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 4, 2018 Allergan plc (NYSE: AGN), a leading global biopharmaceutical company, reported that Chairman and CEO Brent Saunders will participate in a fireside chat at the 2018 Morgan Stanley Global Healthcare Conference in New York, NY (Press release, Allergan, SEPT 4, 2018, View Source [SID1234529262]). The presentation will begin at 10:00 a.m. Eastern Time on Thursday, September 13, 2018.

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The presentation will be webcast live and can be accessed on Allergan’s Investor Relations website at View Source;. The webcast can also be accessed through the following URL: View Source;

An archived version will be available within approximately two hours of the live presentation and can be accessed at the same location for 180 days.

On September 4, 2018 Horizon Pharma plc (Nasdaq: HZNP) reported that the company will participate in the following conference (Press release, Horizon Pharma, SEPT 4, 2018, View Source [SID1234529263]):

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Morgan Stanley 16th Annual Global Healthcare Conference

Date: Sept. 13, 2018
Presentation Time: 10:35 a.m. ET
Location: New York, NY

On September 4, 2018 Pieris Pharmaceuticals, Inc. (NASDAQ: PIRS), a biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for cancer, respiratory and other diseases, reported that it has dosed the first patient in the Company’s Phase 1 combination clinical trial of PRS-343, its lead proprietary immuno-oncology drug candidate targeting HER2 and 4-1BB, plus atezolizumab (Tecentriq), an approved PD-L1 inhibitor (Press release, Pieris Pharmaceuticals, SEPT 4, 2018, View Source [SID1234529264]).

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The trial, a multicenter, open-label, Phase 1 dose escalation study, is designed to determine the safety, tolerability, and potential synergistic anti-tumor effects of PRS-343 plus anti-PD-L1 immunotherapy in patients with advanced or metastatic HER2-positive solid tumors. Elevated HER2 expression is associated with multiple cancers, including gastroesophageal, bladder, breast, and a range of other tumor types. The trial is fully funded and sponsored by Pieris, while Roche is supplying atezolizumab.

"The initiation of the combination trial of PRS-343 with an anti-PD-L1 immunotherapy marks the beginning of Pieris’ investigation into the potential synergistic effects of its 4-1BB-targeted therapy with PD-1/L1 blockade," said Louis Matis, M.D., Senior Vice President and Chief Development Officer of Pieris. "Given evidence from multiple preclinical studies demonstrating synergistic anti-tumor activity from concurrent 4-1BB activation and PD-(L)1 pathway blockade, we believe that combination therapy with PRS-343 and atezolizumab has the potential to provide significant clinical benefit for patients. We are enthusiastic to be initiating this trial and look forward to reporting our findings from this combination study next year."

About PRS-343

PRS-343 is a bispecific monoclonal antibody-Anticalin fusion protein comprised of a HER2 tumor-targeting antibody genetically linked to a potent Anticalin specific for the immune costimulatory TNF family receptor 4-1BB (CD137). PRS-343 is being developed as the first 4-1BB based bispecific therapeutic to mediate the activation of tumor-specific T lymphocytes selectively within the tumor microenvironment (TME). 4-1BB is a potent costimulatory immunoreceptor and an established marker for tumor-specific infiltrating T lymphocytes, and is, therefore, an attractive target for cancer immunotherapy. In in vivo preclinical tumor models, PRS-343 has demonstrated potent T lymphocyte activation localized to the TME of established HER2-positive tumors, indicating the potential for both enhanced safety and efficacy.

About HER2-Positive Malignancies

HER2 is a tyrosine kinase receptor growth-promoting protein found on the surface of some cancer cells and is associated with aggressive disease progression. Multiple tumor types can express HER2 including breast, gastroesophageal, bladder, biliary (cholangiocarcinoma), colorectal, endometrial, ovarian, non-small cell lung, pancreatic, head and neck, and other cancers.