On June 6, 2016 ProNAi Therapeutics, Inc. (NASDAQ: DNAI), a drug development company advancing targeted therapeutics for patients with cancer, reported interim results from the Wolverine Phase 2 trial of PNT2258 for the treatment of relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) (Press release, ProNAi Therapeutics, JUN 6, 2016, View Source [SID:1234513054]). ProNAi will host an Analyst and Investor Event today from 7:00-8:00am CT at the Hyatt Regency McCormick Place in Chicago where management will discuss these results and provide an update on the PNT2258 development program.

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"Although we observed modest efficacy from PNT2258 in this interim analysis of Wolverine, we do not view these results as robust enough to justify continued development of the drug in DLBCL. We have decided to suspend development of PNT2258 pending further review of these data in order to determine next steps for both this asset and the DNAi platform," said Dr. Nick Glover, President and CEO of ProNAi. "We continue to maintain a strong balance sheet and will focus our resources and activities on advancing our newly licensed Cdc7 inhibitor, PNT141, as well as on securing additional assets to build a broad and diverse pipeline of oncology drugs under our development."

Wolverine is a multicenter Phase 2 study designed to evaluate the safety and efficacy of PNT2258 monotherapy in 61 response evaluable r/r DLBCL subjects and to explore the correlation between various baseline patient characteristics, including biomarkers, and response rate.

Interim safety and efficacy data as of April 25, 2016 are reported for the first 37 subjects enrolled. PNT2258 showed single-agent activity in r/r DLBCL subjects with a response rate of 8.1% overall (n = 37) and 15.8% in the response evaluable subgroup (n = 19), defined as subjects meeting the amended eligibility criteria of a performance status (PS) of 0-1, exposure to 1-3 prior systemic regimens and having received at least eight doses of PNT2258 within 35 days of starting therapy. No responses were observed in the 10 subjects with a PS of 2 and/or > 4 prior lines of therapy enrolled prior to the amendment, nor to date in the eight additional subjects enrolled subsequent to the data cutoff date for this interim analysis.

PNT2258 is also being evaluated in patients with Richter’s Transformation in the Brighton study, a multi-center, single-arm Phase 2 trial. To date, five subjects have been enrolled in this study, of which four have discontinued. The other subject has completed two cycles of treatment. No responses have been observed to date.

"We designed and conducted a robust, well-executed set of experiments, both clinical and preclinical, in order to further our understanding of the PNT2258 asset and the underlying DNAi technology. Unfortunately, advanced DLBCL and Richter’s Transformation are challenging diseases to treat, and PNT2258 did not markedly improve outcomes in these indications," said Dr. Barbara Klencke, Chief Development Officer of ProNAi. "On the basis of these interim assessments, we have decided to close the Wolverine and Brighton studies to further enrollment of new subjects. On behalf of ProNAi, we would like to thank the patients and their families, investigators and staff involved in these studies for their participation and support."

PNT2258 Development
PNT2258 is a clinical-stage drug candidate based on a new therapeutic approach known as DNA interference (DNAi). The DNAi oligonucleotides contained within PNT2258 are designed to target and hybridize with a complementary strand of genomic DNA associated with the BCL2 oncogene.

PNT2258 was evaluated in two studies prior to the Wolverine Phase 2 trial:

In a Phase 1 study (PNT2258-01 study [NCT01191775]) in 22 subjects with advanced solid tumors, PNT2258 was well tolerated at doses from 1 through 150 mg/m2. A Phase 2 dose and schedule was identified from this study.

A pilot, signal seeking study (PNT2258-02 study [NCT01733238]) conducted at three sites enrolled 13 subjects with r/r B-cell non-Hodgkin’s lymphoma (NHL). Significant, durable responses were observed in the four subjects with DLBCL, along with other noteworthy complete responses (CR) or partial responses (PR) and durable stable disease (SD) in follicular lymphoma subjects. Six subjects were progression free at 12 months and progression free survival extended to two years and beyond in four of these six subjects. The majority of the AEs were Grade 1 or 2 in severity and no Grade 5 AEs were observed. Five of the six subjects who were progression free at 12 months with PNT2258 were relapsed (not refractory) at study entry and had responded with their last prior therapy with a median time-to-treatment failure of 48 months, range 23.7-87.6 months. All four responding DLBCL subjects had received 1 or 2 prior therapies.

