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

Russia to Send Spacecraft to Space Station to Bring Home Crew

Russia said Wednesday that it will send an empty spacecraft to the International Space Station next month to bring home three astronauts whose planned return vehicle was damaged by a strike from a tiny meteorite.

The Russian space agency, Roscosmos, made the announcement after examining the flight worthiness of the Soyuz MS-22 crew capsule at the space station, which sprang a radiator coolant leak in December.

Roscosmos and NASA officials said at a joint press briefing that an uncrewed Soyuz spacecraft, MS-23, would be sent to the station February 20 to bring Russian cosmonauts Dmitry Petelin and Sergei Prokopyev and NASA astronaut Frank Rubio back to Earth.

“We’re not calling it a rescue Soyuz,” said Joel Montalbano, the space station program manager at NASA’s Johnson Space Center in Houston. “I’m calling it a replacement Soyuz.

“Right now, the crew is safe onboard the space station,” he added.

MS-22 flew Petelin, Prokopyev and Rubio to the space station in September. They were scheduled to return home in the same spacecraft in mid-March.

But MS-22 began leaking coolant on December 14 after being hit by what U.S. and Russian space officials said they believed was a micrometeorite.

“Everything does point to a micrometeorite,” Montalbano said.

Sergei Krikalev, executive director of human space flight programs at Roscosmos, said the “current theory is that this damage was caused by a small particle about 1 millimeter in diameter.”

Krikalev said the decision to use MS-23 to fly the crew home was made because of concern over high temperatures in MS-22 during reentry.

“The main problem to land the current Soyuz with crew would be thermal conditions because we lost heat rejection capability,” he said. “We may have a high temperature situation on Soyuz in the equipment compartment and in the crew compartment.”

Montalbano said discussions were also underway with SpaceX officials about potentially returning one or more crew members on the SpaceX Crew Dragon capsule currently docked with the space station.

Four astronauts were flown to the station by a SpaceX rocket in October for a mission expected to last about six months.

“We could safely secure the crew members in the area that the cargo normally returns on the Dragon,” Montalbano said.

“All that is only for an emergency, only if we have to evacuate ISS,” he stressed. “That’s not the nominal plan or anything like that.”

Krikalev said MS-22 would return to Earth after the two cosmonauts and the NASA astronaut leave on MS-23. It would bring back equipment and experiments that are not “temperature sensitive,” he said.

Soyuz MS-23 had been initially scheduled to fly Russian cosmonauts Oleg Kononenko and Nikolai Chub and NASA’s Loral O’Hara to the space station on March 16.

Space has remained a rare venue of cooperation between Moscow and Washington since the start of the Russian offensive in Ukraine and ensuing Western sanctions on Russia.

The space station was launched in 1998 at a time of increased U.S.-Russia cooperation following the Cold War space race.

Russia has been using the aging but reliable Soyuz capsules to ferry astronauts into space since the 1960s.

Source: Voice of America

Plan Advanced to Save Louisiana Wetlands

The race is on to save the ecologically crucial wetlands surrounding the final 160 kilometers of the Mississippi River, America’s most iconic waterway.

“We are losing our communities, our culture, our fisheries, and our first line of defense against the hurricanes that threaten us,” said Kim Reyher, executive director of the Coalition to Restore Coastal Louisiana.

Adjacent to New Orleans, Plaquemines Parish is disappearing at an alarming rate. In recent decades, nearly 700 square kilometers of land have been consumed by the Gulf of Mexico because of the devastating combination of sinking land and rising sea levels. The parish includes wetlands that are home to thousands of Louisianans and many species of wildlife deemed critical to the ecology — and economy — of the region.

In December, the U.S. Army Corps of Engineers signed off on the state’s ambitious $2.2 billion plan to divert sediment from the Mississippi River and, it is hoped, protect and restore the vanishing region, which contributes to Louisiana’s robust seafood and energy sectors.

“The most fortunate thing about the situation we find ourselves in,” Reyher told VOA, “is that we have the tools necessary to build more land by mimicking what the Mississippi River had done for millennia. We can make ourselves safer moving forward.”

That is what this plan hopes to do. But not everyone is convinced.

“They say this is a 50-year plan, but who of us is going to be around in 50 years?” asked Dean Blanchard, owner of Dean Blanchard Seafood in vulnerable Grand Isle, Louisiana, speaking with VOA. “They’ve been trying to build back land for decades and so far I haven’t seen them build enough for two of us to stand on. It just doesn’t work.”

Choking the muddy Mississippi

It wasn’t long ago in geological terms that what is now south Louisiana didn’t exist at all. The region is known as an alluvial delta, built over thousands of years as the country’s major rivers carried sediment from the Rocky Mountains in the west and deposited them into the Gulf of Mexico.

Over time, that process created land stretching from Gulf-facing Plaquemines Parish in the south to areas as far north as Baton Rouge, the state capital. New Orleans, a world-renowned hub of culture and tourism, also owes its existence to this sediment.

“But land down here sinks back into the Gulf unless it’s replenished with new sediment,” Reyher explained. “In the past, that replenishment would come from the seasonal overflowing of the muddy, sediment-rich Mississippi River. But, of course, no one wants to live in a place with annual flooding, so that’s why we built the levees.”

Those levees — barriers largely built in the 20th century on either bank of the river — have helped keep residents safe from river flooding.

But the levees also block the flow of new sediment, making the region more vulnerable to land loss due to erosion and rising sea levels. Ecologists project another 400 square kilometers of land could disappear by the end of the century.

