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.

On July 29, 2019 Sanofi reported that Second-quarter 2019 sales growth(3) driven by Sanofi Genzyme, Sanofi Pasteur and Emerging Markets (Press release, Sanofi, JUL 29, 2019, View Source [SID1234537868]).

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Net sales were €8,628 million, up 5.5% on a reported basis, up 3.9%(3) at CER and up 5.8% at CER/CS(4).
Sanofi Genzyme sales up 21.8% due to strong launch performance of Dupixent.
Vaccines sales increased 24.7% mainly reflecting the recovery and growth of Pentaxim in China and low basis for comparison.
CHC sales up 1.1%, as U.S. growth more than offset lower sales in Europe impacted by non-strategic brand divestments.
Primary Care GBU sales declined 10.4% at CER/CS mainly as a result of lower Diabetes sales.
Emerging Markets sales(5) grew double-digits (up 10.0%) supported by higher Vaccines and Rare Disease sales.
2019 business EPS guidance revised upward

Q2 2019 business net income increased 5.3% to €1,641 million and 4.9% at CER.
Q2 2019 business EPS(1) up 4.8% at CER to €1.31.
Q2 2019 IFRS EPS was -€0.07 (-115.5%) reflecting a €1.8 billion impairment charge mainly related to Eloctate.
Business EPS(1) in 2019 is now expected to grow approximately 5% at CER(6) barring unforeseen major adverse events. Applying the average July 2019 exchange rates, the currency impact on 2019 business EPS is estimated to be between 1% and 2%.
Key regulatory milestones achieved in R&D

Isatuximab accepted for review by the FDA and EMA for approval in relapsed/refractory multiple myeloma.
Libtayo approved for advanced cutaneous squamous cell carcinoma in the EU.
Dupixent recommended by CHMP for atopic dermatitis in adolescents.
Dupixent approved in the U.S. for chronic rhinosinusitis with nasal polyposis.
FDA accepted for review MenQuadfi, a meningococcal vaccine candidate.

Sanofi Chief Executive Officer, Olivier Brandicourt, commented:

"Sanofi continued its growth phase with a solid business performance in the second quarter, led by the strong launch of Dupixent driven by the accelerated uptake in atopic dermatitis and asthma in the U.S. Specialty Care and Vaccines were significant contributors across all geographies. Our increased focus in R&D delivered important results with several positive data read-outs and the achievement of regulatory milestones. We are confident in the growth outlook for the year. Consequently, we have revised upward our guidance for full-year business EPS growth to approximately 5%."

(1) In order to facilitate an understanding of operational performance, Sanofi comments on the business net income statement. Business net income is a non-GAAP financial measure (see Appendix 10 for definitions). The consolidated income statement for Q2 2019 is provided in Appendix 3 and a reconciliation of reported IFRS net income to business net income is set forth in Appendix 4;(2) including a €1.8 billion impairment charge mainly related to Eloctate – see page 12; (3) Changes in net sales are expressed at constant exchange rates (CER) unless otherwise indicated (see Appendix 10); (4) Constant Structure: Adjusted for divestment of European Generics business and sales of Bioverativ products to SOBI; (5) See definition page 9; (6) 2018 business EPS was €5.47.

R&D update

Consult Appendix 6 for full overview of Sanofi’s R&D pipeline

Regulatory update

Regulatory updates since April 26, 2019 include the following:

