On November 14, 2018 Athenex, Inc. (NASDAQ:ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported its financial results and business highlights for the three- and nine-months ended September 30, 2018 (Press release, Athenex, NOV 14, 2018, View Source;p=RssLanding&cat=news&id=2377084 [SID1234531432]).

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"We achieved continued positive momentum at Athenex in the third quarter in our strategy to build a global biopharmaceutical business and to create more effective, safer and tolerable treatments for cancer patients," stated Dr. Johnson Lau, Chief Executive Officer of Athenex. "Our Phase III Oraxol program reached an important milestone with the second positive DSMB review in September and we remain on track to complete enrollment and report data from this study in 2019. We also continue to make progress with other drug candidates in our Orascovery platform, with Oratecan and Oradoxel ready to advance to Phase II studies. The addition of the cellular immunotherapy and biologic platforms have expanded our oncology-focused product pipeline. For KX2-391, the most advanced candidate in our Src kinase program, we are working with our partner Almirall on developing a commercial plan for this product."

Third Quarter 2018 and Recent Business Highlights:

Clinical Platforms:

Announced that the Data and Safety Monitoring Board (DSMB) overseeing the Company’s ongoing randomized, controlled Phase III trial of Oraxol in metastatic breast cancer recommended unanimously that the study continue as planned. The DSMB also congratulated the Company on the rapid patient recruitment and promising results achieved.

Presented updated encouraging efficacy and safety data of Oraxol in the treatment of metastatic breast cancer patients who had failed previous chemotherapies in a pharmacokinetics (PK) and Phase II study conducted in Taiwan at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in Munich, Germany.

Announced acceptance of an Investigational New Drug (IND) application for Eribulin ORA, Athenex’s oral version of Eribulin. Initiation of clinical trials is currently planned for the first half of 2019. This is the eighth US IND allowance that Athenex has obtained.

Identified suitable dosing regimens of Oratecan and Oradoxel for advancement into Phase II studies, based on recent PK data.

Announced positive results from pilot studies conducted in China by Xiangxue Life Sciences in end-stage cancer patients who were treated with T-cell receptor affinity enhancing specific T-cell therapy (TAEST), a form of cancer immunotherapy. Axis Therapeutics Limited, a joint venture between Athenex and Xiangxue Life Sciences established in September 2018, owns the worldwide (excluding China) rights to research, develop and commercialize T-cell receptor-engineered T cells (TCR-T), including TAEST technology.

Announced positive data from two Phase III pivotal efficacy studies of KX2-391 in the treatment of actinic keratosis (AK).
Commercial Business

Developed detailed launch plans for Oraxol and KX2-391.

Athenex Pharmaceutical Division ("APD") currently markets a total of 25 products with 48 SKUs and is planning to launch 2 new products before year end with 4 additional new SKUs.

Athenex Pharma Solutions ("APS") currently markets 6 products in total with 16 SKUs.
Corporate and Strategic Highlights:

Promoted Mr. Randoll Sze to Chief Financial Officer.

Announced a strategic realignment of joint projects between Athenex and its collaborative partner, Hanmi Pharmaceutical.
Third Quarter 2018 Financial Results:

Revenue for the three months ended September 30, 2018 was $18.4 million, an increase of $4.4 million, or 32%, as compared to $14.0 million for the three months ended September 30, 2017. The increase was primarily attributable to an increase in licensing revenue of $5.0 million, a $1.0 million increase in sales of the Company’s 503B products, and a $0.8 million increase in medical device sales. This was offset by decreases in API sales of $1.7 million, contract manufacturing revenue of $0.2 million, grant revenue of $0.2 million, and other product sales of $0.2 million.

Cost of sales for the three months ended September 30, 2018 totaled $12.0 million, an increase of $3.9 million, or 48%, as compared to $8.1 million for the three months ended September 30, 2017. This was primarily due to the increase of $1.9 million cost of sales from the recently launched specialty products and $2.0 million cost of sales from 503B and API products. The increase in gross profit was primarily due to the licensing revenue in the current year.

