Ligand Enters Into OmniAb® Platform License Agreement with Tizona Therapeutics

On February 2, 2016 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported it has entered into a worldwide license agreement with Tizona Therapeutics, Inc., an immunology company developing next generation therapies for cancer and autoimmune disease(Press release, Ligand, FEB 2, 2016, View Source [SID:1234508944]). Under the license, Tizona will use the OmniRat, OmniMouse and OmniFlic platforms to generate fully human mono- and bispecific antibodies. Ligand will be eligible to receive annual platform access payments as well as patent filing fees, clinical milestone payments and royalties for each successful OmniAb antibody. Tizona will be responsible for all costs related to the program.

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"We have now added Tizona as a new partner as they expand their immuno-oncology and inflammation drug discovery efforts," said John Higgins, Chief Executive Officer of Ligand Pharmaceuticals. "This is the second licensing deal struck by Ligand on OmniAb and the 18th commercial partner overall, which represents a strong continued momentum for the technology. We believe the OmniAb platform has great potential to enable the discovery and development of novel medicines to meet major medical needs."

About OmniAb

OmniAb includes three transgenic animal platforms for producing mono- and bispecific human therapeutic antibodies. OmniRat is the industry’s first human monoclonal antibody technology based on rats. It has a complete immune system with a diverse antibody repertoire and generates antibodies with human idiotypes as effectively as wild-type animals make rat antibodies. OmniMouse is a transgenic mouse that complements OmniRat and expands epitope coverage. OmniFlic is an engineered rat with a fixed light chain for development of bispecific, fully human antibodies. The three platforms use patented technology, have broad freedom to operate and deliver fully human antibodies with high affinity, specificity, expression, solubility and stability.

Myriad Genetics Reports Fiscal Second-Quarter 2016 Financial Results

On February 02, 2016 Myriad Genetics, Inc. (NASDAQ:MYGN) reported financial results for its fiscal second-quarter 2016, provided an update on recent business highlights, maintained its fiscal year 2016 revenue guidance, raised its fiscal year 2016 earnings guidance and provided fiscal third-quarter 2016 financial guidance (Press release, Myriad Genetics, FEB 2, 2016, View Source [SID:1234508950]).

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"We are pleased with the first half of fiscal year 2016 which has positioned us to deliver upon our financial guidance for the full year," said Mark C. Capone, president and chief executive officer of Myriad. "Our new products are making significant strides towards broader market adoption and reimbursement on a worldwide basis. Additionally, we are excited to announce that our companion diagnostic portfolio has expanded to five tests with the addition of two new tests that have been incorporated into additional pharmaceutical company collaborations. We remain on track to achieve our five-year strategic goals and build Myriad into a diversified, global, leader in personalized medicine."

Business Highlights

myRisk Hereditary Cancer
Myriad presented an interim analysis of a large clinical utility study comparing myRisk Hereditary Cancer to BRACAnalysis at the San Antonio Breast Cancer Symposium (SABCS). In the interim analysis, myRisk Hereditary Cancer increased the number of patients receiving clinically appropriate risk reduction measures by 61 percent.
The Company announced today that 61 percent of its hereditary cancer revenue is now under three-year, non-cancellable, payer contracts.

Vectra DA
Vectra DA volumes were up 13 percent year-over-year in the fiscal second-quarter with more than 38,000 tests performed.
At the American College of Rheumatology Annual Meeting, Myriad presented multiple studies on the potential ability of Vectra DA to predict therapy response. One study demonstrated that Vectra DA predicts response for methotrexate incomplete responders to DMARDs or biologics. In another study, Vectra DA predicted which patients could taper their therapy without experiencing flares.
During the second quarter, Myriad announced the issuance of the first patent pertaining to the Vectra DA testing process by the U.S. Patent and Trademark Office.

Prolaris/Urology
Prolaris sample volume was up 104 percent year-over-year and 26 percent sequentially with over 3,500 tests ordered.
At the 2016 ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium (ASCO GU), Myriad presented data on more than 11,000 men with prostate cancer to evaluate their ability to pursue active surveillance based upon the Prolaris Combined Score (PCS); 63 percent of the men qualified for active surveillance based on their PCS, almost doubling the number of eligible patients when compared to traditional pathology.
Myriad also presented its first validation study on the myPlan Renal Cancer prognostic test at ASCO (Free ASCO Whitepaper) GU. When the myPlan score was combined with pathological stage to provide a combined prognostic score (CPS), patients with a high CPS had a three-fold increased risk of recurrence compared to patients with a low score.

Companion Diagnostics
At SABCS, Myriad presented multiple studies demonstrating the ability of the myChoice HRD test to predict response to DNA damaging agents. In a pooled analysis of five statistically significant studies, patients with a positive myChoice HRD score had a three-fold increase in pathological complete response when compared to those patients with a negative score.
Today, Myriad is announcing the addition of two new companion diagnostics. The first is a tumor sequencing panel that contains the full sequencing of 80 clinically actionable genes and is customizable for our pharmaceutical partners to support clinical trials. The second new companion diagnostic is a proprietary assay that evaluates the functionality of the immune pathway and predicts response to immunotherapy. The Company already has signed undisclosed research collaborations with major pharmaceutical partners on each of these new products to be evaluated in combination with myChoice HRD.

