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

Security situation in Sahel has worsened: UN envoy

UNITED NATIONS— The security situation has deteriorated in large parts of West Africa and the Sahel despite efforts by national security forces and international partners, said a UN envoy.

In the past six months, more than 10,000 schools across the Sahel had to close, leaving millions of children unable to acquire the necessary skills to build their lives and their countries, said Giovanie Biha, the UN secretary-general’s deputy special representative and officer-in-charge of the UN Office for West Africa and the Sahel (UNOWAS).

Furthermore, nearly 7,000 health centers were forced to shut down due to the activities of armed groups, violent extremists and criminal networks, she told the Security Council in a briefing.

“These non-state armed groups are fighting among themselves for supremacy and control of resources, pushing states to the margin and causing untold misery to millions of people who had to leave their communities to seek safety,” she said. “Indeed, the central Sahel continues to face multidimensional challenges, unprecedented levels of security and humanitarian challenges, socio-political instability, further compounded by the impact of climate change, and food insecurity, which was exacerbated by the conflict in Ukraine.”

Against this backdrop, UNOWAS supports the Independent High-Level Panel on Security and Development in the Sahel led by former Nigerien President Mahamadou Issoufou, to find more innovative solutions and generate national, regional, and international commitment for change in the Sahel, said Biha.

A holistic approach is necessary and the establishment of the initiative’s joint force is an important development in this regard, she said.

Despite the many challenges facing the countries of the region, especially the Sahel, the region remains a land of immense opportunities. The UN Integrated Strategy for the Sahel has leveraged these opportunities through its three pillars of building resilience, promoting good governance, and strengthening peace and security, said Biha.

“In accordance with our mandate, we will continue to work together with our regional and international partners for the consolidation of peace, security and democracy in West Africa and the Sahel.”

Source: NAM NEWS NETWORK

January 11, 2023

Tigray Forces Start Handing Over Heavy Weapons as Part of Peace Deal

Ethiopia’s military says Tigrayan forces have started handing over heavy weapons as part of the peace deal to end the two-year civil war.

Ethiopia’s federal defense force in a statement Wednesday confirmed Tigray forces have started handing over heavy weapons— the latest progress in line with a November peace deal.

The statement said the “first round” of weapons were transported on Tuesday in Agula camp, 36 kilometers from Tigray’s capital, Mekelle.

Ethiopian Army Commander Lieutenant Colonel Aleme Tadele said the arms transfer included tanks, rockets, and mortars.

The statement said observers from the African Union and various countries’ militaries were present to verify the transfer from the Tigray People’s Liberation Army.

The confirmation came after TPLF spokesman Getachew Reda early Wednesday tweeted news of the handover.

He said they “hope and expect this will go a long way in expediting the full implementation of the agreement.”

The AU-brokered peace deal, signed in South Africa, saw the two sides agree the TPLF would disarm in return for restoration of aid and services to Tigray and the withdrawal of foreign forces.

The deal came after two years of devastating war that saw Tigray largely cut off from the rest of the world, hundreds of thousands of people killed, and millions displaced.

The two sides have met a few times in Kenya’s capital, Nairobi, to discuss implementing the deal.

Since December, Ethiopia has allowed humanitarian aid to enter Tigray and restored power, water, banking, and telecommunications to the region.

Witnesses say in late December Eritrean troops who fought on the side of federal forces withdrew from two cities in Tigray.

However, the TPLF accuses Eritrean troops of committing atrocities during the conflict and says they are still active in some areas of Tigray.

Rights groups say all sides in the conflict are guilty of rapes, torture, and extra-judicial killings that could amount to war crimes, and cite evidence of ethnic cleansing against Tigrayans.

While the rapid progress on implementing the peace deal has been welcomed internationally, it’s not yet clear what action, if any, will be taken to see justice for the victims.

Source: Voice of America

January 11, 2023

1 child or youth died every 4.4 seconds in 2021: UN

UNITED NATIONS— An estimated 5 million children died before their fifth birthday and another 2.1 million children and youth aged between 5 and 24 years lost their lives in 2021, according to the latest estimates released by the UN Inter-agency Group for Child Mortality Estimation.

In a separate report also released on Tuesday, the group found that 1.9 million babies were stillborn during the same period.

“Every day, far too many parents are facing the trauma of losing their children, sometimes even before their first breath,” said Vidhya Ganesh, UN Children’s Fund director of the Division of Data Analytics, Planning and Monitoring, in a press release. “Such widespread, preventable tragedy should never be accepted as inevitable. Progress is possible with stronger political will and targeted investment in equitable access to primary health care for every woman and child.”

The reports show some positive outcomes with a lower risk of death across all ages globally since 2000. The global under-5 mortality rate fell by half since the start of the century, while mortality rates in older children and youth dropped by 36 percent, and the stillbirth rate decreased by 35 percent. This can be attributed to more investments in strengthening primary health systems to benefit women, children and young people.

However, gains have reduced significantly since 2010, and 54 countries will fall short of meeting the Sustainable Development Goals target for under-5 mortality. Unless swift action is taken to improve health services, almost 59 million children and youth will die before 2030, and nearly 16 million babies will be lost to stillbirth, warn the agencies.

Children continue to face wildly differentiating chances of survival based on where they are born, with sub-Saharan Africa and Southern Asia shouldering the heaviest burden, the reports show.

Though sub-Saharan Africa had just 29 percent of global live births, the region accounted for 56 percent of all under-5 deaths in 2021, and Southern Asia for 26 percent of the total. Children born in sub-Saharan Africa are subject to the highest risk of childhood death in the world — 15 times higher than the risk for children in Europe and Northern America.

Mothers in these two regions also endure the painful loss of babies to stillbirth at an exceptional rate, with 77 percent of all stillbirths in 2021 occurring in sub-Saharan Africa and South Asia. Nearly half of all stillbirths happened in sub-Saharan Africa. The risk of a woman having a stillborn baby in sub-Saharan Africa is seven times more likely than in Europe and North America, the reports show.

Access to and availability of quality health care continues to be a matter of life or death for children globally. Most child deaths occur in the first five years, of which half are within the very first month of life. For those youngest babies, premature birth and complications during labor are the leading causes of death. Similarly, more than 40 percent of stillbirths occur during labor, most of which are preventable when women have access to quality care throughout pregnancy and birth. For children that survive past their first 28 days, infectious diseases like pneumonia, diarrhea and malaria pose the biggest threat, according to the reports.

While COVID-19 has not directly increased childhood mortality, with children facing a lower likelihood of dying from the disease than adults, the pandemic may have increased future risks to their survival. In particular, the reports highlight concerns around disruptions to vaccination campaigns, nutrition services, and access to primary health care, which could jeopardize their health and well-being for many years to come. In addition, the pandemic has fuelled the largest continued backslide in vaccinations in three decades, putting the most vulnerable newborns and children at greater risk of dying from preventable diseases.

Source: NAM NEWS NETWORK