On July 20, 2015 BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) reported an update on the ABRAZO Phase 2 study of its poly ADP-ribose polymerase (PARP) inhibitor, talazoparib (formerly referred to as BMN 673) for the treatment of patients with deleterious germline BRCA 1 or BRCA 2 mutations and locally advanced and/or metastatic breast cancer (Press release, BioMarin, JUL 20, 2015, View Source [SID:1234506535]).

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The company announced that the ABRAZO Phase 2 trial has met the study’s protocol-specified threshold for documented tumor reduction (using the RECIST response rate criteria) in order to warrant expanding enrollment in the study from 70 to 140 patients. The ABRAZO study includes two cohorts of patients with BRCA mutated metastatic breast cancer. The first cohort consists of patients who have initially responded to a platinum-containing regimen then progressed, while the second cohort consists of patients who have received more than two prior chemotherapy regimens for metastatic disease. The protocol-specified expansion criteria requires that a minimum of five responses per cohort, of up to 35 patients, be observed in order to expand the study. The minimum of 5 responses was seen prior to full enrollment in each cohort.

The ABRAZO study is the first study treating BRCA breast cancer patients with a PARP inhibitor monotherapy that has demonstrated activity in patients who are in a salvage setting defined as having failed at least two prior chemotherapy regimens for metastatic disease. In addition, this is the first reported data showing tumor reduction from a PARP inhibitor in BRCA breast cancer patients previously treated with a platinum regimen. The trial, now targeting enrollment of a total of 140 patients, is expected to be fully enrolled in the first quarter of 2016 with results expected by year end 2016. These interim results of the ABRAZO study are planned to be presented at an upcoming medical meeting in 2016.

"We are pleased to have met our protocol-specified criteria in the ABRAZO Phase 2 trial allowing us to expand enrollment and complete the study," said Hank Fuchs, M.D., Chief Medical Officer at BioMarin. "If successful, single agent efficacy in a salvage setting potentially could support registration, adoption and use by patients who have exhausted therapeutic options. We also are thrilled to have seen anti-tumor activity in patients previously treated with platinum regimens. This is an unprecedented finding in BRCA metastatic breast cancer, which may provide a further treatment option for these patients."

The company also updated guidance for completion of enrollment of the pivotal EMBRACA study, which the company now estimates to be in the first half of 2016. EMBRACA is a Phase 3, open-label, 2:1 randomized trial to compare the safety and efficacy of oral PARP inhibitor talazoparib versus protocol-specific physician’s choice in patients who have locally advanced and/or metastatic breast cancer with germline BRCA mutations. Prior guidance had been for enrollment of 430 patients by year end 2015. Since study initiation, a newly completed review of published data suggests that the median progression-free survival (PFS) is lower than originally estimated for the control arm in this patient population, and that fewer than the originally estimated 430 patients may need to be enrolled in order to achieve the targeted hazard ratio.

ABRAZO Trial Design

This is a Phase 2, 2-Stage, 2-Cohort Study of oral PARP inhibitor talazoparib (BMN 673) in patients with locally advanced and/or metastatic breast cancer with germline BRCA mutations.

The purpose of this study is to evaluate the safety and efficacy of talazoparib (BMN 673) in patients with locally advanced or metastatic breast cancer with a deleterious germline BRCA 1 or BRCA 2 mutation. Subjects will be assigned to either Cohort 1 or 2 based on prior chemotherapy for metastatic disease:

Cohort 1) Subjects who have previously responded (PR or CR) to a platinum-containing regimen for metastatic disease with disease progression > 8 weeks following the last dose of platinum

Cohort 2) Subjects who have received more than two prior chemotherapy regimens for metastatic disease and no prior platinum therapy for metastatic disease

EMBRACA Trial Design

This is a Phase 3, open-label, 2:1 randomized trial to compare the safety and efficacy of oral PARP inhibitor talazoparib (BMN 673) versus protocol-specific physician’s choice in patients who have locally advanced and/or metastatic breast cancer with germline BRCA mutations.

