On November 20, 2017 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) reported the first patient has been enrolled in DESTINY-Gastric01, a pivotal phase 2 study in Japan and South Korea evaluating the safety and efficacy of DS-8201, an investigational HER2-targeting antibody drug conjugate (ADC), in patients with HER2-positive advanced gastric or gastroesophageal junction adenocarcinoma resistant or refractory to trastuzumab (Press release, Daiichi Sankyo, NOV 20, 2017, View Source [SID1234522175]).

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"Japan and South Korea have some of the highest rates of gastric cancer worldwide and there have been limited advances in targeted treatments over the past decade," said Koichi Akahane, PhD, MBA, Executive Officer, Head of Oncology Function, R&D Division, Daiichi Sankyo. "The initiation of this pivotal study will allow us to evaluate whether the smart delivery of chemotherapy with DS-8201 may be a potential new treatment option to help address the high unmet medical need of gastric cancer."

Approximately one in five gastric cancers overexpress HER2, a tyrosine kinase receptor growth-promoting protein found on the surface of some cancer cells.1 HER2-expressing gastric cancer is an area of unmet medical need as advances in the treatment of the disease have been limited, largely due to its genetic complexity and heterogeneity.2 Currently, no approved HER2-targeting therapy options exist for patients with HER2-positive advanced gastric cancer after trastuzumab.

"We are excited to initiate this second pivotal study of DS-8201 as it represents an important next step to accelerate the development of DS-8201," said Antoine Yver, MD, MSc, Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo. "With limited treatment options available for advanced gastric cancer, including no approved antibody drug conjugate, we are exploring the potential of DS-8201 as a new treatment option for this type of HER2-expressing cancer."

About DESTINY-Gastric01
DESTINY-Gastric01 is a pivotal phase 2, open-label study investigating the safety and efficacy of DS-8201 in patients with HER2-expressing advanced gastric cancer or gastroesophageal junction adenocarcinoma (defined as IHC3+ or IHC2+/ISH+) who have progressed on two prior regimens including fluoropyrimidine agent, platinum agent and trastuzumab. Patients will be randomized 2:1 to DS-8201 or physician’s choice of treatment (paclitaxel or irinotecan monotherapy). The primary endpoint of the study is objective response rate. Secondary endpoints include progression-free survival, overall survival, duration of response, disease control rate, time to treatment failure, pharmacokinetics and safety.

DESTINY-Gastric01 also will include two non-randomized exploratory cohorts to examine the safety and efficacy of DS-8201 in patients with HER2 low-expressing advanced gastric cancer, who have not been treated previously with a HER2-targeting therapy. The first exploratory cohort will enroll patients with HER2 low-expression defined as IHC2+/ISH-, and the second exploratory cohort will include HER2 low-expression defined as IHC1+.

The study is expected to enroll up to 180 patients in the pivotal cohort and 40 patients in the exploratory cohorts in Japan and South Korea. For more information about this clinical trial, visit www.ClinicalTrials.gov.

On November 20, 2017 Prima BioMed Ltd (ASX: PRR; NASDAQ: PBMD) ("Prima" or the "Company") reported rebranding of the Company from Prima BioMed Ltd to Immutep Ltd ("Immutep") following shareholder approval at its Annual General Meeting on 17 November 2017 (Press release, Prima Biomed, NOV 20, 2017, View Source [SID1234522200]).

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Following the acquisition of Immutep S.A.S (the Company’s 100% owned subsidiary in France) in December 2014 and subsequent sale under license of the Company’s former cancer vaccine CVac to Sydys Corporation, its sole focus has been on developing its portfolio of LAG-3 based immunotherapy assets.
The name Immutep has a strong association with LAG-3 and its founder, Prima’s Chief Scientific Officer and Chief Medical Officer, Dr Frederic Triebel. Additionally, many of the Company’s clinical partner associations are with Immutep and several patents remain registered under the Immutep name.

CEO Marc Voigt said: "As the global leader in LAG-3, the name Immutep better represents our corporate identity and activities. As it is already embedded in our day to day operations, costs associated with the rebrand will be minimal so it makes both strategic and economic sense. Immutep is already associated with LAG-3 and we see this as an important step in building awareness of our market position and exciting asset portfolio."
Subject to relevant regulatory approvals, the Company’s new ASX Code will be ‘IMM’ and its new Nasdaq code will be ‘IMMP’.

