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 FcƳRIIB, 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 FcƳRIIB 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

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

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

World Bank Warns Global Economy Could Easily Tip Into Recession in 2023

The World Bank slashed its 2023 growth forecasts on Tuesday to levels teetering on the brink of recession for many countries as the impact of central bank rate hikes intensifies, Russia's war in Ukraine continues, and the world's major economic engines sputter.

The development lender said it now expected global GDP growth of 1.7% in 2023 — the slowest pace outside the 2009 and 2020 recessions in nearly three decades. In its previous Global Economic Prospects report, in June 2022, the bank had forecast 2023 global growth at 3.0%

The bank said major slowdowns in advanced economies, including sharp cuts to its forecast to 0.5% for both the United States and the euro zone, could foreshadow a new global recession less than three years after the last one.

"Given fragile economic conditions, any new adverse development — such as higher-than-expected inflation, abrupt rises in interest rates to contain it, a resurgence of the COVID-19 pandemic or escalating geopolitical tensions — could push the global economy into recession," the bank said in a statement accompanying the report.

The bleak outlook will be especially hard on emerging market and developing economies, the World Bank said, as they struggle with heavy debt burdens, weak currencies and income growth, and slowing business investment that is now forecast at a 3.5% annual growth rate over the next two years — less than half the pace of the past two decades.

"Weakness in growth and business investment will compound the already devastating reversals in education, health, poverty and infrastructure and the increasing demands from climate change," World Bank President David Malpass said in a statement.

China's growth in 2022 slumped to 2.7%, its second slowest pace since the mid-1970s after 2020, as zero-COVID restrictions, property market turmoil and drought hit consumption, production and investment, the World Bank report said. It predicted a rebound to 4.3% for 2023, but that is 0.9 percentage-point below the June forecast due to the severity of COVID disruptions and weakening external demand.

The World Bank noted that some inflationary pressures started to abate as 2022 drew to a close, with lower energy and commodity prices, but warned that risks of new supply disruptions were high, and elevated core inflation may persist. This could cause central banks to respond by raising policy rates by more than currently expected, worsening the global slowdown, it added.

The bank called for increased support from the international community to help low-income countries deal with food and energy shocks, people displaced by conflicts, and a growing risk of debt crises. It said new concessional financing and grants are needed along with the leveraging of private capital and domestic resources to help boost investment in climate adaptation, human capital and health, the report said.

The report comes as the World Bank's board this week is expected to consider a new "evolution road map" for the institution to vastly expand its lending capacity to address climate change and other global crises. The plan will guide negotiations with shareholders, led by the United States, for the biggest revamp in the bank's business model since its creation at the end of World War II.

World Vision Zimbabwe Impact Report 2022

Keeping Our Promise

Financial year 2022 marks the second year of the World Vision Zimbabwe FY 21-25 Strategy Cycle. This Strategy is based on our Global partnership strategy, 'Our Promise', which represents a bold commitment to the most vulnerable girls and boys to transform their lives and bring hope as well as realising the Sustainable Development Goals. In light of the ever-changing context, WVZ has remained agile, innovative and adaptive to ensure that our strategy remains relevant in addressing threats to children. This year, the office celebrates God's faithfulness with many key achievements, including:

Deepening our commitment to the most vulnerable children, WV Zimbabwe in financial year 2022 reached a total of 948,301 children through its programming.

Focusing our ministry for greater results by being impact driven, in financial year 22 WV Zimbabwe facilitated distribution of 728,827 Long-Lasting Insecticidal Nets (LLINs) through the Global fund Malaria grant, reaching 263,734 households translating to 1,178,039 individuals. This has seen a 71.8% increase in access to LLINs for the target population from 22% in 2020 to 93.8% in 2022, thereby ensuring that 607,609 adults and 570,430 children are protected from the risk of malaria infections and death.

**Collaborating and advocating for broader impact, WVZ worked with the parliamentary portfolio committees on: education; health; women affairs gender and community development throughout the year with a primary goal to lobby accelerated enactment of the Marriage Law which came into effect in June, 2022. One hundred and forty-one (141) child leaders participated in the local and national policy dialogues on the existing gaps to criminalise and abolish child marriage.

Living out our Christian faith and calling with boldness and humility, the office-built integrity as a strong Christian partner, capable of stimulating a diverse mix of faith actors in support of collective action for children. In FY 22, WV Zimbabwe in partnership with AWANA and Scripture Union equipped a total of 15,142 parents and care givers with positive parenting skills this was an increase from the 14,772 parents reached in FY21.

As an organisation, we have committed to changing ourselves and finding new ways to work together through our mind sets and behaviours to realise the God-given potential among us. The FY22 Our Voice survey results provide very encouraging signs of progress made by WV Zimbabwe. Staff indicated that they receive appropriate recognition for doing good work (73%), which is a 5% increase from FY21. Furthermore, staff pointed out that they have the authority to make decisions that improve the quality of their work (75%), a 3 % increase from FY21. These scores are evidence of a significant step forward in changing our culture to realise Our Promise.

World Vision Zimbabwe is grateful to partners and supporters who have made it possible to make significant progress in improving the well-being of children especially the most vulnerable within their families and communitie

Source: World Vision