PDS Biotechnology

What PDS Biotechnology does

PDS Biotechnology Corporation (NASDAQ: PDSB) is a clinical-stage biopharmaceutical company headquartered in Princeton, New Jersey that develops targeted cancer immunotherapies and infectious disease vaccines based on two proprietary T-cell activating platforms, Versamune® and Infectimune™. The Versamune® platform is designed to deliver disease-specific antigens for in vivo uptake and processing while activating the type 1 interferon immunological pathway, generating potent tumor-specific CD4+ and CD8+ killer T cells independent of patient HLA background. The company's lead oncology candidate, PDS0101 (Versamune® HPV), targets HPV16-positive cancers—principally recurrent/metastatic head and neck squamous cell carcinoma—where Phase 2 (VERSATILE-002) data reported median overall survival of 39.3 months, disease control rate of 77.4%, and 21% of patients with 90–100% tumor shrinkage. Additional pipeline assets include PDS01ADC, a tumor-targeted IL-12 immunocytokine that uses the NHS76 antibody to bind DNA exposed in tumor cell death; PDS0102 (Versamune®-TARP) for prostate, breast and AML; PDS0103 (Versamune®-MUC1) for breast, colon, lung and ovarian cancers; and PDS0202, an Infectimune™-based universal influenza vaccine leveraging COBRA antigens licensed from the University of Georgia.\n\nThe company's competitive position rests on the combination of these two platform assets—using Versamune® for T-cell priming alongside PDS01ADC's targeted IL-12 delivery to the tumor microenvironment—intended to generate a potent tumor-specific T-cell attack while suppressing the tumor's immune defenses. Notable clinical signals include a 77.8% objective response rate in metastatic colorectal cancer patients treated with PDS01ADC versus approximately 35% in a parallel cohort, a >80% two-year survival rate in the mCRC PDS01ADC cohort, a 100% 36-month survival rate in MD Anderson IMMUNOCERV cervical cancer patients completing 5/5 doses, and a 75% 36-month survival rate in ICI-naïve HPV16-positive patients (versus a published median OS of 7–11 months). PDS0101 has received FDA Fast Track Designation, US Patent 15,724,818 extends protection to October 2037, and newly granted composition-of-matter patents (including a 2026 Japanese patent) extend exclusivity into the 2040s.\n\nAs a clinical-stage company with no approved or commercial products, PDS Biotech is pre-revenue and funds operations through public equity offerings, a $35 million Horizon Technology Finance debt facility, and registered direct offerings. The company has not yet built a commercial sales organization but has assembled an academic and industry collaboration network—most notably a Merck agreement to combine PDS0101 with KEYTRUDA® (pembrolizumab), plus investigator-initiated and NCI-led Phase 2 trials at MD Anderson Cancer Center, Mayo Clinic, University of North Carolina Lineberger, the National Cancer Institute, and the National Institute of Allergy and Infectious Diseases. Upon potential FDA approval of PDS0101, the company would commercialize to U.S. and European oncologists treating HPV16-positive head and neck cancer patients, likely through specialty pharmacy/oncology sales channels and leveraging the existing Merck relationship for combination therapy positioning.

Name

PDS Biotechnology

Legal name

PDS Biotechnology Corporation

Website

https://pdsbiotech.com

Company type

Public

Founded year

2019

Operating status

Operating

Headcount range

11–50 employees

Short description

PDS Biotechnology is a clinical-stage biopharmaceutical company developing targeted cancer immunotherapies and infectious disease vaccines using its proprietary Versamune® and Infectimune™ T-cell activating platforms, with lead candidate PDS0101 now in Phase 3 for HPV16-positive head and neck cancer.

Ownership category

akta.pro rank

Product category

Cancer Immunotherapy

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Pharmaceutical Preparation Manufacturing (325412), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Biological Products, (No Disgnostic Substances) (2836), Pharmaceutical Preparations (2834)

akta.pro primary industry

Therapeutic Vaccines (cancer, chronic infection immunotherapy) (HLAAAEAB)

akta.pro secondary industries

Antibody-Drug Conjugates (ADCs) & Antibody Conjugates (HLAAAAAE), Therapeutic Vaccines (e.g., Cancer/Chronic Infection) (HLAIAEAG)

Keywords

• Cancer immunotherapy
• T cell activating platform
• Infectious disease vaccines
• HPV16-positive cancer treatment
• Tumor-targeted immunocytokines

