene therapy manufacturing organisations, to help us manufacture our gene therapy ARU-1801, a potential cure for sickle cell disease that can be given with one low dose of chemotherapy."

PAKISTAN GRANTS EUA TO SINOPHARM’S COVID-19 VACCINE

The Drug Regulatory Authority of Pakistan (DRAP) has granted emergency use authorisation (EUA) to China National Pharmaceutical Group’s (Sinopharm) Covid-19 vaccine.

Reuters reported that the latest development comes after the country approved Covid-19 vaccine developed by AstraZeneca and Oxford University.

According to the Pakistan Health Ministry, the country is holding discussions with various vaccine manufacturers.

The two Covid-19 vaccines have been granted conditional authorisation.

A DRAP spokesman said that the vaccines were analysed for their safety and quality and the authorisation will be reviewed on a quarterly basis for further safety, efficacy and quality data.

Pakistan Health Minister Faisal Sultan said that the country could obtain “in the range of tens of millions” of vaccine shots as part of an agreement signed with Cansino Biologics in China.

At present, Cansino’s Ad5-nCoV Covid-19 vaccine candidate is concluding Phase III clinical trials in Pakistan.

Sultan added that preliminary data from the trial of the vaccine is expected in mid-February.

BRAZIL APPROVES SINOVAC AND ASTRAZENECA COVID-19 VACCINES FOR EMERGENCY USE

Brazil has granted approval to AstraZeneca and Chinese firm Sinovac Biotech’c Covid-19 vaccines for emergency use, allowing the country to begin inoculation as cases surge.

Brazilian health regulator Anvisa approved the vaccines citing a rise in cases, as well as the absence of options for Covid-19 treatment, Bloomberg reported.

Anvisa director Meiruze Freitas said that even though government technicians said they require more information about the vaccine, its benefits surpass the risks.

The media company quoted Freitas as saying: “We must continue monitoring the vaccines to capture adverse effects that were perhaps not seen in trials.”

Health Minister Eduardo Pazuello said in a press meet in Rio de Janeiro that the government would not do a ‘photo op’ vaccination.

Pazuello added that after a ‘symbolic delivery’ of vaccines to states on 18 January, the vaccination programme will begin on 20 January with delivery based on locations which are at higher risk, in a bid to provide more doses.

Initially, the elderly, Brazil’s local population and healthcare staff will receive the vaccines.

FDA APPROVES PFIZER’S XALKORI IN ALCL IN CHILDREN, YOUNG ADULTS

The US FDA has approved the supplemental New Drug Application (sNDA) for Pfizer’s Xalkori (crizotinib) for treating paediatric patients aged one year and above and young adults with anaplastic lymphoma kinase (ALK)-positive relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL).

The latest development derives from results of Study ADVL0912, which showed Xalkori treatment resulted in an objective response rate of 88%.

The multicentre, single-arm, open-label study enrolled 121 patients aged between one and 21 years and included 26 patients with relapsed or refractory, systemic ALK-positive ALCL after at least one systemic treatment.

Furthermore, Xalkori’s safety profile in ALK-positive ALCL in children and young adults was observed to be similar to those in patients suffering from ALK-positive and ROS1-positive metastatic NSCLC.

Pfizer Global Product Development Oncology chief development officer Chris Boshoff said: “We are proud to deliver the first biomarker-driven therapy for children and young adults with ALCL. Xalkori offers a meaningful new treatment option for young patients with relapsed or refractory ALK-positive ALCL."

SII EXPECTS WHO EMERGENCY APPROVAL OF COVID-19 VACCINE SOON

The Serum Institute of India (SII) expects to soon receive World Health Organisation (WHO) emergency use authorisation for the Oxford University/AstraZeneca Covid-19 vaccine, produced for mid and low-income countries.

Reuters quoted SII chief executive Adar Poonawalla as saying at the Reuters Next conference: “The emergency use licensure from the WHO should be available and coming through in the next week or two, hopefully, because we have submitted everything.”

Poonawalla added that SII was aiming to initiate deliveries of the WHO-backed COVAX initiative by this month-end.

A single dose of the vaccine will cost $3 for low-income countries and sold to others at a ‘slightly higher’ rate.

The vaccine maker already sold 11 million doses to the Indian Government, which is planning to initiate the world’s largest mass vaccination campaign on 16 January.

Indian Prime Minister Narendra Modi will launch the rollout of the drive at a total of 3,006 session sites virtually.

In the first phase, the country intends to vaccinate around 300 million people.

Earlier this month, the Drugs Controller General of India approved Covid-19 vaccines of Serum Institute of India and Bharat Biotech for restricted use in emergency situations.

FDA ACCEPTS PRIORITY REVIEW OF MERCK’S PNEUMOCOCCAL VACCINE

The US FDA has accepted priority review of the Biologics License Application (BLA) of Merck’s investigational 15-valent pneumococcal conjugate vaccine candidate, V114, for preventing invasive pneumococcal disease in adults.

The vaccine candidate has pneumococcal polysaccharides from 15 serotypes conjugated to a CRM197 carrier protein and also serotypes 22F and 33F.

The BLA and priority review status are backed by results from Phase II and Phase III clinical studies in the adult population. These include healthy adults and people at high risk, such as those with chronic medical conditions, HIV and aged 65 years and above.

Furthermore, additional studies in the BLA back V114’s usage in clinical settings, such as in co-administration with the quadrivalent influenza vaccine, as well as in sequential administration with PNEUMOVAX 23 and show identical performance among consecutive lots of V114.

Separately, a licensure application for V114 in adults is under review by the European Medicines Agency.