minocycline (BPX-01) / Timber Pharma - LARVOL DELTA

Ligand-inducible, prostate stem cell antigen (PSCA)-directed GoCAR-T cells in advanced solid tumors: Preliminary results from a dose escalation. (ASCO-GI 2019) - P1/2; "...BPX601 is an autologous, T-cell product engineered to contain a PSCA-CD3ζ CAR plus the small molecule rimiducid (Rim)-inducible MyD88/CD40 costimulatory domain... Patients received only cyclophosphamide (CTX) for lymphodepletion (LD) within three days before BPX601 infusion... BPX601 with single-dose Rim was well-tolerated and resulted in enhanced T cell expansion and prolonged persistence in some patients despite lack of LD. Evidence of clinical benefit in this heavily pretreated mPDAC population was seen. Part 2 is planned to open soon and will include CTX/fludarabine LD to maximize engraftment as well as gastric and prostate cancers."

CAR T-Cell Therapy • IO Biomarker

Ligand-inducible, prostate stem cell antigen (PSCA)-directed GoCAR-T cells in advanced solid tumors: Preliminary results from a dose escalation. (ASCO-GI 2019) - P1/2; "...BPX601 is an autologous, T-cell product engineered to contain a PSCA-CD3ζ CAR plus the small molecule rimiducid (Rim)-inducible MyD88/CD40 costimulatory domain... Patients received only cyclophosphamide (CTX) for lymphodepletion (LD) within three days before BPX601 infusion... BPX601 with single-dose Rim was well-tolerated and resulted in enhanced T cell expansion and prolonged persistence in some patients despite lack of LD. Evidence of clinical benefit in this heavily pretreated mPDAC population was seen. Part 2 is planned to open soon and will include CTX/fludarabine LD to maximize engraftment as well as gastric and prostate cancers."

CAR T-Cell Therapy • IO biomarker • Gastrointestinal Cancer • Genito-urinary Cancer • Oncology • Pancreatic Cancer • Prostate Cancer • Solid Tumor

Ligand-inducible, prostate stem cell antigen (PSCA)-directed GoCAR-T cells in advanced solid tumors: Preliminary results from a dose escalation study (ESMO-IO 2018) - P1/2; "...BPX601 is an autologous, T-cell product engineered to contain a PSCA-CD3 CAR plus the small molecule rimiducid (Rim)-inducible MyD88/CD40 costimulatory domain...Results Patients received only cyclophosphamide (CTX) for lymphodepletion (LD) within 3 days before BPX601 infusion...Evidence of clinical benefit in this heavily pretreated mPDAC population was seen. Part 2 is planned to open soon & will include CTX/fludarabine LD to maximize engraftment as well as gastric & prostate cancers."

CAR T-Cell Therapy • IO biomarker • Gastrointestinal Cancer • Genito-urinary Cancer • Oncology • Pancreatic Cancer • Prostate Cancer • Solid Tumor

"bpx501 should get fast track desg."

Biosimilar

"My understanding - progress BPX501 in Europe as planned & focused on one rare FDA-approvable IND" (@dhovekamp42)

Biosimilar

Administration of Oral Extended Release Minocycline for Assessment of Skin and Plasma Concentrations of Minocycline (clinicaltrials.gov) - P4; N=12; Completed; Sponsor: BioPharmX, Inc.; Active, not recruiting ➔ Completed

Trial completion • Biosimilar • Immunology

OPAL: BPX-01 Minocycline Topical Gel in the Treatment of Acne Vulgaris (clinicaltrials.gov) - P2; N=225; Active, not recruiting; Sponsor: BioPharmX, Inc.; Recruiting ➔ Active, not recruiting

Enrollment closed • Biosimilar • Immunology

The changing landscape of acne therapeutics (DermatologyTimes) - "'A better understanding of acne pathophysiology and the role of inflammation has...yielded a better understanding of how existing therapies treat the disease and have led to more comprehensive treatment strategies that are multitargeted,' says Leon Kircik, M.D....'Topical application of minocycline for acne would optimize the therapeutic effect while reducing systemic effects,' says Dr. Kircik."

Media quote

Pooled Safety Analysis of FMX101 4% Topical Minocycline Foam for the Treatment of Moderate-to-Severe Acne Vulgaris: Results From Three Phase 3 Studies (SDPA Fall 2019) - P3, N=2,449; FX2014-04 (NCT02815267); FX2014-05 (NCT02815280); FX2017-22 (NCT03271021); Sponsor: Foamix Ltd.; "These included pruritus, facial pain, cyst, skin hemorrhage, face swelling, and yellow skin. Local tolerability assessments were 'none' or 'mild' for more than 95% of the subjects. Mild erythema was the most frequently recorded cutaneous response in both treatment groups. FMX101 4% topical minocycline foam was demonstrated to be safe and well tolerated when administered daily for 12 weeks for the treatment of acne."

P3 data

Topical minocycline formulations: Evaluation and comparison of dermal uptake efficacy. (PubMed, Int J Pharm X) - "As our results indicate, a 1, 2% minocycline hydrophilic gel may deliver sufficient drug (>15 μg/g) to potentially demonstrate clinical efficacy. These findings suggest that topical hydrophilic minocycline gel may provide a novel tool for topical acne therapy."

Clinical • Journal

Treating Acne With Topical Antibiotics: Current Obstacles and the Introduction of Topical Minocycline as a New Treatment Option (PubMed, J Drugs Dermatol) - "Recent clinical studies have demonstrated that a hydrophilic minocycline gel (BPX-01) and a lipophilic minocycline foam (FMX101) both reduced acne lesion counts with negligible systemic absorption. J Drugs Dermatol. 2019;18(3):240-244."

Journal

PRISM: Topical Minocycline Gel for Inflammatory Lesions of Papulopustular Rosacea (clinicaltrials.gov) - P2; N=207; Active, not recruiting; Sponsor: BioPharmX, Inc.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

Open Label Phase 2 Feasibility Study of BPX-04 Topical Minocycline Gel in Rosacea (clinicaltrials.gov) - P1/2; N=30; Completed; Sponsor: BioPharmX, Inc.; Active, not recruiting ➔ Completed

Clinical • Trial completion