The primary objective of the study is to compare progression-free survival (PFS) of subjects treated with talazoparib (BMN 673) as a monotherapy relative to those treated with protocol-specific physician’s choice. The secondary objectives are to evaluate objective response rate (ORR) and overall survival (OS). Exploratory objectives are to evaluate duration of response (DOR) and health-related quality of life.

About Hereditary Breast Cancer with BRCA Mutation

BRCA1 and BRCA2 are human genes that belong to a class of genes known as tumor suppressors. Mutation of these genes has been linked to hereditary breast and ovarian cancer. A woman’s risk of developing breast and/or ovarian cancer is greatly increased if she inherits a deleterious (harmful) BRCA1 or BRCA2 mutation. Men with these mutations also have an increased risk of breast cancer. Both men and women who have harmful BRCA1 or BRCA2 mutations may be at increased risk of other cancers.

Source: National Cancer Institute at the National Institutes of Health View Source

On July 20, 2015 Adaptimmune Therapeutics plc (Nasdaq: ADAP), a clinical stage biopharmaceutical company focused on the use of T-cell therapy to treat cancer, reported that data from its Phase I/II study of its affinity enhanced T-cell receptor (TCR) therapeutic targeting the NY-ESO-1 cancer antigen in patients with multiple myeloma has been published in Nature Medicine (Press release, Adaptimmune, JUL 20, 2015, View Source [SID:1234506534]).

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The paper entitled NY-ESO-1 Specific TCR Engineered T-cells Mediate Sustained Antigen-specific Antitumor Effects in Myeloma by Drs. Aaron P. Rapoport, Edward Stadtmauer and Gwendolyn Binder-Scholl et al. describes the persistence and tumor trafficking, antitumor effect and safety profile of Adaptimmune’s NY-ESO TCR therapeutic (ADAP NY-ESO TCR) in 20 patients with advanced multiple myeloma. The paper became available through advance online publication on July 20, 2015, and will appear in the August 2015 print edition of Nature Medicine.

This is the first published study of lentiviral vector mediated TCR gene expression in humans. Novel findings include encouraging clinical responses, prolonged duration of persistence of TCR engineered cells and continued expression of the TCR on the cell surface; which is a departure from previously published studies in TCR gene therapy. In addition, high levels of IL-6 were detected, without serious cytokine release syndrome, which is in contrast to the side effects observed with multiple antibody-based CD19 immunotherapeutics to date. Clinical response rates were higher than expected for the patient population enrolled, and evidence supporting the expected mechanism of action of the TCR engineered cells was found.

"We believe these are significant data for Adaptimmune and for the cancer gene therapy field," commented Dr. Rafael Amado, Adaptimmune’s Chief Medical Officer. "The trial showed that autologous transduced cells can be safely administered to patients with advanced myeloma in the context of stem cell transplantation, and that the transduced cells persist for a prolonged period of time. There was also encouraging evidence of antitumor effect which supports further investigation of cell and gene therapy in myeloma."

The publication describes results of a Phase I/II trial to evaluate the safety and activity of autologous T-cells engineered to express an affinity-enhanced T-cell receptor (TCR) recognizing a naturally processed peptide shared by the cancer-testis antigens NY-ESO-1 and LAGE-1. All enrolled patients had symptomatic myeloma with active disease, representing an advanced stage population. Five patients (25 percent) had prior autologous stem cell transplant (ASCT) and 12 (60 percent) with cytogenetic abnormalities, including seven categorized as high-risk. After autologous stem cell collection, patients were conditioned with high-dose melphalan followed two days later by autologous stem cell infusion (ASCT). Patients received ADAP NY-ESO TCR (an average of 2.4 billion NY-ESOc259 -engineered CD3 T-cells) two days after ASCT.

Clinical Results
Encouraging clinical responses were observed in 16 patients (80 percent) in the study: Of the 20 patients, 14 patients (70 percent) had a near complete response or complete response, and another two had a very good partial response (VGPR) by three months post treatment. According to the authors, this compares favorably to the expected response frequencies following ASCT or double sequential (tandem) ASCT where response rates are typically less than 40 percent in patients without high risk disease.
Persistence and the manufacturing method

Persistence of gene modified cells in the patients was prolonged. In this study, 19/20 patients continued to have gene marked cells detectable in blood at six months post infusion, and long term persistence of engineered cells in the peripheral blood was detectable in 90 percent of patients who reached two years follow up. Continued TCR expression was detected at two years, which suggested gene silencing was not occurring. Engineered T-cells also trafficked to sites of tumor; a majority of patients (15/20) underwent marrow biopsy for response assessment at day 100; 14/15 had detectable engineered cells. Previous studies with engineered T-cells (Burns et al., 2009; Robbins et al., 2014) reported no demonstrated persistence and expression beyond one month.

