NovalGen
NovalGen is a London-based clinical-stage biotechnology company developing multi-specific biologics via its proprietary AutoRegulation (AR) platform, enabling drugs to self-regulate immune activation and reduce toxicities. Its pipeline spans oncology, autoimmune, and metabolic disorders, with the AR-enabled NVG-222 in Phase 1.
- Company typePrivate
- Founded2019
- HeadquartersLondon, United Kingdom
- Headcount11–50
- GTM typeB2B
- OfferingServices
What NovalGen does
NovalGen is a London-based clinical-stage biotechnology company founded in 2019 by Professor Amit Nathwani, developing multi-specific biologics based on its proprietary AutoRegulation (AR) platform technology for oncology, autoimmune, haematological, and metabolic disorders. The AR platform addresses a fundamental limitation of immunotherapy—mechanism-of-action toxicities such as cytokine release syndrome (CRS) and ICANS—by engineering biologics to self-detect risk of severe toxicities at the site of action and self-deactivate, then replenish from circulating active drug as risk subsides. The company's lead asset, NVG-222, is a half-life-extended ROR1xCD3 bispecific T-cell engager equipped with AutoRegulation and became the world's first self-regulating immunotherapy to receive MHRA Clinical Trial Authorisation (September 2025) and to dose a patient in Phase 1 (March 2026), sponsored and delivered by Cancer Research UK's Centre for Drug Development at UCLH.
NovalGen's pipeline is anchored by clinical proof-of-concept data from the precursor molecule NVG-111 (same ROR1- and CD3-binding domains without AR functionality), which demonstrated a 58% objective response rate in patients with relapsed/refractory CLL and MCL with durability to 24 months and 30% MRD4 negativity in CLL participants. The broader preclinical pipeline includes NVG-666 (AR-enabled TCE targeting CD19 for autoimmune diseases with potential outpatient use), NVG-444 (UKRI-funded bispecific FVIII mimetic for haemophilia A), and NVG-555 (bispecific checkpoint inhibitor with AR for additive-toxicity prevention). R&D operations are co-located with UCL Medical School at the Royal Free Hospital, leveraging the academic infrastructure and Professor Nathwani's UCL affiliation.
The company is pre-commercial with no disclosed revenue, no disclosed funding rounds, and operates with 11–50 employees. Its business model centers on advancing candidates through clinical development toward eventual commercialization via standard pharmaceutical supply chains upon regulatory approval. Manufacturing is outsourced to CDMO partners HALIX B.V. and Mabion. Marketing is conducted through scientific publications and conference presentations (ASCO, ASH, iwCLL, ISTH), patient organization engagement, and a corporate LinkedIn presence rather than traditional commercial channels. The leadership team and board combine academic founders with experienced biotech operators from Freeline, Kymab, Tizona, GSK, and UCB Pharma.
NovalGen firmographics
Firmographics- Name
- NovalGen
- Legal name
- NovalGen Ltd.
- Website
- https://novalgen.com
- Company type
- Private
- Founded year
- 2019
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- NovalGen is a London-based clinical-stage biotechnology company developing multi-specific biologics via its proprietary AutoRegulation (AR) platform, enabling drugs to self-regulate immune activation and reduce toxicities. Its pipeline spans oncology, autoimmune, and metabolic disorders, with the AR-enabled NVG-222 in Phase 1.
- Ownership category
- akta.pro rank
NovalGen industry classification
Industry- Product category
- Cancer Immunotherapy
- NAICS
- Biological Product (except Diagnostic) Manufacturing (325414), Research and Development in Biotechnology (except Nanobiotechnology) (541714), Pharmaceutical and Medicine Manufacturing (3254)
- SIC
- Biological Products, (No Disgnostic Substances) (2836), Pharmaceutical Preparations (2834)
- akta.pro primary industry
- Monoclonal Antibody Therapeutics (mAbs) (HLAAAAAA)
- akta.pro secondary industries
- Antibody Discovery & Engineering Platforms (display tech, bispecifics, Fc engineering) (HLAAAIAB), Immunology & Autoimmune Specialty Pharmaceuticals (HLAIACAB)
Keywords
Where NovalGen is headquartered
LocationHeadquarters
- HQ city
- London
- HQ country
- United Kingdom
- HQ region
- Europe
Offices2 records
Markets served
NovalGen business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Technology or R&D, Personnel, Operations, Supply Chain, Marketing or Sales, Others
Revenue model
- Biopharmaceutical Development and Commercialization: NovalGen is a clinical-stage biotechnology company developing breakthrough multi-specific biologics. As a pre-commercial company, revenue generation is not yet active. The company's pipeline includes NVG-222 (Phase 1 for hematological malignancies and solid tumors), NVG-666 (preclinical for autoimmune diseases), and other AR-enabled candidates. Commercialization of these candidates, if approved, would represent the primary revenue stream.
