Category: Asean

Collaboration furthers Zenas’ vision to bring innovative immunology-based medicines to patients around the world by leveraging Bristol Myers Squibb’s long-standing expertise in immune-mediated diseases

Zenas will receive a $50 million up-front cash payment and an equity investment from Bristol Myers Squibb, along with additional potential milestone-based payments and royalties in the licensed territory

WALTHAM, Mass., Sept. 05, 2023 (GLOBE NEWSWIRE) — Zenas BioPharma, a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immunology-based therapies, today announced that it has entered into a license and collaboration agreement with Bristol Myers Squibb Company to develop and commercialize obexelimab for autoimmune diseases in Japan, South Korea, Taiwan, Singapore, Hong Kong and Australia.

Obexelimab is an investigational bifunctional, non-cytolytic, humanized monoclonal antibody that binds CD19 and FcγRIIb to inhibit B cells, plasmablasts, and CD19-expressing plasma cells. Obexelimab is currently being studied as a subcutaneous injection in a global Phase III trial in patients with IgG4-Related Disease (IgG4-RD), a disease for which there are currently no approved treatments. The compound is also being studied in a global Phase II/III trial in patients with warm antibody Auto-Immune Hemolytic Anemia (wAIHA).

“This collaboration marks an important step forward in realizing our vision for obexelimab to benefit patients living with auto immune diseases globally,” said Lonnie Moulder, Founder and Chief Executive Officer of Zenas BioPharma. “The deeply experienced and passionate team at Bristol Myers Squibb is an ideal partner based on their proven development, regulatory and commercial capabilities in Japan and throughout the licensed territory.”

“This collaboration represents an important opportunity to address unmet needs for people living with IgG4-RD, for which there are no approved treatment options,” said Steve Sugino, Senior Vice President & General Manager, Japan, Bristol Myers Squibb. “We are excited to work with Zenas BioPharma to expand the reach of obexelimab in the licensed territory and to make an impact on the lives of patients that are waiting.”

Under the terms of the license agreement, Zenas will receive a $50 million up-front cash payment and is eligible to receive additional payments in connection with the achievement of certain development, regulatory and commercial milestones, as well as royalties on net sales of obexelimab in the licensed territory. In exchange, Bristol Myers Squibb will receive exclusive rights to develop and commercialize obexelimab in the licensed territory. In addition, Bristol Myers Squibb is making an equity investment in Zenas.

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, including in various autoimmune diseases, 198 subjects were treated with obexelimab. In these clinical studies, obexelimab demonstrated 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. More information on the Phase 3 (SApHiAre) study is available at clinicaltrials.gov: NCT05786573.

About IgG4-related disease

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 may also impair vaccine responses, including those for SARS-CoV-2 and influenza.

About Zenas BioPharma

Zenas BioPharma is a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immunology-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
IR@zenasbio.com

GlobeNewswire Distribution ID 8916029

Media Contact:
Fiona Habben
Senior Marketing Manager – Global
Fiona.habben@ai-media.tv

Foothill Ranch, Calif., Aug. 31, 2023 (GLOBE NEWSWIRE) — Global sweetness and flavor innovator Sweegen has announced that its Bestevia® Rebaudiosides M (Reb M), D, and E have received full authorization from the Taiwan FDA for use in food and beverages. This recent regulatory approval marks another milestone in Sweegen successfully opening new markets in countries where brands seek new generation stevia ingredients to expand their sugar reduction solutions.

Reb M, a high-purity steviol glycoside derived from the stevia plant, is renowned for its clean and sugar-like taste profile. The best-tasting part of the stevia leaf, such as Reb M is found in trace quantities of the leaf’s composition.

For food and beverage producers, Sweegen’s Reb M technology offers several commercially significant advantages. Sweegen’s Signature Stevia starts with stevia, not GMO corn or sugar beets. The ingredient innovator leverages proprietary bioconversion technology to produce a range of zero-calorie sweeteners with assured quality, regulatory compliance, and competitive prices. These products generate a lower carbon footprint.

As Sweegen continues to excel in commercialization and secures essential regulatory approvals in key markets like the EMEA and the U.K., the company witnesses substantial sales growth throughout 2023.

In addition to those critical regulatory approvals, Sweegen now offers its food and beverage manufacturing customers the right to use its Reb M in all non-alcoholic beverages anywhere in the world without infringing the relevant application patents. Customers already use Sweegen’s Reb M in other applications.

“At Sweegen, our focus revolves around safety, quality, and adherence to regulatory standards,” said Vice President of Technical and Regulatory Affairs, Hadi Omrani. “We are expanding our global footprint by opening new markets to create access to innovative sweetener technologies.”

With increased interest from the global CPG companies and their desire for guaranteed capacity and supply chain redundancy, Sweegen has been working to establish and expand production facilities in major markets, including EMEA, North America, and APAC.

“The approval of Bestevia Reb M in Taiwan represents a breakthrough for brands aiming to create better-for-you foods and beverages,” said Vice President of Global Innovation, Casey McCormick. “Bestevia Reb M opens innovative avenues for reducing and even eliminating sugar, surpassing consumer expectations and contributing to public health goals aimed at curtailing sugar intake.”

Sweegen has recently achieved FEMA GRAS status for its sweet proteins, brazzein and thaumatin II, which serve as valuable complements to steviol glycosides in the realm of food and beverage production. This addition reinforces Sweegen’s commitment to broadening its portfolio of innovative taste-modulating flavors. These sweet proteins are pivotal in assisting food and beverage manufacturers in meeting the rising demand for better-for-you products, aligning seamlessly with consumers’ holistic wellness preferences. The brazzein technology takes center stage in Sweegen’s newly launched Sweetensify flavor technology for taste modulation. It is an ideal tool for brands aiming to replicate sugar-like tastes in their food and beverage offerings.

