Neurimmune and Ethris Sign Collaboration Agreement to Rapidly Develop Inhaled mRNA-based Antibody Therapy for the Treatment of COVID-19

Ethris’ mRNA technology, the production of specific, neutralizing antibodies directly in patients’ lungs provides the opportunity to significantly impact the viral lung disease that is the primary driver of morbidity and mortality. The planned treatment could be effective in all COVID-19 patients.

Neurimmune is identifying human anti-SARS-CoV-2 antibodies from the immune cells of recovered COVID-19 patients using its RTM™ Technology platform. Potent neutralizing antibodies will be translated into therapeutic SNIM®RNA products for inhalation. Based on current development plans, the first product candidate is expected to begin clinical testing in the fourth quarter of 2020, pending regulatory approval.

“The speed and precision that mRNA technologies provide make them well-suited for designing therapeutic candidates to treat the COVID-19 pandemic. We have built a strong platform for developing potent mRNAs to treat pulmonary disorders and local delivery in the lung may provide significant therapeutic benefits. By combining our approach with Neurimmune’s proven human antibody technology, we are well-positioned to expediently develop a treatment that could save lives,” said Ethris CEO, Dr. Gita Dittmar.

Under the collaboration agreement, Neurimmune and Ethris will jointly conduct research and development activities while sharing costs and revenues resulting from the collaboration. The companies intend to initiate the manufacturing of the drug product for clinical trials this summer and will inform about progress made as to the collaboration advances.

 

First cell treatment to fight the coronavirus awaits FDA approval for clinical trial

The Food and Drug Administration is expected to approve the first of a whole new type of weapon to be tested in the international struggle against COVID-19 as the disease continues to sweep across the globe.

New Jersey-based therapeutics company Celularity announced that its cancer treatment, CYNK-001, is awaiting “investigational new drug” status for COVID-19 from the FDA, which could come any day. Once the treatment gets the status, it will immediately enter a preliminary clinical trial to see if it can help people suffering from the illness. Independent immunologists say the rationale for the treatment is solid but warn that it could exacerbate the most severe cases of the disease. If the new strategy proves effective, Celularity stands ready to rapidly increase production.

The therapy will join hundreds of other treatments currently undergoing FDA-approved testing for COVID-19. Statistically speaking, about one-third of such experimental drugs advance to Phase III for large-scale, rigorous testing. 

If CYNK-001 is among the effective treatments, Celularity will be ready to ramp up production quickly. It can derive about 1,000 stem cells from a single placenta. The company recently built a $75 million factory in New Jersey and anticipates being able to produce tens to hundreds of thousands of treatments by summer.

 

Pluristem begins dosing with COVID-19 therapy in Israel

Pluristem Therapeutics has started dosing COVID-19 patients in Israel with PLX cells under a compassionate use programmed approved by the country’s health ministry. Dosing was performed in three patients at two hospitals. Pluristem intends to recruit more coronavirus patients in the coming days. PLX cells are off-the-shelf allogeneic mesenchymal-like cells with immunomodulatory properties that could trigger the immune system’s natural regulatory T-cells and M2 macrophages. This mechanism is expected to block the over activation of the immune system, which leads to complications.

 

It is hoped that the approach will potentially decrease the incidence andor severity of pneumonia and pneumonitis associated with COVID-19 infection. In preclinical testing, PLX cells showed therapeutic benefit in pulmonary hypertension, lung fibrosis, acute kidney injury, and gastrointestinal injury. All these complications are linked to severe COVID-19. Pluristem Therapeutics CEO and President Yaky Yanay said: “In addition to our current activity in Israel, we are in discussions with regulators in the US and Europe to define our clinical strategy for COVID-19. “Pluristems’ advanced manufacturing capabilities enable us to serve the potential need of treating large numbers of patients under compassionate use and clinical studies across numerous countries and hospitals in accordance with our expansion programmed and regulatory approvals.”

 

Stem cell therapy shows efficacy at treating COVID-19, finds study

A group of researchers has used a stem cell treatment on a patient in Beijing, China to effectively boost the immune system to fight the COVID-19 coronavirus. “A lot of people are trying finding the answers,” said Dr Kunlin Jin, who led the research in collaboration with researchers at the University of North Texas Health Science Center at Fort Worth, US.  Jin said that early findings are promising and the international effort to test this treatment continues as a long-term study with more patients in China.

“Our study showed that intravenous infusion of clinical-grade human mesenchymal stem cells is a safe and efficient approach for treating patients with COVID-19 pneumonia, including in elderly patients displaying severe pneumonia,” commented Jin. The stem cells were injected intravenously into the bloodstream of seven patients in YouAn Hospital in Beijing who were severely ill, while three patients were injected with a placebo. The seven patients who received stem cells were successfully treated and discharged from the hospital within 14 days, report the researchers. Of the patients who received the placebo, one died, one became severe and the third had Acute Respiratory Distress Syndrome (ARDS).

 

More data needed to support the use of hydroxychloroquine for COVID-19

Hydroxychloroquine, which is sold by Concordia Pharmaceuticals under the brand name Plaquenil, and chloroquine are oral prescription drugs that have been used for many years to prevent and treat malaria and certain inflammatory conditions. Although these agents are well-established, they possess the potential to cause numerous side effects and should be used with caution in those who are diabetic, those with neurological disorders, and those with vision disorders. Recent data highlights how hydroxychloroquine retinopathy is more common than previously reported. Other side effects include cardiomyopathy and bone marrow suppression, but these are not commonly reported. Initial in vitro studies with hydroxychloroquine have demonstrated antiviral activity using severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infected Vero cells. The study prospectively observed a population of 30 patients with mild COVID-19, where hydroxychloroquine was administered at a dose of 400mg per day for five days (HCQ) and randomized against a control group.

Currently, there are not enough data to support hydroxychloroquine use for COVID-19 treatment at the level of expectations set by President Trump. As such, larger and more robust randomized clinical trials are needed to inform clinical guidance on the use, dosing, or duration of hydroxychloroquine for prophylaxis or the treatment of SARS-CoV-2 infection.