January 11, 2023

Zenas BioPharma Announces First Patient Dosed in Phase 3 Clinical Study of Obexelimab for the Treatment of Immunoglobulin G4-Related Disease (IgG4-RD)

Global Phase 3 INDIGO study will evaluate the efficacy and safety of obexelimab in patients with IgG4-RD, a chronic and serious fibroinflammatory disease typically affecting multiple organs

IgG4-RD is the first of several potential disease indications to be pursued for obexelimab given its unique non-depleting, B-cell inhibition

WALTHAM, Mass., Jan. 11, 2023 (GLOBE NEWSWIRE) — Zenas BioPharma, a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immune-based therapies, today announced that the first patient has been dosed in the INDIGO Phase 3 registrational study of obexelimab. The INDIGO study will evaluate the clinical efficacy and safety of obexelimab treatment in the prevention of IgG4-related disease (IgG4-RD) flare. Obexelimab is a high-affinity bifunctional antibody that inhibits B-cell lineages by simultaneously binding to CD19 and Fc_ƳRIIB, thereby downregulating B-cell activity in patients with autoimmune diseases associated with autoantibodies, such as IgG4-RD.

“IgG4-RD is a chronic and serious fibroinflammatory condition that can affect nearly any organ system and can have a profound impact on many patients, leading to severe organ damage or death,” said Hua Mu, M.D., Ph.D., Chief Executive Officer at Zenas. “There are no currently approved treatments for patients living with IgG4-RD. Based upon the promising data from a Phase 2 study of obexelimab in IgG4-RD patients, we are excited to continue to evaluate the potential of obexelimab in the INDIGO study.”

About the INDIGO Study

The INDIGO study is a global multicenter, randomized, double-blind, placebo-controlled study enrolling up to 200 adults with active IgG4-RD signs/symptoms (i.e., flare) that require steroid therapy. Patients will be randomized in a ratio of 1:1 to receive either obexelimab or placebo, administered as subcutaneous injections.

The primary endpoint of INDIGO is time to first IgG4-RD flare (defined as the reappearance of previous signs/symptoms or appearance of new signs/symptoms of IgG4-RD) that requires initiation of rescue therapy from randomization to Week 52. Safety will be evaluated throughout the study duration.

More information on the INDIGO study (NCT05662241) is available at clinicaltrials.gov.

About Obexelimab

Obexelimab is an investigational Phase 3-stage, novel bifunctional antibody with first-in-class potential that inhibits B-cell lineages that express CD19. Simultaneous binding to CD19 and Fc_ƳRIIB by obexelimab mimics a natural antigen-antibody complex and downregulates B cell activity. In several early-stage clinical studies, 198 subjects were treated with obexelimab. In these clinical studies, the molecule demonstrated effective inhibition of B cell function without depleting the cells and generated an encouraging treatment effect in patients with multiple autoimmune diseases. Zenas acquired exclusive worldwide rights to obexelimab from Xencor, Inc.

About IgG4-RD

IgG4-RD is a chronic and serious fibroinflammatory disease typically affecting multiple organs (e.g., pancreas, liver, kidney, bile duct, salivary and lacrimal glands). Approximately 20,000 people are diagnosed with IgG4-RD in the US, with similar prevalence rates across geographies. Many patients have some degree of irreversible organ damage at the time of diagnosis. Although nearly all patients initially respond to glucocorticoid (GC) therapy, a majority of patients will relapse/flare within a few months of discontinuing treatment, requiring rescue therapy. Chronic GC therapy is also associated with toxicity in many patients.

About Zenas BioPharma

Zenas BioPharma is a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immune-based therapies for patients around the world. With clinical development and operations globally, Zenas is advancing a deep and balanced global portfolio of potential first- and best-in-class autoimmune therapeutics in areas of high unmet medical need while meeting the value requirements of the dynamic global healthcare environment. The company’s pipeline continues to grow through our successful business development strategy. Our experienced leadership team and network of business partners drive operational excellence to deliver potentially transformative therapies to improve the lives of those living with autoimmune and rare diseases. For more information about Zenas BioPharma, please visit www.zenasbio.com and follow us on Twitter at @ZenasBioPharma and LinkedIn.

