Keeping tabs on Covid-19: Cell and gene clinical trials advance despite Covid-19 crisis and new clinical trial studies partner with big pharma

Cutting-edge therapies celebrate new milestones including tissue-based therapeutic clinical trial studies to combat Covid-19 and a new regulatory proposal to support gene therapy clinical trials

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As the pharma industry stands firm in its commitment to advance the sector to fight Covid-19, news has emerged from the European Commission who intend to streamline the development of therapies using genetically modified organisms to treat Covid-19. The governing body claims this proposal could have positive effects on mitigating burdensome requirements for gene therapy clinical trials in the future.

In this light, Pharma IQ’s weekly round-up focuses on advancing therapies and clinical trials to combat Covid-19.

Regenerative medicine and advanced therapies thriving despite Covid-19 disruption

A H1 2020 global sector report from The Alliance for Regenerative Medicine’s (ARM) detailed, trends and metrics in the gene, cell and tissue-based therapeutic sector in the midst of the Covid-19 pandemic.

Results included global public and private financing from regenerative medicine and advanced therapy developers, and highlighted a 120 per cent increase over the first half of 2019. The ARM report also showcased robust pipelines of therapies targeting indications in cancers, infectious diseases and inherited disorders. There are currently 1,078 ongoing regenerative medicine clinical trials worldwide, including 97 in Phase 3, and 11 ongoing trials targeting patients with severe complications of Covid-19.

Janet Lambert, CEO of ARM, commented: “The regenerative medicine and advanced therapy sector has shown remarkable resilience in the face of many new challenges posed by Covid-19. Most importantly, we are continuing to see patients benefit from the profound therapeutic effects of both approved products and those currently in clinical development.

“ARM will continue to work with our membership and with policymakers in the second half of 2020 to further advance these transformative technologies. We are committed to bringing these life-changing therapies to patients in need,” Lambert added.

CluePoints provides clinical studies with risk management support package during Covid-19

CluePoints, a software company specializing in the life sciences sector, has issued clinical studies affected by the Covid-19 pandemic with risk management support packages to ensure ongoing and new clinical trials can perform risk planning and mitigation activities during the global health crisis.

In addition, with sponsors and contract research organizations (CROs) facing a myriad of new recommendations and guidelines issued by the US Food and Drug Administration (FDA), European Medicines Agency and other regulatory agencies due to coronavirus, CluePoints claimed the complimentary support package was an indispensable contribution allowing sponsors and CROs to accelerate their response.

Patrick Hughes, Co-Founder and Chief Commercial Officer of CluePoints, said: “The response to our complimentary risk assessment package has been fantastic. It has been an extremely challenging time for clinical trial management, especially with the need to perform risk assessments for each study to identify and mitigate risks pertinent to the Covid-19 crisis.

“Sponsors and CROs both recognize the benefits of early risk identification and are accelerating the implementation of risk-based quality management solutions to circumvent the challenges of onsite monitoring disappearing overnight,” continued Hughes. “Our solutions are currently being utilized by more than 100 sponsors in the context of this crisis, allowing them to focus their attention at the right time on what really matters most to ensure study success.”

NIH tests antibodies in Covid-19 clinical trial alongside Eli Lilly and AbCellera  

The National Institutes of Health (NIH) has announced patients admitted with Covid-19 can volunteer to enroll in a clinical trial at selected hospitals to test the safety and efficacy of an investigational monoclonal antibody LY-CoV555 to treat coronavirus symptoms.

In a statement, NIH claimed LY-CoV555 was identified in a blood sample from a recovered Covid-19 patient. The LY-CoV555 antibodies are infection fighting that can bind to the surface of viruses and prevent the virus infecting cells. These manufactured antibodies have been developed and manufactured by Eli Lilly and Company’s Lilly Research Laboratories  in a partnership with AbCellera.

Anthony S. Fauci, MD, Director of the US National Institute of Allergy and Infectious Diseases, said: “Studying the impact of this investigational therapeutic on multiple patient populations at the same time is critical to determining whether it can help Covid-19 patients with differing levels of disease severity. These concurrent trials have the potential to yield significant and comprehensive clinical data.”

Dr. Francis S. Collins, MD, PhD, NIH Director, added: “Under Operation Warp Speed, the US government has brought together multiple agencies to accelerate the development, manufacture and distribution of medical countermeasures for Covid-19. The clinical studies are just a few examples of this critical activity, which emphasizes flexibility and minimizes delays to generate scientifically sound results.”

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