On May 26, 2017 Endocyte, Inc. (NASDAQ:ECYT), a leader in developing targeted small molecule drug conjugates (SMDCs) and companion imaging agents for personalized therapy, reported that two posters will be presented on its lead, clinical-stage assets, EC1456 and EC1169, at the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held June 2 – 6, 2017, in Chicago (Press release, Endocyte, MAY 26, 2017, View Source [SID1234519303]).

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Updated data will be presented on EC1456-01, a two part phase 1 dose escalation (Part A) and expansion (Part B) study. The presentation includes data for 87 Part A treated patients with advanced solid tumors and 6 Part B treated patients with FR-positive non-small cell lung cancer (NSCLC) as of the data cutoff on May 18, 2017. All patients were imaged to assess folate receptor expression with 99mTc-etarfolatide (FR expression not an eligibility criteria for Part A). Preliminary data from our first patient enrolled in the EC1456 ovarian surgical study, EC1456-02, will also be presented.

An update also will be provided for EC1169-01, a two-part phase 1 dose escalation (Part A) and expansion (Part B) study in patients with metastatic castration-resistant prostate cancer (mCRPC). The presentation includes data for the expansion phase (Part B) for 24 taxane-exposed mCRPC patients and 16 taxane-naïve mCRPC patients as of the data cutoff on May 15, 2017. All patients were imaged to assess PSMA expression with 99mTc-EC0652 (PSMA expression not an eligibility criteria).

The posters will be available on Endocyte’s website following presentation at the conference.

Presentations are as follows:

Abstract #: 2576
Title: Phase 1 dose escalation study of the folate receptor-targeted small molecule drug conjugate EC1456
Presenter: Dr. Wael Harb, Horizon Oncology Center
When: Monday, June 5, 8:00 a.m. – 11:30 a.m. CDT
Session Title: Poster Session: Developmental Therapeutics—Clinical Pharmacology and Experimental Therapeutics


Abstract #: 5038
Title: Phase 1 study of the PSMA-targeted small-molecule drug conjugate EC1169 in patients with metastatic castrate-resistant prostate cancer (mCRPC)
Presenter: Dr. Michael Morris, Memorial Sloan Kettering Cancer Center
When: Monday, June 5, 1:15 p.m. – 4:45 p.m. CDT
Session Title: Poster Session: Genitourinary (Prostate) Cancer

About EC1456

EC1456 is an investigational therapeutic SMDC constructed of a high affinity FR-targeting ligand conjugated through a spacer and bioreleasable linker system to a potent cytotoxic microtubule inhibitor, tubulysin B hydrazide (TubBH). Patient FR-status is determined using the investigational companion imaging agent, etarfolatide. EC1456 is currently being evaluated in a phase 1 study in patients with advanced solid tumors (Part A) and FR-positive NSCLC (Part B) (ClinicalTrials.gov Identifier: NCT01999738) and a phase 1 exploratory study in patients with ovarian cancer undergoing surgery (ClinicalTrials.gov Identifier: NCT03011320).

About EC1169

EC1169 is an investigational therapeutic SMDC constructed of a high affinity prostate specific membrane antigen (PSMA)-targeting ligand conjugated through a bioreleasable linker system to a potent microtubule inhibitor, TubBH. Patient PSMA-status is determined using the investigational companion imaging agent, EC0652. EC1169 is currently being evaluated in a phase 1 study in patients with metastatic castration-resistant prostate cancer (mCRPC) (ClinicalTrials.gov Identifier: NCT02202447).

On May 26, 2017 Kite Pharma, Inc., (Nasdaq:KITE), a leading cell therapy company, reported that the U.S. Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) for axicabtagene ciloleucel (Press release, Kite Pharma, MAY 26, 2017, View Source [SID1234519299]). The submission follows positive data demonstrated with a single infusion of axicabtagene ciloleucel in the ZUMA-1 Phase 2 trial in patients with refractory aggressive non-Hodgkin lymphoma (NHL). The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of November 29, 2017.

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"Patients with refractory aggressive NHL face a dire prognosis with only a 50 percent chance of surviving six months. This underscores the urgent medical need for these patients and why every day matters, from development to manufacturing to clinical experience," said David Chang, M.D., Ph.D., Executive Vice President of Research and Development and Chief Medical Officer of Kite. "We firmly believe in the potential for axicabtagene ciloleucel to address this need and forge a new path for the future of cell therapy."

The filing acceptance is supported by data from the ZUMA-1 Phase 2 trial which met the primary endpoint of objective response rate (ORR) recorded after a single infusion of axicabtagene ciloleucel with 82 percent (p < 0.0001). At a median follow-up of 8.7 months, 44 percent of patients were in ongoing response, which included 39 percent of patients in complete response (CR).