The method of T-cell manufacture may be key to enabling persistence; CD3/CD28 costimulation was used to manufacture cells in this study, and as well as in CAR studies for CD19 and HIV by the coauthors, and all of these studies demonstrate long term persistence of gene marked cells. This technology induces activation of the T-cell receptor through CD3 and simultaneous costimulation to the T-cells though the CD28 receptor. This selects for younger T-cells and also helps to program them for prolonged expansion. Adaptimmune holds an exclusive license from ThermoFisher (formerly Life Technologies Corporation) for methods of expanding and activating T-cells transduced with engineered T-cell receptors (TCR), including use of the ThermoFisher DynaBeads CD3/CD28 technology.

Tolerability Profile
Infusions were well-tolerated without clinically apparent cytokine release syndrome (CRS), or macrophage activation syndrome (MAS), despite high IL-6 levels. The observation of safety is a significant finding; CRS and MAS have been reported as significant safety concerns in multiple antibody-based CD19 immunotherapeutics to date. This differentiated safety profile may be related to physiological signaling and/or the antigen target and expression levels.

Anti-tumor activity
To evaluate antigen-specific anti-tumor activity of the engineered T-cells, RNA transcript levels in marrow specimens were quantitatively measured for NY-ESO-1 and LAGE-1, as well as CD138 as a measure of myeloma/plasma cell burden. Relative to levels at enrollment, loss of NY-ESO-1 and LAGE-1 transcripts was observed in 12/15 patients at day 100, and in 11/13 at day 180. At day 100, 3/15 patients had detectable levels of NY-ESO-1 and LAGE-1 transcripts. Notably, disease relapse was correlated with antigen escape (loss of NY-ESO and Lage expression in 2/10 cases) or loss of engineered T-cells (8/10 patients).

"These data suggest that treatment with enhanced NY-ESO-1/LAGE-1 TCR-engineered T-cells is not only safe but of potential clinical benefit to patients with certain types of aggressive multiple myeloma," said Aaron P. Rapoport, MD, the Gary Jobson Professor in Medical Oncology at the University of Maryland School of Medicine and the Director of the Blood and Marrow Transplant Program at the University of Maryland Marlene and Stewart Greenebaum Cancer Center. "This study establishes a strong foundation for further research in cellular immunotherapy of myeloma. We hope to investigate additional combination approaches to boost the durability and function of the engineered T-cells to achieve even longer and deeper clinical responses."

"This is the first report of TCR engineered T-cell therapy that has shown durable persistence in patients," said Dr. Carl June, Richard W. Vague Professor in Immunotherapy, Department of Pathology and Laboratory Medicine, University of Pennsylvania. "These data are encouraging for the TCR platform, which I believe will be an important technology due to its ability to target intracellular antigens."

About Multiple Myeloma
Multiple myeloma is a cancer formed by malignant plasma cells. Normal plasma cells are found in the bone marrow and are an important part of the immune system, which is made up of several types of cells that work together to fight infections and other diseases. Multiple myeloma is characterized by several features, including low blood counts, bone and calcium problems, infections, kidney problems, monoclonal gammopathy, and others; and by the proliferation of these plasma cells within bone marrow. The American Cancer Society estimates that approximately 26,850 new cases will be diagnosed in the United States in 2015. Average five-year survival rates are estimated to be less than 45 percent with survival rates depending on factors such as age, stage of diagnosis and suitability for auto-SCT, which is used as part of the treatment for eligible patients with multiple myeloma. Despite recent therapeutic advances, multiple myeloma remains an incurable but treatable cancer. Patients are typically treated with repeat rounds of combination therapy with the time intervals to relapse becoming shorter with each successive line of therapy. The majority of patients eventually have a relapse which cannot be further treated.

