On December 8, 2017 Adaptive Biotechnologies, the leader in using next-generation sequencing (NGS) to detect minimal/measurable residual disease (MRD) in blood cancers, and its collaborators reported that they will present 22 studies, including a late-breaker presentation, at the 59th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in Atlanta, December 9-12 (Press release, , DEC 8, 2017, View Source [SID1234522517]). Data presented at ASH (Free ASH Whitepaper) will demonstrate how Adaptive’s clonoSEQ Assay to measure MRD, the cancerous cells remaining in the body after treatment, can inform clinical care in patients with B and T cell lymphoid malignancies. Additionally, at ASH (Free ASH Whitepaper), Adaptive and its collaborators will present data from studies utilizing the company’s research-based immunosequencing platform, immunoSEQ, to identify potential biomarkers of response to therapy.

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"MRD is increasingly viewed as a critical endpoint in lymphoid cancers used to assess a patient’s response to cancer treatment and evaluate disease burden over time. At Adaptive, we are excited to see the growing use of this endpoint to support clinical trials and patient management," said Charles Sang, Senior Vice President of Diagnostics. "We leveraged our foundational immunosequencing platform to develop the clonoSEQ Assay which provides a highly sensitive and standardized determination of residual disease in patients with lymphoid malignancies."

clonoSEQ, the first clinical application of Adaptive’s pioneering immunosequencing platform, is helping to set a new standard for assessment of minimal residual disease in the clinic. It will be featured in a late breaker presentation, 5 orals and 7 posters. Data will be presented across a range of cancers – 9 multiple myeloma, 1 peripheral T-cell lymphoma, 1 mantle cell lymphoma, 1 chronic lymphocytic leukemia, 1 follicular lymphoma. Abstracts of importance include:

LBA-4 Phase 3 Randomized Study of Daratumumab Plus Bortezomib, Melphalan, and Prednisone (D-VMP) Versus Bortezomib, Melphalan, and Prednisone (VMP) in Newly Diagnosed Multiple Myeloma (NDMM) Patients (Pts) Ineligible for Transplant (ALCYONE) (LBA-4)
Minimal Residual Disease in Multiple Myeloma: Final Analysis of the IFM2009 Trial (Abstract #435)
Daratumumab, Lenalidomide, and Dexamethasone (DRd) Versus Lenalidomide and Dexamethasone (Rd) in Relapsed or Refractory Multiple Myeloma (RRMM): Updated Efficacy and Safety Analysis of Pollux (Abstract #739)
Below is a full list of clonoSEQ and immunoSEQ related abstracts that will be presented at ASH (Free ASH Whitepaper) this year.

CLONOSEQ ORAL ABSTRACT AND POSTER PRESENTATION HIGHLIGHTS:

Saturday, December 9, 2017

Oral Presentation, Abstract #154 Initial Treatment with Lenalidomide Plus Rituximab for Mantle Cell Lymphoma: 5-Year Follow-up and Correlative Analysis from a Multi-Center Phase II Study

Presenter: Jia Ruan, MD, PhD, Weill Cornell Medicine and New York Presbyterian Hospital, New York, NY

Time: 12:45 – 1:00 PM

Location: Bldg A, Lvl 4, A411-A412 (Georgia World Congress Center)

Poster Presentation, Abstract #1824 Daratumumab in Combination with Pomalidomide and Dexamethasone for RRMM Patients with ≥2 Prior Lines of Therapy: Updated Analysis of MMY1001

Presenter: Thierry Facon, Department of Haematology, Lille University Hospital, Lille, France

Time: 5:30 – 7:30 PM

Location: Bldg A, Lvl 1, Hall A2 (Georgia World Congress Center)

Poster Presentation, Abstract #1852 Daratumumab, Bortezomib, and Dexamethasone Versus Bortezomib and Dexamethasone for Relapsed/Refractory Multiple Myeloma (RRMM) Patients: An Update of Overall Survival in Castor

