On September 5, 2018 Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a clinical-stage biopharmaceutical company focused on the development of CAR-T cell therapies, reported the successful injection of the first patient under the amended protocol of the THINK trial, which assesses treatment with CYAD-01 after a non-myeloablative preconditioning chemotherapy regimen of cyclophosphamide and fludarabine in refractory metastatic colorectal cancer (CRC) patients (Press release, Celyad, SEPT 5, 2018, View Source [SID1234529285]).

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"The first dosing of CYAD-01 in the amended THINK trial marks another important step for our company," said Dr. Christian Homsy, CEO of Celyad. "CYAD-01 has shown promising signs of clinical activity as a standalone approach, and we are committed to maximizing the clinical benefit for patients by evaluating CYAD-01 in a range of clinical settings. We aim to evaluate the anti-tumor activity of CYAD-01 not only as a standalone approach, but also with prior preconditioning and standard of care chemotherapy in both hematological malignancies and solid tumors. These additional studies will elucidate the best clinical path forward for a patient population severely in need of new therapeutic options."

The amended THINK is a single arm, open-label, Phase I study designed to evaluate the safety and anti-tumor activity of CYAD-01 only in metastatic CRC patients following the administration of cyclophosphamide (300 mg/m²) and fludarabine (30 mg/m²). Based on initial data from the trial, a per protocol expansion cohort may be initiated.

CYAD-01 is an investigational CAR-T therapy in which a patient’s T cells are engineered to express the chimeric antigen receptor NKG2D, a receptor expressed on natural killer (NK) cells that binds to eight stress-induced ligands expressed on tumor cells. CYAD-01 is currently in clinical development through a number of trials for hematological malignancies and solid tumors.

On September 5, 2018 BerGenBio ASA (OSE:BGBIO) reported that the company and its collaborators will present interim clinical data from its Phase II clinical development programme with bemcentinib (BGB324), a first-in-class highly selective oral AXL inhibitor, in non-small cell lung cancer (NSCLC) at the 19th World Conference on Lung Cancer (WCLC) in Toronto (23 – 26 September 2018) (Press release, BerGenBio, SEP 5, 2018, View Source [SID1234529422]).

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Full abstracts are available online at View Source from 5 PM (Eastern Time) on 5 September 2018 and details of the presentations are below. The posters presented at WCLC will be made available at www.bergenbio.com in the Investors / Presentations section following the sessions.

Poster presentations at WCLC:
Tuesday 25 September, 4:45 – 6:00 PM (Eastern Time)

Ph II Study of Oral Selective AXL Inhibitor Bemcentinib (BGB324) in Combination with Pembrolizumab in Patients with Advanced NSCLC (BerGenBio study reference: BGBC008)
James Lorens, PhD et al
Session: P2.04 – Immunooncology
Abstract code: P2.04-27
Ph I/II Study of Oral Selective AXL Inhibitor Bemcentinib (BGB324) in Combination with Erlotinib in pts with EGFRm NSCLC (BerGenBio study reference: BGBC004)
Lauren Averett Byers, MD et al
Session: P2.13 – Targeted Therapy
Abstract code: P2.13-10
A Ph I/II Study of Oral Selective AXL Inhibitor Bemcentinib (BGB324) with Docetaxel in pts with Previously Treated NSCLC (BerGenBio study reference: BGBIL005)
David Gerber, MD et al
Session: P2.01 – Advanced NSCLC
Abstract code: P2.01-37
A Phase II Study of Oral Selective AXL Inhibitor Bemcentinib (BGB324) in Combination with Pembrolizumab in pts with Malignant Mesothelioma (trial not active yet)
Dean Fennell, PhD et al
Session: P2.06 – Mesothelioma
Abstract code: P2.06-09 – MiST3
About WCLC
19th World Conference on Lung Cancer (WCLC 2018) is the leading meeting on Thoracic Oncology. It is organised by the International Association for the Study of Lung Cancer and will gather more than 7,000 international delegates. WCLC 2018 will take place in the Metro Toronto Convention Centre in Toronto, Ontario Canada, 23 – 26 September 2018.

About the BGBC008 trial
The BGBC008 trial is a Phase II multi-centre open-label study of bemcentinib in combination with KEYTRUDA (pembrolizumab) in previously treated, immunotherapy naïve, patients with advanced adenocarcinoma of the lung, the most common form of non-small cell lung cancer (NSCLC). The objective of the trial is to determine the anti-tumour activity of this novel drug combination and responses will be correlated with biomarker status (including AXL kinase and PD-L1 expression).

As of September 2018, the first stage of the trial has been fully recruited, and the first efficacy endpoint was met. Responders to the combination treatment included patients negative for PD-L1 for whom KEYTRUDA monotherapy is not effective.

For more information please access trial NCT03184571 at www.clinicaltrials.gov.

About the BGBC004 trial
The BGBC004 trial is a phase I/II multi-centre open-label study of bemcentinib in combination with TARCEVA (erlotinib) in patients with EGFR mutation driven (EGFRm) Stage IIIb or Stage IV NSCLC. The trial is designed to evaluate reversal of resistance to EGFR targeted therapy in later line patients who are negative for the T790M resistance mutation (arm B) as well as prevention of resistance to TARCEVA in patients receiving the EGFR inhibitor first line (arm C).

The first efficacy endpoint was met in Arm B and encouraging preliminary data has been presented for Arm C. The dose-finding part of the trial, arm A, is completed and was presented at WCLC 2017.

For more information please access trial NCT02424617 at www.clinicaltrials.gov.

About the BGBIL005 trial
The BGBIL005 trial is an investigator-led phase I/II study of bemcentinib in combination with docetaxel chemotherapy in previously treated, relapsed / resistant NSCLC patients. Patient recruitment into the study is progressing and encouraging clinical responses have been reported following the combination treatment.

