WHO prequalifies Ebola vaccine: November’s industry headlines

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Take a look at this month’s industry headlines including new results for Takeda’s dengue vaccine, new approvals for Merck’s Ebola vaccine and the advent of a siderophore antibiotic – the first of this kind.

GlaxoSmithKline announces Phase IIb study results for M72/AS01E pulmonary TB vaccine

GSK (London, UK) has announced the final analysis of a Phase IIb study at the Union World Conference on Lung Health (30 October – 2 November, Hyderabad, India). The results show that the vaccine M72/AS01E significantly reduced the incidence of pulmonary TB in HIV-negative adults with latent TB infection, with an overall efficacy of 50% during the 3 years after vaccination.

Mark Feinberg, CEO of IAVI, a non-profit research organization that helped conduct the study, commented: “While additional trials need to be conducted to confirm these findings in other populations, we have never before seen a vaccine that provides protection in adults who are already infected with the bacteria that cause TB.”

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Roche pays US $200 million as part of a deal with Dicerna to develop RNAi therapies for hepatitis B

Roche (Basel, Switzerland) have agreed to pay US $200 million upfront as part of a deal with Dicerna Pharmaceuticals (MA, USA). The deal is potentially worth over $1.5 billion, in order to facilitate development of RNAi therapies for hepatitis B, including the early-stage drug DCR-HBVS.

The companies will also use Dicerna’s RNAi technology platform combined with technology from Roche to develop additional anti-HBV infection.

As part of the agreement, Dicerna is eligible to receive payments of up to $1.47 billion, regulatory and commercial milestones, as well as royalties based on potential sales of DCR-HBVS and any further products.

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US sues Gilead claiming infringement on patents related to Truvada and Descovy for HIV PrEP

The US Department of Health and Human Services (HHS) has filed a lawsuit against Gilead Sciences (CA, USA) alleging the company infringed patents for Truvada and Descovy for pre-exposure prophylaxis (PrEP) to prevent HIV infection.

Gilead initially obtained FDA approval for the two post-infection HIV treatments. However, HHS has observed that Gilead has since granted approvals for the drugs to be used for PrEP. Gilead has argued that the patents for PrEP and PEP granted to HHS since 2015 are “not valid” and that it “[rejects]any notion of willful infringement.”

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Takeda’s dengue vaccine proves effective in Phase III trial

Takeda Pharmaceutical Company (Tokyo, Japan) has announced that the Phase III trial of its dengue virus vaccine has met the primary efficacy endpoint. The results of the Tetravalent Immunization against Dengue Efficacy Study (TIDES) show that the TAK-003 dengue vaccine was effective in preventing dengue fever caused by any of the four serotypes. The vaccine was also found to be well tolerated with no significant safety concerned identified.

The TIDES trial is continuing. “We are excited to publish the data in a peer-reviewed journal as quickly as possible,” commented Rajeev Venkayya, President of the Global Vaccine Business Unit in Takeda. “In parallel, we are advancing the clinical development, commercial manufacturing, and stakeholder consultations to support a potential future global launch of the vaccine.”

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EU approves Merck & Co.’s Ebola vaccine Ervebo

Merck & Co. (NJ, USA) have announced the European Commission has granted marketing approval to Ervebo, the first-ever Ebola vaccine. Also known as V920, this vaccine received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) and is currently being reviewed by the US FDA, with a decision expected in March 2020.

The vaccine is currently being used by the WHO as part of a specific protocol to protect people at risk of infection in the Democratic Republic of Congo. CEO Kenneth Frazier said the company is “continuing to work with the FDA and the African countries on their regulatory reviews over the coming months and with the WHO on vaccine prequalification, which will help broaden access to this important vaccine for those who need it most.”

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WHO prequalifies Ebola vaccine, allowing it to become widely available in high-risk countries

The WHO have prequalified the Ebola vaccine Ervebo, a step that will speed up its licensing, access and roll-out in countries with a high risk of outbreak.

“This is a historic step towards ensuring the people who most need it are able to access this life-saving vaccine,” said Tedros Adhanom Ghebreyesus, WHO Director-General. “Five years ago, we had no vaccine and no therapeutics for Ebola. With a prequalified vaccine and experimental therapeutics, Ebola is now preventable and treatable.”

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South-African start-up wins Africa Challenge award for its mission to eradicate malaria

Erada Technology Alliance (Ebene, Mauritius) has received € 3000 at the AfricArena conference In Cape Town for its saliva-based rapid diagnostic test .

The test, known as SALIVA! detects the Plasmodium parasite that causes malaria through a saliva sample. SALIVA! Is a collaboration between Erada Technology Alliance, clinical research carried out by Rhoel Dinglasan (University of Florida, FL, USA), Oasis Diagnostics (WA, USA) and Fusion Antibodies (Belfast, UK).

Founder Benji Pretorius, who himself contracted malaria, said: “It is such an honor to be named the winner of the Africa Challenge, and our sincere thanks go to Hello Tomorrow and AfricArena for selecting us. As someone who has survived malaria myself, it gives me great pride to be involved in the fight to make the world malaria-free; this funding is a great stride forward and will be essential for us to take SALVA!’s development one step further.”

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US FDA approves first siderophore antibiotic, cefiderocol

The US FDA has approved cefiderocol (Fetroja), a siderophore cephalsporin that has been tested as a treatment for complicated urinary tract infections (cUTIs).

The approval, granted to Shionogi & Co. (Osaka, Japan), follows results from the PEKS-cUTI trial, in which 72.6% of the patients had a resolution of symptoms and eradication of the bacteria. Although the treatment does come with a warning regarding a higher all-cause mortality rate of critically ill patients compared with other antibiotics.

Paula Garvey, Manship Chair of Medicine at the Louisiana State University School of Medicine (LA, USA), concluded: “With today’s approval of cefiderocol, the infectious disease community now has a new type of antibiotic with a unique mechanism of cell entry to add to their toolkit to assist in the complexity of treating highly resistant pathogens that are occurring with increasing frequency in life-threatening infections.”

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Vaccitech reports on clinical progress for its two Phase II universal influenza studies

Vaccitech Ltd (Oxford, UK), a clinical-stage T cell immunotherapy company, has provided a positive update on recruitment and vaccination for its Universal influenza A vaccine MVA-NP+M1 across two Phase II clinical studies, FLU009 and FLU010. The study will address both pandemic and seasonal influenza vaccine markets.

Want to discover more about a universal flu vaccine? Take a look at our interview with Ed Schmidt >

Bill Enright, Chief Executive Officer of Vaccitech, commented: “We are pleased by the progress of both our Phase II clinical trials for our universal influenza vaccine and are on track to announce top line data in early 2020. There remains a pressing need to find an effective universal vaccine across all A virus strains that can be manufactured at speed and we believe that our VTP-100 product is a potential solution to this global health issue.”

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