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Brazil Purchases AstraZeneca’s COVID-19 Vaccine Worth US$360 million 

Brazil’s government recently announced that an amount of US$356 million in funds will be used to purchase and eventually produce the potential COVID-19 vaccine developed by AstraZeneca and Oxford University researchers. 

Brazil’s Acting Health Minister General, Eduardo Pazuello called the vaccine the most promising in fighting against the virus and said that the vaccine is expected to be available early next year. He added that Brazil would initially receive 100 million doses, allowing vaccination for half the country’s population. And from then, they would eventually produce the vaccine.  

According to ministry data, Brazil has nearly 3 million confirmed cases now since the pandemic began, while the official death toll has risen to over 98,000.  

AstraZeneca’s vaccine candidate is seen as the frontrunner in the global race to deliver an effective vaccine, just a week before, the company signed a deal to produce the vaccine in China. 

(Source: Channel News Asia, 2020)

GentiBio Launches with $20M Seed Funding To Develop Engineered Regulatory T Cells to Deliver Immune Tolerizing Therapies for Autoimmune and Inflammatory Diseases 

GentiBio, an early staged biotherapeutics company has recently announced that it has gained $20 million seed funding from OrbiMed, Novartis Venture Fund, and RA Capital Management respectively. They have also announced that the company has entered into exclusive licensing partnerships to advance their unique immune tolerance platform with Seattle Children’s Research Institute, BRI (Benaroya Research Institute), and MIGAL (MIGAL Galilee Research Institute).  

Through the partnership, Seattle Children’s, BRI, and MIGAL will exclusively license unique technologies to GentiBio that overcome many of the current limitations of Tregs therapeutics. GentiBio’s platform also enables the scaled production of robust EngTregs cell therapy products that are antigen-specific and tunable.  

The platform could also potentially accelerate the development of new therapeutics to treat and cure a variety of diseases, including autoimmune diseases.   

(Source: PR Newswire, 2020)

Incyte has high hopes for the virtual launch of rival to CAR-T therapies. (High Hopes for Incyte’s Virtual Launch of Rival CAR-T Therapies) 

Last week, the US FDA (Food and Drug Authority) approved anti-CD19 monoclonal antibody tafasitamab for use in adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The second-line approval puts Incyte and partner MorphoSys in rivalry with Gilead Sciences and Novartis. 

Incyte’s Vice President, Barry Flannelly reassured that despite the many challenges and risks posed by COVID-19, they remain confident that the launch of the new product will be successful. He added that Incyte has had experience in launching products in a time of pandemic-induced restrictions, thus, they have the know-how to overcome challenges posed by the ongoing pandemic. 

Incyte’s fibroblast growth receptor inhibitor, Pemazyre was approved by the FDA for use back in April and has since then generated over $4 million of sales and is looking to grow that figure in the upcoming months. 

The company will use its experience from Pemazyre’s success and apply it to the upcoming launch of Tafasitamab and hopes to garner the same success. 

(Source: Biopharma Reporter, 2020) 

NIH Commences Clinical Trial to Test Antibody Treatment in COVID-19 Patients 

As part of one of NIH’s ongoing study, Accelerating COVID-19 Therapeutic Interventions and Vaccines program has commenced clinical trials of patients with COVID-19. 

The trial will take place at select hospitals around the world that are part of existing clinical trial networks that are brought together to accelerate the development, manufacture, and distribution of medical countermeasures for COVID-19. 

The ACTIV-3 trial can be modified to test additional experimental therapeutics and flexibly allow novel therapeutics to enter at either stage 1 or stage 2. In addition, if a treatment is deemed safe and effective in the initial stage after review by an independent data and safety monitoring board, the investigational therapeutic proceeds to stage 2 testing, where more subjects are enrolled. Likewise, if a treatment is deemed unsafe or not likely to be effective, it will be dropped. 

The ACTIV-3 study will commence by studying the investigational monoclonal antibody LY-CoV555, which was identified in a blood sample from a recovered COVID-19 patient. NIAID’s director said that through the study of the effects of this therapeutic on multiple subjects will help determine the safety and efficacy it has on different patients with differing disease severity. 

The ACTIV-3 clinical trial aims to enroll approximately 300 subjects with mild to moderate COVID-19 with fewer than 13 days of symptoms. Once their COVID-19 infections have been confirmed and they have consented to take part in the study, participants will be randomly assigned to receive either an intravenous infusion of LY-CoV555 or a saline placebo infusion. Participants will also additionally receive standard care for COVID-19, including the antiviral Remdesivir. They will then be observed for 90 days after enrollment and will receive regular examinations and have blood samples taken periodically during this time to analyze their response to the therapeutic. 

(Source: NIH, 2020)

3 Big Drugmakers: Amgen, Takeda and AbbVie in Joint COVID-19 Study. 

Coming together to collaborate in tackling COVID-19, Amgen, Takeda, and AbbVie are conducting a joint clinical trial to see whether their products can improve outcomes for patients that are severely affected by the virus. 

The clinical trial will test Amgen’s psoriasis drug, Otezla, Takeda’s hereditary angioedema therapy Firazyr and AbbVie’s experimental nonalcoholic steatohepatitis drug cenicriviroc to see if it is able to reduce potentially life-threatening immune overreaction observed in some serious COVID-19 patients. The primary goal of the study is to improve at least 1 point on an 8-point World Health Organization ordinal COVID status scale for at least 48 hours for patients with severe COVID-19. 

Rather than each company operating its own trial, the collaborative study allows for multiple trial arms that can test several potential COVID-19 therapies simultaneously and modify protocols in real-time based on observed outcomes, thereby reducing the number of participants and time required to evaluate drugs. 

Drugs this way can proceed in the trial if early signs are positive. If the signal for improvement is strong, a drug may become the new standard of care, and without the trial stops, new therapies could be added onto the new backbone regimen as the trial moves forward. 

AbbVie, Amgen, and Takeda recently helped form the COVID R&D Alliance, a group of more than 20 biopharma companies working to accelerate the development of drugs against COVID-19 and related symptoms. The new study is a collaboration between the group, Quantum Leap Healthcare Collaborative, the designer of the adaptive platform, and the FDA. 

Each of the three companies is hopeful that their respective candidate might work as Otezla inhibits PDE4, which is thought to indirectly modulate the production of inflammatory molecules. Firazyr works in an acute HAE attack by inhibiting the receptor of inflammatory molecule bradykinin. Cenicriviroc is a blocker of chemokine receptors CCR2 and CCR5, which are also linked to acute respiratory distress syndrome in COVID-19. 

(Source: Fierce Pharma, 2020)