The effective date for the name change and the ticker codes on the ASX and NASDAQ will be on or around the commencement of trading on Friday, 1 December 2017.
Further shareholder information regarding the change of name can be accessed on the Company’s website www.primabiomed.com.au.

On November 20, 2017 ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP), a biopharmaceutical company developing new gene and cell-based immunotherapies for cancer, reported positive data updates supporting survival benefit and the underlying immune system mechanism for Ad-RTS-hIL-12 plus veledimex, the Company’s controlled human interleukin-12 (hIL-12) gene therapy candidate for brain cancer, at the 22nd Annual Meeting and Education Day of the Society for Neuro-Oncology (SNO) (Press release, Ziopharm, NOV 20, 2017, View Source [SID1234522161]). This gene therapy has demonstrated a targeted, anti-tumor immune response for the treatment of recurrent glioblastoma (rGBM).

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New data presented shows median overall survival (mOS) of 12.5 months has been sustained for patients treated with Ad-RTS-hIL-12 plus 20mg of veledimex (n=15) at a longer mean follow-up time of 11.1 months as of October 18, 2017. This mOS of 12.5 months continues to compare favorably to the 5 to 8 months survival established in historical controls for patients with rGBM. Furthermore, the four patients with rGBM who received low-dose steroids maintained 100 percent survival at a mean follow-up time of 11.1 months. An anti-tumor effect was also evident with centralized review of magnetic resonance imaging (MRI) showing decreasing size of brain tumor lesions in several patients.

Additionally, data linking the intra-tumor production of hIL-12 to patients’ overall survival was presented by Francois Lebel, M.D., Chief Medical Officer of ZIOPHARM during an oral poster session, "A Phase 1 Study of Ad-RTS-hIL-12 plus Veledimex in Adult Recurrent Glioblastoma." Highlights of this presentation include:

Immunohistochemistry analyses from three of three patient biopsies after completion of veledimex demonstrated that IL-12 activates and sustains an immune response within rGBM;
All three biopsies of rGBM lesions demonstrated evidence of an anti-tumor response with extensive infiltration of CD8+ T cells within the rGBM;
Biopsies all showed sustained (greater than 4 months) production of interferon-gamma, a cytokine crucial to arming an immune response in the tumor microenvironment;
Ratio of circulating killer CD8+ T cells to suppressor FOXP3+ T cells correlates with survival;
Interferon-gamma was undetectable in the blood at the time of biopsies providing further evidence of an on-target response;
Expression levels of both PD-1 and PD-L1 were upregulated in all the biopsies, which suggests added potential efficacy for combining Ad-RTS-hIL-12 plus veledimex with an immune checkpoint inhibitor;
Ad-RTS-hIL-12 plus veledimex continues to be safe and well tolerated, as adverse events (AE) were predictable and reversible, neurologic AEs were relatively mild and transient, and there were no drug-related deaths.
"These new mechanistic data, especially taken together with the promising extension of patients’ median overall survival, provide additional validation that controlling IL-12 can engage the body’s own immune system safely to generate a T-cell response against rGBM. We are excited to see increasing evidence of a targeted, local immune response making brain tumors hot and illustrating how this immunotherapy contributes to patients’ survival," said Dr. Antonio Chiocca, M.D., Ph.D., lead author of this presentation and the 2017 President of the Society for Neuro-Oncology, Professor of Neurosurgery at Harvard Medical School, Surgical Director of the Center for Neuro-oncology at Dana-Farber Cancer Institute, and Chairman of Neurosurgery and Co-Director of the Institute for the Neurosciences at Brigham and Women’s Hospital.

