On July 29, 2019 OncoImmunity AS reported that it has been acquired by NEC Corporation, the renowned Japanese IT and network company, that recently launched its Artificial Intelligence (AI) driven drug discovery business (Press release, NEC OncoImmunity, JUL 29, 2019, View Source [SID1234555210]). OncoImmunity AS will now become a subsidiary of NEC and operate under the name of NEC OncoImmunity AS.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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OncoImmunity AS, founded in 2014, develops software that identifies neoantigen targets for truly personalized cancer vaccines, cell therapies and optimal patient selection for cancer immunotherapy clinical trials. Prior to the acquisition, OncoImmunity AS was funded by a consortium of Norwegian life science and tech investors led by Radforsk, who played a proactive role in developing the company under the guidance of the company’s Chairman Anders Tuv, who was instrumental for and also managed the sales process on behalf of all shareholders. Under the acquisition, NEC will maintain its focus on drug discovery, while NEC OncoImmunity AS continues its neoantigen prediction services.

Both NEC and OncoImmunity AS share a common vision that individualized cancer treatments can be significantly improved by harnessing the power of AI. AI holds tremendous promise in enabling each and every patient to receive the optimal personalized therapy. OncoImmunity AS will benefit from NEC’s proprietary neoantigen prediction modules and its wide array of IT expertise such as data management and security. The OncoImmunity AS platform has unique advantages in accurately predicting antigen presentation to the tumor cell surface, a key determinant for identifying clinically relevant immunogenic neoantigens. By integrating complementary knowledge and resources, this acquisition makes NEC OncoImmunity AS a forerunner in the field of neoantigen prediction. The acquisition signals positive momentum in the field of personalized cancer immunotherapy, where the prediction of immunogenic neoantigens remains a central challenge for clinical success, with two of the predominant players in the neoantigen prediction field now joining forces.

"This acquisition creates a scientific synergy that will enable OncoImmunity AS’s continued dedication to the development of bioinformatics solutions for truly personalized cancer immunotherapy. The combined technology will be of tremendous benefit to our current and future clinical partners," said Dr. Trevor Clancy, Chief Scientific Officer and Co-founder of OncoImmunity AS.

"The OncoImmunity AS team are delighted to be joining the NEC Group and firmly believe that the union will realize great synergies, marrying the mutual strengths of OncoImmunity AS’s and NEC’s neoantigen prediction pipelines with NEC’s expertise in AI, data management and security. These synergies will help strengthen NEC’s individualized immunotherapy programs, whilst simultaneously positioning NEC OncoImmunity AS as the leading neoantigen prediction service provider in the field," said Dr. Richard Stratford, Chief Executive Officer and Co-founder of OncoImmunity AS.

"NEC strongly believes that healthcare based on genomics paves the way for individualized medicine. OncoImmunity AS is a recognized player in the neoantigen prediction field, and their compelling systems are expected to form valuable synergies with NEC. We are confident that this acceleration of development will provide promising new avenues that lead to better cancer treatments," said Osamu Fujikawa, Senior Vice President, NEC Corporation.

On July 29, 2019 Stemline Therapeutics, Inc. (Nasdaq: STML), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics, reported that the company will host a conference call and webcast on Friday, August 2, 2019 at 8:00 a.m. ET to report its second quarter 2019 financial results and other business highlights (Press release, Stemline Therapeutics, JUL 29, 2019, https://ir.stemline.com/news-releases/news-release-details/stemline-therapeutics-host-conference-call-second-quarter-2019 [SID1234537848]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The conference call can be accessed by dialing 1-888-220-8451 (domestic) or 1-323-794-2588 (international) and referring to conference ID 7887580. The webcast can be accessed via the company’s website (www.stemline.com), at the bottom of the "Investors & Media" section in the "News & Events" page, and will be available live and for replay shortly after the event.

About ELZONRIS
ELZONRIS (tagraxofusp-erzs), a CD123-directed cytotoxin, is approved by the U.S. Food and Drug Administration (FDA) and commercially available in the U.S. for the treatment of adult and pediatric patients, two years or older, with blastic plasmacytoid dendritic cell neoplasm (BPDCN). For full prescribing information in the U.S., visit www.ELZONRIS.com. In Europe, a marketing authorization application (MAA) is under review by the European Medicines Agency (EMA). ELZONRIS is also being evaluated in additional clinical trials in other indications including chronic myelomonocytic leukemia (CMML), myelofibrosis (MF), and acute myeloid leukemia (AML).

About BPDCN
BPDCN is an aggressive hematologic malignancy with historically poor outcomes and an area of unmet medical need. BPDCN typically presents in the bone marrow and/or skin and may also involve lymph nodes and viscera. The BPDCN cell of origin is the plasmacytoid dendritic cell (pDC) precursor. The diagnosis of BPDCN is based on the immunophenotypic diagnostic triad of CD123, CD4, and CD56, as well as other markers. For more information, please visit the BPDCN disease awareness website at www.bpdcninfo.com.

