On December 7, 2018 Bio-Thera Solutions, a clinical-stage pharmaceutical company, reported that patient dosing has begun in a Phase I clinical study of BAT4306F in relapsed/refractory CD20-positive B-cell non-Hodgkin’s lymphoma patients. BAT4306F is an ADCC-enhanced CD20 monoclonal antibody that has demonstrated enhanced potency in preclinical studies with potential to be a "best-in-class" therapeutic (Press release, BioThera Solutions, DEC 7, 2018, View Source [SID1234531957]).

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"Initiating our Phase I clinical trial for BAT4306F represents a major milestone for Bio-Thera Solutions as BAT4306F is our first clinical candidate developed for the treatment of hematologic malignancies," said Shengfeng Li, CEO, Bio-Thera Solutions. "While the BAT4306F development plan will be initially focused on CD20-positive B-cell non-Hodgkin’s lymphoma we believe BAT4306F also has great potential as a treatment for other hematologic malignancies."

The Phase 1, multicenter, open-label, dose-escalation clinical trial of BAT4306F is designed to assess the safety and tolerability of BAT4306F as a single agent. The study will enroll subjects with relapsed/refractory CD20-positive B-cell non-Hodgkin’s lymphoma. Key objectives in the study include determining maximum tolerated dose, dose-limiting toxicity, pharmacokinetics and recommended doses for phase II clinical studies.

More information on the trial is available at View Source (CTR20181568).

About BAT4306F

BAT4306F is an investigational ADCC-enhanced CD20 monoclonal antibody that has the potential to be a "best-in-class" therapeutic. BAT4306F is currently being evaluated in relapsed/refractory CD20-positive B-cell non-Hodgkin’s lymphoma. CD20 is a naturally occurring receptor that is overexpressed in many types of hematologic malignancies. BAT4306F is being developed for use as a single agent and in combination with other agents for a variety of hematologic malignancies.

On December 7, 2018 Syros Pharmaceuticals (NASDAQ: SYRS), a leader in the development of medicines that control the expression of genes, reported new preclinical data on SY-1365, its first-in-class selective cyclin-dependent kinase 7 (CDK7) inhibitor, showing that it inhibits tumor cell growth in hormone receptor-positive (HR-positive) breast cancer cell lines that are resistant to treatment with CDK4/6 inhibitors and that it has synergistic activity in combination with fulvestrant in these treatment-resistant cells (Press release, Syros Pharmaceuticals, DEC 7, 2018, View Source [SID1234531956]). These data are being presented by Syros’ collaborators from Dana-Farber Cancer Institute at the San Antonio Breast Cancer Symposium (SABCS).

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"While CDK4/6 inhibitors have emerged as an important class of treatments for HR-positive metastatic breast cancer, patients eventually develop resistance," said Rinath M. Jeselsohn, M.D., Instructor in Medicine at Dana-Farber and principal investigator of the research presentation. "These data shed light on potential mechanisms behind resistance to CDK4/6 inhibitors, pointing to CDK7 as one of the genes critical to the growth of treatment-resistant HR-positive breast cancer cells and selective CDK7 inhibition as a promising new approach for the treatment of HR-positive breast cancer. I look forward to the continuing to evaluate SY-1365 in the ongoing Phase 1 trial focused on breast and ovarian cancers."

Researchers from Dana-Farber characterized an HR-positive breast cancer cell line that is resistant to treatment with CDK4/6 inhibitors, and they demonstrated that these cells have alterations in the RB-pathway, including loss of the retinoblastoma (Rb) protein, higher levels of p107, CDK2 and cyclin E2, and lower levels of the estrogen receptor.

The aim of this study was to identify genes critical for the growth and survival of these cells by evaluating both resistant and sensitive cell lines. The researchers also tested SY-1365 in these resistant cell lines as a single agent and in combination with fulvestrant, an estrogen receptor degrader. The data, highlighted in a Spotlight poster discussion session, show that:

CDK7 and ESR1 are critical for in vitro cell growth in both CDK4/6 inhibitor-sensitive and CDK4/6 inhibitor-resistant cells.
SY-1365 significantly arrests cell cycle progression and reduces the expression of cancer-promoting genes in both CDK4/6 inhibitor-sensitive and -resistant cell lines.
SY-1365 in combination with fulvestrant demonstrates synergistic activity in CDK4/6 inhibitor resistant cells.
"We are encouraged by these new preclinical data, which speak both to the importance of CDK7 inhibition in HR-positive breast cancer and to the specific potential of this approach in patients who develop resistance to CDK 4/6 inhibitors.," said David Roth, M.D., Chief Medical Officer of Syros. "We are particularly pleased by the data for SY-1365 in combination with fulvestrant, which demonstrate synergistic activity in CDK4/6 inhibitor-resistant HR-positive breast cancer cells. These data support the ongoing clinical evaluation of SY-1365 in combination with fulvestrant in HR-positive breast cancer patients who progress after treatment with a CDK 4/6 inhibitor. We are actively enrolling patients in the Phase 1 trial and are committed to exploring the full potential of CDK7 inhibition with SY-1365 for people with difficult-to-treat cancers."

