John Theurer Cancer Center/RCCA collaborate with GTC to internalize proprietary NGS DNA and RNA testing

On May 27, 2020 John Theurer Cancer Center (JTCC), at Hackensack Meridian Health Hackensack University Medical Center in New Jersey, and Genomic Testing Cooperative (GTC), Irvine, CA, reported an agreement to establish a state-of-the-art, next generation sequencing (NGS) laboratory for molecular profiling (Press release, Genomic Testing Cooperative, MAY 27, 2020, View Source [SID1234558537]). This NGS laboratory, located at John Theurer Cancer Center, will serve all physicians within Regional Cancer Care Associates (RCCA), a network of cancer care professionals in New Jersey, Connecticut, and Maryland.

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As a leading cancer institute and a member of the NCI-approved Georgetown Lombardi Comprehensive Cancer Center Consortium, John Theurer Cancer Center will perform molecular profiling of all cancers in its patients with solid tumors or blood cancers. The results of such profiling will facilitate precision medicine: matching patients with therapies that target the molecular abnormalities driving the growth of their cancers. Furthermore, this molecular profiling will drive the expansion of the cancer center’s innovation and dedication to advancing the science of oncology practice in the community.

The John Theurer Cancer Center NGS laboratory will adapt highly validated tests developed by GTC for DNA and RNA profiling. Paired DNA and RNA profiling is increasingly employed in genomics research to uncover molecular mechanisms underlying the development and progression of disease and to explore personal genotype and phenotype correlations.

"Collaborations such as these demonstrate the commitment of the Hackensack Meridian Health system to improving the care of people with cancer, one of the country’s most common illnesses and a leading cause of death in the United States," noted Robert C. Garrett, FACHE, chief executive officer, Hackensack Meridian Health. "Technologies such as NGS with DNA and RNA profiling put us at the forefront of cancer care and research."

"The sophisticated algorithms and artificial intelligence software used for analyzing sequencing data and linking them to clinical data are based on deep knowledge in technical and clinical needs," added Andre Goy, MD, physician-in-chief for Oncology at Hackensack Meridian Health and chair of John Theurer Cancer Center.

"We are delighted to be working with the team at GTC. We selected GTC tests because of the significant diligence and scientific rigor used in their development," said David S. Siegel, MD, PhD, chief, Myeloma Division at John Theurer Cancer Center and founding director, Institute for Multiple Myeloma at the Hackensack Meridian Center for Discovery and Innovation. "We believe that profiling both RNA and DNA in cancers is crucial — not only for increasing accuracy and providing thorough evaluation, but also for innovation and the development of new clinical research approaches."

"Given the increasing number of novel therapies, particularly targeted therapies in solid tumors, having the ability to identify ‘mutation drivers’ that help us make healthcare decisions is becoming an increasingly routine practice in oncology," said Martin Gutierrez, MD, head of Phase I and Thoracic Oncology at John Theurer Cancer Center. "Real world experience have shown that this genomic information should be used more frequently to improve patients’ outcomes."

Maher Albitar, MD, chief executive officer and chief medical officer at GTC, stated, "Working with John Theurer Cancer Center to establish an NGS laboratory at a patient care site aligns with our mission as a cooperative company focused on making high-quality molecular profiling available and affordable for every patient with cancer. Furthermore, this collaboration will allow GTC to co-develop new tests with John Theurer Cancer Center by utilizing clinical and outcomes data from John Theurer Cancer Center, which will accelerate innovation in oncology and result in better patient care."

"When you help one person overcome cancer, you make life better for their families, friends, and coworkers, too," explained Mark D. Sparta, FACHE, president and chief hospital executive, Hackensack University Medical Center and executive vice president of Population Health, Hackensack Meridian Health. "Bringing a tool like NGS into the routine care of people with cancer can improve lives — and by extension, entire communities."

"Cancer affects many residents and their loved ones in northern New Jersey. Having NGS at John Theurer Cancer Center, coupled with the technologies of GTC, puts our doctors in a strong position to better understand what is driving the growth of their patients’ cancers so they can match them with the most effective therapies," said Ihor Sawczuk, MD, FACS, Regional President of the Northern Market. "We are incredibly fortunate to have this resource right here in Hackensack."

More than 30,000 new cancer patients are treated by RCCA physicians annually. John Theurer Cancer Center participates in more than 350 ongoing clinical trials.

About Hackensack Meridian Health

Hackensack Meridian Health is a leading not-for-profit health care organization that is the largest, most comprehensive and truly integrated health care network in New Jersey, offering a complete range of medical services, innovative research and life-enhancing care.

