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FDA Advisory Committee Unanimously Recommends CTL019 (tisagenlecleucel) for Approval

On July 13, 2017 Oxford BioMedica plc ("Oxford BioMedica" or "the Group") (LSE:OXB), a leading gene and cell therapy group, reported that the US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee voted unanimously 10 to 0 in favour of approval of Novartis investigational therapy CTL019 (tisagenlecleucel) for the treatment of relapsed and refractory (r/r) paediatric and young adult patients with B-cell acute lymphoblastic leukaemia (ALL) (Press release, Oxford BioMedica, JUL 13, 2017, View Source [SID1234519799]).

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Novartis announced in March that the FDA accepted its BLA filing and granted priority review for CTL019 in paediatric and young adult patients with B-cell ALL. The BLA review is ongoing and is under FDA priority review.

Oxford BioMedica is the sole manufacturer of the lentiviral vector that encodes CTL019. As announced in October 2014, Oxford BioMedica will also receive undisclosed royalties on potential future sales of Novartis CAR-T products. Oxford BioMedica recently signed an agreement with Novartis for the commercial and clinical supply of lentiviral vectors used to generate CTL019 and other undisclosed CAR-T products, for which Oxford BioMedica could potentially receive in excess of $100m from Novartis over the next three years.

John Dawson, Chief Executive Officer of Oxford BioMedica, commented: "The positive vote by 10 to 0 provides further support for CTL019, a novel immunocellular therapy, and we are proud to be a part of this important development. We continue to work closely with Novartis in delivering the lentiviral vector that encodes CTL019, a product the company described earlier this year as having "blockbuster" potential."

FDA Oncologic Drugs Advisory Committee Unanimously Recommends Approval of Mylan and Biocon’s Proposed Biosimilar Trastuzumab

On July 13, 2017 /PRNewswire/ — Mylan N.V. (NASDAQ, TASE: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) reported that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended approval of the companies’ proposed biosimilar trastuzumab (Press release, Mylan, JUL 13, 2017, View Source [SID1234519803]). The committee voted 16-0 in support of eligible indications of the reference product, Herceptin, which include HER2-positive breast cancer in the metastatic and adjuvant settings.

Mylan President Rajiv Malik commented: "We are pleased with ODAC’s recommendation to support the approval of Mylan’s proposed biosimilar trastuzumab to increase affordability, competition and most importantly overall access and use. As one of the largest suppliers of cancer medicines by volume in the U.S., Mylan is committed to serving this important patient community. We look forward to working with FDA to further increase access to this important treatment option for the thousands of patients affected by HER2-positive breast cancer each year."

Biocon CEO and Joint Managing Director Dr. Arun Chandavarkar said: "We welcome ODAC’s endorsement of our biosimilar trastuzumab as it brings our collaboration a step closer to addressing the critical needs of cancer patients in the U.S. We now look forward to engaging with the FDA to seek final approval in order to expand access to a high-quality, affordable option for treating HER2-positive breast cancers."

Data presented to ODAC included results from analytical, nonclinical and clinical studies which demonstrated that our proposed biosimilar trastuzumab is highly similar to Herceptin, in line with the FDA assessment provided in the pre-meeting briefing documents. ODAC determined that no clinically meaningful differences exist between the biosimilar product and Herceptin in terms of safety, purity and potency. As such, the committee concluded that the totality of evidence supports a recommendation for FDA approval.

FDA uses advisory committees and panels to obtain independent expert advice on a variety of matters, including product approvals. FDA often follows the advice of ODAC in determining whether a product should come to market, although they are not required to follow it.

Mylan and Biocon’s proposed biosimilar trastuzumab also is under review by regulatory authorities in Australia, Canada, Europe and several emerging markets.

About the Biocon and Mylan Partnership
Mylan and Biocon are exclusive partners on a broad portfolio of biosimilar and insulin products. The proposed biosimilar trastuzumab is one of the six biologic products co-developed by Mylan and Biocon for the global marketplace. Mylan has exclusive commercialization rights for the proposed biosimilar trastuzumab in the U.S., Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries. Biocon has co-exclusive commercialization rights with Mylan for the product in the rest of the world.

CTI BioPharma Announces European Medicines Agency Validation of Pacritinib Marketing Authorization Application for Patients with Myelofibrosis who have Thrombocytopenia

On July 13, 2017 /PRNewswire/ — CTI BioPharma Corp. (NASDAQ and MTA: CTIC) reported that European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for pacritinib for the treatment of patients with myelofibrosis who have thrombocytopenia (platelet counts less than 100,000 per microliter) (Press release, CTI BioPharma, JUL 13, 2017, View Source [SID1234519802]).

Validation confirms that the submission is complete and initiates the centralized review process by the EMA’s Committee for Medicinal Products for Human Use (CHMP). The CHMP review period is 210 days, excluding question or opinion response periods, after which the CHMP opinion is reviewed by the European Commission, which usually issues a final decision on EU authorization within three months. If authorized, pacritinib would be granted a marketing license valid in all 28 EU member states.

"The MAA validation is a significant milestone for CTI BioPharma as we seek to bring pacritinib to patients with myelofibrosis who have thrombocytopenia that could benefit from its unique profile," said Adam R. Craig, M.D., Ph.D., President and CEO of CTI BioPharma. "We look forward to working with the CHMP/EMA during their review of this application."

The MAA is primarily supported by data from two randomized Phase 3 clinical trials, PERSIST-1 and PERSIST-2, that evaluated pacritinib in patients with myelofibrosis.

