Zenas BioPharma Announces Publication of Phase 2 Study of Obexelimab, an Investigational Treatment for IgG4-Related Disease (IgG4-RD), in The Lancet Rheumatology

Study found obexelimab produced rapid, strong, and sustained clinical improvement, including complete clinical remission, in most patients with active IgG4-RD

Results support the continued development of obexelimab for the treatment of IgG4-RD and potentially other B cell-mediated autoimmune conditions

WALTHAM, Mass., Aug. 01, 2023 (GLOBE NEWSWIRE) — Zenas BioPharma, a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immune-based therapies, announces The Lancet Rheumatology has published findings from a Phase 2 study evaluating obexelimab for the treatment of patients with IgG4-Related Disease (IgG4-RD). Based on the results of this study, a Phase 3 study in patients with IgG4-RD is ongoing to further investigate the efficacy and safety of obexelimab administered as a subcutaneous injection.

IgG4-RD is a chronic, immune-mediated fibro-inflammatory disease that can affect multiple organs including the major salivary glands, orbits, lacrimal glands, pancreas, biliary tree, lungs, kidneys, and retroperitoneum. Approximately 20,000 patients are diagnosed with IgG4-RD in the United States alone. Despite its increasing recognition, there remains a need for further research and effective therapeutic options for individuals living with this debilitating disease.

Across the world, the use of glucocorticoids is widely considered to be the standard of care for treating IgG4-RD. There are no approved treatment options for this condition. While commonly used, glucocorticoids and available B cell depleting therapies rarely lead to long-term, treatment-free remissions, and are associated with a high risk of toxicity in these patients. Such therapies also impair vaccine responses, including those for SARS-CoV-2 and influenza.

In a prospective, open-label, single arm, single-center pilot study to assess the efficacy and safety of obexelimab in the treatment of patients with IgG4-RD (clinicaltrials.gov registration NCT02725476), obexelimab demonstrated strong improvement in the IgG4-RD Responder Index, a measure of disease activity, by inhibiting B cell function, without depleting B cells.

The published manuscript, titled “Obexelimab for the Treatment of Patients with IgG4-Related Disease: An Open-Label, Single-Arm, Pilot Study to Evaluate Efficacy, Safety, and Mechanism of Action,” is available online and will appear in the August issue of The Lancet Rheumatology 2023;5(8) [E428-E429].

The following are the key findings in the paper:

  • Obexelimab produced rapid, strong, and sustained clinical improvement, including complete remission (IgG4-RD Responder Index score of 0), in most patients with active IgG4-RD.
  • During obexelimab treatment, reductions in circulating B cells, including plasmablasts, were observed without evidence of cell death.
  • Additionally, reduction of circulating B cells and rapid return to near normal levels after treatment discontinuation suggests that obexelimab may lead to B cell sequestration in lymphoid organs or the bone marrow.
  • Obexelimab was well tolerated. The majority of treatment-related adverse events were grades 1 or 2, with the most common adverse events being gastrointestinal infusion-related events, most of which were mild.

“Our findings are a significant step forward in understanding the underlying mechanisms of IgG4-Related Disease; paving the way for more targeted treatment strategies,” said John Stone, MD, MPH, Professor of Medicine at Harvard Medical School, and the Edward A. Fox Chair in Medicine at Mass General Hospital. “Our team is honored to have our research recognized by The Lancet Rheumatology, and we are immensely grateful to the patients who participated in this groundbreaking study.”

About Obexelimab

Obexelimab is an investigational Phase 3-stage, bifunctional, non-cytolytic, humanized monoclonal antibody that mimics the action of antigen-antibody complexes by binding CD19 and FcγRIIb to inhibit B-lineage cell activity. In several early-stage clinical studies in various autoimmune diseases, 198 subjects were treated with obexelimab. In these clinical studies, obexelimab demonstrated effective inhibition of B cell function without depleting the cells, resulting in encouraging treatment effect in patients with various autoimmune diseases. Zenas acquired exclusive worldwide rights to obexelimab from Xencor, Inc.