Presenter: Suzanne Lentzsch, Columbia University Medical Center, New York, NY

Time: 5:30 – 7:30 PM

Location: Bldg A, Lvl 1, Hall A2 (Georgia World Congress Center)

Poster Presentation, Abstract #1883 Daratumumab, Lenalidomide, and Dexamethasone Versus Lenalidomide and Dexamethasone in RRMM Based on Prior Treatment History, Renal Function, and Cytogenetic Risk: Subgroup Analyses of Pollux

Presenter: Philippe Moreau, Hematology, University Hospital Hôtel-Dieu, Nantes, France

Time: 5:30 – 7:30 PM

Location: Bldg A, Lvl 1, Hall A2 (Georgia World Congress Center)

Sunday, December 10, 2017

Oral Presentation, Abstract #435 Minimal Residual Disease in Multiple Myeloma: Final Analysis of the IFM2009 Trial

Presenter: Hervé Avet-Loiseau, MD, PhD, UC-Oncopole, Unite de Genomique du Myelome, Toulouse, France

Time: 12:30 – 12:45 PM

Location: Bldg C, Lvl 1, Hall C4 (Georgia World Congress Center)

Oral Presentation, Abstract #496 A Multicenter, Phase II Study of Ibrutinib Plus FCR As Frontline Therapy for Younger CLL Patients

Presenter: Matthew S. Davids, MD, Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA

Time: 5:15 – 5:30 PM

Location: Bldg B, Lvl 5, Murphy BR 3-4 (Georgia World Congress Center)

Poster Presentation, Abstract #2728 Next-Generation Sequencing Based Monitoring of Circulating-Tumor DNA in Untreated Peripheral T-Cell Lymphoma

Presenter: Christopher Melani, MD, Lymphoid Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Baltimore, MD

Time: 6:00 – 8:00 PM

Location: Bldg A, Lvl 1, Hall A2 (Georgia World Congress Center)

Poster Presentation, Abstract #3145 Daratumumab, Bortezomib, and Dexamethasone Versus Bortezomib and Dexamethasone in RRMM: Updated Efficacy and Safety Analysis of Castor

Presenter: Andrew Spencer, MD, Malignant Haematology and Stem Cell Transplantation Service, Alfred Health-Monash University, Melbourne, Australia

Time: 6:00 – 8:00 PM

Location: Bldg A, Lvl 1, Hall A2 (Georgia World Congress Center)

Monday, December 11, 2017

Oral Presentation, Abstract #739 Daratumumab, Lenalidomide, and Dexamethasone (DRd) Versus Lenalidomide and Dexamethasone (Rd) in Relapsed or Refractory Multiple Myeloma (RRMM): Updated Efficacy and Safety Analysis of Pollux

Presenter: Meletios A. Dimopoulos, National and Kapodistrian University of Athens, Athens, Greece

Time: 2:45 – 3:00 PM

Location: Bldg C, Lvl 1, Hall C1 (Georgia World Congress Center)

Poster Presentation, Abstract #4533 High Rate of Sustained Minimal Residual Disease Negativity Predicts Prolonged Survival for the Overall Patient Population in the Phase 2 KRd Plus Autologous Stem Cell Transplantation MMRC Trial

Presenter: Andrzej J. Jakubowiak, MD, University of Chicago Medical Center, Chicago, IL

Time: 6:00 – 8:00 PM

Location: Bldg A, Lvl 1, Hall A2 (Georgia World Congress Center)

Poster Presentation, Abstract #4685 Measurable Residual Disease (MRD) Testing in Multiple Myeloma Using an Improved Testing Technology: Population Impact

Presenter: Marita Zimmermann, PhD, MPH, Veritech Corporation, Seattle, WA

Time: 6:00 – 8:00 PM

Location: Bldg A, Lvl 1, Hall A2 (Georgia World Congress Center)