Wolverine Phase 2 DLBCL Study Interim Results
The Wolverine Phase 2 trial (PNT2258-03-DLBCL [NCT02226965]) is a multicenter, single-arm, open-label study of PNT2258 at a dose of 120 mg/m2 administered as a 4-hour IV infusion on days 1-5 of a 21-day cycle in adults with r/r FDG-PET positive, measureable DLBCL. Other inclusion criteria included: ECOG PS ≤ 2, adequate bone marrow, renal and hepatic function, and exposure to CD20-targeted therapy, an alkylating agent, and a steroid. Following a protocol amendment, enrollment was limited to patients with PS of 0-1 who had been exposed to 1-3 prior systemic regimens.

The primary objective of the study is to assess overall response rate defined as the proportion of subjects with CR/complete metabolic response (CMR) or PR/partial metabolic response (PMR) according to the revised 2014 International Working Group criteria for lymphoma (Lugano Classification) in approximately 61 response evaluable subjects. Subjects are imaged with FDG-PET/CT at Baseline and after 3, 5, and 8 cycles.

A key study objective is to evaluate biomarker data, including BCL2, MYC, and cell of origin (COO), in order to identify correlations and possible predictors of outcome to treatment with PNT2258. Tumor samples are centrally assessed by IHC for protein expression, FISH for chromosomal rearrangement, and by Lymph2Cx gene expression array for COO.

PNT2258 demonstrated single agent activity in Wolverine, with a response rate of 8.1% overall (n = 37) and 15.8% in the response evaluable subgroup (n = 19); all responses were evaluated as PMR. The disease control rate (disease control rate defined as CMR plus PMR plus no metabolic response) was 18.9% overall and 36.8% in the response evaluable subgroup. Of the 37 subjects, the median progression free survival was 1.9 months.

Overall, the safety profile of PNT2258 appears acceptable in subjects with PS 0-1 and ≤ 3 prior lines of therapy. The median treatment duration was 47 days in these subjects compared with 15.5 days in those with PS of 2 and/or ≥ 4 prior lines of therapy. Serious adverse events (SAE) and Grade 5 adverse events (AE) rates, respectively, were 37% and 11% in the 27 subjects with PS 0-1 and ≤ 3 prior lines of therapy, and 60% and 50% in the 10 subjects with PS 2 and/or ≥ 4 prior lines of therapy.

A full report of this interim analysis, including biomarker data, will be presented at an upcoming medical conference

Brighton Phase 2 Richter’s Transformation Study Update

The Brighton Phase 2 trial (PNT2258-04 Richter’s Transformation [NCT02378038]) is a multicenter, single-arm, open-label study of PNT2258 at a dose of 120 mg/m2 administered as a 4-hour IV infusion on days 1-5 of a 21-day cycle in adults with Richter’s Transformation. To date, five subjects have been enrolled of which four have discontinued. One other subject remains on therapy and has completed two cycles of treatment. No responses have been observed to date.

DNAi Platform Development
ProNAi will also be halting all further investment in the DNAi platform.

Analyst & Investor Event
ProNAi will host an Analyst and Investor Event today, Monday, June 6, 2016 from 7:00 – 8:00am CT where the company will present an update on the PNT2258 development program, including interim results from the Wolverine Phase 2 trial. Presenters will include: Dr. Nick Glover, President and Chief Executive Officer, Dr. Barbara Klencke, Chief Development Officer, Dr. Angie You, Chief Business & Strategy Officer and Head of Commercial, and Dr. Christian Hassig, Senior Vice President, Research. The event will take place in the Hyde Park A/CC11A event room at the Hyatt Regency McCormick Place located at 2233 S. Dr. Martin Luther King Jr. Dr., Chicago, Illinois. This event will be webcast live and will be accessible through the company’s website at www.pronai.com. An archived replay of the webcast will also be available.