The ongoing Phase 1 trial of SY-1365 is a multi-center, open-label trial designed to evaluate the safety, tolerability and anti-tumor activity of SY-1365 in patients with advanced solid tumors. Following completion of the dose escalation portion of the trial, Syros opened expansion cohorts to further assess the potential of SY-1365 in multiple ovarian and breast cancer patient populations. The expansion cohorts are evaluating SY-1365: as a single agent in primary platinum-refractory ovarian cancer patients; as a single agent in ovarian cancer patients who have relapsed after three or more therapies; in combination with carboplatin in ovarian cancer patients who have relapsed after one or more prior therapies; and in combination with fulvestrant in patients with HR+ metastatic breast cancer who have progressed after treatment with a CDK4/6 inhibitor. An additional cohort is enrolling patients with any solid tumor accessible for biopsy to further evaluate the mechanism of action of SY-1365. Additional details about the trial can be found using the identified NCT03134638 at www.clinicaltrials.gov.

On December 7, 2018 Biologics by McKesson, an independent specialty pharmacy for oncology and other complex therapeutic areas, reported that it has been selected by Astellas Pharma US, Inc. to be in the limited distribution network for XOSPATA (gilteritinib) (Press release, McKesson, DEC 7, 2018, View Source [SID1234531958]).

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XOSPATA is indicated for the treatment of adult patients who have relapsed or refractory Acute Myeloid Leukemia (AML) with a FMS-like tyrosine kinase 3 (FLT3) mutation as detected by an FDA-approved test. XOSPATA was approved by the U.S. Food and Drug Administration (FDA) on November 28, 2018, based on an interim analysis of data from the ongoing phase III ADMIRAL trial. In May 2018, the FDA accepted, with Priority Review, the company’s New Drug Application (NDA) for gilteritinib. Previously, gilteritinib was granted both Orphan Drug designation and Fast Track designation by the FDA.

Acute Myeloid Leukemia (AML) is a cancer that impacts the blood and bone marrow, and its incidence increases with age. The American Cancer Society estimates that in 2018, approximately 19,000 new patients will be diagnosed with AML in the U.S. XOSPATA is the first and only FLT3-targeting agent approved by the FDA for the treatment of adult patients with relapsed or refractory FLT3 mutation-positive (FLT3mut+) AML.

"Patients with FLT3 mutation–positive relapsed or refractory acute myeloid leukemia have had limited treatment options," said Brandon Tom, PharmD, vice president, Commercial Services, Biologics by McKesson. "We are pleased to be able to offer this much needed new drug to this patient population, who accounts for approximately 30 percent of all AML patients."

Biologics by McKesson is committed to and recognized for its high level of customer service as well as its innovative, high-touch and multidisciplinary patient-centric approach. Each team includes a pharmacist with in-depth knowledge of oncology therapies, an experienced oncology nurse and a financial counselor who is familiar with various financial assistance programs and organizations that help cancer patients. This highly-skilled care team works together to develop individualized care plans that address each patient’s unique clinical, financial and emotional needs and streamlines communication back to the treating provider, enabling high-quality care and differentiated outcomes. In addition, the Biologics by McKesson team works closely with payers to ensure patients can access the specialty medications they need.

Physicians may submit prescriptions to Biologics by McKesson via phone (800.850.4306), fax (800.823.4506) or eScribe. For electronic prescribing systems, physicians may search for Biologics within their EMR system.

On December 7, 2018 Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX) reported that it will present at the 2018 BMO Capital Markets Prescriptions for Success Healthcare Conference at 1:20 PM ET on Wednesday, December 12, 2018. Live audio of the presentation can be accessed by visiting the "Events" page of the company’s website at investor.pacira.com. A replay of the webcast will also be available for two weeks following the event (Press release, Pacira Pharmaceuticals, DEC 7, 2018, View Source;p=RssLanding&cat=news&id=2379929 [SID1234531942]).

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On December 7, 2018 Agendia, Inc., a world leader in precision oncology, reported findings from two key studies presented at the 2018 San Antonio Breast Cancer Symposium (SABCS) this week, reinforcing the utility and benefits of its MammaPrint 70-Gene Breast Cancer Risk-of-Recurrence and BluePrint Breast Cancer Molecular Subtyping tests (Press release, Agendia, DEC 7, 2018, View Source [SID1234531959]). Both studies underscore the growing importance of genomic testing in helping physicians to personalize breast cancer treatment management.

