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Moderna Therapeutics Expands Pipeline of Innovative mRNA-based Vaccines to Target HIV, Nipah Virus and More

Moderna recently announced that it’ll continue to pursue advancement programs around three new vaccine candidates in 2021. These include potential vaccines for Nipah Virus, Human immunodeficiency virus (HIV), and Seasonal Flu. In light of the company’s COVID-19 vaccine having been awarded emergency use authorization (EUA), by the U.S. Food and Drug Administration (FDA) and recommended by the The European Medicines Agency (EMA) for authorization in the European Union (EU), Moderna is looking into new mRNA-based technology for these upcoming vaccine candidates.

The new programs will focus on not only seasonal flu, but also a combinatory vaccine that could target both the regular flu and SARS-CoV-2, the virus that is known to lead to COVID-19. The vaccine candidate for HIV, which is developed in collaboration with both the AIDS Vaccine Initiative and the Bill and Melinda Gates Foundation, is expected to enter into Phase 1 trials this year. In addition, the company has created a vaccine for the Nipah virus, which is a highly lethal illness that can cause respiratory and neurological symptoms, and which is especially a threat in India, Bangladesh, Malaysia and Singapore.

Apart from these vaccines, Moderna is developing mRNA-based vaccines against the Zika virus, and pandemic influenza or H7N9 vaccine. In addition, it is working on targeting other infections such as the cytomegalus virus (CMV), Epstein-Barr virus (EBV), human metapneumovirus (hMPV), and the parainfluenza type 3 (PIV3) vaccine (mRNA-1653).

(Source: News-Medical.Net, 2021)


INOVIO’s VGX-3100 Demonstrates Positive Phase 2 Efficacy In Treatment of Precancerous Vulvar Dysplasia Caused by HPV-16/18

INOVIO announced positive efficacy results for an open-label Phase 2 trial of VGX-3100 to treat HPV-16 and HPV-18-associated vulvar dysplasia. 63% of the trial participants aged between 12 – 19 were observed and treated with VGX-3100 at six months post-treatment. Three out of the 20 participants with histology data (15%) resolved their vulvar HSIL and had no HPV-16/18 virus detectable in the healed area. By comparison, the spontaneous resolution of vulvar HSIL caused by HPV-16/18 is estimated to be only 2%. The trial also showed VGX-3100 to be safe and well-tolerated. Based on these results, INOVIO is planning to pursue Phase 3 trials.

Phase 2 Vulvar Dysplasia Trial Highlights – VGX-3100

• Trial participants were 24 women between 22 and 70 years of age

80% (20/25) had VIN3 disease and 88% (22/25) had a history of 1 or more recurrences.

• 19 participants had digital photography data, and 12 (63%) had clinically significant lesion reduction as defined by a reduction of lesion area of more than 25%.

• 20 participants had histology and virology data and 3 (15%) resolved their vulvar HSIL and had no HPV-16/18 virus detectable in the healed area.

• Histology was assessed by up to two independent pathologists and non-detectability of HPV-16/18 from lesion tissue using PCR (polymerase chain reaction)-based testing, at six months following the administration of VGX-3100.

• Efficacy endpoints were measured six months post-treatment.

• Safety will continue to be assessed for 18 months following the last dose.

• The most observed adverse event was injection site pain, the majority of which were mild-to-moderate.

• No cases of vulvar cancer have been observed in the trial.

(Source: PR Newswire, 2021)


NEUVOGEN Announces Next Generation Cancer Vaccine Strategy

NEUVOGEN recently announced its novel cancer vaccine strategy to alter how solid tumors are treated. Its strategy employs a systems approach to discover and develop the next generation of whole cell cancer vaccine immunotherapies. The team has overcome myriad challenges plagued past whole cell vaccines and has completed the pre-clinical validation of its technology platform.

“We believe NEUVOGEN’s cancer vaccines will deliver the broadest immune-priming ever achieved to transform the way solid tumors are treated. Our novel immunotherapy platform holds the promise of creating better and safer treatment options for patients.” He also went on to explain that “Our team of scientists and clinicians have extensive experience in therapeutic cancer vaccines, and they are now poised to advance our pipeline of compelling candidates into clinical development.  We are truly excited to enter this next phase to further demonstrate the promise of our novel whole cell cancer vaccine strategy and ultimately bring game changing products to the immunotherapy market”.   

Todd Binder, Chief Executive Officer of NEUVOGEN

NEUVOGEN’s goal is to bring to market a pipeline of therapeutic cancer vaccines that activate the body’s immune system to eradicate solid tumors and significantly extend the lives of patients while having limited side effects commonly linked with traditional cancer treatments.

ADVANCING IMMUNONCOLOGY THERAPY WITH A ROBUST ADJUVANT

Its technology directly addresses three key limitations that have plagued past efforts in cancer vaccine development:  inadequate tumor target breadth; inadequate immune priming; lack of a systematic approach to overcome immune suppressive mechanisms within the tumor microenvironment.                                                                     

Its advancing discovery and development programs are stated to transform how solid tumors are treated:

  • Successfully priming against broad array of targets in patient populations where cancer vaccine mono-therapy has demonstrated clinical efficacy signals in large studies
  • Seizing advantage of the breadth afforded by whole cell tumor vaccines to incorporate multiple tumor-targeting strategies in a single platform.

APPLYING THE WHOLE CELL VACCINE TECHNOLOGY PLATFORM 
                                                                                                                                           The platform is designed to instantaneously prime the broadest array of targets, impacting multiple biologic pathways with the goal of directing an immune response against overlapping targets on every cell within a tumor.  Based upon decades of whole cell vaccine research, NEUVOGEN has generated multiple solid tumor candidates with the potential to create a potent and durable tumor response.

“NEUVOGEN has the potential to disrupt the current immunoncology treatment paradigm by turning our technologies into a pipeline of truly novel cancer immunotherapies for various solid tumors.”

Kendall M. Mohler, PhD, former CSO of Juno Therapeutics

(Source: PR Newswire, 2021) 


Jubilant Therapeutics Announces Research Collaboration With The Aim To Reduce Clinical Severity of COVID-19

Jubilant Therapeutics Inc announced a collaboration with The Wistar Institute, an international leader in biomedical research with special expertise in cancer research and vaccine development, to evaluate the ability of Peptidyl Arginine Deiminase 4 (PAD4) inhibitors provided by Jubilant Therapeutics to block neutrophil extracellular trap (NET) formation in the context of COVID-19 related cytokine storms.

“We are very pleased to announce our collaboration with the renowned Wistar Institute. Even with COVID-19 vaccines on the horizon, we know its wrath will persist for some time to come and the need to reduce its death toll remains critical. Beyond COVID-19, understanding the potential of PAD4 inhibitors to address aberrant NET formation will be important due to their role in the pathogenesis of many disease states beyond viral infections.”

Syed Kazmi, President and Chief Executive Officer of Jubilant Therapeutics

“This collaboration with Jubilant Therapeutics will further advance our comprehensive research efforts to find therapeutics to diminish cytokine storms and decrease COVID-19 symptom gravity. It is our hope that Jubilant Therapeutics’ inhibitors will prove successful in blocking NET formation to this end.”

Yulia Nefedova, M.D., Ph.D., Associate Professor, Immunology, Microenvironment & Metastasis Program at The Wistar Institute

(Source: PR Newswire, 2021)