Teva and AbCellera Enter Into Agreement to Discover Rare Monoclonal Antibodies

Feb. 2, 2016– Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) and AbCellera have entered into a collaborative research agreement whereby AbCellera will apply its high-throughput single cell antibody platform for the discovery of rare monoclonal antibodies (Press release, Teva, FEB 2, 2016, View Source;p=RssLanding&cat=news&id=2134715 [SID:1234508952]).

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"We are pleased to work with AbCellera utilizing this company’s novel biologics technology," said Michael Hayden, MD, PhD, President of Global R&D and Chief Scientific Officer at Teva. "This agreement will be complementary to our existing antibody discovery process with the potential to strengthen Teva’s capabilities in novel biologics discovery."

Under the terms of the agreement, AbCellera will receive an upfront payment, research payments, and is eligible to receive undisclosed downstream milestones associated with the development and approval of therapeutic antibodies.
"These are tough problems that need new technologies to move them forward. Our platform brings important advantages to enable the discovery of rare antibodies with defined specificity and functional activity against difficult membrane protein targets," said Dr. Carl Hansen, President and CEO of AbCellera. "We look forward to a close collaboration with the team of scientists at Teva, and are excited at the chance to help advance this important program."

Bristol-Myers Squibb Foundation Awards Eight Grants Totaling Nearly $11.5M to Make Lung and Skin Cancer Screening, Care More Accessible in High-Risk U.S. Communities

On February 1, 2016, Bristol-Myers Squibb Foundation reported eight grants totaling nearly $11.5 million that will help make lung and skin cancer screening programs, care and patient support more accessible to underserved populations (Press release, Bristol-Myers Squibb, FEB 1, 2016, View Source [SID:1234508926]). The goal is to develop, validate and sustain models that deliver equitable and optimal outcomes.

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The grants were awarded through the Foundation’s Bridging Cancer Care and Specialty Care for Vulnerable Populations initiatives. Bridging Cancer Care focuses on pilot projects in select southeastern U.S. states with the highest lung cancer burden to advance evidence-based strategies to improve lung cancer screening and assist patients diagnosed with lung cancer access and navigate cancer care and community-based supportive services. Specialty Care for Vulnerable Populations supports care collaborations among primary care and specialty care providers and patient engagement and social support in order to improve the quality of specialty care services for underserved populations living with lung cancer, skin cancer or HIV.

Lung cancer is the leading cause of cancer death in the U.S., with a mortality rate higher than any other cancer, primarily because the cancer is not detected or treated at an early stage.

"Obstacles to screening, especially for minority and underserved populations, often result in patients receiving a late-stage diagnosis, which dramatically reduces their chances for survival," says John Damonti, president, Bristol-Myers Squibb Foundation. "We are pleased to engage our partners to develop innovative programs that will improve the health outcomes of underserved patient populations facing lung cancer, to help prevent skin cancer among migrant worker populations and to advocate for system-wide change to remove barriers to specialty care."

The Association of Community Cancer Centers (ACCC) received a three-year, $4.1 million grant to develop a collaborative approach to improving lung cancer care for Medicaid patients. ACCC will develop and validate an Optimal Care Coordination Model and engage ACCC’s member cancer programs and practices which includes more than 20,000 multidisciplinary providers, community health centers, patient advocacy organizations, health system leadership, payers and policymakers, to strengthen and complete lung cancer systems of care and improve outcomes for Medicaid patients.

"Lung cancer is the deadliest cancer facing our nation today, and tackling this disease requires a fully integrated approach that treats the full patient," says Steven L. D’Amato, BSPharm, BCOP, president, ACCC. "With this collaboration, ACCC looks forward to bringing our unmatched expertise in multidisciplinary cancer care to improve cancer coordination across the country so that vulnerable populations living with lung cancer have access to the treatment they need."

