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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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 10, 2019 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) reported the launch of VANFLYTA (quizartinib), an oral FLT3 inhibitor, in Japan for the treatment of adult patients with relapsed/refractory FLT3-ITD acute myeloid leukemia (AML) (Press release, Daiichi Sankyo, OCT 10, 2019, View Source [SID1234540951]).

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Marketing approval of VANFLYTA by Japan’s Ministry of Health, Labor and Welfare (MHLW) in June 2019 was based on the results of the global pivotal phase 3 QuANTUM-R study and a phase 2 study of VANFLYTA in Japanese patients with relapsed/refractory FLT3-ITD AML. Results of QuANTUM-R were published in The Lancet Oncology.[1] Results from the phase 2 study in Japan patients were recently published in the International Journal of Hematology.[2]

"We are proud to launch VANFLYTA in Japan making it available to both physicians and patients as an important new therapeutic option with a survival benefit over salvage chemotherapy for the treatment of patients with relapsed/refractory FLT3-ITD AML," said Takashi Ikegami, PhD, Vice President, Head of Specialty Marketing in Japan, Daiichi Sankyo. "Now patients have access to a treatment that targets FLT3-ITD, a driver mutation in AML linked to poor prognosis and aggressive disease that results in increased relapsed rate and reduced overall survival for patients compared to those without this mutation."

About FLT3-ITD AML
AML is an aggressive blood and bone marrow cancer that causes uncontrolled growth and accumulation of malignant white blood cells that fail to function normally and interfere with the production of normal blood cells.[3] AML is the most common adult leukemia in Japan,[4] with approximately 5,500 new cases diagnosed each year. The five-year survival rate of AML reported from 2005 to 2011 was approximately 26 percent, which was the lowest of all leukemias.3
FLT3 gene mutations are one of the most common genetic abnormalities in AML.[5] FLT3-ITD is the most common FLT3 mutation, affecting approximately one in four patients with AML.[6] FLT3-ITD is a driver mutation that presents with high leukemic burden and has poor prognosis and a significant impact on disease management for patients with AML.[7] Patients with FLT3-ITD AML have a worse overall prognosis, including an increased incidence of relapse, an increased risk of death following relapse, and a higher likelihood of relapse following hematopoietic stem cell transplantation, as compared to those without this mutation.[8],[9]

About QuANTUM-R and Phase 2 Japan Study
In the QuANTUM-R study, a statistically significant improvement in overall survival was demonstrated when comparing VANFLYTA to salvage chemotherapy. The hazard ratio for VANFLYTA was 0.76 [95% CI: 0.58, 0.98], and the median overall survival was 6.2 months [95% CI: 5.3, 7.2] in patients receiving VANFLYTA compared to 4.7 months [4.0, 5.5] salvage chemotherapy. The most common treatment-related adverse drug reactions in those receiving VANFLYTA were nausea (33.2%, 80/241 patients), electrocardiogram QT prolonged (24.9%, 60/241 patients), anemia (24.9%, 60/241 patients), and thrombocytopenia (21.2%, 51/241 patients) in the Japanese labeling.

The open-label, single-arm phase 2 study evaluating VANFLYTA in Japanese patients with relapsed/refractory FLT3-ITD AML met its primary endpoint of achieving a pre-determined composite complete remission rate at interim analysis, triggering an early stop of the study due to efficacy. The efficacy and safety profile of VANFLYTA observed in the phase 2 study in Japan appears consistent with that of QuANTUM-R.

About VANFLYTA
VANFLTYA, an oral FLT3 inhibitor, is the lead product in the AML Franchise of Daiichi Sankyo. VANFLYTA currently is only approved for use in Japan for the treatment of adult patients with relapsed/refractory FLT3-ITD AML, as detected by an MHLW-approved test.

Ongoing studies include QuANTUM-First, a pivotal phase 3 study evaluating VANFLYTA in combination with standard chemotherapy in newly diagnosed FLT3-ITD AML in the U.S., Europe and Japan; and phase 1/2 development for pediatric and young adult relapsed/refractory FLT3-ITD AML in North America and Europe; and phase 1 development in combination with milademetan, an investigational MDM2 inhibitor, for relapsed/refractory FLT3-ITD AML and newly-diagnosed FLT3-ITD AML unfit for intensive chemotherapy in the U.S. Milademetan is an investigational agent that has not been approved for any indication in any country. Safety and efficacy have not been established.

On October 9, 2019 Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento"), a clinical stage, antibody-centric biopharmaceutical company developing new therapies to turn malignant cancers into manageable and possibly curable diseases, reported the closing of its previously announced registered direct offering of 10,869,566 shares of its common stock and warrants to purchase up to 10,869,566 shares of its common stock, at a combined purchase price of $2.30 per share and related warrant (Press release, Sorrento Therapeutics, OCT 9, 2019, View Source [SID1234540950]). The net proceeds to Sorrento from this offering are expected to be approximately $23.3 million, after deducting the placement agent’s fees and other estimated offering expenses. Sorrento currently intends to use the net proceeds from the offering for the continued clinical development of its RTX and CD38 CAR-T programs and general research and development, working capital and general corporate purposes.

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H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

The securities described above were offered by Sorrento pursuant to a "shelf" registration on Form S-3 (File No. 333-221443) previously filed with the Securities and Exchange Commission (the "SEC") on November 9, 2017, amended on December 1, 2017 and declared effective by the SEC on December 6, 2017. The offering of the securities was made only by means of a prospectus supplement that forms a part of the registration statement. A prospectus supplement and accompanying base prospectus relating to the securities being offered were filed with the SEC on October 8, 2019. Electronic copies of the prospectus supplement and accompanying base prospectus may be obtained on the SEC’s website at www.sec.gov or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at 646-975-6996 or e-mail at [email protected].

This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

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

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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 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.

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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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.