More information on the Phase 3 (INDIGO) study for the treatment of IgG4 Related Disease is available at clinicaltrials.gov: NCT05662241.

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 facing 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 8884766

Conagen and Sumitomo Chemical jointly develop a new era of renewable carbon materials

Bedford, Mass., Aug. 01, 2023 (GLOBE NEWSWIRE) — Conagen, the bioplatform innovator and biomanufacturer, and Sumitomo Chemical, Japan’s leading chemical company, have announced to jointly develop p-hydroxystyrene (HS) and its polymer, poly p-hydroxystyrene (PHS), using a combination of biosynthesis, chemosynthesis, and polymerization. The monomer and the polymer are 100% renewable carbon, marking a new era of sustainable production.

Developing PHS using a combination of biosynthesis, chemosynthesis, and polymerization represents a significant breakthrough in sustainable material production. Efforts to reduce reliance on petroleum and transition towards renewable and sustainable alternatives have gained momentum in recent years. With renewable biomass as the starting material, this joint devolvement between Conagen and Sumitomo Chemical creates an environmentally friendly and cost-effective product. The partnership is in the lead position of active global initiatives to reduce petroleum-based products’ consumption and environmental impact.

This partnership represents a significant milestone in developing sustainable materials, and this approach to PHS production is expected to reduce the carbon footprint associated with traditional chemical synthesis methods. It is a crucial step towards more sustainable manufacturing processes with a positive impact.

The Conagen-Sumitomo partnership leverages Conagen’s expertise in microbial strain design and development with Sumitomo Chemical’s proficiency in chemical production and commercialization. The collaboration aims to create a platform that enables the production of sustainable chemicals to replace petrochemicals in an extended range of many applications.

PHS is used to produce polymers, resins, and other chemicals. The monomer HS can also be used as an input for the synthesis of other substances, such as pharmaceuticals and fragrances. The applications of HS and PHS are limitless and can span uses from electronics to personal care and other consumer products.

“This partnership represents a significant step forward in pursuing green chemicals for sustainable material production,” said J. McNamara, Ph.D., V.P. of chemical applications at Conagen. “Our commitment is a testament to the power of collaboration and the potential of combining our technologies with synthetic and polymer chemistries to create innovative, sustainable solutions that can significantly reduce petroleum-based products in the environment,” McNamara stated. “Together, we’re marking a new era of carbon-neutral material production efforts.”

The monomer HS, with the chemical formula C8H8O, is a derivative of styrene in which a hydroxyl group (-OH) is attached to the aromatic ring’s para position (carbon atom 4). The HS and PHS are examples of green chemistry for minimizing waste, reducing hazardous chemicals, and using catalysts that can be easily separated and reused. This joint development project promises to potentially pave the way for developing novel renewable and sustainable materials. “Similar technology can be used to produce other key chemical ingredients by fermentation at industrial scale, such as cinnamic acid, monohydroxy-benzoic acid, and dihydroxy-benzoic acid,” said McNamara.

About Conagen

Conagen is making the impossible possible. It is a product-focused, synthetic biology R&D company with large-scale manufacturing service capabilities. Its proprietary strain development, fermentation, and scale-up technologies enhance our partners’ sales, production, and profitability across a broad spectrum of current and developing markets in food, beverage, nutrition, flavor and fragrance, pharmaceutical, and renewable materials.

About Sumitomo Chemical

Sumitomo Chemical is Japan’s leading chemical company, with a global presence in the chemicals, petrochemicals, and plastics industries. The company is committed to sustainability and has a product portfolio contributing to the United Nations Sustainable Development Goals.Top of Form

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Ana Capretz, Head of Public Relations and Communications
Conagen
+1-781-271-1588
[email protected]

GlobeNewswire Distribution ID 8884420

Rhino killings decrease by 11%

In the first six months of this year, 231 rhinos were killed in South Africa, representing an 11% decrease when compared to the same period last year.

This represents a decline of 28 animals killed for their horn.

