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Prostate cancer is one of the most common cancers in men, with approximately 12.9% of men likely to be diagnosed with it at some point during their lifetime. So, it is easy to see why the indication is a primary focus for several biotech companies working in the oncology field. When prostate cancer is found early, it is highly treatable and even curable; but metastatic and castration-resistant prostate cancer, two advanced forms of the disease, are considered largely incurable and symptoms can be difficult to treat. While currently available therapies can help to manage these types of prostate cancer and extend people’s lives, biotechs are always on the search for more effective treatment options, with a particular focus on targeted therapies. In this article, we look at six prostate cancer companies advancing the next generation of therapies for all stages of the disease.
Candel Therapeutics
- Technology: Multimodal biological immunotherapies
- Lead prostate cancer candidate: Aglatimagene besadenovec (CAN-2409)
- Recent news: Announced a $100 million royalty funding agreement with RTW to fund the potential launch of aglatimagene
Candel Therapeutics is focused on the development of off-the-shelf multimodal biological immunotherapies that elicit an individualized, systemic anti-tumor immune response to help patients fight cancer. The company has two multimodal biological immunotherapy platforms based on novel, genetically modified adenovirus and herpes simplex virus (HSV) gene constructs, respectively.
Candel’s lead candidate – from its adenovirus platform – is called aglatimagene besadenovec (CAN-2409) and is being investigated as a treatment for multiple cancer types, including localized prostate cancer. The therapy is a replication-defective adenovirus that is injected into the prostate and delivers the HSV thymidine kinase gene to tumor cells. When administered with an oral prodrug of valacyclovir (an antiviral medication used to treat infections caused by HSV), the HSV thymidine kinase converts the prodrug into a cytotoxic metabolite that blocks DNA synthesis and induces cell death, releasing tumor antigens into an immunologically primed tumor microenvironment. This regimen is ultimately designed to induce an individualized and specific CD8+ T cell-mediated response against the tumor.
In December 2024, Candel saw its stock surge 200% when it announced phase 3 data for aglatimagene, linking it to a 14.5% relative improvement in disease-free survival – an endpoint that looked at cancer recurrence or death from any cause.
Last month, the prostate cancer company announced a $100 million royalty funding agreement with RTW to bankroll the potential launch of aglatimagene for the treatment of localized prostate cancer, with the funding being subject to the candidate receiving U.S. Food and Drug Administration (FDA) approval. Paul Peter Tak, president and chief executive officer (CEO) of Candel, said in a press release that the company remains on track to submit a Biologics License Application (BLA) for aglatimagene in Q4 of this year.
Coherus Oncology
- Technology: Monoclonal antibodies
- Lead prostate cancer candidate: Tagmokitug (CHS-114)
- Recent news: Closed a $50.1 million public offering
Coherus Oncology, which already has an approved cancer therapy in Loqtorzi for the treatment of nasopharyngeal cancer, has established a pipeline with two mid-stage clinical candidates targeting different types of solid tumors, including liver, head and neck, colorectal, and prostate.
The biotech company’s candidate in development for prostate cancer is called tagmokitug (CHS-114). It is a highly selective cytolytic CCR8 monoclonal antibody that specifically binds and preferentially depletes CCR8+ tumor regulatory T cells (Tregs) with no off-target binding. Preclinical and clinical biomarker research for the asset was published in the December 2025 issue of Molecular Cancer Therapeutics, with the findings showing that it demonstrated no off-target binding and selectively eliminates CCR8+ T regulatory cells and not other T cells, supporting its potential as an anticancer treatment.
While the candidate is more clinically advanced in other cancer types – it is being evaluated in a phase 1b/2a study in colorectal cancer and a phase 1b study in esophageal squamous cell carcinoma, among others – Coherus Oncology announced a clinical supply agreement with Johnson & Johnson (J&J) in February to evaluate it in combination with the big pharma’s pasritamig, a T-cell engaging bispecific antibody, in a phase 1b clinical study in patients with metastatic castration-resistant prostate cancer. This study is expected to begin in 2H 2026, according to the company.
Also in February, the company closed a $50.1 million public offering. It said that it intends to use the proceeds from this to support the ongoing commercialization of Loqtorzi, to continue the clinical development of its product candidates, and for working capital and other general corporate purposes.
