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ECRC AND AMRITA THERAPEUTICS ANNOUNCE COLLABORATION ON REGULATORY AND DRUG DEVELOPMENTSTRATEGY FOR ONCOLOGY PEPTIDE AT-01C

On November 12, 2015 ECRC, LLC and Amrita Therapeutics Limited reported collaboration on regulatory and drug development strategy for AT-01C, a p53 (tumor suppressor activator) compound with antimetastasis activity (Press release, Amrita Therapeutics, NOV 12, 2015, View Source [SID:1234512735]). Dr. Tomasz H. Zastawny, ECRC President and CEO, said: "We are delighted that Amrita has chosen ECRC as its US partner to advance AT-01 to the clinic. This is an ideal collaboration, combining my personal and ECRC’s expertise of PRA, one of the leading New England consultancy groups, with Amrita’s proprietary research platform. Together, we can accelerate Amrita’s pipeline development to bring the effective oncology treatment to the patients who need them in the US, India and globally."

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Under this agreement, ECRC and Amrita will collaborate on Pre-IND regulatory and early clinical development of AT-01C and other products. Amrita’s patent-protected peptides demonstrate antiinflammatory, p53 (tumor suppression) and anti-metastasis properties through stabilitzation of the SMAR1 protein and down-regulation of oncogenes. Therapeutics’s lead oncology peptide AT-01C shows effectiveness against colorectal, bladder and liver cancer, and is non-toxic to healthy tissues.

OncoGenex Pharmaceuticals, Inc. Reports Financial Results for Third Quarter 2015

On November 12, 2015 OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) reported third quarter 2015 financial results and provided a summary of clinical developments and anticipated milestones (Press release, OncoGenex Pharmaceuticals, NOV 12, 2015, View Source [SID:1234508223]).

Clinical Developments and Anticipated Near-term Milestones

Custirsen – Phase 3 Prostate Cancer Trials

On September 27, 2015, OncoGenex announced results from additional exploratory analyses of the Phase 3 SYNERGY trial demonstrating that custirsen treatment significantly lowered serum clusterin (sCLU) levels from baseline in men with metastatic castrate-resistant prostate cancer (mCRPC). In addition, these data presented at the 2015 European Cancer Congress (ECC 2015) in Vienna showed that sCLU reductions after custirsen treatment resulted in higher two-year survival rates in patients who were at increased risk for poor outcomes. Of those patients with lower sCLU levels, the data also showed a correlation to an overall survival benefit for custirsen-treated patients who were at increased risk for poor outcomes.

On October 8, 2015, OncoGenex announced that the European Medicines Agency (EMA) completed its review of the proposed amendment to the company’s Phase 3 AFFINITY protocol and statistical analysis plan. Both the U.S. Food and Drug Administration (FDA) and the EMA have now completed their reviews and are supportive of the proposed amendment to the AFFINITY protocol and statistical analysis plan.

Final results from the first of two analyses of the custirsen Phase 3 AFFINITY trial are expected by the end of this year. The first of these two analyses will determine the ability of custirsen to extend survival in a subgroup of men who are at increased risk for poor outcomes. This group is comprised of men having two or more of five common clinical features, including poor performance status, elevated prostate-specific antigen (PSA), elevated lactate dehydrogenase (LDH), decreased hemoglobin, and the presence of liver metastasis. If the final analysis shows efficacy in this subgroup, OncoGenex would proceed with discussions with the FDA and a new drug application filing.

At the same time as the final analysis for the subgroup, interim analyses for both futility and efficacy is scheduled to occur in the intent to treat, or entire patient population, of the AFFINITY trial. If this interim analysis shows early efficacy, OncoGenex would proceed with an NDA filing for the entire trial population. If the early efficacy interim analysis does not show a highly significant difference, the study will continue as planned with final results are expected in the second half of 2016.
Apatorsen – Phase 2 Bladder, Lung Cancer Trials

On September 27, 2015, the company announced additional analyses from the Borealis-1 trial for its other lead product candidate, apatorsen. The results confirmed that patients with advanced bladder cancer at increased risk for poor outcomes had increased baseline levels of both circulating tumor cells (CTC) and serum heat shock protein 27 (Hsp27). The study showed that baseline Hsp27 and CTC levels were additional risk factors for survival outcomes. These results were presented at ECC 2015 and have been accepted for oral presentation at the upcoming 7th European Multidisciplinary Meeting on Urological Cancers (EMUC 2015).

On September 30, 2015, the company announced that Borealis-2, an investigator-sponsored, randomized Phase 2 trial, met its target enrollment of 200 patients. The trial is designed to evaluate apatorsen in combination with docetaxel in patients with advanced or metastatic bladder cancer who have disease progression following first-line platinum-based chemotherapy. Borealis-2 is sponsored by Hoosier Cancer Research Network and being conducted at 27 sites across the United States. Results are expected in 2016.