Tuesday, December 12, 2017

Late Breaker Presentation: LBA-4 Phase 3 Randomized Study of Daratumumab Plus Bortezomib, Melphalan, and Prednisone (D-VMP) Versus Bortezomib, Melphalan, and Prednisone (VMP) in Newly Diagnosed Multiple Myeloma (NDMM) Patients (Pts) Ineligible for Transplant (ALCYONE)

Presenter: Maria-Victoria Mateos, University Hospital of Salamanca/IBSAL, Salamanca, Spain

Time: 7:30 AM-9:00 AM

Location: Bldg C, Lvl 1, Hall C2-C3 (Georgia World Congress Center)

IMMUNOSEQ ABSTRACT AND POSTER PRESENTATION HIGHLIGHTS:

Saturday, December 9, 2017

Poster Presentation, Abstract #1898 Quantifying the Size and Diversity of the Human Alloresponse Via High-Throughput T Cell Receptor Sequencing

Presenter: Susan DeWolf, MD, Columbia Center for Translational Immunology (CCTI), Columbia University Medical Center, New York, NY

Time: 5:30 – 7:30 PM

Location: Bldg A, Lvl 1, Hall A2 (Georgia World Congress Center)

Poster Presentation, Abstract #2069 Novel Human Anti-HLA-Bw4 and B61 Monoclonal Antibodies Kill Malignant B Cells Via CDC/ADCC While Sparing Normal Peripheral Blood Cells

Presenter: Hiroyuki Takamatsu, MD, PhD, Department of Hematology, Kanazawa University, Kanazawa, Japan

Time: 5:30 – 7:30 PM

Location: Bldg A, Lvl 1, Hall A2 (Georgia World Congress Center)

Sunday, December 10, 2017

Poster Presentation, Abstract #2454 Surveillance of the Immune Repertoire of Aplastic Anemia Patients Using Deep Sequencing

Presenter: Cassandra Hirsch, BS, Department of Translational Hematology and Oncology, Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH

Time: 6:00 – 8:00 PM

Location: Bldg A, Lvl 1, Hall A2 (Georgia World Congress Center)

Poster Presentation, Abstract #2734 Longitudinal Analyses of the Genomic, Transcriptomic, and T-Cell Repertoire in Diffuse Large B-Cell Lymphoma Demonstrates Changes in Signaling and Immune Recognition at Relapse

Presenter: Shamzah Araf, MRCP, MBBS, Centre for Haemato-Oncology, Barts Cancer Institute, Queen Mary University of London, London, United Kingdom

Time: 6:00 – 8:00 PM

Location: Bldg A, Lvl 1, Hall A2 (Georgia World Congress Center)

Poster Presentation, Abstract #2771 Intratumoral G100 Induces Systemic Immunity and Abscopal Tumor Regression in Patients with Follicular Lymphoma: Results of a Phase 1/ 2 Study Examining G100 Alone and in Combination with Pembrolizumab

Presenter: Christopher Flowers, MD, MS, Winship Cancer Institute Bone Marrow & Stem Cell Transplantation, Atlanta, GA

Time: 6:00 – 8:00 PM

Location: Bldg A, Lvl 1, Hall A2 (Georgia World Congress Center)

Monday, December 11, 2017

Oral Presentation, Abstract #649 Results from a Phase 1/2 Study of Brentuximab Vedotin in Combination with Nivolumab in Patients with Relapsed or Refractory Hodgkin Lymphoma

Presenter: Alex F. Herrera, MD, City of Hope, Duarte, CA

Time: 10:30 – 10:45 AM

Location: Bldg A, Lvl 4, Marcus Aud. (Georgia World Congress Center)

Oral Presentation, Abstract #728 The Tumor Microenvironment Is Independently Prognostic of Conventional and Clinicogenetic Risk Models in Follicular Lymphoma

Presenter: Joshua W.D. Tobin, University of Queensland, Australia

Time: 3:00 – 3:15 PM

Location: Bldg C, Lvl1, C101 Auditorium (Georgia World Congress Center)