Kura Oncology Establishes Collaboration with Foundation Medicine to Support Tipifarnib Development in HRAS Mutant Head and Neck Cancer

On July 13, 2017 Kura Oncology, Inc. (NASDAQ:KURA), a clinical stage biopharmaceutical company focused on the development of precision medicines for oncology, reported it has entered into a collaboration agreement with Foundation Medicine, Inc. (NASDAQ:FMI) to support patient enrollment for Kura’s clinical program for tipifarnib in patients with relapsed and/or refractory HRAS mutant squamous cell carcinoma of the head and neck (SCCHN) (Press release, Kura Oncology, JUL 13, 2017, View Source [SID1234519798]).

"We’re excited to collaborate with Foundation Medicine, a leader and innovator in precision medicine, molecular information and comprehensive genomic profiling, as part of our strategy to reach a broader population of patients with high unmet medical need," said Troy Wilson, Ph.D., J.D., President and CEO of Kura Oncology. "Our preliminary data suggests tipifarnib has activity in patients with HRAS mutant squamous cell head and neck cancer, who have failed other treatment options, and we believe Foundation Medicine’s unique expertise and outreach to physicians treating SCCHN patients, in particular, in the community treatment setting fit well with our company’s objectives and values."

Through this collaboration, Foundation Medicine’s SmartTrials Precision Enrollment program will contact physicians treating individuals across the U.S. diagnosed with SCCHN whose tumors harbor HRAS mutations as detected in the course of routine clinical care. The treating physicians will be contacted and informed of Kura’s ongoing Phase 2 study of tipifarnib, including relevant details about the trial, including trial patient characteristics and investigational centers, to assist the physician in evaluating tipifarnib as a potential treatment option.

Tipifarnib is an inhibitor of farnesylation, a key cell signaling process implicated in cancer initiation and development, and is under investigation in multiple ongoing clinical trials. Tipifarnib has demonstrated encouraging preclinical and clinical activity, including durable partial responses, in an ongoing Phase 2 clinical trial in patients with HRAS mutant SCCHN. Additional information about this clinical trial can be found at clinicaltrials.gov.

About HRAS Mutant SCCHN

Head and neck cancer is one of the leading causes of cancer-related deaths worldwide, with squamous cell carcinomas accounting for most head and neck cancers. The relapsed and/or refractory SCCHN patient population has an overall survival of approximately 6-8 months and few therapeutic options. New therapies for SCCHN, including immunotherapy, typically show a response rate in the range of 10-20%. HRAS is a proto-oncogene that has been implicated in the development and progression of SCCHN. HRAS mutant SCCHN has an estimated annual incidence of approximately 2,800 to 3,400 patients in the U.S. and represents a significant unmet medical need.

Initiation Of Clinical Trial Collaboration Evaluating Halozyme’s PEGPH20 In Combination With Anti-PDL1 Immunotherapy

On July 13, 2017 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported the initiation of a multi-arm clinical trial evaluating PEGPH20, Halozyme’s investigational new drug, in combination with atezolizumab (TECENTRIQ), an anti-PDL1 cancer immunotherapy from Genentech, a member of the Roche Group (Press release, Halozyme, JUL 13, 2017, View Source [SID1234519797]). The combination will be tested in patients with previously treated metastatic pancreatic ductal adenocarcinoma. The study is sponsored by and funded by Genentech.

The study is part of a clinical collaboration agreement announced by the companies last year to evaluate PEGPH20 and atezolizumab in up to eight tumor types, including pancreatic and gastric cancers.

The Phase 1b/2, open-label, multicenter, randomized clinical trial is designed to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of immunotherapy-based treatment combinations compared with the standard chemotherapy regimens.

Patients will be enrolled regardless of their hyaluronan (HA) level, with analysis conducted retrospectively on a subset population of HA-high patients identified using the Ventana HA companion diagnostic assay.

HA is a glycosaminoglycan, or chain of natural sugars in the body that can accumulate around cancer cells creating high pressure in a tumor, constricting blood flow and thereby reducing access of chemotherapy and immunotherapeutic agents. PEGPH20 is an enzyme that temporarily degrades HA, reducing tumor pressure and potentially increasing blood flow, allowing greater access for chemotherapies and immunotherapies to treat the tumor.

The study will be conducted in the U.S., as well as countries outside the U.S.

The collaboration between Halozyme and Genentech includes testing the experimental combination in MORPHEUS, Roche’s Novel Cancer Immunotherapy Development Platform. MORPHEUS is a Phase 1b/2 adaptive platform to develop combinations of cancer immunotherapies more rapidly and efficiently.

"This clinical trial expands the study of PEGPH20 in pancreatic cancer, evaluating previously treated pancreas cancer patients and combining PEGPH20 with an anti-PDL1 monoclonal antibody for the first time," said Dr. Helen Torley, president and chief executive officer. "We are pleased to provide PEGPH20 in this collaboration study, to evaluate and potentially advance new treatment options for patients with pancreatic cancer, one of the hardest to treat cancers."

About PEGPH20 (pegvorhyaluronidase alfa)
PEGPH20 is an investigational PEGylated form of Halozyme’s proprietary recombinant human hyaluronidase under clinical development for the potential systemic treatment of tumors that accumulate hyaluronan. PEGPH20 is an enzyme that temporarily degrades HA, a dense component of the tumor microenvironment that can accumulate in higher concentrations around certain cancer cells, potentially constricting blood vessels and impeding the access of other therapies.

FDA granted orphan drug designation to PEGPH20 for treatment of pancreas cancer and fast track designation for PEGPH20 in combination with gemcitabine and nab-paclitaxel for the treatment of metastatic pancreas cancer. Additionally, the European Commission, acting on the recommendation from the Committee for Orphan Medicinal Products of the European Medicines Agency, designated investigational drug PEGPH20 an orphan medicinal product for the treatment of pancreas cancer.