Sweegen is dedicated to revolutionizing the sweetener market with innovative solutions that promote healthier choices without compromising taste. The full authorization of Bestevia Reb M in Taiwan reinforces Sweegen’s leadership in the nature-based sweetener space and positions the company as a trusted partner for food and beverage manufacturers worldwide.Top of FormBottom of Form

About Sweegen

Sweegen provides sweet-taste solutions for food and beverage manufacturers around the world.

The company aims to reduce sugar and artificial sweeteners in the global diet. Partnering with customers, Sweegen creates delicious zero-sugar products that consumers love. With the best modern sweeteners in its portfolio, such as Bestevia® Rebs B, D, E, I, M, and N, and sweet proteins brazzein and thaumatin, along with its deep knowledge of flavor modulators and texturants, Sweegen delivers market-leading solutions that customers want, and consumers prefer. Well. Into the Future.

Forward-Looking Statements

This press release includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1996. Sweegen’s actual results may differ from the estimates, assumptions, and other illustrative material contained herein, and consequently, a reader should not rely on these forward-looking statements as predictions of future events. These forward-looking statements include, without limitation, illustrative information regarding Sweegen’s bottom-up assumed market potential, assumed hit rate, and the resulting revenue based on these model inputs. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from the expected results.

Industry, Market, and Other Data

In this press release, we rely on and refer to information and statistics regarding market participants in the sectors in which Sweegen competes and other data. We obtained this information and statistics from our own internal estimates and third-party sources, including reports by market research firms and company filings. We do not expressly refer to these sources. All of this information involves a number of assumptions and limitations, and the sources of such information cannot guarantee the accuracy or completeness of such information. The industry in which Sweegen operates is subject to a high degree of uncertainty and risk due to a variety of important factors, any of which could cause results to differ materially from those expressed in the estimates made by Sweegen or third parties.

Further Cautionary Statement Concerning Forward-Looking Statements

This press release contains forward-looking statements, including, among other statements, statements regarding the future prospects for Reb M stevia leaf sweetener, brazzein, and thaumatin. These statements are based on current expectations but are subject to certain risks and uncertainties, many of which are difficult to predict and beyond Sweegen’s control.

Relevant risks and uncertainties could cause actual results to differ materially from those expressed in or implied by the forward-looking statements and, therefore, should be carefully considered. Sweegen assumes no obligation to update any forward-looking statements as a result of new information or future events or developments.

Attachments

• Boba tea is one of Taiwan’s favorite beverages
• Taipei beverage aisle

Ana Capretz, Head of Public Relations and Communications
Sweegen
949-709-0583
ana.capretz@sweegen.com

GlobeNewswire Distribution ID 8914192

FREYBURG, Germany, Aug. 30, 2023 (GLOBE NEWSWIRE) — Nikkiso Clean Energy & Industrial Gases Group (Group) is pleased to sponsor this year’s Central Hydrogen Congress event and present its hydrogen growth strategy for German and European clean energy markets.

Nikkiso’s Clean Energy & Industrial Gases business has more than 50 years of cryogenics experience, and with the Group’s recent acquisition of Cryotec, it has greatly increased its ability to support and enable the growing hydrogen markets in Europe.

“Nikkiso’s leadership in advanced hydrogen technologies and applications and our extensive global experience building hydrogen infrastructure and developing innovative solutions will support Germany’s desire to accelerate its energy transition to a net zero economy using hydrogen,” said Peter Wagner, CEO, Nikkiso Clean Energy & Industrial Gases.

Nikkiso Cryotec is a member of Nikkiso Clean Energy & Industrial Gases, located in Wurzen, Saxony. The business specializes in custom solutions for CO₂ plants and plants that produce and technical gases. It has more than 2,000m² (21,500 ft²) of manufacturing area and more than 2,000 m² (21,500 ft²) of storage space which enables in-house production of numerous international projects.

Currently, Nikkiso Cryotec is developing customized solutions for industry and agriculture, transportation and traffic, medical and pharmaceutical industry, chemical and petrochemical industry as well as for metal processing and metallurgy.

“Our sponsorship of the Central German Hydrogen Congress event is a symbol of Nikkiso’s commitment to growing our presence in Germany and the European clean energy markets,” said Corinne Ziege, managing director, Nikkiso Cryotec.

“We intend to support the development of efficient and safe infrastructure for hydrogen supply, develop hydrogen fueling stations throughout Germany and Europe, and support public advocacy and education efforts regarding the use of hydrogen as a clean energy source.”

About Nikkiso Clean Energy & Industrial Gases Group
Nikkiso Clean Energy & Industrial Gases Group is part of the Industrial Division of Nikkiso co. Lt. Japan. The Group operates in the US, under Cryogenic Industries, Inc. (a member of Nikkiso Co., Ltd.). The Group member companies manufacture, and service engineered cryogenic gas processing equipment (pumps, turboexpanders, heat exchangers, etc.), and process plants for Industrial Gases, Natural Gas Liquefaction (LNG), Hydrogen Liquefaction (LH2) and Organic Rankine Cycle for Waste Heat Recovery as well as Carbon Capture Solutions. 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 approximately 20 operating entities.

For more information, please visit www.NikkisoCEIG.com and www.Nikkiso.com.

MEDIA CONTACT:
Nikkiso Cryotec
+49 3425 8965 1610
corinne.ziege@cryotec.de

GlobeNewswire Distribution ID 8913498