On October 4, 2017 Siamab Therapeutics, Inc. and Boehringer Ingelheim reported that they have entered into a strategic discovery collaboration with the goal of developing anti-cancer therapeutics targeting tumor associated carbohydrate antigens (TACAs) (Press release, Siamab Therapeutics, OCT 4, 2017, View Source [SID1234520783]). Siamab will apply its proprietary technology platform to generate TACA-specific antibodies for use in multiple solid tumor applications. Financial terms of the agreement are not being disclosed.

TACAs represent unique cancer-selective targets that are present in the majority of solid tumors including ovarian, pancreatic, prostate, colon, gastric and breast, and are exploited by tumor cells to suppress innate immune function, enable tissue invasion and metastasis, resist chemotherapy and promote a stem-cell phenotype. Selective targeting of TACAs can therefore provide novel approaches for this exciting new era of cancer immunology research.

Under the terms of the agreement, Siamab will use its platform to discover TACA selective targeting antibodies. Boehringer Ingelheim will have the option to conduct further engineering, development and commercialization of the anti-TACA antibodies resulting from the collaboration. The agreement is for one TACA target, with the option for Boehringer Ingelheim to add a second. Siamab will be eligible to receive research funding and technical input, as well as potential milestone and royalty payments for each program.

“We are excited to partner with Boehringer Ingelheim, a global leader in oncology research and development, to leverage our proprietary technology platform to identify anti-TACA antibody therapeutics against new targets,” said Jeff Behrens, president and chief executive officer of Siamab Therapeutics. “This collaboration combines our expertise in the rapid discovery and characterization of highly specific, high affinity anti-TACA antibodies with Boehringer Ingelheim’s antibody drug discovery and development experience in novel cancer therapeutics. We look forward to working together to identify new anti-cancer therapeutics.”

“Boehringer Ingelheim’s collaboration with Siamab provides an opportunity to discover and develop new antibody therapeutics that target TACAs, which are emerging as an important new class to treat cancer and an area that we are actively exploring,” said Jonathon Sedgwick Ph.D., Vice President and Global Head, Cancer Immunology and Immune Modulation Research.

On October 4, 2017 Sierra Oncology, Inc. (SRRA), a clinical stage drug development company focused on advancing next generation DNA Damage Response (DDR) therapeutics for the treatment of patients with cancer, reported that it will host a Key Opinion Leader (KOL) luncheon on the topic of “Beyond PARP: The Clinical Potential of Next Generation DNA Damage Response Therapeutics” on Thursday, October 12th from 12:00-1:30pm at the Lotte New York Palace, Reid Salon, 455 Madison Ave, New York City (Press release, Sierra Oncology, OCT 4, 2017, View Source [SID1234520781]).

The meeting will feature presentations by three KOLs in DDR scientific and clinical development:

Leonard Post, PhD, Chief Scientific Officer of Vivace Therapeutics; former CSO of BioMarin Pharmaceutical, will discuss lessons learned from PARP inhibitor development, with a focus on optimizing drug properties;

Eric J. Brown, PhD, Associate Professor of Cancer Biology at the Perelman School of Medicine of the University of Pennsylvania, will discuss the ATR/Chk1 pathway and its biology, highlighting emerging views on the importance of replication stress;

Geoffrey I. Shapiro, MD, PhD, Associate Professor of Medicine at Harvard Medical School; Clinical Director at the Center for DNA Damage and Repair, and Director of the Early Drug Development Center at Dana-Farber Cancer Institute, will discuss translating emerging DDR science into the cancer clinic, emphasizing the importance of patient selection strategies.

In addition to the KOL presentations, Dr. Nick Glover, President and CEO of Sierra Oncology, will provide a brief overview on the company’s ongoing clinical development program for SRA737, a potent, highly selective, orally bioavailable small molecule inhibitor of the emerging DDR target, Chk1.

