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With orphan designations

Overview

Malignant tumor of the penis is a rare malignancy primarily affecting older men, with >95% being squamous cell carcinoma (SCC). Risk factors include HPV infection, poor hygiene, phimosis, and lack of circumcision. Staging (TNM system) guides treatment, ranging from organ-preserving therapies for localized disease to radical surgery or multimodal approaches for advanced/metastatic cases [1][3][8][9].

Population

  • Highest incidence in men aged 50–85; disproportionately affects low/middle-income countries (e.g., Brazil, Uganda) [6][14].

  • In the U.S., elevated rates among Hispanic (6.58/million) and Black men (4.02/million), particularly in Southern states [2][6][10].

Burden

  • Global incidence rising (+1.3% annual increase in 15 countries) [14]; 5-year survival drops from 95% (localized) to 35% (lymph node-positive) [4][9].

  • Treatment complications (sexual dysfunction, lymphedema) impair quality of life; 11.8% positive surgical margins reported in advanced cases [5][7][14].

Therapies

  • Early-stage: Topical chemotherapy (5-fluorouracil/imiquimod, 57% response), laser ablation, or glans-sparing surgery [1][3][7][11].

  • Locally advanced: Partial/total penectomy with inguinal lymph node dissection ± radiation (60 Gy) [1][11][13].

  • Metastatic: TIP chemotherapy (53% response) or immunotherapy (pembrolizumab/atezolizumab for PD-L1+/MSI-H cases) [4][7][15].

Categories: rare neoplastic diseases, rare urogenital diseases

Research Papers

1,584 drug discovery papers related to Malignant tumor of penis, with 6 first-in-class and 0 next-in-class early-stage therapies forecasted to outperform the average preclinical success rate. Recent publications:

1,584 drug discovery papers related to Malignant tumor of penis, with 6 first-in-class and 0 next-in-class early-stage therapies forecasted to outperform the average preclinical success rate. Recent publications:

2026-07-09 | Penile Metastasis as a First Manifestation of Metastatic Castrate Resistant Prostate Cancer: A Case Report and Review of Management Challenges

Introduction: Penis is a rare site of metastasis of prostate cancer, with an incidence of 0.3%. Penile metastasis is often detected incidentally via imaging modalities. Symptomatic cases may present with penile nodules, deformity, or urinary symptoms, and a biopsy is required for confirmation. Treatment varies based on disease extent and patient condition, ranging from tumour-directed approaches (penectomy, radiotherapy) to systemic therapies. Case Presentation: A 69-year-old man with high-risk non-metastatic prostate cancer (T3bN0M0) underwent pelvic radiotherapy and androgen deprivation therapy (ADT). Five months later, he presented with urinary difficulty and penile pain. Imaging revealed multiple nodules within corpora cavernosa, along with lung lesions suggesting metastatic disease. A biopsy confirmed penile metastasis from prostate adenocarcinoma (Gleason score 9). Following a multidisciplinary team discussion, penectomy was ruled out, and the patient underwent palliative radiotherapy (RT), 20 Gy in 5 fractions, followed by systemic chemotherapy with docetaxel and carboplatin. Despite four cycles of chemotherapy, the disease progressed into the lungs, and the patient’s performance status declined. The patient was transitioned to palliative care and passed away 12 months after the diagnosis of penile metastasis. Conclusion: Penile metastasis from prostate cancer is rare but an aggressive entity with a median survival ranging from 6 to 18 months. Penile metastasis shall be in the differentials when patients present with priapism, penile pain, and urinary difficulty. Tumour-directed approaches, including surgery and RT, could be curative. Emerging therapies such as stereotactic body radiotherapy (SBRT) and PSMA-targeted radioligand therapy may improve outcomes for this rare and aggressive manifestation.

Open article ↗



2026-07-06 | Vaccine Therapy for the Management of Penile Cancer: Evidence, Opportunities and Challenges

