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Kura Oncology Announces Data Presentations for Tipifarnib at the International Conference on Malignant Lymphoma and the European Hematology Association Annual Meeting

On June 7, 2017 Kura Oncology, Inc. (NASDAQ:KURA), a clinical stage biopharmaceutical company focused on the development of precision medicines for oncology, reported that preliminary data from the ongoing Phase 2 clinical trial evaluating the efficacy, safety and biomarkers of tipifarnib in the treatment of relapsed or refractory peripheral T-cell lymphoma (PTCL) were selected for a poster presentation at the 14th International Conference on Malignant Lymphoma (ICML) being held June 14-17, 2017 in Lugano, Switzerland (Press release, Kura Oncology, JUN 7, 2017, View Source [SID1234519462]). In addition, Kura’s preliminary Phase 2 data in PTCL were also selected for a poster presentation at the 22nd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) taking place June 22-25, 2017 in Madrid, Spain.

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Details for the Poster Presentation at ICML

Title: Preliminary Results from an Open-label, Phase II Study of Tipifarnib in Relapsed or Refractory T-cell Lymphoma
Presenter: Thomas E. Witzig, M.D., Mayo Clinic
Abstract Number: 255
Date and Time: Wednesday, June 14, 2017, poster may be viewed from Wednesday, June 14, 2017 at 12:00 CET through Friday, June 16, 2017 at 18:30 CET
Location: Marquee Parco Ciani

Details for the Poster Presentations at EHA (Free EHA Whitepaper)

Title: Preliminary Results from an Open-label, Phase II Study of Tipifarnib in Relapsed or Refractory T-cell Lymphoma
Presenter: Thomas E. Witzig, M.D., Mayo Clinic
Abstract Number: P571
Poster Session: EHA (Free EHA Whitepaper) 22
Date / Time: Saturday, June 24, 2017, 7:30 – 19:00 CET
Location: IFEMA, Poster Area, Hall 7

In addition, data from a preclinical study of tipfarnib in T-cell leukemia by Dr. Mondejar (IDIVAL, Santander, Spain) showing cell line sensitivity to common T leukemia mutations will be presented at EHA (Free EHA Whitepaper) as an E-poster.

Title: T-Cell Leukemia Sensitivity to Farnesyl Transferase Inhibition Using Tipifarnib
Abstract Number: E834
Date / Time: Friday, June 23, 09:30 CET through Saturday, June 24, 19:30 CET
Location: Poster Area, E-poster screens

Foundation Medicine to Identify Patients Eligible for National Cancer Institute’s NCI-MATCH (Molecular Analysis for Therapy Choice) Study

On June 7, 2017 Foundation Medicine (NASDAQ: FMI) reported a collaboration with the National Cancer Institute (NCI) and ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) for their precision medicine cancer trial, NCI-Molecular Analysis for Therapy Choice (NCI-MATCH or EAY131) (Press release, Foundation Medicine, JUN 7, 2017, View Source [SID1234519461]). This ongoing study is evaluating the benefit of genomically-guided treatments targeting specific alterations within a person’s tumor, regardless of cancer type. Foundation Medicine will notify physicians at the more than 1,100 clinical sites participating in NCI-MATCH when the comprehensive genomic profiling (CGP) assays they ordered to guide clinical care, FoundationOne or FoundationOne Heme, reveal findings that may make a patient eligible for one of several NCI-MATCH treatments.

The FoundationOne and FoundationOne Heme assays comprehensively interrogate hundreds of cancer-related genes in solid tumors, or hematologic cancers and advanced sarcomas, respectively, to identify genomic alterations that can help match a patient with a therapy that targets those alterations. Foundation Medicine and its CGP assays were selected for participation in NCI-MATCH based on the validation, reliability and accuracy of the assays, the ability to review a high volume of patient cases due to the mainstream use of FoundationOne and FoundationOne Heme in clinical care today, and the ability to provide assay results in a format that can be uploaded into MATCHbox, the trial’s informatics system that generates patient treatment assignment information for the trial’s panel of experts to review.

"The NCI-MATCH trial is vital to learning more about the genomic basis of cancer biology and the best ways to improve cancer treatment for each individual patient," said Vincent Miller, M.D., chief medical officer at Foundation Medicine. "We believe this innovative trial design leveraging genomics to inform potential treatment modalities will become the standard for oncology clinical studies, particularly to identify signals of effectiveness that can be studied in larger, more definitive trials. We believe our collaboration will help the clinical sites participating in the trial to identify a larger number of patients who may be eligible to enroll for treatment."

Through this collaboration, Foundation Medicine will assist ECOG-ACRIN and the NCI in casting a wider net for patients that may be eligible for NCI-MATCH. Foundation Medicine will identify individuals whose tumors are profiled through standard clinical care with FoundationOne or FoundationOne Heme and are found to harbor genomic alterations being studied in NCI-MATCH, as determined by Foundation Medicine’s proprietary SmartTrials engine that allows for alteration-level specificity in matching patients to the trial. If the individual is identified at a site that is participating in the trial, Foundation Medicine’s SmartTrials outreach services will notify their treating physician that the patient may be eligible for enrollment into NCI-MATCH. The oncologist can take the information into consideration when discussing treatment options with his or her patients. Foundation Medicine initiated inclusion of NCI-MATCH in this outreach in May 2017.