Kyntra Bio
- Technology: Antibody-drug conjugates
- Lead prostate cancer candidate: FG-3246 (FOR46)
- Recent news: Announced positive data from an investigator-sponsored phase 1b/2 study, in which FG-3246 was given in combination with enzalutamide
Oncology- and rare disease-focused biotech Kyntra Bio (formerly called FibroGen), which has a drug on the market called Evrenzo that has been approved in Europe, Japan, and other countries for the treatment of anemia in chronic kidney disease patients, is now developing a candidate for the treatment of metastatic castration-resistant prostate cancer. The asset in question is called FG-3246 (FOR46) and is a potential first-in-class fully human antibody-drug conjugate (ADC), exclusively in-licensed from Fortis Therapeutics.
FG-3246 works through binding to an epitope of CD46, a cell receptor target that induces internalization upon antibody binding, is present at high levels in prostate cancer and other tumor types, and demonstrates very limited expression in most normal tissues. The drug is comprised of an anti-CD46 antibody, YS5, linked to the anti-mitotic agent, MMAE, which is a clinically and commercially validated ADC payload. Kyntra Bio is developing this alongside a companion diagnostic PET imaging agent, FG-3180, which uses the same CD46-targeting antibody together with an 89Zr tracker.
FG-3246 is currently being evaluated in a phase 2 monotherapy trial, with interim data expected in the second half of 2026. The therapy has already demonstrated anti-tumor activity in both preclinical and clinical studies.
Furthermore, Kyntra Bio recently announced positive data from an investigator-sponsored phase 1b/2 study, in which FG-3246 was given in combination with enzalutamide (an androgen receptor inhibitor). The results showed that, in biomarker-unselected patients with androgen receptor pathway inhibitor-treated, taxane-naïve metastatic castration-resistant prostate cancer, the combination therapy led to a median radiographic progression-free survival of seven months in the overall study cohort, with a median radiographic progression-free survival of 10.1 months observed in patients who progressed on only one prior androgen receptor pathway inhibitor.
Monte Rosa Therapeutics
- Technology: Molecular glue degraders
- Lead prostate cancer candidate: MRT-2359
- Recent news: Announced updated, positive clinical data from the ongoing phase 1/2 trial of MRT-2359
Molecular glue company Monte Rosa Therapeutics is advancing highly selective molecular glue degraders for indications in immunology and inflammation (I&I) and oncology. According to the company, these medicines are small molecule protein degraders that have the potential to treat many diseases that other modalities, including other degraders, cannot. Monte Rosa has established a discovery engine called QuEEN (Quantitative and Engineered Elimination of Neosubstrates) that combines AI-guided chemistry, diverse chemical libraries, structural biology, and proteomics to rationally design its molecular glue degraders with “unprecedented selectivity.”
The company’s lead oncology asset is intended for the treatment of castration-resistant prostate cancer. Known as MRT-2359, it is a potent, highly selective, and orally bioavailable molecular glue degrader of GSPT1, a translation termination factor. Because MYC-driven cancers, including prostate cancer, depend on enhanced translation of oncoproteins to support rapid growth, MRT-2359 exploits this therapeutic vulnerability by disrupting translation through the selective degradation of GSPT1.
The therapy is being investigated in combination with enzalutamide in an ongoing phase 1/2 study in patients with castration-resistant prostate cancer. In February, Monte Rosa Therapeutics announced updated, positive clinical data from the phase 1/2 trial, building on data released in December 2025. The updated results demonstrated that, in patients with androgen receptor mutations, treatment with the combination therapy led to a 100% prostate-specific antigen (PSA) response rate (five out of five patients) and a 100% disease control rate, including two patients with RECIST (Response Evaluation Criteria in Solid Tumors) partial responses and three with stable disease, all showing a reduction in the size of target lesions. Meanwhile, across all 15 evaluable patients, the overall RECIST disease control rate was 67%, and 10 out of 15 patients showed tumor size reductions of target lesions.
The company now plans to initiate a new, signal-confirming phase 2 study of MRT-2359 targeting androgen receptor mutant patients in Q3 2026.