Research and development expenses for the three months ended September 30, 2018 totaled $51.2 million, an increase of $39.3 million, or 329%, as compared to $11.9 million for the three months ended September 30, 2017. This was primarily due to an increase in licensing fees and clinical expenses. In particular, there was a $29.5 million non-cash license fee related to the purchase of TCR-T in connection with the establishment of Axis Therapeutics, of which $24.5 million related to the fair value of the IPR&D and $5.0 million related to the Company’s common stock issued to Xiangxue Life Sciences.

SG&A expenses for the three months ended September 30, 2018 totaled $11.5 million, an increase of $1.1 million, or 11%, as compared to $10.4 million for the three months ended September 30, 2017. This was primarily due to an increase in professional fees of $0.9 million from legal fees incurred in conjunction with the launch of 503B products and an increase in employee compensation of $0.5 million, offset by a decrease of $0.3 million in selling and marketing expenses related to the launch of specialty products.

Net loss attributable to Athenex for the third quarter ended September 30, 2018 was $46.2 million, or ($0.70) per diluted share, compared to a net loss of $23.3 million, or ($0.41) per diluted share, in the same period last year. Excluding the non-cash license fee of $24.5 million, the net loss attributable to Athenex for the third quarter ended September 30, 2018 was $21.6 million.

In July 2018, Athenex closed a privately placed debt and equity financing deal with Perceptive Advisors, LLC for gross proceeds of $100.0 million and aggregate net proceeds of $97.1 million, net of fees and offering expenses. The Company entered into a 5-year senior secured loan for $50.0 million of this financing and issued 2,679,528 shares of its common stock at a purchase price of $18.66 per share for the remaining $50.0 million.

Cash, cash equivalents and short-term investments were $141.4 million at September 30, 2018, compared to $51.0 million at December 31, 2017. Based on the current operating plan, the Company expects that its cash, cash equivalents and short-term investments as of September 30, 2018, together with cash to be generated from operating activities, will enable it to fund its operating expenses and capital expenditure requirements into the fourth quarter of 2019.

Nine Months Ended September 30, 2018 Financial Results:

Revenue for the nine months ended September 30, 2018 was $67.8 million, an increase of $44.7 million, or 193%, as compared to $23.2 million for the nine months ended September 30, 2017. The increase was primarily attributable to $30.0 million in upfront license fees, a $13.7 million increase in specialty products sold through the Company’s Commercial Platform, a $2.0 million increase in sales of 503B products, and a $0.4 million increase in API and medical device sales.

Cost of sales for the nine months ended September 30, 2018 totaled $32.7 million, an increase of $17.6 million, or 117%, as compared to $15.1 million for the nine months ended September 30, 2017. This was primarily due to the increase of $13.2 million cost of sales from the specialty products and $4.4 million cost of sales from 503B and API products.

Research and development expenses for the nine months ended September 30, 2018 totaled $99.1 million, an increase of $43.1 million, or 77%, as compared to $55.9 million for the nine months ended September 30, 2017. This was primarily due to an increase in licensing fees and clinical expenses. In particular, there was a $29.5 million non-cash license fee related to the purchase of TCR-T in connection with the establishment of Axis Therapeutics, of which $24.5 million related to the fair value of the IPR&D and $5.0 million related to the Company’s common stock issued to Xiangxue Life Sciences.

SG&A expenses for the nine months ended September 30, 2018 totaled $37.4 million, an increase of $3.6 million, or 11%, as compared to $33.8 million for the nine months ended September 30, 2017. This was primarily due to an increase in costs related to operating as a public company.

Net loss attributable to Athenex for the nine months ended September 30, 2018 was $90.3 million, or ($1.42) per diluted share, compared to a net loss of $102.9 million, or ($2.18) per diluted share, for the nine months ended September 30, 2017. Excluding the non-cash license fee of $24.5 million, the net loss attributable to Athenex for the nine months ended September 30, 2018 was $65.8 million.

Outlook and Upcoming Milestones:

Due to the timing of a collaborative payment from a partner, the Company currently expects its full year 2018 revenue to be in the lower end of the guidance range of $100 million to $125 million, inclusive of licensing-fee revenue. The operational business is on track and the Company expects to receive the collaborative payment in the first half of 2019.