Addressing a media briefing on Tuesday, Minister of Forestry, Fisheries and the Environment, Barbara Creecy, said during this period poaching trends also continued to show a move away from the Kruger National Park to provincial and private reserves.

“Forty-two rhinos were poached in the Kruger National Park and 143 in KwaZulu-Natal province from January to June 2023. Forty-six of the rhinos killed were in privately-owned nature reserves and 143 in provincially-owned reserves,” the Minister said in Pretoria.

Due to the demand for rhino horn remaining a constant threat to rhino populations, collaboration between the law enforcement agencies supported by private security remained key.

An important development in strengthening the collaboration between law enforcement to effectively address the organised nature of rhino poaching and wildlife trafficking is Cabinet’s approval National Integrated Strategy to Combat Wildlife Trafficking (NISCWT) in May this year.

“This strategy aims to break the illicit value chain of wildlife trafficking in South Africa and beyond its borders. It represents a commitment by government to direct law enforcement ability and effort and mobilise society support to address the threat wildlife tracking poses to national security and the country’s rich biodiversity.

“Although currently our main focus is rhino, the strategy also aims to address the illegal trade in, and poaching of, other species that are threatened by trafficking syndicates, like abalone,” Creecy said.

Joint initiatives pay dividends

In the first six months of this year efforts by both the South African Police Service (SAPS) and the National Prosecuting Authority (NPA) have led to the conviction of 31 offenders.

The majority of sentences were custodial. In Skukuza, one suspect found guilty of killing three rhino and possession of unlawful arms and ammunition was sentenced to an effective 32 year imprisonment.

In another matter, three accused, found driving in Kruger National Park with five rhino horns hidden in the vehicle, a hunting rifle with a silencer, ammunition and knives, were convicted for the killing of three rhinos in the park, possession of unlawful firearms and ammunition, possession of dangerous weapons and trespassing.

Accused one and two were sentenced to 34 years imprisonment, while accused 3 was sentenced to 39 years imprisonment.

In Limpopo, an accused individual was sentenced on a charge of murder, killing of two rhinos, unlicenced firearm and ammunition to an effective sentence of 24 years imprisonment.

In the Eastern Cape, six accused were convicted on charges of conspiracy to commit rhino poaching, notably no rhinos were killed, and the possession of unlicenced firearm and ammunition and effectively sentenced to imprisonment ranging from 16 to 20 years.

“The role of rangers in supporting the prosecution and sentencing of those arrested for wildlife crimes committed in the Kruger cannot be underestimated.

“There is strong collaboration between the SAPS forensic teams and South African National Parks (SANParks) Environmental and Corporate Investigations (ECI) when attending crime scenes to ensure the collection of vital evidence to link suspects to the crime scenes. It is also done to ensure minimum contamination of the crime scene.

“During the meeting held earlier this year with the Director of Public Prosecutions’ Environmental Working Group we discussed the challenge relating to the opposing of bail due to the fact that rhino poaching is not listed as a scheduled offence.

“Research is being conducted to propose, if viable, legislative amendments to address this challenge,” the Minister said.

Creecy said it was unfortunate that rhino poachers have continued to target the Hluhluwe/iMfolozi game reserve in KwaZulu-Natal where Ezemvelo KZN Wildlife, supported by the Department of Forestry, Fisheries and the Environment and iSimangaliso Wetland Park, continue to implement a number of measures to combat rhino poaching.

Among these has been the establishment of a Tactical Operations Joint Control Centre which now facilitates the SAPS deployments to Hluhluwe/iMfolozi Park (HiP).

The department has made available R40 million for the repair and replacement of the boundary fence around the Hluhluwe/iMfolozi game reserve, which is regularly breached and through which wild animals can escape to nearby communities.

The National Prosecuting Authority has designated a prosecutor to facilitate rhino cases in KwaZulu-Natal and cases have been prioritised and identified to be expedited through the court processes.

Criminal syndicates

In response to a range of studies that point out collusion between ranger services and criminal syndicates, the Kruger National Park has developed a holistic Ranger Services – Integrity Management Plan.

