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

Nkwanta South: ‘My First Day at School’ observed for new pupils

Nkwanta South (O/R), Jan 11, GNA – The Nkwanta South Municipal Assembly and the Education directorate on Tuesday welcomed all pupils and students in the Municipality on resumption of new academic year.

Mr Bright K. Lenwah, the Municipal Chief Executive (MCE)together with Mr Jonathan Kosinah, the Municipal Education Director visited some schools in the Municipality, which recorded a low turnout of students, while about 90 per cent of teachers were present and ready to teach.

Presenting some learning materials such as ‘my first copy books’, pencils, erasers, and slates to the beginners and the primary one pupil, Mr Lenwah MCE, urged them to study hard to become prominent people in society through education.

He also exhorted the teachers to give out their best by impacting the necessary knowledge they acquired on the pupils since the children are the reason they have been sent there.

Mr Jonathan Kosinah, the Municipal Education Director expressed his displeasure about the low attendance of the pupils but commended the teachers for their presence.

He urged all Headteachers and their teachers to up their games by educating parents on the need to bring their wards to school, especially those of school age but still at home.

He further called on parents and guidance to allow their wards to come to school because classes had started which they would not leave anyone behind.

They were accompanied by Mr Joseph Abugre, Municipal Coordinating Director, Mr Mawuena Damson, Administration and Finance officer of Ghana Education Service (GES), among others.

Source: Ghana News Agency

GES advises parent to monitor children’s school attendance

Koforidua – Mr. Emmanuel Asiedu-Acheampong, Eastern Regional Public Relations Officer of the Ghana Education Service (GES), has asked parents to participate in their children’s school attendance to reduce absenteeism and foster positive attitudes toward school.

He said parents should get more involved in their children’s education by monitoring their attendance, providing them with school supplies, and communicating with teachers about their academic progress.

Mr Asiedu-Acheampong, who stated this in an interview with the Ghana News Agency on the first day of the 2022/2023 academic year, noted that parent participation in child’s education increased their self-efficacy and self-esteem.

In a related event, Mr Isaac Appaw Gyasi, Municipal Chief Executive of New Juaben South, has visited some public schools and interacted with both kindergarten (KG) and class one pupils on their “first day at school.”

His visit was intended to welcome incoming fresh students on their first day of school and to emphasise the value of education in the development of life skills.

Adweso SDA Basic School, St. Dominic Primary A and B, Trinity Presbyterian Model School, Police M/A KG – Koforidua, and Nana Kwaku Boateng Basic ‘A’ School were among the schools visited by the MCE in company of GES officials.

Mr. Gyasi noted in all the schools that education played a critical role in the socioeconomic well-being of people and then advised children to learn hard, comply with school rules and regulations, and be courteous to become good future leaders.

Some schools had encouraging student attendance, while others had low turnout.

Madam Mary Agyekum, Headmistress of Nana Kwaku Boateng Basic ‘A’ School, which had a low attendance, expressed hope that students would return in large numbers in the coming days. 

There were six students in KG 1 and eight in Class 1. Some of the issues encountered during the field tour included inadequate classroom blocks and a drainage system, which the MCE pledged the assembly would support to remedy the situation.

The New Juaben South Municipal Assembly, on the other hand, has nearly finished the building of ultramodern KG blocks at Nana Kwaku Boateng Basic ‘A’ School and Trinity Presbyterian Model School.

Mr Mustapha Haruna, Education Director of New Juaben South Municipality, advised pupils to refrain from indiscipline as that could jeopardise their academic activities.

Source: Ghana News Agency

My First Day at School – Parents advised to prioritise children’s education

Basisan, (UWR) – Parents in the Basisan community of the Sissalla East Municipality, Upper West Region, have been advised to invest in their children’s education as a guarantee of their future security. 

Mr Amidu Chinnia Issahaku, the Deputy Minister of Water Resources and Sanitation, said they must take advantage of the Free Senior High School introduced by the Government to offer their children higher education. 

He said this during a tour of some schools in the community to mark “My First Day at School” for primary one and Kindergarten pupils, organised by the Ghana Education Service. 

He promised to drill a borehole for the Basisan Basic School where he taught some years ago. 

Mr Lewil Charles, the Sissalla East Municipal Director of Education, asked the children to stay in school and learn to become respected and responsible adults and urged the parents to continue to encourage their children to stay in school. 

At the Tumu United Basic School, 18 children were present for “My First Day at School” while at the KG One, 10 children were present. 

Madam Daina Kanton, the Assistant Headmistress, said the low turnout was as a result of the Christmas festivities and expressed the hope that more children would report before the first week ended.

At the Tumu College of Education Demonstration Basic School, 157 boys and 171 girls were present out of a total population of 465. 

At the Falahia Basic school 78 girls and 42 boys reported to school, totaling 120, out of 263 population. 

