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
[email protected]

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
[email protected]

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
[email protected]

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, [email protected]

Franck Paucod, Partner, Mazars SA, [email protected]

GlobeNewswire Distribution ID 1000776648

January 11, 2023

Llandudno beach reopened, Hout Bay beach and Dalebrook to Kalk Bay updates: 11 January 2023

Llandudno beach has reopened while, as a precautionary measure, the Dalebrook tidal pool and Hout Bay beach were closed on Tuesday, 10 January. Read more below:

Thank you to beach-goers for their cooperation when sewage-related matters temporarily affect public access to our beaches.

Llandudno beach reopened

Water samples taken for water quality testing indicated the levels are within the minimum requirement for recreational activities as determined by the National Water Quality Guidelines.

Health warning signage has been removed.

Hout Bay beach closed until further notice

The City is investigating (a) possible pollution source(s) that has led to the temporary closure of Hout Bay beach, as a precautionary measure.

Various City departments have been activated to respond to this incident.

City Health will be taking water samples on a daily basis for water quality testing until such time as the levels are within the minimum requirement for recreational activities as determined by the National Water Quality Guidelines.

Health warning signage is in place, advising the public accordingly.

Dalebrook tidal pool has been temporarily closed again. The beach section between the tidal pools, from Dalebrook to Kalk Bay, remains closed until further notice.

The temporary closure is due to a sewer overflow, and the cause is still under investigation.

City Health has been taking water samples on a daily basis for water quality testing and will continue to do so until such time as the levels are within the minimum requirement for recreational activities as determined by the National Water Quality Guidelines.

Health warning signage remains in place at the beach section and will be placed at Dalebrook tidal pool, advising the public accordingly.

Please note:

The public is advised to avoid contact with the water as indicated above until further notice.

This is a precaution as contact with the water could result in potential gastro-intestinal issues and therefore any person who enters the water does so at their own risk.

The City apologises for any inconvenience and thanks the public for its cooperation during this time.

Source: City Of Cape Town

January 11, 2023

Metro cops make arrests, recover stolen Gift of the Givers property in partnership with SAPS

City of Cape Town Metro Police Specialised teams have made three arrests and recovered some of the property stolen from a Gift of the Givers warehouse over the weekend. Relief packs for fire victims were among the stolen items. In total, 10 suspects have been arrested as part of a multi-agency operation with the South African Police Services (SAPS).

Following up on a tip-off on Monday, metro police were able to nab three suspects, who were handed over at Philippi SAPS along with the recovered goods.

‘Metro Police officers played a role in the multi-agency joint operation together with SAPS and other roleplayers which led to 10 arrests in total, three of which were made by our officers. Information was gained of the stolen Gift of the Givers property being stored at four different warehouses in Hanover Park. Arrests were made for “possession of stolen goods”. Further investigation by SAPS will be needed to ensure all those responsible face the full might of the law. Crime scenes need to be properly processed, including forensic and fingerprint samples, and detective resources will be needed to process results and bring all those involved to book,’ said Alderman JP Smith, Mayoral Committee member for Safety and Security.

‘We salute the commendable work of our metro police officers and partner law enforcement agencies including SAPS. The successful arrests and recovery of goods stolen from Gift of the Givers shows what is possible when all authorities join forces to fight crime. We can do even more to help SAPS fight crime if more policing powers are devolved to our well-trained municipal officers. We continue to call on President Cyril Ramaphosa and the Ministers of Police and Justice to devolve powers, particularly for criminal investigation, so that we can produce prosecution-ready case dockets to gain convictions. For too long, our country has struggled with diminishing SAPS resources, with criminals emboldened by investigations and prosecutions that end up going nowhere. The City is ready to help SAPS immediately if more powers are devolved,’ said Mayor Geordin Hill-Lewis.

‘The City has already made a substantial investment in expanding our boots on the ground through Metro Police, Law Enforcement and specialised units, including the Law Enforcement Advancement Programme together with the Western Cape Government. But that alone will not achieve the impact needed in communities living in daily fear of crime. For that reason, our focus over the next four years will be on information management and expanding our role in investigations through our units – the Strategic Information Management System (SIMS) and the Safety and Security Investigations Unit (SSIU). This will occur alongside major investments in cutting-edge camera-based safety technologies for data-led policing operations,’ said Alderman Smith.

Source: City Of Cape Town

January 11, 2023

High Court grants final eviction order for Baxter Street unlawful occupation

The Western Cape High Court recently granted a final eviction order in the City of Cape Town’s bid to evict the unlawful occupiers at Baxter Street, Durbanville. The order includes a standing interdict against any further unlawful occupation at Baxter Street and the further city-owned public spaces identified in the order. Following service of the final order by the Sheriff of the court, ongoing offers of social assistance and dignified transitional shelter were made by the City’s Social Development and Early Childhood Development Department (SDECD), including on the date of the eviction. On Tuesday this week, the Sheriff of the court attended on the eviction of the remaining unlawful occupiers who refused offers of social support. Read more below:

The final eviction order follows efforts over time by the City’s SDECD officials to offer social assistance to those persons unlawfully occupying the public space at Baxter Street, including access to dignified transitional shelter at NGO-run night shelters and City-run Safe Spaces.

These facilities offer social programmes to assist people off the streets sustainably, reintegrate them into society, and reunite them with family. Personal development planning and employment opportunities are made available, as are referrals for mental health, medical, and substance abuse treatment.

On the date of the eviction, several more unlawful occupiers accepted offers of dignified transitional shelter, and the City was further able to reunite several people with their families. The unlawful occupants who were ultimately required to vacate the premises had refused all offers of social assistance over time.

Safe Spaces and night shelters remain open on an ongoing basis to help people off the streets.

Accepting sustainable solutions off the streets is the best choice for dignity, health, and well-being.

Our city’s public places serve important social, community and economic purposes, and must be open and available to all to be used within the confines of the law.

City expanding Safe Space dignified transitional shelter

The City intends expanding the availability of and access to dignified transitional shelters in Cape Town and its accompanying social programmes, to reintegrate affected persons into society.

In addition to supporting NGO-run shelters, the City will spend R142 million over the next three years to expand and operate City-run Safe Spaces beyond the CBD and Bellville.

In Durbanville, consideration is being given for a new Safe Space in the area, among these locations being at the new Public Transport Interchange Development.

The City’s Safe Space model includes:

• dignified shelter,

• comfort and ablutions,

• two meals per day,

• access to a social worker on-site,

• personal development planning,

• various social services including ID Book and social grant assistance,

• family reunification services

• access to substance and alcohol abuse treatment,

• skills training,

• employment opportunities, and

• access to Expanded Public Works Programme opportunities

Source: City Of Cape Town