Akron Biotech Signs Agreement with Synairgen plc to Supply Interferon-beta for COVID-19 Treatment

BOCA RATON, FL – October 19, 2020 – Akron Biotechnology today announced it has signed an agreement with Synairgen plc (LSE: SNG) for the provision of SNG001, Synairgen’s wholly-owned inhaled interferon beta (IFN-beta) therapeutic candidate for the treatment of COVID-19 patients. Akron Biotech provides cGMP-compliant solutions to support the development and commercialization of advanced therapies.

Synairgen reported positive results from its Phase II trial of SNG001 in 101 hospitalized COVID-19 patients in July 2020, indicating that its inhaled IFN-beta could provide a valuable treatment option in the face of the global COVID-19 pandemic. Furthermore, the safety, biomarker, and efficacy data for SNG001 provided from the interim analysis of Synairgen’s Phase II COPD trial in September 2020 was supportive of the on-going development of SNG001 in COVID-19 patients.

Akron will support the future clinical and commercial development of SNG001 through the provision of its IFN-beta in Synairgen’s formulation. “Akron’s expertise in recombinant protein manufacturing and large-scale production capacity add significant value to our further development and commercialisation of SNG001,” commented Synairgen CEO Richard Marsden. “The ability to rapidly scale the production of SNG001 will allow Synairgen to meet expected clinical and commercial demand for the drug, ensuring that patients have access to this promising treatment.”

“The agreement with Synairgen reflects our ongoing commitment to meet the growing demand for validated, cGMP-compliant solutions to advance novel therapies,” said Claudia Zylberberg, PhD, Founder and CEO of Akron Biotech. “We are excited to support Synairgen in its quest to further this exciting treatment for COVID-19, bringing a promising new therapy to patients with few viable options.”

About Akron Biotechnology

Akron is a leading provider of cGMP-compliant solutions to support the development of advanced therapies. An ISO 13485-certified company operating in line with cGMP guidelines and international standards, Akron leverages more than 100,000 square feet of development and manufacturing capacity to provide therapy developers the scale, compliance, and regulatory support necessary to drive novel treatments from discovery to commercialization. For more information, please visit www.akronbiotech.com.

About Synairgen plc

Synairgen is a respiratory drug discovery and development company founded by University of Southampton Professors Stephen Holgate, Donna Davies and Ratko Djukanovic. The business, focused primarily on lung viral defense in asthma, COPD, and COVID-19, uses its differentiating human biology BioBank platform and world-renowned international academic KOL network to discover and develop novel therapies for respiratory disease. Synairgen is quoted on AIM (LSE: SNG). For more information about Synairgen, please see www.synairgen.com.

Akron Biotech is committed to help defeat COVID-19 – Together we cure

Coronavirus disease 2019 (COVID-19) is a pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Symptoms tend to appear 2-14 days after exposure to the virus and can range from mild to severe, with some patients requiring  hospitalization¹.

In response to this global crisis, the scientific community has come together to develop vaccines, treatments, and improved diagnostic tools. As one of the leading manufacturers of GMP-compliant biologics and ancillary materials, we have been collaborating closely with several companies and academic institutions working tirelessly to develop novel treatments for this disease.

We have remained fully operational, taking the necessary precautions to make sure that, above all else, our employees and families remain safe. Moreover, we have adopted additional security measures in all of our manufacturing and logistics processes and are prioritizing the use of virus inactivated raw materials in our human blood-derived products, including our sera, plasma, and fibronectin.

If you are working on COVID-19 treatments, please reach out to us. Akron Biotech offers several products and services that can accelerate the development of your potentially life-saving treatments. Whether you are working to develop a cell therapy targeting COVID-19 and need materials for further manufacturing use, or are developing a biologic and need to source active pharmaceutical ingredients to support your efforts, please reach out. We are here to do everything we can to support the global community through these unprecedented times.