About the NCI-MATCH Study
NCI-MATCH is a phase II precision medicine trial that seeks to determine the effectiveness of treatment that is directed by genomic profiling in patients with solid tumors, lymphomas, or myelomas that have progressed following all standard treatments expected to prolong overall survival or rare cancer types for which there is no standard treatment. The study attempts to demonstrate that matching certain drugs or drug combinations in adults whose tumors have specific gene abnormalities will effectively treat cancer, regardless of its type. Such discoveries could be eligible to move on to larger, more definitive trials.

Cellceutix Announces Company Name Change to Innovation Pharmaceuticals Inc.

On June 7, 2017 Cellceutix Corporation, (OTCQB:CTIX) ("the Company"), an emerging biopharmaceutical company, reported to shareholders, and the public at large, that the company name is changing to Innovation Pharmaceuticals Inc. (IPI) and it has received a new Committee on Uniform Securities Identification Procedures (CUSIP) number of 45782D 100 (Press release, CellCeutix, JUN 7, 2017, View Source [SID1234519460]).

Innovation Pharmaceuticals more accurately describes the innovative nature of our first-in-class pipeline of mid-stage drug candidates. These changes will have no impact on the marketability of the Company’s securities, or the ability to trade the common stock through brokerage firms. Stockholders of the Company are not required to exchange their stock certificates in connection with the name change.

The Company’s common stock will continue to trade under stock symbol "CTIX" on OTCQB until market close on June 8, 2017. Trading on the OTCQB under the new Innovation Pharmaceuticals name and ticker symbol "IPIX" will begin at market open on June 9, 2017.

The Company’s new website address will change to www.IPharmInc.com. In the interim, the Company will maintain www.cellceutix.com.

The name change will be discussed at the upcoming live shareholder and investor conference call, to be held on Thursday, June 8, 2017, at 11am EDT. Senior Company management will be responding to recently posed questions submitted by email. Live call-in questions will also be addressed.

Oxford BioMedica notes FDA Advisory Committee to review CTL019

On 7 June 2017: Oxford BioMedica plc ("Oxford BioMedica" or "the Group") (LSE:OXB), a leading gene and cell therapy group, notes that the US Food and Drug Administration (FDA) has scheduled an Oncologic Drugs Advisory Committee meeting on 12 July 2017 to review the CTL019 (tisagenlecleucel-T) Biologics License Application (BLA) filing in relapsed and refractory (r/r) paediatric and young adult patients with B-cell acute lymphoblastic leukaemia (ALL) (Press release, Oxford BioMedica, JUN 7, 2017, View Source [SID1234519459])

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Novartis announced in March 2017 that the FDA accepted CTL019 for review and granted priority review status.

Oxford BioMedica is the sole manufacturer of the lentiviral vector expressing CTL019 for Novartis. As announced in October 2014, Oxford BioMedica will also receive undisclosed royalties on potential future sales of Novartis CAR-T products.

Novartis interim results from global, pivotal CTL019 trial show durable complete responses in adults with r/r DLBCL

On June 7, 2017 Novartis reported findings from an interim analysis of its multi-center Phase II JULIET study (NCT02445248) of CTL019 (tisagenlecleucel) in adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL), which will be presented at the International Conference on Malignant Lymphoma (ICML) meeting, Lugano, Switzerland (Abstract #007; Wednesday, June 14, 3:40 PM CEST) (Press release, Novartis, JUN 7, 2017, View Source [SID1234519458]). The global, pivotal study showed a three-month overall response rate (ORR) of 45% (23 of the 51 patients evaluated), with 37% achieving a complete response (CR) and 8% achieving a partial response (PR), respectively. CR remained stable from three months through data cutoff among the patient group[1] .

"The overall response rate seen in this early analysis is impressive for these heavily pre-treated patients with relapsed/refractory DLBCL, who have limited treatment options," said JULIET lead investigator, Stephen Schuster, MD, Professor of Hematology/Oncology in the Perelman School of Medicine at the University of Pennsylvania (Penn) and Penn’s Abramson Cancer Center. "The goal for these patients is achieving durable response. The most promising aspect of these data is that, at the time of this interim analysis, all patients with complete response at three months have remained in complete response."

JULIET is the first multi-center global registration study for CTL019 in adult patients with r/r DLBCL and the second global CAR-T cell therapy trial, following the Novartis ELIANA study (NCT02435849) of CTL019 in pediatric and young adult patients with r/r B-cell acute lymphoblastic leukemia (ALL). JULIET was conducted in collaboration with Penn and enrolled patients from 27 sites in 10 countries across the US, Canada, Europe, Australia and Japan. It is the largest study examining a CAR-T cell therapy exclusively in DLBCL patients.