Source: Ghana News Agency

UPSA hosts Ministry of Education’s maiden Thanksgiving Service

The University of Professional Studies, Accra (UPSA) was the centre of attraction when the Management and staff of the Ministry of Education and its allied agencies came together on Tuesday to offer thanksgiving to God for a fruitful 2022 and pray for a better 2023.

The maiden thanksgiving service, spearheaded by the Minister of Education, Dr Yaw Osei-Adutwum, was also to seek God’s guidance for the year as the ministry embarks on its transformative drive.

The event, themed “Restructuring Education for National Transformation: Our Role,” was attended by the Vice-Chancellor of UPSA, Prof Abenego F. O. Amartey, the Pro-Vice-Chancellor, Prof John Kwaku Mensah Mawutor, and the Chairman of the Governing Council of UPSA, Dr Kofi Ohene-Konadu.

Dr. Osei-Adutwum stated that the Ministry of Education is on a new upward trajectory that will completely transform Ghana’s education sector.

He said the better days of Ghana’s education are still ahead and therefore urged workers of the ministry and its associated agencies to support the transformative agenda of the ministry, which he said will “help change the course of the history of education in Ghana.”

He said to achieve this, public servants must move from an attitude of “it cannot work” to a more positive posture of “how can we make it work?”

“As a ministry, let’s take impossibility out of our vocabulary and strive to be innovative in our approach to education,” he said. “Few years ago, we were told free SHS was not feasible, but today it is working, so let’s all commit to this new journey and support the MOE.”

Chairman of the Church of Pentecost, Apostle Eric Nyamekye urged Ghanaians to cultivate a grateful attitude by counting and naming their blessings, no matter how insignificant they may appear.

He stated that most people often wish they were better off than they are and thus lose sight of the need to be grateful for the small blessings they have received from God.

However, the revered man of God believes that it is in expressing gratitude for the little things that God will open bigger opportunities in people’s lives.

“In life, when you don’t appreciate the little things, you don’t receive the bigger breakthroughs you are looking for,” Apostle Nyamekye said. “Our God is a God of gratitude and will give more to those who show their gratitude, no matter their circumstance.”

He advised Christians and Ghanaians, for that matter, to embrace what he described as the “seven pillars of wisdom” in order to be prosperous in the years ahead.

“These pillars are prudence, knowledge, discretion, counsel, sound judgement, insight, and power,” he said. “Apply them to your lives as workers in the Ministry of Education, and there will be no turning back for you.”

Participating institutions for the maiden edition of the thanksgiving service of the Ministry of Education included the Ghana Education Service (GES), the National Service Secretariat (NSS), Ghana Education Trust Fund (GETFund), the Council for Technical and Vocational Education Training (COTVET), the National Council for Curriculum and Assessment (NaCCA), and UPSA.

Source: University of Professional Studies

Court remands two persons over theft

Accra – An Accra Circuit Court has remanded two persons into Police custody for stealing and abetment of crime.

The accused persons are: Anthony Abeiku, a 22-year-old fuel attendant, and Mahuya Ibrahim, a 65-year-old scrap dealer.

An accomplice in the case, one Ahmed, is currently on the run and has also been charged with three counts of stealing and abetment of crime.

They all pleaded not guilty.

The case has been adjourned to January 16, 2023.

Earlier, the defence counsel prayed to the court for bail.

Prosecuting, Police Chief Inspector Samuel Ahiabor opposed to the grant of bail for the accused persons.

The prosecution argued that, Abeiku was an ex-convict, who, allegedly had been involved in series of criminal cases and also,  would be a flight risk, when granted bail.

He prayed that, the accused persons be remanded into Police Custody to assist Police to conclude investigations.

The trial judge, Mrs Kizita Naa Quashie, upheld the prosecution’s prayer.

The prosecution said, the complainant Parry Kwadwo Adade was a banker,  who lived at Sakumono Estate whilst all the accused persons lived at Ashaiman.

It said on June 7, 2022, Mr Adade returned from work and noticed that someone had broken into his room.

The prosecution said Mr Adade also realised that his items, including one 55 inches Samsung TV, worth GHC 5,000.00, a 40 inches TV worth GHC 3,500.00, a Dell Laptop worth GHC 5,000.00, a Tablet valued at GHC 2,000.00 and three wrist watches with GHC 3,000.00 had been stolen.

It said, Mr Adade reported to the Police at the Sakumono District branch and investigation was conducted into the matter with messages sent across in search of the suspects.

The prosecution said, on December 24, 2022, Abeiku, who had finished his prison term at Nsawam Prison, was arrested for partaking in series of robbery and stealing cases with Ahmed within Accra, Ashaiman, and Tema and its environs.

It said the accused admitted his offence and also disclosed that Ahmed had been involved in many criminal cases and had been held in other Police stations after his return from Nsawam Prison some months ago.

The prosecution said Ibrahim admitted that, he had been a regular buyer from Abeiku and Ahmed’s stolen goods after “operation”.

It said the case was still under investigation as the accused persons were assisting the Police to trace their accomplices, check other places they had operated, victims and the whereabouts of the stolen items.  

Source: Ghana News Agency