International
International revenues were up 29 percent sequentially in the second quarter and accounted for four and a half percent of total revenue in the quarter.
At SABCS, Myriad presented a study that evaluated 928 patients in the TransATAC cohort that compared the performance of EndoPredict to the widely-used first generation breast cancer prognostic test. In this study, EndoPredict more accurately predicted 10-year distant metastases when compared to the first-generation prognostic test.
During the fiscal second-quarter, Myriad won a competitive tender for EndoPredict in France that is expected to generate revenue during calendar year 2016. Additionally, Helsana, the largest insurance provider in Switzerland, announced a favorable coverage decision for Prolaris.

Share Repurchase
During the quarter, the Company repurchased approximately 0.6 million shares, or $25 million, of common stock under our share repurchase program and ended the quarter with approximately $92 million remaining on our current share repurchase authorization.

Fiscal Third-Quarter and Fiscal Full-Year 2016 Financial Guidance

The Company is maintaining its fiscal full-year revenue guidance of $750 to $770 million and raising its adjusted earnings per share guidance from the previous range of $1.60 to $1.65 to $1.63 to $1.68. Additionally, Myriad is issuing fiscal third-quarter 2016 financial guidance with revenues of $183 to $185 million and adjusted earnings per share of $0.37 to $0.39.

These projections are forward-looking statements and are subject to the risks summarized in the safe harbor statement at the end of this press release. The Company will provide further details on its business outlook during its conference call today to discuss the fiscal second-quarter financial results and fiscal third-quarter and fiscal full-year 2016 financial guidance.

ImmuNext’s anti-VISTA Antibody Enters the Clinic for Cancer

ImmuNext reported that the first patient has been dosed in a Phase 1 clinical trial of the anti-VISTA antibody, JNJ-61610588 (Press release, ImmuNext, FEB 2, 2016, http://immunext.com/news.php [SID:1234511069]). JNJ-61610588 is the first anti-VISTA antibody to enter the clinic.
The compound is a monoclonal antibody designed for the treatment of cancer, and was developed as part of the license and collaboration agreement with Janssen Biotech, Inc. Janssen Research & Development is running the study.
The Phase I trial will enroll patients with advanced solid tumors. The initial portion of the study is designed to evaluate safety, pharmacokinetics, and pharmacodynamics of ascending doses of JNJ-61610588.
Additional information may be found at clinicaltrials.gov, using identifier NCT02671955.

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Navidea Provides Update on Lymphoseek® and Immunodiagnostics Development Pipeline

On February 2, 2016 Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB), reported an update on its commercial and clinical development efforts with respect to its Lymphoseek (technetium Tc 99m tilmanocept) injection, the first and only FDA-approved receptor-targeted lymphatic mapping agent, and the Manocept immunodiagnostic development pipeline (Press release, Navidea Biopharmaceuticals, FEB 2, 2016, View Source;p=RssLanding&cat=news&id=2135015 [SID:1234508951]).

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2015 Commercial Highlights

In 2015, the Company created and executed a new commercialization strategy for Lymphoseek to better leverage the label expansion approved by the FDA in October 2014 and, over time, accelerate its market penetration. This included a complete refresh of the brand, moving away from a feature-based selling approach to a customer-centric one focused on the benefits to the surgeon and patient.

In concert with the rebranding efforts, the Company also recruited, hired and trained a new salesforce in the latter part of the second quarter of 2015. The new direct sales team focused on targeting the highest priority territories. The Company anticipated the sales team’s contributions would be most significant starting the fourth quarter of 2015 and onward based on the four- to six-month sales cycle of Lymphoseek.

The initial launch of the new commercialization strategy resulted in the following during 2015:

Grew sales by 141% year over year, based on preliminary unaudited Lymphoseek sales to Navidea of $10.2 million for 2015 representing total brand revenue of approximately $20 million;

Ended the year at an annualized sales run rate for Lymphoseek of over $15 million in revenue to Navidea, which does not reflect the opportunity for additional growth in existing and expansion sales territories throughout 2016;

Achieved an increase of 55% in "average daily doses sold" from the end of 2014 through the end of 2015;

Increased penetration into large accounts – nearly tripling the number of accounts that averaged more than 20 doses per month in 2015 versus 2014; and,

Expanded the network of cancer centers and hospitals that use or plan to use Lymphoseek which now includes 17 of the top 20 US Best Hospitals for Adult Cancer as reported by the most recent U.S. News and World Report.

Rick Gonzalez, President and Chief Executive Officer, said, "We enter 2016 with positive momentum behind our new commercialization strategy. We expect our sales team’s strong contributions to continue to accelerate product revenues throughout the year. In addition, European sales revenues are expected to be generated from commercialization efforts to begin in the fourth quarter. In parallel, our R&D team is aggressively advancing our immunodiagnostics pipeline focused on significantly larger market opportunities including Rheumatoid Arthritis (RA), which has a prevalence of approximately 3.8 million patients in the U.S. and Europe. We will share additional details on our plans for 2016, including an update on Macrophage Therapeutics and the sale of NAV4694, during our upcoming year-end earnings conference call."