Clinical Platforms:

12 month follow-up data from KX2-391 Phase III studies for the treatment of AK are expected in the second quarter of 2019.
Oraxol Phase III clinical trial in metastatic breast cancer is expected to complete target enrollment by the end of 2018, with top line data expected in mid-2019.
Oratecan and Oradoxel Phase II studies are expected to initiate in the first half of 2019.
Expect to file INDs for TCR-T candidates and Pegtomarginase by mid-2019.
Corporate Updates:

The Company will be hosting a Research and Development Day for the investment community on December 17, 2018 to provide an update on its major clinical programs.
The exterior of the Dunkirk facility is expected to be completed by the first half of 2019. The facility is expected to be completed by the end of 2019 and operational in mid-2020.
Construction of the Chongqing API plant is expected to be completed by the end of 2018, with completion of the facility expected by mid-2019.
Construction of the Chongqing dosage plant is expected to break ground in the first half of 2019.
Conference Call and Webcast Information:

The Company will host a conference call and live audio webcast today, Wednesday, November 14, 2018 at 8:00 a.m. Eastern Time to discuss the financial results and provide a business update.

To participate in the call, dial 877-407-0784 (domestic) or 201-689-8560 (international) fifteen minutes before the conference call begins and reference the conference passcode 13683946.

To join the webcast, click on View Source

A replay of the call will be accessible two hours after its completion through November 21 by dialing 844-512-2921 (in the U.S.) or 412-317-6671 (outside the U.S.) and entering passcode 13683946. The live conference call and replay can also be accessed via audio webcast on the Investor Relations section of the Company’s website, located at www.athenex.com.

On November 14, 2018 RedHill Biopharma Ltd. (Nasdaq: RDHL) (Tel-Aviv Stock Exchange: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company primarily focused on proprietary drugs for gastrointestinal diseases and cancer, reported a poster presentation on YELIVA (opaganib, ABC294640)1 for multiple myeloma at the upcoming EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium2 on Molecular Targets and Cancer Therapeutics, on Friday, November 16th in Dublin (Press release, RedHill Biopharma, NOV 14, 2018, View Source [SID1234531300]).

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The abstract3 (poster board number PB-045), which will be presented by Yubin Kang, MD, of Duke Health, is entitled "Sphingosine kinase 2 (SK2) targeting in the treatment of multiple myeloma: preclinical and phase I studies of opaganib, an SK 2 inhibitor, in multiple myeloma". The abstract describes data from preclinical studies and a Phase Ib/II study conducted by Dr. Kang with YELIVA for the treatment of multiple myeloma.

The open-label, dose escalation Phase Ib/II study evaluating YELIVA in patients with refractory or relapsed multiple myeloma that were previously treated with proteasome inhibitors and immunomodulatory drugs is ongoing at Duke University Medical Center. Enrollment for the Phase Ib portion of the study has been completed with a total of 11 patients enrolled and treated in three dose cohorts. Results from the Phase Ib portion of the study did not show any dose-limiting toxicities. Additionally, while efficacy was not the primary endpoint of the Phase I study, it was observed that out of 10 evaluable subjects, two subjects had stable disease for over four months and one patient achieved a very good partial response (VGPR).
In addition, results from preclinical studies demonstrated that SK2 is overexpressed in multiple myeloma cell lines and in human multiple myeloma specimens and plays a critical role in myeloma cell growth, proliferation and survival. Additional preclinical studies described in the abstract demonstrated that treatment with YELIVA effectively inhibited myeloma tumor growth in vitro and in vivo in mouse xenograft models. The authors conclude that YELIVA as a single agent or in combination with a B-cell lymphoma 2 (Bcl-2) inhibitor has the potential for treatment of relapsed/refractory multiple myeloma patients that were previously treated with proteosome inhibitors and immunomodulatory agents.

The Phase Ib/II study with YELIVA for multiple myeloma is supported by a $2 million grant from the National Cancer Institute (NCI) Small Business Innovation Research Program (SBIR) awarded to Apogee Biotechnology Corp., in conjunction with Duke University, with additional support provided by RedHill.

Dr. Yubin Kang, MD, associate professor in the division of hematologic malignancies and cellular therapy in the department of medicine at Duke University School of Medicine, is the lead investigator for the Phase Ib/II study with YELIVA for multiple myeloma, as well as the head of the laboratory performing the preclinical studies.

YELIVA is a proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor being developed by RedHill and targeting multiple oncology, inflammatory and gastrointestinal indications. A single-arm Phase IIa study evaluating the activity of YELIVA as a single agent in patients suffering from advanced, unresectable intrahepatic, perihilar and extrahepatic cholangiocarcinoma is being conducted at renowned clinical institutions in the U.S.

