Candid Therapeutics Company Profile

Background

Candid Therapeutics, Inc., established in 2024 and headquartered in San Diego, CA, is a clinical-stage biotechnology company dedicated to developing transformative therapies for autoimmune diseases. The company's mission is to lead the advancement of T-cell engagers (TCEs) targeting B-cell depletion, aiming to address significant unmet medical needs in immunology. By focusing on innovative bispecific antibody therapies, Candid seeks to revolutionize the treatment landscape for various autoimmune conditions.

Key Strategic Focus

Candid's strategic focus centers on the development and commercialization of TCE antibodies designed to selectively deplete B lymphocytes, which play a pivotal role in autoimmune pathology. The company is advancing two lead B-cell depleting TCE antibody drug candidates:

CND106: A BCMAxCD3 bispecific antibody, initially developed by Vignette Bio and licensed from EpimAb Biotherapeutics.

CND261: A CD20xCD3 bispecific antibody, originally from TRC 2004 and licensed from Genor Biopharma.

Both candidates have completed Phase 1 dose escalation studies in oncology patients, demonstrating potential as best-in-class therapies for various autoimmune diseases. Candid aims to explore the efficacy of these TCEs across multiple autoimmune indications by targeting different B-cell protein targets and evaluating varying depths of B-cell depletion.

Financials and Funding

In September 2024, Candid Therapeutics successfully raised over $370 million in capital through a financing round co-led by Venrock Healthcare Capital Partners, Fairmount, TCGX, and venBio Partners. Other notable investors include Foresite Capital, Third Rock Ventures, Fidelity Management & Research Company, Samsara BioCapital, Qiming Venture Partners USA, OrbiMed, Boxer Capital, Redmile Group, Vida Ventures, Two River, Franklin Templeton, LifeSci Venture Partners, Mirae Asset Capital Life Science, Polaris Innovation Fund, and Soleus Capital. This substantial financial backing underscores strong investor confidence in Candid's strategic vision and positions the company to advance its clinical development programs and expand its pipeline.

Pipeline Development

Candid's pipeline is anchored by its two lead TCE antibody drug candidates:

CND106 (BCMAxCD3 bispecific antibody): Completed Phase 1 dose escalation studies in oncology patients.

CND261 (CD20xCD3 bispecific antibody): Also completed Phase 1 dose escalation studies in oncology patients.

Both candidates are being repositioned for autoimmune indications, with plans to initiate clinical trials targeting specific autoimmune diseases. The company is committed to rapidly advancing these assets through clinical development to address unmet needs in the autoimmune disease space.

Technological Platform and Innovation

Candid Therapeutics leverages advanced bispecific antibody technology to develop T-cell engagers that selectively target B-cell antigens. This approach enables precise modulation of the immune system, offering potential advantages over existing therapies. The company's proprietary technologies include:

Bispecific Antibody Engineering: Designing antibodies that simultaneously bind to CD3 on T cells and specific B-cell antigens (e.g., BCMA, CD20), facilitating targeted B-cell depletion.

T-Cell Engager (TCE) Platform: Developing scalable and patient-friendly TCEs that can be administered without the complexities associated with cell therapies.

These innovations position Candid at the forefront of immunotherapy development for autoimmune diseases.

Leadership Team

Candid's leadership comprises seasoned professionals with extensive experience in biotechnology and pharmaceutical development:

Ken Song, MD: Chairman, President, and CEO. Dr. Song has over 25 years of experience in entrepreneurship, investing, clinical medicine, and research. He previously led RayzeBio from its inception to a $4.1 billion acquisition by Bristol Myers Squibb.

Tim Lu, MD, PhD: Chief Medical Officer & Chief Scientific Officer. Dr. Lu has over 20 years of clinical and research experience, notably contributing to the development of novel oral IL-17 drugs for autoimmune diseases at DICE Therapeutics.

Arvind Kush: Chief Financial Officer & Chief Business Officer. Mr. Kush brings over 15 years of finance and investment banking experience, having previously served as CFO at RayzeBio and as a Managing Director in healthcare investment banking at Bank of America Securities.

