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 Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company developing highly selective medicines for patients with genomically defined cancers, reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to LOXO-292, a selective RET inhibitor, for (Press release, Loxo Oncology, SEPT 5, 2018, View Source [SID1234529287]):

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the treatment of patients with metastatic RET-fusion-positive non-small cell lung cancer who require systemic therapy and have progressed following platinum-based chemotherapy and an anti-PD-1 or anti-PD-L1 therapy; and for
the treatment of patients with RET-mutant medullary thyroid cancer who require systemic therapy, have progressed following prior treatment and have no acceptable alternative treatment options.
"We look forward to working with FDA to streamline the development of LOXO-292 in the two patient populations that have comprised the bulk of our initial clinical trial enrollment," said Josh Bilenker, M.D., chief executive officer at Loxo Oncology. "Given the many available therapies for non-small cell lung cancer and medullary thyroid cancer, we are pleased that LOXO-292 has shown encouraging data in refractory patients, and hope to demonstrate the full potential of this treatment in additional populations over time."

The LOXO-292 Breakthrough Therapy Designation was based on data from the ongoing global Phase 1/2 LIBRETTO-001 clinical trial. In 2019, the company plans to provide an update on the overall long-term LOXO-292 clinical development plan, based on feedback from global regulators.

The FDA’s Breakthrough Therapy Designation is intended to expedite the development and review of a drug candidate that is planned for use to treat a serious or life-threatening disease or condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.

About LOXO-292
LOXO-292 is an oral and selective investigational new drug in clinical development for the treatment of patients with cancers that harbor abnormalities in the rearranged during transfection (RET) kinase. RET fusions and mutations occur across multiple tumor types with varying frequency. LOXO-292 was designed to inhibit native RET signaling as well as anticipated acquired resistance mechanisms that could otherwise limit the activity of this therapeutic approach. LOXO-292 has been granted Breakthrough Therapy Designation by the U.S. FDA.

LOXO-292 is currently being studied in the global LIBRETTO-001 Phase 1/2 trial. For additional information about the LOXO-292 clinical trial, please refer to www.clinicaltrials.gov. Interested patients and physicians can contact the Loxo Oncology Physician and Patient RET Clinical Trial Hotline at 1-855-RET-4-292 or email [email protected].

About RET-Altered Cancers
Genomic alterations in the RET kinase, which include fusions and activating point mutations, lead to overactive RET signaling and uncontrolled cell growth. RET fusions have been identified in approximately 2% of non-small cell lung cancer, 10-20% of papillary and other thyroid cancers, and a subset of other cancers. Activating RET point mutations account for approximately 60% of medullary thyroid cancer (MTC). Both RET fusion cancers and RET-mutant MTC are primarily dependent on this single activated kinase for their proliferation and survival. This dependency, often referred to as "oncogene addiction," renders such tumors highly susceptible to small molecule inhibitors targeting RET.

On September 5, 2018 Stemline Therapeutics, Inc. (Nasdaq: STML), a clinical-stage biopharmaceutical company developing novel oncology therapeutics, reported that Ivan Bergstein, M.D., Stemline’s CEO, will present at the H.C. Wainwright 20th Annual Global Investment Conference on Wednesday, September 5, 2018 at 9:10 AM ET at the St. Regis New York Hotel (Press release, Stemline Therapeutics, SEPT 5, 2018, View Source [SID1234529288]). A live webcast of the presentation can be viewed on the company’s website at www.stemline.com.

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On September 5, 2018 Blueprint Medicines Corporation (NASDAQ: BPMC), a leader in discovering and developing targeted kinase medicines for patients with genomically defined diseases, reported that company management will participate in a fireside chat at the 16th Annual Morgan Stanley Global Healthcare Conference on Wednesday, September 12, 2018 at 1:40 p.m. ET (Press release, Blueprint Medicines, SEPT 5, 2018, View Source [SID1234529289]).

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A live webcast of the presentation will be available by visiting the Investors section of Blueprint Medicines’ website at View Source A replay of the webcast will be archived on Blueprint Medicines’ website for 30 days following the presentation.