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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]).

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"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.

Amgen And Allergan To Discuss Data Supporting Biologics License Application For ABP 215, A Biosimilar Candidate To Avastin® (bevacizumab)

On July 13, 2017 Amgen (NASDAQ:AMGN) and Allergan plc. (NYSE:AGN) reported that the Companies will discuss data supporting the ABP 215 Biologics License Application (BLA) with the Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Administration (FDA) (Press release, Amgen, JUL 13, 2017, View Source [SID1234519796]). ABP 215 is a biosimilar candidate to Avastin (bevacizumab) and is the first bevacizumab biosimilar candidate to be considered by the FDA.

"Amgen has worked diligently to apply our more than 35 years of experience in biotechnology to the development of biosimilars," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Today, we’re looking forward to discussing the comprehensive data package for ABP 215, Amgen’s first prospective oncologic biosimilar, with the FDA advisory committee."

During the meeting, Amgen will present a comprehensive data package including the analytical, pharmacokinetic and clinical data, which demonstrate ABP 215 and bevacizumab are highly similar, with no clinically meaningful differences in terms of the efficacy, safety and immunogenicity between the products. Clinical studies included results from a Phase 3 study in patients with non-squamous non-small cell lung cancer (NSCLC), which met its primary endpoint of showing clinical equivalence to bevacizumab.

ABP 215 is a biosimilar candidate to bevacizumab, a recombinant immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that binds to vascular endothelial growth factor (VEGF) and inhibits the interaction of VEGF with its receptors, VEGF receptor-1 and VEGF receptor-2, thus inhibiting establishment of new blood vessels necessary for the maintenance and growth of solid tumors.

"ABP 215 is the first product of our collaboration with Amgen to reach this important milestone," said David Nicholson, chief R&D officer at Allergan. "If approved, ABP 215 has the potential to provide another high quality treatment option for cancer patients and pave the way for additional high quality oncology biosimilars from Allergan and Amgen."

The FDA is not bound by the Committee’s recommendation but does takes its advice into consideration when considering the approval of a new therapeutic. The FDA has set a Biosimilar User Fee Act (BsUFA) target action date of Sept. 14, 2017, for ABP 215.

Amgen and Allergan are collaborating on the development and commercialization of four oncology biosimilars. Amgen has a total of 10 biosimilars in its portfolio, one which has been approved by the FDA.

About ABP 215
ABP 215 is being developed as a biosimilar to bevacizumab, which is approved in the U.S., EU and other regions for the treatment of patients with unresectable, locally advanced, recurrent or metastatic non-squamous NSCLC as well as metastatic carcinoma of the colon or rectum; metastatic renal cell carcinoma; and other region-specific indications. On Dec. 2, 2016, Amgen and Allergan also submitted a Marketing Authorization Application to the European Medicines Agency for ABP 215.

About the Amgen and Allergan Collaboration
In December 2011, Amgen and Allergan plc. (then Watson Pharmaceuticals, Inc.) formed a collaboration to develop and commercialize, on a worldwide basis, four oncology antibody biosimilar medicines. This collaboration reflects the shared belief that the development and commercialization of biosimilar products will not follow a pure brand or generic model, and will require significant expertise, infrastructure, and investment to ensure safe, reliably supplied therapies for patients. Under the terms of the agreement, Amgen will assume primary responsibility for developing, manufacturing and initially commercializing the oncology antibody products.

About Amgen Biosimilars
Amgen Biosimilars is committed to building upon Amgen’s experience in the development and manufacturing of innovative human therapeutics to expand Amgen’s reach to patients with serious illnesses. Biosimilars will help to maintain Amgen’s commitment to connect patients with vital medicines, and Amgen is well positioned to leverage its more than 35 years of experience in biotechnology to create high quality biosimilars and reliably supply them to patients worldwide.

For more information, visit www.amgenbiosimilars.com and follow us on www.twitter.com/amgenbiosim.

Aduro Announces Milestone Achieved Relating to Collaboration with Merck for Development of Anti-CD27 Antibody for the Treatment of Cancer

On July 13, 2017 Aduro Biotech, Inc. (Nasdaq:ADRO), a biopharmaceutical company with three distinct immunotherapy technologies, reported that the company has earned a $2.0 million milestone payment under its worldwide licensing agreement with Merck (known as MSD outside the United States and Canada) for work supporting the preparation of an Investigational New Drug Application (IND) for its anti-CD27 antibody (Press release, Aduro Biotech, JUL 13, 2017, View Source [SID1234519795]).

"We are pleased with the progress being made on the pre-clinical development of the anti-CD27 antibody, which was created with our proprietary B-select monoclonal antibody technology and selected by Merck for continued development," stated Hans van Eenennaam, Ph.D., chief operational officer, Aduro Biotech Europe. "Aduro’s anti-CD27 antibody targets the CD27 co-stimulatory pathway, an important component in stimulating an anti-cancer immune response. We look forward to working closely with Merck in their effort to advance this promising and novel approach in the field of immunotherapy into clinical development."