Investor and Media Contact:
Joe Farmer, President & COO
Zenas BioPharma
IR@zenasbio.com

GlobeNewswire Distribution ID 8727743

January 11, 2023

Nikkiso Clean Energy & Industrial Gases Group Announces their First On-Site FAT Testing at their Marine Facility in Busan, Korea

TEMECULA, Calif., Jan. 10, 2023 (GLOBE NEWSWIRE) — Nikkiso Clean Energy & Industrial Gases Group (“Group”), a part of the Nikkiso Co., Ltd (Japan) group of companies, is proud to announce its first on-site FAT testing at their new Marine facility in Busan, Korea. This accomplishment exemplifies their commitment to and support of the growth of the Korean market.

Since July 2022, they have been fabricating high-pressure pump skids in the 4,000 square meter facility. With the successful completion of this FAT test for Hapag Lloyd AG (for the largest fuel gas supply system), they demonstrate the capabilities of their factory and its LN2 (liquid nitrogen) test facility. This facility continues to provide the commissioning and maintenance support previously provided. With the HP pumps skid fabrication and testing capabilities, they now provide full-system marine solutions to their customers.

The FAT test is mandatory prior to skid delivery, which tests for overall performance (i.e., pump maximum flowrate, vaporizer performance, lube-oil (LO) system, nitrogen purge system, cryogenic valves, etc.). It must be witnessed by shipowner, class society, and customers, verifying the product meets its performance requirements.

According to Jay Lee, General Manager, Korea, “Nikkiso ACD has been the preferred supplier for Fuel Gas skids to the Korean shipbuilding industry for over 20 years! With our new skid packaging and testing facility located near the shipyards in Korea, we now have even greater capacity to provide local support and meet the significant global marine demands.”

“This is an important next step for our Group and the LNG powered Marine market, and an expanded benefit for our Marine customers. Nikkiso CE&IG will now be able to provide and test full systems and support our customers with a turnkey system solution,” according to Peter Wagner, CEO of Cryogenic Industries and President of the Group.

Contact Information:
Nikkiso Clean Energy and Industrial Gases – Korea
Head Office & Factory: 83, Nosansanupjung-ro, Gangseo-gu, Busan, 46752, Korea
Branch office: #1912, 170, Gwanggyojungang-ro, Yeongtong-gu, Suwon, Gyeonggi-do, 16614, Korea
info@NikkisoCEIG-Korea.com

ABOUT CRYOGENIC INDUSTRIES
Cryogenic Industries, Inc. (now a member of Nikkiso Co., Ltd.) member companies manufacture and service engineered cryogenic gas processing equipment (pumps, turboexpanders, heat exchangers, etc.) and process plants for Industrial Gases, and Natural Gas Liquefaction (LNG), Hydrogen Liquefaction (LH2) and Organic Rankine Cycle for Waste Heat Recovery. Founded over 50 years ago, Cryogenic Industries is the parent company of ACD, Nikkiso Cryo, Nikkiso Integrated Cryogenic Solutions, Cosmodyne and Cryoquip and a commonly controlled group of 20 operating entities.

For more information, please visit www.nikkisoCEIG.com and www.nikkiso.com.

