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Moffitt Cancer Center and ITUS Corporation Announce Scheduling of Pre-IND Meeting with the FDA for their CAR-T Therapy

On September 5, 2018 ITUS Corporation (NASDAQ: ITUS) and its research partner, Moffitt Cancer Center, reported that a pre-IND meeting with the US FDA has been scheduled on Tuesday, October 16, 2018 (Press release, Anixa Biosciences, SEP 5, 2018, View Source [SID1234530493]). The meeting is to discuss numerous aspects of the planned clinical trial of their CAR-T therapy for ovarian cancer.

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Dr. Amit Kumar, CEO of ITUS stated, "We are pleased to be meeting with the FDA this fall, as anticipated. We have submitted pre-clinical data, as well as a series of questions, to the FDA. Coming out of this meeting, our goal is to have a good understanding of the design for the clinical trial in our Investigational New Drug (IND) application. Assuming the FDA does not require additional animal studies, we hope to file the IND application in early 2019, with human testing potentially beginning shortly thereafter."

Dr. Jose Conejo-Garcia, Co-head of Immunology at Moffitt Cancer Center, the inventor of the technology, and the Principal Investigator of the team developing the therapy, added, "We are heading towards the first in human trial of our hormone receptor based Chimeric Antigen Receptor T-cell technology, which internally we refer to as Chimeric Endocrine Receptor T-cell technology (CER-T). Our unique approach, could create a whole new platform for CAR-T that takes advantage of hormone-receptor combinations. To date CAR-T therapy has only shown efficacy in certain liquid tumors. We hope our approach will enable chimeric receptors expressed on T cells to work on the vastly larger numbers of solid tumors relative to hematological malignancies".

Orion Biotechnology acquires patent portfolio for potent CCR5 chemokine antagonist

On September 25, 2018 Orion Biotechnology Canada Ltd., a developer of novel medical treatments, reported that its subsidiary, Orion Biotechnology Switzerland Sàrl, has successfully closed a transaction with the Mintaka Medical Research Foundation for the acquisition of the 5P12-RANTES molecule (Press release, Orion Biotechnology, SEP 5, 2018, View Source [SID1234530101]) . 5P12-RANTES is a potent CCR5 chemokine antagonist which Orion will develop in a number of areas, including; immuno-oncology, multiple sclerosis and HIV prevention.

The acquisition includes its worldwide patent portfolio, and has resulted in a partnership with the Geneva, Switzerland based Mintaka Medical Research Foundation, and the Wellcome Trust of London, England. No financial details of the transaction were released.

"We are thrilled to add the enormous potential of the 5P12-RANTES portfolio to our pipeline" said Mark Groper, President and CEO of Orion Biotechnology. "It adds depth to our pipeline, strengthens our intellectual property portfolio, and provides the basis for the development of several additional novel immunotherapies".

"I’m excited that we were able to successfully form this partnership with Orion Biotechnology" said Robin Offord, Executive Director of the Mintaka Medical Research Foundation. "Mintaka looks forward to continuing its work on humanitarian (anti-HIV) uses of 5P12-RANTES with the help of the highly innovative and capable team at Orion and the substantial resources that they bring to the table. Also, 5P12-RANTES has surprised us all by its potential in a wide range of other medical indications and Orion is well placed to exploit these applications to the full".

Daniel Gill, from Wellcome’s Innovations team said: "HIV remains a significant global health issue and we are pleased to continue our collaboration on the development of 5P12-RANTES with Orion Biotechnology. 5P12-RANTES has significant potential in other areas of unmet need and we are excited that Orion will expand development of the molecule in other therapeutic areas such as immune-oncology and multiple sclerosis."

BerGenBio to present interim phase 2 clinical data with selective AXL inhibitor bemcentinib in non-small cell lung cancer at WCLC

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]).

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

Neurocrine Biosciences to Present at the Morgan Stanley 16th Annual Global Healthcare Conference

On September 5, 2018 Neurocrine Biosciences, Inc. (NASDAQ: NBIX) reported that it will present at the Morgan Stanley 16th Annual Global Healthcare Conference at 8:10 a.m. ET on Wednesday, Sept. 12, 2018, in New York City. Kevin Gorman, Chief Executive Officer of Neurocrine Biosciences, will present at the conference.