About CD27 and Aduro’s Anti-CD27 Antibody
CD27 is a co-stimulatory receptor expressed on different immune cells, such as T-lymphocytes and NK (natural killer) cells. It has been recognized as having an important role in priming, enhancing and sustaining a productive anti-cancer (CD8 T-cell) adaptive immune response. In preclinical studies, anti-CD27 activation in combination with immune checkpoint inhibition has demonstrated the ability to achieve complete tumor eradication.

In 2014, Merck, through a subsidiary, entered into a worldwide license agreement for the development and commercialization of CD27 antibody agonists. Aduro’s anti-CD27 antibody, which was identified with its proprietary B-select monocolonal antibody technology, targets a functional epitope on CD27 demonstrating potent activation of the CD27 co-stimulatory pathway in pre-clinical studies. As a part of the worldwide license agreement, and in addition to payments received, including the $15 million up-front payment, Aduro is eligible to receive future development, commercial and net sales milestone payments. In addition, Aduro is eligible to receive royalties in the mid-single digits to low teens based on any net sales of the product, if it is approved for marketing.

Novartis CAR-T cell therapy CTL019 unanimously (10-0) recommended for approval by FDA advisory committee to treat pediatric, young adult r/r B-cell ALL

On July 12, 2017 Novartis reported that the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) unanimously (10-0) recommended approval of CTL019 (tisagenlecleucel), an investigational chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of relapsed or refractory (r/r) pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL) (Press release, Novartis, JUL 12, 2017, View Source [SID1234519794]).

"The panel’s unanimous recommendation in favor of CTL019 moves us closer to potentially delivering the first-ever commercially approved CAR-T cell therapy to patients in need," said Bruno Strigini, CEO, Novartis Oncology. "We’re very proud to be expanding new frontiers in cancer treatment by advancing immunocellular therapy for children and young adults with r/r B-cell ALL and other critically ill patients who have limited options. We look forward to working with the FDA as they complete their review."

Acute lymphoblastic leukemia comprises approximately 25% of cancer diagnoses among children under 15 years old and is the most common childhood cancer in the US[1]. Effective treatment options for patients with r/r ALL are limited. In pediatric and young adult patients with B-cell ALL that have relapsed multiple times or become refractory to treatment, the five-year disease-free survival is less than 10-30%[2],[3],[4].

The ODAC recommendation is based on review of the CTL019 r/r B-cell ALL development program, which includes the Novartis-led ELIANA study (NCT02435849), the first pediatric global CAR-T cell therapy registration trial. Findings from a US multicenter trial and a single site trial examining the safety and efficacy of CTL019 among pediatric and young adult patients with r/r B-cell ALL also supported the recommendation and the Biologics License Application (BLA)[5].

CTL019 was first developed by the University of Pennsylvania (Penn) and uses the 4-1BB costimulatory domain in its chimeric antigen receptor to enhance cellular responses as well as persistence of CTL019 after it is infused into the patient, which may be associated with long-lasting remissions in patients. In 2012, Novartis and Penn entered into a global collaboration to further research, develop and commercialize CAR-T cell therapies, including CTL019, for the investigational treatment of cancers. Children’s Hospital of Philadelphia (CHOP) was the first institution to investigate CTL019 in the treatment of pediatric patients and led the single site trial.

"It is encouraging to see the FDA panel’s recommendation and continued momentum behind this innovative therapy, which has potential to help young patients with relapsed/refractory B-cell ALL," said the Penn team’s leader, Carl June, MD, the Richard W. Vague Professor of Immunotherapy, director of the Center for Cellular Immunotherapies in Penn’s Perelman School of Medicine and director of the Parker Institute for Cancer Immunotherapy at Penn. "We look forward to continuing to work with Novartis to help make a lasting impact on the way this disease is treated."

"We know firsthand from treating children and young adults with relapsed/refractory B-cell ALL that they desperately need innovative medicines that provide a new approach to managing this aggressive disease," said Stephan Grupp, MD, PhD, the Yetta Deitch Novotny Professor of Pediatrics at the Perelman School of Medicine at Penn, Director of the Cancer Immunotherapy Frontier Program and Chief of the Section of Cellular Therapy and Transplant at CHOP. "Today’s vote in favor of CTL019 is a positive step and we appreciate Novartis’ commitment to pediatric patients."

Earlier this year, Novartis submitted a BLA for CTL019 to the FDA, marking the first submission by Novartis for a CAR-T cell therapy. CTL019 previously received FDA Breakthrough Therapy designation and is under Priority Review by the FDA. The FDA will consider the vote as it reviews the BLA, although it is not obligated to follow the recommendation. Novartis continues to invest in the necessary infrastructure for the potential commercialization of CTL019, including manufacturing and the establishment of a network of certified treatment centers.

Novartis plans additional filings for CTL019 in the US and EU later this year, including applications with the FDA and European Medicines Agency (EMA) for the treatment of adults with r/r diffuse large B-cell lymphoma (DLBCL).

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 manufacturing facility to create T cells that are genetically coded to express a chimeric antigen receptor to recognize and fight cancer cells and other B-cells expressing a specific antigen.

ELIANA (NCT02435849) is the first pediatric global CAR-T cell therapy registration trial, with study enrollment having occurred across 25 centers in the US, Canada, EU, Australia and Japan.

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.