MEDIA CONTACT:
Anna Quigley
+1.951.383.3314
aquigley@cryoind.com

GlobeNewswire Distribution ID 8727431

January 11, 2023

FURA Gems Appoints Mazars SA and Initiates the Process for Responsible Jewellery Council (RJC) Registration

FURA Gems

Ruby, Emerald and Sapphire from FURA Gems

DUBAI, United Arab Emirates, Jan. 11, 2023 (GLOBE NEWSWIRE) — FURA Gems announced today it had initiated the certification process with the RJC, demonstrating its commitment to responsible business practices. The project will be headed by Mazars Switzerland, which will accompany FURA Gems and all its operating mining locations in Colombia for emeralds, Mozambique for rubies, and Australia for sapphire through the process of RJC preparation. FURA has already registered its Australian location with RJC, and FURA will now look to expand the certification for the group and all its operating sites. With Mazar’s support, FURA will target to complete the certification process on or before December 31, 2023, for all its operating locations.

The certification with RJC is part of the ambitious ESG strategy deployed by FURA since its foundation in 2017. Earlier last year, FURA announced the partnership with Gübelin to provide traceability for all its stones through the Provenance Proof Blockchain. RJC Certification marks an additional important step towards achieving FURA’s ambitious ESG goals.

“This is a strong statement from our side, as we launch certification of all our mines producing emeralds, rubies and sapphires,” says Dev Shetty, Founder & CEO of FURA Gems. “The certification process will enable us to formalize our commitment since our foundation: to provide the jewellery market with traceable, sustainably sourced colour gemstones. To achieve this, we have identified Mazars as the ideal partner to conduct the process throughout our production sites and at the headquarters level. Mazars offers the ideal combination of regional expertise and global perspective, enabling us to conduct the project with the greatest level of competencies & professionalism.”

Franck Paucod, Partner at Mazars, explains, “We are thrilled to accompany FURA Gems through the demanding process of RJC COP Certification. Conducting the project for the three (3) mines simultaneously shows FURA’s commitment to responsible mining. We are confident that with our experiences in the gems and jewellery sector, we will be able to support FURA with its commitment to building the solid framework to achieve the RJC certification.”

ABOUT FURA GEMS

FURA Gems Inc. is a coloured gemstone mining and marketing company established in 2017. Headquartered in Dubai, United Arab Emirates, FURA has over 1,200 employees across continents. It is the first pioneering, creative and ethical enterprise to cover the entire spectrum of coloured gemstones. It operates three mining subsidiaries in Colombia, Mozambique, and Australia that mines emeralds, rubies, and sapphires. FURA also initiated its exploration program in Madagascar for sapphire mining. It is the fastest-growing coloured gemstone mining company to ensure the stability and traceability of ethically mined coloured gemstones from rough to retail.

ABOUT MAZARS

Mazars is an internationally integrated partnership, specialising in audit, accountancy, advisory, tax and legal services. Operating in over 90 countries and territories around the world, Mazars draws on the expertise of more than 44,000 professionals to assist clients of all sizes at every stage in their development.

Mazars Switzerland is specialised in the watch & jewellery industry. Mazars can either accompany clients throughout the RJC Code of Practice COP certification preparation and registration which is the case for FURA Gems or perform audits for the certification of companies in conformity of the RJC COP.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/80695a84-8e96-48d7-a21d-6548f0e035e7

FURTHER INFORMATION

Gianluca Maina, Marketing Director, FURA Gems, gianluca.maina@furagems.com

Franck Paucod, Partner, Mazars SA, franck.paucod@mazars.ch

GlobeNewswire Distribution ID 1000776648

January 11, 2023

US Flights Gradually Resuming After Computer Outage Grounds Planes

The U.S. Federal Aviation Administration said Wednesday normal air traffic operations are gradually resuming across the United States after a malfunction affected one of its computer systems, delaying 5,400 flights and cancelling another 900.

The FAA had earlier ordered airlines to pause all domestic departures for several hours due to an issue with its Notice to Air Missions System but now says the “ground stop has been lifted.” Military flights in the U.S. were not affected.

The White House initially said that there was no evidence of a cyberattack. But President Joe Biden said “we don’t know” the cause of the computer outage. He told reporters he’s directed the Department of Transportation to investigate the cause of the disruption.