Following the presentation, the KOLs, along with members of Sierra’s Senior Management team, will be available to answer questions. If you would like to ask a question during the live Q&A, please submit your request via email at [email protected]

For those who are unable to attend in person, a live webcast and replay will be accessible here:

Webcast: www.sierraoncology.com

Direct link: View Source

About the Key Opinion Leaders

Leonard Post, PhD, is Chief Scientific Officer of Vivace Therapeutics and also serves as an advisor to numerous biotechnology companies and to venture investors. Until July 2016, he was Chief Scientific Officer of BioMarin Pharmaceutical, and before that was CSO and cofounder of LEAD Therapeutics which was acquired by BioMarin in 2010. His work in DNA repair involved the discovery of the PARP inhibitor talazoparib at LEAD and its development into Phase 3 at BioMarin. Talazoparib is currently being tested in EMBRACA, a Phase III clinical study in gBRCA+ locally advanced and/or metastatic breast cancer. From 2000-2006, he was Senior Vice President of Research and Development at Onyx Pharmaceuticals, during the clinical development of Nexavar from IND through NDA approval. Prior to Onyx, he was at Parke-Davis Pharmaceutical where he was VP of Discovery Research; and before that at The Upjohn Company in several positions. Dr. Post is currently a member of the board of directors of Viralytics Ltd., an Australian Stock Exchange-listed company; and of private companies Orphagen Pharmaceuticals, Fedora Pharmaceuticals and Oxyrane Ltd.

Eric J. Brown, PhD is an Associate Professor of Cancer Biology at the Perelman School of Medicine at the University of Pennsylvania. Dr. Brown’s laboratory examines how signaling maintains genome stability during DNA synthesis and how this function is essential to cancer cells. His laboratory was the first to report that oncogenic stress is sufficient to cause selective sensitivity to ATR inhibition. Dr. Brown’s laboratory is currently identifying predictive biomarkers of therapeutic benefit and the mechanisms of action of these drugs through a combination of genome-wide breakpoint mapping and replication fork proteomics. In collaboration with clinical researchers, these biomarkers of response will be exploited in current and future clinical trials. Collectively, the Brown laboratory seeks both to define the mechanisms of action of ATR/Chk1 inhibitors and to identify their optimal uses in cancer therapies. Dr. Brown received his PhD (Immunology) from Harvard University in 1996. He performed his doctoral research with Dr. Stuart Schreiber at Harvard University, where he purified and cloned the mammalian target of rapamycin (mTOR). In his postdoctoral research in Dr. David Baltimore’s laboratory at the California Institute of Technology, Dr. Brown investigated the impact of ATR suppression on genome stability and checkpoint signaling in response to replication stress.

Geoffrey I. Shapiro, MD, PhD is an Associate Professor of Medicine at Harvard Medical School and Director of the Early Drug Development Center at Dana-Farber Cancer Institute. Dr. Shapiro runs one of the largest Phase 1 clinical trials programs in the United States and dedicates his time to developing leading cancer treatments. He is also a member of Dana-Farber’s Thoracic Oncology Program and a member of the Dana-Farber/Harvard Cancer Center SPORE (Specialized Program of Research Excellence) in Lung Cancer. Dr. Shapiro conducts both basic and translational research on cyclin-dependent kinase inhibitors, with a focus on defining the role of these inhibitors in the cellular response to DNA damage. Dr. Shapiro received his PhD in 1987 and his MD in 1988 from Cornell University, followed by postgraduate training in internal medicine at Beth Israel Hospital, Boston. He completed a fellowship in medical oncology at Dana-Farber Cancer Institute, during which he investigated the role of cell-cycle-related proteins in lung cancer. He joined the Dana-Farber faculty in 1994.

On October 4, 2017 Celsion Corporation (NASDAQ:CLSN), an oncology development company, reported that it will host a Research and Development (R&D) Day for investors and analysts on Thursday, October 12, 2017 (Press release, Celsion, OCT 4, 2017, View Source [SID1234520777]). The event is scheduled to take place from 4:00 to 6:00 p.m. Eastern Time in New York City, and will be simultaneously streamed as a webcast.

