Global Roundup: Celltrion Prepares to Trap COVID-19 in Phase III
South Korea’s Celltrion Group is pushing to take its inhaled antibody cocktail into Phase III development for COVID-19 patients. The monoclonal antibody will be aimed at patients who exhibit mild-to-moderate symptoms due to infection with COVID-19. The company said it anticipates the study will include 2,200 patients across the globe.
Celltrion’s antibody cocktail is a combination of monoclonal antibodies with regdanvimab (CT-P59) and CT-P63. While other monoclonal antibodies have been removed from use due to the rate of infections driven by the Omicron variant, Celltrion’s monoclonal antibody is aimed at newly emerging mutations of SARS-CoV-2, including the Omicron variant. The global Phase III trial proposed in the Investigational New Drug application is designed to evaluate the safety and efficacy profile of the inhaled COVID-19 antibody cocktail.
The muco-trapping antibody platform in the cocktail is designed to trap the virus in airway mucus in order to prevent its spread within the body. Additionally, the antibody cocktail is designed to eliminate the virus from the lungs through the body’s own ability to clear mucus.
“Inhaled delivery substantially reduces the dose required to achieve a therapeutic effect compared to intravenous injections, thereby reducing the cost of treatment. An inhalable treatment can be self-administered in at-home settings, and at a scale not achievable using the conventional inpatient intravenous infusion treatments. We are working diligently to increase access to effective and safe monoclonal antibodies that are convenient and cost-effective,” HoUng Kim, head of the medical and marketing division at Celltrion said in a statement.
Elsewhere around the globe:
Rafarma Pharmaceuticals – Cyprus-based Rafarma announced its subsidiary Slavich Noya Technology is expanding its production capabilities through the acquisition of two BOBST machines designed to boost substrate processing. These technological acquisitions will significantly expand the company's operational capabilities, Rafarma said.
BMG LABTECH GmbH – Germany’s BMG Labtech has expanded its instrument offerings with the new VANTAstar microplate reader. The VANTAstar is a compact multi-mode microplate reader and is equipped with three features that enable an effortless detection setup and improve data quality: Enhanced Dynamic Range (EDR) technology, a rapid full-plate auto-focus and automatic luminescence cross-talk reduction. VANTAstar was developed for ease of use and flexibility for a wide range of applications in basic research and life sciences. The VANTAstar was officially introduced to the public at the SLAS 2022 conference and exhibition in Boston.
Treos Bio – London-based Treos Bio announced the first patient in its Phase IB OBERTO 201 study has been dosed. OBERTO 201 is assessing PolyPEPI1018, the company’s lead product candidate, as an add-on to standard-of-care third-line chemotherapy for the treatment of patients with late-stage microsatellite stable metastatic colorectal cancer (mCRC). The study will assess 15 patients who have been diagnosed with mCRC and are beginning the third line of treatment with chemotherapy. The primary endpoint of the study is safety and secondary endpoints are progression-free survival as well as other measures of anti-tumor activity and immunologic response.
Cytovation– Norwegian immuno-oncology company Cytovation AS entered into a collaboration with the Recurrent Respiratory Papillomatosis Foundation to advance the development of CyPep-1 for the treatment of this orphan disease alongside its cancer development program. Recurrent Respiratory Papillomatosis is a rare neoplastic disease that is characterized by the growth of benign tumors in the respiratory tract caused by the human papilloma virus. A Phase I/II study is expected to begin in the second half of 2022.
Main Capital Partners – Netherlands-based Main Capital Partners announced an investment into biomedion GmbH, a Berlin-based company. biomedion is a GxP Data Cloud Platform provider. biomedion’s flagship application is the holistic data management platform neuronOS, which allows life and health science companies to collect raw data from hundreds or thousands of instruments within the companies’ laboratories and to store it in a secure, responsive and F.A.I.R. manner (findable, accessible, interoperable and reusable).
EdiGene – China-based EdiGene signed a licensing deal with Arbor Biotechnologies to gain access to Arbor’s proprietary CRISPR gene editing technology for certain ex vivo engineered cell therapy programs in the field of oncology. The technology is a part of Arbor’s proprietary CRISPR gene-editing portfolio, which has been tailored to address the underlying pathology of genetic diseases.
Clearmind Medicine – Psychedelic medicine company Clearmind, which is based in Toronto, secured $1.25 million in private placement from Medigus Ltd. Clearmind and Medigus intend to form a joint venture in the food industry field, based on Clearmind's psychedelics intellectual property. The joint venture expects to focus on the product development of food supplements.
Recce Pharma – Australia’s Recce posted positive data from seven healthy patients who received 500mg of RECCE 327 in a Phase I study.
Salipro Biotech AB – Sweden’s Salipro received a European patent that covers the composition-of-matter, methods and uses of the company’s novel antigen technology.
Gedea Biotech – Also based in Sweden, women’s health company Gedea Biotech completed the recruitment of patients in the NEFERTITI clinical study of its lead product, pHyph, a vaginal tablet for topical treatment of bacterial vaginosis (BV). Results from the first treatment period are expected in the second quarter of this year. This is expected to put the company in a strong position to achieve CE-marking by the end of the year. Bacterial vaginosis is the most common vaginal infection and affects around 10-30% of women of reproductive age.
Healx – U.K.-based Healx, an AI-powered company, and Ovid Therapeutics entered into a licensing agreement to develop and commercialize gaboxadol. Under the agreement, Healx plans to investigate the compound as part of a potential combination therapy for Fragile X syndrome, as well as a treatment for other indications. Gaboxadol has previously been tested as a monotherapy for Fragile X syndrome in a Phase IIa clinical study by Ovid. Healx will now seek to find an optimal treatment for the condition by combining gaboxadol with other compounds, including HLX-0201. Alongside the initial focus on Fragile X syndrome, Healx plans to use its cutting-edge indication expansion technology to identify other conditions that could also be treated by gaboxadol.
Congruence Therapeutics – Canada’s Congruence secured $50 million in a Series A financing round. Congruence’s computational platform, Revenir uses mathematical modeling, physics and machine learning to characterize the biophysical defects of misfolded proteins that cause disease, then designs compounds to rescue the mutated proteins by correcting these defects in silico. The financing was led by Amplitude Ventures and Fonds de solidarité FTQ, with participation from Lumira Ventures, Investissement Quebec, OrbiMed Advisors, Driehaus Capital Management, and other undisclosed backers.
Merck KGaA– Darmstadt, Germany-based Merck KGaA signed an agreement with AI innovator Quris to bolster its in vitro and in vivo approaches to drug design. The collaborative project allows Merck KGaA to assess Quris’s platform with the initial assessment focusing on identifying potential liver toxicity risks for drug candidates, with special emphasis on ones that preclinical experiments failed to identify, the company said.
Telix Pharmaceuticals– Australia-based Telix struck a clinical supply agreement with Berlin-based Eckert & Ziegler Strahlen- und Medizintechnik AG for highly pure no-carrier-added lutetium-177 (177Lu), a therapeutic isotope used in Telix’s portfolio of molecularly-targeted radiation (MTR) investigational products.