In January 2026, Monte Rosa Therapeutics priced a $300 million public offering that should help to fund the advancement of its prostate cancer asset.
Telix Pharmaceuticals
- Technology: Radiopharmaceuticals
- Lead prostate cancer candidate: TLX591-Tx
- Recent news: Announced that part one of its global phase 3 trial of TLX591-Tx had achieved its primary objectives
Telix Pharmaceuticals is focused on the development and commercialization of therapeutic and diagnostic (theranostic) radiopharmaceuticals. The company has an extensive pipeline focused on urologic oncology indications like prostate, kidney, and bladder cancers, neuro-oncology indications like glioma, musculoskeletal oncology indications like sarcoma, and hematology.
The radiopharma company’s lead asset, TLX591-Tx (lutetium-177 rosopatamab tetraxetan), is an antibody-based radiopharmaceutical designed to treat metastatic castration-resistant prostate cancer by targeting the prostate-specific membrane antigen (PSMA). The asset is in late-stage development, with Telix announcing last week that part one of its global phase 3 trial of TLX591-Tx had achieved its primary objectives, demonstrating an acceptable safety and tolerability profile with no new safety signals observed.
The phase 3 trial is comparing the therapy combined with standard of care treatments like enzalutamide versus standard of care treatments alone. According to Telix, it has already advanced the study into part two – a 2:1 randomized treatment expansion – in jurisdictions where the clinical trial has obtained approval from health authorities. Now, part one data will be presented to the FDA to seek an Investigational New Drug (IND) amendment to progress into part two in the U.S. as well.
Vir Biotechnology
- Technology: T cell engagers
- Lead prostate cancer candidate: VIR-5500
- Recent news: Priced a $150 million public offering and entered into a partnership with Astellas
T-cell engager company Vir Biotechnology is developing an early-stage candidate called VIR-5500 for the treatment of metastatic castration-resistant prostate cancer. T-cell engagers (TCEs) are powerful, up-and-coming anti-tumor agents that can direct the immune system, specifically T-cells, to destroy cancer cells, and many oncology deals have focused on this drug class in recent times.
Indeed, Vir Biotechnology made its own T cell engager deal in February when it entered into a global strategic collaboration with Japanese pharma giant Astellas to advance VIR-5500 for prostate cancer, with an aim to accelerate the development of the candidate, which is currently in a phase 1 trial. As part of the agreement, Vir Biotechnology received $335 million in upfront and near-term milestone payments, will split U.S. profit/loss equally with Astellas (50/50), and is eligible to receive up to an additional $1.37 billion in development, regulatory, and sales milestones.
VIR-5500 is a PROX-TEN dual-masked CD3 T-cell engager targeting PSMA. This means that it combines a bispecific PSMA and CD3 binding T cell engager with PRO-XTEN masking technology, which is designed to keep T cell engagers inactive (or masked) until they reach the tumor microenvironment, where tumor-specific proteases cleave off the mask and activate the T cell engagers, leading to the killing of cancer cells by T-cells.
Vir Biotechnology recently reported positive updated results from its phase 1 study of its prostate cancer asset, showing that it has a favorable safety profile and was well-tolerated with no dose-limiting toxicities observed to date. Meanwhile, dose‑dependent activity was observed across the entire treatment group as measured by both PSA declines and radiographic responses. In the highest dose cohorts, PSA50 declines occurred in 82%, and PSA90 declines occurred in 53% of PSA-evaluable patients.
Also in February, the company priced a $150 million public offering.
Prostate cancer therapy market on the rise as awareness grows
With prostate cancer remaining one of the most commonly diagnosed cancers in men, there is a growing demand for effective treatment options across all stages of the disease – a factor that will lead the global prostate cancer therapeutics market to grow from $13.45 billion in 2024 to $21.23 billion by 2030. This signals a compound annual growth rate (CAGR) of 8.05%, and is driven by rising awareness, increasing incidence rates, and advancements in diagnostic and treatment technologies like those being developed by the companies listed in this article.
Overall, the future is looking positive for prostate cancer patients, and the hope is that biotechs will be able to come up with treatment options that can either prolong the lives of people with more advanced forms of prostate cancer or even cure them altogether.
