PDS Biotechnology
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.
- Company typePublic
- Founded2019
- HeadquartersNorth Brunswick, United States
- Headcount11–50
- GTM typeB2B
- OfferingHardware or Manufacturing
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.
PDS Biotechnology firmographics
Firmographics- 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
PDS Biotechnology industry classification
Industry- 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
Where PDS Biotechnology is headquartered
LocationHeadquarters
- HQ city
- North Brunswick
- HQ country
- United States
- HQ region
- North America
Offices2 records
Markets served
PDS Biotechnology business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Personnel, Operations, Marketing or Sales
Revenue model
- 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
- 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
PDS Biotechnology product offering
Product offeringCore 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
Companies that use PDS Biotechnology
Customer profileNamed customers4 records
Segments5 records
Ideal customer profiles2 records
PDS Biotechnology technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature5 records
PDS Biotechnology partnerships and signals
Strategic signalPartnerships
Eight partnerships are on record, tiered core and minor.
- University of Texas MD Anderson Cancer CentercoreLeads 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 CliniccoreInvestigator-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)coreNIAID-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 InstitutecoreLicensed 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 GeorgiacoreLicensed 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 partnership to support awareness and education around head and neck cancers and HPV16-positive cancer treatments.
- Farmacore / Blanver ConsortiumminorPartnership 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.)coreCollaboration 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
PDS Biotechnology competitors and assessment
Company assessmentBroad 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
PDS Biotechnology social profiles
Digital presencePDS Biotechnology compliance and trust
Trust signalCompliance1 record
PDS Biotechnology financial estimates
Financial estimateRevenue estimate
Valuation estimate
PDS Biotechnology leadership team
Management profileNumber of profiles
Profiles10 records
PDS Biotechnology funding detail
Funding detailFunding overview
Funding rounds8 records
Investors2 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
PDS Biotechnology M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about PDS Biotechnology
What does PDS Biotechnology do?
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.
Is PDS Biotechnology a public or private company?
PDS Biotechnology is a public company. It is classified as public and is currently operating.
When was PDS Biotechnology founded?
PDS Biotechnology was founded in 2019. It employs 11 to 50 people.
Where is PDS Biotechnology based?
PDS Biotechnology is headquartered in North Brunswick, United States, in the North America region.
How does PDS Biotechnology make money?
Two revenue lines are on record. Pharmaceutical Product Sales are the primary driver. The others are licensing Royalties.
Who are PDS Biotechnology's main competitors?
Broad incumbents on record are Bristol-Myers Squibb and Merck & Co.. Direct peers are Immatics, Moderna, Heat Biologics, Adaptimmune, Gritstone bio, Marker Therapeutics, BioNTech and Hookipa Pharma.
Does PDS Biotechnology have an API?
No public API is recorded for PDS Biotechnology.
What industry is PDS Biotechnology in?
PDS Biotechnology's product category is Cancer Immunotherapy. Its primary akta.pro industry code is HLAAAEAB, Therapeutic Vaccines (cancer, chronic infection immunotherapy), with a secondary code of HLAAAAAE, Antibody-Drug Conjugates (ADCs) & Antibody Conjugates. Its NAICS code is 325414 and its SIC code is 2836.