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Tonix Pharmaceuticals has signed a research collaboration and exclusive licensing agreement with the University of Alberta in Canada for three new vaccine candidates to prevent Covid-19.

The partnership will develop the three vaccine candidates, which are based on the horsepox vector platform and designed to express various SARS-CoV-2 antigens.

In February this year, Tonix Pharmaceuticals collaborated with non-profit Southern Research to develop another Covid-19 vaccine candidate, TNX-1800, which is also based on horsepox vector platform but designed to express SARS-CoV-2 Spike protein.

The three newly licensed Covid-19 vaccine candidates are named TNX-1810, TNX-1820 and TNX-1830.

Horsepox is the vector system that forms the company’s TNX-801 potential vaccine for smallpox and monkeypox. TNX-801 has been developed to induce predominant T cell responses, while the new vaccine candidates are meant for pure T cell responses.

University of Alberta professor David Evans said: “TNX-1810, TNX-1820 and TNX-1830 are designed to express different protein antigens from SARS-CoV-2. It is currently unknown what type of vaccine and which antigens from SARS-CoV-2 will provide effective protection from Covid-19.

“Orthopoxviruses like horsepox induce strong innate and adaptive immunity and long-lasting T-cell immunity. We have designed TNX-1810, TNX-1820 and TNX-1830 to express and induce immunity to SARS-CoV-2 proteins that are different from Spike.”

With over 1,000 trials being disrupted and more trials being added to this category daily, there is a direct impact on trial site activation and patient enrollment.

With the recent development of the current Covid-19 pandemic, there has been an increased urgency for both industry and non-industry sponsors to focus on finding a suitable therapeutic or vaccine for this highly contagious viral disease. In an effort to find a suitable treatment and prevention options for Covid-19 infection, more Covid-19 clinical trials are being planned and initiated, while a large number of clinical trials for non-Covid-19 indications are suffering delays.

With many regulatory agencies such as the FDA and EMA offering accelerated approval for Covid-19 therapeutics and vaccines, it could be in part that sponsors have shifted focus and research onto the current pandemic. But the majority of trial disruption could be attributed to patient safety, strict lockdown, social distancing, and the high demand for medical professionals to treat Covid-19 patients. High profile pharmaceutical companies have announced disruptions to planned and ongoing trials, postponing trial start dates and halting subject enrolment.

The Covid-19 Dashboard on the Pharma Intelligence Center dynamically tracks these disrupted trials from the Clinical Trials Database, along with the list of companies that are the sponsor, collaborator, or contract research organisation (CRO).

With over 1,000 trials being disrupted and more trials being added to this category daily, there is a direct impact on trial site activation and patient enrollment. Many of these sites are either being used for other purposes or are temporarily closed. With many countries enforcing strict lockdown measures, sponsors are unable to activate these sites, making it harder for existing trials to continue. According to GlobalData’s Clinical Trials Database, 56.1 % of disrupted trials are currently suspended while 20.7% are ongoing, but not recruiting any additional participants. When looking at site locations, the US had the highest number of disrupted trial sites at 66.1% followed by the UK at 12.8%, France at 9.3%, Spain at 6.5%, and Germany at 5.2%, as shown in Figure 1. According to the guidance of FDA and EMA procedures, many of these disrupted trial sites are now being repurposed for Covid-19 trials. Activation of new trial sites is usually not recommended for non-Covid-19-related trials unless no other solution exists for the ongoing trials. According to the EMA, “If there is an urgent need to open a new trial site for critical trial visits, for example outside the hospital, this may be implemented as an urgent safety measure (USM) first, followed later by a substantial amendment (SA) application for the approval and initiation of this additional site.” With the possibility of reallocating trial sites, there is also the need to move subject data such as medical records. In such cases, it is highly recommended from the EMA that this is done virtually and that any eCRFs can be adjusted accordingly to allow the receiving site to enter new data.