Additional SNO presentations included:

"A Phase 1 Study of Ad-RTS-hIL-12 plus Veledimex in Pediatric Brain Tumors," was presented in a poster by Stewart Goldman, M.D., Division Head Hematology-Oncology, Neuro-Oncology & Stem Cell Transplantation at Ann & Robert H. Lurie Children’s Hospital in Chicago. The Company previously announced that the first patient was dosed in this open-label study designed to assess the safety and tolerability of a single intratumoral injection of Ad-RTS-hIL-12 plus veledimex in children.
"Controlled Expression of IL-12 Improves Survival in Glioma by Activating the Immune Response in Mice and Humans," was presented during an oral session by John A. Barrett, Ph.D., Vice President of R&D/Translational Medicine at ZIOPHARM.
Dr. Barrett delivered a second oral presentation, "Controlled Expression of IL-12 Improves Survival in Glioma by Activating the Immune Response in Mice and Humans."
A copy of all four SNO presentations is available in the Presentations and Publications section of the Company’s website, www.ziopharm.com.

"The established safety profile and tolerability of intra-tumor administration of Ad-RTS-hIL-12 plus oral veledimex, the durability of the overall survival results, and now the powerful evidence of sustained immune activation all support our goal of delivering a new treatment option to patients with recurrent glioblastoma," said Dr. Lebel. "We continue to work with regulators and thought leaders to initiate a pivotal study of Ad-RTS-hIL-12 plus veledimex in this setting before year end. In addition, the immunohistochemistry analyses revealing extensive and persistent immune cell infiltration within brain tumors and upregulation of immune checkpoint biomarkers support our initiation of a study of Ad-RTS-hIL-12 plus veledimex combined with an anti-PD-1 drug this year."

Conference Call and Webcast

In connection with this announcement, ZIOPHARM will host a conference call and webcast slide presentation featuring Drs. Chiocca and Goldman today, Nov. 20, at 10:15 a.m. ET. The call can be accessed by dialing 1-844-309-0618 (U.S. and Canada) or 1-661-378-9465 (international). The conference ID number is 8089664. To access the accompanying slides and live webcast, or the subsequent archived recording, visit the "Investors & Media" section of the ZIOPHARM website at www.ziopharm.com. The webcast will be recorded and available for replay on the Company’s website for two weeks.

About Ad-RTS-hIL-12 plus Veledimex:

ZIOPHARM is advancing Ad-RTS-hIL-12 plus veledimex as a gene therapy for glioblastoma. Ad-RTS-hIL-12 is an adenoviral vector administered via a single injection into the tumor and engineered to express hIL-12, a powerful cytokine that has demonstrated the potential to stimulate a targeted, anti-tumor immune response. The expression of hIL-12 is controlled and modulated with the RheoSwitch Therapeutic System (RTS) by the small molecule veledimex, an activator ligand which has been shown to cross the blood-brain barrier. The Company completed enrollment in a multi-center, Phase 1 dose escalation trial designed to evaluate Ad-RTS-hIL-12 in patients with recurrent or progressive Grade III or IV glioma. The trial evaluated three veledimex dosing cohorts (20mg, n = 15; 30mg, n = 4; and 40mg, n = 6). Patients undergoing resection were injected intratumorally with Ad 2 x 1011 viral particles and received daily oral activator veledimex for 15 doses. The majority of patients in the 20mg cohort had 2 or more recurrences prior to entry in the study, indicating very advanced disease. ZIOPHARM anticipates initiation of a pivotal registration trial for Ad-RTS-hIL-12 plus veledimex for the treatment of rGBM by the end of 2017. The Company has also initiated a Phase 1 study to evaluate the stereotactic administration of Ad-RTS-hIL-12 plus veledimex in adult patients with rGBM, as well as a trial to evaluate the gene therapy as a treatment for pediatric brain tumors. In addition, ZIOPHARM plans to initiate enrollment of adult patients with rGBM who will receive a single dose of Ad-RTS-hIL-12 plus veledimex in combination with a checkpoint inhibitor targeting programmed cell death protein 1 (PD-1) by the end of 2017.

On November 20, 2017 Glactone Pharma reporrted that in strong competition and after external examination, it has been awarded a SEK 886,500 grant (approx. USD 106,000) from Vinnova (Sweden’s Innovation Agency) in the second phase of a program aimed at innovative startup companies (Press release, Glactone Pharma, NOV 20, 2017, View Source [SID1234522150]). The funded project will be used to characterize Glactone Pharma’s lead STAT3 inhibitor, a potential new drug for the treatment of cancers. A STAT3 inhibitor has great potential to address large unmet medical needs and help patients.

