Affimed has filed a 20-F – Annual and transition report of foreign private issuers [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 20-F, Affimed, 2018, MAR 20, 2018, View Source [SID1234524903]).

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On March 20, 2018 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the Phase III IMpower131 study met its co-primary endpoint of progression-free survival (PFS) and demonstrated that the combination of TECENTRIQ (atezolizumab) plus chemotherapy (carboplatin and Abraxane [albumin-bound paclitaxel; nab-paclitaxel]) reduced the risk of disease worsening or death (progression-free survival; PFS) compared with chemotherapy alone in the initial (first-line) treatment of people with advanced squamous non-small cell lung cancer (NSCLC) (Press release, Hoffmann-La Roche, MAR 20, 2018, View Source [SID1234525401]). Safety for the TECENTRIQ and chemotherapy combination appeared consistent with the known safety profile of the individual medicines, and no new safety signals were identified with the combination. At this interim analysis a statistically significant overall survival (OS) benefit was not observed and the study will continue as planned. These data will be presented at an upcoming oncology congress.

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"Squamous non-small cell lung cancer is difficult to treat and there have been limited new treatment options over the last few decades," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "We will share the IMpower131 results with global health authorities and we look forward to seeing more mature overall survival data."

As per the statistical analysis plan in IMpower131, Arm B (TECENTRIQ plus carboplatin and nab-paclitaxel) must demonstrate a statistically significant OS result vs. Arm C (carboplatin and nab-paclitaxel), before an analysis between Arm A (TECENTRIQ plus carboplatin and paclitaxel) and Arm C can be made for PFS and OS.
Currently, Roche has eight Phase III lung cancer studies underway evaluating TECENTRIQ alone or in combination with other medicines and five are expected to report this year.

About the IMpower131 study
IMpower131 is a Phase III, open-label, multicentre, randomised study evaluating the efficacy and safety of TECENTRIQ in combination with carboplatin and nab-paclitaxel or TECENTRIQ in combination with carboplatin and paclitaxel versus chemotherapy (carboplatin and nab-paclitaxel) alone in people with stage IV squamous NSCLC who have not been previously treated with chemotherapy. The study enrolled 1,021 people who were randomised equally (1:1:1) to receive:
TECENTRIQ plus carboplatin and paclitaxel (Arm A), or
TECENTRIQ plus carboplatin and nab-paclitaxel (Arm B), or
Carboplatin and nab-paclitaxel (Arm C, control arm)
During the treatment-induction phase, people in Arm A received four or six cycles of TECENTRIQ plus carboplatin and paclitaxel , given on day one of each 21-day cycle. This was followed by maintenance therapy with TECENTRIQ every three weeks until progression of the cancer, or for as long as clinical benefit was observed.
During the treatment-induction phase, people in Arm B received four or six cycles of TECENTRIQ, carboplatin and nab-paclitaxel. TECENTRIQ and carboplatin were administered on day one of each 21-day cycle. Nab-paclitaxel was administered on days one, eight and 15 of each 21-day cycle. This was followed by maintenance therapy with TECENTRIQ every three weeks until progression of the cancer, or for as long as clinical benefit was observed.
During the treatment-induction phase, people in Arm C received four or six cycles of carboplatin and nab-paclitaxel. Carboplatin was administered on day one of each 21-day cycle, and nab-paclitaxel was administered on days one, eight and 15 of each 21-day cycle. In the maintenance phase, participants received best supportive care.
The co-primary endpoints were:
PFS as determined by the investigator using RECIST v1.1 in the intention-to-treat (ITT) population (Arm B vs. Arm C)
Overall survival (OS) in the ITT population (Arm B vs. Arm C)
IMpower131 met its PFS co-primary endpoint per study protocol. This analysis of IMpower131 evaluated Arm B vs. Arm C.
About NSCLC
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 NSCLC comprises non-squamous and squamous-cell lung cancer, the squamous form of which is characterised by flat cells covering the airway surface when viewed under a microscope. The squamous form tends to grow near the centre of the lung, and accounts for approximately 25-30% of all NSCLC cases.3

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 60 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.

Abraxane is a registered trademark of Abraxis Bioscience, LLC, a wholly owned subsidiary of Celgene Corporation.
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.
To learn more about the Roche approach to cancer immunotherapy please follow this link:
View Source

On March 19, 2018 RedHill Biopharma Ltd. (NASDAQ:RDHL) (Tel-Aviv Stock Exchange:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company primarily focused on late clinical-stage development and commercialization of proprietary drugs for gastrointestinal diseases and cancer, reported the presentation of a poster at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2018 Annual Meeting (Press release, RedHill Biopharma, MAR 19, 2018, View Source [SID1234524878]). The abstract (number 4200) will be presented by Mark L. Levitt, MD, Ph.D., Medical Director, Oncology at RedHill, on Tuesday, April 17, 2018 from 1:00 PM to 5:00 PM CDT, at McCormick Place, Chicago, IL.

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The abstract1 presentation, entitled ‘New potential therapeutic applications of WX-UK1, as a specific and potent inhibitor of human trypsin-like proteases’, describes data from non-clinical studies concluding that WX-UK1, the active metabolite of RHB-107 (formerly MESUPRON) (INN: upamostat), is a potent and specific inhibitor of five human serine proteases (trypsin-3, trypsin-2, trypsin-1, matriptase-1 and trypsin-6). Several of these serine proteases are associated with cancer progression and metastasis. The non-clinical studies suggest new potential therapeutic applications of WX-UK1 in oncology and inflammatory gastrointestinal diseases. The abstract was authored by scientists from the Department of Molecular Biology and Genetics of Aarhus University in collaboration with RedHill2.

