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Kyverna’s KYV-101 Receives U.S. FDA RMAT Designation for KYV-101 in the Treatment of Patients With Refractory Stiff-Person Syndrome

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The application was evaluated based on the positive clinical outcomes of KYV-101 in patients treated in Germany under a named-patient treatment option

The Regenerative Medicine Advanced Therapies designation will allow Kyverna to receive expert guidance on efficient drug development and use of surrogate endpoints from senior FDA officials

EMERYVILLE, Calif., July 15, 2024 /PRNewswire/ — Kyverna Therapeutics, Inc. (Kyverna), a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases, announced today the designation as Regenerative Medicine Advanced Therapy (RMAT) by the U.S. Food and Drug Administration (FDA) for its autologous, fully human CD19 chimeric antigen receptor (CAR) T-cell product candidate, KYV-101, to be used for the treatment of patients suffering from refractory stiff-person syndrome. 

“Stiff-person syndrome has devastating and life-altering effects on patients suffering from this rare autoimmune disease,” said Amanda Piquet, M.D., director of the Autoimmune Neurology Program at CU Anschutz Medical Campus, Aurora, CO. “I look forward to the data that will emerge from the KYSA-8 trial as this trial could drastically change the treatment landscape for SPS.”

“We are eager to begin generating data from our sponsored trial to advance the knowledge on a potential immunological reset of the patient’s immune system,” said Peter Maag, Ph.D., chief executive officer at Kyverna. “We are humbled by the resilience of the SPS patients and their hope for a potential paradigm-shifting treatment option that could provide durable, immunosuppressant-free remission.”

About Stiff Person Syndrome (SPS) 
SPS is a rare, progressive neurological autoimmune disorder causing debilitating muscle stiffness in the torso, arms, and legs, impacting the ability to walk or move. Patients typically present with muscle spasms and stiffness, resulting in difficulty turning and bending. When stiffness is severe, the patients’ posture resembles a statue. Muscle spasms and stiffness can be precipitated by unexpected stimuli, including sounds, like a phone ring or a siren, sudden touches or conditions triggering anxiety and emotional upset which, when severe, are misdiagnosed as a primary anxiety disorder1. 

About KYV-101
KYV-101 is an autologous, fully human CD19 CAR T-cell product candidate for use in B cell-driven autoimmune diseases. The CAR in KYV-101 was designed by the National Institutes of Health (NIH) to improve tolerability and tested in a 20-patient Phase 1 trial in oncology. Results were published by the NIH in Nature Medicine2.

KYV-101 is currently being evaluated in sponsored, open-label, Phase 1/2 and Phase 2 trials of KYV-101 in the United States and Germany across two broad areas of autoimmune disease: rheumatology and neurology.

With 50 patients treated so far with the CAR in KYV-101 in both oncological and autoimmune conditions at more than 15 locations in Europe and the U.S., we believe that the differentiated properties of KYV-101 are critical for the potential success of CAR T cells as autoimmune disease therapies.

KYV-101 is also being evaluated in investigator-initiated trials for multiple indications in multiple geographies.

About Kyverna Therapeutics
Kyverna Therapeutics, Inc. (Nasdaq: KYTX) is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. 

Our lead CAR T-cell therapy candidate, KYV-101 is advancing through clinical development with sponsored clinical trials across two broad areas of autoimmune disease: rheumatology and neurology, including Phase 2 trials for stiff person syndrome, multiple sclerosis and myasthenia gravis, a Phase 1/2 trial for systemic sclerosis, and two ongoing multi-center, open-label Phase 1/2 trials in the United States and Germany for patients with lupus nephritis. 

Kyverna’s pipeline includes next-generation CAR T-cell therapies in both autologous and allogeneic formats with properties intended to be well suited for use in B cell-driven autoimmune diseases.

Forward-Looking Statements
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” The words, without limitation, “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these or similar identifying words. Forward-looking statements in this press release include, without limitation, those related to: the potential impact of named-patient case studies; Kyverna’s goals to develop certain paradigm-shifting treatment options; Kyverna’s beliefs about the differentiated properties of KYV-101; and Kyverna’s clinical trials. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties related to market conditions, and other factors discussed in the “Risk Factors” section of Kyverna’s most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q that Kyverna has filed or may subsequently file with the U.S. Securities and Exchange Commission. Any forward-looking statements contained in this press release are based on the current expectations of Kyverna’s management team and speak only as of the date hereof, and Kyverna specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. 

