Novartis and Molecular Partners commence Covid-19 treatment trial
28 May | vaccines
Novartis and Molecular Partners have commenced the Phase II/III EMPATHY clinical trial of a new DARPin therapeutic candidate, ensovibep (MP0420), to treat Covid-19.
These clinical trials will be carried out by Novartis while Molecular Partners will fund the studies.
The global, multi-centre EMPATHY trial programme is assessing the safety and efficacy of ensovibep in adult patients in the initial stages of Covid-19 infection to prevent symptom deterioration and hospitalisation.
Approximately 400 subjects will be enrolled in Phase II, which will determine the optimal dose based on safety and activity. Preliminary results from this study are expected in August.
Subsequently, the Phase III part will enrol 1,700 subjects and results are set to be available in the first half of next year.
On obtaining satisfactory preliminary results from the EMPATHY trial, Novartis plans to pursue expedited approval through the US Food and Drug Administration’s (FDA) Emergency Use Authorization (EUA).
Molecular Partners CEO Patrick Amstutz said: “By virtue of its tri-specific design, ensovibep was built to resist viral mutations and indeed shows potent inhibition of all variants of concern to date, with the potential to maintain activity also for future variants.
“This type of broad-spectrum activity is essential for any treatment of relevance for patients with Covid-19.”
27 may | Drug development
CARLYLE GROUP TO ACQUIRE PHARMA COMPANY VECTURA FOR $1.36BN
Carlyle Group has entered an agreement through which its affiliate Murano Bidco will acquire 100% shares of pharmaceutical firm Vectura Group in a deal worth $1.36bn (£958m).
According to the deal, Vectura shareholders will receive $2 (£1.55) for each share, including a cash dividend of $0.27 (£0.19).
The total acquisition value represents a premium of nearly 27% of the closing price of $1.7 (£1.22) per share of Vectura on 25 May.
Murano Bidco is a recently founded company that is indirectly controlled by Carlyle Europe Partners V Fund.
A UK-based pharmaceutical company, Vectura focuses on providing inhaled drug delivery solutions that aid its partners to deliver their treatments to patients.
The company has a portfolio of 13 inhaled and 11 non-inhaled products that are commercialised by its partners with royalty streams globally.
27 may | Drug development
NIKANG THERAPEUTICS SECURES $200M IN SERIES C FUNDING
NiKang Therapeutics has secured $200m in a Series C funding round to develop new small molecules for difficult-to-drug targets in oncology indications.
The financing round was led by Cormorant Asset Management, HBM Healthcare Investments and Octagon Capital Advisors.
Several other companies took part, including the latest investors EcoR1 Capital, Perceptive Advisors, Wellington Management, Ally Bridge Group and Pavilion Capital, among others.
All the present investors of NiKang, which includes CBC Group, RTW Investments, Lilly Asia Ventures, Matrix Partners China and Casdin Capital, participated in the financing round.
As part of the funding, Viela Bio former CEO and chairman Bing Yao and Octagon Capital Advisors founder and chief investment officer Ting Jia will join NiKang’s board of directors.
25 May | infectious diseases
CIPLA TO MARKET ROCHE’S COVID-19 ANTIBODY COCKTAIL IN INDIA
Cipla has announced that the first batch of Roche’s antibody cocktail, Casirivimab and Imdevimab, is now available for treating Covid-19 in India, with a second batch of the drug to be available next month.
Casirivimab and Imdevimab are human immunoglobulin G-1 (IgG1) monoclonal antibodies that act against SARS-CoV-2 spike proteins to hinder the attachment of the virus and its human cell entry.
Indicated for restricted use in emergency cases, the cocktail can treat mild-to-moderate Covid-19 in adults and paediatric patients who are at increased risk of developing severe disease and do not need oxygen.
Recently, the Indian drug regulator Central Drugs Standards Control Organisation granted EUA to the antibody cocktail in the country.
The drug also has similar approvals in the US and various EU countries.
