What ISA Pharmaceuticals does

ISA Pharmaceuticals B.V. is a privately held, clinical-stage Dutch biotechnology company founded in 2004 in Leiden (headquartered in Oegstgeest at the Leiden Bio Science Park) that develops rationally designed synthetic therapeutic vaccines for cancer and persistent viral infections. Its product engine rests on two proprietary platforms: the Synthetic Long Peptide (SLP®) technology — which delivers peptide vaccines covering the most immunogenic regions of target antigens and induces both CD4+ and CD8+ T-cell responses regardless of HLA type — and the AMPLIVANT® toll-like receptor (TLR) ligand adjuvant, which enhances dendritic cell targeting and is reported to be roughly 100-fold more potent than reference adjuvants. The clinical pipeline comprises four core programs (ISA101b for HPV16-induced oropharyngeal and cervical cancer; ISA103 for PRAME-positive uveal melanoma and other tumors; ISA104 for chronic hepatitis B; ISA106 for SARS-CoV-2 in immunocompromised patients), plus MyISA® as a personalized neoantigen offering. The most advanced clinical data is the randomized Phase 2 OpcemISA trial (n=199), in which ISA101b plus a checkpoint inhibitor doubled objective response rate versus placebo plus checkpoint inhibitor in a predefined biomarker-defined subgroup of HPV16+ oropharyngeal cancer patients.

ISA does not sell commercial products and does not serve end consumers. Revenue is generated exclusively through licensing agreements and co-development partnerships that yield upfront fees, research and clinical milestone payments, and royalties on eventual net sales — exemplars include the Transgene license for tuberculosis vaccines, the Scancell collaboration on Modi-1/AMPLIVANT® combinations, and historical strategic co-development with Regeneron on ISA101b plus cemiplimab. The company's go-to-market is enterprise, partnership-driven business development aimed at pharmaceutical companies, academic medical centers, and cancer research institutions (e.g., MD Anderson Cancer Center, Erasmus MC, LUMC, Institut Gustave Roussy), with clinical trial sponsorships serving as the principal commercialization vector until regulatory approval enables commercial launch. Investors include Invest-NL, Regeneron, the European Investment Bank, and Cancer Focus Fund LP, with cumulative disclosed funding of approximately €59 million ($65 million equivalent) across rounds in 2013, 2019, 2021, and 2023.

Name

ISA Pharmaceuticals

Legal name

ISA Pharmaceuticals B.V.

Website

https://isa-pharma.com

Company type

Private

Founded year

2004

Operating status

Operating

Headcount range

11–50 employees

Short description

ISA Pharmaceuticals is a Dutch clinical-stage biotech (founded 2004) that develops synthetic long peptide (SLP®) and AMPLIVANT® therapeutic vaccines for HPV16-induced cancers, PRAME-positive tumors, chronic hepatitis B, and SARS-CoV-2, generating revenue via licensing and co-development partnerships with pharmaceutical companies and academic medical centers.

Ownership category

akta.pro rank

Product category

Cancer Immunotherapy

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Scientific Research and Development Services (5417)

SIC

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

akta.pro primary industry

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

akta.pro secondary industry

Personalized Therapeutic Design (neoantigen vaccines, individualized cell/gene therapies) (HLAAANAK)

Keywords

• Synthetic peptide vaccines
• Cancer immunotherapy
• Therapeutic cancer vaccines
• Peptide drug development
• Immuno-oncology research

Headquarters

HQ city

Leiden

HQ country

Netherlands

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Licensing and Royalty Revenue: ISA Pharmaceuticals generates revenue through licensing agreements where partners gain rights to use its proprietary SLP® and AMPLIVANT® technologies. The company receives upfront fees, research and clinical milestone payments, and royalties on net sales of products resulting from these agreements. Example: license agreement with Transgene for TB vaccine development.
2. Co-development and Milestone Payments: Revenue from co-development partnerships where ISA collaborates on clinical development and receives milestone payments upon achievement of research, clinical, and regulatory objectives. Example: Cancer Focus Fund $5M investment supporting ISA103 clinical development at MD Anderson.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels5 records

Core offering

ISA Pharmaceuticals develops targeted, rationally designed synthetic long peptide (SLP®) immunotherapeutics for the treatment of cancer and persistent virus infections. Its portfolio includes ISA101b for HPV16-induced cancers, ISA103 for PRAME-positive tumors, ISA104 for chronic hepatitis B, ISA106 for SARS-CoV-2, and the personalized MyISA® neoantigen therapy, all powered by the proprietary SLP® peptide platform and AMPLIVANT® TLR-ligand adjuvant technology. The company advances its pipeline through co-development and licensing partnerships with pharmaceutical companies and academic medical centers.

