SpectrumX | November 25, 2022
SpectrumX, a UK-based healthcare and pharmaceutical company announces that following a constructive scientific advice meeting with the Medicines and Healthcare products Regulatory Agency on Monday, 14th November, the Company is prepared to move forward with the next stage in clinical development of its respiratory drug candidate SPX-001.
Per regulatory guidelines, SpectrumX will submit a combined Clinical Trial and Ethics Committee application for a placebo-controlled phase Ib influenza viral challenge study of SPX-001 in healthy volunteers to the MHRA in December 2022.
SPX-001 is SpectrumX’s nebulised respiratory infection drug candidate, based on the Company’s licensed hypochlorous acid based SPC-069 drug substance, which is believed to have broad-spectrum antipathogenic properties.
“We believe SPX-001 could be a significant new weapon in the fight against viral respiratory infections, and this is a critical milestone in progressing our drug candidate toward targeted market authorisation approval. We would like to thank the MHRA for their helpful guidance and responses to our initial proposal to begin human clinical trials, and we hope this brings us another step closer to trialling what we believe is a revolutionary treatment for respiratory infections.”
Commenting, Damien Hancox, CEO of SpectrumX
Dr Donna Lockhart, Consulting Head of Medicines at SpectrumX, said: “After productive discussions at a scientific advice meeting with the MHRA, during which we presented our lab-driven data, supporting evidence from existing literature, and key features of our novel solution, SPX-001, supporting its potential effects in combating respiratory infections, as well as our proposed clinical study protocol, I am pleased that we are one step closer to starting our clinical trial programme and the subsequent processes that are essential to market authorisation.”
If approved, this will the first in-human trial to deliver SPX-001 via a nebulizer to test its efficacy and safety versus a placebo treatment in healthy subjects infected with influenza. Following successful completion of the planned trial, SpectrumX will move forward with further trials in patients with respiratory infections to gather the additional necessary data for a market authorisation approval.
As previously announced, SpectrumX has already begun the production process for SPX-001, working with a GMP-certified partner, which will accelerate trial-readiness once requisite approvals have been received.
SpectrumX is a UK-based healthcare and pharmaceuticals company focused on bringing to market an innovative respiratory infection therapy and the roll-out of the most powerful hand sanitiser in the world to the NHS and other healthcare clients. Both products utilise unique, patent-pending HOCl formulations. HOCl is naturally occurring in human white blood cells and is a key contributor in the immune response to infection. HOCl also has direct killing activity against bacteria, viruses and fungi. It is well-tolerated in humans while also being the most effective known disinfectant when used on surfaces.
CELL AND GENE THERAPY
Cimeio | November 29, 2022
Cimeio Therapeutics, a biotechnology company developing a novel approach to cell therapies, today announced the U.S. Patent Office has issued a key patent covering the company’s Shielded-Cell & Immunotherapy Pairs platform.
U.S. Patent No. 11,499,168 covers a method for in vivo selective depletion of edited primary hematopoietic cells or non-edited primary hematopoietic cells. This method was first discovered and developed in the lab of company founder Lukas Jeker, M.D., Ph.D., at the University of Basel, and is exclusively licensed to Cimeio.
“This comprehensive intellectual property provides broad protection for our platform. We believe this patent, along with those we’ve filed for our target antigen and immunotherapy portfolio, cements us as a leader in the emerging field of cell shielding and will enable the broad development of our SCIP platform.”
Cimeio CEO Thomas Fuchs
Cimeio uses genome editing to insert novel protein variants into hematopoietic stem cells or other types of cells, allowing the cells to maintain their function while making them resistant to paired immunotherapy depletion. Cimeio’s platform has effectively shielded cells from depletion mediated by antibodies, T-cell engagers, ADCs, and CAR-T cells in preclinical studies.
The company is advancing its first programs towards clinical development for genetic and malignant hematologic diseases. As previously disclosed, two posters for the company’s pipeline programs will be presented at the American Society of Hematology meeting in December 2022 in New Orleans.
Cimeio is an applied gene editing and immunotherapy company developing a portfolio of Shielded-Cell & Immunotherapy Pairs® which has the potential to transform hematopoietic stem cell transplant. Cimeio’s technology platform is based on the design and expression of modified variants of naturally occurring cell surface proteins in HSCs. These novel variants maintain their function but are resistant to depletion when targeted by a paired immunotherapy which has high affinity for the wild-type version of these proteins. This technology has significant therapeutic potential, which Cimeio is using to develop curative treatments for patients with genetic diseases, hematologic malignancies, and severe autoimmune disorders.
Sirona Biochem Corp. | November 24, 2022
Sirona Biochem Corp. announces that, subsequent to the LOI, Sirona and Wanbang Biopharmaceuticals have signed an expanded, international partnership agreement to collaborate on licencing Sirona’s SGLT2 inhibitor, TFC-039, as a pharmaceutical treatment in both animal and human health. The agreement adds human health to the partnership as a result of new licencing opportunities currently in due diligence.
Wanbang and Sirona initially signed a licensing agreement for TFC-039, whereby Wanbang obtained the rights to develop the compound as a diabetes treatment in China and Sirona retained the global rights. Sirona has since been in discussions with animal health companies to advance TFC-039 as a treatment for diabetes and chronic kidney disease in companion animals. SGLT2 inhibitors provide an opportunity to treat inflicted animals with an oral medication as opposed to the traditional method of daily insulin injections. More recently, Sirona has entered into due diligence with a large pharmaceutical company with a regional interest in developing the compound for human diabetes.
Together, Sirona and Wanbang share extensive knowledge and scientific results of TFC-039. Partnering will significantly increase the speed to third-party partnerships and commercialization. The shared data spans over 12 years of research and development, and includes in vitro and in vivo preclinical work, multiple clinical studies, advanced manufacturing process development and the ability to commercially manufacture TFC-039.
“We have a long-standing relationship with Wanbang and are excited to combine our two companies’ expertise to license TFC-039. Wanbang has invested millions of dollars into the clinical stage research and development of the manufacturing processes for TFC-039. These pieces of data are critical to large organizations and will greatly increase the opportunities to move forward. The probability of a successful licensing agreement has been made much stronger by leveraging our alliance with Wanbang. We have had a successful year building Sirona’s pipeline, with positive movement on all projects and we’re looking forward to continuing this success with our SGLT2 inhibitor as well as our antiviral and anti-aging projects in 2023.”
Dr. Howard Verrico, CEO
About Wanbang Biopharmaceuticals and Fosun Pharmaceuticals
Wanbang Biopharmaceuticals develops, manufactures, and markets drugs with indications for chronic disease treatment, antibiotics, and other endocrine diseases in China. Founded in 1981, the company is headquartered in Xuzhou, China, and is a subsidiary of Shanghai Fosun Pharmaceutical Group. Fosun is a leader in the pharmaceutical industry and is regarded as one of the top five domestic pharmaceutical companies in China.
About Sirona Biochem Corp.
Sirona Biochem is a cosmetic ingredient and drug discovery company with a proprietary platform technology. Sirona specializes in stabilizing carbohydrate molecules with the goal of improving efficacy and safety. New compounds are patented for maximum revenue potential.
Sirona’s compounds are licensed to leading companies around the world in return for licensing fees, milestone fees and ongoing royalty payments. Sirona’s laboratory, TFChem, is located in France and is the recipient of multiple French national scientific awards and European Union and French government grants.