The most common grade 3 or higher adverse events included anemia (43 percent), neutropenia (39 percent), decreased neutrophil count (32 percent), febrile neutropenia (31 percent), decreased white blood cell count (29 percent), thrombocytopenia (24 percent), encephalopathy (21 percent) and decreased lymphocyte count (20 percent). There were three deaths throughout the course of the registrational trial not due to disease progression, of which two events, were deemed related to axicabtagene ciloleucel.

In December 2015, axicabtagene ciloleucel received Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for DLBCL, TFL, and PMBCL. The company expects to submit its Market Authorization Application (MAA) of axicabtagene ciloleucel with the European Medicines Agency (EMA) in the third quarter of 2017.

ZUMA-1 is supported in part by funding from The Leukemia & Lymphoma Society (LLS) Therapy Acceleration Program.

About axicabtagene ciloleucel

Kite’s lead product candidate, axicabtagene ciloleucel, is an investigational therapy in which a patient’s T cells are engineered to express a chimeric antigen receptor (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. Axicabtagene ciloleucel 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 (FDA) and Priority Medicines (PRIME) regulatory support for DLBCL in the EU.

On May 26, 2017 Aduro Biotech, Inc. (NASDAQ:ADRO) reported that the Aduro management team will host an investor event with special guest speaker Jason J. Luke, M.D., FACP, Assistant Professor of Medicine at the University of Chicago and a principal investigator for the Phase 1 dose-escalation trial of ADU-S100 in patients with advanced/metastatic solid tumors or lymphomas (Press release, Aduro Biotech, MAY 26, 2017, View Source [SID1234519298]). This event will take place in conjunction with the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, IL on Saturday June 3, 2017, at 6:00 a.m. Central Time.

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Dr. Luke is a clinical investigator and a medical oncologist whose research focuses on translational therapeutic advances for melanoma and early phase drug development, particularly immunotherapy.

To access the live webcast and subsequent archived recording of this and other company presentations, please visit the investor section of Aduro’s website at www.aduro.com.

On May 26, 2017 Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, reported an oral presentation, as well as four trials in progress posters, at the 2017 ASCO (Free ASCO Whitepaper) annual meeting in Chicago, Illinois on June 2 through June 6, 2017 (Press release, Adaptimmune, MAY 26, 2017, View Source [SID1234519297]).

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During an oral presentation scheduled for 1:15-1:27 PM CDT on June 5th, Dr. Sandra P. D’Angelo of the Memorial Sloan Kettering Cancer Center will present a full update on Cohorts 1, 2, 3, and 4 from Adaptimmune’s ongoing study of NY-ESO SPEAR T-cells in patients with synovial sarcoma.

The Company will host a webinar / teleconference on June 6th from 8:00–9:00 AM EDT (1:00 -2:00 PM BST) to discuss the updated synovial sarcoma clinical data. Call in details and the webinar link will be made available in the Investors section of Adaptimmune’s website (View Source).

The four trials in progress posters will summarize the study designs for Adaptimmune’s ongoing NY‑ESO trials in myxoid/round cell liposarcoma (MRCLS), ovarian cancer, and non-small cell lung cancer (NSCLC); the Company’s ongoing MAGE-A10 trial in NSCLC, and its MAGE-A10 triple tumor study in patients with head and neck, melanoma, or urothelial "bladder" tumors.

Adaptimmune will also host a corporate exhibition booth in the Oncology Professionals Hall (Booth #5031).

Details regarding the oral presentation and the four trials in progress posters are as follows:

Oral Presentation:
Monday, June 5, 2017
Session: Developmental Therapeutics—Immunotherapy

• Abstract ID: 3000
— Title: "Open label, non-randomized, multi-cohort pilot study of genetically engineered NY-ESO-1 specific NY-ESO-1c259t in HLA-A2+ patients with synovial sarcoma (NCT01343043)"
— Presentation Time: 1:15-1:27 PM CDT
— Location: Hall D1

Trials in Progress Posters:
Monday, June 5, 2017
Session: Developmental Therapeutics—Immunotherapy
Presentation Time: 8:00-11:30 AM CDT
Location: Hall A

• Abstract ID: TPS3094
— Poster Board #: 187b
— Title: "A phase I/IIa, open-label, clinical trial evaluating the safety and efficacy of autologous T-cells expressing enhanced T-cell receptors (TCRs) specific for NY-ESO-1 in patients with recurrent or treatment refractory ovarian cancer (NCT01567891)"


• Abstract ID: TPS3097
— Poster Board #: 189a
— Title: "A pilot study of NY-ESO-1c259 T-cells in subjects with advanced myxoid/round cell liposarcoma (NCT02992743)"


• Abstract ID: TPS3096
— Poster Board #: 188b
— Title: "Two phase I/II open-label clinical trials evaluating the safety and efficacy of autologous T‑cells expressing enhanced TCRs specific for NY-ESO-1 or MAGE-A10 in subjects with stage IIIb or stage IV non-small cell lung cancer (NCT02588612/NCT02592577)"


• Abstract ID: TPS3098
— Poster Board #: 189b
— Title: "A phase I single-arm, open-label clinical trial evaluating safety of MAGE-A10c796T in subjects with advanced or metastatic head and neck, melanoma, or urothelial tumors (NCT02989064)"

On May 26, 2017 AstraZeneca, along with its global biologics research and development arm, MedImmune, reported that will demonstrate how it is rapidly delivering on the Company’s science-led strategy for transformational cancer medicine development at the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, US, 2-6 June 2017 (Press release, AstraZeneca, MAY 26, 2017, View Source(asco)-annual-meeting-26052017.html [SID1234519289]).