Due to site closures and lockdown measures, many companies involved in trial site management and coordination are feeling an economic hit. The top three countries with affected companies are the US, UK, and France. Contract research organisations are experiencing a hit too, with many organisations having to disrupt trials. According to GlobalData’s Clinical Trials Database, the top three CROs that are affected are IQVIA, Covance, and Sarah Cannon Research Institute. Among CROs, a statement from ICON highlights that 65% of their global sites are impacted in some way, which poses a period of financial uncertainty. Many companies are reviewing alternative approaches by using remote measures and virtual clinical trials, which aim to bring the study directly to the patient via online data collection and video call progress checks. It is important to note that with many countries easing lockdown, some trial sites may begin to reopen slowly to focus on other studies. With many companies shifting to alternative ways to conduct trials, it is possible that even after the Covid-19 pandemic the use of virtual trials will remain prominent.

Ferring Pharma has reported what it says is the first positive phase 3 trial of a microbiome therapy – based on healthy bacteria – showing it can reduce recurrences of a serious gastrointestinal infection.

The ongoing trial is testing the therapy – RBX2660 – as a treatment for Clostridioides difficile infection or C. diff, a bacterium that causes diarrhoea and inflammation in the colon and is a major cause of illness and death worldwide.

RBX2660 is a mix of microbes taken from the gut of healthy people that is designed to repopulate the GI tract and out-compete C. diff, reducing and hopefully eradicating the infection. Ferring acquired the drug along with its developer Rebiotix in 2018.

Ferring and Rebiotix are only releasing the top-line message from the PUNCH CD 3 study, which is that RBX2660 has showed “preliminary positive efficacy”, and the companies say they will report the data in more detail later this year.

They will also start talking to the FDA later this year to discuss a regulatory filing for the drug, which has fast track, orphan, and breakthrough designations from the FDA.

1. diff causes nearly 30,000 deaths each year in the US, says Ferring, and recurrent infections with the bacterium make up 10%-15% of all hospital-treated infections.

The primary outcome measure in PUNCH CD 3 is the proportion of patients with recurrent C. diff infection within eight weeks of starting treatment with either RBX2660 or placebo. Patients will be followed for several months to check safety.

Crucially, the drug doesn’t involve the use of antibiotics, which are the standard treatment for C. diff but are known to disrupt the healthy balance of the trillions of organisms in the gut microbiome, and increase the risk that the infection will come back.

As they are based on microorganisms already found in the body microbiome therapies should be safe and well-tolerated.

With data in hand from a phase 3 trial, Ferring and Rebiotix claim to be at the front of the pack among developers of live microbiota-based therapies, which now number in the dozens worldwide and also include several firms with C. diff programmes in play.

Others working in this area include UK-based Microbiota, working in partnership with Roche on C. diff as well as inflammatory bowel disease (IBD), as well as Vedanta, Seres Therapeutics, Evelo, Finch Therapeutics and uBiome.

Vedanta has a longstanding partnership with Johnson & Johnson and is working on C. diff – with a phase 2 trial on the go – as well as IBD, while Finch is partnered with Takeda and has a C. diff candidate in phase 2 and IBD programmes in preclinical development.

Some companies are looking outside the GI area. Nestle-backed Seres has lead programmes in IBD and C. diff but is also partnering with MD Anderson Cancer Center in the US on a microbiome-based therapy for melanoma, a kind of skin cancer.

Meanwhile, France’s LNC Biotech is testing a microbiome-based therapy for anxiety and depression, and Axial Biotherapeutics has preliminary clinical data in autism.

Shares of Moderna jumped nearly 11% from the moment the bell rung this morning following its announcement that it received regulatory permission to begin a Phase II study of its mRNA vaccine candidate for COVID-19.

In a brief announcement this morning, Moderna said it expects to begin the mid-stage study soon with 600 patients and is finalizing protocols for a hoped-for Phase III study mRNA-1273, which is expected to begin in early summer of 2020.

