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Umoja Biopharma

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Overview

Umoja Biopharma is a pioneering biotechnology company focused on developing innovative immunotherapies, particularly in the field of cell and gene therapies. The company's mission is to unlock the potential of CAR T cell therapies, making them more accessible, scalable, and effective for patients with solid tumor and blood cancers. Umoja's integrated scientific platforms include:

  1. VivoVec: A proprietary, third-generation lentiviral vector technology for in vivo gene delivery, enabling the body to produce its own cancer-fighting CAR T cells.
  2. RACR (Rapamycin-Activated Cytokine Receptor): A system using rapamycin to support the survival and expansion of CAR T cells generated in vivo, eliminating the need for lymphodepletion via chemotherapy.
  3. iCIL (RACR-induced cytotoxic lymphocytes): A platform generating synthetic cancer-fighting cells from induced pluripotent stem cells (iPSCs) at a large scale.
  4. TumorTag: A small molecule that 'tags' cancer and its stromal cells, allowing precise targeting by CAR T cells. Umoja's manufacturing capabilities are centered around The CLIMB (Colorado Laboratory & Innovative Manufacturing Building), a state-of-the-art facility in Louisville, Colorado. This facility supports lentiviral vector development and manufacturing through Phase 2 clinical studies. The company is led by a team of experienced professionals, including co-founders Andrew Scharenberg, MD (CEO) and Ryan Crisman, PhD (CTO). Umoja's approach aims to overcome limitations of current ex vivo cellular immunotherapies by developing 'off-the-shelf' cell therapies that are scalable, cost-effective, and widely accessible.

Leadership Team

Umoja Biopharma's leadership team comprises experienced professionals from the biotechnology and pharmaceutical industries: Executive Leadership:

  • Andrew Scharenberg, MD: Co-founder and CEO
  • Ryan Crisman, PhD: Co-founder and CTO
  • David Fontana, PhD: COO and CBO
  • Britton Russell: CFO
  • Chris Moore, JD: Chief Legal Officer Senior Vice Presidents:
  • Ryan Larson, PhD: SVP and Head of Research
  • Sally M. Dyer: SVP and General Manager of Colorado Operations
  • Jacob Garcia, MD: SVP of Clinical Operations & Development
  • Helen Kim: SVP of Regulatory Affairs
  • Jennifer Lester, MA: SVP of IT & Informatics
  • Bruce Kerwin, PhD: SVP of Process and Product Development Vice Presidents:
  • Chris Lewis: VP of Quality
  • Geoff Quinn: VP of Corporate Operations
  • Mae-Lee Pang: VP of Human Resources
  • Mike Fitzpatrick: VP of Business Development and Operations Board of Directors:
  • Scott Myers: Chairman
  • Andrew Scharenberg, MD: CEO
  • Luke Evnin, PhD: MPM Capital representative
  • John Hamer, PhD: DCVC Bio representative
  • Anna French, PhD: Qiming Venture Partners USA representative Advisory Board:
  • Michael Jensen, MD: Co-founder and Co-chair of Scientific Advisory Board
  • Hans-Peter Kiem, MD, PhD: Fred Hutch Endowed Chair for Cell and Gene Therapy
  • Rimas Orentas, PhD: Ben Towne Center for Childhood Cancer
  • Igor I Slukvin, MD, PhD: University of Wisconsin, Madison This diverse team brings extensive experience in immunotherapy, cell and gene therapy, drug development, and business operations to drive Umoja Biopharma's mission forward.

History

Umoja Biopharma, a Seattle-based biotechnology company, was founded in 2019 by a team of experienced professionals:

  • Dr. Andrew Scharenberg: Co-founder and CEO
  • Dr. Michael Jensen: Vice President of Seattle Children's Therapeutics
  • Dr. Philip Low: Professor at Purdue University
  • Ryan Crisman: Co-founder and CTO The company's technology is based on pioneering work from Seattle Children's Research Institute and Purdue University, focusing on in vivo CAR T-cell immunotherapy. Key milestones:
  1. 2020: Raised $53 million in Series A funding
  2. 2021: Secured an additional $210 million in funding
  3. January 2025: Announced a $100 million Series C round
  4. November 2024: Appointed Scott Myers as Chairman of the Board Umoja has established a state-of-the-art lentiviral vector development and manufacturing facility in Louisville, Colorado, addressing scalability and manufacturing challenges. The company's pipeline includes several preclinical programs and one program, UB-TT170, which has entered Phase 1 trials. Umoja aims to initiate clinical trials in multiple geographies and has recently initiated its first US IND. Umoja Biopharma's mission is to transform the delivery of CAR-T cell therapies, making them more accessible and effective for a broader range of patients with cancer.

Products & Solutions

Umoja Biopharma, a clinical-stage biotechnology company, is at the forefront of developing innovative immunotherapies for oncology and autoimmunity. Their key products and solutions include:

VivoVec™ In Vivo Gene Delivery Technology

VivoVec™ is Umoja's flagship platform that enables direct in vivo delivery of genetic material to generate CAR-T cells within the patient's body. This groundbreaking approach eliminates the need for external cell modification, addressing time lag and manufacturing challenges associated with traditional ex vivo CAR-T cell therapies.