On July 20, 2015 Exelixis reported positive top-line results from the primary analysis of METEOR, the phase 3 pivotal trial comparing cabozantinib to everolimus in 658 patients with metastatic renal cell carcinoma (RCC) who have experienced disease progression following treatment with a VEGF receptor tyrosine kinase inhibitor (TKI) (Press release, Exelixis, JUL 20, 2015, View Source [SID:1234506521]).

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The trial met its primary endpoint of demonstrating a statistically significant increase in progression-free survival (PFS) in the first 375 randomized patients as determined by an independent radiology committee (IRC). Cabozantinib reduced the risk of disease progression or death by 42 percent compared to the everolimus arm (hazard ratio [HR]=0.58, 95 percent CI 0.45-0.75, p<0.0001).

Data pertaining to overall survival (OS) in the entire study population of 658 patients, a secondary endpoint of the trial, were immature at the data cutoff. A prespecified interim analysis, triggered by the primary analysis for PFS, showed a trend in OS favoring cabozantinib (HR = 0.67, unadjusted 95 percent CI 0.51 – 0.89; p=0.005). At the time of the interim analysis, the pre-specified p-value of 0.0019 to achieve statistical significance was not reached. The trial will continue to the final analysis of OS anticipated in 2016.

METEOR’s primary analysis included a review of serious adverse event (SAE) data. Based on this analysis, the frequency of SAEs of any Grade regardless of causality was approximately balanced between study arms. The rate of treatment discontinuation due to adverse events was low (10%) in both study arms.

Detailed results of the trial will be submitted for presentation at an upcoming medical conference.

In April 2015, cabozantinib received Fast Track designation by the U.S. Food and Drug Administration (FDA) for the potential treatment of advanced RCC patients who have received one prior therapy. Based on the outcome of METEOR, Exelixis plans to complete regulatory filings in the United States and European Union in early 2016.

"We are eager to offer new treatment options for patients with metastatic RCC, particularly in the second-line setting where the most commonly utilized therapies have demonstrated a uniformly modest progression-free survival benefit," said Toni K. Choueiri, M.D., clinical director of the Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute, and METEOR’s principal investigator. "The magnitude of the improvement in PFS observed with cabozantinib compared to everolimus in the METEOR trial is an exciting and important development — it suggests an opportunity to improve care and outcomes for patients with metastatic RCC."

"The positive top-line results from METEOR represent strong progress for the kidney cancer community and for Exelixis, bringing us one step closer to our shared goal of delivering a new and meaningfully differentiated therapeutic option for the many metastatic RCC patients in need," said Michael M. Morrissey, Ph.D., the company’s president and chief executive officer. "With these data now in hand, Exelixis’ highest corporate priority becomes the submission of U.S. and EU regulatory filings, which we intend to complete in early 2016."

Dr. Morrissey continued, "Delivering these top-line results for METEOR is one of multiple clinical development and regulatory milestones that we have planned for this year. These milestones collectively have the potential to significantly enhance the opportunities before us and bring value to the multiple stakeholders we serve. We look forward to sharing the detailed results of METEOR with the oncology community at an upcoming medical conference, and we thank all of the patients, families, investigators, and clinical staff who made the trial possible."

Conference Call and Webcast

Exelixis’ management will host a conference call to discuss the METEOR results beginning at 8:30 a.m. EDT/ 5:30 a.m. PDT today, July 20, 2015. To join the call, participants may dial 877-358-0169 (domestic) or 706-679-2029 (international) and provide the conference call passcode 90168151 to join by phone. To listen to a live webcast of the conference call, visit the Event Calendar page under Investors & Media at www.exelixis.com.

An archived replay of the webcast will be available on the Event Calendar page under Investors & Media at www.exelixis.com for at least thirty days. An audio-only phone replay will be available until 11:59 p.m. EDT on July 22, 2015. Access numbers for the phone replay are: 855-859-2056 (domestic) and 404-537-3406 (international); the passcode is 90168151.

