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]).

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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.

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.

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] .

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"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].

On June 7, 2017 Mateon Therapeutics, Inc. (OTCQX:MATN), a biopharmaceutical company developing vascular disrupting agents (VDAs) for the treatment of orphan oncology indications, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the company’s product candidate OXi4503 for the treatment of acute myeloid leukemia (AML) (Press release, Mateon Therapeutics, JUN 7, 2017, View Source [SID1234519457]).

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Fast Track designation is a process designed to facilitate the development and expedite the review of drugs to treat serious or life-threatening conditions and address unmet medical need. Once an investigational agent receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication allows potential issues to be resolved quickly and as they arise, often leading to earlier drug approval and access by patients.

"The receipt of Fast Track designation from the FDA represents an important milestone for our OXi4503 program and follows promising results, including three complete remissions, from the initial cohorts of our on-going OX1222 study in patients with relapsed/refractory AML," said William D. Schwieterman, M.D., President and Chief Executive Officer of Mateon. "This latest development provides further momentum for this groundbreaking study, and occurs in advance of the completion of the fifth patient cohort in OX1222 – which we expect by the end of this year."

About Acute Myeloid Leukemia

A devastating form of cancer of the blood and bone marrow, AML is the most common type of acute leukemia in adults and accounts for the greatest number of leukemia deaths in the United States. There is no standard regimen of care for patients who relapse following front-line treatment or have refractory disease. According to the NIH’s National Cancer Institute Surveillance, Epidemiology and End Results (SEER) program, there are an estimated 21,380 new cases and 10,590 deaths expected in 2017 in the United States. AML arises from a clonal hematopoietic stem cell and is characterized by accumulation of malignant myeloblasts in the bone marrow and resulting in ineffective hematopoiesis. AML often responds initially to front-line treatment of conventional cytotoxic chemotherapy, but it often relapses and long-term disease-free survival is low, posing a significant challenge to treat relapsed and/or refractory disease.

About OXi4503

OXi4503 (combretastatin A1-diphosphate or CA1P) is a dual-mechanism vascular disrupting agent. In preclinical and clinical studies, it has been observed to compromise the tumor vasculature, resulting in extensive tumor cell death and necrosis while also possibly affecting the cell shape and attachment of hematopoietic stem cells. OXi4503 is being evaluated for relapsed/refractory AML and myelodysplastic syndrome (MDS) in combination with cytarabine in OX1222, a phase 1b/2 study. In addition to Fast Track status, OXi4503 has been granted orphan drug designation for the treatment of AML in both the United States and Europe.

On June 07, 2017 (GLOBE NEWSWIRE) — Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical stage biotechnology company focused on the development of novel cancer therapeutics, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to CB-839 in combination with everolimus, for the treatment of patients with metastatic renal cell carcinoma who have received 2 or more prior lines of therapy (Press release, Calithera Biosciences, JUN 7, 2017, View Source [SID1234519455]). CB-839 is a first-in-class, oral, selective, potent inhibitor of glutaminase being evaluated in Phase 1/2 clinical trials for the treatment of solid tumors including renal cell carcinoma, triple negative breast cancer, non-small cell lung cancer, and melanoma.

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"We are pleased that CB-839 has been granted Fast Track designation, demonstrating the FDA’s commitment to facilitate the development and expedite the review of our glutaminase inhibitor as an important new therapy for patients with relapsed renal cell carcinoma," said Susan Molineaux, PhD, President and Chief Executive Officer of Calithera. "We look forward to initiating a global randomized trial of CB-839 in combination with everolimus for the treatment of renal cell carcinoma in the second half of 2017."

The FDA’s Fast Track designation is designed to facilitate the development and expedite the review of drugs and biologics, to treat serious or life threatening conditions, and to fill an unmet medical need. Specifically, Fast Track designation facilitates frequent interactions with the FDA review team, including meetings to discuss all aspects of development to support approval, and also provides the opportunity to submit sections of an NDA on a rolling basis as data become available.