Based in India, Cipla will market the drug using its distribution channels in the country. The drug will be accessible through hospitals and Covid-19 treatment centres.
25 May | drug development
QIMR BERGHOFER RESEARCHERS CREATE DRUGS FOR COVID-19
Researchers from QIMR Berghofer Medical Research Institute in Queensland, Australia, have created two new peptide-based drugs to potentially prevent and treat Covid-19.
The first drug can be administered before being exposed to SARS-CoV-2 and aids in enhancing the vaccine efficacy while the second drug can potentially hinder the virus spread in cells that are infected.
Instead of targeting SARS-CoV-2, these early intervention drugs target how human cells react to the virus.
Currently, these drugs are being studied in hamsters at Infectious Disease Models and Innovative Therapies, a pre-clinical and clinical research centre in France. Initial data showed that the drugs are non-toxic and have reduced side effects.
The drugs were discovered after scientists found an earlier unknown way of entry that SARS-CoV-2 uses to attack cells and cause Covid-19.
According to lab tests, the first drug masks the angiotensin-converting enzyme 2 (ACE2) receptor protein on human cells to lower infection.
QIMR noted that the virus spike protein utilises the ACE2 receptor to attach to and attack cells.
Even if the virus enters cells, the second drug can hinder the virus’ mode of attacking the host cell and replication.
24 May | regulation
FDA APPROVES JANSSEN’S RYBREVANT FOR NSCLC TREATMENT
The US FDA has granted accelerated approval to Janssen Pharmaceutical of Johnson and Johnson’s (J&J) Rybrevant (amivantamab-vmjw) to treat adults with locally advanced or metastatic non-small cell lung cancer (NSCLC).
Rybrevant is indicated for NSCLC patients with epidermal growth factor receptor (EGFR) exon 20 insertion mutations whose disease advanced on or after using platinum-containing chemotherapy. The drug is the first targeted treatment to receive FDA approval in this indication.
A fully human, bispecific antibody, the drug is designed to target EGFR and MET receptors. It attaches extracellularly and hinders tumour growth, causing the death of tumour cells.
In March last year, the FDA granted breakthrough therapy designation to Rybrevant while a priority review of the biologics license application commenced in December.
The latest accelerated approval is based on positive data from the ongoing Phase I CHRYSALIS study of Rybrevant monotherapy in patients who have received platinum-based chemotherapy.
Updated results from the multi-centre, open-label trial showed strong activity and extended responses, with a tolerable safety profile in NSCLC patients with EGFR exon 20 insertion mutations.
In brief
Numab Therapeutics secures $110m in Series C funding round
Numab Therapeutics has raised approximately $110m (CHF100m) through Series C funding to expedite the clinical development of its multi-specific antibody pipeline in oncology and inflammation.
The funding round was co-led by new investors Novo Holdings and HBM Partners.
Sorrento gets Brazilian ANVISA’s clearance for Phase II Covid-19 trial
Sorrento Therapeutics has received clearance from the Brazilian regulatory agency ANVISA to conduct a Phase II clinical trial of an injectable infusion of mesenchymal stem cells, COVI-MSC, to treat Covid-19 patients with acute respiratory distress syndrome.
EC to procure 1.8 billion doses of Pfizer-BioNTech’s Covid-19 vaccine
The European Commission (EC) has signed a new contract with BioNTech and Pfizer to procure additional 1.8 billion doses of their Covid-19 vaccine, Comirnaty, between this year end to 2023.
The latest agreement, entered by the EC on behalf of all European Union member states, will allow it to buy 900 million doses of the existing vaccine and a variant-specific vaccine. The commission also holds an option to procure an additional 900 million doses.
Exscientia signs $1.2bn AI drug discovery deal with BMS
Bristol-Myers Squibb (BMS) and Exscientia have signed a partnership agreement to leverage artificial intelligence (AI) for the discovery of small molecule drug candidates in various therapeutic areas, including oncology and immunology.