For more information please access trial NCT02922777 at www.clinicaltrials.gov.

About the MiST3 trial
The MiST3 trial is an investigator-led phase II study of bemcentinib in combination with KEYTRUDA in patients with relapsed mesothelioma. The trial, which is not active as of September 2018, is sponsored by the University of Leicester (Leicester, UK), and funded by the British Lung Foundation with support from Merck Sharp and Dohme Limited and BerGenBio. Up to 25 patients are planned to be enrolled at 3 clinical research sites in the UK.

For more information please access trial NCT03654833 at www.clinicaltrials.gov

On September 4, 2018 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, reported its Phase II clinical trial of drug candidate Namodenoson (CF102) for the treatment of advanced hepatocellular carcinoma (HCC) in patients whose disease has progressed on sorafenib therapy (Press release, Can-Fite BioPharma, SEPT 4, 2018, View Source [SID1234529260]). Top line efficacy results are expected by end of year.

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The global Phase II study is being conducted in the U.S., Europe and Israel. Patients with advanced HCC, Child Pugh B, who failed Nexavar (sorafenib) as a first line treatment are treated twice daily with 25 mg of oral Namodenoson or placebo using a 2:1 randomization. The primary endpoint of the Phase II study is Overall Survival (OS). Secondary endpoints include Progression Free Survival (PFS), safety, and the relationship between outcomes and A3AR expression.

Advanced liver cancer is categorized into 3 subclasses including Child Pugh A, mostly treated with Nexavar, Child Pugh B and Child Pugh C. Although a few drugs for the treatment of advanced liver cancer have recently launched, none are specifically aimed at treating patients who have reached the Child Pugh B stage. This represents a major unmet need and potentially positions Namodenoson as an important drug candidate to treat this patient population.

Enrollment of 78 patients was completed in August 2017. While the trial continues treating subjects in a blinded fashion (either Namodenoson 25 mg BID or matching placebo), Can-Fite notes that of the 78 subjects originally enrolled, 22 completed at least 12 cycles of treatment (each cycle is 28 days of treatment), of whom 5 completed 24 cycles. The longest-treated subject has been receiving study medication for over 3 years.

Accumulated safety data to date continues to indicate a favorable safety profile, with no clinically significant novel or emerging events attributed to chronic treatment with Namodenoson.

Can-Fite’ CEO, Dr. Pnina Fishman, commented, "We are pleased with the progress so far in our clinical trial for Namodenoson for the treatment of advanced HCC, the third leading cause of cancer deaths worldwide, and look forward to data release. We believe a major advantage of Namodenoson stems from its favorable safety profile demonstrated thus far, in which Namodenoson selectively targets diseased cells while sparing normal cells which express very low levels of the A3 receptor.

Can-Fite received Orphan Drug Designation for Namodenoson in Europe and the U.S., as well as Fast Track Status in the U.S. as a second line treatment for HCC.

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is being evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.

On September 4, 2018 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a Fortress Biotech (NASDAQ: FBIO) Company focused on the development of novel immunotherapies based on proprietary chimeric antigen receptor engineered T cell (CAR T) technology and gene therapies for rare diseases, reported oral and poster presentations related to its CAR T therapies at the 4th Annual CAR-TCR Summit 2018, to be held September 4-7,2018, at the Seaport Hotel & World Trade Center in Boston (Press release, Mustang Bio, SEP 4, 2018, View Source [SID1234529307]).

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Details on the oral presentations are as follows:
Title: Confronting Analytical Challenges of Chimeric Antigen Receptor T Cell
Presenter: Junxia Wang, M.D., Ph.D., Director of Analytical Development, Mustang Bio
Track: Manufacturing
Date and Time: Tuesday, September 4, 2018, 3 p.m. EDT

Title: CAR T Cell Therapy for Glioblastoma: Progress, Promises and Challenges
Presenter: Behnam Badie, M.D., Professor and Chief, Division of Neurosurgery & Director, Brain Tumor Program,
City of Hope Medical Center
Track: Focus Day: Overcoming CAR T Toxicity in Solid Tumors
Date and Time: Friday, September 7, 2018, 12 p.m. EDT

Title: CAR T cells and Combination Therapies: The Next Chapter of the Immuno-Oncology Revolution
Panelist: Ekta Patel, Ph.D., Associate Director of Translational Sciences, Mustang Bio
Track: Focus Day: Alternative CAR Strategies
Date and Time: Friday, September 7, 2018, 1 p.m. EDT
Details on the poster presentation are as follows:

Title: Considerations for the Industrialization of a Phase 1 Academic CD20 CAR-T Manufacturing Process
Presenter: Suchit Sahai, Ph.D., Staff Scientist, Process Development, Fred Hutchinson Cancer Research Center
Track: Scientific Poster Session
Date and Time: Thursday, September 6, 2018, 8 a.m. EDT

Dr. Sadik Kassim, Chief Scientific Officer of Mustang Bio, will also present a plenary talk titled "From Academia to
Industry: Lessons Learned in the Development of CAR-T Therapies" during the opening ceremony on Wednesday,
September 5, 2018, at 8:45 a.m. EDT.

On September 4, 2018 Seattle Genetics, Inc. (NASDAQ:SGEN) reported that management will present at the Morgan Stanley Global Healthcare Conference on Thursday, September 13, 2018 at 2:05 p.m. EDT (Press release, Seattle Genetics, SEP 4, 2018, View Source;p=RssLanding&cat=news&id=2365825 [SID1234529344]). The presentation will be webcast live and available for replay from Seattle Genetics’ website at www.seattlegenetics.com in the Investors section.

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