Stéphane Bancel, Moderna’s chief executive officer, said the Phase II study is a crucial step in advancing the vaccine candidate as the company looks toward the goal of moving into Phase III. If all goes well, Bancel said the company is making plans to have a Biologics License Application for the vaccine up for approval in early 2021. Having a vaccine for COVID-19 available as quickly as possible is one step in helping society return to a greater sense of normalcy.

“We are accelerating manufacturing scale-up and our partnership with Lonza puts us in a position to make and distribute as many vaccine doses of mRNA-1273 as possible, should it prove to be safe and effective,” Bancel said in a statement.

The agreement with Lonza was struck only a few days ago to bolster the manufacture of the vaccine candidate that the world is hoping against hope will succeed in clinical trials. The two companies entered into a 10-year collaboration for large-scale manufacture of the company’s vaccine, mRNA-1273, as well as other potential Moderna products.

The Moderna vaccine candidate is an mRNA vaccine against SARS-CoV-2 that encodes for a prefusion stabilized form of the Spike (S) protein. As BioSpace has previously reported, the vaccine contains a section of messenger RNA that codes for a protein associated with COVID-19. When the vaccine is injected into a patient, the mRNA moves into the cells, where they then agitate the protein. The body’s immune system should then treat the protein like the virus and attack it, developing an immune response that it will then use if it comes into contact with the actual virus.

Moderna’s vaccine candidate is one of the more promising ones, according to Anthony Fauci, the director of the U.S. National Institute of Allergy and Infectious Diseases, and the scientific face of the White House COVID-19 task force. In addition to the Moderna vaccine candidate, Fauci recently pointed to a candidate under development by researchers at Oxford University’s Jenner Institute. Fauci said that those two candidates are creating substantial immune responses in animal models and said the “promise is great.”

Development of Moderna’s vaccine candidate is being supported by a $483 million grant from the Biomedical Advanced Research and Development Authority (BARDA). The funds, awarded before the unexpected ouster of the agency’s director Rick Bright, are expected to accelerate the development of Moderna’s vaccine candidate.

There are more than 100 vaccine candidates in development, according to a recent report from the World Health Organization. Among those include a handful that have already entered clinical trials, including Moderna’s candidate. The most advanced in terms of clinical testing is CanSino’s Phase II trial assessing its Adenovirus Type 5 Vector, Ad5-nCoV.

The first treatment for adult patients with metastatic non-small cell lung cancer (NSCLC) who also have a specific genetic mutation was approved Wednesday by the U.S. Food and Drug Administration (FDA).

Developed by Novartis, the drug, Tabrecta™ (capmatinib), is designed for a type of NSCLC that has spread to other parts of the body and cannot be removed by surgery. It specifically targets NSCLC tumors that have an abnormal mesenchymal-epithelial transition gene that leads to MET exon 14 skipping (METex14).

Trials showed an overall response rate of 68% in treatment naïve patients, and 41% in previously-treated METex14 patients. This oral MET inhibitor is expected to become available to patients in the coming days.

“Lung cancer is increasingly being divided into multiple subsets of molecularly defined populations with drugs being developed to target these specific groups,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research. “Tabrecta is the first approval specifically for the treatment of patients with non-small cell lung cancer whose tumors have mutations that lead to MET exon 14 skipping. This patient population now has an option for a targeted therapy, which they didn’t have prior to today.”

NSCLC is a disease in which malignant cancer cells form in the tissues of the lung. It is the most common type of lung cancer, accounting for 85% to 90% of the 2 million lung cancer cases throughout the world, and about 228,000 in the U.S. While nearly 75 of those patients have a genomic mutation, only 3% to 4% (4,000 to 5,000 patients) have the METex14 mutation. Without a targeted therapy, prognosis was poor.

The danger in this form of cancer is the high likelihood that the cancer cells will spread from the lungs to other organs and body parts. Cancer metastasis consists of a sequential series of events, and MET exon 14 skipping is recognized as a critical event for metastasis of carcinomas.