Oral Presentation, Abstract #825 The T-Cell Receptor Repertoire Predicts Interim-PET in Patients with DLBCL Treated with R-CHOP: An Observational Study from a Prospective Clinical Trial

Presenter: Mohamed Shanavas, MD, University of Queensland Diamantina Institute, Brisbane, Australia

Time: 5:00 PM

Location: Bldg C, Lvl 3, Georgia BR 1-3 (Georgia World Congress Center)

Poster Presentation, Abstract # 4506 Day 90 Post-Allogeneic Hematopoietic Cell Transplantation T Cell Receptor Diversity Level Correlates with Risk of Relapse in Patients with Multiple Myeloma

Presenter: Robert Korngold, PhD, John Theurer Cancer Center, Hackensack Univ. Med. Ctr. Jurist Research Bldg., Hackensack, NJ

Time: 6:00 – 8:00 PM

Location: Bldg A, Lvl 1, Hall A2 (Georgia World Congress Center)

About Minimal/Measurable Residual Disease

Minimal/measurable residual disease (MRD) in hematologic malignancies refers to cancer cells that remain in the body of a person with cancer after treatment. In the case of clonoSEQ this includes ALL and MM. These cells can be present at levels undetectable by traditional morphologic, microscopic examination of blood, bone marrow or a lymph node biopsy. Sensitive molecular technologies, such as next-generation sequencing utilized by the Adaptive Biotechnologies clonoSEQ Assay, may be employed to facilitate the reliable detection of MRD at levels below the limits of traditional assessment.

About the clonoSEQ Assay

The Adaptive Biotechnologies clonoSEQ Assay enables physicians to utilize a molecular, next-generation sequencing-based minimal/measurable residual disease (MRD) detection method. The clonoSEQ Assay detects and quantifies DNA sequences found in malignant cells which can be tracked throughout treatment. This robust assay provides consistent, accurate measurement of disease burden which potentially allows physicians to visualize response to treatment over time. The clonoSEQ assay is not approved or cleared by the FDA and is currently available in a CLIA-certified laboratory. clonoSEQ test results should only be used taking into account all available clinical information and should not be used as the sole determinant of patient care and management.

About the immunoSEQ Platform

Adaptive’s immunoSEQ Platform helps researchers make discoveries in areas such as oncology, autoimmune disorders, infectious diseases and basic immunology. The immunoSEQ Assays can identify millions of T- and B-cell receptors from a single sample in exquisite detail. Offered as a Service or Kit, immunoSEQ Assays provide quantitative, reproducible sequencing results along with access to powerful, easy-to-use analysis tools. The immunoSEQ Assays are for research use only and are not for use in diagnostic procedures.

On December 7, 2017 Enzo Biochem Inc. (NYSE:ENZ) reported improved operating results for the first fiscal quarter ended October 31, 2017, including year over year double digit revenue growth at Enzo Clinical Labs (Press release, Enzo Biochem, DEC 7, 2017, View Source [SID1234522442])

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.

First Quarter’s Highlights (Year Over Year):

· Total revenue in the first fiscal quarter increased to $27.7 million, or 5%, from $26.3 million in the prior year period.
· Clinical Labs revenue totaled $20.3 million, or an increase of 10% from $18.6 million a year ago.
· Gross profit increased 1%, with operating income improving $0.7 million, or 53%. Gross margin was 44%.
· The GAAP and non-GAAP net loss was $0.6 million or ($0.01) per fully diluted share, an improvement of $0.8 million, or 56% over the prior year’s net loss of $1.5 million or $(0.03) per fully diluted share.
· Total cash and cash equivalents at October 31, 2017 was $66.8 million, an increase of $2.7 million from July 31, 2017. Tight cost controls and efficiencies resulted in positive $2.6 million cash flow from operations in the quarter.
· During the quarter, the New York State Health Department issued conditional approval of the final three women’s health related molecular diagnostic tests which completes a 13-analyte panel, placing Enzo in a leading position to benefit from higher-margin proprietary women’s health diagnostics.
· Plant facilities in Farmingdale, NY, undergoing expansion to accommodate anticipated growth in manufacturing of growing roster of new molecular diagnostic assays and to increase laboratory capacity and to support GMP certification.

