Destiny Pharma. Regulatory News (DEST)

Destiny Pharma and SporeGen® announce update from research collaboration under Innovate UK grant award to develop a biotherapeutic treatment (SPOR-COV®) for COVID-19 and Influenza

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

Brighton, United Kingdom - 2nd May 2023 - Destiny Pharma plc (AIM: DEST), a clinical stage innovative biotechnology company focused on the development of novel medicines that can prevent life-threatening infections, today announces very encouraging results from its collaboration with SporeGen Limited ("SporeGen"), a UK biotechnology company working exclusively on Bacillus and its applications. 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 Professor Aras Kadioglu at the University of Liverpool and contract research organisations. The data from these studies show:

1. Prophylaxis of COVID-19 observed in SARS‑CoV‑2 preclinical challenge models.

2. 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.

3. SPOR-COV nasal spray use as a potential adjunct/booster to existing vaccines is supported by preliminary immunological research.

4. Technical development programme lead by HURO has been successful and enabled a scalable manufacturing process for GMP material.

5. 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."

Webcast

Destiny Pharma Plc is pleased to announce that Neil Clark, Chief Executive Officer, will provide a live presentation relating to today's RNS via Investor Meet Company on Tuesday 2nd May 2023 at 10:00am BST.

The presentation is open to all existing and potential shareholders.

Investors can sign up to Investor Meet Company for free and add to meet Destiny Pharma Plc via:

https://www.investormeetcompany.com/destiny-pharma-plc/register-investor

Investors who already follow Destiny Pharma Plc on the Investor Meet Company platform will automatically be invited.

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."

ENDS

For further information, please contact:

Destiny Pharma plc Neil Clark, CEOShaun Claydon, CFO+44 (0)1273 704 440 pressoffice@destinypharma.com

HURO Biotech

Linh Nguyen Managing Director

+84-28 3622 8889 ext. 111

linhnth@hurobiotech.com  

Optimum Strategic Communications  Mary Clark / Nick Bastin / Jonathan Edwards / Eleanor Cooper+44 (0) 203 922 0891 DestinyPharma@optimumcomms.com

finnCap Ltd (Nominated Advisor and Joint Broker) Geoff Nash / George Dollemore, Corporate FinanceAlice Lane / Nigel Birks / Harriet Ward, ECM+44 (0) 207 220 0500

Shore Capital (Joint Broker)

Daniel Bush / James Thomas / Lucy Bowden

+44 (0) 207 408 4090

MC Services AG Anne Hennecke / Andreas Burckhardt+49-211-529252-12

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

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 HURO Biotech

HURO Biotech is a pioneering biotechnology company in South East Asia focusing on innovative solutions for sustainable human health from sporebiotics and postbiotics. The company started in 2012 as a biotech center of The PAN Group - the leading agriculture, food and nutrition business in Vietnam. Since its spinoff in 2019, HURO has committed to improving human long-term health, while implementing affordable solutions for public health, with trusted proprietary products from beneficial microbes and biotech advancement, with best-in-class production quality and verifiable health claims. HURO is the only Vietnamese facility with GMP-WHO certified production of both probiotics and postbiotics.

 https://hurobiotech.com/en/about/