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Kyverna Therapeutics

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Overview

Kyverna Therapeutics, Inc. (Nasdaq: KYTX) is a clinical-stage biopharmaceutical company focused on developing innovative cell therapies for autoimmune diseases. The company's primary goal is to harness the power of T cells to achieve potentially treatment-free remission by resetting the immune system.

Lead Product Candidate

KYV-101, Kyverna's lead CAR T-cell therapy candidate, targets CD19 and is advancing through clinical trials for various autoimmune diseases:

  • Phase 2 trials for multiple sclerosis, myasthenia gravis, and stiff-person syndrome
  • Phase 1/2 trials for systemic sclerosis and lupus nephritis
  • Ongoing multi-center, open-label Phase 1/2 trials in the US and Germany for lupus nephritis

Clinical Progress

As of July 31, 2024, Kyverna had treated 36 autoimmune patients with KYV-101, reporting promising initial safety and efficacy data. No severe ICANS (Immune Cell-Associated Neurotoxicity Syndrome) or CRS (Cytokine Release Syndrome) Grade ≥3 were reported. KYV-101 has received FDA Regenerative Medicine Advanced Therapy (RMAT) Designations for stiff-person syndrome and myasthenia gravis.

Pipeline

Kyverna is developing next-generation CAR T-cell therapies in both autologous and allogeneic formats, including KYV-201, an allogeneic CD19 CAR T-cell product candidate.

Leadership

Recent key appointments include:

  • Dan Maziasz as Chief Business Officer
  • Cara Bauer as Chief Human Resources Officer
  • Tracy Rossin as Senior Vice President of Corporate Affairs, Communications, and Investor Relations

Financials

Kyverna raised approximately $366.9 million in gross proceeds from its initial public offering in February 2024, supporting the advancement of its clinical development programs.

Headquarters and Culture

Based in the San Francisco East Bay, Kyverna fosters a collegial, collaborative environment that nurtures diverse scientific talent to develop transformative cell therapies. Kyverna Therapeutics stands at the forefront of developing innovative cell therapies aimed at providing durable, immunosuppressant-free remission for patients with severe autoimmune diseases.

Leadership Team

Kyverna Therapeutics' leadership team comprises experienced professionals dedicated to advancing cell therapies for autoimmune diseases. Key members include:

Chief Executive Officer (CEO)

  • Warner Biddle: Appointed on September 16, 2024, Biddle brings over 30 years of global experience in commercial, product planning, and franchise leadership. His background includes successful launches of CAR T therapies at Kite Pharma.

Board of Directors

  • Ian Clark: Chairman of the Board, guiding strategic decisions and welcoming new leadership.
  • Christi Shaw: Appointed on September 16, 2024, Shaw has extensive experience in executive roles at major pharmaceutical and biotech companies. She also serves on boards of Avantor, Beam Therapeutics, and ReAlta Lifesciences.

Research and Development

  • Dominic Borie, M.D., Ph.D.: President of Research and Development, formerly CEO. Borie continues to advance core programs, including KYV-101, and manages strategic partnerships with Gilead and Intellia.

Former Leadership

  • Peter Maag, Ph.D.: Served as CEO from October 2022 to September 2024. During his tenure, Maag established a strong foundation for the company, translating exploratory science into a robust clinical program and securing a successful initial public offering. The leadership team at Kyverna Therapeutics is committed to advancing cell therapies for autoimmune diseases, with a particular focus on CAR T-cell therapies like KYV-101 for the treatment of lupus nephritis and other conditions.

History

Kyverna Therapeutics has made significant strides in developing innovative cell therapies for autoimmune diseases since its inception. Key milestones include:

Founding and Early Funding (2020)

  • Secured $25 million in Series A funding from investors including Vida Ventures, Westlake Village BioPartners, and Gilead Sciences.
  • Announced a strategic collaboration with Gilead Sciences, including an upfront payment of $17.5 million and potential milestones of up to $570 million.

Series B Financing (2022)

  • Closed an oversubscribed $85 million Series B financing round led by Northpond Ventures, with participation from existing and new investors.

Clinical Development and Regulatory Milestones

  • Advanced lead product candidate KYV-101, a CAR T-cell therapy targeting CD19 for B cell-driven autoimmune diseases.
  • Initiated clinical trials in neurology and rheumatology, including Phase 2 trials for multiple sclerosis, myasthenia gravis, and stiff-person syndrome.
  • Received FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for KYV-101 in treating Stiff-Person Syndrome and Myasthenia Gravis.

Financial and Clinical Updates (2024)

  • Reported $346.2 million in cash, cash equivalents, and available-for-sale marketable securities as of June 30, 2024.
  • Presented promising initial safety and efficacy data for KYV-101, with no severe immune cell-associated neurotoxicity syndrome (ICANS) or cytokine release syndrome (CRS) reported in the first 36 autoimmune disease patients treated.

Ongoing Research and Development

  • Continues to develop its therapeutic platform, combining advanced T-cell engineering and synthetic biology technologies.
  • Working on synReg T cells, a synthetic version of Regulatory T cells (Tregs), to control immune homeostasis. Kyverna Therapeutics has established itself as a leader in cell therapy development for autoimmune diseases, supported by substantial funding and strategic collaborations. The company's progress in clinical trials and regulatory achievements positions it well for future advancements in this critical field.