Barry Weiner, President, Comments:

"The first quarter of fiscal 2018 saw additional progress in moving aggressively towards our model as an integrated, growth-oriented molecular diagnostics company, and a low-cost medically related assay provider and reference service organization. Revenues continued to grow, spurred by double digit growth in the quarter at Clinical Labs, the result of expanded product and service capabilities and geographical expansion, along with increasing volume from our association with leading healthcare insurance providers. Sales, general and administrative costs (SG&A) are being held in check, even as product development and research efforts continue. We are also completing preparations to launch our marketing and sales program of our comprehensive products and reference services menu, while also adding to our Lab’s capability, particularly in the women’s health diagnostic field.

"We are preparing to offer one of the industry’s most advanced and well-rounded 13-analyte women’s health diagnostics panel, which last month was presented at the annual meeting of the prestigious Association for Molecular Pathology. The study our group reported on demonstrated that Enzo’s AMPIPROBE technology provides a new proprietary approach to creating clinically sensitive and specific multiplex real-time PCR assays, which, when run in tandem, can serve as a comprehensive panel for the accurate detection and identification of vaginitis-associated microorganisms. Enhanced by our proprietary AMPIPROBE technology, it offers faster, more specific and more sensitive molecular vaginitis testing, which we expect to improve diagnoses of vaginitis, a leading medical concern among women. Increasingly, when measured against the performance of similar assays, Enzo products continue to outperform, as reported recently in a leading diagnostic pathology publication, which cited our Polyview technology for viewing the clinical morphology of HPV specimens as having no false positives. That compared favorably to other leading competitive products that did have false positives in their tests.

"Our focus is on gaining sustained profitability and advancing healthcare in today’s challenging environment by providing affordable and reliable diagnostic testing. With Medicare reimbursement rates expected to decline materially over the next three years based on a new formula being adopted in place of one used over the past 30 years, the challenges are clear. Enzo’s transformative blueprint may help to alleviate this new challenge to the nation’s independent labs. This opportunity is reflected in our expanding line of medically related, versatile, highly efficient platforms and assays that are increasingly professionally recognized for their sensitivity and economics."

First Quarter Results
Total revenues increased to $27.7 million or 5% higher than the prior year period driven by increased Clinical labs services revenue from MDx tests. Gross profit was $12.2 million or 44% of total revenue. Total operating expenses were $12.9 million, a decline of $0.5 million or 4% over a year ago.

The GAAP and Non-GAAP net loss amounted to $(0.6) million, or $(0.01) per fully diluted share, compared to the year ago net loss of $(1.5) million or $(0.03) per fully diluted share, an improvement of $0.8 million. EBITDA and Adjusted EBITDA were essentially break even compared with a loss of $(0.6) million a year ago, a $0.5 million improvement year over year.

As of October 31, 2017 working capital amounted to $71.4 million, cash and cash equivalents totaled $66.8 million, up $2.7 million from three months earlier. Apart from capital leases, there was no debt.

Quarterly Segment Results

Enzo Clinical Labs revenues increased to $20.3 million, or 10%, from $18.6 million a year ago. As noted above, expansion of its diagnostics services to additional nearby geographical locations, the increased product mix of diagnostic tests, particularly in the women’s health field, and greater volume, all are contributing to its steady test and service growth. Gross profit increased to $8.3 million, from $7.7 million, with gross margin as a percentage of revenues at 41% for both the current and year ago quarters. Total operating expenses increased by 3.6%, to $6.9 million. Operating income amounted to $1.4 million, a nearly 40% increase.