Penile squamous cell carcinoma (PSCC) is a rare malignancy with limited therapeutic options in advanced and recurrent diseases. Advanced PSCC is typically managed with multimodal therapy, including neoadjuvant chemotherapy or chemoradiation followed by surgery; however, durable responses remain uncommon, and outcomes after recurrence are poor. Cancer vaccines represent a promising immunotherapeutic strategy, as these treatments induce tumor-specific immunity and heightened immune surveillance against penile cancer cells. While therapeutic cancer vaccines have not yet demonstrated consistent clinical efficacy as monotherapy in PSCC, their integration with complementary immune-modulating approaches, particularly immune checkpoint blockade, represents a rational strategy to enhance antitumor immunity. This review summarizes the rationale for vaccine development in PSCC, with emphasis on HPV-derived antigens, neoantigens, and emerging tumor-associated targets. We examine major vaccine platforms, including viral-vector, peptide-based, nucleic acid, and dendritic cell-based approaches. We also discuss how spatial transcriptomics, single-cell RNA sequencing, artificial intelligence-assisted antigen prediction, and nanotechnology-enhanced delivery systems may support future personalized vaccine development. Overall, therapeutic vaccines remain investigational in PSCC but may become relevant within biomarker-driven, combination-based immunotherapy strategies.

Open article ↗



2026-06-12 | Burden of HPV-associated cancers in Peruvian men: Evidence from national health data.

HPV-associated cancers in men represent a growing public health concern in Latin America, yet evidence on burden remains limited. We analyzed national data in Peru (2015-2019) to estimate outpatient consultations, hospitalization, and death rates for HPV-associated cancers and applied site-specific attributable fractions to derive HPV-attributable burden. Rates were age-standardized (ASR) to the WHO World Standard Population. Sensitivity analysis excluded mortality data for 2015-2016 to account for improvements in cause‑of‑death completeness. Between 2015 and 2019, 5,996 outpatient consultations for HPV-associated cancers in men were recorded (ASR: 8.2 per 100,000), mainly due to head and neck (56.3%) and penile (30.4%) cancers. A total of 1,136 hospitalizations were identified (ASR: 1.6 per 100,000), with head and neck and penile cancers accounting for 46.3% and 45.9% of total hospitalizations, respectively. Rates increased with age, reaching 38.0 outpatient consultations and 7.5 hospitalizations per 100,000 among men ≥60 years, but were also present among younger (<30 years) and middle-aged (30-59 years) men. Applying attributable fractions, 2,056 outpatient consultations (ASR: 2.8) and 402 hospitalizations (ASR: 0.6) were HPV-attributable, with penile cancer contributing the largest share. A total of 859 deaths from HPV-associated cancers were recorded (ASR: 1.2), of which 208 were HPV-attributable (ASR: 0.3), predominantly among men aged ≥60 years (77.2%). Sensitivity analysis had minimal impact on mortality estimates. HPV‑attributable cancers impose a substantial and preventable burden on Peruvian men. Strengthening universal HPV vaccination, ensuring high coverage, expanding multi‑age catch‑up strategies, and improving access to early diagnosis and treatment are essential to reduce future burden.

Open article ↗



2026-07-09 | Penile Metastasis as a First Manifestation of Metastatic Castrate Resistant Prostate Cancer: A Case Report and Review of Management Challenges

Introduction: Penis is a rare site of metastasis of prostate cancer, with an incidence of 0.3%. Penile metastasis is often detected incidentally via imaging modalities. Symptomatic cases may present with penile nodules, deformity, or urinary symptoms, and a biopsy is required for confirmation. Treatment varies based on disease extent and patient condition, ranging from tumour-directed approaches (penectomy, radiotherapy) to systemic therapies. Case Presentation: A 69-year-old man with high-risk non-metastatic prostate cancer (T3bN0M0) underwent pelvic radiotherapy and androgen deprivation therapy (ADT). Five months later, he presented with urinary difficulty and penile pain. Imaging revealed multiple nodules within corpora cavernosa, along with lung lesions suggesting metastatic disease. A biopsy confirmed penile metastasis from prostate adenocarcinoma (Gleason score 9). Following a multidisciplinary team discussion, penectomy was ruled out, and the patient underwent palliative radiotherapy (RT), 20 Gy in 5 fractions, followed by systemic chemotherapy with docetaxel and carboplatin. Despite four cycles of chemotherapy, the disease progressed into the lungs, and the patient’s performance status declined. The patient was transitioned to palliative care and passed away 12 months after the diagnosis of penile metastasis. Conclusion: Penile metastasis from prostate cancer is rare but an aggressive entity with a median survival ranging from 6 to 18 months. Penile metastasis shall be in the differentials when patients present with priapism, penile pain, and urinary difficulty. Tumour-directed approaches, including surgery and RT, could be curative. Emerging therapies such as stereotactic body radiotherapy (SBRT) and PSMA-targeted radioligand therapy may improve outcomes for this rare and aggressive manifestation.