Product overview

ISA Pharmaceuticals develops a portfolio of targeted, rationally designed immunotherapeutics for cancer and persistent virus infections. The core pipeline includes ISA101b (lead product for HPV16-induced cancers in late-stage development), ISA103 (PRAME-targeting immunotherapy for uveal melanoma), ISA104 (chronic Hepatitis B vaccine in Phase 1), and ISA106 (SARS-CoV-2 immunotherapy in late preclinical development). The company also offers MyISA for personalized neoantigen-based immunotherapy. All immunotherapeutics are powered by two proprietary technology platforms: SLP (Synthetic Long Peptide) technology for antigen delivery and immune activation, and AMPLIVANT TLR-ligand adjuvant technology for enhanced dendritic cell targeting and prolonged immune response.

Differentiator

Problem solved

Functional benefit

Brands

• SLP®: Synthetic Long Peptide immunotherapy technology platform
• AMPLIVANT®
• MyISA®

Products and services

• ISA101b (HPV16) Therapeutic cancer vaccine targeting human papillomavirus type 16 (HPV16)-induced cancers including head and neck cancer and cervical cancer. Induces strong and specific T-cell immune responses to HPV16 E6 and E7 antigens and is being developed both as monotherapy and in combination with checkpoint inhibitors (anti-PD1 antibodies) and chemotherapy. Granted FDA Fast Track Designation (September 2021) for recurrent/metastatic HPV16-positive oropharyngeal cancer and US FDA Orphan Drug Designation for HPV16-positive cervical cancer.
• ISA103 (PRAME) PRAME-targeting synthetic long peptide immunotherapy for the treatment of uveal melanoma and other PRAME-positive cancers including lung, breast, head & neck, kidney, melanoma, and neuroblastoma. Uses SLP® technology to generate strong and specific T-cell immune responses against the PRAME protein.
• ISA104 (HBV) Therapeutic synthetic long peptide vaccine for chronic Hepatitis B virus infection designed to elicit a strong and specific T-cell immune response against HBV with the aim of achieving functional cure in chronically infected patients.
• ISA106 (SARS-CoV-2)

Quantifiable outcome

• Doubling of objective response rate (ORR) from 26.7% (placebo + CPI) to 51.9% (ISA101b + CPI) in predefined biomarker-defined subgroup of HPV16+ oropharyngeal cancer patients in OpcemISA Phase 2 trial (n=199)
• +4 more outcomes

Named customers5 records

Segments4 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature2 records

Partnerships

Eight partnerships are on record, tiered core and minor.