ASCO 2016 Poster Presentation
Title: A phase 2 study of PNT2258 in patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL): An initial report from the Wolverine study
Trials in Progress Abstract: #TPS7577
Poster: #130b
Poster Session: Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia
Date and Time: Monday, June 6, 2016, 8:00 – 11:30am CT
Location: McCormick Place, Event room: Hall A, 2301 S King Dr, Chicago, Illinois
Track: Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia
Presenter: Jason R. Westin, MD, MS, Department of Lymphoma/Myeloma, The University of Texas MD Anderson Cancer Center
The poster will be available on June 6, 2016 on the company’s website at www.pronai.com

On June 6, 2016 NewLink Genetics Corporation (NASDAQ:NLNK), a biopharmaceutical company focused on bringing novel immuno-oncology medicines to patients, reported the presentation of data from two studies on two posters highlighting the combination therapeutic potential of indoximod, an indoleamine-(2,3)-dioxygenase (IDO) pathway inhibitor, at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago (Press release, NewLink Genetics, JUN 6, 2016, View Source [SID:1234513051]).

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Both posters are available online here.

Updates on Phase 1b/2 trial of the IDO inhibitor indoximod plus checkpoint inhibitors for the treatment of unresectable stage 3 or 4 melanoma

The trial design allows for the combination of indoximod with either ipilimumab or one of the PD-1 checkpoint inhibitors pembrolizumab or nivolumab. The combination of indoximod with other checkpoint inhibitors has been well tolerated thus far with no increase in toxicity noted in this Phase 1b/2 study. Overall, 40 patients had been enrolled in the combined Phase 1b/2 study long enough to have response data available at the time of data cut off. The poster data presented at ASCO (Free ASCO Whitepaper) were based on data via site reported RECIST criteria available from 28 subjects, the objective response rate, comprised of complete response plus partial response, for these patients is 36 percent (10 of 28) with three complete responses. Interestingly, the subset of 15 patients who received indoximod in combination with pembrolizumab had an objective response rate of 53 percent (8 of 15) with two complete responses (13 percent). The trial continues to enroll, with 55 patients currently enrolled in Phase 2.

"Although early, the 53 percent response rate in patients with metastatic melanoma treated with indoximod and pembrolizumab appears promising," said Zakharia Yousef, M.D., Assistant Professor of Medicine, Division of Hematology, Oncology and Blood & Marrow Transplantation at the University of Iowa and Holden Comprehensive Cancer Center.

Phase 2 trial of the IDO pathway inhibitor indoximod plus gemcitabine/nab-paclitaxel for the treatment of metastatic pancreas cancer: interim analysis

The combination of indoximod and gemcitabine/nab-paclitaxel continues to be well tolerated by patients with metastatic pancreatic cancer. These data come from the Phase 1/2 trial in which treatment-naïve metastatic pancreatic cancer patients were treated with the combination therapy in continuous four week cycles. As of the data cut off for the analysis, a total of 45 patients (Phase 1 and 2) were enrolled in the trial long enough to potentially have cycle 4 imaging available by the ASCO (Free ASCO Whitepaper) presentation. Data via site reported RECIST criteria were available on 31 patients. At the time of this analysis, objective response rate was 45 percent (14 of 31) and multiple durable responses ≥6 months were observed. Two patients achieved a complete response (6 percent), both at Cycle 8, showing delayed kinetics that may indicate an immune based mechanism. The trial continues to enroll patients and a biopsy cohort expansion is underway.

"The objective response rate, observance of complete responses, and delayed and durable response patterns are promising for this combination regimen for patients with metastatic pancreas cancer," said Andrea Wang-Gillam, M.D., Ph.D., Assistant Professor of Medicine, Division of Oncology, Section of Medical Oncology, at Washington University School of Medicine.

Further Study of Indoximod Combinations Planned

"These are promising data as indoximod continues to demonstrate potential in combination therapies with other checkpoint inhibitors and with chemotherapies for different cancers, with encouraging rates for objective responses while being well-tolerated," said Charles Link, Jr., M.D., Chairman and Chief Executive Officer. "We believe these data further support that the IDO pathway is one of the key immune checkpoint targets. We anticipate continued clinical progress in these and additional indoximod combinations during 2016."