Headquarters

HQ city

North Brunswick

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales

Revenue model

1. Pharmaceutical Product Sales: Pre-revenue clinical-stage biotech company. Expected to generate revenue through sales of proprietary immunotherapy drugs upon FDA approval, starting with PDS0101 for HPV16-positive head and neck cancer
2. Licensing Royalties: May pursue licensing arrangements for Versamune® and Infectimune™ platforms to other pharmaceutical companies

Go-to-market motion1 record

Distribution channels2 records

Marketing channels5 records

Core offering

PDS Biotechnology develops clinical-stage immunotherapy product candidates for cancer and infectious diseases using its proprietary Versamune® and Infectimune™ T-cell activating platforms. Its lead candidate PDS0101 targets HPV16-positive head and neck and other HPV-related cancers in combination with checkpoint inhibitors, and additional candidates (PDS01ADC, PDS0102, PDS0103, PDS0301, PDS0202) target solid tumors and influenza. The company is pre-revenue and is advancing PDS0101 through a Phase 3 trial (VERSATILE-003) toward potential FDA accelerated approval.

Product overview

PDS Biotechnology is a late-stage immunotherapy company developing a pipeline of targeted cancer immunotherapies and infectious disease vaccines based on proprietary Versamune® and Infectimune™ T cell activating platforms. The core product portfolio includes lead candidate PDS0101 (Versamune® HPV) for HPV16-positive cancers, PDS01ADC tumor-targeted IL-12 immunocytokine, and pipeline candidates PDS0102, PDS0103, and PDS0202 for various cancers and infectious diseases. The Versamune® platform enables in vivo delivery of disease-specific antigens and activation of type 1 interferon pathway, while Infectimune™ provides robust antibody and T cell responses for vaccine applications.

Differentiator

Problem solved

Functional benefit

Products and services

• PDS0101 (Versamune® HPV) Novel HPV-targeted immunotherapy combining Versamune® technology with HPV16 protein fragments to induce potent killer T cells that recognize and attack HPV16-positive cancers (head and neck, cervical, anal, penile, vaginal, vulvar); administered by subcutaneous injection alone or with checkpoint inhibitors.
• PDS01ADC Tumor-targeted IL-12 immunocytokine that uses the NHS76 antibody to bind DNA exposed in areas of tumor cell death, delivering IL-12 directly to the tumor while minimizing systemic exposure. In trials for metastatic colorectal cancer (MSS/pMMR), metastatic castration-resistant prostate cancer, and other solid tumors.
• PDS0102 (Versamune®-TARP) Versamune®-based immunotherapy combined with TARP antigen targeting prostate cancer, breast cancer, and acute myeloid leukemia (AML).
• PDS0103 (Versamune®-MUC1) Versamune®-based immunotherapy combined with MUC1 antigen targeting multiple cancers including breast, colon, lung, and ovarian cancers.
• PDS0202 (Infectimune™ Universal Flu Vaccine) Universal influenza vaccine combining the proprietary Infectimune™ platform with COBRA (Computationally Optimized Broadly Reactive Antigens) licensed from the University of Georgia, designed to provide broad protection against multiple flu strains.
• PDS0301 Novel investigational tumor-targeting IL-12 antibody-drug conjugate that enhances the proliferation, potency, and longevity of T cells in the tumor microenvironment.

Quantifiable outcome

• 77.8% objective response rate in metastatic colorectal cancer patients with PDS01ADC vs 35% in parallel trial without PDS01ADC
• +6 more outcomes

Named customers4 records

Segments5 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Eight partnerships are on record, tiered core and minor.