The presentations will focus on the Company’s research and development programs and will feature leading experts in directed chemotherapies, DNA-based immunotherapies and immuno-oncology, including:

ThermoDox – Pivotal Phase III OPTIMA Study for Primary Liver Cancer

Won Young Tak, M.D., Ph.D., Professor Internal Medicine, GI & Hepatology Kyungpook National University Hospital Daegu, Republic of Korea
Stephen N. Wong, M.D., Principle Investigator OPTIMA, Chinese General Hospital, Philippines
Robert M. Eisele, M.D., Deputy Head of Department, Dept. of General, Visceral, Vascular and Pediatric Surgery, Medical Faculty of the University of Saarland, Homburg, Germany

GEN-1 Immunotherapy – A Powerful, Pro-Immune Modulator of Cancer’s Microenvironment

Premal H. Thaker, M.D., Associate Professor in Gynecologic Oncology, Washington University School of Medicine, St. Louis, Missouri
Richard C. Koya, MD, PhD, Associate Professor of Oncology and Immunology, Director of the Vector Development & Production Facility, Associate Director of the Center for Immunotherapy, Roswell Park Cancer Institute, Center for Immunotherapy, Buffalo, NY
A live webcast of the presentations will be available on Celsion’s website at View Source beginning at approximately 4:15 p.m. Eastern Time. To ensure a timely connection, users should register at least 15 minutes prior to the scheduled start. The webcast will be archived for replay following the event for 90 days.

About the OPTIMA Study

The Phase III OPTIMA Study is expected to enroll up to 550 patients in up to 70 clinical sites in the United States, Europe, China and Asia Pacific, and will evaluate ThermoDox in combination with optimized RFA, which will be standardized to a minimum of 45 minutes across all investigators and clinical sites for treating lesions three to seven centimeters, versus optimized RFA alone. The primary endpoint for the trial is Overall Survival, which is supported by post-hoc analysis of data from the Company’s 701 patient HEAT Study, where optimized RFA has demonstrated the potential to significantly improve survival when combined with ThermoDox. The statistical plan calls for two interim efficacy analyses by an independent Data Monitoring Committee.

About the OVATION Study

The Phase Ib trial was designed to evaluate weekly intraperitoneal dosing of GEN-1 in combination with neoadjuvant chemotherapy, the standard of care for patients newly diagnosed with ovarian cancer. Concurrently with neoadjuvant chemotherapy, enrolled patients will receive escalating weekly doses of GEN-1, from levels beginning at 36mg/m², to 47mg/m², 61mg/m² and 79mg/m² weekly for 8 treatments in total, with interval debulking surgery to follow. The regimen will primarily be evaluated for its safety and tolerability. GEN-1, designed using Celsion’s proprietary TheraPlas platform technology, is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system, which enables cell transfection followed by persistent, local secretion of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anti-cancer immunity acting through the induction of T-lymphocyte and natural killer (NK) cell proliferation.

On October 4, 2017 Bristol-Myers Squibb Company (NYSE:BMY), in collaboration with Blue Faery: The Adrienne Wilson Liver Cancer Association, a leading liver cancer patient advocacy organization, reported the findings from a new survey exploring the experiences of caregivers of people living with early or advanced stage liver cancer in the U.S. According to the caregivers surveyed, 90 percent wish there was more public awareness of the seriousness of a liver cancer diagnosis and 77 percent think liver cancer doesn’t get as much attention as other cancers.1 Bristol-Myers Squibb Company (NYSE:BMY), in collaboration with Blue Faery: The Adrienne Wilson Liver Cancer Association, a leading liver cancer patient advocacy organization, reported the findings from a new survey exploring the experiences of caregivers of people living with early or advanced stage liver cancer in the U.S. According to the caregivers surveyed, 90 percent wish there was more public awareness of the seriousness of a liver cancer diagnosis and 77 percent think liver cancer doesn’t get as much attention as other cancers.1 (Press release, Bristol-Myers Squibb, OCT 4, 2017, View Source [SID1234520776])

This is despite the fact that the incidence of liver cancer in the U.S. has more than tripled since 1980, and hepatocellular carcinoma (HCC) – the most common type of liver cancer – is the fastest-growing cause of cancer death in the U.S.2,3,4

Prior to diagnosis, many caregivers (43%) of patients with advanced stage disease did not think their loved one was at risk for liver cancer, and nearly half (47%) said they were aware of liver cancer but not very knowledgeable.1 In fact, before their loved one was diagnosed, nearly three-quarters of these caregivers (72%) thought that heavy alcohol use was the most common risk factor for liver cancer.1 However, the reality is that chronic infection with Hepatitis B virus (HBV) or Hepatitis C virus (HCV) is the most common risk factor for liver cancer.4,5

“Before my sister was diagnosed with HCC, I thought the only cause of liver cancer was alcoholism,” said Andrea Wilson, President and Founder, Blue Faery: The Adrienne Wilson Liver Cancer Association. The Liver Cancer Outlook survey found that this is common among liver cancer caregivers, with only one in five (20%) of those surveyed being familiar with risk factors or the signs and symptoms of liver cancer.1 “These survey results reinforce the need to decrease the stigma surrounding the disease and to increase awareness, research efforts and resources available to patients and their caregivers.”