Veru initiates enrolment in Phase III trial of sabizabulin for Covid-19
Veru has enrolled the first subject in Phase III clinical trial of sabizabulin to treat hospitalised Covid-19 patients who are at high risk for acute respiratory distress syndrome.
24 May | regulation
JAPAN AUTHORISES ASTRAZENECA AND MODERNA’S COVID-19 VACCINES
The Ministry of Health, Labour and Welfare (MHLW) of Japan has authorised AstraZeneca’s Covid-19 vaccine, Vaxzevria (ChAdOx1-S [Recombinant]) and Moderna’s mRNA Covid-19 vaccine for emergency use in the country.
Vaxzevria is indicated for active immunisation of people aged 18 years and above for preventing Covid-19.
Co-developed by the University of Oxford and Vaccitech, Vaxzevria is an adenovirus-based vaccine with the SARS-CoV-2 spike protein genetic material.
The MHLW authorisation for Vaxzevria is based on positive efficacy and safety results from Phase III trials led by Oxford University in the UK, Brazil and South Africa, as well as a Phase I/II study in Japan.
According to the recommendation of Japan’s Pharmaceuticals and Medical Devices Agency, two intramuscular 0.5ml doses of Vaxzevria can be administered to adults four to 12 weeks apart.
24 May | clinical trials
GSK-VIR’S COVID-19 DRUG SOTROVIMAB OBTAINS POSITIVE EMA OPINION
The European Medicines Agency’s (EMA) Committee for Human Medicinal Products (CHMP) has issued a positive scientific opinion for GlaxoSmithKline (GSK) and Vir Biotechnology’s sotrovimab (VIR-7831) as early Covid-19 treatment.
A SARS-CoV-2 monoclonal antibody, sotrovimab attaches to an epitope on the virus to hinder resistance development.
Integrating Xencor’s Xtend technology, the investigational antibody can potentially achieve increased concentration in the lungs for penetration into Covid-19-affected airway tissues and for an increased half-life.
As per the CHMP opinion, sotrovimab can be used to treat Covid-19 patients aged 12 years and above who weigh at least 40kg, do not need supplemental oxygen and are at risk of disease progression.
The EMA started a review of the antibody last month.
The CHMP based its opinion on the review of efficacy and safety results from the Phase III COMET-ICE trial, including an interim analysis and multiple in vitro studies.
In brief
Numab Therapeutics secures $110m in Series C funding round
Numab Therapeutics has raised approximately $110m (CHF100m) through Series C funding to expedite the clinical development of its multi-specific antibody pipeline in oncology and inflammation.
The funding round was co-led by new investors Novo Holdings and HBM Partners.
Sorrento gets Brazilian ANVISA’s clearance for Phase II Covid-19 trial
Sorrento Therapeutics has received clearance from the Brazilian regulatory agency ANVISA to conduct a Phase II clinical trial of an injectable infusion of mesenchymal stem cells, COVI-MSC, to treat Covid-19 patients with acute respiratory distress syndrome.
EC to procure 1.8 billion doses of Pfizer-BioNTech’s Covid-19 vaccine
The European Commission (EC) has signed a new contract with BioNTech and Pfizer to procure additional 1.8 billion doses of their Covid-19 vaccine, Comirnaty, between this year-end to 2023.
The latest agreement, entered by the EC on behalf of all European Union member states, will allow it to buy 900 million doses of the existing vaccine and a variant-specific vaccine. The commission also holds an option to procure an additional 900 million doses.
Exscientia signs $1.2bn AI drug discovery deal with BMS
Bristol-Myers Squibb (BMS) and Exscientia have signed a partnership agreement to leverage artificial intelligence (AI) for the discovery of small molecule drug candidates in various therapeutic areas, including oncology and immunology.
Veru initiates enrolment in Phase III trial of sabizabulin for Covid-19
Veru has enrolled the first subject in Phase III clinical trial of sabizabulin to treat hospitalised Covid-19 patients who are at high risk for acute respiratory distress syndrome.