Clinical Development Update

The Company continues to work toward a more focused development program using its Manocept platform in immunodiagnostics, including the FDA label expansion for Lymphoseek (Tc99m tilmanocept) into RA and Kaposi’s sarcoma (KS). Importantly, the costs of these development programs will be defrayed by NIH grants awarded to the Company in 2015 totaling over $3.8 million.

In the next 90 days, the Company intends to:

Advance Lymphoseek Label Expansion into RA:

Meet with the FDA before the end of March 2016 to share preclinical results on the intravenous route of administration (IVROA) and discuss and agree on the Phase 1 and 2 clinical plan for our Rheumatoid Arthritis (RA) immunodiagnostic program. This is a follow-up meeting to the one that took place in May 2015, where the Company and the FDA confirmed requirements for a preclinical submission package for the use of Lymphoseek in IVROA; and,

Finalize preparations to initiate a Phase 1 pilot trial evaluating subcutaneous injection of Tc99m tilmanocept in active RA subjects in the first half of 2016. During the second half of 2016, the Company intends on initiating a subsequent Phase 1/2 registrational trial of IV-administered Tc99m tilmanocept for the RA immunodiagnostic application.

Support the existing Lymphoseek label in Lymphatic Mapping:
Expand patient enrollment in the FDA/EMA mandated pediatric trial for children with melanoma, rhabdomyosarcoma, or other solid tumors who are undergoing lymph node mapping and who meet special criteria for pediatric sentinel node biopsy. Since the first patient was dosed in December 2015, two new sites have been added including Cincinnati Children’s Hospital Medical Center;

Enroll first patient at the MD Anderson Cancer Center in the Company’s multi–center cervical cancer study;

Initiate patient enrollment in the Investigator Initiated Study (IIS) endometrial cancer study directed by Dr. Michael McHale at UC San Diego Health System; and,

Expand patient enrollment in the cardiovascular immunodiagnostic study, an IIS study in collaboration with Massachusetts General Hospital. Based on encouraging findings in the first patients dosed, we are very excited by the potential and are seeking to accelerate and expand this funded program using a protocol for IVROA.

About Lymphoseek
Lymphoseek (technetium Tc 99m tilmanocept) injection is the first and only FDA-approved receptor-targeted lymphatic mapping agent. It is a novel, receptor-targeted, small-molecule radiopharmaceutical used in the evaluation of lymphatic basins that may have cancer involvement in patients. Lymphoseek is designed for the precise identification of lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer. Lymphoseek is approved by the U.S. Food and Drug Administration (FDA) for use in solid tumor cancers where lymphatic mapping is a component of surgical management and for guiding sentinel lymph node biopsy in patients with clinically node negative breast cancer, melanoma or squamous cell carcinoma of the oral cavity. Lymphoseek has also received European approval in imaging and intraoperative detection of sentinel lymph nodes in patients with melanoma, breast cancer or localized squamous cell carcinoma of the oral cavity.

Accurate diagnostic evaluation of cancer is critical, as results guide therapy decisions and determine patient prognosis and risk of recurrence. Overall in the U.S., solid tumor cancers may represent up to 1.2 million cases per year. The sentinel node label in the U.S. and Europe may address approximately 600,000 new cases of breast cancer, 160,000 new cases of melanoma and 100,000 new cases of head and neck/oral cancer diagnosed annually.

Lymphoseek Indication and Important Safety Information
Lymphoseek is a radioactive diagnostic agent indicated with or without scintigraphic imaging for:

Lymphatic mapping using a handheld gamma counter to locate lymph nodes draining a primary tumor site in patients with solid tumors for which this procedure is a component of intraoperative management.

Guiding sentinel lymph node biopsy using a handheld gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma.

Important Safety Information
In clinical trials with Lymphoseek, no serious hypersensitivity reactions were reported, however Lymphoseek may pose a risk of such reactions due to its chemical similarity to dextran. Serious hypersensitivity reactions have been associated with dextran and modified forms of dextran (such as iron dextran drugs).
Prior to the administration of Lymphoseek, patients should be asked about previous hypersensitivity reactions to drugs, in particular dextran and modified forms of dextran. Resuscitation equipment and trained personnel should be available at the time of Lymphoseek administration, and patients observed for signs or symptoms of hypersensitivity following injection.
Any radiation-emitting product may increase the risk for cancer. Adhere to dose recommendations and ensure safe handling to minimize the risk for excessive radiation exposure to patients or health care workers. In clinical trials, no patients experienced serious adverse reactions and the most common adverse reactions were injection site irritation and/or pain (<1%).

FULL LYMPHOSEEK PRESCRIBING INFORMATION CAN BE FOUND AT:
WWW.LYMPHOSEEK.COM

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.