About the METEOR Phase 3 Pivotal Trial

METEOR is an open-label, event-driven trial with the primary endpoint of progression-free survival (PFS). The target enrollment for METEOR was 650 patients, and 658 patients were ultimately randomized. The trial was conducted at approximately 200 sites in 26 countries, and enrollment was weighted toward Western Europe, North America, and Australia. Patients were randomized 1:1 to receive 60 mg of cabozantinib daily or 10 mg of everolimus daily, and were stratified based on the number of prior VEGF receptor TKI therapies received, and on commonly applied RCC risk criteria developed by Motzer et al. No cross-over was allowed between the study arms.

The trial protocol specified that the primary analysis of PFS would be conducted among the first 375 patients randomized. This design was employed to ensure sufficient follow up and a PFS profile that would not be primarily weighted toward early events. Such disproportionate weighting of events was a potential risk if the entire study population required for the secondary endpoint analysis of OS had also served as the population for the primary analysis of PFS. The analysis of PFS was event-driven, and was designed to observe 259 events, providing 90% power to detect a HR of 0.67 (assuming a median PFS of 5 months for the everolimus arm and 7.5 months for the cabozantinib arm). Enrollment of the first 375 patients was completed in June 2014 and the median follow-up for these patients was 13.4 months at the time of the data cut off for the primary analysis for PFS.

Secondary endpoints for METEOR include OS and objective response rate. The secondary endpoint of OS assumes a median of 15 months for the everolimus arm and 20 months for the cabozantinib arm. The study was designed to observe 408 deaths in the entire intent-to-treat population of 650 planned patients, providing 80% power to detect a HR of 0.75. An interim analysis of OS at the 2-sided 0.0019 level per the Lan-DeMets O’Brien-Fleming alpha-spending function was planned at the time of the primary analysis for PFS, if the trial met the primary PFS endpoint.

About Metastatic Renal Cell Carcinoma

The American Cancer Society’s 2015 statistics cite kidney cancer as among the top ten most commonly diagnosed forms of cancer among both men and women in the United States.1 Clear cell renal cell carcinoma is the most common type of kidney cancer in adults.2 If detected in its early stages, the five-year survival rate for RCC is high; however, the five-year survival rate for patients with advanced or late-stage metastatic RCC is under 10 percent, with no identified cure for the disease.3

Treatments for metastatic RCC had historically been limited to cytokine therapy (e.g., interleukin-2 and interferon) until the introduction of targeted therapies into the RCC setting a decade ago. In the second and later-line setting, which encompasses approximately 17,000 drug-eligible patients in the U.S. and 37,000 globally,4 two therapies have been approved for the treatment of patients who have received prior VEGF receptor TKIs. However, despite the availability of several therapeutic options, currently approved agents have shown little differentiation in terms of efficacy and have demonstrated only modest PFS benefit in patients refractory to sunitinib, a commonly-used first-line therapy.

The majority of clear cell RCC tumors exhibit down-regulation of von Hippel-Lindau (VHL) protein function, either due to gene inactivation or epigenetic silencing, resulting in a stabilization of the hypoxia-inducible transcription factors (HIFs) and consequent up-regulation of VEGF, MET, and AXL.5 The up-regulation of VEGF may contribute to the angiogenic nature of clear cell RCC, and expression of MET or AXL may be associated with tumor cell viability, a more invasive tumor phenotype, and reduced overall survival. 6 Up-regulation of MET and AXL in clear cell RCC has also been shown to occur in response to treatment with VEGF receptor TKIs in preclinical models, indicating a potential role for MET and AXL in the development of resistance to these therapies.7

About Cabozantinib

Cabozantinib inhibits the activity of tyrosine kinases including MET, VEGF receptors, AXL, and RET. These receptor tyrosine kinases are involved in both normal cellular function and in pathologic processes such as oncogenesis, metastasis, tumor angiogenesis, and maintenance of the tumor microenvironment.

COMETRIQ (cabozantinib) is currently approved by the U.S. Food and Drug Administration for the treatment of progressive, metastatic medullary thyroid cancer (MTC).

The European Commission granted COMETRIQ conditional approval for the treatment of adult patients with progressive, unresectable locally advanced or metastatic MTC. Similar to another drug approved in this setting, the approved indication states that for patients in whom Rearranged during Transfection (RET) mutation status is not known or is negative, a possible lower benefit should be taken into account before individual treatment decisions.