 Along with Tabrecta, the FDA also approved a FoundationOne® CDX (F1CDx) to detect mutations that lead to MET exon14 skipping within tumors. F1CDx is a next-generation sequencing-based in vitro diagnostic device that is capable of detecting several mutations.

“With NSCLC, understanding whether a mutation is driving the cancer is critical, and it’s important for doctors and patients to use comprehensive biomarker testing at the time of diagnosis or progression to check for mutations like those that cause METex14,” said Andrea Ferris, president and CEO of LUNGevity. “Knowing more about the molecular makeup of their tumor will help patients and their healthcare teams make informed treatment-related decisions from the start.”

Novartis was granted Breakthrough Therapy Designation for capmatinib. According to FDA guidelines, treatments that receive Breakthrough Therapy Designation must target a serious or life-threatening disease and demonstrate a substantial improvement over existing therapies on one or more significant preliminary research endpoints. It was approved under the Accelerated Approval pathway and given Priority Review designation as well as Orphan Drug designation. The FDA viewed this as a part of its commitment to the health of seriously ill patients despite the COVID-19.

“In the face of the COVID-19 pandemic, our regular work on reviewing treatments for patients with cancer is moving forward,” Pazdur said. “We are working to address critical issues for patients with cancer and their health care providers and continuing to expedite oncology product development in this critical time.”

The approval of Tabrecta is based on results from the pivotal GEOMETRY mono-1, a Phase II multi-center, non-randomized, open-label, multi-cohort study in adult patients with EGFR wild-type, metastatic NSCLC. The trial evaluated 97 adult patients.

Tabrecta, a kinase inhibitor, works by blocking a key enzyme that helps tumor cell grow.

In the METex14 population (n=97), the confirmed overall response rate was 68% (95% CI, 48-84) and 41% (95% CI, 29-53) among treatment-naive (n=28) and previously treated patients (n=69), respectively, based on the Blinded Independent Review Committee (BIRC) assessment per RECIST v1.1¹. 

In patients taking Tabrecta, the study also demonstrated a median duration of response of 12.6 months (95% CI, 5.5–25.3) in treatment-naive patients (19 responders) and 9.7 months (95% CI, 5.5-13.0) in previously treated patients (28 responders)¹. There is no data to determine whether the increased duration of response will translate into long lives for patients. Studies to determine longer-term effects are ongoing.

The most common treatment-related adverse events, experienced by 20 or more of the patients, are peripheral edema, nausea, fatigue, vomiting, dyspnea, decreased appetite. Additional common effect included weakness or tiredness, diarrhea or constipation, cough, paint in the chest, fever, back pain, and weight loss.

“Non-small cell lung cancer is a complex disease, with many different possible mutations that may encourage the cancer’s growth,” said Juergen Wolf, M.D., from the Center for Integrated Oncology, University Hospital Cologne, and lead investigator for the GEOMETRY study. “MET exon 14 skipping is a known oncogenic driver. With today’s decision by the FDA, we can now test for and treat this challenging form of lung cancer with a targeted therapy, offering new hope for patients with NSCLC harboring this type of mutation.”

Pfizer and its development partner BioNTech have begun dosing the first people in the US with a potential COVID-19 vaccine, as part of their ongoing phase 1/2 clinical trial. 

The companies said that the first participants were dosed at the NYU Grossman School of Medicine and University of Maryland School of Medicine. 

The goal is to test the safety, immune reaction, and optimal dose of four mRNA vaccine candidates in a single, continuous study. 

Mainz-based BioNTech had originally developed one of the vaccines involved codenamed BNT161, as part of the trial that began in Germany at the end of last month. 

A dose level escalation stage will recruit up to 360 healthy subjects into two age cohorts – 18-55 years of age and 65-85 years of age. 

The first recruits will be in the younger cohort and older adults will only be immunised with a given dose level of a vaccine candidate once it has been shown as safe and effective in the younger group. 

Active sites currently include NYU Grossman School of Medicine and the University of Maryland School of Medicine, with the University of Rochester Medical Center/Rochester Regional Health and Cincinnati Children’s Hospital Medical Center to begin recruitment shortly. 