About CD123
CD123 is a cell surface target expressed on a wide range of myeloid tumors including blastic plasmacytoid dendritic cell neoplasm (BPDCN), certain myeloproliferative neoplasms (MPNs) including chronic myelomonocytic leukemia (CMML) and myelofibrosis (MF), acute myeloid leukemia (AML) (and potentially enriched in certain AML subsets), myelodysplastic syndrome (MDS), and chronic myeloid leukemia (CML). CD123 has also been reported on certain lymphoid malignancies including multiple myeloma (MM), acute lymphoid leukemia (ALL), hairy cell leukemia (HCL), Hodgkin’s lymphoma (HL), and certain Non-Hodgkin’s lymphomas (NHL). In addition, CD123 has been detected on some solid tumors as well as autoimmune disorders including cutaneous lupus and scleroderma.

On July 29, 2019 Allergan reported that issued a worldwide recall of its BIOCELL textured breast implants and BIOCELL tissue expanders following reports of women being diagnosed with cancer, with some cases resulting in death (Press release, Allergan, JUL 29, 2019, View Source [SID1234537866]). The company’s recall followed an FDA Safety Alert and an FDA Recall Request.

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Allergan, a medical device manufacturer, has recalled all of its BIOCELL textured breast implants and tissue expanders, removing the products from the market worldwide. The recall was announced after the United States Food and Drug Administration (FDA) reported a significant increase in the number of cases of women with Allegan’s BIOCELL textured breast implants who have been diagnosed with breast-implant associated anaplastic large cell lymphoma (BIA-ALCL), a type of non-Hodgkin’s lymphoma.

The affected BIOCELL textured breast implants and BIOCELL tissue connectors have already been recalled by three dozen countries worldwide. The FDA reports that there is now a total of 573 cases of BIA-ALCL worldwide in women who had Allergan BIOCELL textured breast implants, with 33 of these women dying from cancer. The FDA also states that women with Allergan BIOCELL textured breast implants are 6 times more likely to develop BIA-ALCL than with similar breast implants manufactured by other medical device companies in the United States.

Specific BIOCELL Textured Breast Implants and Tissue Connectors Subject to Recall

Allergan’s recall of its BIOCELL textured breast implants includes the following products:

Natrelle saline-filled breast implants;
Natrelle silicone-filled breast implants;
Natrelle Inspira silicone-filled breast implants; and
Natrelle 410 Highly Cohesive Anatomically Shaped silicone-filled breast implants.
Allergan’s recall of its BIOCELL tissue expanders includes the following products:

Biocell Tissue Expanders:
Natrelle 133 Plus Tissue Expander; and
Natrelle 133 Tissue Expander with Suture Tabs.
All unused products will be removed from shelves. Women with any of the above-listed breast implants are instructed to see their doctor if they have any swelling or pain near the breast implant. Women are not instructed to have the breast implants removed if they do not have any symptoms.

Parker Waichman LLP is Offering a Free Legal Claim Review

Parker Waichman LLP is helping victims recover monetary compensation for lymphoma caused by Allergan’s BIOCELL textured breast implants and tissue connectors. If you or a loved one are diagnosed with breast-implant associated anaplastic large cell lymphoma (BIA-ALCL), call Parker Waichman LLP to hold Allergan responsible by filing a civil lawsuit. For more information, please contact attorney Jerrold S. Parker at Parker Waichman LLP through the firm’s website YourLawyer.com or by calling 1-800-YOURLAWYER (1-800-968-7529).

On July 29, 2019 VBI Vaccines Inc. (Nasdaq: VBIV) ("VBI"), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, reported that the first patient has been dosed in Part B of the ongoing Phase 1/2a clinical study of VBI-1901, VBI’s oncology immunotherapeutic, in recurrent glioblastoma (GBM) patients (Press release, VBI Vaccines, JUL 29, 2019, View Source [SID1234537850]).

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"We were very encouraged by the results we saw in Part A of the study, notably that three out of the six patients in the high-dose cohort had evidence of stable disease by magnetic resonance imaging," said David Anderson, Ph.D., VBI’s Chief Scientific Officer. "In part B of the study, we are narrowing the enrollment criteria to first-recurrent GBM patients so that we may better assess the potential correlation between immunogenicity and tumor and clinical responses to VBI-1901. GBM is an incredibly aggressive and devastating disease with very few treatment options, and we believe VBI-1901 has the potential to help address this tragic unmet medical need."

The ongoing two-part study is a multi-center, open-label study conducted at The Neurological Institute of New York Columbia University Medical Center, Dana-Farber Cancer Institute, and Massachusetts General Hospital.