“This plan aims to improve ranger morale and resilience to corruption by providing services that enhance ranger health and well-being, provide training and counselling, offer a range of financial management services and debt management.

“The Ranger Service has also enlisted the Association of Savings and Investment South Africa (ASISA) Foundation to provide specialised financial literacy training for all field rangers. This was attended by 334 employees,” the Minister said.

SANParks has also established an integrity testing system – a polygraph policy – for new recruits and to support anti-corruption investigations.

To ensure the safe passage of tourists, SANParks has joined a task team championed by the Deputy Minister of Tourism, Fish Mahlalela, in collaboration with the traditional leaders of adjoining communities, the SAPS and private security companies to ensure constant patrols along the identified hotspots en route to the Kruger National Park.

“South Africa’s national parks are situated in areas of extreme poverty and are surrounded by many vulnerable communities.

“In order to ensure that communities on the outskirts of parks benefit from tourism and thus help to keep tourists safe, SANParks has held a number of stakeholder engagements with entrepreneurs in the past four years with regard to the provision of goods and services to our national parks.

“In addition, through Working for Water, Ecosystems and Wetlands programmes, we have created 33 222 work opportunities for communities living on the outskirts of our national parks,” the Minister said.

Source: South African Government News Agency

dtic hosts business editors ahead of BRICS

South Africa intends to bring the African agenda to the fore at the upcoming 15th BRICS Summit, which will take place in Johannesburg from 22 – 24 August.

The Deputy Director-General of Exports at the Department of Trade, Industry and Competition (dtic), Lerato Mataboge, said at the BRICS [Brazil, Russia, India, China and South Africa] Business Editors’ Breakfast, which was held in Johannesburg on Monday, that the summit is an opportune platform to have a robust conversation on “issues of diversifying exports towards value added trade, increasing productive capacities, increasing entrepreneurial opportunities and the skills dividend”.

All these are areas that bear relevance to the theme of the highly-anticipated summit, which is ‘BRICS and Africa: Partnership for Mutually Accelerated Growth, Sustainable Development and Inclusive Multilateralism’.

Mataboge said in addition to infrastructure and industrial development and market integration, attention must be given to accelerating growth and accruing value on the African continent; increasing investment flows to Africa, technology transfer, employment opportunities, and improved incomes and economic inclusion and transformation.

South Africa, as the current chair of BRICS, will be chairing the summit soon after its fruitful participation in the 2nd Russia-Africa Summit, which was held in St. Petersburg last week. The summit came after South Africa successfully held a Friends of BRICS National Security Advisors’ Meeting and the BRICS Urbanisation Forum in Durban last week.

The business editors’ session formed part of activities in the road leading to the 15th BRICS Summit. The session was a high-level engagement with the editorial heads of agenda-setting media titles, with the objective of outlining the trade and investment posture of the BRICS Business Council, programme of work of the economic work stream of BRICS in South Africa, as well as the tangible economic opportunities that emerge for South Africa and the African continent.

AfCFTA

In outlining South Africa’s stance on driving the continent’s agenda at the BRICS Summit, Mataboge outlined the benefits of the African Continental Free Trade Area (AfCFTA), saying it creates a legal framework that aims to remove barriers and unlock opportunities for trade and investment for local and global businesses, especially in the creation of regional value chains in Africa.

Notably, she said women and youth-owned businesses are poised to benefit from the AfCFTA, with the necessary financial and non-financial support.

“The AfCFTA creates a single market projected to grow to 1.7 billion people and $6.7 trillion in consumer and business spending by 2030. By 2050, the population would have grown to 2.5 billion people, with combined business and consumer spending reaching $16.12 trillion,” Mataboge said.

Highlighting the AfCFTA’s industrialisation opportunities, Mataboge said the AfCFTA Private Sector Engagement Strategy is set to capture value into the continent. She pointed out four sectors including automotive, agriculture and agro-processing, pharmaceuticals and transport and logistics as having high potential for investment, with “potential to meet African demand through local production and potential value as exports to the rest of the world”.