For more information, please visit https://kyvernatx.com

Investor Contact:
George Thampy
Kyverna Therapeutics
InvestorRelations@kyvernatx.com 

Kyverna Media Contact:
Consort Partners for Kyverna
kyvernatx@consortpartners.com 

1 Dalakas, M.C., Neurotherapeutics 2022; 19, 832–847.
2 Brudno et al., Nature Medicine 2020; 26:270-280. 

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SOURCE Kyverna Therapeutics

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Minister Champagne wraps up visit to Silicon Valley

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PALO ALTO, CA, Nov. 16, 2024 /CNW/ – Today, the Honourable François-Philippe Champagne, Minister of Innovation, Science and Industry, concluded a visit to Palo Alto, California, where he met with business and tech leaders.

The Minister met with the CEO and Founder of Plug and Play, one of the world’s most active startup accelerators. He also met with the CEO and Founder of Groq, a company specializing in artificial intelligence (AI) chip technology.

Minister Champagne also met with key members of the C100, a not-for-profit association of over 400 Canadian expatriates advancing tech entrepreneurship in the Silicon Valley area.

While in Silicon Valley, Minister Champagne took the opportunity to visit the U.S. Department of Defense’s Defense Innovation Unit, which is designed to accelerate the adoption of cutting-edge commercial technologies by the U.S. military.

The Minister was also a guest speaker at the Trilateral Commission’s North American Group meeting where he was interviewed on a panel by Michael Duffy, Opinions editor at large of The Washington Post.

Quote

“Coming on the heels of the launch of the Canadian AI Safety Institute, this visit to Silicon Valley was a great opportunity to engage with tech leaders and entrepreneurs. As AI and other emerging technologies reshape national security, the economy and society at large, Canada will continue to play a central role in strengthening North America’s long-term competitiveness.”
– The Honourable François-Philippe Champagne, Minister of Innovation, Science and Industry

Associated links

Canada launches Canadian Artificial Intelligence Safety InstituteThe Trilateral Commission

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Find more services and information on the Innovation, Science and Economic Development Canada website.

Follow Innovation, Science and Economic Development Canada on social media.
X (Twitter): @ISED_CA | Facebook: Canadian Innovation | Instagram: @cdninnovation | LinkedIn: Innovation, Science and Economic Development Canada

SOURCE Innovation, Science and Economic Development Canada

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The Mortgage Calculator Delivers Real-Time VA Loan Rates with Advanced Application Tools

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The Mortgage Calculator introduces innovative VA loan calculators and tools featuring live mortgage rates updated by the minute. These tools empower veterans and active-duty military personnel with accurate, real-time insights into VA loan programs.

MIAMI, Nov. 16, 2024 /PRNewswire-PRWeb/ — The Mortgage Calculator, a licensed lender, has launched an advanced VA mortgage calculator platform with real-time mortgage rate integration for all VA loan programs from over 100 banks and lenders. Veterans and active-duty military personnel can now access live VA mortgage rates, updated by the minute, to make precise financial decisions. This technology ensures unmatched accuracy and transparency in VA loan planning.

Offering live mortgage rates is a pivotal enhancement for borrowers. This unique feature allows veterans and active-duty personnel to make well-informed decisions, whether purchasing a home or refinancing with an IRRRL.

The platform also offers tools to calculate VA mortgage loan payments and explore refinancing options like IRRRL loans (Interest Rate Reduction Refinance Loans). These tools simplify the loan application process and provide a complete understanding of financing options available to eligible borrowers.

Key Features of the Real-Time VA Loan Platform:

Live VA Loan Rates: Borrowers can view rates updated every minute, offering precise, real-time market data for all VA loan programs from multiple banks and lenders.Interactive VA Loan Calculator: Helps users estimate monthly payments based on current live rates, including refinancing options like IRRRL.Customizable Financial Tools: Provides tailored insights into VA loan affordability, terms, and eligibility requirements.Seamless Integration Across VA Loan Programs: Supports home purchases and refinancing with clarity and transparency.

“Offering live mortgage rates is a pivotal enhancement for borrowers,” said Jose Gonzalez, CSO of The Mortgage Calculator. “This unique feature allows veterans and active-duty personnel to make well-informed decisions, whether purchasing a home or refinancing with an IRRRL.”