About the Phase 1/2a Study Design

VBI’s two-part Phase 1/2a study is a multi-center, open-label, dose-escalation study of VBI-1901 in up to 28 patients with recurrent GBM:

Part A:

Dose-escalation phase that defined the safety, tolerability, and optimal dose level of VBI-1901 in recurrent GBM patients.
This phase enrolled 18 recurrent GBM patients across three dose cohorts of VBI-1901: 0.4 µg, 2.0 µg, and 10.0µg.

Part B:

Subsequent extension of the optimal dose level, 10.0 µg, as defined in the Part A dose escalation phase.
This phase is expected to enroll an expanded cohort of approximately 10 additional first-recurrent GBM patients.

VBI-1901 is administered intradermally and is adjuvanted with granulocyte-macrophage colony-stimulating factor (GM-CSF), a potent adjuvant that mobilizes dendritic cell function. Patients in both phases of the study will receive the vaccine immunotherapeutic every four weeks until tumor progression.

Additional information, including a detailed description of the study design, eligibility criteria, and investigator sites, is available at ClinicalTrials.gov using identifier NCT03382977.

On July 29, 2019 Genomic Health, Inc. (NASDAQ: GHDX) reported financial results and business progress for the quarter ended June 30, 2019 (Press release, Genomic Health, JUL 29, 2019, View Source [SID1234537851]). The company’s earnings call and webcast previously scheduled for Thursday, August 1 will now occur Monday, July 29 at 8 a.m. eastern time as a joint transaction call with Exact Sciences Corp.

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"In the second quarter of 2019 we delivered 19% topline revenue growth and twice the profit compared to last year. These record results were driven by strength across our entire business with first-half revenue growth of 13% in U.S. invasive breast cancer, 44% in U.S. early-stage prostate cancer and 28% outside of the United States," said Kim Popovits, chairman of the board, chief executive officer and president of Genomic Health. "With this record first-half performance, a public reimbursement recommendation in Germany and increasing private coverage for our urology tests, we are raising both our full-year 2019 revenue and net income guidance."

Second Quarter Financial Results

Total revenue for the second quarter of 2019 was $114.1 million compared with $95.6 million for the second quarter of 2018, an increase of 19.4%, and an increase of 20.1% on a non-GAAP constant currency basis. U.S. product revenue was $96.0 million for the second quarter of 2019 compared with $81.4 million for the second quarter of 2019, an increase of 17.9%.

Revenue delivered across key product areas was as follows:

U.S. invasive breast revenue from Oncotype DX Breast Recurrence Score tests was $82.2 million for the second quarter of 2019 compared with $72.5 million for the second quarter of 2019, an increase of 13.4%.
U.S. prostate test revenue from Oncotype DX Genomic Prostate Score (GPS) tests was $9.6 million for the second quarter of 2019 compared with $6.7 million for the second quarter of 2018, an increase of 42.3%.
International product revenue for the second quarter of 2019 was $18.1 million compared with $14.2 million for the second quarter of 2018, an increase of 27.7%, and an increase of 32.7% on a non-GAAP constant currency basis.
Net income was $16.0 million, or $0.43 and $0.42 per share on a basic and diluted basis, respectively, for the second quarter of 2019, an improvement of $7.7 million, compared with net income of $8.3 million, or $0.23 per share on a basic and diluted basis, for the second quarter of 2018. Operating income was $15.5 million for the second quarter of 2019, an improvement of $8.4 million, compared with operating income of $7.1 million for the second quarter of 2018.

More than 38,470 Oncotype test results were delivered in the second quarter of 2019, an increase of 14.5%, compared with more than 33,590 test results delivered in the same period in 2018. Tests delivered across key product areas was as follows:

Breast Recurrence Score tests delivered in the U.S. grew 13.3% in the second quarter of 2019 compared with the same period in 2018.
GPS tests delivered in the U.S. grew 12.3% in the second quarter of 2019 compared with the same period in 2018.
Oncotype DX international tests delivered grew 21.2% in the second quarter of 2019 compared with the same period in 2018 and represented approximately 23.9% of total test volume in the second quarter of 2019.
Six Months Ended June 30, 2019 Financial Results

Total revenue for the six months ended June 30, 2019, was $222.9 million compared with $188.2 million for the same period in 2018, an increase of 18.4%, and an increase of 19.1% on a non-GAAP constant currency basis. U.S. product revenue was $187.0 million for the six months ended June 30, 2019, compared with $160.3 million for the same period in 2018, an increase of 16.7%.