Enzo Life Sciences revenues were $7.1 million compared to $7.4 million a year ago, a decline of $0.3 million or 5%. Gross profit approximated $4 million and gross margin as a percentage of revenue was 54%, compared to $4.4 million and 57%, respectively, a year ago. With the continued focus on reducing costs and improving efficiency, SG&A declined by 11%, to $2.6 million, with total operating expenses declining 12%, to $3.2 million.

Conference Call

The Company will conduct a conference call Friday, December 8, 2017 at 8:30 AM ET. The call can be accessed by dialing 1-888-459-5609. International callers can dial 1-973-321-1024. Please reference PIN number 3678737.

Interested parties may also listen over the Internet at: View Source

To listen to the live call on the Internet, please go to the web site at least fifteen minutes early to register, download and install any necessary audio software. For those who cannot listen to the live broadcast, a replay will be available approximately two hours after the end of the live call, through midnight (ET) on December 22, 2017. The replay of the conference call can be accessed by dialing 1-855-859-2056, and when prompted, use PIN number 3678737. International callers can dial 1-404-537-3406, using the same PIN number.

NON-GAAP Financial Measures

To comply with Regulation G promulgated pursuant to the Sarbanes-Oxley Act, Enzo Biochem attached to this news release and will post to the Company’s investor relations web site (www.enzo.com) any reconciliation of differences between non-GAAP financial information that may be required in connection with issuing the Company’s quarterly financial results.

The Company uses EBITDA as a measure of performance to demonstrate earnings exclusive of interest, taxes, depreciation and amortization. Adjustments to EBITDA are for items of a non-recurring nature and are reconciled on the table provided. The Company manages its business based on its operating cash flows. The Company, in its daily management of its business affairs and analysis of its monthly, quarterly and annual performance, makes its decisions based on cash flows, not on the amortization of

assets obtained through historical activities. The Company, in managing its current and future affairs, cannot affect the amortization of the intangible assets to any material degree, and therefore uses EBITDA as its primary management guide. Since an outside investor may base its evaluation of the Company’s performance based on the Company’s net loss not its cash flows, there is a limitation to the EBITDA measurement. EBITDA is not, and should not be considered, an alternative to net loss, loss from operations, or any other measure for determining operating performance of liquidity, as determined under accounting principles generally accepted in the United States (GAAP). The most directly comparable GAAP reference in the Company’s case is the removal of interest, taxes, depreciation and amortization.

We refer you to the tables attached to this press release which includes reconciliation tables of GAAP to Non-GAAP net income (loss) and EBITDA to Adjusted EBITDA.

On December 7, 2017 Seattle Genetics, Inc. (NASDAQ: SGEN) reported updated data from an ongoing phase 1 clinical trial evaluating ladiratuzumab vedotin in patients with metastatic triple negative breast cancer (TNBC) at the 2017 San Antonio Breast Cancer Symposium (SABCS), taking place December 5-9, 2017 (Press release, Seattle Genetics, DEC 7, 2017, View Source;p=RssLanding&cat=news&id=2321594 [SID1234522430]). Ladiratuzumab vedotin is an investigational antibody-drug conjugate (ADC) designed to deliver a potent and clinically validated cell-killing agent, monomethyl auristatin E (MMAE), to cancer cells which express the protein LIV-1. LIV-1 is expressed on multiple solid tumors including breast, prostate, melanoma, ovarian, uterine, and cervical cancers.

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"Overall, the phase 1 results we’ve presented at SABCS confirm previous findings that single-agent treatment with ladiratuzumab vedotin was generally well-tolerated and showed encouraging antitumor activity in patients with heavily-pretreated metastatic TNBC," said Robert Lechleider, M.D., Senior Vice President, Clinical Development at Seattle Genetics. "We continue to evaluate ladiratuzumab vedotin monotherapy in TNBC, with planned combination studies in earlier lines of treatment, demonstrating our overarching commitment to improve the health of women with this devastating disease."

Findings from this ongoing phase 1 study of ladiratuzumab vedotin in patients with metastatic breast cancer were last presented at the 2016 SABCS. The updated results presented today in a spotlight session describe the safety, tolerability, and antitumor activity of ladiratuzumab vedotin in 28 additional patients with TNBC.

