On July 24, 2019 The Gray Foundation reported that it has awarded $25 million in funding to seven multi-institute teams conducting research related to the prediction, prevention, and treatment of BRCA-related cancers (Press release, The Gray Foundation, JUL 24, 2019, View Source [SID1234537849]).

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The teams will receive up to $5 million each for their projects, which include ones focusing on the validation of liquid biopsy assays for the early detection of cancer in high-risk BRCA mutation carriers; tracking and preventing breast cancer in BRCA mutation carriers; identifying and targeting post-transcriptionally modified neoantigens in BRCA mutant tumors; and researching the relationship between the local microbiome and host immune system in breast cancer.

Other funded projects are investigating the determinants of immune activity and molecular features in BRCA mutation carriers; examining the pathogenesis of early BRCA-associated cancer for risk prediction and disease prevention; and dissecting BRCA-mediated tumor suppression pathways.

Scientists leading the research are from Weill Cornell Medicine, the Cleveland Clinic, the University of Pennsylvania, the University of Texas Health Science Center at San Antonio, and Johns Hopkins University School of Medicine.

Other participating institutes include the Massachusetts Institute of Technology, the Wellcome Sanger Institute, Beth Israel Deaconess Medical Center, the University of Cambridge, Dana Farber Cancer Institute, the University of British Columbia, Brigham and Women’s Hospital, Stanford University, QIMR Berghofer, Memorial Sloan Kettering Cancer Center, and Case Western Reserve University.

On July 24, 2019 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to MB-102 (CD123 CAR T) for the treatment of acute myeloid leukemia (AML) (Press release, Mustang Bio, JUL 24, 2019, View Source [SID1234537797]). The FDA also previously granted Orphan Drug Designation to MB-102 (CD123 CAR T) for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN).

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Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, "We are pleased that MB-102 has received Orphan Drug Designation in two indications, AML and BPDCN. AML most commonly occurs in senior adults, many of whom have to forgo chemotherapy due to other health conditions. MB-102 has the potential to be an important new treatment for these and other patients, and to potentially address multiple areas of high unmet medical need. We expect to initiate a multicenter Phase 1/2 clinical trial in patients with AML, BPDCN and high-risk myelodysplastic syndrome in the coming months."

MB-102 is currently being studied in a City of Hope, first-in-human Phase 1 dose-escalation clinical trial evaluating the safety and anti-tumor activity of escalating doses of MB-102 in patients with relapsed or refractory AML (cohort 1) and BPDCN (cohort 2). Patients receive a single dose of MB-102 with an option for a second infusion if they continue to meet safety and eligibility criteria and still have CD123+ disease. MB-102 has demonstrated complete responses at low doses in AML and BPDCN without dose-limiting toxicities. City of Hope developed CD123 CAR T.

The FDA grants Orphan Drug Designation to drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the U.S. Orphan Drug Designation provides certain incentives, such as tax credits toward the cost of clinical trials and prescription drug user fee waivers. If a product holding Orphan Drug Designation receives the first FDA approval for the disease in which it has such designation, the product is entitled to seven years of market exclusivity, which is independent from intellectual property protection.

About Acute Myeloid Leukemia
AML is a cancer of the myeloid line of blood cells, characterized primarily by the rapid growth of abnormal white blood cells that build up in the bone marrow and interfere with the production of normal blood cells. CD123 is an attractive target for T cell-based adoptive immunotherapy due to high levels of CD123 expression in AML.

About MB-102 (CD123 CAR T)
MB-102 (CD123 CAR T) is a CAR T cell therapy that is produced by engineering patient T cells to recognize and eliminate CD123-expressing tumors. CD123 is widely expressed on bone marrow cells of patients with myelodysplastic syndromes, as well as in hematologic malignancies, including AML, B-cell acute lymphoblastic leukemia, hairy cell leukemia, BPDCN, chronic myeloid leukemia and Hodgkin’s lymphoma.

In the first-in-human clinical trial at City of Hope (NCT02159495), MB-102 has demonstrated complete responses at low doses in AML and BPDCN without dose-limiting toxicities, as reported at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2017 and the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Special Conference on Tumor Immunology and Immunotherapy in November 2018. Dose escalation continues at City of Hope in both indications.

On July 24, 2019-Helix BioPharma Corp. (TSX: HBP), ("Helix" or the "Company"), an immunooncology company developing innovative drug candidates for the prevention and treatment of cancer, reported that it will be presenting at the RHK Capital 2019 Disruptive Growth & Healthcare Conference (www.disruptnyc.com).

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RHK Capital’s Disruptive Growth & Healthcare Conference showcases life science companies that focus on solutions for unmet medical needs and growth companies with disruptive technologies and business models. The 2019 Disruptive Growth & Healthcare Conference will be held on Wednesday, September 4th and Thursday, September 5th in New York.