• Erasmus Medical Center RotterdamcoreStrategic or Co-development Partner · 31 August 2023Erasmus MC is the sponsor of the HEB-PEP Phase 1 first-in-human study of ISA104 in chronic hepatitis B patients. The study is conducted in collaboration with the Gastroenterology & Hepatology department of Erasmus MC in Rotterdam and is co-funded by a PPP Allowance from Health~Holland, Top Sector Life Sciences & Health.
• Leiden University Medical Center (LUMC) and Centre for Human Drug Research (CHDR)minorStrategic or Co-development Partner · 27 April 2023ISA is collaborating with LUMC and CHDR on the development of ISA106, an SLP therapy against SARS-CoV-2, with data presented at the CIMT Annual Meeting 2023 demonstrating robust T cell responses in preclinical studies.
• MD Anderson Cancer CentercoreStrategic or Co-development Partner · 4 January 2023MD Anderson Cancer Center in Houston, Texas is conducting the Phase 1b/2 trial of ISA103 in uveal melanoma under Principal Investigator Dr. Sapna Patel, Director of MD Anderson's Uveal Melanoma Program. The trial will enroll 90 patients in a dose-finding phase followed by an expansion cohort.
• Erasmus MCminorStrategic or Co-development Partner · 20 July 2021ISA, in partnership with Erasmus MC, was awarded a TKI grant and expanded its clinical pipeline to include the ISA104 HBV program.
• Regeneron PharmaceuticalscoreStrategic or Co-development Partner · 18 December 2017Strategic immuno-oncology collaboration established in December 2017 for the development of ISA101b in combination with Regeneron's anti-PD-1 antibody cemiplimab (Libtayo®). Three clinical trials were conducted under this collaboration: OpcemISA (randomized Phase 2 in OPC), ProcemISA (Phase 2 in anti-PD1-resistant OPC), and a Phase 2 trial in cervical cancer. Regeneron has elected not to exercise its option on ISA101b.
• SanofiminorStrategic or Co-development Partner · 18 December 2017Sanofi co-develops cemiplimab (Libtayo®) with Regeneron. ISA's clinical collaboration with Regeneron involves cemiplimab, making Sanofi an indirect partner in the ISA101b combination development program.
• Leiden University Medical Center (LUMC)coreStrategic or Co-development PartnerLUMC serves as a key strategic research collaborator for ISA Pharmaceuticals. Research teams from LUMC and ISA have co-authored multiple publications on SLP® technology, dendritic cell processing, and immunotherapy mechanisms. Prof. Sjoerd van der Burg from LUMC serves as Principal Investigator for multiple clinical trials.
• Scancell Holdings plcminorStrategic or Co-development PartnerCollaboration agreement for the manufacturing, development and commercialisation of Modi-1 / AMPLIVANT® combination therapy, announced in February 2018.

Scale indicators9 records

Recent moves7 records

Expansion highlights6 records

Emerging players

• CureVac: German mRNA therapeutics company developing cancer vaccines (CV8102, partnered products) and infectious disease vaccines. Competes with ISA in oncology immunotherapy with an alternative mRNA-based platform.
• Nouscom: Swiss clinical-stage biotech developing neoantigen-based therapeutic cancer vaccines using viral vector platforms. Competes with ISA's MyISA® in the personalized cancer vaccine segment with overlapping clinical-stage assets in solid tumors.
• Arbutus Biopharma: Develops HBV-targeted therapeutics including capsid inhibitors and RNAi agents aimed at functional cure of chronic Hepatitis B. Competes with ISA104 in the chronic HBV functional cure space using different therapeutic modalities.
• Genocea Biosciences: Clinical-stage biotech developing therapeutic cancer vaccines using the ATLAS neoantigen identification platform. Competes with ISA in personalized and targeted cancer immunotherapy, though focused on different antigens.

Direct peers

• Adaptimmune Therapeutics: Develops SPEAR T-cell therapies targeting PRAME (ADP-A2M4CD8) and other cancer-testis antigens. Direct competitor in the PRAME-positive cancer space (uveal melanoma, head & neck) where ISA103 is being developed, though with cell therapy rather than vaccine modality.
• Transgene: French biotech developing TG4001 therapeutic HPV vaccine and myvac® personalized cancer vaccines. Already an ISA licensing partner (TB vaccine agreement 2011) and operates as both collaborator and competitor in the HPV/therapeutic cancer vaccine category.
• Hookipa Pharma: Develops HB-201/HB-202 arenavirus-based therapeutic vaccines for HPV16+ cancers, the same primary indication as ISA101b. Direct competitor in HPV-driven oropharyngeal and cervical cancer immunotherapy.
• Scancell Holdings: UK-based developer of peptide-based therapeutic cancer vaccines (Modi-1, Modi-2) using ISA's AMPLIVANT® adjuvant under collaboration. Most direct technical peer given shared peptide vaccine + TLR ligand adjuvant approach and overlapping HPV/MAGE target focus.

Broad incumbents

• Moderna: Develops mRNA-4157 (V940) personalized cancer vaccine partnered with Merck. As the leading mRNA oncology player with strong pharma backing, Moderna represents the most well-capitalized competitor in the cancer vaccine space where ISA operates.
• BioNTech SE: Global leader in mRNA-based cancer immunotherapy with BNT122 (autogene cevumeran) personalized cancer vaccine partnered with Roche/Genentech. Competes with ISA's MyISA® in the personalized cancer vaccine space and represents the dominant platform competitor to peptide-based approaches.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/isa-pharmaceuticals

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles10 records

Funding overview

Funding rounds3 records

Investors1 record

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 ISA Pharmaceuticals