The latest news, approvals and clinical trials you need to know about this month
A malaria vaccine has proved to be 77% effective in early trials, and could be a major breakthrough against the disease, says the University of Oxford team behind it.
Pharma companies are set to produce 11.4 billion Covid-19 vaccine doses by the end of the year, according to Goldman Sachs.
India’s second Covid-19 wave pushed the nation's pharma industry growth to 59% in April.
The European Union's drugs regulator has said the Pfizer Covid vaccine can now be stored at fridge temperature for up to a month.
The US Government has vowed to send 20 million doses of US-approved coronavirus vaccines overseas by the end of June.
2-deoxy-d-glucose
The Drug Controller General of India has approved the drug 2-deoxy-d-glucose for emergency use among people with moderate and severe Covid-19.
Source: The Hindu
Zynrelef (bupivacaine and meloxicam) Injection
Heron Therapeutics has received approval from the US Food and Drug Administration (FDA) for Zynrelef to provide postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy and total knee arthroplasty.
Source: Healio
Jemperli (dostarlimab)
GlaxoSmithKline (GSK) has received approval from both the European Commission and FDA for Jemperli (dostarlimab), a programmed death receptor-1 (PD-1)-blocking antibody, for treating endometrial cancer.
Source: GSK
KLOXXADOTM (naloxone hydrochloride)
The US FDA has approved Hikma Pharmaceuticals’s KLOXXADOTM (naloxone hydrochloride) nasal spray 8mg for the emergency treatment of known or suspected opioid overdose.
Source: Hikma
Tecentriq
Roche’s Tecentriq has been approved by the European Commission as a first-line monotherapy treatment for people with a type of metastatic non-small cell lung cancer.
Source: Roche
Clinical Trials
First Alzheimer’s disease drug candidate designed by AI enters Phase I clinical trials
The world’s first Alzheimer’s disease drug candidate designed by artificial intelligence (AI) is entering Phase I clinical trials, thanks to a successful collaboration between Exscientia Ltd and Sumitomo Dainippon Pharma.
Source: PharmaField
Volunteers sought for clinical trial of Covid vaccine made in Scotland
Researchers are recruiting thousands of UK volunteers for the final stage clinical trial of a candidate coronavirus vaccine that is being manufactured in Scotland. Doctors plan to give the Valneva vaccine to 4,000 adults from the beginning of May in a Phase II/III trial that will run from more than 20 sites across England and two hospitals in Edinburgh and Glasgow.
Source: The Guardian
Latest results put Oxford–AstraZeneca Covid-19 vaccine back on track
A key phase III clinical trial found the vaccine to be 76% effective at preventing Covid-19, the company announced on 25 March, two days after it was accused of misrepresenting interim results, which reported a slightly higher efficacy of 79%.
Source: Nature
Magenta’s multiple myeloma treatment trial meets primary endpoint
Magenta Therapeutics has reported that Phase II clinical trial of MGTA-145 in combination with plerixafor in multiple myeloma patients met the primary endpoint. All ten subjects met the primary goal of mobilising two million CD34+ stem cells per kg in up to two days of same-day mobilisation and apheresis, preliminary results showed.
Source: Clinical Trials Arena
Inovio reports positive data from Phase II Covid-19 DNA vaccine trial
The Inovio vaccine Phase II trial assessed the safety, tolerability and immunogenicity of two doses of INO-4800 to detect optimal dose(s) for age groups, namely 18 to 50 years and 51 years and above, for the Phase III efficacy analysis.
Source: Pharmaceutical Technology
Orchard’s gene therapy improves overall survival in ADA-SCID trials
Orchard Therapeutics has reported data from three Phase I/II clinical studies of investigational gene therapies, including OTL-101, to treat adenosine deaminase severe combined immunodeficiency (ADA-SCID).
Source: Clinical Trials Arena
BRIEFING
Malaria vaccine trial results could lead to breakthrough
A malaria vaccine has proved to be 77% effective in early trials