Press Release

Sernova Provides Positive Clinical and Platform Portfolio Update

Published

7 months ago

April 2, 2024

(via TheNewswire)

Type 1 diabetes (T1D) Cohort 2 patient data demonstrates favorable islet engraftment and long-term survival of human donor islets in the Cell Pouch
First treated Cohort 1 patient in the T1D clinical trial to celebrate four years of insulin independence and normalized HbA1c
With recent positive findings in post-surgical hypothyroidism large animal study, Sernova anticipates filing an Investigational New Drug (IND) application in 2024
Additional chronic disease indications identified for further pipeline expansion with a focus on endocrine disorders

LONDON, Ontario; BOSTON, Massachusetts – TheNewswuire – April 2, 2024 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-stage biotechnology company focused on the development of regenerative medicine cell therapies for treatment of chronic diseases, today provided a business update. Following a review of the company’s therapeutic pipeline and emerging opportunities for its Cell Pouch system platform technologies, Sernova confirms key priorities including its lighthouse program in insulin dependent Type 1 Diabetes plus its intention to advance an IND filing for its post-operative hypothyroidism program.

Data from a patient in Cohort 2 of the company’s lead clinical program for insulin dependent Type 1 diabetes (T1D) confirms histologic evidence of long-term (one year) robust survival of abundant human donor islets throughout the Cell Pouch. Additional Cohort 2 findings are specific to an advanced immunosuppression regimen planned for use in its upcoming Phase I/II trial with stem cell-derived islets under co-development with Evotec.

Cohort 2 patients treated with an advanced immunosuppression protocol avoided graft rejection and experienced minimal side effects in comparison to those patients observed in Cohort 1. None of the six patients in Cohort 2 treated with the advanced regimen have tested positive for donor specific antibodies (DSAs), a marker of graft rejection, in comparison to three of six patients who developed DSAs under the conventional immunosuppression regimen in Cohort 1. Ancillary medication, used in some Cohort 2 patients, demonstrated highly favorable graft survival and function for islets transplanted to the Cell Pouch and has been integrated into the updated regimen and implemented for all subsequent patient trial enrollments. The company anticipates reporting additional data from Cohort 2 of its ongoing Phase 1/2 clinical trial of its expanded 10-channel Cell Pouch during the second half of the year at major medical conferences.

Sernova is pleased to report that this month marks the four-year anniversary of the first patient in Cohort 1 of this Phase 1/2 study who will celebrate insulin independence and normalized blood sugar levels, based on two transplants of human donor islets to the Cell Pouch plus a marginal portal vein top up.

“Based on the favorable results we are observing in ongoing pre-clinical studies, we have concluded that our hypothyroidism program represents another compelling opportunity by which to improve patients’ lives. We look forward to completing our pre-clinical work, engaging with regulatory agencies, and preparing for an IND filing later this year, with the goal of advancing a second indication into the clinic, further demonstrating the Cell Pouch as a drug delivery vehicle platform technology. Also of note, in addition to allowing for long term payload survival, our Cell Pouch has powerful containment and retrievability capabilities that we expect will have tremendous value for pharmaceutical companies looking to treat patients with cell therapies,” said Cynthia Pussinen, Chief Executive Officer of Sernova.

“In parallel with these activities, and our ongoing hemophilia A work, we have identified several high value indications with unmet medical needs that could potentially benefit from our platform Cell Pouch technology, with an initial focus on endocrine disorders. In the coming months, we will be conducting commercial assessments to prioritize those areas where we can best extend our reach to more patients while creating enduring value for our shareholders. I am excited for what we are poised to achieve this year and look forward to providing further updates in the future,” Ms. Pussinen concluded.

ABOUT SERNOVA AND ITS CELL POUCH SYSTEM PLATFORM FOR CELL THERAPY

Sernova Corp. is a clinical-stage biotechnology company that is developing therapeutic cell technologies for chronic diseases, including insulin-dependent diabetes, thyroid disease, and blood disorders that include hemophilia A. Sernova is currently focused on developing a ‘functional cure’ for insulin-dependent diabetes with its lead technology, the Cell Pouch System, a novel implantable and scalable medical device with immune protected therapeutic cells.

