On January 14, 2019 Physicians’ Education Resource (PER), a leading resource for continuing medical education (CME), reported that it will conduct two CME-accredited satellite symposia on bladder cancer and renal cell carcinoma at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary (GU) Cancers Symposium on Feb. 14 and 15 at the San Francisco Marriott Marquis in California, Phil Talamo, president of PER (Press release, Physicians’ Education Resource, JAN 14, 2019, View Source [SID1234532639]).

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!

"We are thrilled to host two different programs on the changing landscape of treating bladder cancer and renal cell carcinoma during this year’s ASCO (Free ASCO Whitepaper) GU," Talamo said. "Our educational programs will feature experienced experts presenting new clinical evidence to help attendees make decisions on selecting the best therapies to optimize patient outcomes in two very difficult to treat tumor settings."

The PER satellite symposiums are:

Shifting Paradigms in Bladder Cancer: How Immunotherapeutic Strategies Are Changing Courses of Care will be held on Thursday, Feb. 14, from 7 to 9 p.m. PST in the Salon 8 Yerba Buena Ballroom, Lower B2 Level. The symposia will be chaired by Daniel P. Petrylak, M.D., professor of medicine and urology at Yale School of Medicine and co-director of the Signal Transduction Research Program at Yale Cancer Center. During this interactive symposium, renowned experts will discuss the impact of evolving evidence on the use of immuno-oncology agents, including combination strategies, in the management of bladder cancers. To register, click here.
Medical Crossfire: Crossroads in Advanced RCC Decision-Making: With Many Options, How Will You Treat Your Patient Today? … And Tomorrow? will be held on Friday, Feb. 15, from 7 to 9 p.m. PST in the Salon 8 Yerba Buena Ballroom, Lower B2 Level. The symposia will be chaired by Toni K. Choueiri, M.D., director of the Lank Center for Genitourinary Oncology, director of the Kidney Cancer Center, a senior physician at Dana-Farber Cancer Institute, and the Jerome and Nancy Kohlberg chair and professor of medicine at Harvard Medical School. During this case-based, interactive, live symposium, distinguished faculty members will review the most recent data and best practices. A lively debate and discussion between faculty and attendees will address clinical challenges and questions faced in daily practice. To register, click here.
Each satellite symposium is accredited by the Accreditation Council for Continuing Medical Education for 2.0 AMA PRA Category 1 Credits for physicians.

On January 14, 2019 Quanterix Corporation (NASDAQ:QTRX), a company digitizing biomarker analysis with the goal of advancing the science of precision health, reported that it will be presenting at the 21st Annual Needham Growth Conference, on Jan. 16, at 4:10 p.m., EST, at the Lotte New York Palace Hotel, New York City (Press release, Quanterix, JAN 14, 2019, View Source [SID1234532638]).

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!

To access the live webcast of Quanterix’ presentations, please visit the News & Events page within the Investors section of the Quanterix website at www.quanterix.com. Replays of the webcast will be available on the Quanterix website for 90 days following the conference.

On January 14, 2019 Bio-Thera Solutions Ltd ("Bio-Thera") reported that it has reached a licensing agreement with Cipla Limited (BSE: 500087; NSE: CIPLA EQ; and hereafter referred to as "Cipla") for BAT1706, its bevacizumab biosimilar, under which Cipla will have exclusive rights to distribute and market the drug in select emerging markets (Press release, BioThera Solutions, JAN 14, 2019, View Source [SID1234532637]).

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!

BAT-1706 is a mAb biosimilar to Genentech’s Avastin which is currently approved for six indications including metastatic colorectal cancer, recurrent glioblastoma and non-squamous non-small cell lung cancer. Bio-Thera’s BAT-1706 is currently in a global Phase III study (NCT03329911) in patients with previously untreated advanced non-squamous non-small cell lung cancer. Bio-Thera intends to file for regulatory approval with the China National Medical Products Administration (NMPA), the European Medicines Agency (EMA) and the United States Food and Drug Administration (USFDA) in 2020.

This partnership will leverage Cipla’s strong local presence, sales and marketing capabilities in the select emerging markets. Bio-Thera will be responsible for full development, product registration with the FDA and EMA, and commercial supply of BAT1706 out of its manufacturing facilities in Guangzhou, China.