Pfizer and BioNTech’s development programme includes four vaccine candidates, each representing a different combination of mRNA format and target antigen.  

The design of the trial allows for the testing of the various mRNA candidates simultaneously in order to identify the safest and potentially most efficacious candidate in a greater number of volunteers, in a manner that will allow the sharing of data with regulatory authorities in real time. 

Pfizer and BioNTech are hopeful of success and are already scaling up production for global supply, with the big pharma investing at risk in an effort to produce an approved COVID-19 as quickly as possible for the most in need around the world. 

Millions of doses could be available if a vaccine proves safe and effective by the end of this year, increasing to hundreds of millions in 2021. 

Pfizer-owned sites in three US states – Massachusetts, Michigan and Missouri – and Puurs, Belgium have been identified as manufacturing centres for COVID-19 vaccine production, with more sites to be selected. 

BioNTech plans to ramp up its manufacturing sites in Mainz and Idar-Oberstein in Germany to provide further doses. 

BioNTech and Pfizer will work to jointly market the vaccine globally if approved, excluding China where the German biotech has a collaboration with Fosun Pharma for both clinical development and marketing. 

According to the latest update from the World Health Organisation, there are now eight potential COVID-19 vaccines in the clinic including Pfizer and BioNTech’s candidate. 

The U.S. Food and Drug Administration (FDA) announced on Tuesday that it has approved dapagliflozin, also known under the brand name Farxiga, for the treatment of heart failure in adults with reduced ejection fraction. The drug can potentially reduce the risk of cardiovascular death and hospitalization for heart failure.

AstraZeneca’s Farxiga is now the first in its drug class of sodium-glucose co-transporter 2 (SGLT2) inhibitors to be approved to treat adults with the New York Heart Association’s functional class II-IV heart failure with reduced ejection fraction. AstraZeneca was granted with the approval of Farxiga related to heart failure by the FDA.

In a clinical trial, Farxiga appeared to improve survival and reduce the need for hospitalization in adults with heart failure and reduced ejection fraction.

 To determine the efficacy of the drug, researchers looked at the number of instances of cardiovascular death, hospitalization for heart failure and urgent heart failure visits. Some trial participants were given a once-daily dose of 10mg of Farxiga, while others were given a placebo. After approximately 18 months, those who were given Farxiga had fewer cardiovascular deaths, hospitalizations for heart failure and urgent heart failure visits compared to their counterparts. 

“Heart failure is a serious health condition that contributes to one in eight deaths in the U.S. and impacts nearly 6.5 million Americans,” said Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiology and Nephrology in the FDA’s Center for Drug Evaluation and Research. “This approval provides patients with heart failure with reduced ejection fraction an additional treatment option that can improve survival and reduce the need for hospitalization.”

Farxiga can cause side effects including dehydration, urinary tract infections and genetical yeast infections. It can also potentially result in serious cases of necrotizing fasciitis of the perineum in people with diabetes and low blood sugar when combined with insulin.

On Tuesday, BioCardia, Inc. also announced positive preclinical datasupporting its new drug application for anti-inflammatory cell therapy for heart failure. BioCardia’s allogenic neurokinin 1 receptor positive mesenchymal stem cell (NK1R+ MSC) therapy appeared to improve heart function in a study. NK1R+ MSC is being marketed under the name CardiALLO.

Researchers looked at 26 animals treated with both low dose and high dose CardiALLO in their study. Echocardiographic measures of cardiac ejection fraction, fractional shortening and cardiac outflow all notably improved in the animals.

“In light of these positive data on our allogenic NK1R+ MSC therapy, we expect to meet our internal timeline to complete our submission to the FDA for our first indication for CardiALLO, and potentially receive IND acceptance by the end of the second quarter,” said BioCardia Chief Scientific Officer Ian McNiece, PhD. “The MSCs that were studied are subtypes of MSC that we have delivered previously in our co-sponsored trials, which we believe have enhanced potency over MSC generated from unselected bone marrow cells. We look forward to seeing additional data from this animal study that are currently being analyzed, including histology and pathology of the heart and lungs.”