Phase 1 Study of the Antibody-Drug Conjugate Ladiratuzumab Vedotin (SGN-LIV1A) in Patients with Heavily Pretreated Triple-Negative Metastatic Breast Cancer (Poster# PD3-14, Poster Session – Novel Drugs / Predicting Response for HER2+ Breast Cancer at 7:00 – 9:00 a.m. CT on Thursday, December 7, 2017)

A total of 81 patients with LIV-1-expressing metastatic breast cancer were treated with ladiratuzumab vedotin monotherapy given every three weeks. Patients enrolled in the study had received a median of four prior systemic metastatic therapies. Of these patients, 63 were diagnosed with TNBC and 18 had hormone receptor-positive / human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer. At the completion of dose escalation at doses ranging from 0.5 to 2.8 milligrams per kilogram (mg/kg), TNBC expansion cohorts were opened at 2.0 and 2.5 mg/kg to further evaluate safety and antitumor activity of ladiratuzumab vedotin in metastatic TNBC patients. Based on efficacy and safety, the recommended dose is 2.5 mg/kg with a maximum dose of 200 mg per cycle.

Key findings in this heavily pre-treated patient population were presented by Dr. Jennifer Specht, Seattle Cancer Care Alliance and include:

Among the 60 efficacy-evaluable patients with metastatic TNBC, the objective response rate (ORR) was 25 percent, representing all partial responses (PR). The clinical benefit rate (CBR) was 28 percent. CBR is defined as patients achieving complete response (CR) or PR of any duration, plus patients achieving stable disease (SD) lasting at least 24 weeks. Of the 17 efficacy-evaluable patients treated at the recommended dose, 29 percent achieved an objective response (confirmed and unconfirmed), and the CBR was 29 percent.
The median progression-free survival (PFS) and median duration of response (DOR) for patients treated across all dose levels were 11 weeks and 13.3 weeks, respectively. In 19 patients treated at the recommended dose, the median PFS was 12.1 weeks, and the median DOR was 17.4 weeks.
At the recommended dose, ladiratuzumab vedotin was generally well-tolerated and most adverse events were Grade 1/2.
Of the 81 patients treated in the study, peripheral neuropathy events occurred in 16 patients (19.8 percent) and were generally low grade (Grades 1/2) and manageable. Seven patients discontinued treatment due to adverse events.
Grade 3/4 adverse events included neutropenia and anemia. The Grade 3/4 incidence of neutropenia at the 2.5 mg/kg dose was 38.7 percent. As previously reported, two patients experienced febrile neutropenia, and there was one treatment-related death due to presumed sepsis among patients who received doses greater than 200 mg. No other treatment-related deaths occurred in the study.
Enrollment continues for patients with metastatic TNBC at the recommended dose of 2.5 mg/kg, with a maximum dose of 200 mg per cycle.
Additional details about this spotlight poster presentation (Poster PD3-14) are available here. More information about the ladiratuzumab vedotin phase 1 clinical trial in TNBC, including enrollment centers, is available by visiting www.clinicaltrials.gov.

About Triple Negative Breast Cancer

Breast cancer is the most common cancer among women in the United States, excluding some forms of skin cancer. Of the more than 250,000 new cases expected in the United States this year, about 15 to 20 percent will be TNBC, which has a particularly poor prognosis. Breast cancers are commonly categorized by the expression (or lack thereof) of three proteins, which include the estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2). TNBC lacks expression of these three breast cancer-associated proteins that serve as key therapeutic targets. About one-third of breast cancer patients will eventually develop recurrent or metastatic disease, and current therapies for metastatic TNBC only delay progression. New treatment approaches are needed to improve outcomes for women with TNBC, where there are currently no available targeted therapies.

