captisol-enabled docetaxel (ML061) / Ligand - LARVOL DELTA

Functional genomic insights into Floricoccus penangensis ML061-4 isolated from leaf surface of Assam tea. (PubMed, Sci Rep) - "The obtained results support the notion of F. penangensis ML061-4 being safe for biotechnological and food industry purposes. This is the first report outlining functional genomic insights regarding a member of the genus Floricoccus."

Journal

Complete Genome Sequence of Floricoccus penangensis ML061-4 Isolated from Assam Tea Leaf [Camellia sinensis var. assamica (J.W.Mast.) Kitam.]. (PubMed, J Genomics) - "F. penangensis ML061-4 was originally isolated from the surface of an Assam tea leaf, and its genome is herein shown to contain gene clusters predicted to be involved in complex carbohydrate metabolism and biosynthesis of secondary metabolites."

Journal • Infectious Disease

A phase II study of durvalumab (MEDI4736) for previously treated patients with stage IV squamous NSCLC (SqNSCLC): Lung-MAP Sub-study SWOG S1400A (ELCC 2017) - P2; "The initial protocol was a randomized phase II/III comparison of durvalumab to docetaxel, and was amended to be a single arm phase II trial of single agent durvalumab. Durvalumab demonstrated clinical benefit and durable responses in a previously treated metastatic NSCLC population with manageable toxicity profile. Results are comparable with other anti-PD-1/PD-L1 therapies in metastatic, relapsed NSCLC."

Clinical • P2 data • Biosimilar • Lung Cancer • Non Small Cell Lung Cancer • Oncology

Icotinib as first-line or maintenance therapy in patients with advanced lung adenocarcinoma with positive EGFR mutation and the influence of cytokines shift on survival. (ASCO 2017) - P4; " Treatment-naive patients with EGFR-mutated NSCLC were enrolled and randomly assigned to recieve icotinib or 2- or 4-cycle chemotherapy (pemetrexed + platinum [PP] or docetaxel + platinum [DP]) with icotinib maintenance. First-line chemotherapy plus icotinib maintenance seems to offer better efficacy in advanced NSCLC patients with EGFR mutation. The shift of level of IL-6, HIF-1, PD 1, and PD-L1 in peripheral blood correlates with a better prognosis, however, further study with larger size is warranted to detect the potential role of immune response in regulating survival of patients with EGFR-mutant NSCLC."

Biomarker • Clinical • Biosimilar • Non Small Cell Lung Cancer

Avelumab in metastatic castration-resistant prostate cancer (mCRPC). (ASCO-GU 2017) - P1; "...3 pts had previous chemotherapy with docetaxel, 8 pts received previous vaccine treatment including 4 pts with sipuleucel-T and 4 pts with Prostvac...5 of 18 pts enrolled while on enzalutamide with a rising PSA... These data provide safety data of avelumab on a population of pts with mCRPC. Immune analysis is under way to determine correlation with immune responses in the pts on this trial that had prolonged SD."

Clinical • Prostate Cancer

Avelumab in metastatic castration-resistant prostate cancer (mCRPC). (ASCO 2017) - P1; "...3 pts had previous chemotherapy with docetaxel, 8 pts received previous vaccine treatment including 4 pts with sipuleucel-T and 4 pts with Prostvac...5 of 18 pts enrolled while on enzalutamide with a rising PSA... These data provide safety data of avelumab on a population of pts with mCRPC. Immune analysis is under way to determine correlation with immune responses in the pts on this trial that had prolonged SD."

Clinical • Biosimilar • Prostate Cancer

Randomized, open-label phase Ib/II study of atezolizumab with or without daratumumab in previously treated advanced or metastatic non-small cell lung cancer (NSCLC). (ASCO 2017) - P1b/2; "Atezolizumab (atezo) blocks programmed death-ligand 1 (PD-L1) and was recently approved for metastatic NSCLC that progressed on or during platinum therapy based on data showing improved overall survival (OS) in the atezo vs docetaxel treatment arm. Secondary outcomes include safety, duration of response, clinical benefit rate (≥16 weeks duration), progression-free survival, OS, and pharmacokinetics and immunogenicity of DARA and atezo when given in combination. Approximately 96 pts will be enrolled; 6 pts will receive combination therapy in a safety run-in cohort for evaluation of dose-limiting toxicity followed by 90 pts randomly (1:1) assigned to the 2 treatments."