List of Akron’s Selected Products 

GMP Products

Interferons: 

cGMP Recombinant Human Interferon-beta 1A, rHu IFN-β1A

cGMP Recombinant Human Interferon-alpha 2A, rHu IFN-α2A

cGMP Recombinant Human Interferon-alpha 2B, rHu IFN-α2B

Virus-inactivated products:

cGMP Human Fibronectin Solution (Plasma Derived), Virus Inactivated

cGMP Human AB Serum (Converted from Plasma), Xeno-Free, Virus Inactivated

Proteins & Supplements:

cGMP Heparin Sodium Salt

Cytokines:

cGMP Recombinant Human Interleukin-2, rHu IL-2

cGMP Recombinant Human Interleukin-2 Solution, Pre-Filled Syringe

cGMP Recombinant Human Interleukin-4, rHu IL-4

cGMP Recombinant Human Interleukin-6, rHu IL-6

cGMP Recombinant Human Interleukin-7, rHu IL-7

cGMP Recombinant Human Interleukin-12, rHu IL-12

cGMP Recombinant Human Interleukin-15, rHu IL-15

cGMP Recombinant Human Interleukin-18, rHu IL-18

cGMP Recombinant Human Interleukin-21, rHu IL-21

cGMP Recombinant Human Erythropoietin, rHu EPO

cGMP Recombinant Human Stem Cell Factor, rHu SCF

cGMP Recombinant Human Epidermal Growth Factor, rHu EGF

cGMP Recombinant Human Transforming Growth Factor-beta, rHu TGF-ß 1

cGMP Recombinant Human Granulocyte-Colony Stimulating Factor, rHu G-CSF

cGMP Recombinant Human Granulocyte Macrophage Colony Stimulating Factor, rHu GM-CSF

cGMP Recombinant Human Platelet Derived Growth Factor-AA, cGMP rHu PDGF-AA

cGMP Recombinant Human Platelet Derived Growth Factor-BB, cGMP rHu PDGF-BB

Cryopreservation:

cGMP CryoSolve™, Single-Use Syringe

cGMP CryoSolutions™ 100%, DMSO Solution

cGMP CryoSolutions™ DX, 55% DMSO containing Dextran-40

cGMP CryoSolutions™ MC, 10% DMSO containing Methylcellulose

CryoNovo™ P24 (DMSO-free)

Services 

Aseptic Fill & Finish: Akron provides custom fill & finish services, filling single-use, closed packaging and custom kit options for customers in the cell and gene therapy and biopharmaceutical industries. We offer smart solutions that allow for more streamlined, consistent manufacturing with little to no manipulation, while reducing waste and costs of goods.

We are here for you:

If you are working on COVID-19 treatments and would like to learn more about our cGMP-compliant biologics and ancillary materials listed above, please email sales@akronbiotech.com and a member of our team will get back to you within 24 hours. 

References

1. www.cdc.gov/coronavirus/2019-ncov/

The disruption to daily life from our collective preventative measures against the global SARS-CoV-2 outbreak is obvious to most. Many industries are being held back and we will likely see long-term or permanent effects from the shifts happening with social interaction in and out of the workplace. What may not be so obvious in the engrossing commotion over the COVID-19 danger is the increased vulnerability to patients with previous and ongoing unrelated medical treatments. The visualization below helps show why COVID-19 is taking up so much attention and what other medical issues are competing for care:

The increased prioritization of resources toward fighting COVID-19 has left other medical issues in an abnormally challenging environment. It is especially precarious for cancer patients and the cellular therapy industry that supports cancer treatment development. In this space, however, the extreme caution given to COVID-19 is not unwarranted. One of the primary T-cell therapy treatment toxicities, cytokine release syndrome, also occurs in a subset of COVID-19 cases.¹ This raises alarm bells for companies and regulators alike.