About Indoximod

Indoximod is an orally available small molecule that has shown the potential to interfere with multiple targets within the indoleamine 2,3-dioxygenase (IDO) pathway. It is designed to be used in combination with other therapeutic agents to maximize the body’s immune response against a range of tumor types. Indoximod is currently in multiple Phase 2 clinical trials for the treatment of patients with breast, prostate, pancreatic, melanoma and brain cancers and in Phase 1 clinical trials for the treatment of pediatric patients with primary malignant brain tumors.

On June 06, 2016 Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, reported that two analyses demonstrating the utility of the Myriad myRisk Hereditary Cancer test will be featured in oral presentations at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting (Press release, Myriad Genetics, JUN 6, 2016, View Source [SID:1234513049]). These presentations demonstrate the importance of using a 25-gene panel to evaluate risk for hereditary breast and ovarian cancers.

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"Risk assessment for hereditary cancer is expanding with the use of the myRisk Hereditary Cancer 25-gene panel, approximately doubling the rate of mutation detection over BRCA1/2 testing alone. However, in these studies we sought to understand the magnitude of risk across 25 genes," said Johnathan Lancaster, M.D., Ph.D., chief medical officer, Myriad Genetic Laboratories. "We discovered that mutations in eight genes are associated with a two- to six-fold increase in breast cancer risk and mutations in 11 genes confer a two- to 40-fold increased risk for ovarian cancer. These important findings clarify the risk across diverse genes and support the use of myRisk as part of a clinical risk assessment for patients."

Results of the studies to be presented are described below and abstracts are available at: abstracts.asco.org. Follow Myriad on Twitter via @MyriadGenetics to stay informed about news and updates from the Company.

myRisk Hereditary Cancer Podium Presentations
Title: Magnitude of invasive breast cancer (BC) risk associated with mutations detected by multiple-gene germline sequencing in 95,561 women.
Presenter: Michael Hall, Stanford University Cancer Institute
Date: Monday, June 6, 2016, 8:00 — 11:30 a.m.; Discussion 1:15 — 2:30 p.m.
Location: S404, Abstract 1512, Poster Board 335

This study evaluated the magnitude of invasive breast cancer (BC) risk associated with mutations across a 25-gene panel test. A total of 95,561 patients underwent clinical testing with the myRisk Hereditary Cancer test. Seven percent of patients tested positive for a deleterious mutation. The majority of mutations occurred in BRCA1/2 genes (44 percent) or other genes associated with BC risk (40 percent). There was a significant association with personal BC history and mutations in BRCA1/2, PTEN, TP53, PALB2, CHEK2, BARD1 and ATM. Specifically, estimates ranged from two (ATM, CHEK2, BARD1) to six (BRCA1, PTEN) times increased risk for breast cancer. These findings demonstrate the BC risk across the diverse panel of 25 genes in the myRisk test.

Title: Ovarian cancer risk associated with mutations detected by multiple-gene germline sequencing in 95,561 women.
Presenter: Allison Kurian, Stanford University Cancer Institute
Date: Monday, June 6, 2016, 9:45 — 11:15 a.m.
Location: E450ab, Abstract: 5510

This study evaluated the magnitude of ovarian cancer (OC) risk with mutations across the 25 genes included in the myRisk Hereditary Cancer panel. Data from 95,561 patients were analyzed to examine the association between deleterious mutations and personal history of OC. The results showed that seven percent of patients tested positive for a deleterious mutation. Among 5,020 women affected by OC, 14 percent had a deleterious mutation (63 percent with BRCA1/2, 9.4 percent in Lynch Syndrome genes and 11.2 percent in other genes associated with OC). In this study, 11 genes were associated with a significant risk of OC, including the first report of OC risk associated with the ATM gene. Importantly, one-third of mutations in patients with OC were in non-BRCA and non-Lynch genes, demonstrating that panel testing with the myRisk test identified a broader spectrum of associated cancers.