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With three new oncology medicines addressing the unmet needs of patients with ovarian, lung, and bladder cancers approved in under three years, AstraZeneca is now halfway to delivering on its promise to launch six new medicines for cancer by 2020.

This progress is reflected in the 100 company-sponsored and supported abstracts, including five Best-of-ASCO presentations, 11 oral presentations and eight poster discussions, accepted for the meeting. These include new data on approved and potential new medicines from the Company’s pipeline across multiple scientific platforms and tumour types.

Jamie Freedman, Executive Vice President, Oncology at AstraZeneca, said: "2017 is a pivotal year for our oncology portfolio as global launch and development programmes for Lynparza, Tagrisso and Imfinzi gain momentum, with further pivotal data anticipated in the coming months, in particular in 1st-line non-small cell lung cancer. We are excited to demonstrate the strength of our rapidly-expanding portfolio at ASCO (Free ASCO Whitepaper), including the positive OlympiAD results for Lynparza in BRCA-mutated metastatic breast cancer."

Growing confidence in DNA Damage Response (DDR) approach emphasised by OlympiAD results
‘Late-breaker’ data from the OlympiAD trial of Lynparza (olaparib) versus chemotherapy in BRCA-mutated metastatic breast cancer (Abstract #LBA4) are the first positive Phase III results for a poly ADP-ribose polymerase (PARP) inhibitor beyond ovarian cancer. They are an important next step in the development of AstraZeneca’s DDR approach to selectively targeting of tumours through deficiencies in cancer cell DNA repair mechanisms.

Additional Lynparza data will include:

SOLO-2: Oral presentation of Phase III data on the relationship between health-related quality of life (HRQOL) and patient-centred and clinical outcomes with Lynparza maintenance following chemotherapy in patients with BRCA-mutated platinum-sensitive relapsed serous ovarian cancer (Abstract #5507)
Study 19: Randomised Phase II overall survival and updated progression-free survival data for the combination of Lynparza and cediranib versus Lynparza alone in recurrent platinum-sensitive ovarian cancer (Abstract #5535)
AstraZeneca’s unique DDR pipeline will also be illustrated through an oral presentation of Phase I data on the WEE1 inhibitor, AZD1775, in combination with radiation therapy and temozolomide in patients with newly-diagnosed glioblastoma multiforme (GBM) and evaluation of intratumoural drug distribution in patients with recurrent GBM (Abstract #2005). Additional information will also be presented from a Phase I trial of AZD1775 in combination with neoadjuvant weekly cisplatin and docetaxel in borderline-resectable head and neck squamous cell carcinoma (HNSCC) (Abstract #6034).

Extended evidence of the effect of Tagrisso (osimertinib) on CNS metastases
Latest Tagrisso data from the AURA3 trial to be released during an oral presentation will provide further evidence of the response to treatment in patients with epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC) and CNS metastases (Abstract #9005).

Further insights into the ability of Tagrisso to cross the blood-brain barrier will be provided through updated results from the BLOOM trial of Tagrisso in patients with EGFR mutation-positive NSCLC and leptomeningeal disease (Abstract #2020).

New data on Imfinzi (durvalumab) as monotherapy and in combination
Building on exciting recent milestones for its Immuno-Oncology programme, AstraZeneca will be presenting updated data from the NSCLC and bladder cancer cohorts of the Phase I/II Study 1108 of durvalumab in patients with advanced solid tumours. New data in locally-advanced or metastatic urothelial carcinoma (mUC) (Abstract #4525) reinforce the May 2017 US FDA approval of Imfinzi for the treatment of patients with locally advanced or mUC who have disease progression during or following platinum-containing chemotherapy, or whose disease has progressed within 12 months of receiving platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery.

Updated durvalumab monotherapy Study 1108 results in Stage IIIB/IV NSCLC (Abstract #9085) will also be presented. These data underline AstraZeneca’s forward momentum in lung cancer following the positive top-line results of the Phase III PACIFIC trial of durvalumab as sequential treatment in patients with locally-advanced, unresectable (Stage III) NSCLC. In an oral presentation, MedImmune will present data on a novel relationship in NSCLC between EGFR pathway activation and the immunosuppressive molecule CD73 (Abstract #11505).