Global Roundup: Russian Vaccine Posts 90% Efficacy, RDIF Says

Russian Vaccine

In August, Russia approved Sputnik-V, a vaccine against COVID-19 ahead of the completion of Phase III studies. This week, the National Research Center for Epidemiology and Microbiology in that nation announced the vaccine’s efficacy is at 90% following the latest review of clinical data.

The efficacy announcement followed an analysis of Phase III data. Calculation was based on the analysis of data of volunteers who received both the first and second doses of the Sputnik V vaccine or placebo at the third and final control point of 78 confirmed cases in accordance with the Phase III clinical trials protocol, the government said. The advance to the third and final statistically significant representative control point allowed for the final proof of the efficacy of the vaccine of over 90%, the government said. Among the confirmed cases of coronavirus infection, 20 severe cases were recorded in the placebo group, while no severe cases were recorded in the vaccine group.

Elsewhere around the world:

Thermo Fisher -- To meet accelerating demand for robust clinical supply chain services throughout Europe, Thermo Fisher Scientific has expanded its pharma services footprint with two new facilities in Rheinfelden and Weil am Rhein, Germany. The new sites will boost clinical supply chain continuity and specialized cold chain and cryogenic expertise across Europe and globally. The Rheinfelden site opens in late December 2020 and the Weil am Rhein site will open in January 2021. In Rheinfelden, the new 86,000-square-foot/8,000-square-meter facility significantly increases the company's footprint for secondary packaging, storage, logistics and distribution of clinical supplies to investigator sites across Europe. In Weil am Rhein, the new 9,600-square-foot/890-square-meter cryocenter provides specialized ultra-low-temperature, cryogenic storage and cold chain expertise for clinical supply chain needs for cell and gene-based therapies, including COVID-19 vaccine candidates.

ADCT BioPharma – Switzerland-based ADC and China’s Overland Pharmaceuticals jointly formed a new company, Overland ADCT BioPharma Limited. The new company will develop and commercialize four of ADC Therapeutics’ antibody drug conjugate (ADC) product candidates for difficult-to-treat hematologic and solid tumors – loncastuximab tesirine (Lonca), ADCT-601, ADCT-602 and ADCT-901 – in greater China and Singapore.

Pepscope – Netherlands-based Pepscope announced a €4.3 million funding round that will be used to develop and commercialize the company’s lead product, QuantaKinome. According to the company, QuantaKinome is the first technology to provide direct insights into the activities of hundreds of protein kinases simultaneously inside the cells of diseased tissues. The financing was led by KIKK Capital, together with Oost NL and the Netherlands Enterprise Agency.

Open Orphan – U.K.-based Open Orphan plc, a contract research organization, announced its Phase I study of Codagenix intranasal SARS-CoV-2 (COVID-19) vaccine candidate has received approval from the UK’s independent Medicines and Healthcare Products Regulatory Agency. The study will evaluate safety and immunogenicity of a single-dose nasal vaccine candidate in 48 healthy young adult volunteers.

Havn Life Sciences – Based in Vancouver, Havn announced plans for a preclinical study that will focus on the effects of psilocybin on the immune system. The goal is to determine if a single dose of psilocybin extract can impact the body's inflammatory response and regulate the human immune system. The study is expected to begin in the first quarter of 2021.

Polyphor – Switzerland’s Polyphor announced an extension of its agreement with CARB-X in support of the development of Polyphor’s novel OMPTA (Outer Membrane Protein Targeting Antibiotics) BamA program. The OMPTA-BamA program addresses the deadliest and most resistant Gram-negative bacterial pathogens. Under the extension of the 2019 agreement, CARB-X is committing to Polyphor additional funding of up to $2.3 million, which brings potential funding for this contractual stage to $5.1 million. Polyphor may also receive up to $13 million in future option stages that could take the program through a first-in-human program if certain project milestones are met.

eTheRNA – Belgium’s eTheRNA Immunotherapies NV and Netherlands-based Frame Therapeutics received a €1.9 million Eurostars grant to support development of a therapeutic vaccine for the treatment of kidney cancer. eTheRNA immunotherapies and Frame Therapeutics began collaborating in early 2020, deploying mRNA technologies to develop novel cancer vaccines based on unique genetic mutations in patient tumors to stimulate a patient’s immune system against the tumor. Errors in DNA replication can produce inserts or deletions of individual nucleotides and result in “frameshift” mutations, which can produce altered proteins recognized as non-self by the immune system. Some of these frameshift-derived neoantigens are shared across different patients with similar types of cancer, the companies said.