About YELIVA (opaganib, ABC294640):
YELIVA (opaganib, ABC294640), a new chemical entity, is a Phase II-stage, proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor with anticancer and anti-inflammatory activities, targeting multiple oncology, inflammatory and gastrointestinal indications. By inhibiting SK2, YELIVA blocks the synthesis of sphingosine 1-phosphate (S1P), a lipid-signaling molecule that promotes cancer growth and pathological inflammation. SK2 is an innovative molecular target for anticancer therapy because of its critical role in catalyzing the formation of S1P, which is known to regulate cell proliferation and activation of inflammatory pathways. YELIVA was originally developed by U.S.-based Apogee Biotechnology Corp. and completed multiple successful preclinical studies in oncology, inflammation, GI and radioprotection models, as well as a Phase I clinical study in cancer patients with advanced solid tumors. YELIVA received Orphan Drug designation from the U.S. FDA for the treatment of cholangiocarcinoma. The development of YELIVA was funded to date primarily by grants and contracts from U.S. federal and state government agencies awarded to Apogee Biotechnology Corp., including the U.S. National Cancer Institute.

The ongoing studies with YELIVA (opaganib, ABC294640) for cholangiocarcinoma, multiple myeloma and advanced hepatocellular carcinoma (HCC) are registered on www.ClinicalTrials.gov, a web-based service by the U.S. National Institute of Health, which provides public access to information on publicly and privately supported clinical studies.

On November 14, 2018 The Janssen Pharmaceutical Companies of Johnson & Johnson reported the submission of two Type II variation applications to the European Medicines Agency (EMA) seeking approval for the expanded use of IMBRUVICA (ibrutinib) (Press release, Johnson & Johnson, NOV 14, 2018, View Source [SID1234531316]). One application seeks to include use of ibrutinib in combination with obinutuzumab in previously untreated adults with chronic lymphocytic leukaemia (CLL) and to add long-term follow-up data from the existing label studies RESONATETM (PCYC-1112) and RESONATETM-2 (PCYC-1115). The second is for use of ibrutinib plus rituximab for the treatment of previously untreated and relapsed/refractory adults with Waldenström’s macroglobulinemia (WM).

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"Today’s news brings us one step closer to potentially offering ibrutinib in new combinations for patients where unmet needs still persist," said Dr. Catherine Taylor, Haematology Therapy Area Lead, Europe, Middle East and Africa (EMEA), Janssen-Cilag Limited. "Ibrutinib continues to demonstrate clinical benefit over the long term for a broad group of patients living with blood cancer, and we look forward to working with relevant authorities to secure approval of these new combinations."

Ibrutinib, a first-in-class Bruton’s tyrosine kinase (BTK) inhibitor, is jointly developed and commercialised by Janssen Biotech, Inc., and Pharmacyclics LLC, an AbbVie company.

The CLL submission is supported by positive results from the Phase 3 iLLUMINATE (PCYC-1130) study which investigated ibrutinib in combination with obinutuzumab versus chlorambucil plus obinutuzumab in patients with newly diagnosed CLL.1 Study findings from iLLUMINATE will also be featured as an oral presentation (abstract #691), whilst further analysis of RESONATETM and RESONATETM-2 results in comparison with real-world evidence databases (abstract #4427) will be included at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, taking place in San Diego next month.1,2 A supplemental New Drug Application (sNDA) which was also recently submitted to the U.S. Food and Drug Administration (FDA) received Priority Review.

In WM, the submission is supported by data from the Phase 3 iNNOVATE (PCYC-1127) study evaluating ibrutinib in combination with rituximab, versus rituximab with placebo, in patients with previously untreated and relapsed/refractory WM.3 Follow-up efficacy and safety findings from the iNNOVATE study will also be presented at ASH (Free ASH Whitepaper) 2018 (abstract #149).4 In August 2018, the FDA approved ibrutinib in combination with rituximab for the treatment of WM based on the data from iNNOVATE.5

Additional information about both studies can be found at www.ClinicalTrials.gov (NCT02264574 and NCT02165397).6,7