Hackensack Meridian Health comprises 17 hospitals from Bergen to Ocean counties, which includes three academic medical centers – Hackensack University Medical Center in Hackensack, Jersey Shore University Medical Center in Neptune, JFK Medical Center in Edison; two children’s hospitals – Joseph M. Sanzari Children’s Hospital in Hackensack, K. Hovnanian Children’s Hospital in Neptune; nine community hospitals – Bayshore Medical Center in Holmdel, Mountainside Medical Center in Montclair, Ocean Medical Center in Brick, Palisades Medical Center in North Bergen, Pascack Valley Medical Center in Westwood, Raritan Bay Medical Center in Old Bridge, Raritan Bay Medical Center in Perth Amboy, Riverview Medical Center in Red Bank, and Southern Ocean Medical Center in Manahawkin; a behavioral health hospital – Carrier Clinic in Belle Mead; and two rehabilitation hospitals – JFK Johnson Rehabilitation Institute in Edison and Shore Rehabilitation Institute in Brick.

Additionally, the network has more than 500 patient care locations throughout the state which include ambulatory care centers, surgery centers, home health services, long-term care and assisted living communities, ambulance services, lifesaving air medical transportation, fitness and wellness centers, rehabilitation centers, urgent care centers and physician practice locations. Hackensack Meridian Health has more than 34,100 team members, and 6,500 physicians and is a distinguished leader in health care philanthropy, committed to the health and well-being of the communities it serves.

The network’s notable distinctions include having four hospitals among the top 10 in New Jersey by U.S. News and World Report. Other honors include consistently achieving Magnet recognition for nursing excellence from the American Nurses Credentialing Center and being named to Becker’s Healthcare’s "150 Top Places to Work in Healthcare/2019" list.

The Hackensack Meridian School of Medicine at Seton Hall University, the first private medical school in New Jersey in more than 50 years, welcomed its first class of students in 2018 to its On3 campus in Nutley and Clifton. Additionally, the network partnered with Memorial Sloan Kettering Cancer Center to find more cures for cancer faster while ensuring that patients have access to the highest quality, most individualized cancer care when and where they need it.

Hackensack Meridian Health is a member of AllSpire Health Partners, an interstate consortium of leading health systems, to focus on the sharing of best practices in clinical care and achieving efficiencies.

For additional information, please visit www.HackensackMeridianHealth.org.

About the Center for Discovery and Innovation

The Center for Discovery and Innovation, a newly established member of Hackensack Meridian Health, seeks to translate current innovations in science to improve clinical outcomes for patients with cancer, infectious diseases and other life-threatening and disabling conditions. The CDI, housed in a fully renovated state-of-the-art facility, offers world-class researchers a support infrastructure and culture of discovery that promotes science innovation and rapid translation to the clinic.

GT Biopharma Announces Dosing Of New Patient In GTB-3550 TriKE(TM) Phase I/II Clinical Trial

On May 27, 2020 GT Biopharma, Inc. (OTCQB:GTBP) (GTBP.PA) an immuno-oncology company focused on NK cell engager (TriKE) technology. GT reported that the second patient of the lowest dose of an ascending dose finding study has begun treatment of the GTB-3550 TriKE (Press release, GT Biopharma, MAY 27, 2020, View Source [SID1234558535]). The patient will be evaluated following completion of the third cycle of GTB-3550 TriKE therapy. The clinical trial is being conducted at the University of Minnesota’s Masonic Cancer Center in Minneapolis. Additional clinical trial sites are now being processed.

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The first patient of the Phase I/II study achieved stable disease and increased NK cell production with no adverse side effects. The first patient elicited an encouraging initial efficacy marker response.

The TRIKE clinical trial evaluates GTB-3550 in patients with acute myeloid leukemia or advanced systemic mastocytosis, and will determine safety and tolerability as well as the pharmacologically active dose and maximum tolerated dose of GTB-3550.

TriKE is a multi-targeted immuno-oncology protein-based therapeutic drug. The TriKE addresses the patient delivery and administration issues of liquid tumor cell therapies and NK engagers. Pre-clinical data shows that The TriKE platform technology works in both liquid and solid tumors.

About GTB-3550 Trispecific NK cell Engager (TriKE)

GTB-3550 is the Company’s first TriKE product candidate being initially developed for the treatment AML. GTB-3550 is a single-chain, tri-specific scFv recombinant fusion protein conjugate composed of the variable regions of the heavy and light chains of anti-CD16 and anti-CD33 antibodies and a modified form of IL-15. The natural killer (NK) cell stimulating cytokine human IL-15 portion of the molecule provides a self-sustaining signal that activates NK cells and enhances their ability to kill. The Company is currently in a clinical trial with GTB-3550 in CD33 positive leukemia for acute myeloid leukemia (AML), and is studying myelodysplastic syndrome (MDS), and other CD33+ hematopoietic malignancies along with other solid tumor candidates.

