SporeGen® announces update from research collaboration under Innovate UK grant award to develop a biotherapeutic treatment (SPOR-COV®) for COVID-19 and Influenza
- May 08, 2023
Positive results from testing SPOR-COV in several COVID-19 and influenza research models support potential as prophylactic nasal spray
Toxicology studies support safety profile
Manufacturing process established
Manufacturing and regional licensing agreement signed with HURO Biotech JSC for Vietnam
Phase 1 clinical studies completed successfully in Vietnam by HURO
Retail product based on SPOR‑COV technology launched in Vietnam by HURO
Partners reviewing options for next stage in development of SPOR-COV
London, United Kingdom – 8th May 2023 – SporeGen Limited, a UK innovative biotechnology company working exclusively on spore forming Bacillus bacteria and its applications, today announces very encouraging results from its collaboration with Destiny Pharma Plc. ("Destiny Pharma"), a clinical stage innovative biotechnology company focused on the development of novel medicines that can prevent life-threatening infections. The collaboration has been partly funded by UK Research and Innovation (UKRI) since September 2020 to co-develop SporeGen's SPOR-COV product as a novel, preventive treatment for COVID-19, influenza and potentially other similar respiratory viral infections.
The study results support the original hypothesis that SPOR-COV nasal spray can rapidly stimulate an immune response that primes the human immune system against influenza and coronavirus‑type viral threats such as COVID-19. As a stable, bacterial formulation presented as a nasal spray, SPOR‑COV is straightforward to produce in bulk, negates the need for a cold chain, has the potential to be stockpiled for ‘pandemic preparedness’ and can be used across the world instead of, or alongside, existing vaccines. Destiny Pharma and SporeGen are excited by the results of these research studies and are now planning future studies and seeking partners for the next stage of development.
Under the UKRI grant award the parties have completed several research and development studies working with the University of Liverpool and contract research organisations. The data from these studies show:
- Prophylaxis of COVID-19 observed in SARS‑CoV‑2 preclinical challenge models.
- Significant reduction in signs and symptoms of influenza across multiple preclinical models, including a gold-standard model of influenza infection in “Vaccines” journal (James et al., 2022). Studies were conducted across several investigative sites.
- SPOR-COV nasal spray use as a potential adjunct/booster to existing vaccines is supported by preliminary immunological research.
- Technical development programme lead by HURO has been successful and enabled a scalable manufacturing process for GMP material.
- GLP preclinical safety studies successfully completed and therapeutic window supportive of clinical development defined.
Destiny Pharma and SporeGen are also pleased to have extended the existing collaboration with HURO, an experienced manufacturer of bacterial product formulations based in Vietnam and part of the PAN Group. HURO now have non-exclusive manufacturing rights to supply future SPOR-COV product and also have exclusive rights to commercialise SPOR-COV in Vietnam. In return, HURO will develop the manufacturing process under GMP-WHO standards and is carrying out other research and development activities in Vietnam, including human clinical tolerability studies, which are being shared with SporeGen and Destiny Pharma under the strategic agreement.
HURO have also recently launched “SPEROMED”, a nasal spray healthcare retail product that is based on the SPOR-COV technology designed in Vietnam and is marketed under Vietnamese regulations. Destiny Pharma and SporeGen will receive royalties on sales.
The parties are continuing to review the very positive and exciting results generated by the grant funded collaboration and are planning the next steps for the SPOR-COV programme including the possibility of the first human studies in Europe/USA. The strategy is to seek additional partners to collaborate on the continuing development and commercialisation of SPOR-COV outside of Vietnam.
Dr Simon Cutting, Chief Executive Officer of SporeGen, said: "These data validate the SPOR-COV platform’s effectiveness against multiple pandemic strains of flu and emerging SARS‑CoV‑2 'variants of concern' by targeting the innate immune system. The SPOR-COV approach, unlike traditional vaccination, has been shown to not be impaired by new mutational variants. We are very pleased with these data and the potential benefit to patients and are very excited at the prospect of further development of the SPOR-COV platform.”
Neil Clark, Chief Executive Officer of Destiny Pharma, said: "This Innovate UK funded research project has delivered some very exciting data and we are now discussing next steps with our partners. There is still a clear need for better pandemic preparedness for viral infections such as COVID-19 and influenza and the SPOR-COV product and the associated technology has great potential to deliver new treatments that are safe, effective, low cost and easy to use.”
Khanh Nguyen, Chairman of HURO Biotech, said: “As a pioneering pharmaceutical company focusing on affordable and sustainable health solutions from probiotics and postbiotics for LMICs, HURO values the opportunity to develop SPOR-COV into an innovative product improving public health in Vietnam. We would like to congratulate SporeGen and Destiny Pharma on the most recent encouraging data of SPOR-COV, which will create a solid foundation for further impact in the future.”
About SPOR-COV
SPOR‑COV product consists of a proprietary formulation of Bacillus bacteria that is administered nasally as a spray. Importantly, this product is completely sterile and poses no risk of administering live bacteria. SPOR-COV is different to traditional vaccines in that it utilises the innate immune system with the aim of developing COVID-19 and influenza protection alone or possibly in combination with vaccine therapies a few days after dosing. As an "easy to use" product, for COVID-19 and influenza it has the potential to significantly reduce both infection rates and transmission. The final SPOR-COV product is planned to be straightforward to produce at high volumes and at low cost. Additional attributes are that (i) it can be stockpiled almost indefinitely without the need for cold chain logistics as it is a particularly stable product, (ii) made available globally as a cost-effective measure in the fight against COVID-19 as well as new COVID variants, and (iii) potential efficacy against other respiratory viral infections.”
For further information, please contact:
SporeGen Limited
Dr. Simon Cutting, CEO
+44-(0)20-7691-2090
Ms. Kim Oanh Nguyen, COO
About SporeGen Ltd
SporeGen Limited is a UK biotechnology company working exclusively on spore forming Bacillus bacteria and development of new innovative products including probiotics, medical foods and drugs. SporeGen also develops novel prophylactic and therapeutic products including vaccines. SporeGen was the first to use spores as vaccine delivery vehicles and has coordinated a Phase 1 study of a mucosal vaccine. The company has a number of pipeline products including two unique prophylactic and therapeutic approaches for C. difficile infection and a spore-based prophylactic for COVID-19 and Influenza (SPOR-COV®). The company has licensed (and patented) a number of novel interventions and innovative Bacillus technologies to global food and biotech companies with a number of commercial products on the market including the novel probiotic strains HU58® and HU36®.
For further information on the company, please visit www.sporegen.com
About Destiny Pharma
Destiny Pharma is a clinical stage, innovative biotechnology company focused on the development of novel medicines that can prevent life-threatening infections. Its pipeline has novel microbiome-based biotherapeutics and XF drug clinical assets including NTCD-M3, a Phase 3 ready treatment for the prevention of C. difficile infection (CDI) recurrence which is the leading cause of hospital acquired infection in the US and also XF-73 nasal gel, which has recently completed a positive Phase 2b clinical trial targeting the prevention of post-surgical staphylococcal hospital infections including MRSA. It is also co-developing SPOR-COV, a novel, biotherapeutic product for the prevention of COVID-19 and other viral respiratory infections and has earlier grant funded XF research projects.
For further information on the company, please visit www.destinypharma.com