BioCardia also intends to submit an IND for the use of NK1R+ MSC delivered via intravenous infusion for the treatment of Acute Respiratory Distress Syndrome caused by COVID-19.

Approximately 6.5 million adults in the U.S. are living with heart failure, according to the Centers for Disease Control and Protection. In 2017, it was a contributing cause of death in one out of eight people.

Shares of Portola Pharmaceuticals more than doubled in premarket trading on news that Boston-based Alexion Pharmaceuticals is acquiring the company and its blood-disorder assets for $1.41 billion in cash.

Alexion said the acquisition of Portola will bolster its commercial portfolio and create long-term value for its shareholders. The deal brings Portola’s Andexxa [coagulation factor Xa (recombinant), inactivated-zhzo] under its umbrella. Andexxa, was approved by the U.S. Food and Drug Administration in 2018 and is currently the only approved Factor Xa inhibitor reversal agent. It has demonstrated transformative clinical value by rapidly reversing the anticoagulant effects of Factor Xa inhibitors rivaroxaban and apixaban in severe and uncontrolled bleeding, Alexion noted.

Ludwig Hantson, Alexion’s chief executive officer, said the acquisition is an important step in the company’s strategy to diversify beyond C5 inhibitors like Soliris, the company’s blockbuster drug used to prevent the breakdown of red blood cells in adults with paroxysmal nocturnal hemoglobinuria and as a treatment for the chronic blood disease atypical hemolytic uremic syndrome (aHUS).

“Andexxa is a strategic fit with our existing portfolio of transformative medicines and is well-aligned with our demonstrated expertise in hematology, neurology and critical care. We believe Andexxa has the potential to become the global standard of care for patients who experience life-threatening bleeds while taking Factor Xa inhibitors apixaban and rivaroxaban,” Hantson said in a statement. “By leveraging Alexion’s strong operational and sales infrastructure and deep relationships in hospital channels, we are well positioned to expand the number of patients helped by Andexxa, while also driving value for shareholders.”

Portola CEO Scott Garland said his company has a strong foundation in developing standard-of-care treatments for patients receiving Factor Xa inhibitors. Andexxa is an antidote for the blood-thinning medications rivaroxaban and apixaban. Garland said Andexxa reverses the pharmacologic effect of those drugs within two minutes, which reduces anti-Factor Xa activity by 92%.

“Given their enhanced resources, global footprint and proven commercial expertise, we look forward to working with Alexion to maximize the value of Andexxa. With their commitment to commercial excellence, together, we will be able to drive stronger utilization of Andexxa, increase penetration and accelerate adoption in the critical care setting,” Garland said in the announcement.

In addition to Andexxa, Portola also has Bevyxxa in its pipeline. Portola’s drug is the only anticoagulant approved for hospital and extended duration prophylaxis of 35 to 42 days of venous thromboembolism (VTE) in adult patients who have been hospitalized for an acute medical illness.

The merger agreement has been unanimously approved by the boards of Alexion and Portola. Under terms of the deal, Alexion will acquire Portola’s stock at $18 per share. Portola closed Monday at $7.76 per share. In premarket trading, the stock has risen to nearly $18.

For Alexion, the acquisition of Portola comes about six months after the company’s board of directors rejected a large stakeholder’s call for a sale. In rejecting the recommendation for a sale, the board of directors pointed to several accomplishments the company has made over the past few years, including a redefinition of the company’s strategy by moving into new disease areas such as neurology and diversifying the company’s portfolio. Part of that diversification includes an agreement between Alexion and Stealth Biotherapeutics to advance the development of elamipretide as a potential first-in-class therapy for primary mitochondrial myopathy. Also last year, Alexion and Fortress Biotech subsidiary Caelum Biosciences struck a deal to develop that company’s CAEL-101, a potential treatment for light chain (AL) amyloidosis, a rare systemic disorder caused by an abnormality of plasma cells in the bone marrow.