Go-to-market motion1 record
Distribution channels1 record
Marketing channels4 records
NovalGen product offering
Product offeringCore offering
NovalGen is a clinical-stage biotechnology company developing breakthrough multi-specific biologics based on its proprietary AutoRegulation (AR) platform technology. The company advances T-cell engagers and other bispecific antibodies for oncology, autoimmune, hematological, and metabolic disorders. Its lead candidates NVG-111 and NVG-222 are in Phase 1 clinical evaluation for ROR1-positive hematological malignancies and solid tumors.
Product overview
NovalGen is a clinical-stage biotechnology company developing breakthrough multi-specific biologics based on its proprietary AutoRegulation (AR) platform technology. The company's pipeline comprises NVG-111 (ROR1xCD3 bispecific T-cell engager in Phase 1/2 for CLL/MCL), NVG-222 (half-life extended AR-enabled T-cell engager in Phase 1 for ROR1-positive blood cancers), NVG-666 (AR-enabled TCE for autoimmune diseases), NVG-444 (bispecific FVIII mimetic for haemophilia A), and NVG-555 (bispecific checkpoint inhibitor). The AutoRegulation platform serves as the core technology enabling multiple therapeutic candidates to self-regulate immune activation, reducing toxicity while maintaining efficacy.
Differentiator
Problem solved
Functional benefit
Products and services
- NVG-222 First therapeutic candidate equipped with NovalGen's proprietary AutoRegulation (AR) platform; a half-life-extended bispecific T-cell engager targeting ROR1 and CD3, designed to self-inactivate in response to T cell overactivation to prevent cytokine-mediated toxicities while maintaining therapeutic efficacy. Indicated for ROR1-positive hematological malignancies and solid tumors. Currently in Phase 1 clinical trial sponsored by Cancer Research UK's Centre for Drug Development with first patient dosed March 2026.
- NVG-111 First-in-class bispecific antibody T-cell engager simultaneously binding CD3 on T-cells and ROR1 on tumor cells, redirecting endogenous T-cells to tumor sites for treatment of Chronic Lymphocytic Leukemia (CLL) and Mantle Cell Lymphoma (MCL). Completed Phase 1/2 study showing 58% objective response rate.
- NVG-666 AutoRegulation-enabled T-cell engager for treatment of autoimmune diseases, targeting CD19-positive cells to eliminate autoreactive B cells implicated in autoimmune disease progression. The AR platform prevents mode-of-action-related toxicities, potentially enabling outpatient treatment settings. Pre-clinical stage.
- NVG-444 UKRI-funded bispecific factor VIII mimetic antibody for haemophilia A, equipped with AutoRegulation technology to prevent thrombotic events and microangiopathies associated with conventional FVIII mimetics. Pre-clinical stage.
- NVG-555 Bispecific checkpoint inhibitor antagonising two independent checkpoint pathways, equipped with AutoRegulation technology to prevent additive toxicities associated with checkpoint inhibitor approaches. Pre-clinical stage.
- AutoRegulation (AR) Platform Proprietary platform technology that integrates self-regulating capabilities into a range of immunotherapies (T-cell engagers, bispecific antibodies, CAR-T cells, factor VIII mimetics), enabling drugs to self-inactivate in response to biological signals indicating risk of severe toxicities and to replenish from circulating active drug as risk reduces. Target-agnostic and modality-agnostic licensable platform.
Quantifiable outcome
- 58% objective clinical response rate in relapsed/refractory CLL and MCL patients treated with NVG-111
- +3 more outcomes
Companies that use NovalGen
Customer profileSegments3 records
Ideal customer profiles3 records
NovalGen technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature4 records
NovalGen partnerships and signals
Strategic signalPartnerships
Four partnerships are on record, tiered core.
- Cancer Research UK (CRUK) - Centre for Drug DevelopmentcoreCancer Research UK's Centre for Drug Development is sponsoring and delivering the Phase 1 clinical trial of NVG-222. Cancer Research Horizons manages the commercial partnership between NovalGen and Cancer Research UK. The collaboration leverages CRUK's unparalleled commitment to pioneering therapies and expertise in advancing novel treatments into the clinic. The trial is led by Chief Investigator Dr. William Townsend at UCLH.
- MabioncoreStrategic development and manufacturing partnership for NVG-222. Mabion, a European biologics CDMO, manufactured the first batch of NVG-222 for first-in-human clinical trials under license agreement. The partnership leverages Mabion's manufacturing and development capabilities to minimize pharmaceutical production risk and provides a platform for future collaboration on NovalGen's pipeline.
- HALIX B.V.coreStrategic manufacturing partnership for clinical supply of NovalGen's therapies. HALIX, a contract development and manufacturing organization (CDMO) based in Leiden, Netherlands, successfully completed GMP manufacture of NVG-111 from drug substance to drug product and final release. The partnership enabled efficient technology transfer and successful GMP manufacturing campaign.
