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 7, 2016 Moleculin Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"), a preclinical and clinical-stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, reported it has secured an agreement with Dermin Sp. Zo. O. ("Dermin") to utilize Dermin’s supply of Annamycin for its upcoming clinical trial, substantially reducing the expenditures required of Moleculin for drug product and shortening the time required to produce clinical supplies (Press release, Moleculin, OCT 7, 2016, View Source [SID:SID1234515658]).

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"This was an important agreement and key milestone to be reached as it clearly shortens the pathway as well as lowers the expense involved in our clinical timeline and go to market strategy," commented Walter Klemp, Chairman and Acting CEO of Moleculin. "With this agreement in place, our drug product expense for our upcoming clinical trial will be substantially below what we had previously budgeted. Additionally, Dermin’s existing supply alleviates any potential drug production constraints and advances our ability to begin our next trial expeditiously."

Moleculin previously licensed Annamycin to Dermin within a limited region in Europe, enabling Dermin to deploy Polish grant funds toward producing Annamycin. The agreement reached between the two companies allows Moleculin to utilize this Annamycin in its upcoming clinical trials rather than having to produce new Annamycin for its own use. Dermin benefits from a data sharing arrangement giving it access to Moleculin’s clinical data on a faster timeline than it would be able develop on its own.

Mr. Klemp concluded, "We are pleased with this key agreement in place and remain focused on our upcoming milestones. We look forward to beginning our expanded clinical trials on Annamycin by the first half of 2017."

On October 7, 2016 Cambrex Corporation (NYSE:CBM), a leading manufacturer of small molecule innovator and generic Active Pharmaceutical Ingredients (APIs), reported that it has completed the acquisition of PharmaCore, Inc., a privately-owned company located in High Point, North Carolina, specializing in developing, manufacturing and scaling up small molecule APIs for clinical phase projects. This completes the transaction initially announced on September 26, 2016 (Press release, Cambrex, OCT 7, 2016, View Source [SID:SID1234515685]). With the acquisition of PharmaCore, which has been renamed Cambrex High Point, Inc., Cambrex enhances its capabilities and expertise to efficiently develop early clinical phase products and new technologies.

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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