About Myriad myRisk Hereditary Cancer Testing
The Myriad myRisk Hereditary Cancer test uses an extensive number of sophisticated technologies and proprietary algorithms in an 850 step laboratory process to evaluate 25 clinically significant genes associated with eight hereditary cancer sites including: breast, colon, ovarian, endometrial, pancreatic, prostate and gastric cancers and melanoma. For more information visit: View Source

On June 6, 2016 Kite Pharma, Inc. (Nasdaq:KITE) ("Kite") reported results from SCHOLAR-1 (Retrospective Non-Hodgkin Lymphoma Research), the first, large, systematic, multi-institutional, patient-level meta-analysis of outcomes from 635 patients with chemorefractory diffuse large B-cell lymphoma (DLBCL) (Press release, Kite Pharma, JUN 6, 2016, View Source [SID:1234513046]). The study showed that patients with chemorefractory disease – defined as disease that does not respond to treatment with a chemotherapy-based regimen or has relapsed less than 12 months after autologous stem cell transplant (ASCT) – have consistently poor outcomes regardless of refractory subgroup, line of therapy, and disease stage. The study will be presented today at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (abstract #7516).

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"These study results are important because they confirm the regrettable outcomes that have been observed in the clinical setting for people with this difficult-to-treat form of DLBCL," said Dr. John Kuruvilla, Associate Professor of Medicine at the University of Toronto, and a clinical investigator in the Department of Medical Oncology at Princess Margaret Cancer Centre in Toronto. "While DLBCL is considered curable with initial chemotherapy-based treatment, patients with chemorefractory DLBCL have limited-to-no treatment options and historically poor outcomes, underscoring the significant need for new therapies."

According to the American Cancer Society, non-Hodgkin lymphoma (NHL) accounts for about four percent of all cancers in the United States, making it one of the most common cancers diagnosed. DLBCL is the most common form of the disease, accounting for one out of every three cases of NHL.1 It is estimated that approximately 26,000 people will be diagnosed with DLBCL in the United States in 2016.

"Little is known about the outcomes of people with chemorefractory DLBCL, leaving a large gap in the treatment landscape. These data help to track the course of the disease and provide an important historical benchmark for studies in this patient population," said David Chang, M.D., Ph.D., Kite’s Executive Vice President, Research and Development, and Chief Medical Officer. "We are proud to partner with clinicians, scientists and researchers at MD Anderson Cancer Center, the Mayo Clinic, the University of Iowa, the Canadian Cancer Trials Group, and LYSARC (The Lymphoma Academic Research Organisation) to help establish a better understanding of the disease to determine how best to treat patients with chemorefractory DLBCL."

About the SCHOLAR-1 Study

The SCHOLAR-1 (Retrospective Non-Hodgkin Lymphoma Research) is a retrospective analysis of patients with chemorefractory DLBCL comprised of data from Phase 3 studies from the Canadian Cancer Trials Group (CCTG LY.12 Study) and LYSARC (CORAL Study) and large retrospective databases including from the MD Anderson Cancer Center, Mayo Clinic and University of Iowa Specialized Programs of Research Excellence (SPORE).

In the study, 635 patients with chemorefractory DLBCL were eligible for evaluation based on the following criteria: DLBCL defined as progressive disease as best response to chemotherapy; or stable disease as best response to chemotherapy (received at least 4 cycles of first-line or 2 cycles of later-line therapy); or relapse ≤ 12 months of ASCT. Patients must have received an anti-CD20 monoclonal antibody (unless CD20 negative) and an anthracycline as one of their prior regimens.

Results to be presented at ASCO (Free ASCO Whitepaper) showed:

The overall response rate (ORR; complete response plus partial response) across all 635 patients was 26% (165/635) with only 8% (51/635) achieving a complete response, showing no signs of the disease
The response rates were consistent ranging from 21% to 31% ORR and 2% to 15% complete response (CR) across centers and data sets
Median overall survival was 6.6 months and consistent across subgroups including refractory status, stage of disease and line of therapy

On June 6, 2016 Foundation Medicine, Inc. (NASDAQ:FMI) reported new data informed by comprehensive genomic profiling (CGP) using FoundationOne Heme demonstrating the diverse and distinct genomic landscape of acute myeloid leukemia (AML) in children versus adults (Press release, Foundation Medicine, JUN 6, 2016, View Source [SID:1234513044]). Foundation Medicine conducted comprehensive genomic profiling of tumor samples from 558 patients with AML, including 104 pediatric and 454 adult patients, and identified age-associated genomic alterations in a subset of patients that could influence and personalize treatment and inform the selection of approved targeted therapies or access to novel therapies available in clinical trials.

