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.

On December 7, 2018 GenFleet Therapeutics Co. Ltd. (Shanghai, China) reported that it raised RMB120 million ($17.4 million) in an untranched series A round to bring its first therapy into clinic next year (Press release, GenFleet Therapeutics, DEC 7, 2018, http://www.genfleet.com/en/pc/NewsDetials.aspx?Ttext=NTY= [SID1234574440]).

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Ally Bridge Group led the round, which saw participation from Sinopharm Capital and CSPC, and existing investors HighLight Capital, Qian Long Yu Han and TF Capital.

GenFleet’s most advanced compound, GFH018, is a small molecule inhibitor of transforming growth factor β receptor 1 (TGFβR1; ALK5). The therapy is being developed for hepatocellular carcinoma (HCC) and other "China-prevalent" cancers, co-founder and Chairman Qiang Lu told BioCentury. A first-in-human trial is expected to start in mid-2019.

GenFleet’s seven other undisclosed programs are in preclinical development for cancer or autoimmune disease.

While Lu said GenFleet’s eight programs will not yield "first-in-class therapies per se," they are higher risk and, according to Lu, no therapy against the targets have reached clinical proof of concept elsewhere. "We’re not pursuing another IDO and EGFR," Lu added.

GenFleet’s executive team brings with it a history of drug discovery in China. Lu and GenFleet co-founder and CEO Jiong Lan built the new drug discovery team at Yangtze River Pharmaceutical Group Co. Ltd. (Shanghai, China), Lu said, where he was CSO and VP and Lan was VP and general manager of the Yangtze River subsidiary Shanghai Haiyan Pharmaceutical Technology Co. Ltd. Lu was most recently SVP of operations at CStone Pharmaceuticals Co. Ltd. (Suzhou, China), and before that CSO and VP of Harbin Gloria Pharmaceuticals Co. Ltd. (Beijing, China).
GenFleet CSO Biao Zheng was a VP at Johnson & Johnson (NYSE:JNJ) and led immunology-focused collaborations out of the J&J Innovation Center in Shanghai. He also headed immunology discovery sciences in Shanghai for the GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) subsidiary GlaxoSmithKline Pharma GmbH.

According to BioCentury’s BCIQ database, there are two other TGFβR1 inhibitors in clinical development: galunisertib (LY2157299) from Eli Lilly and Co. (NYSE:LLY), which is in Phase II testing for multiple cancers; and vactosertib (TEW-7197, NOV1301, NOV130101) from MedPacto Inc. (Suwon, South Korea), which is in Phase I/II testing for myelodysplastic syndrome (MDS) and Phase I testing for metastatic gastric cancer and advanced solid tumors.

The target has recently generated partnership interest. In July, MedPacto teamed up with Merck & Co. Inc. (NYSE:MRK) and AstraZeneca plc (LSE:AZN; NYSE:AZN) to test vactosertib in Phase Ib/IIa trials in combination with PD-1 inhibitor Keytruda pembrolizumab in metastatic or locally advanced colorectal, gastric and gastroesophageal junction cancer or with PD-L1 inhibitor Imfinzi durvalumab for metastatic non-small cell lung cancer (NSCLC).

In 2015, Lilly announced a pair of partnerships to test galunisertib in combination studies with agents from Immunocore Ltd. (Abingdon, U.K.) and Bristol-Myers Squibb Co. (NYSE:BMY).

Lu said not including reserves, the series A will give GenFleet 18-24 months of runway. "Down the road we expect [to submit] two INDs per year," he added.

The early stage investment is a rarity for Ally Bridge. According to BCIQ, the firm has not invested in a round classified as a series A since 2015.

On December 7, 2018 OncBioMune Pharmaceuticals, Inc. (OTCQB:OBMP) ("OncBioMune" or the "Company"), a clinical-stage biopharmaceutical company engaged in the development of a proprietary therapeutic cancer vaccine immunotherapy and targeted cancer therapies, is reported to provide an update on the Phase 2 clinical trial of ProscaVax being hosted at Beth Israel Deaconess Medical Center (BIDMC), a teaching hospital of Harvard University (Press release, Oncbiomune, DEC 7, 2018, View Source [SID1234531944]). In the clinical trial, ProscaVax, the Company’s lead immunotherapeutic cancer vaccine consisting of a combination of prostate cancer associated prostate specific antigen (PSA) with the biological adjuvants interleukin-2 (IL-2) and granulocyte-macrophage colony-stimulating factor (GM-CSF), is being evaluated for safety and efficacy in patients with low-risk localized prostate cancer compared to patients in "Active Surveillance."

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OncBioMune has confirmed that a site visit is scheduled for December 19, 2018. This is the check-off meeting before beginning enrollment in the clinical trial, which is expected to transpire in the coming weeks.

"I’m very pleased to say that we are now staring down a major milestone for our company with the site visit to be followed by patient enrollment," commented Dr. Jonathan Head, Chief Executive Officer at OncBioMune. "Enrollment of the first patient in the study is not only a watershed moment for our company and stakeholders, but for the oncology community as a whole. This is the first Phase 2 clinical trial of its type evaluating a therapeutic immunotherapy vaccine in early stage prostate cancer, a stage in disease where patients are left with no options other than to wait for disease progression. We are optimistic that ProscaVax will demonstrate a meaningful benefit to these patients in great need and that ProscaVax will set a new benchmark as a front-line treatment for prostate cancer."