#ENDS#

About ibrutinib

Ibrutinib is a first-in-class Bruton’s tyrosine kinase (BTK) inhibitor, which works by forming a strong covalent bond with BTK to block the transmission of cell survival signals within the malignant B-cells.8 By blocking this BTK protein, ibrutinib helps kill and reduce the number of cancer cells, thereby delaying progression of the cancer.9

Ibrutinib is currently approved in Europe for the following uses:10

Chronic lymphocytic leukaemia (CLL): As a single agent for the treatment of adult patients with previously untreated CLL, and as a single agent or in combination with bendamustine and rituximab (BR) for the treatment of adult patients with CLL who have received at least one prior therapy.
Mantle cell lymphoma (MCL): Adult patients with relapsed or refractory mantle cell MCL.
Waldenström’s macroglobulinemia (WM): Adult patients who have received at least one prior therapy or in first-line treatment for patients unsuitable for chemo-immunotherapy.
The most common adverse reactions seen with ibrutinib include diarrhoea, neutropenia, haemorrhage (e.g., bruising), musculoskeletal pain, nausea, rash, and pyrexia.10

For a full list of side effects and information on dosage and administration, contraindications and other precautions when using ibrutinib please refer to the Summary of Product Characteristics for further information.

About CLL

CLL is typically a slow-growing blood cancer of the white blood cells.11 The overall incidence of CLL in Europe is approximately 4.92 cases per 100,000 persons per year with rates amongst men and women approximately 5.87 and 4.01 cases per 100,000 persons per year, respectively.12 CLL is predominantly a disease of the elderly, with a median age of 72 years at diagnosis.13

CLL is a chronic disease; median overall survival ranges between 18 months and more than 10 years, according to the stage of disease.14 The disease eventually progresses in the majority of patients, and patients are faced with fewer treatment options with each relapse. Patients are often prescribed multiple lines of therapy as they relapse or become resistant to treatments.

About Waldenström’s macroglobulinemia

Waldenström’s macroglobulinemia (WM) is a rare form of non-Hodgkin’s lymphoma (NHL).15 It causes overproduction of a protein called monoclonal immunoglobulin M (IgM) antibody, which causes a thickening of the blood.16 Incidence rates among men and women in Europe are approximately 7.3 and 4.2 per million persons, respectively.17 The causes of WM are unknown, with it typically affecting older adults and being slightly more common in men than women.15,17

On November 14, 2018 Personalis, Inc., a leader in advanced genomics for precision oncology, reported that they are scheduled to present at the upcoming NeoAG Summit in Boston, MA on Thursday, November 15, 2018 at 4 PM ET (Press release, Personalis, NOV 14, 2018, View Source [SID1234531317]).

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The presentation, entitled "ImmunoID NeXT Platform: Improving Neoantigen Prediction, TME Assessment, and ctDNA Detection for Vaccine Development," will introduce Personalis’ new ImmunoID NeXT Platform and discuss how it facilitates highly accurate neoantigen identification, optimal MHC-binding prediction and ranking, and the assessment of the tumor microenvironment and tumor escape mechanisms that may impact response to personalized therapeutics.

ImmunoID NeXT is the first and only platform to provide comprehensive analysis of both a tumor and its microenvironment from a single sample. The platform can be used to investigate the key tumor- and immune-related areas of cancer biology; consolidating multiple oncology biomarker assays into one. This maximizes the biological information that can be generated from a precious tumor specimen.

The presentation will be delivered by Sean Boyle, PhD; Director, Bioinformatics Applications.

On November 14, 2018 Agendia, Inc., a world leader in precision oncology, reported new data from the I-SPY 2 study, presented at the European Organization for Research and Treatment of Cancer (EORTC), the National Cancer Institute (NCI) and the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Symposium (Press release, Agendia, NOV 14, 2018, View Source [SID1234531318]). The two presentations demonstrate both the prognostic, and the predictive role of the MammaPrint 70-Gene Breast Cancer Risk of Recurrence and BluePrint 80-Gene Molecular Subtyping tests in determining which patients are likely to respond to therapies. Dr. Laura van’t Veer, chief research officer and co-founder at Agendia, and Professor of Laboratory Medicine at the University California San Francisco, will present the results at the 30th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium at 15:00 GMT on Wednesday, Nov. 14, 2018.

