Pfizer and BioNTech submit early data to FDA for booster Covid-19 shot
17 August | vaccines
Pfizer and BioNTech have submitted Phase I clinical trial data to the US Food and Drug Administration (FDA) to support the assessment of a booster shot of their Covid-19 vaccine, BNT162b2, for potential licensure.
The vaccine is currently authorised for emergency use by the FDA to prevent Covid-19 in people aged 12 years or above.
The Phase I trial is part of the Phase I/II/III programme assessing the safety, tolerability and immunogenicity of the third, or booster, shot in adult subjects from the Phase I trial of the two-dose regimen in the US.
Subjects in the latest trial were administered a 30µg booster dose of BNT162b2 eight to nine months following the second dose.
According to the trial data from these subjects, the booster shot induced substantially greater levels of neutralising antibody titers against the wild-type, Beta and Delta variants of SARS-CoV-2 versus the levels noted after the two-dose regimen.
16 August | regulation
FDA DECLINES TO APPROVE SESEN BIO’S BLADDER CANCER DRUG VICINEUM
The US FDA has declined to approve Sesen Bio’s biologics license application (BLA) for Vicineum (oportuzumab monatox-qqrs) to treat bacillus Calmette-Guérin-unresponsive non-muscle invasive bladder cancer.
A locally administered recombinant fusion protein, Vicineum works on epithelial cell adhesion molecule antigens on the tumour cell surface to carry a potent protein payload, Pseudomonas Exotoxin A.
Sesen Bio received a complete response letter from the FDA, notifying that the regulatory agency cannot approve the BLA for the drug in its current form.
The FDA also offered recommendations for further clinical data and analyses, apart from chemistry, manufacturing and controls issues linked to a recent pre-approval inspection and product quality, Sesen Bio noted.
13 august | approvals
NICE RECOMMENDS LILLY’S ABEMACICLIB FOR ADVANCED BREAST CANCER
The UK’s National Institute for Health and Care Excellence (NICE) has recommended Eli Lilly’s abemaciclib as an option for adults with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer that has spread to other body parts.
Marketed as Verzenios, abemaciclib is a CDK4/6 inhibitor, which works by hindering proteins in cancer cells that cause the division and growth of the tumour.
As per the NICE draft guidance, abemaciclib is indicated for use as a twice-daily pill along with the hormonal therapy drug, fulvestrant, in adults who have already received hormonal treatment.
The positive recommendation comes after an improved patient access scheme from Lilly.
13 august | clinical trials
SEN-JAM AND DUKE-NUS TO INITIATE PHASE II COVID-19 THERAPY TRIAL IN NEPAL
Sen-Jam has collaborated with Duke-NUS Medical School in Singapore to commence a Phase II clinical trial of the investigational therapy, SJP-002C, for the treatment of Covid-19 in Nepal.
Discovered by Sen-Jam Clinical Development head Jacqueline Iversen, SJP-002C is a combination of a specific non-steroidal anti-inflammatory drug and a specific antihistamine that can potentially disrupt runaway inflammation.
The investigational drug combination, with demonstrated anti-viral properties, could pre-emptively halt Covid-19 progression to the severe acute respiratory syndrome stage, Sen-Jam, a life-science start-up, noted.
12 august | regulation
FDA DECLINES TO APPROVE FIBROGEN’S ROXADUSTAT FOR ANAEMIA OF CKD
The US FDA has declined to approve the new drug application (NDA) for FibroGen’s roxadustat to treat anaemia in chronic kidney disease (CKD) patients.
Being developed in alliance with AstraZeneca and Astellas Pharma, roxadustat is an oral inhibitor of hypoxia-inducible factor prolyl hydroxylase (HIF-PH).
The drug is intended for use in non-dialysis dependent (NDD) as well as dialysis-dependent (DD) adult patients with CKD.
FibroGen received a complete response letter from the FDA, indicating that the regulatory agency will not approve the drug’s NDA in its current form, the company noted.
The CRL also sought a further clinical trial to analyse the safety of the drug in the NDD and DD patients, before resubmission.
The company intends to request a Type A meeting with the FDA soon to hold talks on further action required in the regulatory pathway for Vicineum’s approval.
12 august | clinical trials
I-MAB’S PLONMARLIMAB LOWERS MORTALITY RATE IN PHASE II/III COVID-19 TRIAL
I-Mab has reported positive interim results from the Phase II/III trial of plonmarlimab (TJM2 or TJ003234) to treat cytokine release syndrome (CRS) in severe Covid-19 patients in the US.
Discovered and developed by I-Mab, plonmarlimab is a neutralising antibody that targets a cytokine called human granulocyte-macrophage colony-stimulating factor (GM-CSF), which is involved in inflammation.