In July, the U.S. Food and Drug Administration (FDA) accepted for review the Biologics License Application (BLA) for isatuximab for the treatment of patients with relapsed/refractory multiple myeloma (RRMM). The target action date for the FDA decision is April 30, 2020.
In June, Libtayo (cemiplimab, collaboration with Regeneron) was approved in the European Union (EU) for the treatment of adults with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) who are not candidates for curative surgery or curative radiation.
In June, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Dupixent (dupilumab, collaboration with Regeneron) recommending extending its approval in the EU to include adolescents 12 to 17 years of age with moderate-to-severe atopic dermatitis who are candidates for systemic therapy.
The FDA accepted for review the BLA for Sanofi’s MenQuadfi Meningococcal Polysaccharide Tetanus Toxoid Conjugate Vaccine candidate to help prevent meningococcal meningitis. The target action date for the FDA decision is April 25, 2020.
In June, the FDA approved Dupixent for the treatment of chronic rhinosinusitis with nasal polyposis (CRSwNP) in adults whose disease is not adequately controlled.
In May, the European Commission approved Dupixent for use in adults and adolescents 12 years and older as an add-on maintenance treatment for severe asthma with type 2 inflammation characterized by raised blood eosinophils and/or raised fractional exhaled nitric oxide (FeNO), who are inadequately controlled with high dose inhaled corticosteroid (ICS) plus another medicinal product for maintenance treatment.
In May, SAR341402 (insulin aspart), a rapid acting insulin, was submitted to the EMA for the treatment of Type I and II diabetes.
In April, the FDA approved Praluent (collaboration with Regeneron) to reduce the risk of heart attack, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease.
At the end of July 2019, the R&D pipeline contained 83 projects, including 34 new molecular entities in clinical development. 35 projects are in phase 3 or have been submitted to the regulatory authorities for approval.

Portfolio update

Phase 3:

Topline results from three Phase 3 trials of Zynquista (sotagliflozin) in adults with type 2 diabetes from the InSynchrony clinical program were announced on July 26. Given the primary endpoint results of blood sugar control (HbA1c) reduction in the SOTA-CKD3 and SOTA-CKD4 studies, Sanofi provided notice to Lexicon that it is terminating the collaboration to develop, manufacture, and commercialize Zynquista in all ongoing global type 1 and type 2 diabetes programs. At this time, the ongoing Phase 3 clinical trials will continue and there will be no immediate changes. Sanofi has expressed willingness to work with Lexicon to ensure a smooth transition of the studies. Sanofi remains committed to working and supporting the investigators and patients enrolled in the studies while next steps are discussed with Lexicon.
Results from a phase 3 study evaluating Soliqua/Suliqua (insulin glargine 100 Units/mL and lixisenatide) in adults with type 2 diabetes inadequately controlled by GLP-1 receptor agonist (GLP-1 RA) treatments were presented at the American Diabetes Association (ADA) Scientific Sessions in June. The study met the primary objective by demonstrating a statistically superior reduction of average blood sugar level (HbA1c) after 26 weeks, compared with continuing GLP-1 RA treatment.
Pivotal phase 3 ICARIA-MM trial results were presented at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June and demonstrated that isatuximab added to pomalidomide and dexamethasone (isatuximab combination therapy) showed statistically significant improvements compared to pomalidomide and dexamethasone (pom-dex) alone in patients with relapsed/refractory multiple myeloma (RRMM).
A phase 3 study evaluating cemiplimab, a PD-1 inhibitor, in adjuvant treatment for Cutaneous Squamous Cell Carcinoma (CSCC) started.
Dupilumab , moved into phase 3 in Chronic Obstructive Pulmonary Disease (COPD).
Fitusiran , a siRNA inhibitor targeting AT3, entered phase 3 for pediatric hemophilia.
Nirsevimab ( SP0232, collaboration with Medimmune), a monoclonal antibody, entered phase 3 for respiratory syncytial virus (RSV)
Phase 2:

SAR440340/REGN3500 (collaboration with Regeneron), an investigational IL-33 antibody, met the primary endpoint of improvement in loss of asthma control when comparing monotherapy to placebo in a phase 2 proof-of-concept trial The trial also met a key secondary endpoint, demonstrating SAR440340 monotherapy significantly improved lung function compared to placebo. Patients treated with Dupixent monotherapy did numerically better than SAR440340 across all endpoints, although the trial was not powered to show differences between active treatment arms. The combination of SAR440340 and Dupixent did not demonstrate increased benefit compared to Dupixent monotherapy in this trial.
Phase 1:

A phase 1 trial evaluating SAR441255, a trigonal GLP1R/GIPR/GCGR agonist was initiated.
SAR441236 , a tri-specific neutralizing anti-HIV mAb, entered into phase 1.
An additional seven research projects have been discontinued to enhance the company’s focus on delivering first and best in class medicines

Collaboration

In June, Sanofi and Google announced that they will establish a new virtual Innovation Lab with the ambition to transform how future medicines and health services are delivered by tapping into the power of emerging data technologies. The collaboration aims to change how Sanofi develops new treatments and will focus on three key objectives: to better understand patients and diseases, to increase Sanofi’s operational efficiency, and to improve the experience of Sanofi’s patients and customers.