Bernie Huyghe, PhD: Chief Technology Officer. Dr. Huyghe has over 30 years of experience in biologics CMC development and manufacturing, with prior roles at Viridian Therapeutics, Allogene, and Pfizer.

David Luo: Senior Vice President, Clinical Operations. Mr. Luo has over 20 years of drug development experience across multiple therapeutic areas, including immunotherapies and oncology, with key contributions to eight FDA-approved programs.

Jeff Woodley: General Counsel. Mr. Woodley has over a decade of corporate legal experience, previously serving as General Counsel at RayzeBio and Medalogix, and as an attorney at Latham & Watkins LLP.

Kathryn Shah: Senior Vice President, Portfolio and Program Management. Ms. Shah has 20 years of program management experience in the biotech/pharma industry, with leadership roles at RayzeBio, Ultragenyx, AbbVie, and Abbott.

Peter Wung, MD: Senior Vice President, Clinical Development. Dr. Wung has nearly 15 years of industry and clinical development experience across multiple therapeutic areas, including rheumatology and immunology, with prior roles at AbbVie, Sanofi, and Kyverna.

Leadership Changes

In October 2024, Candid appointed Dr. Angie You and Mr. Dan Puckett to its Board of Directors:

Angie You, PhD: Dr. You is the CEO and a board member of Architect Therapeutics, with prior leadership roles at Amunix Pharmaceuticals, Sierra Oncology, and Aragon Pharmaceuticals.

Dan Puckett: Mr. Puckett served as CFO of Shockwave Medical, playing a pivotal role in its growth leading to a $13.1 billion acquisition by Johnson & Johnson in 2024.

These appointments bring additional expertise in scaling organizations and advancing innovative products into development and commercialization.

Competitor Profile

Market Insights and Dynamics

The autoimmune disease therapeutics market is substantial and growing, driven by increasing prevalence and advancements in treatment modalities. Traditional therapies include immunosuppressants and biologics targeting specific immune pathways. Emerging treatments, such as T-cell engagers and bispecific antibodies, are gaining traction due to their potential for targeted immune modulation with improved safety profiles.

Competitor Analysis

Key competitors in the autoimmune therapeutics space include:

AbbVie: Developer of Humira® (adalimumab), a TNF inhibitor widely used for various autoimmune conditions.

Genentech (a member of the Roche Group): Producer of Rituxan® (rituximab), a monoclonal antibody targeting CD20 on B cells, used in rheumatoid arthritis and other autoimmune diseases.

Eli Lilly and Company: Acquired DICE Therapeutics, focusing on oral IL-17 inhibitors for autoimmune diseases.

Janssen Pharmaceuticals (a Johnson & Johnson company): Develops Stelara® (ustekinumab), an IL-12 and IL-23 inhibitor for conditions like psoriasis and Crohn's disease.

These companies have established therapies in the market, but Candid's focus on T-cell engagers offers a novel approach that may provide advantages in efficacy, safety, and patient convenience.

Strategic Collaborations and Partnerships

Candid has entered into strategic collaborations to enhance its pipeline and technological capabilities:

EpimAb Biotherapeutics: In December 2024, Candid partnered with EpimAb to discover and develop novel T-cell engager candidates for autoimmune indications. Under the agreement, EpimAb is eligible for over $1 billion in development and sales milestones, plus royalties on net sales.

Ab Studio: Also in December 2024, Candid collaborated with Ab Studio to discover and develop novel T-cell engager candidates. Ab Studio will receive undisclosed payments, and Candid has exclusive rights to develop and commercialize programs from this collaboration.

These partnerships aim to broaden Candid's pipeline and leverage cutting-edge antibody design and engineering platforms.

Operational Insights

Candid's strategic positioning involves:

First-Mover Advantage: By focusing on T-cell engagers for autoimmune diseases, Candid aims to be among the first to market with this novel therapeutic approach.