On implantation, The Cell Pouch forms a natural vascularized tissue environment in the body for long-term survival and function of therapeutic cells that release essential factors that are absent or deficient in the bodies of patients with certain chronic diseases. Sernova’s Cell Pouch System has demonstrated its potential to be a ‘functional cure’ for people with T1D in an ongoing Phase 1/2 clinical study at the University of Chicago.

Sernova partnered with Evotec to develop an implantable off-the-shelf iPSC (induced pluripotent stem cells) based islet replacement therapy. This partnership provides Sernova a potentially unlimited supply of insulin-producing cells to treat millions of patients with insulin-dependent diabetes (type 1 and type 2). Sernova’s development pipeline that uses its Cell Pouch System also includes: a cell therapy for hypothyroid disease resulting from thyroid gland removal and an ex vivo lentiviral Factor VIII gene therapy for hemophilia A.

FOR FURTHER INFORMATION, PLEASE CONTACT:

Christopher Barnes

VP, Investor Relations

Sernova Corp.

Tel: +1 519-902-7923

Email: christopher.barnes@sernova.com

Website: www.sernova.com

FORWARD-LOOKING INFORMATION

This release contains statements that, to the extent they are not recitations of historical facts, may constitute “forward-looking statements” that involve various risks, uncertainties, and assumptions, including, without limitation, statements regarding the prospects, plans, and objectives of the company. Wherever possible, but not always, words such as “expects”, “plans”, “anticipates”, “believes”, “intends”, “estimates”, “projects”, “potential for” and similar expressions, or that events or conditions “will”, “would”, “may”, “could” or “should” occur are used to identify forward-looking statements. These statements reflect management’s beliefs with respect to future events and are based on information currently available to management on the date such statements were made. Many factors could cause Sernova’s actual results, performances or achievements to not be as anticipated, estimated or intended or to differ materially from those expressed or implied by the forward-looking statements contained in this news release. Such factors could include, but are not limited to, the company’s ability to secure additional financing and licensing arrangements on reasonable terms, or at all; ability to conduct all required preclinical and clinical studies for the company’s Cell Pouch System and or related technologies, including the timing and results of those trials; ability to obtain all necessary regulatory approvals, or on a timely basis; ability to in-license additional complementary technologies; ability to execute its business strategy and successfully compete in the market; and the inherent risks associated with the development of biotechnology combination products generally. Many of the factors are beyond our control, including those caused by, related to, or impacted by the novel coronavirus pandemic. Investors should consult the company’s quarterly and annual filings available on www.sedarplus.ca for additional information on risks and uncertainties relating to the forward-looking statements. Sernova expressly disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

COMTEX_450218586/2895/2024-04-02T07:00:21

About Author

Cloud PR Wire

See author's posts

Disclaimer: The views, suggestions, and opinions expressed here are the sole responsibility of the experts. No Digi Observer journalist was involved in the writing and production of this article.

Press Release

Step into a World of Strength and Survival with ‘The Eyes From Above’

Published

1 hour ago

October 18, 2024

Cloud PR Wire

Uncover The Secrets Of The Eyes From Above: Jabari Lamb Invites Readers On An Inspiring Journey Of Triumph, Survival, And Self-Discovery

Ride on a journey of power, survival, and the unbreakable human spirit in the new novel by Jabari Lamb titled “The Eyes From Above.” A Nationwide Release will thereafter tell the story of family, perseverance, and reclaiming one’s identity in a world fraught with danger and hostility.

Track the life of Connie, fighting his way through dangerous waters to uncover long-buried truths about his family’s past, as he evades sinister forces who are determined to stop him at every step. In Charleston, South Carolina, this is the story peeling historical trauma, mythical elements, and an African sense of roots into a bewitching tapestry of history, fantasy, and raw emotion.