Open article ↗



2026-07-06 | Vaccine Therapy for the Management of Penile Cancer: Evidence, Opportunities and Challenges

Penile squamous cell carcinoma (PSCC) is a rare malignancy with limited therapeutic options in advanced and recurrent diseases. Advanced PSCC is typically managed with multimodal therapy, including neoadjuvant chemotherapy or chemoradiation followed by surgery; however, durable responses remain uncommon, and outcomes after recurrence are poor. Cancer vaccines represent a promising immunotherapeutic strategy, as these treatments induce tumor-specific immunity and heightened immune surveillance against penile cancer cells. While therapeutic cancer vaccines have not yet demonstrated consistent clinical efficacy as monotherapy in PSCC, their integration with complementary immune-modulating approaches, particularly immune checkpoint blockade, represents a rational strategy to enhance antitumor immunity. This review summarizes the rationale for vaccine development in PSCC, with emphasis on HPV-derived antigens, neoantigens, and emerging tumor-associated targets. We examine major vaccine platforms, including viral-vector, peptide-based, nucleic acid, and dendritic cell-based approaches. We also discuss how spatial transcriptomics, single-cell RNA sequencing, artificial intelligence-assisted antigen prediction, and nanotechnology-enhanced delivery systems may support future personalized vaccine development. Overall, therapeutic vaccines remain investigational in PSCC but may become relevant within biomarker-driven, combination-based immunotherapy strategies.

Open article ↗



2026-06-12 | Burden of HPV-associated cancers in Peruvian men: Evidence from national health data.

HPV-associated cancers in men represent a growing public health concern in Latin America, yet evidence on burden remains limited. We analyzed national data in Peru (2015-2019) to estimate outpatient consultations, hospitalization, and death rates for HPV-associated cancers and applied site-specific attributable fractions to derive HPV-attributable burden. Rates were age-standardized (ASR) to the WHO World Standard Population. Sensitivity analysis excluded mortality data for 2015-2016 to account for improvements in cause‑of‑death completeness. Between 2015 and 2019, 5,996 outpatient consultations for HPV-associated cancers in men were recorded (ASR: 8.2 per 100,000), mainly due to head and neck (56.3%) and penile (30.4%) cancers. A total of 1,136 hospitalizations were identified (ASR: 1.6 per 100,000), with head and neck and penile cancers accounting for 46.3% and 45.9% of total hospitalizations, respectively. Rates increased with age, reaching 38.0 outpatient consultations and 7.5 hospitalizations per 100,000 among men ≥60 years, but were also present among younger (<30 years) and middle-aged (30-59 years) men. Applying attributable fractions, 2,056 outpatient consultations (ASR: 2.8) and 402 hospitalizations (ASR: 0.6) were HPV-attributable, with penile cancer contributing the largest share. A total of 859 deaths from HPV-associated cancers were recorded (ASR: 1.2), of which 208 were HPV-attributable (ASR: 0.3), predominantly among men aged ≥60 years (77.2%). Sensitivity analysis had minimal impact on mortality estimates. HPV‑attributable cancers impose a substantial and preventable burden on Peruvian men. Strengthening universal HPV vaccination, ensuring high coverage, expanding multi‑age catch‑up strategies, and improving access to early diagnosis and treatment are essential to reduce future burden.

Open article ↗



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Drug Discovery Landscape

0 orphan drug designations.

0 orphan drug designations.

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At Explority, we build first-of-its-kind AI to bring clarity to the earliest and riskiest stages of pharmaceutical research by forecasting which therapies are most likely to succeed. Explority AI web and mobile applications are properties of the Explority AI Inc., a company registered in the United States (File No. 10320493).
For all questions: support@explority.ai

Copyright © 2026 Explority AI Inc.

Explority AI logo

228 Park Ave S,
New York, USA.

At Explority, we build first-of-its-kind AI to bring clarity to the earliest and riskiest stages of pharmaceutical research by forecasting which therapies are most likely to succeed. Explority AI web and mobile applications are properties of the Explority AI Inc., a company registered in the United States (File No. 10320493).
For all questions: support@explority.ai

Copyright © 2026 Explority AI Inc.

Explority AI logo

228 Park Ave S,
New York, USA.

At Explority, we build first-of-its-kind AI to bring clarity to the earliest and riskiest stages of pharmaceutical research by forecasting which therapies are most likely to succeed. Explority AI web and mobile applications are properties of the Explority AI Inc., a company registered in the United States (File No. 10320493).
For all questions: support@explority.ai

Copyright © 2026 Explority AI Inc.