On October 7, 2016 Kite Pharma, Inc. (Nasdaq:KITE) reported updated results from the Phase 1 portion of Kite’s ZUMA-1 clinical trial of its lead product candidate, KTE-C19, in patients with chemorefractory, aggressive non-Hodgkin lymphoma (NHL) (Press release, Kite Pharma, OCT 7, 2016, View Source [SID:SID1234515649]). The results were provided in an oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) annual congress. KTE-C19 is an investigational therapy in which a patient’s T cells are genetically modified to express a chimeric antigen receptor (CAR) that is designed to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias.

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"These data complement our recently reported interim topline results from ZUMA-1 Phase 2 and support the potential for KTE-C19 to be a breakthrough therapy for chemorefractory, aggressive NHL," said David Chang, M.D., Ph.D., Executive Vice President, Research and Development, and Chief Medical Officer of Kite. "We are encouraged that the complete remission rate of 43 percent in the Phase 1 portion of the study continues through month 12 and look forward to reporting additional data on the durability of response to KTE-C19 from the Phase 2 portion of ZUMA-1 in 2017."

A summary of the 12-month follow-up data from the Phase 1 portion of the ZUMA-1 study is provided below.

Ongoing complete remissions in phase 1 of ZUMA-1: a phase 1-2 multi-center study evaluating the safety and efficacy of KTE-C19 (anti-CD19 CAR T cells) in patients with refractory aggressive B cell non-Hodgkin Lymphoma (NHL). Abstract 1048O; Presenter: Frederick Locke, M.D., Moffitt Cancer Center, Tampa, FL; Friday, October 7, 2016: 4:00-5:30pm CEST; Proffered Paper session: Immunotherapy of Cancer (SITC) (Free SITC Whitepaper); Location: Copenhagen.

Phase 1 of ZUMA-1 treated a total of 7 patients with chemorefractory, diffuse large B-cell lymphoma (DLBCL)
KTE-C19 related adverse events consisted predominantly of cytokine release syndrome (CRS) and neurotoxicity which were generally reversible
Grade 3 or higher CRS was observed in 14 percent and neurotoxicity in 57 percent; all were reversible except in one patient with dose-limiting toxicity
KTE-C19 achieved rapid and durable responses in patients with chemorefractory disease (objective response rate 71 percent, complete remission rate 57 percent)
Ongoing complete remissions were observed in 3 of 7 patients as of 12-month study follow-up
Three additional posters relating to KTE-C19 clinical trials in progress will also be presented at ESMO (Free ESMO Whitepaper) 2016.

ZUMA-1: A phase 2 multi-center study evaluating anti-CD19 chimeric antigen receptor (CAR) T cells in patients with refractory aggressive non-Hodgkin lymphoma (NHL). Abstract 943TiP; Saturday, October 8, 2016: 1:00-2:00pm CEST; Poster Display session; Location: Hall E.

ZUMA-2: A phase 2 multi-center study evaluating the efficacy of KTE-C19 (Anti-CD19 CAR T cells) in patients with relapsed/refractory Mantle cell lymphoma (R/R MCL). Abstract 945TiP; Saturday, October 8, 2016: 1:00-2:00pm CEST; Poster Display session; Location: Hall E.

ZUMA-3: A phase 1/2 multi-center study evaluation the safety and efficacy of KTE-C19 anti-CD19 CAR T cells in adult patients with relapsed/refractory B precursor acute lymphoblastic leukemia (R/R ALL). Abstract 415TiP; Monday, October 10, 2016: 1:00-2:00pm CEST; Poster Display session; Location: Hall E.

About KTE-C19

Kite Pharma’s lead product candidate, KTE-C19, is an investigational therapy in which a patient’s T cells are engineered to express a CAR to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias, and redirect the T cells to kill cancer cells. KTE-C19 has been granted Breakthrough Therapy Designation status for diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), and primary mediastinal B-cell lymphoma (PMBCL) by the U.S. Food and Drug Administration and Priority Medicines (PRIME) regulatory support for DLBCL in the EU.

On October 7, 2016 Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, reported that four poster presentations will be featured at the 2016 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) annual meeting, October 7-11, 2016 in Copenhagen, Denmark (Press release, Myriad Genetics, OCT 7, 2016, View Source [SID:SID1234515650]).