The ongoing, double-blind, placebo-controlled, randomised Phase II/III trial is assessing the therapeutic role of plonmarlimab in patients with severe Covid-19.
The objective of the trial is to establish safety, efficacy and effects on cytokine levels induced by a single dose of 6mg/kg of plonmarlimab compared to placebo.
According to the preliminary interim analysis data, 83.6% of subjects receiving plonmarlimab had an increased mechanical ventilation free rate versus 76.7% in the placebo arm by day 30.
EC to procure up to 200 million doses of Novavax’s Covid-19 vaccine
Novavax has entered an agreement with the European Commission (EC) to deliver up to 200 million doses of its Covid-19 vaccine candidate, NVX-CoV2373.
A protein-based vaccine candidate, NVX-CoV2373 is made from the genetic sequence of the original SARS-CoV-2 strain.
Amgen plans $550m manufacturing plant in Holly Springs, US
Amgen is set to construct a new multi-product drug substance manufacturing facility in Holly Springs, North Carolina, with an investment of $550m.
The new facility will extend the company’s manufacturing network in the US.
Celltrion obtains priority review in Canada for Covid-19 drug
Health Canada has granted priority review to Celltrion Healthcare’s experimental monoclonal antibody, regdanvimab (CT-P59), for the treatment of Covid-19.
Astellas and Minovia enter deal for mitochondrial cell therapies
Minovia Therapeutics and Astellas Pharma have signed a global strategic partnership and licence agreement to research, develop and market new cell therapy programmes for mitochondrial dysfunction-driven diseases.
Moderna records $4.4bn total revenue in Q2 2021
Moderna has reported total revenue of $4.4bn in the second quarter (Q2) of the fiscal year 2021, a surge from $67m in the same quarter last year.
Total revenue rose this year with commercial sales of Moderna’s Covid-19 vaccine and grant revenue to a reduced extent.
11 august | clinical trials
AZURRX EXPANDS TRIAL OF DRUG FOR COVID-19-LINKED GI INFECTIONS TO UKRAINE
AzurRx BioPharma has expanded the ongoing Phase II RESERVOIR clinical trial of FW-1022 for the treatment of Covid-19-related gastrointestinal (GI) infections in Ukraine.
The company has concluded site initiation visits and added five new trial centres in the country.
FW-1022 is an oral tablet that consists of micronised niclosamide and is designed to carry increased concentrations of the drug directly to the GI tract.
06 august | deals
KITE AND APPIA BIO TO DEVELOP ALLOGENEIC CELL THERAPIES FOR BLOOD CANCER
Gilead unit Kite and Appia Bio have signed a partnership and licence agreement to research and develop off-the-shelf allogeneic cell treatments from hematopoietic stem cells for haematological cancers.
The alliance will leverage Kite’s chimeric antigen receptors (CARs) and Appia Bio’s Appia Cells Utilized for Allogeneic technology platform to create CAR-engineered invariant natural killer T (CAR-iNKT) cells.
With this allogeneic cell therapy platform, Appia Bio uses the biology of lymphocyte development to produce CAR-iNKT cells from HSCs.
According to the deal, Appia Bio will handle both the preclinical and initial clinical research of two CAR-iNKT product candidates.
MCureX and Samyang sign MoU for mRNA vaccine development
OliX Pharmaceuticals’ subsidiary mCureX has entered a memorandum of understanding (MoU) with Samyang Holdings to develop a messenger ribonucleic acid (mRNA) vaccine for Covid-19.
The companies are co-developing a vaccine that could potentially target Covid-19 viral variants.
Argenx to regain rights to cusatuzumab from Janssen’s Cilag
Janssen Pharmaceutical subsidiary Cilag International has decided to discontinue its partnership and licence agreement with argenx for an investigational CD70-targeting antibody, cusatuzumab.
The development comes after Janssen reviewed all available data linked to cusatuzumab and considered the transforming standard of care for AML treatment.
Serum Institute obtains DCGI nod to produce Sputnik V vaccine in India
The Drug Controller General of India (DCGI) has granted approval to the Serum Institute of India to produce Russia’s Covid-19 vaccine, Sputnik V, in the country.
Based on an adenovirus vector, the vaccine is given in two doses with a gap of 21 days.
FDA updates Regeneron’s Covid-19 antibody EUA to lower dose
The US FDA has updated the EUA for Regeneron Pharmaceuticals’ Covid-19 antibody cocktail, REGEN-COV, reducing the dose to 1,200mg from 2,400mg.
Bristol Myers faces $6.4bn lawsuit over cancer drug delay
UMB Bank, a trustee for Celgene’s former shareholders, has filed a lawsuit against Bristol Myers Squibb for allegedly delaying the development and manufacturing of cancer drug lisocabtagene maraleucel (Liso-cel) to avoid contingent value right payments worth $6.4bn.