Global Roundup: Amniotics Snags $6.95 Million to Advance PulmoStem

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Stem cell therapy company Amniotics raised SEK60 million (approximately $6.9 million) in First North IPO to advance lead candidate PulmoStem into the clinic. In addition to its lead candidate, the Swedish company said the infusion of cash will be used to advance its preclinical portfolio of cell therapy candidates based on mesenchymal stem cells (MSC) from amniotic fluid.

Lead candidate PulmoStem, a first-in-class treatment for pulmonary disease, is scheduled to enter the clinic in 2022. Amniotics also anticipates an expansion of its stem cell GMP manufacturing services to research and industry.

“With the proceeds from the IPO, Amniotics has the financial resources required to move our lead candidate PulmoStem into clinical development. It has the potential to make a real difference in patient’s lives. We also have an exciting number of other maturing candidates across a range of indications in our preclinical portfolio,” Chief Executive Officer Kåre Engkilde said in a statement.

Elsewhere around the globe:

RDIF -- The Gamaleya National Research Center of Epidemiology and Microbiology and the Russian Direct Investment Fund announced positive results of the study on neutralizing activity of sera from individuals vaccinated with Sputnik V vaccine against new variants of SARS-CoV-2. Vaccination with Sputnik V produced protective neutralizing titers against new variants, including Alpha B.1.1.7 (first identified in the UK), Beta B.1.351 (first identified in South Africa), Gamma P.1 (first identified in Brazil), Delta B.1.617.2 and B.1.617.3 (first identified in India) and Moscow endemic variants B.1.1.141 and B.1.1.317 with mutations in the receptor-binding domain. RDIF noted that virus neutralizing activity assay is not directly related to effectiveness of a vaccine.

Recce Pharmaceuticals – Australia-based Recce announced multiple patients have been dosed with RECCE 327 (R327) in a topical Phase I/II clinical trial. R327 is being assessed as a spray-on antibiotic in the treatment of infected burn wounds in adults. Burn wound infections can cause significant health problems for patients following a range of burn injuries. Some current therapeutic options are sub-optimal and often associated with delayed wound healing. Methicillin-resistant Staphylococcus aureus (MRSA) is one of the leading organisms causing invasive infection in burns across the world, with burn units reporting rates of infection greater than 50%.

eTheRNA – Belgium-based eTheRNA immunotherapies NV forged a collaboration and license agreement with Ghent University granting the company exclusive worldwide rights to commercialize a new library of novel ionizable lipids. Ionizable lipids are a main driver of LNP activity, enhancing the entrapment and stabilization of mRNA into the LNP and facilitating the release of the mRNA payload into the cell cytoplasm where the mRNA is subsequently translated into the protein of therapeutic interest. The ionizable lipids in the new library have been designed for improved biodegradability.

ProBioGen – Germany’s ProBioGen entered into a research license agreement with Heat Biologics for both ProBioGen's Transposase System DirectedLuck as well as for their proprietary suspension HEK293 cell line. DirectedLuck has been optimized to recognize specific epigenetic marks. It guides the transgene to regions with highest transcriptional activity. ProBioGen's HEK293 has been optimized for manufacture of proteins and viral vectors and is distinguished by robust growths in chemically defined medium in suspension culture, making it a valuable tool for production in large bioreactors.

Provectus Algae – Australia-based Provectus, which specializes in the optimization of algae to produce high-value compounds, won a marine Bioproducts Cooperative Research Center grant. The grant aims to support Australia’s efforts to transform the countries marine bioproducts sector into a globally competitive industry. The company's product pipeline includes two recombinant proteins developed by the Provectus team along with a suite of natural products in development, one of which already has a commercial agreement with a world-leading food and beverage ingredients supplier. Each of these products fit three market segments of focus including food and beverage, animal health, and agricultural chemicals.

PsyTech Inc. – Canada’s PsyTech Inc. has been acquired by Wesana Health Holdings for $21 million. The acquisition is expected to add three components to Wesana’s bottom line, including clinical software-as-a-service (SaaS) platform ‘Tovana Solutions’, the integrated mental health practice network ‘Tovana Clinics’ and PsyTech Connect, the industry’s largest professional psychedelics practitioner community, conferences, and educational courses.

ImCheck Therapeutics – France-based ImCheck announced the publication of preclinical data that demonstrated the fundamental role of butyrophilins (BTNs) in the activation of V gamma 9 V delta 2 (Vγ9Vδ2) T cells leading to an anti-tumor immune response. The data was published in the journal Cell Reports. ImCheck said the data shows an anti-BTN2A1-specific antibody is able to inhibit the cytotoxic function of the Vγ9Vδ2 T cells. These findings advance the understanding of how BTNs activate Vγ9Vδ2 T cell function against tumor cells.  In addition, the results validate ImCheck’s leadership in BTNs and the company’s development of a novel and disruptive pipeline of antibodies that target BTNs as potential therapies in oncology, autoimmune and infectious diseases, the company said.

Open Orphan plc – hVIVO, a subsidiary of Open Orphan, continues to with the UK Government to inoculate up to 20 further volunteers as part of the world's first COVID-19 characterization study. In the study, researchers aim to identify a dose of COVID-19 that causes a safe and reliable infection in unvaccinated COVID-19 naïve volunteers. The UK Government has decided to expand the program to answer further questions that can help in the fight against COVID-19.

Shorla Pharma – Ireland’s Shorla Pharma Limited has secured a toehold in the United States, finding offices in Boston's innovative Cambridge biotech cluster. Shorla specializes in developing innovative oncology drugs, with a focus on orphan and pediatric cancers. The company has an advanced pipeline of oncology products to treat a number of unmet patient needs.

Cyxone – Sweden’s Cyxone closed enrollment of its Phase II COVID-19 trial assessing the rheumatoid arthritis drug, rabeximod. Approximately 90 patients have been enrolled into the trial to date, and after reanalysis of the statistical requirements for study size it has been concluded that the trial currently has sufficient patients to power an analysis of the effect of Rabeximod over placebo. The Cyxone COVID-19 clinical trial study results will be reported in the third quarter of this year.

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