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"Myriad is a pioneer in personalized medicine and is committed to improving the prevention, detection and treatment of cancer," said Jerry Lanchbury, Ph.D., chief scientific officer, Myriad Genetics. "We are excited to present these new studies at ESMO (Free ESMO Whitepaper) that highlight and advance the science of our next-generation companion diagnostics to help inform and improve the treatment of cancer patients."

Please visit the Myriad booth #408 at ESMO (Free ESMO Whitepaper) for more information. Abstracts are available online at: View Source Follow Myriad on Twitter via @MyriadGenetics to stay informed about news and updates from the Company.

Poster Presentations
Title: Outcomes of clinical testing for tumor BRCA1 and BRCA2 gene analysis for 354 patients: First experience with tumor companion diagnostic for PARP inhibitors.
Presenter: Karen Copeland, M.S.
Date: Saturday, Oct. 8, 2016. 1:00-2:00 p.m.
Location: Poster 874P (Abstract 4031). Hall E.

This study assessed 354 patients with ovarian cancer undergoing BRCA1 and BRCA2 full sequencing and large rearrangement DNA analysis using the Tumor BRACAnalysis CDx test. The results show that, of the 354 samples analyzed, 93 (26.3 percent) tested positive for a pathogenic mutation; 57 were found in BRCA1 and 37 in BRCA2. Of the pathogenic mutations detected, 93.6 percent were sequencing variants and 6.4 percent were large rearrangements. These findings highlight the utility of the Tumor BRACAnalysis CDx test to accurately detect BRCA mutations in patients with ovarian cancer.

Title: The molecular landscape of genome instability in prostate cancer.
Presenter: Kirsten Timms, Ph.D.
Date: Monday, Oct. 10, 2016. 1:00-2:00 p.m.
Location: Poster 115P (Abstract 3247). Hall E.

In this study, DNA from 95 prostate cancer (PC) tumors was analyzed to generate homologous recombination deficiency (HRD) and Microsatellite instability (MSI) and cell cycle progression (CCP) scores. Additionally, 45 DNA damage repair (DDR) genes were sequenced and were considered non-functional if both alleles were mutated and/or deleted. If the second allele was intact, these genes were considered defective but functional. The results showed that non-functional DDR genes (CDK12, PALB2, RPA1, ATM, and BRCA2) were observed in seven tumors and DDR gene defects in eight genes were observed in 11 tumors. Importantly, the HRD score was significantly associated with DDR mutation status, Gleason score and CCP score. A significant proportion of aggressive prostate tumors carry molecular signatures associated with response to therapies targeting DDR deficiencies or to immune-therapeutics. This study demonstrates the importance of assessing both alleles when identifying prostate tumors with DDR gene mutations. In the study, an HRD score of ≥20 identified three times as many potential responders to HRD-dependent therapies compared to non-functional DDR gene mutations.

Title: Characteristics of homologous recombination deficiency (HRD) in paired primary and recurrent high-grade serous ovarian cancer.
Presenter: Jai Patel.
Date: Monday, Oct. 10, 2016. 1:00-2:00 p.m.
Location: Poster 113P (Abstract 3290). Hall E.

In this study, the myChoice HRD test was used to evaluate paired primary and recurrent tumors from 54 patients with high-grade serous ovarian cancer (HGSOC), the vast majority of whom were treated with adjuvant carboplatin and paclitaxel. The objective was to determine if changes in the genomic profile of primary and recurrent tumors might impact the myChoice HRD score. The results showed that there were no significant differences in the genomic markers evaluated between primary and recurrent tumors. Importantly, the myChoice HRD test was not impacted by changes in the genomic profile. This finding suggests that testing recurrent HGSOC tumors would not alter treatment strategies relative to analysis of the primary tumor.

Title: Homologous recombination deficiency (HRD) score shows superior association with outcome compared to its individual score components (LOH, TAI, and LST scores) in platinum treated serous ovarian cancer.
Presenter: Jerry Lanchbury, Ph.D.
Date: Monday, Oct. 10, 2016. 1:00-2:00 p.m.
Location: Poster 112P (Abstract 2504). Hall E.

The myChoice HRD score is the sum of three independent measures of HRD, including loss of heterozygosity (LOH), telomeric-allelic imbalance (TAI) and large-scale state transitions (LST). This study compared the myChoice HRD score to its individual score components (LOH, TAI, and LST). The results showed that the myChoice HRD score is a superior prognostic marker of HR deficiency than the individual scores. There were a significant number of discrepancies between the myChoice HRD score and the individual component, which demonstrated a risk of both false positives and negatives. These findings support the use of myChoice HRD, rather than the individual biomarkers, to inform treatment decisions for patients.