Veracyte to Present at the William Blair 40th Annual Growth Stock Conference

On May 27, 2020 Veracyte, Inc. (Nasdaq: VCYT) reported that Bonnie H. Anderson, chairman and chief executive officer, is scheduled to present virtually at the William Blair 40th Annual Growth Stock Conference on Wednesday, June 10, at 12:40 p.m. Central Time (Press release, Veracyte, MAY 27, 2020, View Source [SID1234558534]).

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The link to the live audio webcast of the company’s presentation will be available by visiting Veracyte’s website at View Source A replay of the webcast will be available for 90 days following the conclusion of the live presentation broadcast.

MEI Pharma to Present at the Jefferies Virtual Healthcare Conference

On May 27, 2020 MEI Pharma, Inc. (NASDAQ: MEIP) ("MEI"), a late-stage pharmaceutical company focused on advancing new therapies for cancer, reported that Daniel P. Gold, Ph.D., president and chief executive officer of MEI, will present a company overview and business update at the Jefferies Virtual Healthcare Conference on Tuesday, June 2nd, 2020 at 11:00 AM Eastern Time (Press release, MEI Pharma, MAY 27, 2020, View Source [SID1234558532]). The conference is being held in a virtual format.

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A live audio webcast of the event can be accessed on the Events & Presentations page of the Investors section of MEI Pharma’s website at View Source An archived replay of the webcast will be available on MEI Pharma’s website for at least 30 days after the live event concludes.

MacroGenics Announces Registration Study of Flotetuzumab in Patients with Refractory Acute Myeloid Leukemia

On May 27, 2020 MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported plans for a clinical study intended to support registration in the U.S. of flotetuzumab, an investigational, bispecific CD123 x CD3 DART molecule for patients with acute myeloid leukemia (AML) who are refractory to induction therapy (Press release, MacroGenics, MAY 27, 2020, View Source [SID1234558531]).

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Informed by recent discussions with the U.S. Food and Drug Administration (FDA), the Company plans a single-arm, registration-enabling clinical study to evaluate flotetuzumab in up to 200 patients with primary induction failure (PIF) or early relapse (ER) AML. The study will be conducted as a continuation of the ongoing Phase 1/2 study (NCT02152956; to be updated). Complete remission (CR) and CR with partial hematological recovery (CRh) will be the primary endpoint of the pivotal study. Key secondary endpoints will include durability of response and other supportive clinical endpoints.

"Patients with AML who are refractory to induction therapy or relapse early after an initial response have limited treatment options," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "Clinical and translational data suggest that such refractory AML patients may be responsive to immunotherapy with flotetuzumab. We are very pleased to advance our first DART molecule into a pivotal study with an opportunity to address a significant unmet need."

Data from the Phase 1/2 clinical study of flotetuzumab in patients with PIF/ER AML were presented in December 2019 at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. A CR/CRh rate of 27% (8 of 30) was observed in the intent-to-treat population. The most common treatment-related adverse event was infusion-related reaction/cytokine release syndrome that occurred in all patients and was mostly of short duration and mild to moderate (grade 1 or 2) in severity.

About Acute Myeloid Leukemia

AML is a hematological malignancy characterized by differentiation arrest and uncontrolled clonal proliferation of neoplastic precursors that prevent normal bone marrow hematopoiesis. Nearly 20,000 new cases of AML are diagnosed in the U.S. each year, with a median age of 69 years at diagnosis. Approximately 40-50% of newly diagnosed patients fail to achieve a complete remission with intensive induction therapy (primary induction failure) or experience disease recurrence after a short remission duration (<6 months; early relapsed). A very small number of these patients are expected to respond to salvage therapy. Although new targeted agents have been approved for the treatment of frontline or relapsed/refractory AML in recent years, approximately 50% of patients have no known targetable mutations.

About Flotetuzumab

Flotetuzumab (also known as MGD006) is a clinical-stage bispecific DART molecule that recognizes both CD123 and CD3. CD123, the interleukin-3 receptor alpha chain, has been reported to be over-expressed on malignant cells in AML and other hematologic malignancies. The primary mechanism of action of flotetuzumab is believed to be its ability to redirect T lymphocytes to kill CD123-expressing cells. To achieve this, the DART molecule combines a portion of an antibody recognizing CD3, an activating molecule expressed by T cells, with an arm that recognizes CD123 on the target cells. The FDA has granted orphan drug designation to flotetuzumab for the treatment of AML.