• University of Texas MD Anderson Cancer CentercoreStrategic or Co-development Partner · 3 October 2022Leads IMMUNOCERV Phase 2 clinical trial in first-line treatment of locally advanced cervical cancer with PDS0101. Reported 100% 36-month survival rate in patients who received 5/5 doses of Versamune® HPV.
• Mayo CliniccoreStrategic or Co-development Partner · 15 February 2022Investigator-Initiated Trial MC200710 evaluating PDS0101 alone or in combination with KEYTRUDA® in patients with HPV-associated oropharyngeal cancer at high risk of recurrence. Led by Drs. Routman, Price, Van Abel, and Chintakuntlawar.
• National Institute of Allergy and Infectious Diseases (NIAID)coreStrategic or Co-development Partner · 27 January 2022NIAID-sponsored preclinical work for PDS0202 universal influenza vaccine performed by Dr. Jerold Woodward at University of Kentucky and Dr. Ted Ross at University of Georgia.
• National Cancer InstitutecoreStrategic or Co-development Partner · 8 November 2021Licensed protein from NCI for treatment of acute myeloid leukemia, prostate and breast cancers. NCI conducts multiple Phase 2 clinical trials evaluating PDS0101 and PDS01ADC across various cancer indications.
• University of GeorgiacoreTechnology or Integration · 1 November 2021Licensed COBRA (Computationally Optimized Broadly Reactive Antigens) antigens designed by Dr. Ted Ross for development of universal influenza vaccine PDS0202. Dr. Ross serves as Principal Investigator at NIAID Collaborative Influenza Vaccine Innovation Center.
• Head and Neck Cancer AllianceminorStrategic or Co-development Partner · 27 May 2021Strategic partnership to support awareness and education around head and neck cancers and HPV16-positive cancer treatments.
• Farmacore / Blanver ConsortiumminorStrategic or Co-development Partner · 22 February 2021Partnership with Farmacore and Brazilian-based Blanver to commercialize Versamune®-based T-cell inducing COVID-19 vaccine candidate. Blanver brings pharmaceutical manufacturing and commercialization expertise in Brazil.
• Merck (Merck Sharp & Dohme Corp.)coreStrategic or Co-development Partner · 1 March 2020Collaboration to evaluate PDS0101 in combination with KEYTRUDA® (pembrolizumab) in Phase 2 VERSATILE-002 trial for recurrent or metastatic HPV16-positive head and neck cancer. Partnership facilitates access to Merck's anti-PD-1 therapy for combination treatment.

Scale indicators12 records

Recent moves7 records

Expansion highlights6 records

Broad incumbents

• Bristol-Myers Squibb: Bristol-Myers Squibb is a broad immuno-oncology incumbent with Opdivo, Yervoy, and a growing ADC and bispecific pipeline that overlaps with the HPV+ head and neck, mCRC, and prostate cancer indications PDS Biotech is pursuing.
• Merck & Co. Merck is both PDS Biotech's combination partner (supplying KEYTRUDA® for PDS0101 trials) and a broad incumbent in immuno-oncology with PD-1, ADC, and other franchises that compete with the same indications PDS Biotech is targeting.

Direct peers

• Immatics: Immatics develops TCR-based immunotherapies (ACTengine®, ACTallo®, TCER®) targeting tumor-specific antigens. It is a direct peer in the field of antigen-specific T-cell activating cancer therapies and shares the immunotherapy + checkpoint-inhibitor combination strategy with PDS Biotech.
• Moderna: Moderna is developing mRNA-based personalized and off-the-shelf cancer vaccines (e.g., mRNA-4157/V940 with Merck) — the most direct competitor in the therapeutic cancer vaccine space, and a peer to PDS Biotech's Versamune®-based HPV16 vaccine franchise.
• Heat Biologics: Heat Biologics is a small clinical-stage cancer vaccine company developing T-cell activating immunotherapies (e.g., HS-110, PTX-35) — a closely comparable peer in size, stage, and mechanism to PDS Biotech.
• Adaptimmune: Adaptimmune develops SPEAR T-cell receptor therapies (e.g., afami-cel, Tecelra) for solid tumors, sharing with PDS Biotech the focus on antigen-specific T-cell activation in solid tumor indications.
• Gritstone bio: Gritstone develops neoantigen-based cancer vaccines (GRANITE, SLATE) using a viral vector prime + self-amplifying RNA boost to drive tumor-specific T-cell responses, an approach directly comparable to PDS Biotech's Versamune® platform.
• Marker Therapeutics: Marker Therapeutics is a small clinical-stage company developing multi-tumor-associated antigen (TAA)-specific T-cell therapies, a directly comparable approach to PDS Biotech's antigen-directed T-cell platform.
• BioNTech: BioNTech's oncology pipeline (BNT122/RO7198457, FixVac, individualized mRNA cancer vaccines) directly competes in the antigen-specific T-cell activating cancer vaccine category that PDS Biotech targets with PDS0101.
• Hookipa Pharma: Hookipa is a clinical-stage biotech using arenavirus-based platforms (TheraT®, VaxWave®) to induce potent CD8+ T-cell responses against infectious disease and cancer targets — closely comparable to PDS Biotech's Versamune® and Infectimune™ platforms.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/PDSBiotech
• LinkedInlinkedin.com/company/pds-biotechnology-corporation

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles10 records

Funding overview

Funding rounds8 records

Investors2 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about PDS Biotechnology