RHB-107 is a proprietary, first-in-class, orally-administered potent serine protease inhibitor, presenting a new non-cytotoxic approach to cancer therapy, as well as other indications of high unmet need, such as inflammatory digestive diseases and inflammatory lung diseases. RHB-107 has undergone several Phase I studies and two Phase II proof-of-concept studies in cancer patients.

With the recent identification of several serine proteases as high-affinity molecular targets, RedHill is evaluating utilization of RHB-107 in both cancer and inflammatory digestive diseases.

About RHB-107 (upamostat):
RHB-107 (formerly MESUPRON) (INN: upamostat) is a proprietary, first-in-class, orally-administered potent inhibitor of several serine proteases targeting cancer and inflammatory gastrointestinal diseases. Protease inhibitors have been shown to play key roles in tumor invasion and the metastasis process. High levels of certain proteases are associated with poor prognosis in various solid tumor cancers, such as pancreatic, gastric, breast and prostate cancers. RHB-107 was previously granted FDA Orphan Drug designation for the treatment of pancreatic cancer. RHB-107 presents a new non-cytotoxic approach to cancer therapy with several potential mechanisms of action to inhibit tumor invasion and metastasis. RHB-107 has undergone several Phase I studies and two Phase II proof-of-concept studies. The first Phase II study was in locally-advanced, non-metastatic pancreatic cancer and the second study in metastatic breast cancer in combination with first-line chemotherapeutic agents. RedHill was granted a new patent from the United States Patent and Trademark Office (USPTO) directed to a combination of RHB-107, YELIVA, RedHill’s two Phase II-stage investigational compounds, and a known antibiotic. RedHill acquired the exclusive worldwide rights to RHB-107, excluding China, Hong Kong, Taiwan and Macao, from Germany’s Heidelberg Pharmaceuticals (formerly WILEX AG) for all indications.

On March 19, 2018 Oncoceutics, Inc. reported that multiple abstracts from the company and its commercial and academic collaborators will be presented at the 2018 annual meeting of the American Association of Cancer Research (AACR) (Free AACR Whitepaper) in Chicago, Illinois, on April 14th to April 18th (Press release, Oncoceutics, MAR 19, 2018, View Source [SID1234558371]).

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These abstracts highlight the unique way that ONC201 engages the dopamine receptor, leading to downstream direct anti-tumor and immune oncology effects, which are especially pronounced in tumors with dopamine pathway dysregulation. These tumors include H3 K27M mutant high grade gliomas and other cancers, where ONC201 is now in advanced clinical trials.

Additionally, the abstracts showcase the continued preclinical advancement of other members of the imipridone family. ONC212 will be featured in an oral presentation highlighting its ability to treat aggressive leukemias as a single agent, and effectively synergize with other anti-leukemic agents, specifically BCL-2 inhibitors, due to its unique GPCR target. ONC206 demonstrates parallel characteristics with ONC201, while also being differentiated by a unique binding profile.

The abstracts are listed below and categorized by topic: ONC201 clinical translation; ONC201 preclinical single agent and combinatorial activity; and analogs (ONC206 and ONC212). All poster presentations will be in McCormick Place South, Exhibit Hall A, and the oral presentation of ONC212 will take place in Room S102 – McCormick Place South (Level 1) at the times described below.

ONC201 Clinical Translation:

Selective targeting of dopamine receptor dysregulation in high grade gliomas with imipridone ONC201
April 17, 2018, 8:00 AM

ONC201 induction of apoptosis in hPheo1 cell line supports use of this oral agent in ongoing phase 2 clinical trial against neuroendocrine tumors
April 17, 2018, 1:00 PM

Clinical immunostimulatory activity of imipridone ONC201, a selective DRD2 antagonist, in advanced solid tumor patients
April 18, 2018, 8:00 AM

ONC201 Preclinical Single Agent and Combinatorial Activity

Treatment and signaling contexts for the application of the imipridone ONC201 to prostate cancer cells
April 15, 2018, 1:00 PM

LB-082. ONC201 sensitizes resistant breast cancer cells to TRAIL through death receptor 5 upregulation

April 16, 2018, 8:00 AM – 12:00 PM

Synergistic antitumor effect of ONC201 in combination with radiation therapy
April 16, 2018, 1:00 PM

Combination ONC201 and radiation therapy in the treatment of breast cancer
April 16, 2018, 1:00 PM

Analogs (ONC206 and ONC212):

Receptor pharmacology and anti-cancer activity of selective DRD2/3 antagonist imipridone ONC206
April 17, 2018, 1:00 PM

The novel imipridone ONC212 highly synergizes with the BCL-2 inhibitor ABT-199 in AML and activates orphan receptor GPR132
April 17, 2018, 3:35 PM – Oral Presentation

On March 20, 2018 Arvinas LLC, a private biotechnology company creating a new class of drugs based on protein degradation, reported that John Houston, Ph.D., President and Chief Executive Officer of Arvinas, will present a company overview at the 17th Annual Needham Healthcare Conference on Tuesday, March 27, 2018 at 8:30 a.m. ET in New York, NY (Press release, Arvinas, MAR 19, 2018, View Source [SID1234524882]).

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