On October 9, 2019 GE Healthcare and Theragnostics reported that have entered into a global commercial partnership for a new Prostate-Specific Membrane Antigen (PSMA) PET/CT imaging agent (Press release, Theragnostics, OCT 9, 2019, View Source [SID1234540952]). Theragnostics will lead the development of the tracer, GalliProst, while GE Healthcare will lead all pre-approval commercial preparations and as and when approval is received, all subsequent commercial and distribution activities.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Today, prostate cancer is the fourth largest cancer type accounting for just over 1.2 million new cases and over 350,000 fatalities around the globe in 2018. The diagnostic workflow for detecting prostate cancer starts through a blood test or biopsy, after which patients are typically referred for PET/CT imaging so that radiologists can see their tumor, lymph nodes and any metastasis in order to decide the appropriate course of treatment. The ‘heatmap’ style image enabled by the new tracer shows the precise location and intensity of PSMA, which is expressed on the surface of prostate cancer cells.

Theragnostics has reported data from a phase two clinical study which met its primary and secondary endpoints, demonstrating that one third of newly diagnosed prostate cancer patients – and over 50% of patients with biochemically recurrent disease – had their treatment plans modified as a result of a GalliProst scan. The change in patient management increased to 75% in a post-radical radiotherapy setting.

"We are excited to partner with Theragnostics on GalliProst to give vital insights into prostate cancer," said Sanka Thiru, Global Product Leader, Molecular Imaging Oncology in GE Healthcare’s Pharmaceutical Diagnostics business. "We believe that this partnership enables both parties to leverage each other’s key areas of expertise in order to accelerate the development of GalliProst and ultimately improve patient care."

Greg Mullen, CEO of Theragnostics added "This agreement is validation of the potential for our novel prostate cancer Gallium-68 (68Ga) diagnostic tracer, GalliProst which can benefit the treatment of prostate cancer patients around the globe. We are very pleased to sign our second agreement with GE Healthcare following our agreement last year for a diagnostic tracer for imaging kidney function and scarring."

Both GE Healthcare and Theragnostics will be attending the upcoming European Association of Nuclear Medicine 2019 Congress (EANM) in Barcelona Saturday October 12-16.

On October 9, 2019 Nordic Nanovector ASA (OSE: NANO) reported that the Company and its collaborators at Orano Med will present data and analyses from preclinical studies with 212Pb-NNV003, a CD37 targeting alpha-radioimmunotherapy for the treatment of leukaemia and lymphoma at the 2019 Annual Congress of the European Association of Nuclear Medicine (12-16 October, Barcelona, Spain) (Press release, Nordic Nanovector, OCT 9, 2019, View Source [SID1234540121]).

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In the study, the efficacy of 212Pb-NNV003 was compared with ibrutinib in a disseminated mouse model using the ibrutinib-resistant cell line MEC-2. Ibrutinib is a Bruton’s tyrosine kinase (BTK) inhibitor that forms part of the standard of care for chronic lymphocytic leukaemia (CLL) and non-Hodkgin’s lymphoma (NHL), alongside chemotherapy and anti-CD20 antibody therapy.

The study showed that a single injection of 212Pb-NNV003 is safe and effective for the treatment of CD37-positive CLL and NHL in preclinical models, with promising efficacy in an ibrutinib-resistant CLL model.

Presentation details are as follows:

Targeted alpha therapy with 212Pb-NNV003 is efficient in treatment of ibrutinib-resistant chronic lymphocytic leukaemia in preclinical model

Authors: A. Saidi, H. Heyerdahl, A.F. Maaland, J. Torgue, and J. Dahle

Session: 405 – M2M – Parallel Session: Antibody-Based Radionuclide Therapy

Abstract: OP-134

Date / time: Sunday 13 October, 14:30-14:41 CEST

The abstract book can be downloaded at View Source

For further information, please contact:

IR enquiries

Malene Brondberg, VP Investor Relations and Corporate Communications
Cell: +44-7561-431-762
Email: [email protected]

International Media Enquiries

Mark Swallow/David Dible (Citigate Dewe Rogerson)
Tel: +44-207-638-9571
Email: [email protected]

On October 9, 2019 Oncologie, a biopharmaceutical company using an innovative precision medicine platform to develop next-generation oncology therapeutics, reported the enrollment of the first patient in its global Phase 2 study of bavituximab in combination with Merck’s (known outside of the U.S. as MSD), anti-PD-1 therapy KEYTRUDA (pembrolizumab) in patients with advanced gastric or gastroesophageal cancer (Press release, Oncologie, OCT 9, 2019, View Source [SID1234540139]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Oncologie is collaborating with MSD in this clinical study to evaluate the combination of bavituximab and KEYTRUDA in patients with advanced gastric or gastroesophageal cancer. Bavituximab is a potential first-in-class investigational monoclonal antibody designed to block phosphatidylserine (PS) activation of multiple immune cell receptors, including T-cell immunoglobulin macrophage (TIM) and tumor-associated macrophage (TAM). The rationale to support this study was based on a previously reported retrospective analysis from over 90 patients who were enrolled in a Phase 3 lung cancer study, which demonstrated activity when Bavituximab was given prior to a PD-1 inhibitor.

"Initiating our first sponsored trial is a key milestone for Oncologie as it represents and highlights the progress we’ve made this year," said Laura E. Benjamin, PhD, President and Chief Executive Officer at Oncologie. "This Phase 2 study is intended to further evaluate the antitumor activity and safety of bavituximab plus pembrolizumab in a gastric cancer population. We look forward to evaluating the potential this combination may provide globally."

