Samsung Bioepis Receives Regulatory Approval for Europe’s First Trastuzumab Biosimilar, ONTRUZANT®

On November 20, 2017 Samsung Bioepis Co., Ltd. reported the European Commission’s (EC) marketing authorization of ONTRUZANT, a biosimilar referencing Herceptin (trastuzumab), for the treatment of early breast cancer, metastatic breast cancer and metastatic gastric cancer (Press release, Samsung Bioepis, NOV 20, 2017, View Source [SID1234522145]). ONTRUZANT is the first trastuzumab biosimilar to receive regulatory approval in Europe.

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The EC approval of ONTRUZANT applies to all 28 European Union (EU) member states and the European Economic Area (EEA) member states of Norway, Iceland and Liechtenstein. ONTRUZANT will be commercialized by MSD, which is known as Merck in the United States and Canada.

"Breast cancer remains the most common form of cancer affecting women. We hope ONTRUZANT will play an important role expanding patient access to trastuzumab across the region," said Christopher Hansung Ko, President & CEO of Samsung Bioepis. "Through relentless process innovation and an uncompromising commitment to quality, we remain dedicated to advancing one of the industry’s strongest biosimilar pipelines, so that more cancer patients and healthcare systems across Europe will benefit from biosimilars."

ONTRUZANT is the fourth biosimilar developed by Samsung Bioepis to receive EC marketing authorization. Samsung Bioepis has also received marketing authorizations for Benepali (etanercept), Flixabi (infliximab) and Imraldi (adalimumab).

Phase III IMpower150 study showed Roche’s TECENTRIQ (atezolizumab) and Avastin (bevacizumab) plus chemotherapy significantly reduced the risk of disease worsening or death in the initial treatment of people with a type of advanced lung cancer

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.

Glactone Pharma receives new funding from Vinnova

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.

PledPharma and Solasia enter license agreement to develop and commercialize PledOx® in Asia

On November 17, 2017 PledPharma AB ("PledPharma") (STO: PLED) and Solasia Pharma K.K. ("Solasia") (TSE: 4597) reported that they have entered a license agreement pertaining to the clinical development and commercialization of PledOx in Japan, China, Hong Kong, Macau, South Korea and Taiwan (Press release, Solasia, NOV 17, 2017, View Source [SID1234532512]).

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Under the terms of this agreement, PledPharma grants exclusive development and commercialization rights to PledOx in the territories mentioned and Solasia will pay upfront, development, regulatory and sales milestones of up to ~USD 83 million (SEK 700 million)*. In addition, Solasia will pay industry standard royalty rates on sales applicable for a deal pertaining to an in-licensed asset in Phase III development. Solasia will also fully finance an expansion of the Phase III program to include Asian patients subject to regulatory consultations.

The license agreement is initially focused on the use of PledOx as prevention of chemotherapy induced peripheral neuropathy in colorectal cancer patients. The agreement with Solasia facilitates an expansion of the recently announced global Phase III-program for PledOx with Asian patients, subject to regulatory consultations, aiming to gain sufficient documentation for regulatory approvals in the major Asian markets. In addition, a Phase I study in Japanese and Caucasian Healthy Volunteers with focus on safety, tolerability and pharmacokinetics will be conducted. Following potential regulatory approvals, Solasia will be responsible for the commercialization of PledOx in Japan, China, Hong Kong, Macau, South Korea, and Taiwan.

"We are very excited to announce our partnership with Solasia – an ideal partner during the development, regulatory process and commercialization of PledOx in this very important region. The collaboration will ensure an optimized expansion of the Phase III program to include Asian patients, aiming at further realising the global commercial potential of our drug candidate," said Nicklas Westerholm, Chief Executive Officer and President, PledPharma.

"We are convinced that PledOx, as a novel first in class therapy, will play an important role in fulfilling the significant unmet medical need of preventing chemotherapy induced peripheral neuropathy. Solasia is ideally equipped to support PledPharma during the remaining clinical development and local regulatory processes in Japan, and to effectively launch the product in key Asian markets," said Yoshihiro Arai, President and Chief Executive Officer, Solasia.

As PledPharma announced earlier in November, following interactions with the regulatory authorities, EMA and FDA, the company has finalized the design of the global Phase III program for the drug candidate PledOx. The Phase III studies are anticipated to be initiated at the end of 2017 with top line results expected during 2020.

* The total value of upfront and milestone payments is up to JPY 9.3 billion. The amount given in USD and SEK is subject to exchange rate.

Invitation to corporate presentation
PledPharma will attend the Redeye Life Science Seminar on November 24 at 11:00 CET where PledPharma will provide a company update and an overview of the license agreement with Solasia. The event will be live streamed from Redeyes website www.redeye.se. After the event, the presentation will be available on PledPharma’s website.

10-Q – Quarterly report [Sections 13 or 15(d)]

Eleven Biotherapeutics has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Eleven Biotherapeutics, 2017, NOV 17, 2017, View Source [SID1234522142]).

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