"We are pleased to present Helix at this venue," said Dr. Heman Chao, Helix’s Chief Executive Officer. "As part of the Company’s objective to increase awareness of the Company’s novel DOS47 tumor microenvironment platform, the Company will be actively participating in select conferences and non-deal roadshows during the second half of calendar 2019".

On July 24, 2019 QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported results of operations for the second quarter of 2019, achieving the outlook set for net sales growth and adjusted earnings per share at constant exchange rates (CER) (Press release, Qiagen, JUL 24, 2019, View Source [SID1234537744]).

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QIAGEN also announced that it intends to restructure the current format of its next-generation sequencing (NGS) partnership in China due to the slower-than-expected uptake of in-vitro diagnostic clinical sequencing in this country. Sales from this partnership were planned to be approximately $30 million CER for full-year 2019, and weighted primarily to the second half of this year.

As a result, QIAGEN now expects full-year 2019 net sales growth of approximately 5-6% CER (previously about 7-8% CER) and adjusted diluted EPS of approximately $1.42-1.44 CER per share (previously about $1.45-1.47 CER). For the third quarter of 2019, QIAGEN expects net sales to grow approximately 4-5% CER. Adjusted diluted EPS is expected to be about $0.35-0.36 CER per share.

As previously announced, QIAGEN intends to release its full results for the second quarter and first half of 2019 on Tuesday, July 30, at approximately 22:05 Central European Time (CET) / 21:05 GMT / 16:05, and to hold an investor call as planned on Wednesday, July 31, at (EDT) at 15:00 Central European Time (CET) / 14:00 GMT / 9:00 Eastern Daylight Time (EDT). A live webcast will be made available at this website, and a replay will also be made available after the event.
Second quarter 2019 results in line with outlook
Total net sales rose 1% to $381.6 million in the second quarter of 2019 from $377.2 million in the second quarter of 2018, and grew 5% CER, in line with the outlook for 5% CER growth. The adverse currency movements against the U.S. dollar were in line with QIAGEN’s publicly announced expectations.
Instruments (+9% CER / 12% of sales) led the performance ahead of consumables and related revenues (+4% CER / 88% of sales). Instrument sales rose 15% CER excluding third-party instrument service contracts, led by contributions from the QIAstat-Dx multiplex system launched in 2018 as well as the new QIAcube Connect sample processing instrument launched in early 2019. Molecular Diagnostics (+5% CER / 49% of sales) had double-digit CER growth in instrument sales, while consumables and related revenues rose at a mid-single-digit CER pace. As expected, sales of the QuantiFERON-TB test rose 6% CER in the second quarter of 2019, which was below the annual target of at least 15% CER growth due to the very strong year-ago growth amid the transition to the fourth-generation test version. Also weighing on growth was a decline of 21% CER in revenues from companion diagnostic co-development projects, to $11 million in the quarter. Life Sciences (+5% CER / 51% of sales) benefitted from Pharma (+4% CER / 20% of sales) growth on mid-single-digit CER gains in consumables and related revenues and low-single-digit CER growth in instruments, while Academia / Applied Testing (+5% CER / 31% of sales) had double-digit CER growth in instruments and mid-single-digit growth in consumables.
Operating income was $60.2 million compared to $53.3 million in the same quarter of 2018. Adjusted operating income – which excludes amortization of intangible assets acquired in business combinations and other items such as business integration, acquisition-related costs, litigation costs and restructuring – fell 2% to $99.1 million in the second quarter of 2019, absorbing significant investments for the QIAstat-Dx

multiplex system and development of the new digital PCR system planned for launch in 2020. The adjusted operating income margin was 26.0% of sales compared to 26.8% in the same quarter of 2018.
Net income was $44.7 million in the second quarter of 2019, or $0.19 per diluted share (based on 232.7 million diluted shares), compared to $36.8 million, or $0.16 per share (based on 233.8 million diluted shares) in the second quarter of 2018. Adjusted net income was $77.4 million, or $0.33 per diluted share ($0.34 CER, and in line with the outlook for approximately $0.33-0.34 CER), compared to $77.2 million, or $0.33 per diluted share, in the prior-year quarter, with an adjusted tax rate of 20% in both periods.

On July 24, 2019 Dynavax Technologies Corporation (NASDAQ: DVAX), a fully-integrated biopharmaceutical company focused on developing novel vaccines, reported that it will report its second quarter 2019 financial results on Wednesday, August 7, 2019, after the U.S. financial markets close (Press release, Dynavax Technologies, JUL 24, 2019, View Source [SID1234537725]).

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Dynavax will host a conference call and live audio webcast on Wednesday, August 7, 2019, at 4:30 p.m. (ET)/1:30 p.m. (PT).

The live audio webcast may be accessed through the "Events & Presentations" page on the "Investors" section of the company’s website at www.dynavax.com. Alternatively, participants may dial (877) 423-9813 (domestic) or (201) 689-8573 (international) and refer to conference ID 13693069.

The archived conference call will be available on Dynavax’s website beginning approximately two hours after the event and will be archived and available for replay for at least 30 days after the event.