PSMA-targeted docetaxel (BIND-014) / Pfizer - LARVOL DELTA

Towards a New Horizon in Prostate Cancer: PSMA-Targeted Docetaxel-Conjugated Nanomedicines for Intratumoral Treatment in Xenograft Model (AUA 2023) - "Docetaxel-conjugated mesoporous silica nanomedicines effectively reduced tumor volume in intratumoral administration using a nude mice PC xenograft model. These results are promising, paving the way for a future applicability as a precision intratumoral medicine for PC in humans."

Preclinical • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • FOLH1

Towards a new horizon in prostate cancer: PSMA-targeted Docetaxel-conjugated nanomedicines for intratumoral treatment in xenograft model (EAU 2023) - No abstract available

Preclinical • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

PSMA-targeted small-molecule docetaxel conjugate: Synthesis and preclinical evaluation. (PubMed, Eur J Med Chem) - "Also, it was found that PSMA-targeted docetaxel conjugate is less toxic than docetaxel itself, the decrease of molar acute toxicity in comparison with free docetaxel was up to 20%. Obtained conjugate PSMA-DOC is a good candidate for further expanded preclinical trials because of high antitumor activity, fewer side toxic effects and better solubility."

Journal • Preclinical • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Survey of Clinical Translation of Cancer Nanomedicines-Lessons Learned from Successes and Failures. (PubMed, Acc Chem Res) - "In 1995, the year the first cancer nanomedicine, Doxil, was approved by the Food and Drug Administration (FDA), only 23 manuscripts appeared in a PubMed search for "nanoparticles for cancer" keywords...In some cases, findings from these trials have not only shown improved pharmacokinetics, but also avid drug accumulation within tumor tissues among active-targeting nanoparticles, including BIND-014, CALAA-01, and SGT-94...In other cases, clinical failures and market pressure from improving standard of care products resulted in product terminations and business liquidation. Yet, recent approvals of nanomedicine products for orphan cancers and continuing development of nanoparticle based drugs for immune-oncology applications fuel continuing industrial and academic interest in cancer nanomedicines."

Clinical • Journal • Oncology

A Study of BIND-014 (Docetaxel Nanoparticles for Injectable Suspension) as Second-line Therapy for Patients With KRAS Positive Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2; N=40; Recruiting; Sponsor: BIND Therapeutics

New P2 trial • Biosimilar • Non Small Cell Lung Cancer • Oncology

iNSITE2: A Study of BIND-014 in Patients With Urothelial Carcinoma, Cholangiocarcinoma, Cervical Cancer and Squamous Cell Carcinoma of the Head and Neck (clinicaltrials.gov) - P2; N=73; Terminated; Sponsor: BIND Therapeutics; N=160 ➔ 73; Recruiting ➔ Terminated

Enrollment change • Trial termination • Biliary Cancer • Biosimilar • Gastrointestinal Cancer • Head and Neck Cancer • Oncology

"Teaching old dogs new tricks! Safety and Efficacy of BIND-014, a Docetaxel Nanoparticle Targeting Prostate-Specific Membrane Antigen for Patients With #CRPC ⁦@apccc19⁩ #prostatecancer ⁦@JAMA_current⁩ https://t.co/UKEYbjdv80" (@DrYukselUrun)

Clinical • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Langer’s BIND Biosciences secures $8.7M (Boston Business Journal) - "BIND received a $47.35 million financing from RUSANO, a billion dollar investment fund focused on nanotechnology, existing investors and new investors..'The financing will be used to advance BIND-014...in Phase 2 clinical studies for a number of solid tumor cancers...'"

Financing • Oncology

BIND Therapeutics: Q4 FY 2015 Results (BIND Therapeutics) - Anticipated top-line data from P2 iNSITE 1 trial (NCT02283320) in squamous cell non-small cell lung cancer in April 2016; Anticipated top-line data from P2 iNSITE 2 trial (NCT02479178) in advanced cervical cancer and head and neck cancer in April 2016

Anticipated P2 data • Head and Neck Cancer • Non Small Cell Lung Cancer • Oncology • Uterine Cancer

Bind Therapeutics: Clinical Trial Update (BIND Therapeutics) - Anticipated initiation of stage 2 of P2 iNSITE 2 trial ([NCT02479178) for head and neck cancer by the end of Q1 2016; Anticipated initiation of stage 2 of P2 iNSITE 2 trial ([NCT02479178) in cervical cancer cohort early in Q2 2016

