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KM Biologics Announces Phase I Clinical Study Results of a Live Attenuated Tetravalent Dengue Vaccine (KD-382)

KM Biologics Co., Ltd. (Headquarters: Kumamoto, Japan; CEO: Toshiaki Nagasato) announced the results of the Phase I clinical study (hereinafter the “Study”) of a live attenuated tetravalent vaccine, KD-3821 (hereinafter, the “KD-382 vaccine”), to prevent dengue2.

This study was conducted to evaluate the safety and immunogenicity of the KD-382 vaccine in 60 healthy adults in Australia, which is a non-dengue endemic country, by administering the KD-382 vaccine subcutaneously once or twice with a 4-week interval.

The results show that the KD-382 vaccine is safe and well-tolerated by healthy adults. Moreover, KD-382 showed 100% seroconversion at an early stage and elicited long-lasting and neutralizing antibody response for all 4 serotypes in most subjects over a 1-year follow-up, despite the single-dose administration.

Based on the supporting results indicating the KD-382 vaccine as very promising, we will proceed with preparations for Phase II clinical studies of the KD-382 vaccine in dengue-endemic countries to maximize the value of the vaccine and address the unmet medical needs of people at risk of dengue worldwide.

KD-382 is a live attenuated tetravalent dengue vaccine that is expected to be effective against all four serotypes with a single dose. As a live attenuated virus vaccine is expected to induce both neutralizing antibodies and cellular immunity, similar to natural infection, the long-term persistence of neutralizing antibodies and low probability of disease enhancement due to antibody-dependent enhancement (ADE) can be expected.

(Source: MarketScreener, 2021)


JSR Life Sciences spawns new venture fund; IL-2 biotech completes merger with trivia company subsidiary

JSR Life Sciences unveiled its new Life Sciences Corporate Venture Fund on Tuesday, with the goal of investing in “multiple deals within the next few years.” The initial focus will be emerging companies, according to a statement.

The fund is led by Jason Yuanxin Zhang, who holds a P.h.D in botanical sciences from the University of Hawaii. He served as a postdoc scientist at Lilly more than 20 years ago, and most recently came from Humanwell Healthcare Group where he was COO and managing director of international investment and business development.

“Initiating this fund and offering the ability to invest in the life sciences sector is a natural extension of our core expertise,” JSR CTO Jean-Pierre Wery said in a statement. — Nicole DeFeudis

IL-2 biotech completes merger with trivia company subsidiary
Brooklyn ImmunoTherapeutics has completed its reverse merger with NTN Buzztime, the companies announced Thursday evening.

The combined firm will keep the Brooklyn moniker and function as a wholly-owned subsidiary of NTN Buzztime, which is an interactive entertainment company that broadcasts trivia and other games to bars and restaurants throughout the US. With the deal completed, Brooklyn will now focus on advancing its lead compound, dubbed IRX-2.

“We look forward to continuing to evaluate IRX-2, a human cell-derived IL-2 therapeutic in neoadjuvant (pre-surgical) and adjuvant (post-operative) treatment for advanced head and neck squamous cell cancer,” Brooklyn CEO Ronald Guido said in a statement.

(Source: Endpoints News, 2021)


GSK and Vir Biotechnology Announce Submission of Emergency Use Authorization Request to FDA for VIR-7831 for the Early Treatment of COVID-19

GlaxoSmithKline plc (LSE/NYSE: GSK) and Vir Biotechnology, Inc. (Nasdaq: VIR) today announced the submission of an application to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) for VIR-7831 (GSK4182136), an investigational dual-action SARS-CoV-2 monoclonal antibody for the treatment of adults and adolescents (aged 12 years and older weighing at least 40 kg) with mild-to-moderate COVID-19 who are at risk for progression to hospitalization or death.

The FDA EUA submission is based on an interim analysis of efficacy and safety data from the Phase 3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial – Intent to Care Early) trial, which evaluated VIR-7831 as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalization. Results of the interim analysis, based on data from 583 patients enrolled in the trial, demonstrated an 85% (p=0.002) reduction in hospitalization or death in those receiving VIR-7831 compared to placebo, the primary endpoint of the trial. As a result, the Independent Data Monitoring Committee recommended that the trial be stopped for enrollment due to evidence of profound efficacy. Data from the registrational COMET-ICE trial also will form the basis for a Biologics License Application (BLA) submission to the FDA.

Preclinical data suggest VIR-7831 targets a highly conserved epitope of the spike protein, which may make it more difficult for resistance to develop. New in vitro data from pseudotyped virus assays published online in bioRxiv in March 2021 support this hypothesis as they demonstrate that VIR-7831 maintains activity against current circulating variants of concern including the UK, South African and Brazilian variants. Based on additional soon to be published preclinical data, VIR-7831 also appears to maintain activity against the California variant.

GSK and Vir will continue discussions with the European Medicines Agency (EMA) and other global regulators to make VIR-7831 available to patients with COVID-19 as soon as possible.

(Source: Global Newswire , 2021)