RACR/CAR In Vivo Cell Expansion/Control Platform

This platform utilizes the Rapamycin Activated Cytokine Receptor (RACR) to control and expand immune cells in vivo. By inducing cell expansion and persistence through rapamycin infusion, the RACR system enhances immunotherapy efficacy.

TumorTag Targeting Platform

TumorTag improves tumor cell targeting by labeling multiple targets within the tumor environment with bispecific small molecule adapters (TumorTags). These TumorTags are recognized by universal TagCAR expressed on engineered immune cells, enhancing treatment precision and efficacy.

Engineered Induced Pluripotent Stem Cells (iPSCs)

Umoja is developing an 'off-the-shelf' immunotherapy platform using engineered iPSCs designed to differentiate into lymphocytes such as T cells and natural killer (NK) cells. This approach aims to overcome challenges associated with patient-derived cells, including limited expansion capacity, manufacturing complexity, and high cost.

Strategic Collaborations

  1. Lupagen: Umoja is collaborating with Lupagen to evaluate the use of Lupagen's extracorporeal in vivo delivery system, Side CAR-T™, to enhance the delivery of Umoja's VivoVec particles.
  2. AbbVie: Umoja has entered into a strategic collaboration with AbbVie to develop multiple in-situ generated CAR-T cell therapy candidates using Umoja's VivoVec™ platform. This includes developing up to four additional CAR-T cell therapy candidates for targets selected by AbbVie. These innovative technologies and strategic partnerships underscore Umoja Biopharma's commitment to broadening access to advanced immunotherapies, improving their effectiveness, and enhancing the patient experience.

Core Technology

Umoja Biopharma's core technology revolves around several innovative platforms designed to enhance and expand the reach of CAR T cell therapies, particularly in oncology and autoimmunity:

VivoVec™ Technology

The flagship VivoVec™ platform is an in vivo gene delivery system that enables direct generation of CAR T cells within the patient's body. This technology uses lentiviral vectors to deliver genetic material to the patient's T cells, empowering the body's immune system to fight disease without the need for external cell modification.

RACR-induced Cytotoxic Lymphocytes (iCIL)

Umoja is developing RACR-induced cytotoxic lymphocytes (iCIL) using the RACR (rapamycin activated cytokine receptor) technology. This platform generates synthetic cancer-fighting cells from induced pluripotent stem cells, which can be administered to patients to augment their anti-tumor immune function and work in conjunction with VivoVec-generated CAR T cells.

RACR/CAR™ and TumorTag™ Platforms

These platforms support the survival and targeting of tumor-fighting T cells:

  1. RACR/CAR™: This payload architecture stimulates the body to grow tumor-fighting T cells.
  2. TumorTag™: This platform directs the cells to attack the tumor, enhancing therapeutic effect while minimizing adverse events.

Manufacturing and Development

Umoja Biopharma operates a state-of-the-art lentiviral vector development and manufacturing facility in Louisville, Colorado. This facility is crucial for the production and development of the lentiviral vectors used in the VivoVec™ technology. These integrated platforms work synergistically to overcome the limitations of current ex vivo cellular immunotherapies. By increasing effectiveness, reducing barriers, and expanding access to CAR T cell therapies, Umoja Biopharma aims to revolutionize the field of immunotherapy and improve patient outcomes.

Industry Peers

Umoja Biopharma operates in the biopharmaceutical industry, focusing on immunotherapy and CAR-T cell therapies. The company's key competitors and industry peers include:

Major Competitors

  1. Genentech: Known for innovative cancer therapies and a significant player in immunotherapy.
  2. Bristol-Myers Squibb: Recognized for immunotherapy drugs and substantial investments in research and development.
  3. Merck & Co.: Made significant advancements in immunotherapy, particularly with checkpoint inhibitors.
  4. Gilead Sciences: Although primarily known for antiviral drugs, Gilead has ventured into immunotherapy for cancer and other diseases.
  5. Novartis: A multinational pharmaceutical company with a strong presence in oncology and developing promising immunotherapy drugs.

Other Industry Peers

  • Novavax: Known for vaccine development and involved in various biotechnological research areas.
  • Regeneron: Develops treatments for various diseases, including cancer and autoimmune disorders.
  • Sanofi: A global pharmaceutical company with a diverse portfolio that includes immunotherapies.
  • Johnson & Johnson: Major pharmaceutical company with significant investments in oncology and immunotherapy.
  • Moderna: Known for mRNA-based therapies and exploring immunotherapy options.
  • Pfizer: Global pharmaceutical giant with a broad range of therapeutic areas, including oncology and immunology.
  • AstraZeneca: Major pharmaceutical company with a strong focus on oncology and immunotherapy.

Strategic Partners

Umoja Biopharma has established strategic collaborations to enhance its position in the industry. A notable partnership is with AbbVie, focusing on developing in-situ generated CAR-T cell therapy candidates using Umoja's VivoVec™ platform. This competitive landscape highlights the dynamic nature of the immunotherapy field, with various companies pursuing innovative approaches to treat cancer and autoimmune disorders. Umoja Biopharma's unique in vivo CAR-T cell generation technology positions it as a potential disruptor in this rapidly evolving industry.

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