Anne Arundel Medical Center received a three-year, $1.25 million grant to replicate and expand the medical center’s successful Rapid Access Chest and Lung Assessment Program, which reduced the time from lung cancer screening to diagnosis from as much as four months for outpatients to an average of 16 days by quickly identifying, engaging and managing patients through an increased centralization of care and a thoracic nurse navigator. The program will focus on low-income and racial minority patients who are at risk for or diagnosed with lung cancer in Maryland’s Anne Arundel, Calvert and Prince George counties.

"While Anne Arundel Medical Center’s DeCesaris Cancer Institute’s lung screening and thoracic oncology programs have continued to expand over the past five years, our successes have been more limited among vulnerable, lower-income and minority populations," says Stephen Cattaneo, MD, medical director of Thoracic Oncology at Anne Arundel Medical Center. "The grant from the Bristol-Myers Squibb Foundation will allow us the opportunity to better reach and inform these at-risk patients in our area and surrounding Maryland counties about the need for lung cancer screening while providing desperately needed education and resources for smoking cessation."

The American Cancer Society received a three-year, $1.25 million grant to partner with three federally qualified heath centers (FQHCs) – Valley Health in Huntington, West Virginia; Christ Community Health Services in Memphis, Tennessee; and a third to be identified – to introduce patient education and clinic-based navigation services to support patients from lung cancer screening through diagnosis.

Screening for lung cancer in high-risk current or former smokers is one of the most important emerging cancer control opportunities. The FQHCs will work with primary and specialty care providers to ensure they are prepared to assess patient risk for lung cancer, support a shared decision about screening and provide referrals for those with a positive screening result.

"Implementing lung cancer screening demands an integrated system involving primary care, radiology, pulmonary physicians, screening facilities, as well as a cancer treatment team," says Richard Wender, MD, chief cancer control officer for the Society. "This new grant will allow Society staff to work with the FQHCs to learn how to build capacity to provide high-quality lung cancer screening for low-income communities."

The Patient Advocate Foundation received a three-year, $1.36 million grant for a program linking West Virginia’s lung cancer patients to case management support, which responds to a decision for the Centers for Medicaid and Medicare Services to provide coverage for annual low-dose CT lung cancer screening for at-risk patients. The project will identify barriers to care for vulnerable populations and develop strategies to link patients to providers, increase community awareness of lung cancer screening and make available the Lung Cancer CareLine, a system that provides hands-on comprehensive navigation of the health care system to increase access to emerging therapies and treatment.

The Ralph Lauren Center for Cancer Care and Prevention (RLC), in partnership with Memorial Sloan Kettering Cancer Center, received a two-year, $604,582 grant to pilot a lung cancer screening and continuum of care access program for patients in underserved and high-risk populations in the Harlem and northern Manhattan sections of New York City.

RLC will use new approaches, including community outreach and patient incentives, to encourage more people to get screened for lung cancer. Outreach workers and care navigators from RLC will partner with community-based organizations, houses of worship and primary health care centers to educate people about the importance of lung cancer screening and navigate them through care. Memorial Sloan Kettering will also help to identify high-risk patients through smoking cessation programs as well as assist with access to treatment and care.

"The Ralph Lauren Center for Cancer Care and Prevention has a strong history of pioneering new models, including a groundbreaking patient navigation program in East Harlem," says Gina Villani, MD, MPH, chief executive officer, RLC. "The patients we serve face numerous obstacles to medical screening and care, and often feel disenfranchised by the medical community. Our community-based and community-focused approach will engage those patients to be screened and, if needed, treated for lung cancer."

Farmworker Justice received a two-year, $750,000 grant to engage a diverse range of stakeholders to develop a demonstration project in California and Florida to promote community integration of skin cancer services and reduce the impact of skin cancer among farmworkers and their families. Although farmworkers in the U.S. are exposed to living and working conditions that double their risk of developing melanoma and other skin cancers, access to skin cancer prevention, screening and specialty care and services are difficult to obtain.

"In addition to providing access to skin cancer detection services, resulting in earlier detection of skin cancer and appropriate skin cancer treatment, this project will develop and share effective approaches and strategies to address the particular needs and wishes of farmworker communities and increase the ability to inform and influence national private and public sector decision-makers to better respond to this important public health issue," says Bruce Goldstein, president, Farmworker Justice.