Products & Solutions

Kyverna Therapeutics, a clinical-stage biopharmaceutical company, is at the forefront of developing innovative cell therapies for autoimmune and inflammatory diseases. Their product pipeline and solutions include:

  1. CAR T-Cell Therapies: Kyverna is pioneering next-generation chimeric antigen receptor (CAR) T-cell therapies in both autologous and allogeneic formats. Their flagship product, KYV-101, is a fully human anti-CD19 CAR T-cell therapy currently undergoing Phase 1 clinical trials in the US and Europe. This therapy aims to deplete B cells, offering a potentially curative approach for autoimmune diseases.
  2. Ingenui-T Platform: This proprietary platform optimizes autologous manufacturing processes for CAR T-cell therapies. It enhances patient experience, accelerates product availability, and reduces manufacturing costs, making personalized cell therapies more accessible.
  3. SynReg T Cells: Kyverna is developing synthetic Regulatory T cells (Tregs), known as synReg T cells. These engineered cells mimic the natural immunosuppressive mechanisms of Tregs, providing an additional avenue for managing autoimmunity.
  4. Collaborative Solutions: Kyverna partners with industry leaders to advance their therapies. For instance, their collaboration with Verily utilizes the Immune Profiler platform to identify biomarkers of treatment response in autoimmune patients treated with KYV-101.
  5. Advanced T-Cell Engineering and Synthetic Biology: Kyverna's therapeutic platform combines cutting-edge T-cell engineering with synthetic biology to target and eliminate autoreactive immune cells. This approach aims to reset the immune system, potentially achieving treatment-free remission in autoimmune and inflammatory diseases. By leveraging these innovative products and solutions, Kyverna Therapeutics is poised to transform the treatment landscape for autoimmune and inflammatory disorders, offering new hope for patients with limited therapeutic options.

Core Technology

Kyverna Therapeutics' core technology revolves around advanced T-cell engineering and synthetic biology, specifically tailored for autoimmune and inflammatory diseases. Key components of their technological approach include:

  1. Advanced T-cell Engineering: Kyverna develops next-generation chimeric antigen receptor (CAR) T-cell therapies in both autologous (patient-derived) and allogeneic (off-the-shelf) formats. These therapies are designed to target and eliminate autoreactive immune cells that drive autoimmune diseases.
  2. Synthetic Biology: The company leverages synthetic biology to enhance the functionality and tolerability of their CAR T-cell therapies. This includes using a fully human anti-CD19 CAR T construct with engineered costimulatory domains to minimize cytokine release and improve clinical tolerability.
  3. Anti-CD19 CAR T Construct: Kyverna has secured an exclusive worldwide license from the National Institutes of Health (NIH) for a novel clinical-stage anti-CD19 CAR T construct. This construct, designed for use in both autologous and allogeneic therapies, has demonstrated improved tolerability in clinical studies.
  4. Ingenui-T Manufacturing Platform: This proprietary platform optimizes the production of autologous CAR T-cell therapies. It enhances patient experience, accelerates product availability, and reduces manufacturing costs, making personalized cell therapies more accessible.
  5. SynReg T Cells: In addition to CAR T-cell therapies, Kyverna is developing synthetic Regulatory T cells (Tregs), known as synReg T cells. These engineered cells mimic the natural immunosuppressive mechanisms of Tregs, offering an alternative approach to managing autoimmunity.
  6. CRISPR/Cas9 Collaboration: Kyverna has partnered with Intellia Therapeutics to utilize CRISPR/Cas9-based allogeneic cell engineering platforms. This collaboration aims to develop safer and more effective therapies by combining Kyverna's CAR T-cell constructs with Intellia's genome editing technology. By integrating these advanced technologies, Kyverna Therapeutics is positioned at the cutting edge of cell therapy development for autoimmune and inflammatory diseases, potentially offering transformative treatments for patients with unmet medical needs.

Industry Peers

Kyverna Therapeutics operates in a competitive landscape of biotechnology and pharmaceutical companies focused on innovative therapies for various diseases. While Kyverna specializes in cell therapies for autoimmune and inflammatory conditions, its industry peers and competitors span a broader range of therapeutic areas and technologies. Key players include:

  1. Cell Therapy and Autoimmune Disease Specialists:
  • Autolus Therapeutics (AUTL): Focuses on CAR-T cell therapies
  • Adaptimmune Therapeutics plc: Develops T-cell therapies for cancer and autoimmune diseases
  • Allogene Therapeutics, Inc.: Specializes in allogeneic CAR-T cell therapies
  • Annexon (ANNX): Concentrates on autoimmune and neurodegenerative diseases
  1. Broader Biotechnology Companies:
  • Kura Oncology (KURA): Primarily focused on oncology
  • Arbutus Biopharma (ABUS): Specializes in RNA-targeting therapeutics
  • Stoke Therapeutics (STOK): Concentrates on RNA-based therapies for genetic diseases
  • ORIC Pharmaceuticals (ORIC): Develops therapies targeting cancer and other diseases
  • Ginkgo Bioworks (DNA): A synthetic biology company
  1. Rare Disease and Specialty Pharma:
  • VectivBio (VECT): Works on treatments for rare gastrointestinal diseases
  • Phathom Pharmaceuticals (PHAT): Focuses on gastrointestinal diseases
  • Mereo BioPharma Group (MREO): Develops treatments for rare diseases
  1. Advanced Technology and Precision Medicine:
  • Metagenomi, Inc.: A gene editing biotech company
  • DiaCarta: Known for molecular diagnostics and precision medicine solutions
  • Mission Bio: Focuses on single-cell genomics and precision medicine
  • Quadrants Scientific: Involved in various biotechnological research and development
  1. Oncology and Immunotherapy:
  • CG Oncology, Inc.: Works on oncolytic virus therapies and other cancer treatments While these companies may not all directly compete with Kyverna in the autoimmune cell therapy space, they represent the diverse and innovative landscape of the biotechnology industry. Kyverna's unique focus on cell therapies for autoimmune and inflammatory diseases sets it apart, but it must continue to innovate and differentiate its offerings in this rapidly evolving field.

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