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Glactone Pharma’s objective for this project is to generate data on dosing and efficacy in relevant models and to obtain a correlation between pharmacokinetics and pharmacodynamics of the company’s lead compound. Having this data is important for predicting safe and efficacious doses both for non-clinical and clinical studies, thereby increasing the chances of success. STAT3 is a highly promising target in cancer with both preclinical and clinical data supporting the important roles that STAT3 plays in cancer occurrence and progression. Furthermore, STAT3 is involved in mechanisms that enable tumors and cancer cells to evade the immune system. The company’s lead compound has demonstrated the ability to modulate the immune system through STAT3 blockade in a disease model, and thereby acting as a cancer immunotherapy agent.

Immunotherapy is a treatment modality that activates and utilizes the body’s own immune system to recognize and attack tumors and is today the fastest growing and most promising area of cancer research.

Martin Johansson, CEO of Glactone Pharma, says: "The continued development of Glactone Pharma’s STAT3 inhibitor is greatly helped by this funding awarded by Vinnova and we can continue with our focus of bringing a novel drug to the clinic that potentially can help many patients. In addition, the grant is a recognition of the quality of the research that we are conducting at Glactone Pharma."

About STAT3
STAT3 (Signal Transducer and Activator of Transcription 3) is a transcription factor/signaling protein that is frequently activated in many forms of cancer.

STAT3 plays crucial roles in both tumor cells and in the tumor microenvironment and is a highly promising target for cancer therapy. Direct STAT3 inhibitors have the potential to prevent metastasis, reverse drug resistance and induce apoptosis in cancer cells. Furthermore, STAT3 inhibitors can be combined with immunotherapies to increase response rates and efficacy and with targeted drugs and chemotherapy to reverse and overcome resistance and provide efficacious and safe cancer treatments.

STAT3 is an intractable drug target as it is an intracellular protein with no enzymatic activity and is activated by multiple upstream factors. Despite it not being a "classic drug target", Glactone Pharma has developed orally bioavailable small molecule inhibitors that can directly inhibit the function of STAT3.

On November 20, 2017 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the Phase III IMpower150 study met its co-primary endpoint of progression-free survival (PFS) and demonstrated that the combination of TECENTRIQ (atezolizumab) and Avastin (bevacizumab) plus chemotherapy (paclitaxel and carboplatin) provided a statistically significant and clinically meaningful reduction in the risk of disease worsening or death (PFS) compared to Avastin plus chemotherapy in the first-line treatment of people with advanced non-squamous non-small cell lung cancer (NSCLC) (Press release, Hoffmann-La Roche, NOV 20, 2017, View Source [SID1234522149]). Initial observations for the co-primary endpoint of overall survival (OS) are encouraging. These data are not fully mature and the next OS analysis is expected in the first half of 2018. Safety for the TECENTRIQ and Avastin plus chemotherapy combination appeared consistent with the known safety profile of the individual medicines, and no new safety signals were identified with the combination.

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These data will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Immuno Oncology Congress in Geneva, Switzerland in December 2017.

"We are extremely encouraged by these results and will submit these data to health authorities globally with the goal of bringing a potential new standard of care for the initial treatment of lung cancer," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "In addition to first-line NSCLC, we are testing the ability of TECENTRIQ and Avastin to enhance the potential of the immune system to combat a broad range of other cancers."
About the IMpower150 study

IMpower150 is a multicentre, open-label, randomised, controlled Phase III study evaluating the efficacy and safety of TECENTRIQ in combination with chemotherapy (carboplatin and paclitaxel) with or without Avastin in people with stage IV non-squamous NSCLC who had not been treated with chemotherapy for their advanced disease. It enrolled 1,202 people of which those with ALK* and EGFR mutations were excluded from the primary ITT analysis. People were randomised (1:1:1) to receive:

TECENTRIQ plus carboplatin and paclitaxel (Arm A), or
TECENTRIQ and Avastin plus carboplatin and paclitaxel (Arm B), or
Avastin plus carboplatin and paclitaxel (Arm C, control arm).

During the treatment-induction phase, people in Arm A received TECENTRIQ administered intravenously at 1200 mg in combination with intravenous infusion of carboplatin and paclitaxel on Day 1 of a 3-week treatment cycle for 4 or 6 cycles. Following the induction phase, people received maintenance treatment with TECENTRIQ (1200 mg every 3 weeks) until loss of clinical benefit or disease progression.