CN Bio – U.K.-based CN Bio and the University of Melbourne in Australia forged a collaboration focused on respiratory therapies for recovering COVID-19 patients. The research intends to build on CN Bio’s Organ-on-a-Chip technology, with hopes of developing a model capable of recapitulating the fibrosis and tissue remodeling seen in chronic interstitial lung disease, often occurring following SARS-CoV-2 infection. Subsequently, the University will investigate anti-inflammatory, anti-fibrotic and anti-viral agents to treat patients.

Mologic Ltd. – Also based in the U.K., Mologic announced it is in the final developmental stages of a pen-diagnostic test with the University of Liverpool. The rest will allow farmers and vets to diagnose livestock exposure to fluke on farm, with results available within 10 minutes. Current liver fluke diagnostic tests require laboratory analysis, with typical wait time of a week or more for results.

Sensorium – France’s Sensorium announced Switzerland’s Sonova Holding AG will acquire a 3.7% ownership stake. Sensorion and Sonova plan a strategic collaboration in the field of innovative diagnostic and therapeutic solutions for certain types of hearing loss. The company intends to use the net proceeds from the Capital Increase for possible studies under the co-development agreement, to develop its current gene therapy programs (OTOF and USHER), potentially broaden its gene therapy pipeline, support its pharmacology and clinical studies of SENS-401, and for working capital and general corporate purposes, the company said.

AurorA Science – Italy’s AurorA Science will invest funds in support  of Barcelona-based Peptomyc S.L., a biotech company specializing in the development of a new generation of cell penetrating peptides (CPPs) targeting the Myc oncoprotein for the treatment of different cancer types.

IIG – London’s Intuitive Investments Group plc raised £7.85 million, which will be used to invest in fast growing and/or high potential Life Sciences businesses, based predominantly in the UK, wider Europe and the United States. Investments will be focused on diagnostics and healthcare, medical devices, tools and technologies and bio-therapeutics and pharmaceuticals.

Revitope Oncology – A spinout of University of Birmingham secured a $10 million investment from China’s Junshi Biosciences that provides the company with a 9.9% stake in the startup. Earlier this year, the two companies entered into an $800 million agreement that leverages Revitope’s proprietary protein engineering platform and Junshi’s novel antibody components to deliver first-in-class precision cancer therapies. The Revitope technology, known as the T-cell engager antibody circuit (TEAC), splits antibodies into two halves, and programs each half to recognize a different antigen.  These halves are inactive until they encounter a cancer cell that expresses both antigens, when they reunite and direct an immune response towards the target cell. Targeting two antigens rather than one provides a unique ‘tumor-specific address’ for solid tumors and therefore avoids the unwanted toxicities in healthy tissues that are common side effects with many cancer therapies.

Gedea pHyph – Sweden’s Gedea announced its pHyph antibiotic-free treatment for bacterial vaginosis has a high cure rate and prevents recurrence of the infection. Data was published in the European Journal of Obstetrics & Gynaecology and Reproductive Biology. A follow-up investigation of microbiome samples collected during the study is underway at the Karolinska Intitutet. This investigation is expected to reveal additional insights into patient responses.

FSD Pharma – Toronto-based FSD Pharma dosed the first patient in its Phase IIa study FSD201 (ultramicronized palmitoylethanolamide, or ultramicronized PEA) for the treatment of hospitalized patients with COVID-19. The primary objective of the FSD201 COVID-19 trial is to determine whether FSD201 plus SOC provides a significant improvement in the clinical status of patients (e.g., shorter time to symptom relief). Secondary objectives of the FSD201 COVID-19 trial include determining whether FSD201 plus SOC demonstrates additional benefit in terms of safety, objective assessments such as length of time to normalization of fever, length of time to improvement of oxygen saturation and length of time to clinical progression, including time to mechanical ventilation or hospitalization, and length of hospital stay.

Relaxera – Germany’s Relaxera Pharmazeutische GmbH partnered with Greece’s CBL Patras in the development of human relaxin-2. The agreement designates CBL as the exclusive manufacturing partner for synthetic human relaxin-2. Relaxin-2 will be used to study the effects of relaxin-2 on myocardial fibrosis as well as the mechanism how relaxin-2 protects pancreatic beta cells and might be beneficial for the treatment of impaired glucose tolerance.

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