- University College London (UCL)coreAcademic partnership for research and development. NovalGen's founder and CEO, Professor Amit Nathwani, is a UCL Professor of Haematology. The company maintains laboratory and office space at UCL Medical School, Royal Free Hospital. UCL investigators serve as principal investigators on clinical trials.
Scale indicators4 records
Recent moves7 records
Expansion highlights6 records
NovalGen competitors and assessment
Company assessmentDirect peers
- Autolus Therapeutics: UK-based clinical-stage biotech developing programmed T-cell therapies for cancer, with similar London footprint and academic founder origins. Comparable in geography, stage, and focus on safer T-cell-directed therapies for hematological malignancies.
- Macrogenics: Clinical-stage biotech with proprietary DART and TRIDENT platforms for bispecific antibodies, including T-cell engagers in oncology. Comparable as a multi-specific antibody platform company with similar target classes and clinical focus.
- Maverick Therapeutics: Developed COBRA platform of conditionally active T-cell engagers designed to be activated only in the tumor microenvironment, acquired by Takeda. The COBRA concept of conditional/safe T-cell engagement is the most mechanistically similar peer to NovalGen's AR platform.
- Harpoon Therapeutics: Developed T-cell engagers using a proprietary tri-specific T-cell activating construct (TriTAC) platform, now part of Merck following acquisition. Direct competitor in the safer T-cell engager space with comparable targeting strategies.
- Crescendo Biologics: UK-based clinical-stage biotech developing T-cell engagers (Humabody platform) for oncology, including CD3-binding bispecifics against tumor targets. Highly comparable in geography, stage, modality, and clinical focus on safer T-cell engagers.
- Alligator Bioscience: Swedish clinical-stage biotech developing bispecific antibodies (e.g., mitazalimab, ATOR-4066) with proprietary technology to enhance tumor-directed immune activation. Comparable as a smaller European bispecific antibody developer.
- Zymeworks: Clinical-stage biotech with Azymetric and Effi-function platforms for bispecific and multifunctional antibodies, including T-cell engagers in oncology. Comparable as a bispecific antibody platform company with multiple pipeline programs.
- Molecular Partners: Swiss clinical-stage biotech developing DARPin-based multi-specific therapeutics, including immune-cell engaging candidates in oncology. Comparable as a non-antibody scaffold multi-specific platform company with similar modality innovation.
- F-star Therapeutics: Bispecific antibody platform company developing Fcab-based multi-specifics, with clinical-stage TCE programs in oncology. Directly comparable as a bispecific antibody developer with platform technology at similar stage.
Broad incumbents
- Genmab: Large established biotech with proprietary DuoBody bispecific antibody platform, partnered with AbbVie (epcoritamab) and others. Represents the broad incumbent player in bispecific antibodies and validates the commercial potential of the modality NovalGen is pursuing.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks6 records
Key highlights6 records
Customer concentration
NovalGen social profiles
Digital presenceNovalGen financial estimates
Financial estimateRevenue estimate
Valuation estimate
NovalGen leadership team
Management profileNumber of profiles
Profiles10 records
NovalGen funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
NovalGen 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 NovalGen
What does NovalGen do?
NovalGen is a clinical-stage biotechnology company developing breakthrough multi-specific biologics based on its proprietary AutoRegulation (AR) platform technology. The company advances T-cell engagers and other bispecific antibodies for oncology, autoimmune, hematological, and metabolic disorders. Its lead candidates NVG-111 and NVG-222 are in Phase 1 clinical evaluation for ROR1-positive hematological malignancies and solid tumors.
Is NovalGen a public or private company?
NovalGen is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was NovalGen founded?
NovalGen was founded in 2019. It employs 11 to 50 people.
Where is NovalGen based?
NovalGen is headquartered in London, United Kingdom, in the Europe region.
How does NovalGen make money?
One revenue line is on record: biopharmaceutical Development and Commercialization.
Who are NovalGen's main competitors?
Direct peers on record are Autolus Therapeutics, Macrogenics, Maverick Therapeutics, Harpoon Therapeutics, Crescendo Biologics, Alligator Bioscience, Zymeworks, Molecular Partners and F-star Therapeutics. Genmab is listed as a broad incumbent.
Does NovalGen have an API?
No public API is recorded for NovalGen.
What industry is NovalGen in?
NovalGen's product category is Cancer Immunotherapy. Its primary akta.pro industry code is HLAAAAAA, Monoclonal Antibody Therapeutics (mAbs), with a secondary code of HLAAAIAB, Antibody Discovery & Engineering Platforms (display tech, bispecifics, Fc engineering). Its NAICS code is 325414 and its SIC code is 2836.