People in Arm B received induction treatment with TECENTRIQ (1200 mg) and Avastin administered intravenously at 15 mg/kg in combination with intravenous infusion of carboplatin and paclitaxel on Day 1 of a 3-week treatment cycle for 4 or 6 cycles. People then received maintenance treatment with the TECENTRIQ Avastin regimen until disease progression (Avastin) or loss of clinical benefit/disease progression (TECENTRIQ).

People in Arm C received induction treatment with Avastin administered intravenously at 15 mg/kg plus intravenous infusion of carboplatin and paclitaxel on Day 1 of a 3-week treatment cycle for 4 or 6 cycles. This was followed by maintenance treatment with Avastin alone until disease progression.

The co-primary endpoints were PFS, as determined by the investigator using Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1), and OS. This analysis of the IMpower150 PFS endpoint was only statistically powered to demonstrate a comparison between Arm B versus Arm C.

The primary analysis of the co-primary PFS endpoint in IMpower150 was assessed in two populations: all randomised people without an ALK or EGFR genetic mutation (intention-to-treat wild-type**) and in a subgroup of people who had a specific biomarker (T-effector "Teff" gene signature expression). IMpower150 met its PFS co-primary endpoint per study protocol for both populations assessed.

About NSCLC
Despite recent advances in the treatment of NSCLC, there is still a need for new treatment options. Lung cancer is the leading cause of cancer death globally.1 Each year 1.59 million people die as a result of the disease; this translates into more than 4,350 deaths worldwide every day.2 Lung cancer can be broadly divided into two major types: NSCLC and small cell lung cancer. NSCLC is the most prevalent type, accounting for around 85% of all cases.2

About TECENTRIQ (atezolizumab)
TECENTRIQ is a monoclonal antibody designed to bind with a protein called PD-L1 expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, TECENTRIQ may enable the activation of T cells. TECENTRIQ has the potential to be used as a foundational combination partner with cancer immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers.
Currently, Roche has eight Phase III lung cancer studies underway, evaluating TECENTRIQ alone or in combination with other medicines.

TECENTRIQ is already approved in the European Union, United States and more than 50 countries for people with previously treated metastatic NSCLC and for people with locally advanced or metastatic urothelial cancer (mUC) who are not eligible for cisplatin chemotherapy, or who have had disease progression during or following platinum-containing therapy.

About Avastin (bevacizumab)
Avastin is a biologic cancer treatment approved in combination with chemotherapy for the first-line treatment of advanced NSCLC and, to-date, has helped over 500,000 patients lead longer lives. Avastin is considered a standard of care for the first-line treatment of advanced NSCLC and has been proven to significantly extend overall survival (OS). Avastin is currently approved in combination with any platinum-based chemotherapy in Europe, and with paclitaxel/carboplatin in the US, in first-line non-squamous NSCLC, based on results of the pivotal Phase III E4599 study. Avastin was the first medicine to help people with previously untreated advanced, non-squamous NSCLC live longer (OS) than one year when added to chemotherapy.
About the TECENTRIQ (atezolizumab) and Avastin (bevacizumab) combination
There is a strong scientific rationale to support the use of TECENTRIQ plus Avastin in combination. The TECENTRIQ and Avastin regimen may enhance the potential of the immune system to combat a broad range of cancers, including first-line advanced NSCLC. Avastin, in addition to its established anti-angiogenic effects, may further enhance TECENTRIQ’s ability to restore anti-cancer immunity, by inhibiting VEGF-related immunosuppression, promoting T-cell tumour infiltration and enabling priming and activation of T-cell responses against tumour antigens.
About Roche in cancer immunotherapy
For more than 50 years, Roche has been developing medicines with the goal to redefine treatment in oncology. Today, we’re investing more than ever in our effort to bring innovative treatment options that help a person’s own immune system fight cancer.
By applying our seminal research in immune tumour profiling within the framework of the Roche-devised cancer immunity cycle, we are accelerating and expanding the transformative benefits with TECENTRIQ to a greater number of people living with cancer. Our cancer immunotherapy development programme takes a comprehensive approach in pursuing the goal of restoring cancer immunity to improve outcomes for patients.