India’s Zydus Cadila wants to test a form of interferon, usually used against hepatitis B and C, as a potential treatment for the virus that causes COVID-19. 

According to press reports the company has asked the regulator, the Drugs Controller General of India (DCGI) to test the antiviral pegylated interferon alpha 2-b in adults with COVID-19. 

The drug has already been used to treat COVID-19 in China and Cuba and is included in treatment guidelines laid down by the Chinese government. 

Press reports cite a senior official from the Indian government, who said that talks are under way and the application is being considered by an expert committee. 

Research in the cell cultures in a laboratory in the US found that the SARS-CoV-2 virusis “remarkably sensitive” to recombinant human interferons, reducing viral concentrations by more than 99.99% in certain cells. 

The reports noted research in China, Australia and Canada that showed a short-acting form of interferon reduced duration of viral shedding and levels of the inflammatory cytokine Il-6. 

IL-6 is a target in other research involving drugs from Roche and Sanofi, as it is thought to overstimulate the body’s immune system in seriously ill COVID-19 patients. 

The research suggests that a long-acting version of interferon such as that suggested by Zydus Cadila could be given early in the disease to reduce viral load, reducing the amount of IL-6 produced by the virus and eliminating the harmful immune response. 

The drug is not approved in COVID-19 but is marketed under the brand name PegiHep for treatment of hepatitis B and C. 

Ahmedabad-based Zydus Cadila is already manufacturing hydrochloroquine, which used in India to treat asymptomatic healthcare workers caring for suspected or confirmed COVID-19 cases, asymptomatic household contacts of laboratory-confirmed cases, and COVID-19 patients with severe disease and requiring ICU management. 

According to a COVID-19 therapy tracker from the Milken Institute think tank, there are 199 treatments in consideration for the disease, and 123 vaccines. 

According to the World Health Organization, there are eight potential vaccines for COVID-19 that have made it through to clinical trials.

Norway’s BerGenBio has raised 500 million Norwegian kroner – around $45.4 million euros – in an oversubscribed private placement to develop its pipeline that includes a potential COVID-19 therapy. 

As reported by pharmaphorum last week, BerGenBio’s bemcentinib is the first drug to be tested in a UK trial that is fast-tracking potential COVID-19 therapies into late stage clinical development. 

Bemcentinib is being investigated in the ACCORD-2 trial, a mid-stage trial that feeds into the national phase 3 RECOVERY trial in COVID-19. 

BerGenBio specialises in drugs targeting a biomarker known as AXL, which it hopes could be a cornerstone for therapy for several aggressive diseases including cancers that evade the immune system and do not respond to therapy. 

Aside from COVID-19 bemcentinib is also being developed as a combination and single agent therapy in lung cancer and leukaemia. 

BerGenBio also has first-in-class functional blocking anti-AXL antibody, tilvestamab, which is undergoing phase 1 clinical testing. 

BerGenBio is developing companion diagnostic tests to identify those patient populations most likely to benefit from bemcentinib: this is expected to inform more efficient and targeted registration trials. 

CEO Richard Godfrey said: “This new investment will allow us to expand the clinical development potential of our AXL drug candidates to treat patients with serious aggressive diseases without any effective treatment option.  

“There is growing scientific evidence to support our confidence and belief in our pipeline underlined by the UK Government’s recent request to test bemcentinib in the ACCORD study in COVID-19 patients.” 

In a separate development, Sanofi and Regeneron are to scale back an ongoing phase 3 trial of IL-6 drug Kevzara as a treatment for COVID-19, but are targeting only the most seriously ill patients after mid-stage data revealed its limitations. 

The phase 3 trial the companies are conducting will now only include critically ill patients requiring ventilation or intensive care. 

A 200mg dose will be omitted after showing little effect in phase 2, along with patients graded as “severe”, requiring oxygen therapy but not intensive care.