Nasal Spray Significantly Accelerates Respiratory Virus Clearance in Phase 2a Clinical Study

— Post hoc analyses found a statistically significant reduction in the duration of flu infection and a dose-related trend toward a reduction in symptom duration.

— These results support the further clinical development of INNA-051 to mitigate the impact of natural infection by respiratory viruses such as SARS-CoV-2 and its variants: influenza, RSV, and the common cold, in individuals at risk of more severe illness.

MELBOURNE, Australia, Feb. 14, 2023 (GLOBE NEWSWIRE) — ENA Respiratory, a clinical-stage pharmaceutical company, announced that INNA-051, a first-in-class, broad-spectrum, innate immunomodulator in development for the prophylaxis of respiratory viral infections, was found to significantly impact the course of viral infection in a Phase 2a flu challenge study.

The study included 123 adults (ages 19 to 53) randomized to receive two doses of INNA-051 (low and high dose) or placebo, then challenged with a substantial dose of H3N2 influenza A virus. The viral inoculum was expected to result in a large majority of participants being infected. Interpretation of the study was complicated by lower than anticipated rates of infection in the placebo arm and an unexpectedly large proportion of participants having pre-existing immunity to the challenge strain across all groups (assessed using the hemagglutination inhibition assay). Post hoc analyses excluding those with pre-existing immunity showed that INNA-051-treated participants with PCR laboratory-confirmed infection had a statistically significant shorter duration of infection. This effect was greater with the higher dose. Although not statistically significant, a dose-related reduction in the duration of symptoms was also observed.

Notably, the study confirmed the safety profile of INNA-051. Compared with the placebo group, participants receiving INNA-051 showed no increase in the incidence, magnitude, or duration of any flu symptom, nor enhanced local or systemic signs or symptoms associated with the viral challenge. The most common adverse events associated with the study medication were mild, short-lived and similar to those observed during the initial Phase 1 study.

“This study further supports the concept that boosting the local innate immune response to common respiratory viruses has potential clinical benefit. In this study, INNA-051 was found to be safe and to significantly impact the course of infection. We are eager to investigate INNA-051’s clinical benefit in the context of natural viral respiratory tract infections in individuals at increased risk of more severe illness,” said Christophe Demaison PhD, Managing Director and CEO of ENA Respiratory.

Earlier research in humans and animals has shown that INNA-051 activates the innate immune system in the nose, a common site of infection. These Phase 2a study results mirror those seen in animal respiratory infection models, and are consistent with the INNA-051 mechanism of action. INNA-051 accelerates virus clearance and reduces virus spread to other parts of the body. It is anticipated that INNA-051 prophylaxis will reduce illness severity and healthcare utilization in individuals exposed to respiratory viral infections, especially in those at high risk of complications.

“Many people around the world have now been impacted by a ‘tripledemic’ of flu, RSV and SARS-Cov-2 viruses that have been circulating together in recent months. The surge in illness and hospitalization demonstrates the urgent need for a broad-spectrum treatment to boost immunity against common respiratory illnesses, and these data suggest INNA-051 is a promising option,” said Scott White MD, Chief Medical Officer, ENA Respiratory.

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About ENA Respiratory and INNA-051

ENA Respiratory aims to transform the prevention of respiratory viral infections in populations at-risk of complications. The company is based in Melbourne and Sydney, Australia, and it has secured a Series A investment from Brandon Capital Partners’ managed funds, the Minderoo Foundation, and Uniseed.

INNA-051 is a potent innate immune TLR2/6 agonist. Fast-acting and inducing a durable biologic response supporting weekly administration, INNA-051 works by recruiting innate immune cells and priming epithelial cells of the nasal mucosa to respond more quickly to infections, rapidly eliminating viruses and other pathogens before they spread throughout the body. It is being developed for intranasal delivery to target the primary entry site of viral respiratory infections, as most respiratory viruses, including SARS-CoV-2 and influenza, initially infect and replicate in nasal mucosa epithelial cells. INNA-051 and close analogues have been shown in preclinical studies to be effective against multiple respiratory viruses, including SARS-CoV-2, influenza (H1N1 and seasonal H3N2), and rhinovirus.