Mataboge said together, these four sectors represent R2.6 billion in goods and services’ imports per annum.

South Africa became a member of BRICS in 2010 and attended its first Summit in 2011. BRICS was established as a forum of like-minded, progressive emerging market and developing countries committed to the need to restructure the global political, economic and financial architecture to be more equitable, balanced and resting on the important pillars of multilateralism and international law.

Over time, BRICS extended its cooperation to three pillars: political and security, economic and financial, and social/people-to-people.

At the initiative of South Africa, BRICS also expanded its reach beyond the BRICS members through the BRICS Outreach and BRICS Plus initiatives.

Source: South African Government News Agency

Gauteng Legislature calls for deployment of SANDF against illegal miners

The Gauteng Provincial Legislature’s Portfolio Committee on Community Safety says it will be writing to President Cyril Ramaphosa and Gauteng Premier Panyaza Lesufi to consider the deployment of soldiers in the province to “to end the scourge of illegal mining in the province once and for all”.

This after the discovery of five bodies – suspected to be illegal miners – were found shot in Riverlea over the weekend, following reports of a gun battle between illegal miners.

Furthermore, last month a gas leak led to the deaths of 17 people in the Boksburg area.

In a statement, the committee said illegal mining is causing “escalating lawlessness and mayhem” in the province.

“The Committee views illegal mining as a form of economic sabotage beyond just tax evasion, but also illicit financial flows with a devastating negative effect on the already struggling South African economy. It is also critical to establish the alleged involvement of Mining companies in illegal mining and their contribution to bringing an end to this.

“The Committee further calls upon the Department of Mineral Resources to assist in holding Mining companies that previously owned these mines legally obligated and accountable in taking full responsibility of rehabilitating them,” the statement read.

According to the committee, it will also be calling leaders in the province before it to explain what measures are being explored to curb the illegal scourge.

“The Committee has therefore resolved to call on the Gauteng MEC for Community Safety, together with the Provincial Police Commissioner, to appear before it and give an account on what measures are being put in place to end illegal mining in the province.

“These measures must have clear action plans and timelines, as the people of Gauteng can no longer afford to live in fear due to the so called Zama Zamas who are in their majority illegal foreign nationals. The safety of citizens should be a priority and we cannot allow lawlessness to continue unabated,” the statement read.

Source: South African Government News Agency

Petrol, diesel prices to increase from Wednesday

The Department of Mineral Resources and Energy (DMRE) has announced that the price of all grades of petrol and diesel will increase from Wednesday this week.

The price of illuminating paraffin is also expected to rise with the only decrease to be implemented on the price of LP gas.

Adjustments to the prices will be as follows:

Petrol (both 93 and 95 Octane): 37c increase.

Diesel (0.05% sulphur): 72c increase.

Diesel (0.005% sulphur): 71c increase.

Wholesale illuminating paraffin: 71c increase.

Single Maximum National Retail Price for illuminating paraffin: 95c increase.

Maximum Retail Price of LPGas: R1.61 decrease.

The department explained the reasons for the price adjustments.

“The average Brent Crude oil price increased from $75.10 US Dollars [USD] to $79.75 USD during the period under review. The average international product prices of petrol, diesel and Illuminating paraffin followed the increasing trend of crude oil prices during the period under review. These led to higher contributions to the Basic Fuel Prices of petrol, diesel and illuminating paraffin by 63.59 c/l, 99.09. c/l and 98.71c/l, respectively. However, LP Gas decreased due to lower prices of Propane and Butane.

“The Rand appreciated on average, against the US Dollar [from R18.68 to R18.26 per USD] during the period under review when compared to the previous one. This led to lower contributions to the Basic Fuel Prices of petrol, diesel and illuminating paraffin by 27.64 c/l, 27.36 c/l and 27.10 c/l, respectively.

“The cumulative slate balance on petrol and Diesel as at the end of June 2023 had a positive balance of is R2.69 million. Therefore, there is no slate levy applicable in the petrol and diesel price structure for August 2023,” the DMRE said.

Source: South African Government News Agency