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In collaboration with the Children’s Oncology Group AML Disease Committee, a clinical trials group supported by the National Cancer Institute (NCI), cases with known cytogenetic and molecular aberrations underwent CGP with FoundationOne Heme. The results demonstrated 100% concordance between FoundationOne Heme and conventional biomarker analysis across the various cytogenetic hallmarks of AML, including changes to inv(16) and t(8;21), as well as DNA mutations including FLT3/ITD, NPM1, and CEBPA. Importantly, FoundationOne Heme identified multiple additional mutations, such as structural alterations and copy number variations, including alterations that have therapeutic significance. These results suggest the potential clinical benefit of FoundationOne Heme in AML as compared to single gene or hotspot-based clinical testing, and underscore FoundationOne Heme’s unique capability to enhance risk stratification and identify molecular targets for therapeutic intervention.

The data showed a clear age-associated profile with distinct genomic make-up in pediatric versus adult patients. Novel transcripts such as NSD1-NUP98, KDM5A-NUP98 and CBFA2T3-GLIS2 were identified in 21 patients, 16 of whom were children. Fusions were markedly enriched in pediatric patients, while mutations in epigenetic modifiers occurred almost exclusively in adults, including DNMT3A (22 percent), IDH1/2 (21 percent) and TET2 (15 percent). Mutations in ASXL1 (21 percent), SRSF2 (14 percent) and BCOR (9 percent) were also prevalent in adults, but rare in children (0-6%).

"Like many blood cancers, AML is characterized by recurring genomic alterations that often provide information about disease progression and outcome, making comprehensive genomic profiling incredibly important to informing diagnosis and therapeutic decisions," said Vincent Miller, M.D., chief medical officer, Foundation Medicine. "Recognizing that there are fundamental differences between the genomic alterations in pediatric versus adult AML patients will ultimately arm clinicians with additional information to better understand each patient’s disease and guide therapeutic regimens best suited to a particular age group. We believe these data further support integration of FoundationOne Heme into oncology clinical practice."

The findings were presented in a poster titled, "Distinct Age-Associated Genomic Profiles Identified in Acute Myeloid Leukemia (AML) Using FoundationOne Heme," by Katherine Tarlock, M.D., pediatric hematology-oncology faculty at Seattle Children’s Hospital, and a member of the Children’s Oncology Group AML Committee. The data were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2016 taking place June 3-7 in Chicago.

FoundationOne Heme, an integrated DNA/RNA platform using targeted hybrid-capture next-generation sequencing, is a comprehensive genomic profile developed to detect all types of genomic alterations with therapeutic relevance, including single-nucleotide substitutions, insertions and deletions, copy number alterations and rearrangements, which are not fully evaluated using conventional diagnostic assays. FoundationOne Heme simultaneously detects all classes of genomic alterations in the DNA of 405 cancer-related genes and employs RNA sequencing across 265 genes to capture a broad range of gene fusions, a type of alteration that is a common driver of hematologic cancers. It is designed to provide physicians with clinically actionable information to guide treatment options for patients based on the genomic profile of their cancer.

About Foundation Medicine

Foundation Medicine (NASDAQ:FMI) is a molecular information company dedicated to a transformation in cancer care in which treatment is informed by a deep understanding of the genomic changes that contribute to each patient’s unique cancer. The company offers a full suite of comprehensive genomic profiling assays to identify the molecular alterations in a patient’s cancer and match them with relevant targeted therapies, immunotherapies and clinical trials. Foundation Medicine’s molecular information platform aims to improve day-to-day care for patients by serving the needs of clinicians, academic researchers and drug developers to help advance the science of molecular medicine in cancer. For more information, please visit View Source or follow Foundation Medicine on Twitter (@FoundationATCG).