About Tumor BRACAnalysis CDx
Tumor BRACAnalysis CDx is a companion diagnostic test for identifying both germline and somatic cancer-causing mutations in the BRCA1 and BRCA2 genes. Currently, Tumor BRACAnalysis CDx is a CE-marked genomic test designed to detect the presence of a BRCA1 or BRCA2 gene mutation in ovarian tumor tissue. Additionally, Myriad is actively collaborating with leading pharmaceutical companies and academic centers to further develop Tumor BRACAnalysis CDx as a companion diagnostic for use with certain PARP inhibitors, platinum-based drugs and other chemotherapeutic agents.

On October 6, 2016 Cerulean Pharma Inc. (NASDAQ:CERU), a clinical-stage company developing nanoparticle-drug conjugates (NDCs), reported it will present clinical data from its CRLX101 and CRLX301 programs at the 2016 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting being held in Copenhagen, Denmark on October 7-11 (Press release, Cerulean Pharma, OCT 6, 2016, View Source [SID:SID1234515635]). Details of the ESMO (Free ESMO Whitepaper) poster presentations are as follows:

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Title: A phase 1b/2 study of the nanoparticle-drug conjugate CRLX101 in combination with weekly paclitaxel in patients with platinum-resistant ovarian cancer
Date and time: Saturday, October 8 – 13:00 to 14:00 pm Central European Time
Abstract number: 1483
Location: Hall E
Poster board number: 864P
Summary: CRLX101 is an investigational NDC containing the payload camptothecin. This Phase 1b/2 trial evaluates the potential synergy of CRLX101, a topoisomerase 1 inhibitor, in combination with paclitaxel, a standard of care taxane, in patients with platinum-resistant ovarian cancer (PROC). In this trial, CRLX101 is dosed every other week at 12 or 15 mg/m2 in conjunction with weekly paclitaxel at 80 mg/m2. Data from the nine patients in the Phase 1b portion of the trial suggest CRLX101 administered every other week in combination with weekly paclitaxel demonstrate antitumor activity. Additionally, the combination has been generally well tolerated with no dose-limiting toxicities reported. Early data from the first nine patients in the Phase 2 portion of the trial also show activity and tolerability.

Title: Evaluation of weekly dosing of CRLX101 alone and in combination with bevacizumab in patients with advanced solid tumors
Date and time: Monday, October 10 – 13:00 to 14:00 pm Central European Time
Abstract number: 1781
Location: Hall E
Poster board number: 393P
Summary: CRLX101, an investigational NDC containing the payload camptothecin, has been shown to be active in different tumor types as a topoisomerase 1 inhibitor. This study evaluated the dosing and tolerability of a weekly dosing schedule of CRLX101 alone and in combination with bevacizumab. In arm 1, CRLX101 was administered intravenously as a monotherapy at 12 or 15 mg/m2 weekly; in arm 2, this same dosing regimen was administered in combination with every other week dosing of bevacizumab at 10 mg/kg. In arm 1, the maximum tolerated dose for CRLX101 weekly monotherapy is 15 mg/m2. In arm 2, the maximum tolerated dose for CRLX101 in combination with bevacizumab is either 12 mg/m2 weekly or 15 mg/m2 for 3 of 4 weeks. Partial responses were observed in three patients. There was increased cystitis, but no new safety concerns were observed.

Title: Pharmacokinetics of CRLX101 administered weekly in patients with advanced solid tumors
Date and time: Monday, October 10 – 13:00 to 14:00 pm Central European Time
Abstract number: 1767
Location: Hall E
Poster board number: 394P
Summary: CRLX101 is an investigational NDC containing the payload camptothecin. This study evaluated the pharmacokinetics of CRLX101 in patients with advanced solid tumors. CRLX101 was administered intravenously at 12 or 15 mg/m2 on a weekly dosing schedule. The data suggest CRLX101 exhibits high drug retention in the plasma, slow clearance and controlled slow release of camptothecin from the NDC without drug accumulation, supporting weekly dosing of CRLX101 at 15 mg/m2, which represents a 100% increase in dose intensity when compared to a dosing schedule of every other week.