A study conducted at Mount Sinai Health System (MSHS) in New York City reported significantly increased intubation for COVID-19 patients who also suffered from cancer, and significantly higher mortality for COVID-19 patients under 50 years old who also suffered from cancer.² Given the emergent timeline of this outbreak and suggestions of increased risk for cancer patients, current treatments and new therapy trials have been quickly altered in an attempt to limit exposure to SARS-CoV-2. The FDA and other regulators around the globe have encouraged these changes, even allowing for protocol changes to be implemented before review and final approval.³

This flexibility is necessary to salvage as many clinical trials as possible. The National Cancer Institute (NCI) recently reported that accrual to NCI-funded treatment clinical trials has dropped by half, a trend that is expected to continue.⁴ Some commercial pharmaceutical companies, like Bristol Myers Squibb (a major player in the cellular therapy space), have made the decision to suspend new and ongoing clinical trial enrollment.⁵

With patients and companies deciding to forego experimental treatment, there will be a gap in future therapy approvals. This gap will likely result in depressed projections for pharmaceutical companies and the material suppliers that support the industry. The pre-clinical environment is also experiencing drag with research and development companies around the world implementing precautionary measures like working from home and skeleton staffing on-site. You can find how Akron Biotech is taking care here.

This slowdown in evaluation and development brings up many concerning unknowns about the future. The uncertainty and continued protraction of near-term global timelines for opening travel and business has many of us asking questions like: How long will it be until a majority of companies regain full functionality? What will the long-term effect be for the current population of cancer victims? What will happen to the security of current biopharmaceutical supply chains if demand lowers to a level that endangers material suppliers? How do we best integrate precaution and regulatory guidance into our operations moving forward? Are we now properly prepared for more of the same or a similar situation in the future?

Though we may never return to a world that was identical to the one before this pandemic, there are positive impacts being made now that will continue long into the future. Efficiency and safety improvements are being made throughout society including cleaning procedures and personal hygiene. Regulators and businesses are adapting to a new remote working environment and learning how to be flexible in their approach/strategy to continue business. Supply chain analysts are calculating and discussing how to truly mitigate risk. Some of those conversations include secondary sourcing with a multi-regional geographic approach, and how to re-shore the manufacture of key components such as raw materials, personal protective equipment (PPE), and lifesaving medicines to the United States.

Here at Akron, we are leveraging our global footprint to de-risk the supply of critical ancillary materials used in the cell therapy industry. Also, to assist with COVID-19 initiatives, Akron is continuing to supply key cytokines such as Inferferon to partners developing novel treatments to fight this virus. While all of this is happening, like many other companies, Akron is asking many of the questions that everyone is asking surrounding the impact to the industry. We all know that a resolution will not be immediate, but ancillary material companies such as Akron and the cell therapy companies and researchers we supply must continue to work together to meet demand and ensure clinical trials move forward. While many aspects of our lives may be on hold, cancer is not.

Once the immediate challenges have been mitigated or resolved, the fight must not end – we still need to come together as a community to resume research, clinical trials, and commercial development quicker than ever before to decrease the lag time between the discovery and diffusion of new cancer and orphan-designated therapy options to patients. We believe that our community will emerge from this pandemic with an even stronger sense of purpose and urgency, ensuring that we create the resilience in our supply chains, manufacturing processes, and clinical programs to accelerate the development of new, lifesaving treatments.

1. Saini K, de las Heras B, de Castro J, Venkitaraman R, Poelman M, Srinivasan G, Saini M, Verma S, Leone M, Aftimos P, Curigliano G, Effect of the COVID-19 pandemic on cancer treatment and research., The Lancet Haematology (2020), doi: org/10.1016/S2352-3026(20)30123-X
2. Miyashita H, Mikami T, Chopra N, Yamada T, Chernyavsky S, Rizk D, Cruz C, Do Patients with Cancer Have a Poorer Prognosis of COVID-19? An Experience in New York City., Annals of Oncology (2020), doi: org/10.1016/j.annonc.2020.04.006
3. FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency - Guidance for Industry, Investigators, and Institutional Review Boards
   https://www.fda.gov/media/136238/download
4. At NCI, A Robust and Rapid Response to the COVID-19 Pandemic. Norman E. Sharpless, M.D. Apr. 17, 2020
   https://www.cancer.gov/news-events/cancer-currents-blog/2020/covid-19-cancer-nci-response
5. A Message to Clinical Trial Investigators on Bristol Myers Squibb’s Response to COVID-19. Samit Hirawat, M.D. 20, 2020.
   https://www.bms.com/about-us/responsibility/coronavirus-updates/covid-19-update-letter-to-investigators.html

A Note to Our Valued Partners Regarding COVID-19

As we continue to deal with the challenges and uncertainty of Covid-19 Virus, our priority is to ensure the safety of our employees while minimizing any potential impact to our valued customers and partners.  Therefore, we are taking all the necessary precautions to ensure that our Akron Family is safe and that our facilities are clear of any risks associated with the Virus. In our decision process, we are adhering to the recommendations of the CDC, the WHO, and other global health experts.