Primary progression-free survival (PFS) results from the Spruce trial are expected in the first quarter of 2016, with continued survival follow up expected later next year. The Spruce trial is an investigator-sponsored, randomized, placebo-controlled Phase 2 trial designed to determine if adding apatorsen to carboplatin and pemetrexed therapy can extend PFS outcome in patients with previously untreated advanced non-squamous NSCLC.

"This is a pivotal time in the company’s history with results expected by the end of this year from the first of two custirsen Phase 3 AFFINITY trial final analyses. We look forward to this important milestone," said Scott Cormack, President and CEO of OncoGenex. "We anticipate additional milestones throughout 2016 including final survival analysis of all patients from the AFFINITY study and possible ENSPIRIT lung cancer results, as well as several upcoming Phase 2 data readouts in our apatorsen program."

Financial Update and Results

As of September 30, 2015, our cash, cash equivalents and short-term investments increased to $65.9 million from $47.1 million as of December 31, 2014.
Based on our current expectations, we believe that our cash, cash equivalents, and short-term investments will be sufficient to fund our currently planned operations into the first quarter of 2017, which may include:
announcing AFFINITY trial results, including final results of the poor prognosis subpopulation by the end of 2015 and final analysis for the ITT population in the second half of 2016, depending on timing of the event-driven final analysis;
announcing ENSPIRIT trial results, which could be available in the second half of 2016;
announcing Spruce trial results for the primary PFS endpoint in the first quarter of 2016;
announcing Borealis-2 trial results in 2016;
completing enrollment in the Pacific trial; and,
continuing enrollment in the Spruce-2 trial, formerly referred to as the Cedar Trial
Revenue for the three months ended September 30, 2015 increased to $6.7 million from $4.8 million for the three months ended September 30, 2014. Revenue for the nine months ended September 30, 2015 decreased to $12.1 million from $21.5 million for the nine months ended September 30, 2014.
Total operating expenses for the three and nine months ended September 30, 2015 were $11.4 million and $27.4 million, respectively, compared to $12.0 million and $44.3 million for the three and nine months ended September 30, 2014, respectively.
Net loss for the three and nine months ended September 30, 2015 was $4.6 million, or $0.16 per diluted common share, and $15.1 million, or $0.60 per diluted common share, respectively, compared with $4.9 million, or $0.23 per diluted common share, and $20.6 million, or $1.21 per diluted common share for the three and nine months ended September 30, 2014, respectively.
As of November 12, 2015, OncoGenex had 29,804,273 shares outstanding.

Kite Pharma Reports Third Quarter 2015 Financial Results and Provides Business Update

On November 12, 2015 Kite Pharma, Inc. (Nasdaq:KITE), a clinical-stage biopharmaceutical company focused on developing engineered autologous T cell therapy (eACT) products for the treatment of cancer, reported financial results for the quarter ended September 30, 2015 (Press release, Kite Pharma, NOV 12, 2015, View Source [SID:1234508221]).

"Over the past few months, we have achieved many significant corporate and clinical development milestones, including the initiation of two pivotal Phase 2 studies of our lead product candidate, KTE-C19," noted Arie Belldegrun, M.D., FACS, Chairman, President, and Chief Executive Officer. "Our ZUMA-1 trial is enrolling patients with aggressive, refractory non-Hodgkin’s lymphoma, while our ZUMA-2 trial is enrolling patients with relapsed or refractory mantle cell lymphoma. We also plan to initiate two additional pivotal studies of KTE-C19 in patients with acute lymphoblastic leukemia prior to the end of this year. We look forward to reporting data from these trials in 2016 with the goal of filing our first Biologics License Application by the end of 2016."

Recent Highlights

Completed the Phase 1 portion of the KTE-C19 study in aggressive, refractory non-Hodgkin’s lymphoma (NHL) and recently opened enrollment in the pivotal Phase 2 (ZUMA-1) multi-center trial to support registration and potential commercial launch of KTE-C19 in 2017.

Initiated the second pivotal Phase 2 KTE-C19 study (ZUMA-2) in patients with relapsed or refractory mantle cell lymphoma (MCL) to support registration in this indication.

Obtained Orphan Drug Designations in the EU for KTE-C19 in leading hematological malignancies including designation for the treatment of primary mediastinal B-cell lymphoma, MCL, chronic lymphocytic leukemia/small lymphocytic lymphoma, follicular lymphoma, and acute lymphoblastic leukemia (ALL).

Four abstracts were accepted for presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting, including an abstract on the safety and efficacy data from the Company’s KTE-C19 Phase 1 study in patients with aggressive, refractory NHL.

Expanded our collaboration with the Netherlands Cancer Institute for an exclusive option to license multiple T cell receptor (TCR) gene sequences for the development and commercialization of immunotherapy candidates targeting solid tumors.

Secured an exclusive, worldwide license with the National Institutes of Health to IP related to TCR-based product candidates that target MAGE A3 and A3/A6 antigens.