Key features of INNA-051 intranasal administration include limited minimal or no systemic bioavailability, minimal or no systemic pro-inflammatory cytokine release, no direct type I interferon upregulation which is known to be associated with fever in humans, durable immune response supporting weekly administration, and compatibility with vaccine and intranasal corticosteroids.

For more information, please visit https://enarespiratory.com.

GlobeNewswire Distribution ID 8746674

Fresh Produce Distributor Jacques Remy & Sons Using Descartes’ Route Planning Solution to Reduce Transportation Costs and Improve Service

ATLANTA and PARIS, Feb. 13, 2023 (GLOBE NEWSWIRE) — Descartes Systems Group (Nasdaq: DSGX) (TSX:DSG), the global leader in uniting logistics-intensive businesses in commerce, announced that Jacques Remy & Sons, a leading Belgian distributor of fresh produce, has optimized its multi-country distribution operations with Descartes’ route planning solution. Deployed in less than two months, the cloud-based solution reduced the distributor’s transportation costs, enabled real-time delivery tracking to enhance the customer experience, and ensured the company could efficiently and cost-effectively manage the upswing in sales activity.

“Given an influx of new contracts and the logistical complexities and regulatory constraints of transporting fresh produce to multiple countries, we needed to optimize delivery performance and tracking in order to meet customer expectations,” said Isabelle Libert, Executive Assistant at Jacques Remy & Sons. “The rapid implementation of the routing solution, coupled with Descartes’ change management expertise, enabled us to immediately reap the operational and bottom-line benefits across our combined fleet of vans and transport trucks that deliver to both grocery stores and wholesalers as well as to small business professionals.”

Part of Descartes’ route planning and execution, mobile and telematics suite, Descartes’ route planning and optimization helps brands achieve more agile, efficient and sustainable routing by generating additional delivery capacity and reducing costs. For distribution-intensive companies, like Jacques Remy & Sons, the solution creates delivery efficiencies and improves customer service by optimizing delivery routes and managing their execution through a real-time mobile application used by drivers. Drivers also use the mobile application to capture proof-of-delivery (POD) details. Real-time text or email notifications keep customers up to date with the progress of the delivery to enhance the customer experience.

“We’re pleased that our route planning solution has rapidly transformed delivery management into a differentiating element of Jacques Remy & Sons’ business strategy, making it a lever for customer satisfaction and loyalty,” said Peio Ribas, Senior Vice President Sales, EMENAR at Descartes. “Now that plan versus actual performance tracking is in place, they have the data to calculate the cost of each delivery and vehicle. Our cloud-based route planning, execution, and mobile solution allows companies to consistently provide superior delivery performance while minimizing distribution costs as they scale and grow.”

For more information, visit Descartes’ Routing, Mobile and Telematics resource center.

About Jacques Remy & Sons

Founded in 1974 by the Remy family, Jacques Remy & Sons has distinguished itself by continually offering quality products at affordable prices and maintaining the strictest standards and certification requirements for the transportation of products to our customers. For more information, visit www.jacquesremy.com.

About Descartes

Descartes (Nasdaq:DSGX) (TSX:DSG) is the global leader in providing on-demand, software-as-a-service solutions focused on improving the productivity, performance and security of logistics-intensive businesses. Customers use our modular, software-as-a-service solutions to route, schedule, track and measure delivery resources; plan, allocate and execute shipments; rate, audit and pay transportation invoices; access global trade data; file customs and security documents for imports and exports; and complete numerous other logistics processes by participating in the world’s largest, collaborative multimodal logistics community. Our headquarters are in Waterloo, Ontario, Canada and we have offices and partners around the world. Learn more at www.descartes.com, and connect with us on LinkedIn and Twitter.