Checkpoint inhibition • Clinical • Combination therapy • Biosimilar • Lung Cancer • Non Small Cell Lung Cancer • Oncology

Phase 1b/2 keynote-365 trial: Pembrolizumab (pembro) combination therapy in metastatic castration-resistant prostate cancer (mCRPC). (ASCO 2017) - P1; "... Cohort allocation depends upon prior treatment: cohort A requires prior docetaxel (treatment with 1 other chemotherapy and ≤2 second-generation hormonal manipulations is allowed); cohort B requires prior abiraterone acetate or enzalutamide (but not both); cohort C requires prior abiraterone acetate...Pembro 200 mg will be given every 3 weeks (Q3W) with either olaparib 400 mg twice daily (cohort A), docetaxel 75 mg/m2 Q3W + prednisone 5 mg twice daily (cohort B), or enzalutamide 160 mg once daily (cohort C)...Secondary end points include time to PSA progression, progression-free survival, overall survival, and overall response rate. Enrollment will continue until 70 patients are enrolled for each cohort."

Clinical • Combination therapy • Biosimilar • Prostate Cancer

Phase I dose-escalation study of fractionated-dose 177Lu-PSMA-617 for progressive metastatic castration resistant prostate cancer (mCRPC). (ASCO 2017) - P1; "A series of sequential studies of radiolabeled anti-PSMA antibody J591 revealed 1) targeting and safety [Bander 2003]; 2) safety and prelim efficacy [Milowsky 2004, Bander 2005]; 3) efficacy and initial dose-response [Tagawa 2013]; 4) dose-fractionation allows higher doses, ability to combine with docetaxel, confirmation of dose-response (PSA and overall survival) [ASCO 2010, 2014, 2016]; 5) predictable, reversible myelosuppression is dose-limiting [Tagawa 2013]. Secondary endpoints include toxicity, PSA decline rate, RECIST response, PFS, rPFS, OS. Correlatives include baseline/follow up PSMA imaging, whole body distribution of 177Lu-PSMA-617, CTC count (CellSearch) changes, tissue and circulating genomic assessment of DNA repair pathways, patient reported outcomes (FACT-P and BPI-SF)."

P1 data • Retrospective data • Biosimilar • Prostate Cancer

GU Cancers 2021 | STARTAR: ADT + apalutamide + RT + docetaxel for PSA-recurrent prostate cancer following RP (VJOncology) - "Andrew Armstrong...discusses the interim results of the Phase II STARTAR trial (NCT03311555)...The study demonstrated excellent short-term outcomes in patients treated with ADT plus apalutamide plus RT followed by six cycles of docetaxel. The treatment was generally well-tolerated with the exception of a high rate of drug rash and neutropenia, in line with known safety profiles."

Interview • Video

Partial rpoB Gene Sequencing Identification and Probiotic Potential of Floricoccus penangensis ML061-4 Isolated from Assam Tea (Camellia sinensis var. assamica). (PubMed, Sci Rep) - "penangensis ML061-4 exhibited probiotic characteristics including lactic acid production (9.19 ± 0.10 mg/ml), antibacterial activities (Escherichia coli ATCC 25922 and E. coli O157:H7 DMST 12743), acid and bile salt tolerance (71.1 and 54.9%, respectively), autoaggregation (97.0%), coaggregation (66.0% with E. coli O157:H7), cell surface hydrophobicity (90.0%), bacterial adhesion (82.9% with Lactobacillus plantarum FM03-1), competitive inhibition (17.8% with E. coli O157:H7) and competitive exclusion (34.9% with E. coli O157:H7). Overall, the data suggested that F. penangensis ML061-4 had a great potential to be a probiotic."

Journal

Enhanced in vivo antitumor efficacy of dual-functional peptide-modified docetaxel nanoparticles through tumor targeting and Hsp90 inhibition. (PubMed) - J Control Release - "Furthermore, the targeting NPs exhibited significantly improved antitumor efficacy and biodistribution compared with nontargeting nanodrug and free docetaxel. These findings demonstrate the feasibility of dual-functional NPs for efficient anticancer therapy."

Journal • Biosimilar • Non Small Cell Lung Cancer • Oncology

The antitumor efficacy of docetaxel is enhanced by encapsulation in novel amphiphilic polymer cholesterol-coupled tocopheryl polyethylene glycol 1000 succinate micelles. (PubMed, Drug Deliv Transl Res) - "Interestingly, the blank TPGS-CHMC micelles also showed antitumor activity. Our results demonstrate that TPGS-CHMC is a promising system for DTX delivery that may be suitable for other hydrophobic antitumor drugs."

Journal • Biosimilar • Oncology