The study met its primary objective at interim analysis. Among 51 patients with three months or more of follow-up or earlier discontinuation, best ORR was 59% (95% CI, 44.2-72.4; p<0.0001), with 43% achieving CR and 16% achieving PR. The full JULIET primary analysis is expected to be available later this year and will serve as the basis for US and EU regulatory submissions[1].

In the JULIET study, 57% of all treated patients (85) experienced any grade cytokine release syndrome (CRS), and 26% experienced grade 3/4 CRS (17% grade 3; 9% grade 4) using the Penn Grading Scale, a rigorous scale for grading CRS. CRS is a known complication of the investigational therapy that may occur when the engineered cells become activated in the patient’s body. CRS was managed globally using prior site education on implementation of the CRS treatment algorithm[1].

There were no deaths attributed to CTL019, CRS or cerebral edema, and no incidents of cerebral edema were reported in the study. Thirteen percent of patients had grade 3/4 neurologic adverse events, which were managed with supportive care. Grade 3/4 cytopenias lasting more than 28 days and grade 3/4 febrile neutropenia occurred in 21% and 14% of patients, respectively. Three patients died from disease progression within 30 days of infusion[1].

In the JULIET trial, 43 patients discontinued before infusion and the majority did so due to rapid progression of their disease or deterioration in their clinical status. This reflects the acute and progressive nature of the disease of the patients. Only nine of 141 (6%) enrolled patients could not be infused due to inability to manufacture an adequate dose of CAR-T cells. Over the course of JULIET, with continuous process improvements, manufacturing success rate improved to 97% for the last 30 patients.

"We are pleased the interim results from JULIET highlight the potential for CTL019 to elicit durable responses in patients with relapsed/refractory DLBCL, an area of high unmet need," said Vas Narasimhan, Global Head of Drug Development and Chief Medical Officer, Novartis. "Novartis is committed to progressing our portfolio of CAR-T therapies in hematological and solid tumors to advance the care of cancer patients."

In April 2017, the US Food and Drug Administration (FDA) granted Breakthrough Therapy designation to CTL019 based on data from the JULIET study.

About the JULIET Trial
JULIET (NCT02445248) is a single-arm, open-label, multi-center global Phase II trial of CTL019 in patients aged 18 years or older with r/r DLBCL. Prior to enrollment, patients were required to have received two or more lines of prior chemotherapy and had disease progression or were ineligible for autologous stem cell transplant (autoSCT). Sixty percent of the patients had three or more lines of chemotherapy and 51% had a prior autoSCT.

The primary endpoint of the study is best ORR (defined as CR plus PR) determined by a central review conducted by an independent review committee. Secondary endpoints from the study include overall survival, duration of response and progression-free survival.

About CTL019 Manufacturing
Novartis cryopreserved leukapheresis process allowed for successful manufacturing and treatment of patients from around the world. Cryopreserved leukapheresis gives physicians the flexibility to schedule apheresis at a time that is in the best interest of their patients. Novartis commercial manufacturing for CTL019 will build on its extensive experience in our Morris Plains facility, which has already manufactured CTL019 for hundreds of patients in global clinical trials. Novartis believes that hands-on experience matters in cell therapy manufacturing, and the experience at Morris Plains will be a foundation for manufacturing for commercial purposes and future CAR-T therapies. Novartis has made and continues to make significant investments in capacity and turnaround time and is committed to meeting the needs of CTL019 patients in the future.

About CAR-T and CTL019
CAR-T is different from typical small molecule or biologic therapies because it is manufactured for each individual patient using their own cells. During the treatment process, T cells are drawn from a patient’s blood and reprogrammed in the laboratory to create T cells that are genetically coded to hunt the patient’s cancer cells and other B cells expressing a particular antigen.

CTL019 was first developed by the University of Pennsylvania (Penn) and uses the 4-1BB costimulatory domain to enhance cellular responses. In 2012, Novartis and Penn entered into a global collaboration to further research, develop and then commercialize CAR-T cell therapies, including CTL019, for the investigational treatment of cancers. In March 2017, Novartis announced that the FDA accepted the company’s Biologics License Application filing and granted priority review for CTL019 in the treatment of r/r pediatric and young adult patients with B-cell ALL.

Because CTL019 is an investigational therapy, the safety and efficacy profile has not yet been established. Access to investigational therapies is available only through carefully controlled and monitored clinical trials. These trials are designed to better understand the potential benefits and risks of the therapy. Because of the uncertainty of clinical trials, there is no guarantee that CTL019 will ever be commercially available anywhere in the world.

About DLBCL

DLBCL is the most common form of lymphoma and accounts for approximately 30% of all non-Hodgkin lymphoma cases[2]. Ten to 15% of DLBCL patients fail to respond to initial therapy or relapse within three months of treatment, and an additional 20% to 25% relapse after initial response to therapy[3].