LONDON - Phase I/II data from the Astrazeneca plc COVID-19 vaccine show there were strong antibody and T-cell responses to the adenoviral vectored product. The trial run by Oxford University showed AZD-1222 was tolerated and generated robust immune responses against the SARS-CoV-2 virus in all 1,077 healthy adult participants, ages 18 to 55. It assessed a single dose of AZD-1222 against a comparator meningococcal conjugate vaccine, MenACWY. The results published in The Lancet confirmed a single dose of AZD-1222 resulted in a fourfold increase in antibodies to the SARS-CoV-2 virus spike protein in 95% of participants one month after injection.

COVID-19: Glaxosmithkline invests in Curevac; U.K. makes advance purchase deals

LONDON – Glaxosmithkline plc (GSK) is putting £130 million (US$164.3 million) into one of the leading COVID-19 vaccines developers, Curevac AG, acquiring a 10% stake, and will also invest £104 million cash up front to fund research and development of the company’s mRNA vaccines. In addition, GSK will make a one-off payment of £26 million to reserve capacity at Curevac’s commercial-scale mRNA vaccines manufacturing facility, which currently is under construction.

Synairgen stock rockets as inhaled interferon-beta shows signs of efficacy in COVID-19

DUBLIN – Synairgen plc has detected what appear to be promising efficacy signals in a phase II trial of its inhaled formulation of interferon-beta 1a, SNG-001, in COVID-19. Those in the drug treatment group on the placebo-controlled study, which recruited 101 hospitalized patients, had 79% lower odds of developing severe disease, defined as requiring ventilation or death during the treatment period (day one to day 16), than those in the control arm. The results were statistically significant. The company is not yet reporting on the primary endpoint, the change in condition measured on the ordinal scale of clinical improvement – the scale ranges from 0 (the patient is well) to a maximum of 8 (death) – out to day 28, but the company and its clinical collaborators said during a media briefing that this endpoint was also achieved with statistical significance.

Beyond antibodies: T cells are a critical aspect of long-term COVID-19 immunity

LONDON – From the start of the pandemic antibodies have been the main focus of attempts to understand the immune response to SARS-CoV-2 and ascertain what it will take for vaccines to be protective. Now, the focus is widening to harder-to-measure T cells, with reports beginning to accumulate that people who test positive for the virus show a T-cell adaptive immune response. That is giving cause for hope that it is possible to induce a protective response, given the evidence to date that antibody responses to SARS-CoV-2 are extremely variable and in many cases, ephemeral.

Biocon’s repurposed psoriasis drug gets Indian approval for COVID-19

NEW DELHI – Bangalore-based Biocon Ltd. has received the Indian drug regulator's approval for restricted emergency use of its psoriasis biologic, itolizumab, to treat patients with severe cases of COVID-19 in need of ventilator support. Itolizumab, an immunomodulatory drug developed jointly by Biocon and the Centre of Molecular Immunology, Havana, has been used in India since 2013 to treat acute psoriasis, and has a seven-year track record of safety. Its emergency restricted use is only for moderate to severe cases to prevent the need for ventilators to combat the spread of the disease.

Celltrion starts phase I trials for COVID-19 antiviral antibody treatment CT-P59

HONG KONG – Incheon, South Korea-based Celltrion Inc. will start manufacturing its COVID-19 treatment for clinical trials and commercial distribution, even though it’s only reached phase I trials. The phase I trials began testing the in-house antiviral antibody treatment CT-P59 on July 17, the same day the company received approval from Korea’s Ministry of Food and Drug Safety (MFDS) for its investigational new drug application on the back of positive preclinical results. CT-P59 aims to neutralize the virulent D614G variant, associated with increased viral transmission and wide spread of the COVID-19 virus.

Beigene taps into Assembly’s HBV lineup in pact worth up to $540M

South San Francisco-based Assembly Biosciences Inc. bagged a potential $540 million deal with Beigene Ltd. centered on three clinical-stage therapies for chronic hepatitis B virus (HBV) infection. The terms bring $40 million up front plus as much as $500 million in development, regulatory and sales milestone payments, as well as royalties. Beigene, of Beijing, claims rights to advance and commercialize ABI-H0731, ABI-H2158 and ABI-H3733 in China, including Hong Kong, Macau and Taiwan. ABI-H0731 and ABI-H2158 are in ongoing phase II trials, while ABI-H3733 has reached the phase I stage. The compounds are described as HBV core inhibitors that target the virus at various stages of its life cycle. Shares of Assembly (NASDAQ:ASMB) were trading midday at $27.10, up $2.61, or 10%.

Getting more efficient with clinical trials

The number of clinical trials initiated each year has continued to grow every year over the last decade, sans a slight decrease in 2013, according to data presented in a webcast facilitated by Applied Clinical Trials.

Antengene raises $97M in series C financing

HONG KONG – China and U.S.-based pharmaceutical company Antengene Corp. has closed a $97 million series C financing round, with proceeds mainly directed toward funding the continuing clinical development of its pipeline of hematology and oncology therapies, expanding in-house research and development capabilities, and strengthening its commercial infrastructure in the Asia Pacific markets. 

After EU withdrawal, catumaxomab ready for phase III trials again under China’s Lintonpharm

The first bispecific antibody to win regulatory approval, Removab (catumaxomab) was voluntarily withdrawn due to commercial reasons. Now Chinese biotech Lintonpharm Co. Ltd., of Guangzhou, said it plans to move catumaxomab to a global phase III trial following an IND approval from China’s NMPA, investigating the trifunctional bispecific antibody in patients with peritoneal carcinomatosis, a form of advanced gastric cancer.

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