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Discover why more than 1,500 members use 1stOncology™ to excel in:

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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MammaPrint High1/High2 risk class as a pre-specified biomarker of response to nine different targeted agents plus standard neoadjuvant therapy for ~1000 breast cancer patients in the I-SPY 2 TRIAL (Abstract 2)1

A new analysis from the I-SPY 2 trial showed that a subgroup of "Ultra-High Risk" patients identified by MammaPrint respond better to certain targeted therapies and treatment combinations. Patients were classified as either MammaPrint High Risk (MP1), indicating less aggressive disease, or MammaPrint Ultra-High Risk (MP2), indicating more aggressive disease. Nearly 50 percent of patients were classified as MP2 and had higher rates of pathological complete response (pCR) compared to MP1 patients.

In addition, MP2 patients had a higher chance of achieving pCR if they received veliparib/carboplatin, neratinib, ganitumab, TDM1/pertuzumab or pembrolizumab in addition to the standard paclitaxel treatment alone or in combination with trastuzumab. Together, these findings support the use of the MammaPrint High Risk or Ultra-High Risk result as a predictive biomarker of treatment response.

BluePrint basal subtype predicts neoadjuvant therapy response in ~400 HR+HER2- patients across 8 arms in the I-SPY 2 TRIAL (Abstract 3)2

A second analysis of the I-SPY 2 trial evaluated neoadjuvant chemotherapy response in different subgroups of patients with HR+/HER2- disease. Using the BluePrint Molecular Subtyping test, patients were classified as having either basal, luminal or HER2 subtypes. Patients with the basal subtype were four times more likely to achieve pCR with neoadjuvant therapy than patients with the luminal subtype, and this association was independent of the type of treatment they received. Additionally, more than three-quarters of patients with the HR+/HER2- basal subtype of cancer were classified as having MP2 Ultra-High Risk disease, suggesting that genetic and molecular risk signatures can be used to predict treatment response in similar subgroups of patients.

Dr. Laura van ‘t Veer, Chief Research Officer and Co-founder at Agendia said:

"The results presented at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium demonstrate that MammaPrint is not just a prognostic test, it is also a predictive test. When used in conjunction with BluePrint, it can stratify patients into different subgroups to help identify which are more likely to respond to new treatments or to neoadjuvant chemotherapy and which are not likely to respond and should be given an alternative treatment. We need to further investigate the clinical implications, but this is an important milestone with significant value for women with breast cancer."

Dr. William Audeh, Chief Medical Officer at Agendia said:

"The new studies stemming from the I-SPY 2 trial are very encouraging and highlight the continuing and constantly expanding utility of MammaPrint and BluePrint to identify which patients will respond to specific treatments based on the genomic signatures of their tumors. In discovering the MammaPrint signature with her colleague Dr. Rene Bernards, Dr. van ‘t Veer harnessed the power of genomics to provide a platform capable of yielding continuous new discoveries to further understand and personalize the treatment of breast cancer. As the landmark I-SPY 2 trial further evolves, we anticipate future findings that will continue to bolster the value of precision oncology."

MammaPrint High1/High2 risk class as a pre-specified biomarker of response to nine different targeted agents plus standard neoadjuvant therapy for ~ 1000 breast cancer patients in the I-SPY 2 TRIAL. Poster presented at EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper). November 2018; Dublin, Ireland.
BluePrint basal subtype predicts neoadjuvant therapy response in ~400 HR+HER2- patients across 8 arms in the I-SPY 2 TRIAL. Poster presented at EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper). November 2018; Dublin, Ireland.
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.

About BluePrint

BluePrint is an 80-gene complementary test provided with MammaPrint which allows functional molecular subtyping of a breast cancer sample into three distinct subtypes: Luminal-type, HER2-type and Basal-type, each with marked differences in long-term outcome and response to neoadjuvant chemotherapy.

About I-SPY 2

I-SPY 2 is an interventional, randomized neoadjuvant Phase II clinical trial that is evaluating the efficacy of new targeted drug agents in combination with standard chemotherapy compared to standard therapy alone. The goal of the trial is to identify more treatment regimens for different subsets of breast cancer patients based on the molecular characteristics of their tumors and by learning about which early indicators of response are predictors of treatment success. A MammaPrint High Risk result is a prerequisite for patients included in the trial.