Three Clinical Trial Pipeline Reports Track Progress in Prostate Cancer, NK Cells, and Lung Diseases

DelveInsight has released three separate clinical trial pipeline reports tracking therapeutic development across metastatic prostate cancer, iPSC-derived NK cells, and interstitial lung diseases. The reports provide comprehensive insights into companies, pipeline drugs, and recent regulatory and clinical developments across these three distinct therapeutic areas.

The metastatic prostate cancer pipeline report provides insights about 80+ companies developing 85+ pipeline drugs in the metastatic prostate cancer (mPC) pipeline landscape, covering clinical and nonclinical stage products along with therapeutic assessment by product type, stage, route of administration, and molecule type.

In January 2026, Alliance A032304 (RECIPROCAL) Phase 3 trial launched to optimize PSMA-RLT timing in mCRPC to reduce toxicity. Also in January 2026, ARTBIO dosed first patients in Phase 1 ARTISAN trial of AB001 (alpha radioligand, PSMA-targeted) in mCRPC.

In December 2025, the FDA granted regular approval to rucaparib (Rubraca) for BRCAm-associated mCRPC post-ARPI based on TRITON3 Phase 3. In October 2025, GSK entered $357M exclusive license agreement with Syndivia for ADC targeting mCRPC using GeminiMab platform.

In August 2025, the FDA granted Fast Track designation to HLD-0915 (Halda Therapeutics) for mCRPC. In July 2025, AB Science announced FDA/EMA authorization for confirmatory Phase III trial of masitinib in mCRPC (biomarker-selected, less advanced disease).

Key metastatic prostate therapies and companies include Opevesostat (Merck), AZD5305 (AstraZeneca), SX-682 (Syntrix), Onvansertib (Cardiff Oncology), JANX007 (Janux), ORIC-944 (ORIC Pharmaceuticals), Mevrometostat (Pfizer), Capivasertib (AstraZeneca), ARV-110 (Arvinas), MGC018 (MacroGenics), DS-7300 (Daiichi Sankyo), PSMA [Lu-177]-PNT2002 (Point Biopharma), and EPI-7386 (Essa Pharma).

Opevesostat is an oral, non-steroidal, selective inhibitor of the CYP11A1 enzyme (discovered and developed by Orion) intended to suppress production of steroid hormones and precursors that can activate androgen receptor signaling, and it is in Phase III development for metastatic prostate cancer. AZD5305 is described as a potent, selective PARP1 inhibitor (with 500-fold selectivity for PARP1 over PARP2) designed to drive lethal DNA damage accumulation particularly in cells with HRR pathway deficiencies, and it is in Phase III development for metastatic prostate cancer. SX-682 is a potent small-molecule dual-inhibitor of CXCR1 and CXCR2, chemokine receptors pivotal to myeloid cell suppression of cancer surveillance by the adaptive immune system. By blocking the CXCR1/2 pathway, SX-682 inactivates immunosuppressive myeloid cells, thereby cutting off "at the source" dozens of downstream pro-tumor mechanisms mediated by these cells. Currently, the drug is in Phase II stage of its development for the treatment of metastatic prostate cancer.

The iPSC-derived NK cells clinical trial analysis report delivers insights into ongoing research of 15+ pipeline iPSC-derived NK cells drugs, clinical strategies, upcoming therapeutics, and commercial analysis. The iPSC-derived NK cells pipeline report depicts a robust space with 12+ active players working to develop 15+ pipeline iPSC-derived NK cells drugs.

Key iPSC-derived NK cells companies include Centuary Therapeutics (NASDAQ: IPSC), Cartherics Pty Ltd, Fate Therapeutics (NASDAQ: FATE), Nuwacell Biotechnologies Co., Ltd., HebeCell, and Healios (TYO: 4593). Promising pipeline iPSC-derived NK cells therapies include CNTY-101, CTH-401, FT522, NCR300, HC101a, and AKT-01, which are in different phases of iPSC-derived NK cells clinical trials. Approximately 3+ iPSC-derived NK cell drugs are in the early stages of development.

Induced pluripotent stem cell (iPSC)–derived natural killer (NK) cells are immune effector cells generated by differentiating reprogrammed human somatic cells into NK cells under controlled laboratory conditions. These cells retain the innate cytotoxic properties of NK cells, including the ability to recognize and kill virus-infected or malignant cells without prior antigen sensitization. iPSC-derived NK cells offer key advantages over donor-derived NK cells, such as a renewable, standardized, and scalable "off-the-shelf" source with consistent phenotype and function. They can also be genetically engineered at the iPSC stage to enhance tumor targeting, persistence, or resistance to immunosuppressive tumor microenvironments, making them a promising platform for next-generation cancer immunotherapies.