The Phase 2, multicenter, open-label, single-arm global study will assess the safety, tolerability, and efficacy of the investigational agent bavituximab in combination with pembrolizumab, a PD-1 inhibitor, in patients with advanced gastric and gastroesophageal cancer who have progressed on or after at least one prior standard therapy. The study is expected to enroll approximately 80 patients in the United States, United Kingdom, South Korea and Taiwan. The primary endpoint of the study will assess the antitumor activity of the combination, as well as safety and tolerability. In addition, other endpoints include evaluating drug levels, the effect of treatment on target proteins, and an exploratory analysis using Oncologie’s proprietary RNA biomarker signatures.

More information about this clinical study can be found at clinicaltrials.gov under NCT04099641 .

About Bavituximab

Bavituximab is an investigational chimeric monoclonal antibody that targets the activity of phosphatidylserine (PS). Bavituximab is believed to reverse PS-mediated immunosuppression by blocking the engagement of PS with its receptors, as well as by sending an alternate immune activating

signal. PS-targeting antibodies have been shown to shift the functions of immune cells in tumors, resulting in multiple signs of immune activation and anti-tumor immune responses. This mechanism may play an important role in allowing other cancer therapies to more effectively attack tumors by reversing the immunosuppression that limits the impact of those treatments. Importantly, bavituximab has also demonstrated a manageable safety and tolerability profile in previous clinical trials conducted to date, which may allow it to be combined effectively with other agents.

On October 9, 2019 Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, reported that results from the single agent dose-escalation portion of the ongoing Phase 1 study of AG-270 in patients with MTAP-deleted tumors and the pre-clinical translational research supporting combination strategies have been accepted for presentation at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) being held October 26 – 30, 2019 in Boston (Press release, Agios Pharmaceuticals, OCT 9, 2019, View Source [SID1234540953]). AG-270 is an investigational, first-in-class methionine adenosyltransferase 2a (MAT2A) inhibitor.

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The schedule for the presentations is as follows:

Title: A Phase 1 trial of AG-270 in patients with advanced solid tumors or lymphoma with homozygous MTAP deletion
Oral Date & Time: Sunday, October 27, 2019, 11:50 a.m. – 12:20 p.m. ET
Oral Session: Spotlight on Proffered Papers 1
Oral Location: Level 3, Ballroom AB
Poster Date & Time: Monday, October 28, 2019, 12:30 p.m. – 4:00 p.m. ET
Poster Session: Poster Session B: New Molecular Targets
Poster Location: Level 2, Hall D
Abstract: B116
Presenter: Rebecca Suk Heist, M.D., Massachusetts General Hospital

Title: Mitotic defects induced by MAT2A inhibitors guides translational drug combination strategies with AG-270 and taxanes
Poster Date & Time: Monday, October 28, 2019, 12:30 p.m. – 4:00 p.m. ET
Poster Session: Poster Session B: New Molecular Targets
Poster Location: Level 2, Hall D
Abstract: B115
Presenter: Peter Kalev, Ph.D., Agios Pharmaceuticals

Conference Call Information
Agios will host an investor event on October 27, 2019 at 6:30 p.m. ET in Boston to review the AG-270 Phase 1 dose-escalation data and pre-clinical research. The event will be webcast live and can be accessed under "Events & Presentations" in the Investors and Media section of the company’s website at www.agios.com. The archived webcast will be available on the company’s website beginning approximately two hours after the event.

On October 9, 2019 GE Healthcare and Theragnostics reported that have entered into a global commercial partnership for a new Prostate-Specific Membrane Antigen (PSMA) PET/CT imaging agent (Press release, GE Healthcare, OCT 9, 2019, View Source [SID1234540140]). Theragnostics will lead the development of the tracer, GalliProst, while GE Healthcare will lead all pre-approval commercial preparations and as and when approval is received, all subsequent commercial and distribution activities.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Today, prostate cancer is the fourth largest cancer type accounting for just over 1.2 million new cases and over 350,000 fatalities around the globe in 2018. The diagnostic workflow for detecting prostate cancer starts through a blood test or biopsy, after which patients are typically referred for PET/CT imaging so that radiologists can see their tumour, lymph nodes and any metastasis in order to decide the appropriate course of treatment. The ‘heatmap’ style image enabled by the new tracer shows the precise location and intensity of PSMA, which is expressed on the surface of prostate cancer cells.

Theragnostics has reported data from a phase two clinical study which met its primary and secondary endpoints, demonstrating that one third of newly diagnosed prostate cancer patients – and over 50% of patients with biochemically recurrent disease – had their treatment plans modified as a result of a GalliProst scan. The change in patient management increased to 75% in a post-radical radiotherapy setting.

"We are excited to partner with Theragnostics on GalliProst to give vital insights into prostate cancer," said Sanka Thiru, Global Product Leader, Molecular Imaging Oncology in GE Healthcare’s Pharmaceutical Diagnostics business. "We believe that this partnership enables both parties to leverage each other’s key areas of expertise in order to accelerate the development of GalliProst and ultimately improve patient care."

Greg Mullen, CEO of Theragnostics added: "This agreement is validation of the potential for our novel prostate cancer Gallium-68 (68Ga) diagnostic tracer, GalliProst which can benefit the treatment of prostate cancer patients around the globe. We are very pleased to sign our second agreement with GE Healthcare following our agreement last year for a diagnostic tracer for imaging kidney function and scarring."

Both GE Healthcare and Theragnostics will be attending the upcoming European Association of Nuclear Medicine 2019 Congress (EANM) in Barcelona on October 12-16.