In addition, two program support grants totaling nearly $2 million were awarded to FSG and The Center for Health Law and Policy Innovation at Harvard Law School to help translate successful models emerging from Specialty Care for Vulnerable Populations and Bridging Cancer Care into sustainable cancer and specialty care services through alternative funding, payment reform and institutional and public policy change.

MabVax Therapeutics Receives FDA Authorization for Phase I Clinical Trial with 89Zr-HuMab-5B1 as PET Imaging Agent for Pancreatic Cancer

On February 1, 2016 MabVax Therapeutics Holdings, Inc. (OTCQB: MBVX), a clinical-stage oncology drug-development company, reported receipt of notice from the U.S. Food and Drug Administration (FDA) authorizing initiation of a Phase I clinical trial with 89Zr-HuMab-5B1 as a new generation PET scan cancer imaging agent in patients with pancreatic cancer (Press release, MabVax, FEB 1, 2016, View Source [SID:1234508927]). The Company filed an Investigational New Drug (IND) application for this trial with the FDA on December 29, 2015. MabVax previously announced receipt of FDA authorization for a Phase I trial with HuMab-5B1 as a therapeutic treatment for patients with pancreatic cancer, and patient enrollment in both Phase I trials is expected to commence in the first quarter of 2016.

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The Phase I clinical trial with 89Zr-HuMab-5B1 is designed to enroll up to 28 patients previously diagnosed with pancreatic cancer, who will be administered 89Zr-HuMab-5B1. Patients will return for additional visits on days 2, 4 and 7 for imaging and safety assessments. The trial will evaluate the safety, pharmacokinetics and biodistribution of 89Zr-HuMab-5B1, as well as determine the ideal dose and conditions for an optimal PET scan image. MabVax expects to report the initial set of images from this trial by mid-year 2016 and anticipates that patient enrollment will be completed before the end of 2016.

The 89Zr-HuMab-5B1 imaging agent is MabVax’s HuMab-5B1 fully human antibody conjugated to a radioactive label. It is being developed to take advantage of the antibody’s ability to target pancreatic cancer cells and attach to pancreatic tumors to improve their detection. 89Zr-HuMab-5B1 has demonstrated high-resolution images of tumors in xenograft animal models and results of advanced preclinical study were published in the peer-reviewed Journal of Nuclear Medicine on September 12, 2013. Additionally, MabVax has received $1.75 million from the National Institutes of Health (NIH) for the development of 89Zr-HuMab-5B1 as an imaging agent for pancreatic cancer. 89Zr-HuMab-5B1 also has the potential as a companion diagnostic for MabVax’s HuMab-5B1 therapeutic product.

"Our HuMab-5B1 products represent a novel approach to harnessing the immune system to diagnose and treat cancer, and we are delighted with the FDA’s expeditious response to our IND filings," said David Hansen, MabVax’s President and Chief Executive Officer. "We expect to report interim data from both Phase I trials by the middle of this year, which could have a positive impact on our future commercial and corporate development activities. We also plan to pursue additional programs with HuMab-5B1 as well as follow-on antibodies under development at MabVax that have the potential for dual-product applications for additional types of cancer."

About HuMab-5B1

MabVax’s antibody is fully human and was discovered from the immune response of cancer patients vaccinated with an antigen-specific vaccine during a Phase I trial at Memorial Sloan Kettering Cancer Center. In preclinical research, the HuMab-5B1 antibody has demonstrated high specificity and affinity, and has shown potent cancer cell killing capacity and efficacy in animal models of pancreatic, colon and small cell lung cancers. The antigen the antibody targets is expressed on more than 90% of pancreatic cancers making the antibody potentially broadly applicable to most patients suffering from this type of cancer.