To experience these tools and view live VA mortgage rates, visit the dedicated VA loan calculator page. Borrowers can also calculate savings on VA refinance options with the IRRRL calculator or explore broader resources like the VA mortgage loans guide. For additional information on other mortgage products, such as construction loans, visit the homepage.

About The Mortgage Calculator

The Mortgage Calculator is a licensed Mortgage Lender (NMLS #2377459) that specializes in using technology to enable borrowers to access both Conventional and Non-QM mortgage loan programs with over 100 banks and partners. Using The Mortgage Calculator proprietary technology, borrowers can instantly price and quote thousands of mortgage loan programs in just a few clicks. Our team of over 500 licensed Mortgage Loan Originators can assist our customers with Conventional, FHA, VA and USDA mortgages as well as access thousands of mortgage programs using Alternative Income Documentation such as Bank Statement Mortgages, P&L Mortgages, Asset Based Mortgage Programs, No Ratio CDFI Loan Programs, DSCR Investor Mortgages, Commercial Mortgages, Fix and Flip Mortgages and thousands more! To apply for a mortgage please visit https://themortgagecalculator.com

Mortgage Calculator Company LLC

NMLS#: 2377459

2125 BISCAYNE BLVD SUITE 220

Miami, FL 33137

Media Contact

Kyle Hiersche, The Mortgage Calcualtor, 1 7867331993, pr@themortgagecalculator.com, https://themortgagecalculator.com

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Norck Expands Custom Manufacturing Services with Enhanced Precision CNC Machining, Engineering Support, and Curated Network of Select Manufacturing Partners

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Norck, a global leader in on demand manufacturing, has expanded its services to include precision CNC machining, custom component manufacturing, and on-demand solutions. The company’s curated network of trusted manufacturing partners and personalized one-on-one engineering support set it apart from automated platforms. Serving industries such as aerospace, defense, robotics, and medical, Norck delivers high-quality, precision-engineered components tailored to specific needs. With capabilities in CNC machining, 3D printing, and hybrid manufacturing, Norck empowers businesses to innovate and scale efficiently. Visit www.norck.com for more information.

IRVINE, Calif. and MANNHEIM, Germany, Nov. 16, 2024 /PRNewswire-PRWeb/ — Norck, a global leader in advanced manufacturing and custom component production, is proud to announce a major expansion of its services, focusing on precision CNC machining, custom component manufacturing, and on-demand CNC machining. A key highlight of this growth is the enhancement of Norck’s curated network of select manufacturing partners, ensuring clients benefit from the highest quality standards and consistent reliability.

By partnering with only the best manufacturers, we ensure that every project meets our clients’ exacting standards. Combined with our one-to-one engineering support, this approach guarantees a superior manufacturing experience.

Complementing its growing capabilities, Norck reaffirms its commitment to personalized, one-to-one engineering and design support, setting it apart from competitors with automated platforms. With a strategic combination of expert guidance and a carefully vetted partner network, Norck is revolutionizing the way businesses approach custom parts manufacturing.

Norck’s Motto: “Prototype. Manufacture. Scale Up. On Demand.”

This guiding principle reflects Norck’s dedication to delivering seamless, end-to-end solutions that meet the dynamic needs of modern industries. From initial prototyping to full-scale production, Norck empowers businesses to innovate and grow with speed and precision.

Expanding a Curated Network of Trusted Manufacturing Partners

Norck’s curated network of select manufacturing partners brings together top-tier facilities specializing in CNC machining, injection molding, and metal 3D printing. Each partner is carefully vetted for quality, reliability, and expertise, ensuring seamless collaboration and superior results.

Key Benefits of Norck’s Manufacturing Partner Network:

Consistent Quality Standards: Partners are selected based on strict adherence to global certifications such as ISO 9001 and AS9100.Diverse Capabilities: Access to advanced manufacturing technologies, including custom CNC machining, custom component manufacturing, and on-demand sheet metal fabrication.Streamlined Project Management: Norck acts as a single point of contact, managing every aspect of production and ensuring seamless coordination across its network.

“Our curated network is an integral part of delivering exceptional results to our clients,” said Faruk Guney, CEO of Norck. “By partnering with only the best manufacturers, we ensure that every project meets our clients’ exacting standards. Combined with our one-to-one engineering support, this approach guarantees a superior manufacturing experience.”