Global Media Contact
Cara Strohack                                                    
Tel: +1(800) 419-8495 ext. 202025                        
cstrohack@descartes.com

Cautionary Statement Regarding Forward-Looking Statements

This release contains forward-looking information within the meaning of applicable securities laws (“forward-looking statements”) that relate to Descartes’ solution offering and potential benefits derived therefrom; and other matters. Such forward-looking statements involve known and unknown risks, uncertainties, assumptions and other factors that may cause the actual results, performance or achievements to differ materially from the anticipated results, performance or achievements or developments expressed or implied by such forward-looking statements. Such factors include, but are not limited to, the factors and assumptions discussed in the section entitled, “Certain Factors That May Affect Future Results” in documents filed with the Securities and Exchange Commission, the Ontario Securities Commission and other securities commissions across Canada including Descartes’ most recently filed management’s discussion and analysis. If any such risks actually occur, they could materially adversely affect our business, financial condition or results of operations. In that case, the trading price of our common shares could decline, perhaps materially. Readers are cautioned not to place undue reliance upon any such forward-looking statements, which speak only as of the date made. Forward-looking statements are provided for the purposes of providing information about management’s current expectations and plans relating to the future. Readers are cautioned that such information may not be appropriate for other purposes. We do not undertake or accept any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in our expectations or any change in events, conditions or circumstances on which any such statement is based, except as required by law.

GlobeNewswire Distribution ID 8747199

OPEN Health to acquire leading US-based life science strategy and advisory firm Acsel Health

London, U.K., Feb. 13, 2023 (GLOBE NEWSWIRE) — OPEN Health, a pre-eminent global provider of scientific communications and HEOR & market access services, announced the acquisition of Acsel Health (“Acsel”), a New York-based life science strategy and advisory firm focused on commercial strategy, pricing and market access, and commercial excellence.

Acsel’s deep industry expertise, scientific rigor, and actionable analysis drives its success in providing valued partnership to life science companies. These capabilities will complement OPEN Health’s existing offering, broadening the range of services it offers to pharma and biotech companies.

Lujing Wang, Managing Partner of Acsel Health, said, “We are thrilled to join OPEN Health and to work with a wider team to solve for today’s demands and meet tomorrow’s expectations for pharma and biotech customers. With new colleagues and capabilities to partner with, we are equipped to answer the most challenging cross-disciplinary questions in life science across all key therapeutic areas.”

“Acsel is an extraordinary addition to OPEN Health. Acsel’s expert team and long-standing client relationships significantly strengthen our ability to support the commercialization of our clients’ assets and unlock access for patients.” said OPEN Health CEO, Rob Barker. “We are excited to welcome Acsel Health into the OPEN Health Group and look forward to working with our new colleagues to offer our clients innovative, scientific solutions around the globe.”

Fairmount Partners acted as exclusive financial advisor to Acsel Health. The terms of the transaction were not disclosed.

About OPEN Health

OPEN Health unites deep scientific knowledge with wide-ranging specialist expertise to unlock possibilities that improve health outcomes and patient wellbeing. Working in partnership with our clients, we embrace our different perspectives and strengths to deliver fresh thinking and solutions that make a difference. OPEN Health is a flexible global organization that solves complex healthcare challenges across HEOR and market access, medical communications and creative omnichannel campaigns. For more information on OPEN Health, visit www.openhealthgroup.com.

About Acsel Health

Acsel Health is a consulting firm that partners with renowned life science companies to guide life-changing innovations through their critical stages, from early development through market maturity. Acsel applies best-practice principles to develop and deliver highly individualized solutions to challenges across the product lifecycle for our clients. For more information on Acsel Health, visit www.acselhealth.com.

Attachment

Candice Subero
OPEN Health
candicesubero@openhealthgroup.com

GlobeNewswire Distribution ID 8744608

Aims of China trip have been met: KMT vice chairman

Opposition Kuomintang Vice Chairman Andrew Hsia (???), who is leading a delegation on a visit to China, said Monday in Shanghai that the delegation had achieved the three main goals of its trip and expected more such exchanges in the future.

