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Vycellix Founders Awarded Innovation Grant by Sweden’s Vinnova to Establish New World-Class Research Environment on Development of Next-Generation Natural Killer Cell-based Cancer Immunotherapy

On June 27, 2019 Vycellix, Inc. reported that the Company, founded by leading medical researchers at Sweden’s world renowned Karolinska Institutet, has been included as a collaborative partner in the new Competence Center for Next-Generation NK Cell-based Cancer Immunotherapy ("NextGen-NK") being established at Karolinska Institutet ("KI"), Stockholm, Sweden (Press release, Vycellix, JUN 27, 2019, View Source [SID1234537313]).

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Vinnova, Sweden’s innovation agency, is making a significant investment in NextGen-NK, where universities and companies together will conduct world-class research and innovation in areas that are important for Sweden while contributing to its global sustainability goals. NextGen-NK has received commitments from a consortium of key opinion leaders and experts from academia and the biotech industry to collectively collaborate with the goal of creating a recognized world-class research environment in the field of natural killer cell-based immunotherapy targeting cancers.

NextGen-NK is scheduled to receive up to approximately $12 million in funding over the next five-years from multiple stakeholders including Vinnova, Karolinska Institutet and its industry partners with the opportunity to apply for extended funding for an additional 5-years at a similar level. NextGen-NK will be led by its Director, Hans-Gustaf Ljunggren, M.D., Ph.D., Professor at the Department of Medicine at KI, former Dean of Research at KI, former Director of the Center for Infectious Medicine at KI, Chief Medical Officer for Vycellix, and member of the Nobel Assembly at KI.

"We are extremely honored, humbled and grateful to Vinnova for recognizing the potential global impact on human health by establishing NextGen-NK," stated Dr. Ljunggren. "We propose to develop a precision-medicine strategy to direct NK cells to their cancer targets and to optimally stimulate NK cell activity in the body. And by assembling leading scientists and clinicians, including those whom have played key roles over the past four decades of NK cell innovation, this collaboration and discovery-network is expected to generate outcomes that go far beyond the capability of any individual partner."

NextGen-NK’s Co-Directors will be: Evren Alici, M.D., Ph.D., Associate Professor at the Department of Medicine at KI, Head of the Gene & Cell Therapy Group at KI, and CEO of Vycellix; and Karl-Johan Malmberg, M.D., Ph.D., Professor at the Department of Cancer Immunology, Institute for Cancer Research, Oslo University Hospital and member of Vycellix’s Scientific Advisory Board.

Veracyte to Release Second Quarter 2019 Financial Results on July 30, 2019

On June 27, 2019 Veracyte, Inc. (Nasdaq: VCYT) reported that it will release its financial results for the second quarter 2019 after the close of market on Tuesday, July 30, 2019 (Press release, Veracyte, JUN 27, 2019, View Source [SID1234537312]). Company management will host a conference call and webcast to discuss its financial results and provide a general business update at 5:00 p.m. Eastern time on the same day.

The conference call will be webcast live from the company’s website and will be available via the following link: View Source The webcast should be accessed 10 minutes prior to the conference call start time. A replay of the webcast will be available for one year following the conclusion of the live broadcast and will be accessible on the company’s website at View Source

The conference call can be accessed as follows:

U.S./Canada participant dial-in number (toll-free):

(855) 541-0980

International participant dial-in number:

(970) 315-0440

Conference I.D.:

9769085

McKesson Corporation to Announce First Quarter Fiscal 2020 Results on July 31, 2019

On June 27, 2019 McKesson Corporation (NYSE:MCK) reported that its first quarter fiscal 2020 financial results will be released on Wednesday, July 31, 2019 following the close of market (Press release, McKesson, JUN 27, 2019, View Source [SID1234537311]). The company will host a conference call at 5:00 PM Eastern Time (2:00 PM Pacific Time) the same day to discuss the financial results. During this call, the company will also provide an update on fiscal 2020 outlook assumptions following the completion of the Change Healthcare initial public offering.

A live audio webcast of the conference call will be available on McKesson’s Investor Relations website at View Source, along with the company’s earnings press release, financial tables and slide presentation. The conference call can also be accessed by dialing 323-994-2093. The password is ‘McKesson’.

Multiple Myeloma Research Foundation (MMRF) Launches Leading-edge Immune Atlas Initiative

On June 27, 2019 The Multiple Myeloma Research Foundation (MMRF) reported that it is piloting a new precision medicine research initiative called the Immune Atlas (Press release, Multiple Myeloma Research Foundation, JUN 27, 2019, View Source [SID1234537309]). The objectives of this Immune Atlas pilot are to develop a ‘gold standard’ immune profiling platform for myeloma research studies and to generate robust immune data that is fundamental to the delivery of precision medicine. The Immune Atlas is a critical part of the organization’s bold three-year plan, which focuses, in part, on generating robust immune data to advance precision immuno-oncology efforts.

"Immunotherapy has transformed outcomes for patients with many kinds of cancers that previously had few effective options," said the MMRF President and Chief Executive Officer Paul Giusti. "Progress in immunotherapy in myeloma has been gradual because of the complexity of the disease and a fragmented research effort. As the leader in precision medicine, we are now seeking to accelerate immune agents into the clinic for myeloma patients and ensure that each patient receives treatment that is specific for their immune profile."