Anticipated trial initiation date • Head and Neck Cancer • Oncology • Uterine Cancer

BIND Therapeutics: Q2 2014 Results (BIND Therapeutics) - Anticipated initiation of P2 trial for KRAS mutant NSCLC by end of 2014

Anticipated new P2 trial • Non Small Cell Lung Cancer • Oncology

BIND Therapeutics: JMP Securities Healthcare Conference (BIND Therapeutics) - "BIND-014 Phase 1: Well Tolerated and Promising Signs of Clinical Activity"; "Once Every Week Schedule in Phase 1 Trial (N =27)"; "Well tolerated with predictable and manageable toxicity"; "No new or unexpected toxicities observed"; "Maximum Tolerated Dose declared at 40 mg/m2, dose-limiting toxicities were neutropenia and mucositis"; "Traditional docetaxel toxicities observed generally at low frequency and grade"; "Clinical activity: 2 PR (Breast, GI): 5 SD > 12 weeks (NSCLC, neuroendocrine, GI)"; "Weekly dosing schedule provides 50% greater drug exposure than 3 Weekly schedule"

P1 data • Breast Cancer • Non Small Cell Lung Cancer • Oncology

BIND Therapeutics: Clinical Trial Update (BIND Therapeutics) - Anticipated data from P2 iNSITE 2 trial (NCT02479178) in multiple tumor types in Q1 2016

Anticipated P2 data • Oncology

BIND Therapeutics: Biotech Showcase (BIND Therapeutics) - "BIND-014: mCRPC Trial (004) Meets Primary Endpoint and Suggests Differentiation"; "Substantial clinical activity: 71% of patients achieved rPFS of at least 6 months, Median rPFS of 9.9 months, Median OS was 13.4 months, with 10 patients censored, Confirmed ORR of 21% in 19 patients with measurable disease, 50% reduction in PSA in 30% of patients, Active despite 74% of patients with prior exposure to anti-androgen therapy"; "Well-tolerated: Clinically relevant reduction in toxicities"; "The safety and activity of BIND-014 suggest differentiation from docetaxel, including in patients who have prior exposure to anti-androgen therapy in view of the potential cross-resistance between anti-androgen therapy and docetaxel"

P2 data • Oncology • Prostate Cancer

BIND Therapeutics: JMP Securities Healthcare Conference (BIND Therapeutics) - Anticipated initiation of 20 patient open label trial in KRAS mutant NSCLC in Q3 2014; Anticipated trial completion for P2 trial in 2nd line (docetaxel naive) NSCLC in Q3 2014; Anticipated P2 data for 2nd line (docetaxel naive) NSCLC in Q4 2014; Anticipated P3 trial initiation for 2nd line (docetaxel naive) NSCLC in Q1 2015; Anticipated trial completion for P2 trial for 1st line (chemotherapy naive) mCRPC in H2 2014; Anticipated P2 data for 1st line (chemotherapy naive) mCRPC in Q4 2014; Anticipated P3 trial initiation for 1st line (chemotherapy naive) mCRPC in Q1 2015

Anticipated new P3 trial • Anticipated P2 data • Anticipated trial completion date • Anticipated trial initiation date • Non Small Cell Lung Cancer • Oncology • Prostate Cancer

BIND Therapeutics: Credit Suisse Healthcare Conference (BIND Therapeutics) -  Anticipated stage 1 data readout for P2 trial for bladder, cervical, cholangio and neuroendocrine cancers in H1 2016; Anticipated stage 2 data readout for P2 trial for bladder, cervical, cholangio and neuroendocrine cancers in H2 2016; Anticipated randomized trial initiation for 2nd line NSCLC in H1 2015; Anticipated randomized trial initiation for 1st line mCRPC in H1 2015 

Anticipated P2 data • Anticipated trial initiation date • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer

BIND Therapeutics: JMP Securities Life Sciences Conference (BIND Therapeutics) - Anticipated final stage 1 data readout from P2 iNSITE 2 trial for bladder, cervical, cholangio and head and neck cancer in H1 2016; Anticipated stage 2 data readout from P2 iNSITE 2 for bladder, cervical, cholangio and head and neck cancer in H2 2016   