The three main purposes of the trip were to look after the needs of Taiwanese based in China, convey the problems Chinese regulations have caused SMEs in Taiwan to relevant authorities, and get to know the new Chinese officials in charge of Taiwan affairs, the KMT has said.

The delegation led by Hsia left Taiwan for a multi-city tour of China on Feb. 8.

Since then, Hsia has met with Wang Huning (???), a member of the Politburo Standing Committee of the Chinese Communist Party (CCP), and Sung Tao (??), the head of Beijing’s Taiwan Affairs Office, as well as Yin Li (??), the CCP secretary of Beijing.

The delegation also visited Nanjing.

On Monday morning, Hsia attended an event in Shanghai on exchanges between young entrepreneurs from the two sides of the Taiwan Strait, and was able to make contact with young Taiwanese entrepreneurs operating there.

The event was held online via live video link. Speaking at the virtual event, Hsia said there have been many factors that have hurt cross-strait economic and trade cooperation over the past few years and posed challenges to cross-strait exchanges and cooperation.

Due to the lack of mutual trust between Taiwan and China, the official cross-strait communications mechanism has been suspended, and the follow-up implementation of 23 official agreements between the two sides has been affected or even put on hold, he said.

Unable to get help through official channels, many Taiwanese businessmen have begun to find possible solutions to their problems on their own or sought the KMT’s help, Hsia said.

Under such circumstances, Hsia said, he believed he and the young entrepreneurs in attendance needed to assume greater responsibility and take a more active role to deal with the many problems facing them.

With the three main goals being met in the first six days of the trip, Hsia said he will continue to meet with Taiwanese businessmen in other Chinese cities to learn of their difficulties and ask the Chinese authorities to properly respond to their problems.

Hsia said the mainland has always hoped to promote exchanges between the two sides of the Taiwan Strait, and his trip and the talks his delegation had with the Chinese side has led him to believe there will be more exchanges in the future.

“Both sides have a better understanding of each other, which is a good direction for the peaceful development of the two sides of the Strait,” he said.

Hsia will also make stops in Wuhan, Chongqing and Chengdu during his trip that will last until Feb. 17, according to the KMT.

Source: Focus Taiwan News Channel

Korea appoints new envoy to Taiwan

Korea has appointed Lee Eun-ho, the most recent president of the Korean Security Agency of Trade and Industry (KOSTI), as the country’s new top representative to Taiwan, a source told CNA Monday.

Lee will assume office in Taipei on Feb. 20, the source said.

Lee will replace Chung Byung-won, who has been South Korea’s representative as head of the Korean Mission in Taipei since December 2021 and has just been named Korea’s next ambassador to Sweden, according to the unnamed source.

It is the first time South Korea has appointed an envoy to Taiwan from its Ministry of Commerce, Industry and Energy (MOCIE) instead of from its foreign ministry, as had been the convention since 1992 after the two sides cut official diplomatic ties, the source said.

Lee is also the first top Korean envoy to Taiwan named by President Yoon Suk-yeol, who took office in May 2022.

Born in 1961, Lee received master’s and bachelor degrees in mechanical engineering at Seoul Nation University before receiving a Ph.D. in the same field at the Georgia Institute of Technology in the United States.

He started his public service as the director of MOCIE’s International Standard Division and then of the MOCIE’s E-Business Policy Division, before being posted overseas at the Korean embassy in Vietnam and then in the United Arab Emirates.

He had headed the KOSTI, a government-funded institution established in June 2007 to help Korean corporations comply with export controls and international trade standards, since May 2021.

Source: Focus Taiwan News Channel

NBA to visit Taiwan bound for World Cup warm-up games

Several NBA stars are set to take to the court in Taiwan this summer as New Taipei’s Xinzhuang Gymnasium hosts warm-up for three national teams ahead of the 2023 FIBA Basketball World Cup.

