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.

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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."

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 5, 2018 Innate Immunotherapeutics reported that it has elected to change the Company name to Amplia Therapeutics Limited and the Company stock code will change to ATX from IIL (Press release, Innate Immunotherapeutics, SEPT 5, 2018, View Source [SID1234529286]). The change received shareholder approval in a Special Resolution at the Company’s Annual General Meeting held on 30 August in Melbourne.

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The change of name is part of a wider branding refresh of the Company as it focuses on the development of a pipeline of Focal Adhesion Kinase (FAK) inhibitors for cancer and fibrosis. FAK is an important therapeutic target that is significantly upregulated in highly fibrotic tumours such as pancreatic and ovarian cancer. Drugs targeting FAK have the potential to sensitize the tumour microenvironment to both immuno-oncology drugs and chemotherapies.

Amplia Chairman Dr. Warwick Tong, noted "The Amplia name reflects the therapeutic action of inhibiting FAK to ‘amplify’ the effect of existing immuno-oncology and chemotherapeutic drugs in a number of difficult to treat cancers".

Amplia’s lead drug candidate AMP945 is expected to have a significant clinical advantage over other FAK-targeting molecules because of its high potency and selectivity for FAK. Amplia is also developing AMP886, which is a multi-action inhibitor that, in addition to potent FAK activity, also modulates FLT3 and VEGF, both highly synergistic targets in a number of solid and hematologic cancers. The development of these drug candidates is supported by an international team of worldclass reseachers and clinicians.

On September 5, 2018 Zetagen Therapeutics, Inc., a private, US-based biopharmaceutical company dedicated to driving breakthrough innovation in the treatment of metastatic bone cancers and osteologic interventions, reported its award of a $300,000 (USD) grant from the National Cancer Institute of the National Institutes of Health (NIH) (Press release, Zetagen Therapeutics, SEP 5, 2018, View Source [SID1234643681]). The grant will be used for a Phase I validation study of the Company’s proprietary, drug-eluding implant called ZetaMet (Zeta-BC-003). ZetaMet (Zeta-BC-003) is a synthetic, small-molecule, inductive biologic being developed to suspend tumor growth and regrow bone.

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"We are pleased that the National Cancer Institute, through this award, has recognized the potential ZetaMet (Zeta-BC-003) may hold for treating metastatic bone lesions," said Nikhil Thakur, MD, CMO of Zetagen Therapeutics, Inc. "Osteolytic metastases are among the most challenging of cancers to treat as they both destroy bone and cause debilitating pain in patients."

The grant is part of the Small Business Innovation Research Program (SBIR), a three-phase award system created by the Federal Government for small businesses to engage in research and development that has the potential for commercialization and public benefit. Zetagen exclusively licensed its platform technology from the State University of New York in 2016. The Company’s Phase I validation study will begin in Q4 2018.