Title: A dose-escalation study of weekly intravenous CRLX301 in patients with advanced solid tumor malignancies
Poster presentation: Monday, October 10 – 13:00 to 14:00 pm Central European Time
Abstract number: 1793
Location: Hall E
Poster board number: 413Tip
Summary: CRLX301 is an investigational NDC containing the payload docetaxel currently being investigated in a Phase 1/2a trial of patients with advanced solid tumors. The first portion of the trial determined the maximum tolerated dose for IV CRLX301 administered every three weeks to be 75 mg/m2. The second portion of the trial is evaluating the maximum tolerated dose for weekly administration of CRLX301. Based on data from the first portion of this trial, the weekly starting dose was 25 mg/m2. This dose escalating trial also evaluates safety, PK and antitumor activity.

Electronic copies of the posters will be available upon request following ESMO (Free ESMO Whitepaper) by emailing [email protected].

About CRLX101

CRLX101 is a nanoparticle-drug conjugate (NDC) designed to concentrate in tumors and slowly release its anti-cancer payload, camptothecin, inside tumor cells. CRLX101 inhibits topoisomerase 1 (topo 1), which is involved in cellular replication. CRLX101 has shown activity in multiple tumor types, both as monotherapy and in combination with other cancer treatments. CRLX101 is in Phase 2 clinical development and has been dosed in more than 400 patients. The U.S. FDA has granted CRLX101 Orphan Drug designation for the treatment of ovarian cancer, Fast Track designation in combination with paclitaxel for platinum-resistant ovarian carcinoma, fallopian tube or primary peritoneal cancer, and Fast Track designation in combination with Avastin in metastatic renal cell carcinoma.

About CRLX301

CRLX301 is a dynamically tumor-targeted NDC designed to concentrate in tumors and slowly release its anti-cancer payload, docetaxel, inside tumor cells. In preclinical studies, CRLX301 delivers up to 10 times more docetaxel into tumors, compared to an equivalent milligram dose of commercially available docetaxel and was similar to or better than docetaxel in seven of seven animal models, with a statistically significant survival benefit seen in five of those seven models. In addition, preclinical data show that CRLX301 had lower toxicity than has been reported with docetaxel in similar preclinical studies. CRLX301 is in Phase 1/2a clinical development.

On October 6, 2016 Coherus BioSciences, Inc. (NASDAQ:CHRS), a leading pure-play, global biosimilar company with late-stage clinical products, reported that the U.S. FDA has accepted the filing of 351(k) Biologics License Application for CHS-1701, a pegfilgrastim (Neulasta) biosimilar candidate (Press release, Coherus Biosciences, OCT 6, 2016, View Source;p=irol-newsArticle&ID=2210016 [SID:SID1234515636]).

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The BLA submission is supported by similarity data from analytical, pharmacokinetic, pharmacodynamic and immunogenicity studies comparing CHS-1701 and Neulasta. The biosimilar user fee act (BSUFA) action date is June 9, 2017.

On October 6, 2016 Prima BioMed Ltd (ASX: PRR; NASDAQ: PBMD) ("Prima", the "Company") reported that an abstract for each of its two clinical trials for IMP321 has been accepted for Poster presentation (display) during the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Symposium on ‘Immuno-Oncology—Advances in cancer immunotherapy; From vaccines to antibodies and cell therapies’ from 4-6 November 2016 in Lausanne, Switzerland (Filing, 6-K, Prima Biomed, OCT 6, 2016, View Source [SID:SID1234515644]).
The abstract titles are:

• TACTI-mel (Two ACTive Immunotherapeutics in melanoma): A Phase 1 trial in patients with unresectable or metastatic melanoma receiving IMP321 (LAG-3Ig fusion protein) as an adjunctive therapy to anti-PD-1 therapy with pembrolizumab (Poster #155); and

• AIPAC (Active Immunotherapy PAClitaxel): A Phase IIb trial in hormone receptor-positive metastatic breast carcinoma patients receiving IMP321 (LAG-3Ig fusion protein) or placebo as adjunctive to a standard chemotherapy regimen of paclitaxel (Poster #145).

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Both posters will be on display for the duration of the Symposium. The Poster viewing session will take place over lunch from 13:00-14:15 on Saturday 5 November 2016. The abstracts will also be published in the ESMO (Free ESMO Whitepaper) Symposium on Immuno-Oncology 2016 Abstract Book, a supplement to the official ESMO (Free ESMO Whitepaper) journal "Annals of Oncology".
For more schedule information see View Source