There’s that richness of culture and heritage alive through the eyes of his Gullah Geechee perspective: all the trials and triumphs of the African diaspora. He spent time abroad in South Africa, exploring other pockets of the African continent; he weaves a very personal, detailed narrative of African traditions and powerful ancestral connections that should speak to readers from every part of this world.

For high drama or soul-stirring histories, be sure to read “The Eyes from Above” to question what truth is and what is in memory. This book is available in bookstores all over the country and in stores online.

About the Author

A bold, new voice in literature, Jabari Lamb blends history and mythology and his Gullah Geechee heritage in stories hard to forget. This impressive young writer’s novel, The Eyes From Above, explores African roots and displacement based on his journey learning about the Gullah Geechee people, the history of African-Americans, and his trip to South Africa. A voice unique unto his own, Jabari extends the invitation to the reader to consider the fluidity of memory and identity and, indeed, the truth. The Eyes From Above makes its wonderful debut into the literary world.

Media Contact:

Contact Person: Jabari Lamb

Email: Jabarilamb1847@gmail.com

Phone: 770-580-3190

Website: Jabarilamb.com

City: Atlanta

State: Georgia

Country: United States

About Author

Cloud PR Wire

See author's posts

Press Release

Yijin Hardware Delivers High-Quality Sheet Metal Fabrication Services Worldwide

Published

2 hours ago

October 18, 2024

Cloud PR Wire

United States, 17th Oct 2024, – Yijin Hardware, a key player in precision CNC machining, has announced the global expansion of its sheet metal fabrication services. This development is aimed at supporting industries worldwide with high-quality, custom-engineered metal components. By extending services to new markets, Yijin Hardware strengthens its position as a reliable manufacturing partner for sectors that require precise, durable parts, such as automotive, aerospace, and electronics.

Yijin Hardware Delivers High-Quality Sheet Metal Fabrication Services Worldwide

Yijin Hardware has a long history of providing precision-engineered components, and its expansion into international markets reflects the company’s response to rising demand for reliable sheet metal fabrication services. The new offerings will include laser cutting, metal bending, welding, and a variety of other fabrication processes, designed to accommodate a wide range of industrial applications.

“Precision and quality have always been at the heart of Yijin Hardware’s operations,” said Gavin Yi, CEO of Yijin Hardware. “The expansion of sheet metal fabrication services is a natural progression in the company’s growth, enabling access to more industries worldwide that require high-performance metal components for their operations.”

The sheet metal fabrication sector has seen increasing demand as industries move towards more complex and custom-engineered solutions. Yijin Hardware’s global expansion is positioned to meet these growing needs by offering scalable services that are capable of handling both small-scale production and larger manufacturing runs. The company’s advanced facilities are equipped with the latest machinery, ensuring that each part meets precise specifications and high-quality standards.

Yijin Hardware has also invested heavily in upgrading its production infrastructure to support the increased demand from international clients. Enhancements in laser cutting, welding, and assembly operations have been key factors in enabling the company to offer a more diverse set of services globally. The ability to handle custom and high-volume orders without compromising on quality is a cornerstone of Yijin Hardware’s service offerings.

“Looking ahead, Yijin Hardware is committed to further advancing its manufacturing capabilities,” Gavin Yi added. “There are plans to introduce more cutting-edge technologies that will enhance both CNC machining and sheet metal fabrication services. These advancements will ensure the company remains well-positioned to address the evolving needs of industries in the future.”

Yijin Hardware’s expanded services will cater to industries with a need for complex, high-precision components, including automotive parts, aerospace structures, and electronic enclosures. With a focus on maintaining strict quality control throughout the production process, the company aims to provide solutions that meet exacting industry standards.

As part of its expansion strategy, Yijin Hardware continues to emphasize innovation and efficiency. These principles are expected to guide the company’s future developments as it explores new manufacturing technologies and methods. The expansion also supports the company’s vision of being a global leader in precision engineering.

For further information about sheet metal fabrication services, please contact Yijin Hardware at +1 626 263 5841 or via email at yijing@yijinsolution.com.