CEL-SCI REPORTS MONTHLY PATIENT ENROLLMENT IN JANUARY FOR ITS PHASE 3 HEAD AND NECK CANCER TRIAL

On February 1, 2016 CEL-SCI Corporation (NYSE MKT: CVM) ("CEL SCI" or the "Company") reported that during the month of January it has enrolled 29 patients in its ongoing Phase 3 trial of its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection) in patients with advanced primary head and neck cancer (Press release, Cel-Sci, FEB 1, 2016, View Source [SID:1234508929]). Total patient enrollment for the trial is now 697 as of January 31, 2016 in the world’s largest Phase 3 study in head and neck cancer.

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"Enrollment this month was impacted by the Christmas and Orthodox Christmas holidays. We expect enrollment to increase again in the coming months," stated CEL-SCI CEO Geert Kersten.

The current study goal is to enroll 880 patients through approximately 100 clinical centers in over 20 countries.

About the Multikine Phase 3 Study

The Multikine Phase 3 study is enrolling patients with advanced primary squamous cell carcinoma of the head and neck. The objective of the study is to demonstrate a statistically significant improvement in the overall survival of enrolled patients who are treated with the Multikine treatment regimen plus standard of care ("SOC") vs. subjects who are treated with SOC only.

About Multikine

Multikine (Leukocyte Interleukin, Injection) is an investigational immunotherapeutic agent that is being tested in an open-label, randomized, controlled, global pivotal Phase 3 clinical trial as a potential first-line treatment for advanced primary squamous cell carcinoma of the head and neck. Multikine is designed to be a different type of therapy in the fight against cancer: one that is given BEFORE surgery, radiation and chemotherapy because that is when the immune system is thought to be the strongest, one that appears to have the potential to work with the body’s natural immune system in the fight against tumors.

Multikine is also being tested in a Phase 1 study under a Cooperative Research and Development Agreement ("CRADA") with the U.S. Naval Medical Center, San Diego, and at University of California, San Francisco (UCSF), as a potential treatment for peri-anal warts in HIV/HPV co-infected men and women. Dr. Joel Palefsky, a world-renowned scientist and Key Opinion Leader (KOL) in human papilloma virus (HPV) research and the prevention of anal cancer, is the Principal Investigator at UCSF, which was added to the study in July 2015.

CEL-SCI has also entered into two additional co-development agreements for up to $3 million each with Ergomed Clinical Research Limited to further the development of Multikine for cervical dysplasia/neoplasia in women who are co-infected with HIV and HPV and for peri-anal warts in men and women who are co-infected with HIV and HPV.

Dana-Farber Cancer Institute’s Belfer Center announces Immuno-Oncology research collaboration with Array BioPharma

On February 1, 2016 Dana-Farber Cancer Institute reported an immuno-oncology collaboration with potential applicability in a wide range of oncology indications with Array BioPharma (NASDAQ: ARRY)(Press release, Array BioPharma, FEB 1, 2016, View Source;p=RssLanding&cat=news&id=2134177 [SID:1234508930]).

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The research team at Dana-Farber’s Robert and Renée Belfer Center for Applied Cancer Science will work with Array scientists on novel immune-oncology targets with the goal of bringing innovative medicines to patients. The collaboration will leverage the Belfer Center’s proprietary immuno-oncology platform. Combining Dana Farber’s oncology expertise with the Array’s proficiency in drug discovery provides a unique opportunity to accelerate drug discovery of effective medicines for patients with unmet medical need.

"We are very enthusiastic about working with Array to develop novel immune-oncology drugs because their team has a strong track record of drug discovery success yielding innovative cancer therapies. Together we have the potential to deliver novel molecules that target unique mechanisms to harness the immune system and result in durable efficacy," said Kwok-Kin Wong, MD, PhD, scientific co-director of the Belfer Center for Applied Cancer Science and Dana-Farber Cancer Institute, and professor of medicine at Harvard Medical School.

"We are excited to partner with the Dana-Farber scientists at the Belfer Center. Their capabilities perfectly synergize with the capabilities and drug discovery track record of Array. Specifically, their expertise in target validation, pre-clinical models of immunotherapeutic activity and translational medicine will greatly enable Array’s ability to deliver innovative therapeutics in this area," said Nick Saccomano, PhD, chief scientific officer, Array BioPharma.

Financial terms of the agreement are not being disclosed.