Biden early Wednesday said he had just been briefed by Transportation Secretary Pete Buttigieg, who told him they still had not identified what went wrong.

“I just spoke to Buttigieg. They don’t know what the cause is. But I was on the phone with him about 10 minutes,” Biden said. “I told him to report directly to me when they find out. Air traffic can still land safely, just not take off right now.”

“We continue to look into the cause of the initial problem,” the FAA tweeted.

“I have been in touch with FAA this morning about an outage affecting a key system for providing safety information to pilots,” Buttigieg tweeted after the problem was first reported.

Before taking off, pilots are required to consult NOTAMs, or Notice to Air Missions, which list potential adverse impacts on flights, from runway construction to the potential for icing. The system once was telephone-based, with pilots calling dedicated flight service stations for the information but has now moved online.

Breakdowns in the NOTAM system appear to be rare.

“I don’t ever remember the NOTAM system going down like this. I’ve been flying 53 years,” John Cox, a former airline pilot and now an aviation-safety consultant, told The Associated Press.

According to FAA advisories, the NOTAM system first failed at 8:28 p.m. Eastern time on Tuesday, which prevented new or amended notices from being distributed to pilots. The FAA resorted to a telephone hotline to keep departures flying overnight, but as daytime traffic picked up it overwhelmed the telephone backup system.

Air Force spokeswoman Ann Stefanek said the U.S. military flights were not impacted because the military has its own NOTAMS system separate from the FAA system and the military’s system was not affected by the outage.

European flights into the U.S. appeared to be largely unaffected.

Geoff Freeman, president of the U.S. Travel Association, which represents all components of the travel industry, said in a statement, “Today’s FAA catastrophic system failure is a clear sign that America’s transportation network desperately needs significant upgrades.”

“Americans deserve an end-to-end travel experience that is seamless and secure,” he said. “And our nation’s economy depends on a best-in-class air travel system. We call on federal policymakers to modernize our vital air travel infrastructure to ensure our systems are able to meet demand safely and efficiently.”

Source: Voice of America

January 11, 2023

US Indicts Chinese Student in Democracy Case

A Chinese national who has been studying in Boston has been indicted by a U.S. federal grand jury for allegedly stalking and threatening another Chinese citizen for posting fliers that support democracy in China.

The U.S. Justice Department said Tuesday that 25-year-old Xiaolei Wu, a student at the Berklee College of Music in Boston, was indicted on one count of cyberstalking and one count of interstate transmissions of threatening communications. He was arrested in December on a single count of stalking.

The department says an individual posted a flier either on or near the Berklee campus in mid-October written with pro-democracy slogans “We Want Freedom” and “We Want Democracy.”

Wu allegedly harassed the individual through social media, even threatening to chop off the person’s hands if any more fliers were posted. He also allegedly told the target that he had informed security authorities in China about the fliers and that agents would visit the victim’s family. Prosecutors also say Wu discovered the victim’s email address and posted it online to trigger further harassment.

Wu faces up to five years in prison on each charge of cyberstalking and interstate transmissions of threatening communications, along with a fine of up to $250,000 for each charge. VOA’s Mandarin Service says the Berklee College of Music has temporarily canceled Wu’s student status.

According to VOA’s Mandarin Service, Wu’s alleged harassment efforts began shortly after an October incident in Beijing in which a man identified online as Peng Zaizhou hung a banner on the city’s Sitong Bridge opposing President Xi Jinping’s strict “zero-COVID” lockdown policy. His stance resonated with Chinese students overseas, who began putting up pro-democracy posters.

But the posters were often torn down by Chinese students loyal to Beijing and that some of the Chinese students were harassed to varying degrees. The Chinese Students’ and Scholars Association, which has close ties to Chinese embassies and consulates, has been blamed for the on-campus harassment.

A report by the Hoover Institution, a U.S.-based research center, accuses the CSSA of undermining the academic freedom of other Chinese students and scholars on U.S. campuses.

Source: Voice of America