"Bio-Thera is pleased to partner with Cipla to commercialize our lead biosimilar program in select emerging markets", said Dr. Shengfeng Li, CEO of Bio-Thera. "This partnership is an important first step towards making BAT1706, our bevacizumab biosimilar product, availability globally to help increase patient access to this important cancer therapeutic at affordable prices."

"This agreement is in keeping with Cipla’s stated intention to build a strong pipeline of biosimilars through partnerships. We are committed to working towards ensuring patients receive access to life-saving drugs. Through this partnership, Cipla will leverage its strengths in marketing to take this key oncology biosimilar to patients in need." said Umang Vohra, MD & Global CEO of Cipla Limited.

On January 14, 2019 4SC AG (4SC, FSE Prime Standard: VSC) reported that the first clinical centers of the investigator-sponsored Phase II study EMERGE are open for patient recruitment (Press release, 4SC, JAN 14, 2019, View Source [SID1234532636]). The study is conducted by Prof. David Cunningham, MD FRCP FMedSci, Head of the Gastrointestinal and Lymphoma Unit and Director of Clinical Research at The Royal Marsden NHS Foundation Trust (London, UK).

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!

The multi-center, single-arm, open-label study examines domatinostat (formerly 4SC-202) plus checkpoint inhibitor avelumab in up to 70 patients with advanced gastrointestinal cancer – precisely microsatellite-stable esophago-gastric and colorectal (MSS-GI) cancer. The study is intended to establish the safety of combining domatinostat with avelumab as well as to generate proof-of-concept clinical data in this patient population.

Prof. Cunningham said: "Although checkpoint inhibitors are very successful in various solid tumor indications, MSS-GI cancer has proven to be largely therapy-resistant to these. The EMERGE study will seek to address this high medical need by using domatinostat to render the tumor tissue susceptible to avelumab. We need to study more drug candidates like domatinostat, which aim to broaden the efficacy of checkpoint inhibitors when used in combination."

Jason Loveridge, Ph.D., CEO of 4SC, added: "We are happy to support investigator-sponsored research conducted by third parties on our drug candidates. This research can provide valuable information regarding the safety, efficacy, pharmacology and tolerability of 4SC’s drug candidates and supplement the data generated in our own clinical studies. We are very proud that Prof. Cunningham, a widely respected expert in the field, chose to perform the EMERGE study with domatinostat and we are looking forward to the outcome."

Related articles
20 September 2018, 4SC AG: Domatinostat plus chemotherapy – Overcoming drug resistance

15 August 2018, FDA approves IND application for domatinostat (4SC-202) in melanoma

31 July 2018, First patient enrolled in 2nd dose cohort of Phase Ib/II study SENSITIZE of domatinostat (4SC-202) + pembrolizumab in melanoma

About domatinostat (4SC-202)

Domatinostat is an orally administered small molecule Class I selective HDAC inhibitor with a unique mode of action that was designed to strengthen the body’s own anti-tumor immune response. Domatinostat also influences the tumor microenvironment facilitating infiltration of immune cells into the tumor and making it more visible to the immune system.

Domatinostat has been investigated in a Phase I study with 24 heavily pretreated patients with several types of advanced hematologic cancers and was well tolerated. Positive signs of anti-tumor efficacy were also observed; with one complete remission (28 months) and one partial responder (8 months).

In addition to its therapeutic potential in cancer monotherapy, 4SC is evaluating domatinostat’s capacity as a partner in combination therapies, specifically in the immuno-oncology area. In this respect, 4SC initiated a Phase Ib/II study of domatinostat in combination with the anti-PD-1 checkpoint inhibitor pembrolizumab in patients with advanced-stage melanoma. A second Phase II study of domatinostat in combination with the anti-PD-L1 checkpoint inhibitor avelumab in patients with advanced-stage microsatellite-stable gastrointestinal cancer is conducted by Prof. David Cunningham of The Royal Marsden NHS Foundation Trust (London, UK).

As soon as results from the aforementioned trials will be available, 4SC plans to advance domatinostat into a potentially pivotal study in combination with a checkpoint inhibitor in PD-(L)1 refractory patients with advanced Merkel-cell carcinoma (MCC).