In November 2025, Century Therapeutics announced that CNTY-101 clinical development activities will continue in CARAMEL, a Phase I/II investigator-sponsored trial (IST) led by Professors Georg Schett and Andreas Mackensen and sponsored by the Friedrich-Alexander University Erlangen-Nürnberg. As of November 12, 2025, three B-cell-mediated autoimmune disease patients were treated in this IST. Initial clinical data from CARAMEL is expected to be presented by the trial investigators at the 14th Annual BMT & Cell Therapy Workshop on December 5, 2025. As part of the company's clinical development re-prioritization efforts, Century will be discontinuing its company-sponsored CALiPSO-1 trial in which five patients have been treated with a favorable safety profile with no DLTs, no CRS >grade 2, and no ICANS. In addition, the limited but emerging clinical data suggest encouraging clinical activity in refractory patient populations.

The interstitial lung diseases pipeline report provides comprehensive insights about 120+ companies and 120+ pipeline drugs in the interstitial lung disease pipeline landscape. It covers the interstitial lung diseases pipeline drug profiles, including clinical and nonclinical stage products, as well as therapeutics assessment by product type, stage, route of administration, and molecule type.

On February 11, 2026, Boehringer Ingelheim conducted a study open to adults who are at least 40 years old and have idiopathic pulmonary fibrosis (IPF). People can participate in the study if they have a forced vital capacity (FVC) greater than or equal to 45% of the predicted value and fibrosis of 20% or more confirmed by a high-resolution computed tomography (HRCT) scan. The purpose of this study is to find out if a medicine called BI 765423 can improve lung function in people with IPF. The study will compare BI 765423 with a placebo to see if there is a difference in lung capacity after 3 months of treatment and will also look at changes in certain markers related to lung health.

On February 10, 2026, Rein Therapeutics announced a phase 2 Study of the Safety, Tolerability and Efficacy of Caveolin-1-Scaffolding-Protein-Derived Peptide (LTI-03) in Patients With Idiopathic Pulmonary Fibrosis. Also on February 10, 2026, United Therapeutics announced a study RIN-PF-301 is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the superiority of inhaled treprostinil against placebo for the change in absolute FVC in subjects with IPF over a 52-week period. Subjects will be randomly allocated 1:1 to receive inhaled treprostinil or placebo.

On February 09, 2026, Insmed Incorporated initiated a phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study to Evaluate the Efficacy and Safety of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease.

The leading interstitial lung diseases companies include Roche, aTyr Pharma, Boehringer Ingelheim, FibroGen, LTT Bio-Pharma, Bristol-Myers Squibb, Prometheus Biosciences, HEC Pharm, Bayer, Insmed, Avalyn Pharma, PureTech Health, Novartis, Horizon, MediciNova, Endeavor BioMedicines, Pliant Therapeutics, Kadmon Pharmaceuticals, GenKyoTex, Lung Therapeutics, AdAlta, and Ark Biosciences. Promising interstitial lung diseases pipeline therapies include Dotarem, efzofitimod 450 mg, Fentanyl Citrate, Belimumab, Nintedanib (Ofev®), Anlotinib, Pirfenidone, BI 1015550, Bosentan, Mycophenolate mofetil, and Cyclophosphamide.

DWN12088 is an investigational therapy for idiopathic interstitial lung diseases (IPF), that has shown the promising anti-fibrotic properties and appeared to be safe and well-tolerated in a recently-completed Phase I clinical trial that enrolled healthy volunteers. DWN12088 is an investigational IPF therapy that limits the body's ability to produce collagen by preventing an enzyme called glutamyl-prolyl-tRNA synthetase from adding proline to the protein's sequence. The FDA designated it as an orphan drug for idiopathic interstitial lung diseases (IPF) in 2019. The drug is currently in Phase II stage of clinical trial evaluation to treat IPF.

LYT-100 is PureTech's most advanced wholly-owned therapeutic candidate. A deuterated form of pirfenidone, an approved anti-inflammatory and anti-fibrotic drug, LYT-100 is being advanced for the potential treatment of conditions involving inflammation and fibrosis, including lung disease (e.g., IPF and potentially other PF-ILDs and Long COVID respiratory complications and related sequelae), and disorders of lymphatic flow, such as lymphedema. PureTech completed a Phase 1 multiple ascending dose and food effect study evaluating LYT-100 in healthy volunteers and found it to be well-tolerated at all doses tested. PureTech is evaluating LYT-100 in a Phase 2 trial as a potential treatment for Long COVID respiratory complications and related sequelae as well as in a Phase 2a proof-of-concept study in patients with breast cancer-related upper extremity lymphedema.