Important Safety Information, including Boxed WARNINGS

WARNING: PERFORATIONS AND FISTULAS, and HEMORRHAGE

Serious and sometimes fatal gastrointestinal perforations and fistulas occur in COMETRIQ-treated patients.
Severe and sometimes fatal hemorrhage occurs in COMETRIQ-treated patients.
COMETRIQ treatment results in an increase in thrombotic events, such as heart attacks.
Wound complications have been reported with COMETRIQ.
COMETRIQ treatment results in an increase in hypertension.
Osteonecrosis of the jaw has been observed in COMETRIQ-treated patients.
Palmar-Plantar Erythrodysesthesia Syndrome (PPES) occurs in patients treated with COMETRIQ.
The kidneys can be adversely affected by COMETRIQ. Proteinuria and nephrotic syndrome have been reported in patients receiving COMETRIQ.
Reversible Posterior Leukoencephalopathy Syndrome has been observed with COMETRIQ.
Avoid administration of COMETRIQ with agents that are strong CYP3A4 inducers or inhibitors.
COMETRIQ is not recommended for use in patients with moderate or severe hepatic impairment.
COMETRIQ can cause fetal harm when administered to a pregnant woman.
Adverse Reactions – The most commonly reported adverse drug reactions (≥25%) are diarrhea, stomatitis, palmar-plantar erythrodysesthesia syndrome (PPES), decreased weight, decreased appetite, nausea, fatigue, oral pain, hair color changes, dysgeusia, hypertension, abdominal pain, and constipation. The most common laboratory abnormalities (≥25%) are increased AST, increased ALT, lymphopenia, increased alkaline phosphatase, hypocalcemia, neutropenia, thrombocytopenia, hypophosphatemia, and hyperbilirubinemia.

Please see full U.S. prescribing information, including Boxed WARNINGS, at www.COMETRIQ.com/downloads/Cometriq_Full_Prescribing_Information.pdf

Please refer to the full European Summary of Product Characteristics for full European Union prescribing information, including contraindication, special warnings and precautions for use at www.sobi.com once posted.

On July 20, 2015 Agenus reported that it has acquired rights to antibodies targeting Carcinoembryonic Antigen Cell Adhesion Molecule 1 (CEACAM1), a glycoprotein expressed on T cell and NK cell lymphocytes from Diatheva s.r.l., an Italian biotech company controlled by SOL S.p.A (Filing, 8-K, Agenus, JUL 20, 2015, View Source [SID:1234506507]).

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CEACAM1 is overexpressed in melanoma, bladder, lung, colon, pancreas, and gastric cancers and has been shown to modulate innate and adaptive immune suppression in pre-clinical studies. Antibodies targeting CEACAM1 are thought to have the potential to effectively treat cancer alone or in combination with other checkpoint modulator antibodies, including those in Agenus’ development pipeline.

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"CEACAM1 is emerging as a powerful immune modulator, with significant evidence that blocking its interactions could strengthen immune cells’ attack on cancer," said Robert Stein, M.D., Ph.D., Chief Scientific Officer of Agenus. "Diatheva’s anti-CEACAM1 monoclonal antibodies expand and complement our broad portfolio of checkpoint modulators and personalized cancer vaccines, with the potential to create best-in-class combination therapies for treating patients with cancer."

Under the license agreement, Agenus receives exclusive, worldwide rights for development and commercialization of CEACAM1 antibodies from Diatheva. Agenus is responsible for certain upfront, early development, clinical trial and regulatory milestone payments for the successful development of CEACAM1 antibodies totaling as much as $44 million. Diatheva is also eligible to receive additional sales milestones and royalties.

Professor Mauro Magnani, Ph.D., Founder and Scientific Director of Diatheva, stated, "Agenus’ proven immuno-oncology and development capabilities, represents an exciting opportunity for Diatheva’s most advanced human monoclonal antibodies. Agenus’ selection of our anti-CEACAM1 antibodies is indicative of the quality of Diatheva’s research and will support reinvestment in our company’s pipeline."