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BluePrint reclassifies 85 percent of HER2-positive, and clarifies HER2-equivocal breast cancers in a real-world diagnostic setting1

The first study addressed challenges acknowledged within the Aphinity and ExteNET trials regarding the potential benefits of added HER2-targeted treatment in breast cancer as well as the uncertainty regarding the nature of tumors classified as HER2 "equivocal" by traditional immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH). A previous trial showed that BluePrint reclassified almost half of HER2-postive/ER-positive patients identified as HER2-positive using IHC/FISH to the Luminal subtype with differential neoadjuvant treatment response.2,3

In this study, Agendia scientists analyzed HER2-positive and HER2-equivocal cancers (as defined by the 2013 CAP Guidelines), comparing IHC/FISH status from pathology results to BluePrint molecular subtype in a real-world diagnostic setting. In IHC/FISH HER2-amplified tumors, BluePrint reclassified 85 percent to non-HER2 molecular subtypes, mostly Luminal-type for ER-positive tumors and Basal-type for ER-negative tumors. BluePrint also classified all HER2-equivocal tumors to non-HER2 subtypes, Luminal and Basal, which could not be derived from IHC/FISH. No HER2 "equivocal" cancers by IHC/FISH displayed a HER2-driven genotype.

Dr. William Audeh, chief medical officer at Agendia, said: "The findings from this real-world study indicate that additional therapeutic options should be considered for some women with clinically HER2-positive cancers with genomic profiles of Luminal or Basal subtypes. These data also provide further precision to clarify the clinical uncertainty regarding the HER2 "equivocal" subtype. This study further reinforces the critical role BluePrint plays in helping to inform more personalized treatment decisions by adding to a growing body of evidence demonstrating the importance of tumor molecular subtyping in breast cancer."

MammaPrint identifies 46 percent of patients under 50 years of age with an intermediate recurrence score as Low Risk4

The second study reevaluated data from the PROMIS (PRospective Study Of MammaPrint in Patients With an Intermediate Recurrence Score) trial using the same subgroup analyses that was used in the TAILORx trial. It aimed to establish greater certainty regarding the benefits of chemotherapy among female breast cancer patients under 50 with an intermediate recurrence score from the 21-gene assay (RS 18-30). The new analyses found 46 percent of these women had a low genomic risk of recurrence as assessed by MammaPrint and were unlikely to benefit from chemotherapy. Researchers also found that in the MINDACT trial, MammaPrint patients younger than age 45 and between the ages of 45-55 who also have a Low Risk result had a favorable 5-year distant metastasis-free survival of 95-98 percent in both clinically low and high risk groups.

Dr. Hatem Soliman, medical director of clinical trials at the Moffitt Cancer Center and lead study author, said: "The TAILORx trial raised important questions about the benefits of chemotherapy in women under 50, so we were pleased to see that our new subgroup analysis of the PROMIS data, using the same approach as seen in TAILORx, showed that MammaPrint provides greater certainty regarding which women are unlikely to benefit from chemotherapy. Patient quality of life, in the short-term and longer-term, is paramount, so the role of MammaPrint in signaling where physicians can safely de-escalate their patients’ treatments, and thus side effects, is important."

A full list of abstracts featuring MammaPrint and BluePrint presented during SABCS can be viewed here: View Source(2018NOV)%20-%20SABCS%202018%20Abstract%20Summary%20interactive.pdf

1. BluePrint molecular subtyping versus HER2 assessment by immunohistochemistry and FISH in the real-world diagnostic setting. Poster presented at SABCS. December 2018; San Antonio, Texas.

2. Whitworth P, et al., Chemosensitivity Predicted by BluePrint 80-Gene Functional Subtype and MammaPrint in the Prospective Neoadjuvant Breast Registry Symphony Trial (NBRST). Ann Surg Oncol. 2014; 21(10): 3261–3267.

3. Pathological complete response in basal subtype tumors predicts improved distant metastasis free survival in the NBRST trial. Poster presented at ASCO (Free ASCO Whitepaper) 2018; Chicago, Illinois.

4. MammaPrint identifies 46% of patients, age ≤50 years with oncotype RS 18-30, as low risk and safe to forgo chemotherapy. Poster presented at SABCS. December 2018; San Antonio, Texas.

About MammaPrint

MammaPrint is an in vitro diagnostic medical device, performed as a testing service in a central laboratory, using the 70-gene expression profile of breast cancer tissue samples to assess a patient’s risk for distant metastasis. The device is FDA-cleared and CE-marked, enabling use in the European Union. MammaPrint is indicated for use by physicians as a prognostic marker only, along with other clinical-pathological factors. It is not intended to determine the outcome of disease, nor to suggest or infer an individual patient’s response to therapy. MammaPrint is the only test of its kind recommended for lymph node-negative and lymph node-positive patients by both the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and National Comprehensive Cancer Network (NCCN). The test is also recommended by many other national and international clinical practice guidelines.