About Ladiratuzumab Vedotin

Ladiratuzumab vedotin is a novel investigational ADC targeted to LIV-1 protein utilizing Seattle Genetics’ proprietary ADC technology. Most metastatic breast cancers express LIV-1, which also has been detected in a number of other cancers, including melanoma, prostate, ovarian, uterine, and cervical cancers. Ladiratuzumab vedotin consists of a LIV-1-targeted monoclonal antibody linked to a potent microtubule-disrupting agent, monomethyl auristatin E (MMAE) by a protease-cleavable linker, using the same technology as ADCETRIS (brentuximab vedotin). This novel ADC agent is designed to bind to LIV-1 on cancer cells and release the cell-killing agent into target cells upon internalization. Ladiratuzumab vedotin may also cause antitumor activity through other mechanisms, including activation of an immune response. Seattle Genetics currently has four clinical studies underway or planned for ladiratuzumab vedotin in breast cancer with a focus on TNBC.

On December 7, 2017 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that the company will be webcasting its corporate presentation at the BMO Capital Markets Healthcare Conference in New York, NY (Press release, Jazz Pharmaceuticals, DEC 7, 2017, View Source;p=RssLanding&cat=news&id=2321712 [SID1234522443]).

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Matt Young, executive vice president and chief financial officer, will provide an overview of the company and a business and financial update at the conference on Thursday, December 14, 2017 at 10:30 a.m. EST / 3:30 p.m. GMT.

A live audio webcast of the presentation may be accessed from the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com. Please connect to the website prior to the start of the presentation to ensure adequate time for any software downloads that may be necessary to listen to the webcast.

An archive of the webcast will be available for at least one week following the presentation on the Investors section of the company’s website at www.jazzpharmaceuticals.com.

On December 7, 2017 Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) and Halozyme Therapeutics, Inc. (NASDAQ:HALO) announced today a collaboration and license agreement that enables Alexion to use Halozyme’s ENHANZE drug-delivery technology in the development of subcutaneous formulations for their portfolio of products (Press release, Halozyme, DEC 7, 2017, View Source [SID1234522425]). The agreement provides Alexion with the opportunity for exclusive development of up to four targets, including a next generation subcutaneous formulation of ALXN1210 (ALXN1210 SC), the company’s investigational long-acting C5 complement inhibitor, to potentially further extend the dosing interval of ALXN1210 SC to once every two weeks or once per month.

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"Alexion’s goal is to provide continued innovation and more treatment options that can significantly improve the lives of patients with rare diseases," said John Orloff, M.D., Executive Vice President and Head of Research & Development at Alexion. "We are excited to partner with Halozyme and look forward to utilizing its ENHANZE technology, which enables rapid injection of subcutaneous treatments and potentially increases bioavailablity, in our development programs."

"We are delighted to support Alexion’s innovative development initiatives focused on improving the lives of patients with rare diseases," said Dr. Helen Torley, president and CEO of Halozyme. "ENHANZE has become the industry standard for converting intravenous therapies to a subcutaneous delivery, helping partners and health care providers reduce the treatment burden and administration time for patients."

Under the terms of the agreement, Halozyme will receive an initial $40 million with the potential to earn additional payments of up to $160 million for each target developed, subject to achievement of specified development, regulatory and sales-based milestones. Halozyme will also receive mid-single digit royalties on sales of commercialized products.

The Halozyme ENHANZE technology is based on a proprietary recombinant human hyaluronidase enzyme (rHuPH20) that temporarily degrades hyaluronan — a glycosaminoglycan or chain of natural sugars in the body — to aid in the dispersion and absorption of other injected therapeutic drugs. For Halozyme partners, this technology may allow for more rapid delivery of injectable medications through subcutaneous injection (just under the skin). This delivery has been shown in studies to reduce health care practitioner time required for administration and shorten time for drug administration.

Alexion is Halozyme’s eighth global collaboration and license partner for the ENHANZE technology, and the third partnership formed in 2017. These partnerships cover nearly 50 therapeutic targets and include three commercialized products.