Revenue delivered across key product areas was as follows:

U.S. invasive breast revenue from Breast Recurrence Score tests was $162.0 million for the six months ended June 30, 2019, compared with $143.4 million for the same period in 2018, an increase of 13.0%.
U.S. prostate test revenue from GPS tests was $18.1 million for the six months ended June 30, 2019, compared with $12.5 million for the same period in 2018, an increase of 44.3%.
International product revenue for the six months ended June 30, 2019 was $35.9 million compared with $27.9 million for the same period in 2018, an increase of 28.4%, and an increase of 33.2% on a non-GAAP constant currency basis.
Net income was $29.0 million, an improvement of $24.5 million, compared with net income of $4.5 million, for the same period in 2018. Operating income was $27.0 million for the six months ended June 30, 2019, an improvement of $24.3 million, compared with operating income of $2.7 million for the same period in 2018.

Cash, cash equivalents and short-term marketable securities at June 30, 2019 were $244 million, an increase of $34 million compared with $210 million at December 31, 2018.

Updated 2019 Financial Guidance

Recent Business Highlights

Clinical/Guidelines

Results from a new analysis of TAILORx confirmed the original, definitive conclusions reported in 2018 with additional detail on clinical risk, focusing on patients with early-stage breast cancer age 50 years or younger. These findings, published in The New England Journal of Medicine and presented at the 2019 ASCO (Free ASCO Whitepaper) Annual Meeting, showed that stratifying patients by clinical risk alone does not predict chemotherapy benefit.
Updated American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) guidelines established TAILORx-defined cutoffs for determining chemotherapy benefit with the Oncotype DX Breast Recurrence Score test in node-negative breast cancer, increasing the proportion of women who can be spared unnecessary treatment based on the landmark TAILORx and NSABP B-20 randomized clinical trials.
Recently updated ESMO (Free ESMO Whitepaper) guidelines for early-stage breast cancer elevated the Breast Recurrence Score test to the highest 1A level of evidence based on the prospective TAILORx and PlanB studies.
Global Reimbursement

On June 20, the German Federal Joint Committee (G-BA) issued an exclusive nationwide reimbursement decision for the Oncotype DX Breast Recurrence Score test. This decision follows the conclusion of the German Institute for Quality and Efficiency in Health Care (IQWiG) that only the Oncotype DX test has sufficient evidence to guide breast cancer adjuvant chemotherapy decisions based on results from the landmark TAILORx study.
On July 1, a three-year registry program started in Belgium to provide patients with funded access to the Oncotype DX Breast Recurrence Score test in breast cancer reference centers throughout the country.
Additional private insurers established new coverage for the Oncotype DX Genomic Prostate Score test, bringing the total number of U.S. covered lives to more than 116 million, including Medicare.
Multiple private insurers established reimbursement for the Oncotype DX AR-V7 Nucleus Detect test, bringing the total number of U.S. covered lives to more than 75 million, including Medicare.
Additional private insurers established reimbursement for the Oncotype DX Breast Recurrence Score test in patients with 1-3 positive nodes, bringing the total number of U.S. covered lives in this breast cancer population to more than 144 million, including Medicare.
Non-GAAP Disclosure

The company provides adjusted EBITDA and constant currency, which are non-GAAP financial measure, to supplement the financial information provided on a GAAP basis. Non-GAAP adjusted EBITDA excludes items that are included in GAAP income (loss) from operations, and excludes stock-based compensation expense and depreciation and amortization and their related tax effects. Constant currency is calculated by comparing the company’s quarterly average foreign exchange rates for the three and six months ended June 30, 2019 and 2018. The constant currency disclosures take current local currency revenue and translate it into U.S. dollars based upon the foreign currency exchange rates used to translate the local currency revenue for the applicable comparable period in the prior year, rather than the actual exchange rates in effect during the current period. Constant currency does not include any other effect of changes in foreign currency rates on the company’s results or business. The company believes that these non-GAAP measures reflect operating results that are more indicative of the company’s ongoing operating performance while improving comparability to prior periods, and, as such, may provide investors with an enhanced understanding of the company’s past financial performance and prospects for the future. In addition, the company’s management uses such non-GAAP measures internally to evaluate and assess its core operations and to make ongoing operating decisions. Non-GAAP information is not intended to be considered in isolation or as a substitute for comparable information prepared in accordance with GAAP. Investors are encouraged to review the reconciliation of these non-GAAP measure to their most directly comparable GAAP financial measures as detailed in the tables accompanying this press release.

Conference Call Details
To access the live conference call today, July 29, 2019, at 8:00 a.m. Eastern Time via phone, please dial (877) 201-0168 from the United States and Canada, or +1 (647) 788-4901 internationally. The conference call ID is 8288326. Please dial in approximately 10 minutes prior to the start of the call. To access the live and subsequently archived webcast of the conference call, go to the Investor Relations section of the company’s website at View Source Please connect to the website at least 15 minutes prior to the presentation to allow for any software download that may be necessary.