On January 14, 2019 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for its investigational Bruton’s tyrosine kinase (BTK) inhibitor, zanubrutinib, for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy (Press release, BeiGene, JAN 14, 2019, View Source [SID1234532635]).

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!

"We are very excited to receive the Breakthrough Therapy designation from the FDA," said Jane Huang, M.D., Chief Medical Officer, Hematology, at BeiGene. "Zanubrutinib has been designed to maximize BTK occupancy and minimize off-target effects. We believe that the Breakthrough Therapy designation underscores the potential of zanubrutinib as a meaningful treatment for patients with MCL who have received at least one prior therapy. More than 1,300 patients worldwide have been treated with zanubrutinib, and it’s being developed in a broad clinical program that currently includes seven Phase 3 or pivotal trials conducted globally or in China."

About Breakthrough Therapy Designation
The FDA’s Breakthrough Therapy designation program is intended to expedite the development and review of a drug candidate that is planned to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. According to the FDA’s guidelines, the features of the program include more intensive FDA guidance on an efficient drug development program, an organizational commitment involving senior managers, and eligibility for rolling review and priority review. The Food and Drug Administration Safety and Innovation Act (FDASIA) requires the following actions, as appropriate: holding meetings with the sponsor and the review team throughout the development of the drug, providing timely advice to, and interactive communication with, the sponsor regarding the development of the drug to ensure that the development program to gather the nonclinical and clinical data necessary for approval is as efficient as practicable; taking steps to ensure that the design of the clinical trials is as efficient as practicable, when scientifically appropriate, such as by minimizing the number of patients exposed to a potentially less efficacious treatment; assigning a cross-disciplinary project lead for the FDA review team to facilitate an efficient review of the development program and to serve as a scientific liaison between the cross-disciplinary members of the review team (i.e., clinical, pharmacology-toxicology, chemistry, manufacturing and control, compliance) for coordinated internal interactions and communications with the sponsor through the review division’s regulatory health project manager; and involving senior managers and experienced review staff, as appropriate, in a collaborative, cross-disciplinary review. The designation may be rescinded if the drug candidate does not continue to meet the criteria for Breakthrough Therapy designation.

About Mantle Cell Lymphoma
Lymphoma is a diverse group of malignancies that originates from B-, T- or NK- cells. Mantle cell lymphoma (MCL) is typically an aggressive form of non-Hodgkin lymphoma (NHL) that arises from B-cells originating in the "mantle zone." In the United States, about 70,800 new cases of NHL were expected in 2014, with MCL representing about six percent (about 4,200 cases) of all new cases of NHL in the United States. In 2013, the incidence of lymphoma was 4.2 per 100,000 and the mortality was 2.2 per 100,000 in mainland China, making it the eleventh most common cancer and the tenth leading cause of cancer death. MCL usually has a poor prognosis, with a median survival of three to four years, although occasionally patients may have an indolent course. Frequently, MCL is diagnosed at a later stage of disease.

About Zanubrutinib
Zanubrutinib (BGB-3111) is an investigational small molecule inhibitor of Bruton’s tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated in a broad pivotal clinical program globally as a monotherapy and in combination with other therapies to treat various B-cell malignancies.

Clinical trials of zanubrutinib include a fully-enrolled, global Phase 3 clinical trial in patients with Waldenström macroglobulinemia (WM) comparing zanubrutinib to ibrutinib, the currently only approved BTK inhibitor for WM; a global Phase 3 clinical trial in patients with previously untreated chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL); a pivotal Phase 2 trial in patients with relapsed/refractory (R/R) follicular lymphoma in combination with GAZYVA (obinutuzumab); a Phase 3 trial comparing zanubrutinib to ibrutinib in patients with R/R CLL/SLL; and a global Phase 1 trial. In China, BeiGene has completed two pivotal Phase 2 clinical trials of zanubrutinib in patients with MCL and CLL/SLL and the enrollment in the pivotal Phase 2 clinical trials in patients with WM.

Zanubrutinib has been granted Fast Track designation for the treatment of patients with WM and Breakthrough Therapy designation for the treatment of adult patients with MCL who have received at least one prior therapy by the U.S. Food and Drug Administration (FDA). The NDAs in China for R/R MCL and R/R CLL/SLL have been accepted by the China National Medical Products Administration (NMPA) and granted priority review.