Anticipated P2 data • Head and Neck Cancer • Oncology

BIND Therapeutics: BioCentury Newsmakers in the Biotech Industry (BIND Therapeutics) - Anticipated data readout from P2 iNSITE 1 trial (NCT02283320) in KRAS mutant NSCLC in H2 2015/H1 2016; Anticipated data readout from P2 iNSITE 1 trial in squamous histology NSCLC in H2 2015/H1 2016

Anticipated P2 data • Non Small Cell Lung Cancer • Oncology

BIND Therapeutics: Annual Report 2015 (BIND Therapeutics) - Anticipated expiry of issued patents between 2025 and 2030; Anticipated expiry of pending patents between 2028 and 2035

Anticipated patent expiry • Oncology

BIND Therapeutics: Cowen and Company Healthcare Conference (BIND Therapeutics) - “BIND-014 mCRPC Topline Data”; “Patients with metastatic castrate-resistant prostate with no prior chemotherapy treated BIND-014 60 mg/m2 administered every 21 days (n=42)”; “Primary endpoint: radiographic progression-free survival (rPFS)”; “Substantial clinical activity in a less responsive patient population than historical controls: 31/42 (74%) had prior abiraterone and/or enzalutamide vs. 0% in TAX-327, Median rPFS of 8.1 months vs. 6-8 months in earlier stage historical controls, 60% of patients enrolled attained a rPFS of 6 months or greater, Reduced incidence of typical docetaxel-related hematologic and non-hematologic toxicities, Internally consistent activity in secondary endpoint outcomes, including PSA responses and reductions in circulating tumor cell counts, Overall survival immature. As of December 15, 2014, two patients continue on treatment and 24 patients continue to be followed for overall survival”

P2 data • Oncology • Prostate Cancer

BIND Therapeutics: Annual Report 2014 (BIND Therapeutics) - “BIND-014: Phase 2 Data in NSCLC”; “Tumor Response: all patients (BIND-014 Q3W schedule at 60 mg/m2, n=40”

P2 data • Non Small Cell Lung Cancer • Oncology

BIND Therapeutics: Cowen and Company Healthcare Conference (BIND Therapeutics) - Anticipated final data from P2 trial (NCT01792479) in KRAS+ NSCLC in 2015/H1 2016; Anticipated final data from P2 trial (NCT02283320) in squamous NSCLC in 2015/H1 2016

Anticipated P2 data • Non Small Cell Lung Cancer • Oncology

BIND Therapeutics: Oppenheimer & Co. Healthcare Conference (BIND Therapeutics) - Anticipated data readout from P2 trial for KRAS NSCLC in Q1 2016; Anticipated data readout from P2 trial for squamous NSCLC in Q1 2016; Anticipated data readout from P2 trial for 1st-line chemotherapy naive mCRPC in early Q1 2015; Anticipated stage 1 data readout from P2 trial for bladder, cervical, cholangio and head and neck cancer in H1 2016; Anticipated stage 2 data readout from P2 trial for bladder, cervical, cholangio and head and neck cancer in H2 2016  

Anticipated P2 data • Oncology

BIND Therapeutics reports phase 2 data from iNSITE 1 and iNSITE 2 trials with BIND-014 and provides strategic update (Businesswire) - P2, N=69, 160; NCT02283320, NCT02479178; Sponsor: BIND Therapeutics; “BIND Therapeutics…today announced preliminary top-line results from the BIND-014…phase 2 iNSITE 1 trial in advanced non-small cell lung cancer (NSCLC) of squamous histology and the iNSITE 2 trial in cervical and head and neck cancers…In the iNSITE 1 trial…BIND-014 demonstrated a 52.5 percent...for the intent-to-treat population (n=40) and a 70.0 percent...in the per protocol population (n=30)…In the first stage of the iNSITE 2 trial…BIND-014 demonstrated an objective response rate of 10 percent in the head and neck cancer cohort (n=20); there were no objective responses in the cervical cancer cohort (n=23).”

P2 data • Non Small Cell Lung Cancer • Oncology

BIND Therapeutics: JMP Securities Healthcare Conference (BIND Therapeutics) - "BIND-14 Phase 2 NSCLC Interim KRAS Mutant Analysis"; "Data as of 5/9"

P2 data • Non Small Cell Lung Cancer • Oncology