The MMRF has partnered with leading academic centers that will employ cutting edge analytical technologies to comprehensively characterize the immune repertoire and activity of key immune cell populations in myeloma patients. The five centers involved in the pilot are from the Multiple Myeloma Research Consortium (MMRC): Beth Israel Deaconess Medical Center, Emory University, Mayo Clinic Rochester, Mount Sinai School of Medicine, and Washington University.

"The great strength of the MMRF is the ability to bring partners together to collaborate on efforts that advance cures for myeloma patients," said the MMRF Chief Scientific Officer Daniel Auclair, PhD. "We are so fortunate to have these five best-in-class institutions as members of our Multiple Myeloma Research Consortium (MMRC), who can bring cutting-edge scientific analysis to bear on the most pressing needs of our patients. Once this immune profiling platform is validated, it can be rolled out to bring the promise of precision immunotherapy to the entire myeloma community."

About Multiple Myeloma

Multiple myeloma (MM) is a cancer of the plasma cell. It is the second most common blood cancer. An estimated 30,770 adults (16,400 men and 14,730 women) in the United States will be diagnosed with MM in 2019 and an estimated 12,770 people are predicted to die from the disease. The five-year survival rate for MM is approximately 47%, versus 31% in 1999.

SpringWorks Therapeutics Announces Global Clinical Collaboration with GlaxoSmithKline to Evaluate Nirogacestat in Combination with Belantamab Mafodotin in Patients with Relapsed or Refractory Multiple Myeloma

On June 27, 2019 SpringWorks Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, reported that the company has entered into a clinical trial collaboration agreement with GlaxoSmithKline to evaluate SpringWorks Therapeutics’ investigational gamma secretase inhibitor (GSI), nirogacestat, in combination with GlaxoSmithKline’s investigational anti-B-cell maturation antigen (BCMA) antibody-drug conjugate (ADC), belantamab mafodotin (formerly GSK2857916), in patients with relapsed or refractory multiple myeloma (Press release, SpringWorks Therapeutics, JUN 27, 2019, View Source [SID1234537308]).

Gamma secretase is an enzyme that cleaves multiple transmembrane proteins, including BCMA. As evidenced in publications and preclinical experiments, treatment with a GSI, including nirogacestat, can increase BCMA cell surface expression levels on multiple myeloma cells1, potentially improving the activity of BCMA-targeted therapies, including BCMA ADCs.

"While significant advances have been made in treating multiple myeloma over the past decade, a significant unmet need remains for patients who have relapsed or are refractory to available treatments," said Saqib Islam, Chief Executive Officer of SpringWorks Therapeutics. "We are delighted to enter into this agreement with GlaxoSmithKline, who also invested in our recent Series B financing, and we look forward to exploring the potential benefit of nirogacestat and belantamab mafodotin for multiple myeloma patients. With this collaboration, we are pleased to further expand on our strategy in building our targeted oncology portfolio with another industry leader."

Under the terms of the agreement, GlaxoSmithKline will sponsor and conduct the adaptive Phase 1b study to evaluate the safety, tolerability and preliminary efficacy of the combination, and will assume all development costs associated with the study. GlaxoSmithKline and SpringWorks Therapeutics will also form a joint development committee to manage the clinical study.

About Nirogacestat

Nirogacestat is an investigational, oral, selective, small molecule gamma-secretase inhibitor in Phase 3 clinical development for desmoid tumors, which are rare and often debilitating and disfiguring soft-tissue tumors. Gamma secretase cleaves multiple transmembrane protein complexes, including Notch, which is believed to play a role in activating pathways that contribute to desmoid tumor growth. In June 2018, the FDA granted Orphan Drug designation for nirogacestat for the treatment of desmoid tumors, and in November 2018, the FDA granted Fast Track designation for nirogacestat for the treatment of adult patients with progressive, unresectable, recurrent or refractory desmoid tumors or deep fibromatosis.

In addition, gamma secretase has been shown to directly cleave membrane-bound BCMA, resulting in the release of the BCMA extracellular domain, or ECD, from the cell surface. By inhibiting gamma secretase, membrane-bound BCMA can be preserved, increasing target density while reducing levels of soluble BCMA ECD, which may serve as decoy receptors for BCMA-directed therapies.2 Nirogacestat’s ability to enhance the activity of BCMA-directed therapies has been observed in preclinical models of multiple myeloma.

About belantamab mafodotin (GSK2857916)

Belantamab mafodotin is an investigational anti-B-cell maturation antigen (BCMA) antibody-drug conjugate in Phase 2 clinical development for patients with relapsed/refractory multiple myeloma and other advanced hematologic malignancies expressing BCMA.

In 2017, belantamab mafodotin was awarded Breakthrough Therapy designation from the U.S. Food and Drug Administration and PRIME designation from the European Medicines Agency; these designations are intended to facilitate development of investigational medicines that have shown clinical promise for conditions where there is significant unmet need.