According to a press statement released by the T1 LEAGUE Monday, Taiwan will host games involving Olympic silver medalist France, as well as Lithuania and Latvia in preparation for this year’s World Cup, co-hosted by Japan, the Philippines and Indonesia.

The top eight finishers at the World Cup, which begins on Aug. 25, will also secure qualification for the 2024 Paris Olympics.

The warm-up games have been co-organized by Bros Sports Marketing Co. and the T1 LEAGUE, which credited the success of bringing the teams to Taiwan to the league’s two Lithuanian players, Edgaras Zelionis (New Taipei CTBC DEA) and Mindaugas Kupsas (Kaohsiung Aquas).

Both Lithuanian big men have been selected for the league’s upcoming All-Star Game on Feb. 28.

“Taiwan and Lithuania have been sharing a great bond, plus the DEA’s addition of Edgaras this season, so the Lithuanian Trade Representative Office contacted us around January to see if we were willing to host the World Cup warm-up games,” said Edward Chang (???), T1 league secretary-general.

Lithuania has long enjoyed a high status in European basketball due to its storied history, Chang said, adding that it had invited the other two countries to join soon after having the Taiwan side’s nod.

The schedule for the warm-up games will be announced on Feb. 17, according to the statement.

In addition to winning the silver medal at the 2020 Tokyo Olympics, France finished third in the last two FIBA World Cups, while Lithuania also made it to the semifinals in 2010 and 2014.

Local fans will likely be able to catch a glimpse of NBA All-Stars, including the French Rudy Gobert (Minnesota Timberwolves), Lithuania’s Domantas Sabonis (Sacramento Kings), and the Latvian Kristaps Porzingis (Washington Wizards).

Fans may also get a chance to see 19-year-old Frenchman Victor Wembanyama, whose dexterity and shooting caliber rare in the 7-foot-4 size has made his game a sight to see. He is widely tipped to be picked first overall in June’s NBA draft, and described as “more like an alien” than a “unicorn” by leading all-time NBA scorer LeBron James.

Unicorn or alien, Taiwan fans might soon be able to find their own answers in New Taipei this August.

Source: Focus Taiwan News Channel

FDA orders recall of 10,000 doses of infective endocarditis drug

Taiwan’s Food and Drug Administration (FDA) on Monday announced the recall of 10,000 doses of Targocid, a drug used to treat infective endocarditis.

Hung Kuo-teng (???), the head of the FDA’s Medicinal Products Division, said the recall was for the antibiotic Targocid 400mg powder produced in batch 1J5721 by French multinational pharmaceutical company Sanofi.

The FDA demanded that the 10,000 doses from the specific batch in Taiwan must all be recalled by March 6, and clinics, hospitals and pharmacies have been asked to stop prescribing the drug and assist in recall efforts.

Hung said Sanofi had voluntarily notified the FDA last October that issues might have arisen in the drug’s production line.

Hung said the FDA subsequently asked the company to investigate, which revealed that the batch in question was slightly contaminated with a water soluble corticosteroid known as methylprednisolone hemisuccinate (MPHS).

The corticosteroid is used to relieve a number of ailments such as severe allergic reactions, respiratory diseases, and nervous system conditions.

Approximately 120,000 doses of Targocid are prescribed under Taiwan’s national health insurance program annually, according to Hung, accounting for 80 percent of the market for drugs of the same nature made with the same active ingredients and dosage.

Hung said, however, that patients who rely on the medication do not have to worry that a recall will cause a shortage of the drug because there are other brands offering the same active ingredient.

For anyone who has concerns, the FDA recommended making appointments with their doctors to discuss alternative medications.

Targocid’s primary application is for the treatment of infective endocarditis brought on by staphylococcus.

Secondary applications include the treatment of osteomyelitis, pneumonia, sepsis, soft tissue infection and small intestine inflammation.

Source: Focus Taiwan News Channel