On July 29, 2019 Arvinas, Inc. (Nasdaq: ARVN), a biotechnology company creating a new class of drugs based on targeted protein degradation, reported the appointment of Ronald Peck, M.D. to the newly created position of Chief Medical Officer (CMO) (Press release, Arvinas, JUL 29, 2019, View Source [SID1234537833]). Dr. Peck brings to Arvinas more than twenty years of clinical and drug development experience, most recently serving as Senior Vice President, Clinical Research at Tesaro, where he oversaw all clinical development efforts for the company’s entire pipeline, including Zejula (niraparib) and Tesaro’s immuno-oncology programs.

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"Dr. Peck arrives at the right time for our company, as we advance ARV-110 through a Phase 1 clinical trial and expect to initiate a Phase 1 clinical trial of ARV-471 in the third quarter of 2019," said John Houston, Ph.D., President and CEO of Arvinas. "Ron is a highly accomplished clinician with a strong track record of successful drug development, leading novel oncology programs from the earliest phases through to registration. His experience is strongly aligned with our goals at this pivotal time for the company."

"Arvinas is leading the industry with its new and exciting technology platform of PROTAC targeted protein degraders," said Dr. Peck. "The company has tremendous momentum. With one clinical program, which also received Fast Track designation from FDA, and another program entering the clinic soon, I anticipate Arvinas will be the first company in the field to have clinical data with a targeted protein degrader. I am excited to be joining Arvinas, and look forward to pursuing the development of PROTAC protein degraders to benefit patients and address unmet medical needs in oncology and in other devastating and life-threatening diseases."

Prior to his work at Tesaro, Dr. Peck served as the CMO of Kolltan Pharmaceuticals, a privately-held clinical-stage biotechnology company where he oversaw the clinical development of monoclonal antibodies targeting receptor tyrosine kinases. Dr. Peck began his industry career at Bristol Myers Squibb (BMS), where he spent 15 years in drug development, eventually serving as Vice President, YERVOY (ipilimumab) Global Development Lead. At BMS, he played a key role in the approval and commercialization of YERVOY (ipilimumab) across all indications and contributed to the successful development of multiple other oncology assets, including IXEMPRA (ixabepilone). Early in his BMS career, Dr. Peck contributed to the life cycle development of ABILIFY (aripiprazole) within the neuroscience clinical research organization. Dr. Peck received his bachelor’s degree in chemistry from Georgetown University in Washington, D.C., his M.D. from Thomas Jefferson University Medical College in Philadelphia, PA., and completed a residency and hematology/oncology fellowship at Georgetown University in Washington, D.C before serving as Assistant Professor of Medicine at the University of Virginia.

About PROTAC Protein Degraders

Arvinas’ PROTAC protein degraders harness the body’s own natural protein disposal system to degrade disease-causing proteins. PROTAC protein degraders recruit an E3 ligase to tag the target protein with ubiquitin, which directs its degradation through the proteasome, a large protein complex that breaks down the ubiquitinated target protein into small peptides and amino acids. As the target protein is degraded, the PROTAC protein degrader is released and acts iteratively to destroy additional target protein.

PROTAC protein degraders offer numerous potential advantages as therapeutics, including broad tissue distribution, routes of administration that include oral delivery, and simpler manufacturing than other new modalities, such as cell-based therapies. Arvinas has developed and optimized a proprietary library of protein targeting ligands, E3 ligase ligands, and linkers, which allow the company to rapidly identify and optimize efficient protein degraders with favorable characteristics for successful drug development.

On July 29, 2019 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer, wet age-related macular degeneration through our license to Santen Pharmaceutical Co. Ltd., and utilizing our product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., reported that Charles Theuer, M.D., Ph.D., President and CEO, will participate in the Wells Fargo Securities 2019 Biotech Corporate Access Day on August 1, 2019 in San Francisco (Press release, Tracon Pharmaceuticals, JUL 29, 2019, View Source [SID1234537852]).

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