Therefore, Akron has implemented the following changes until Friday, April 3 with the understanding that we will further assess the situation at that time.

Akron Facilities and Employees

• • Effective March 16, 2020 through April 3, 2020, Akron has transitioned non-essential employees to a remote work-from-home (WFH) model. Our essential employees, which consist of those performing business-critical manufacturing/laboratory functions, and others who support those activities, continue to perform those critical functions while being closely monitored to ensure their safety at all times.

• • Akron’s facilities remain open, and we are fully operational. However, the WFH model reduces our staff onsite which reduces the risk of exposure to others.

• • All in-person meetings or visits with customers, partners or vendors have been cancelled or postponed. We have encouraged our employees to use teleconferences or other electronic means to stay in contact with our valued customers, partners and vendors during this time.

• • Akron has adopted additional security measures in all our manufacturing processes and is prioritizing the use of virus inactivated raw materials in our human blood-derived products, including sera, plasma and fibronectin.

Travel

• • Akron has postponed or cancelled all domestic or international travel until further notice.  In addition, we strongly encouraged all employees to reconsider any personal travel to locations that have been identified as high-risk. All employees must pre-report any and all personal international travel plans to their immediate Supervisor.

• • Akron employees will not be attending any conferences or industry meetings until further notice.

Preventive & Hygiene Advice to all Employees

• We have posted Wash your Hands Signs throughout our facility as a reminder that hand washing in critical.  Use hand sanitizer, readily available throughout our facilities, when soap and water are not available.
• Avoid touching your face and sharing personal items.
• Avoid touching surfaces which are touched by many other people. Be proactive in wiping surfaces as needed. Wipes have been stationed throughout our facilities.

• Avoid customary greetings such as shaking hands or embracing.
• With the flu/cold/allergies season here practice respiratory hygiene: coughing/sneezing into a tissue/napkin or inside of elbow.
• Stay at home if you feel sick. Seek medical attention in case of fever, cough or breathing difficulties and follow directions of your local health authority.  ​​​​​​​If you have reason to believe that you or a family member has been exposed to the Virus, stay home and contact your physician, as well as your Manager.

We will continue to closely monitor the situation with Covid-19 Virus.  Furthermore, we will promptly make any additional changes necessary to ensure that we keep our employees safe and the facilities in optimal operating conditions while prioritizing the needs of our valued customers and partners.

The Akron Family thanks you for trusting us to meet your ancillary material needs.  As always, please do not hesitate to contact us if you need further information.

A Letter From Our CEO

Dear Valued Partner,

In challenging and uncertain times, it’s our collective responsibility to take care of one another. At Akron Biotech, our top priority is always our customers and our staff. That’s why we are closely monitoring the COVID-19 situation around the clock, ensuring that we take all necessary precautions to keep our staff safe and our facilities clear of any risks related to the coronavirus. This includes adhering to recommendations from the CDC, the WHO, and other global health authorities.

We are leveraging our secure platforms and communication tools to maximize flexibility. We remain fully operational and will keep you updated as the situation continues to evolve. More than ever, we remain steadfast in our belief in the importance of ensuring the safety and integrity of the therapies we are working together to advance. For this reason, we have adopted additional security measures in all of our manufacturing processes and are prioritizing the use of virus inactivated raw materials in our human blood-derived products, including our sera, plasma, and fibronectin.

As always, thank you for trusting Akron Biotech for your ancillary material needs. Every day, we work together to find treatments and cures to the world’s most complicated illnesses. If this unprecedented climate is any indication, our work is more important than ever.

We are here for you.

Claudia Zylberberg, Ph.D.
Chief Executive Officer
Akron Biotechnology