The live presentation will be webcast and may be accessed on the Company’s website under Investors at View Source A replay of the presentation will be available on the website approximately one hour after the conclusion of the event and will be archived for approximately one month.

Roche Provides Update on Supplemental Biologics License Application (sBLA) for TECENTRIQ in First-line Metastatic Non-Squamous NSCLC

On September 05 2018, Roche reported that it was notified by the U.S. Food and Drug Administration (FDA) that the review period for the supplemental Biologics License Application (sBLA) for TECENTRIQ (atezolizumab) in combination with Avastin (bevacizumab), carboplatin and paclitaxel for the initial treatment of people with metastatic non-squamous non-small cell lung cancer (NSCLC) has been extended by three months (Press release, Hoffmann-La Roche, SEP 5, 2018, View Source [SID1234529354]). The extension allows the FDA time to review additional information requested in support of the sBLA. FDA determined that the submission of this information constituted a major amendment to the sBLA resulting in this extension of the PDUFA goal date. The FDA is expected to make a decision on approval by December 05, 2018. In May 2018, TECENTRIQ in combination with Avastin, carboplatin and paclitaxel was granted Priority Review from the FDA for the initial treatment of people with metastatic non-squamous NSCLC based on results from the Phase III IMpower150 study.

About NSCLC
Lung cancer is the leading cause of cancer death globally.[1] Each year 1.59 million people die as a result of the disease; this translates into more than 4,350 deaths worldwide every day.[2] Lung cancer can be broadly divided into two major types: NSCLC and small cell lung cancer. NSCLC is the most prevalent type, accounting for around 85% of all cases.[2] NSCLC comprises non-squamous and squamous-cell lung cancer, the squamous form of which is characterised by flat cells covering the airway surface when viewed under a microscope. The squamous form tends to grow near the centre of the lung, and accounts for approximately 25-30% of all NSCLC cases.[3]

About TECENTRIQ
TECENTRIQ is a monoclonal antibody designed to bind with a protein called PD-L1 expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, TECENTRIQ may enable the activation of T cells. TECENTRIQ has the potential to be used as a foundational combination partner with cancer immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers.

Currently, Roche has eight Phase III lung cancer studies underway, evaluating TECENTRIQ alone or in combination with other medicines.

TECENTRIQ is already approved in the European Union, United States and more than 70 countries for people with previously treated metastatic NSCLC and for certain types of untreated or previously treated metastatic urothelial carcinoma (mUC).

About Avastin (bevacizumab)
Avastin is a biologic cancer treatment approved across several types of cancers including advanced stages of breast cancer, colorectal cancer, non-small cell lung cancer, kidney cancer, ovarian cancer and cervical cancer, and recurrent glioblastoma. Avastin is approved in combination with chemotherapy for the first-line treatment of advanced NSCLC and, to-date, has helped over 500,000 patients lead longer lives. Avastin is considered a standard of care for the first-line treatment of advanced NSCLC and has been proven to significantly extend overall survival (OS). Avastin is currently approved in combination with any platinum-based chemotherapy in Europe, and with paclitaxel/carboplatin in the US, in first-line non-squamous NSCLC, based on results of the pivotal Phase III E4599 study. Avastin was the first medicine to help people with previously untreated advanced, non-squamous NSCLC live longer (OS) than one year when added to chemotherapy.

About the TECENTRIQ (atezolizumab) and Avastin (bevacizumab) combination
There is a strong scientific rationale to support combining TECENTRIQ and Avastin. The TECENTRIQ and Avastin regimen may enhance the potential of the immune system to combat a broad range of cancers, including first-line advanced NSCLC. Avastin, in addition to its established anti-angiogenic effects, may further enhance TECENTRIQ’s ability to restore anti-cancer immunity, by inhibiting VEGF-related immunosuppression, promoting T-cell tumour infiltration and enabling priming and activation of T-cell responses against tumour antigens.