But with the Army Corps’ approval of what is being called the Mid-Barataria Sediment Diversion, some believe there is hope.

“We have been studying this for a very long time,” said Chip Kline, board chairman of the Louisiana Coastal Protection and Restoration Authority, which will be responsible for executing the plan.

“The project will mimic the pre-levee natural land building processes of the Mississippi River and strategically reconnect the river to our sediment-starved estuaries,” he said. “It will establish a consistent sediment source to nourish the newly created land in a way that provides a more sustainable solution than other options such as mechanical dredging.”

Doubt and outrage

The architects of the Mid-Barataria Sediment Diversion believe this is the best available plan. They do, however, concede there will be consequences, particularly for the region’s fishermen, shrimpers and oyster harvesters.

“The water in which our oysters, shrimp and many of our fish thrive is salty,” local shrimper George Barisich told VOA. “So, when you divert all of this fresh Mississippi River water in there, it’s going to kill them. It’s going to destroy those fish populations for years and it’s going to destroy us fishermen.”

Even calling it fresh water, according to Barisich, is misleading.

“This isn’t the same water that traveled down the continent hundreds of years ago,” he said. “This now has pesticides and [feces] from every farm and household along the 2,000-mile (3,200-km) Mississippi River. It’s not going to build our wetlands; it’s going to destroy it.”

Although the project is backed by Louisiana Governor John Bel Edwards, not everyone in state government is enthusiastic.

“I want what’s best for the people of Louisiana,” Lieutenant Governor Billy Nungesser told VOA, “and this isn’t it. We’ve tried building land his way before and it doesn’t work. The land gets washed away in six months because the Mississippi River doesn’t carry the same amount of sediment it did thousands of — or even a hundred — years ago.”

Mitigating consequences

Reyher, from the Coalition to Restore Coastal Louisiana, said she’s sympathetic to the concerns fishermen in the region have.

“This is going to impact them, we understand that,” she said. “That’s why we are including $360 million in the plan to assist them and mitigate those consequences.”

She continued: “But, if we do nothing, we’re admitting defeat. We’re talking about whole communities and millions of people that would eventually need to be relocated.”

Lieutenant Governor Nungesser said he also hopes to avoid that outcome. But he also says solutions need to be focused on the short term as well.

“We don’t have to sacrifice people now for some plan that we won’t know doesn’t work until 50 years down the road,” he said. “I’ve been a policymaker here for years, and we know what works. We have seen that specifically building up ridges and islands and berms that protect us from storms — that can keep us safe. And it can do it while protecting the culture and communities around Louisiana’s last surviving sacred resource — our seafood.”

Proponents of the project say the Mid-Barataria Sediment Diversion is the most effective and cost-efficient tool they have — a key component of a 50-year, $50 billion suite of solutions to save south Louisiana.

“Nothing like this has ever been done in the region,” Donald Boesch, professor of marine science at the University of Maryland, told VOA. “This project is designed to capture and distribute sediment during the times of year it is most available. And we can do it in a way that minimizes the water that will kill our fisheries while maximizing the … sediment that will save and re-establish south Louisiana.”

Louisiana must decide by February whether to accept or appeal the Army Corps’ permit conditions. The plan could draw lawsuits from opponents.

Source: Voice of America

Angola aim CHAN quarterfinals

Luanda – Angola have set the quarter-finals as the goal to achieve in the 7th edition of the African Football Championship (CHAN), a competition reserved for players of domestic competitions, to be held from January 13 to February 4, in Algeria.

If compared to Angola’s history in the competition, the goal set this time by the national team is very modest, taking into account that they were runner-up in 2011 after 3-0 defeat to Tunisia in the final.

In their second appearance, in Rwanda in 2016, Angola was eliminated in the group stage after conceding defeats to Democratic Republic of Congo 2-4, and Cameroon (0-1), with just a win against Ethiopia 2-1.

In the competition, held in 2018, in the Kingdom of Morocco, Angola was eliminated in the quarter-finals by Nigeria, with a 1-2 defeat.

In their fourth appearance in the tournament, the national team will only play on the 16th, against Mali, in a group D match, in the city of Oran, and then against Mauritania.

The CHAN`2023 will have the participation of eighteen national teams. Besides Angola, Algeria (host country), Morocco, Libya, Senegal, Mauritania, Mali, Niger, Ghana, Côte d’Ivoire, Congo Brazzaville, Democratic Republic of Congo (DRC), Cameroon, Sudan, Ethiopia, Uganda, Madagascar and Mozambique.

Among the competing countries, Morocco and the DRC, with two titles each, are the leaders of the competition that started in 2009.

Morocco won in 2018 and 2020, while the DRC (2009 and 2016). They are followed with one trophy each by Tunisia (2011) and Libya (2014).

The top two teams from groups A, B and C, made up of four teams each qualify for the quarterfinals. Series D (Angola, Mali and Mauritania) and E (Cameroon, Congo Brazzaville), with three teams, will each qualify one team for the next round, making a total of eight.

Fixtures:

(Friday Group A): Algeria – Libya

(Saturday/Group A): Ethiopia – Mozambique

(Saturday/Group B): DRC-Uganda

(Saturday/Group B): Cote d’Ivoire-Senegal

(Sunday/Group C: Morocco-Sudan

(Sunday/Group C: Madagascar-Ghana

(Monday/Group D): Mali-Angola

(Monday /Group E: Cameroon-Congo Brazzaville

Source: Angola Press News Agency