Personalized Engineering and Design Support

Unlike platforms that rely heavily on automation, Norck emphasizes a one-on-one collaboration model with clients. This personalized approach ensures that designs are optimized for manufacturability, cost-efficiency, and performance before production begins.

Key Features of Norck’s Engineering and Design Support:

Dedicated Design Consultants: Clients work with experienced engineers who understand their unique requirements and industry challenges.

Seamless Iteration: From concept refinement to rapid prototyping, Norck supports clients at every step to perfect their designs.

Material Selection Guidance: Expert advice to choose the best materials for durability, performance, and cost-effectiveness.

Feasibility Analysis: Comprehensive evaluations to ensure manufacturability and optimal production outcomes.

Precision CNC Machining and Custom Component Manufacturing

Norck’s precision CNC machining services are at the forefront of its manufacturing offerings. With a focus on high-quality production and design optimization, Norck delivers custom CNC parts and components that meet even the most complex specifications.

Key Highlights:

On-Demand CNC Machining: Rapid, efficient production tailored to client needs, from prototypes to large-scale production.

Wire EDM Services: Precision machining for intricate designs requiring tight tolerances.

Custom CNC Machining Near Me: Localized support through Norck’s extensive partner network for faster turnaround times and convenience.

Advanced Metal 3D Printing Services

Norck has also enhanced its metal 3D printing services, providing innovative solutions for lightweight and complex custom metal parts. These services are integrated with Norck’s engineering support to ensure clients achieve the perfect balance of creativity and manufacturability.

Key Features:

Custom Metal 3D Printing: Production of intricate and durable components for aerospace, automotive, and medical applications.Hybrid Manufacturing Solutions: Combining CNC machining and 3D printing for advanced design possibilities.Injection Molding and On-Demand Sheet Metal FabricationNorck’s comprehensive offerings include injection molding and on-demand sheet metal fabrication, enabling clients to produce high-quality custom parts at scale. By leveraging its curated network, Norck delivers consistent results across all manufacturing disciplines.

Industries Served

Norck proudly serves a diverse range of industries, providing tailored solutions to meet specific sector requirements:

Norck offers specialized manufacturing solutions across various industries, delivering precision-engineered components and services tailored to each sector’s unique requirements.

Aerospace: Norck provides high-precision components that meet stringent aerospace standards, ensuring safety and reliability in critical applications.

Defense: Supplying robust and reliable parts, Norck supports mission-critical defense systems and equipment, adhering to rigorous quality and performance criteria.

Robotics: Norck creates intricate components essential for the efficient operation of robotic systems and automation technologies, enhancing performance and precision.

Automotive: Manufacturing custom parts, Norck enhances vehicle performance, durability, and safety across various automotive applications.

Medical: Producing biocompatible and precision-engineered components, Norck supports medical devices, surgical tools, and healthcare technologies, ensuring safety and efficacy.

Consumer Products: Producing high-quality, durable components, Norck serves a wide range of consumer goods, from electronics to appliances, ensuring product longevity and reliability.

Industrial: Providing durable and reliable parts, Norck supports machinery, tools, and industrial systems, ensuring operational efficiency and longevity.

Hardware: Crafting precision hardware components, Norck caters to construction, infrastructure, and various manufacturing applications, meeting specific project needs.

Electronics: Delivering custom components, Norck supports electronic devices, ensuring compatibility and performance in advanced systems.

Energy: Supplying high-performance parts, Norck serves renewable energy, oil and gas, and power generation applications, contributing to efficient energy solutions.

Norck’s tailored solutions ensure each industry’s unique requirements are met with precision and reliability, reinforcing its commitment to quality and innovation.

About Norck

Norck is a global leader in advanced manufacturing, specializing in precision CNC machining, custom component manufacturing, metal 3D printing, and injection molding. With a strong commitment to innovation, quality, and customer satisfaction, Norck delivers tailored manufacturing solutions to businesses worldwide. By combining personalized engineering support, cutting-edge technologies, and a curated network of trusted manufacturing partners, Norck empowers industries to achieve their most ambitious goals.

For more information about Norck’s services and solutions, visit www.norck.com

Media Contact

Dennis Weiss, NORCK INC – NORCK GMBH, 1 949-232-0251, ed@norck.com, www.norck.com

Ed Braun, NORCK INC – NORCK GMBH, www.norck.com

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SOURCE NORCK INC – NORCK GMBH; NORCK INC – NORCK GMBH

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