The survey of 90 U.S. caregivers of people living with early stage (n=30) and advanced stage (n=60)1 liver cancer identified a number of insights into the caregiver experience, including:

Limited familiarity with the disease : Few caregivers said they were familiar with risk factors (17%) or the signs and symptoms of the disease (12%), prior to their loved one’s diagnosis.1
Lack of information about treatment options and/or areas of research: More than half of caregivers of people with advanced stage liver cancer surveyed (58%) admit it’s hard to understand what treatment options are available to their loved one. Nearly all (95%) of these caregivers believe more information needs to be available about different types of liver cancer treatment options and/or areas of research, and eight in ten (82%) wish they knew where to go for this information.1
The impact of stigma: Half of the caregivers (56%) agree there is a stigma (i.e., shame) associated with liver cancer and that these negative perceptions about liver cancer make it difficult to find support (60%).1
To address the needs these caregivers identified in the survey and in recognition of Liver Cancer Awareness Month (October), Bristol-Myers Squibb and Blue Faery have launched LiverCancerOutlook.com, a dedicated website offering information about liver cancer and providing links to additional resources for patients and caregivers.

“As a leader in oncology, Bristol-Myers Squibb strives every day to understand and address the unmet needs of patients and their caregivers, including those within the liver cancer community,” said Awny Farajallah, M.D., Vice President, Head of U.S. Medical Oncology, Bristol-Myers Squibb. “The Liver Cancer Outlook survey results underscore the importance of better educating patients and caregivers, and we are proud to collaborate with Blue Faery to help provide much-needed information and hope to those who are living with the daily challenges of the disease.”

In 2017, it is estimated there will be approximately 41,000 new diagnoses of liver and intrahepatic bile duct cancers in the U.S. and an estimated 29,000 people will die from the disease.2 HCC is the most common type of primary liver cancer, cancer that starts in the liver.6 In addition to HBV and HCV infections, gender, race and ethnicity, cirrhosis, obesity, type 2 diabetes, certain genetic syndromes and non-alcoholic steatohepatitis (NASH) are common risk factors.5,7 HCC in adults is often diagnosed in later stages.8,9 A patient’s prognosis depends on factors such as the stage of the cancer (i.e., tumor size, how much of the liver is affected, whether the cancer has spread), how well the liver is working and the patient’s general health.10

The survey uncovered important insights into the attitude and mindset of caregivers. The survey showed that caregiver outlook for their loved one’s future is dependent on the stage of the disease.1 In fact, caregivers of advanced stage liver cancer patients are significantly more likely than those caring for early stage patients to report negative feelings (93% vs. 60%) such as helpless (50% vs. 17%), sad (50% vs. 7%), frustrated (40% vs. 13%), and angry (23% vs. 3%).1

A majority of these caregivers of advanced stage patients acknowledge that a lot of progress is being made in liver cancer research (63%) and that they would feel hopeful about additional treatment options becoming available (58%).1

Research efforts are ongoing, and in the past year additional options have become available for patients with advanced liver cancer. Nearly all caregivers of advanced stage patients (97%) wish they knew about the latest developments in liver cancer treatment or areas of research.1 The most commonly reported treatment option/area of research that these caregivers are interested in learning more about is Immuno-Oncology (93%), followed by targeted therapy (88%), tumor embolization (85%), tumor ablation (83%), liver cancer surgery (83%), chemotherapy (83%), and radiation therapy (78%).1

About Liver Cancer Outlook

The Liver Cancer Outlook survey was conducted online by Bryter on behalf of Bristol-Myers Squibb between July 24 and August 31, 2017 in the U.S., of 90 caregivers of people living with early stage (n=30) and advanced stage (n=60) liver cancer. Only caregivers of patients with active disease were included in the survey. Upon completion of the survey, the data has been tabulated and significance tested at the 95% confidence interval.1 Bryter abides by the rules and guidelines of the Market Research Society. A full methodology is available upon request.