Media Contact

Organization: Yijin Hardware

Contact
Person: Gavin Yi

Website:

http://yijinsolution.com/

Email:

yijing@yijinsolution.com

Country:United States

The post Yijin Hardware Delivers High-Quality Sheet Metal Fabrication Services Worldwide appeared first on
Brand News 24.
It is provided by a third-party content
provider. Brand News 24 makes no
warranties or representations in connection with it.

About Author

Cloud PR Wire

See author's posts

Press Release

Yijin Hardware Offers Global CNC Machining Services from China

Published

2 hours ago

October 18, 2024

Cloud PR Wire

United States, 17th Oct 2024, – Yijin Hardware, a well-established provider of custom CNC machining services, has announced its expansion into global markets. The company, recognized for its precision manufacturing capabilities, aims to support international businesses in industries such as aerospace, automotive, electronics, and medical with tailored CNC solutions. This move comes as industries worldwide increasingly require high-quality, custom-manufactured components to meet modern production needs.

Yijin Hardware Offers Global CNC Machining Services from China

Yijin Hardware’s decision to extend its services beyond China reflects its commitment to addressing the needs of a broader range of industries. With years of experience in CNC machining, the company has developed a reputation for delivering reliable and precise parts to a diverse set of clients. The expansion will provide industries worldwide with access to Yijin Hardware’s capabilities, backed by advanced technology and stringent quality control.

Gavin Yi, CEO of Yijin Hardware, commented on the expansion: “This move into international markets represents a significant milestone. Yijin Hardware has always emphasized precision and reliability, and this expansion allows those same standards to be brought to clients around the world. Whether the project involves a small batch of components or a large production run, the company is prepared to meet the exacting standards required by global industries.”

Operating from its facilities in Shenzhen, Yijin Hardware manages the full lifecycle of production, from initial design to final inspection. This comprehensive approach ensures that each project is carefully monitored to meet specific client requirements. Yijin Hardware’s ability to offer customized machining solutions is seen as a key factor in its growth, particularly as companies increasingly seek specialized components for complex applications.

Previously focused primarily on the domestic market in China, Yijin Hardware’s expansion aims to deliver the same level of precision and service to international clients. By positioning itself as a global CNC machining provider, the company plans to strengthen relationships with existing partners while establishing new connections in other regions.

This global expansion comes at a time when demand for CNC machining services is rising due to the increasing complexity of product designs and the need for enhanced precision in manufacturing. As industries continue to evolve, CNC machining remains crucial to ensuring that parts meet exact specifications. Yijin Hardware has embraced this role through continuous investment in advanced equipment and machining techniques.

Looking ahead, Yijin Hardware is also focused on the future of manufacturing and its impact on sustainability. The company plans to explore new methods that reduce material waste and promote more efficient production processes. According to Gavin Yi, “As the company expands globally, attention is focused not only on immediate goals but also on contributing to long-term sustainable manufacturing. CNC machining plays a critical role in reducing waste and improving production efficiency. Yijin Hardware is committed to finding ways to make processes more environmentally friendly, to become a leader in both precision and sustainability.”

Yijin Hardware’s entry into global markets signals a broader shift in its strategy, focusing on serving a more diverse range of industries with its expertise in CNC machining. By offering international clients access to its advanced manufacturing solutions, the company aims to become a trusted partner for businesses looking to streamline production with high-quality, custom-manufactured parts.

For more information about Yijin Hardware’s global CNC machining China, inquiries can be directed via phone at +1 626 263 5841 or by email at yijing@yijinsolution.com.

Media Contact

Organization: Yijin Hardware

Contact
Person: Gavin Yi

Website:

http://yijinsolution.com/

Email:

yijing@yijinsolution.com

Contact Number: 16262635841

Country:United States

The post Yijin Hardware Offers Global CNC Machining Services from China appeared first on
Brand News 24.
It is provided by a third-party content
provider. Brand News 24 makes no
warranties or representations in connection with it.