Secured an exclusive license to Alpine Immune Sciences’ transmembrane immunomodulatory protein (TIP) technology for chimeric antigen receptor and TCR-based products.

Appointed Dr. Franz B. Humer, former Chairman and Chief Executive of Roche Holding Ltd., to our Board of Directors.
Strengthened our Scientific Advisory Board with the addition of Drs. James Allison and Padmanee Sharma, recognized leaders from MD Anderson Cancer Center.

Held the official inauguration for Kite EU, our European headquarters in Amsterdam.
Completed construction of our clinical supply manufacturing facility in Santa Monica.

Third Quarter 2015 Financial Results

Cash Position: As of September 30, 2015, Kite had $368.6 million in cash, cash equivalents, and marketable securities, compared to $367.0 million as of December 31, 2014.

Cash Burn: Cash burn was $24.3 million for the third quarter of 2015, compared to $8.0 million for the third quarter of 2014. This increase was primarily due to the ramp up of our operations supporting the KTE-C19 program, including costs to build out our clinical manufacturing and commercial manufacturing facilities.

Net Loss: GAAP net loss attributable to common stockholders was $27.4 million, or $0.63 per share, for the third quarter of 2015, compared to $9.1 million, or $0.24 per share, for the third quarter of 2014. Non-GAAP net loss attributable to common stockholders for the third quarter of 2015 was $16.6 million, or $0.38 per share. Non-GAAP net loss for the third quarter of 2015 excludes non-cash stock-based compensation expense of $10.8 million for the third quarter of 2015. Please see "Note Regarding Use of Non-GAAP Financial Measures" for a reconciliation of GAAP net loss to non-GAAP net loss.

Revenue: Revenue was $5.1 million for the third quarter of 2015 compared to $0 for the third quarter of 2014. The increase was primarily due to revenue recognized under the Amgen collaboration.

Total Operating Expenses: Total GAAP operating expenses for the third quarter of 2015 were $32.9 million, compared to $9.1 million for the third quarter of 2014.

R&D Expenses: GAAP research and development (R&D) expenses were $21.7 million for the third quarter of 2015, compared to $5.7 million for the third quarter of 2014, an increase of $16.0 million. This increase was primarily attributable to a $9.1 million increase in research and clinical development expenses supporting the advancement of our KTE-C19 studies and our additional development programs, $3.2 million in expenses related to increased personnel and consulting costs, and $3.7 million of non-cash stock-based compensation expense.

G&A Expenses: GAAP general and administrative (G&A) expenses were $11.1 million for the third quarter of 2015, compared to $3.4 million for the third quarter of 2014, an increase of $7.7 million. This increase was primarily attributable to a $3.0 million increase in personnel related expenses, $0.9 million for license obligations, and $3.8 million of non-cash stock-based compensation.

2015 Financial Guidance: Kite’s guidance remains unchanged. Kite expects to burn between $100 million and $125 million in cash for the full year 2015, which includes both operating expenses and capital expenditures. This guidance does not include cash inflows or outflows for business development activities.

Immune Design Reports Third Quarter 2015 Financial Results

On November 12, 2015 Immune Design (Nasdaq: IMDZ), a clinical-stage immunotherapy company focused on oncology, reported financial results and a corporate update for the third quarter ended September 30, 2015, which includes advancement of its immuno-oncology programs and a cash position of $120.5 million (Press release, Immune Design, NOV 12, 2015, View Source [SID:1234508220]).

Corporate Update and Recent Highlights

Yesterday, Immune Design announced the dosing of the first patient in the randomized Phase 2 trial of CMB305, the company’s "prime boost" immuno-oncology product candidate, combined with Genentech’s investigational cancer immunotherapy, atezolizumab (MPDL3280A; anti-PD-L1) in patients with soft tissue sarcoma. The trial is being conducted pursuant to a clinical collaboration with Genentech, a member of the Roche Group, which will provide atezolizumab.

On November 5, Immune Design announced that preclinical research on G100, the company’s intratumoral TLR4 agonist-based product candidate, will be presented in an oral presentation at the 57th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting taking place December 5-8, 2015 in Orlando, Florida.

On November 3, Immune Design announced new preclinical data showing that each of G100, which contains a potent synthetic TLR4 agonist, and a dendritic-cell targeting hybrid lentiviral vector from its ZVex immunotherapy platform synergize with immune check point inhibitors and demonstrate potent local and systemic anti-tumor activity in cancer models. These data were presented at the 30th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Conference.

In October, Immune Design highlighted the application of its GLAASTM discovery platform in MedImmune’s Phase 2 clinical trial of MEDI7510. MEDI7510 is an investigational agent for the prevention of respiratory syncytial virus (RSV) under development by MedImmune, the global biologics research and development arm of AstraZeneca.

In August, Immune Design announced the establishment of clinical collaborations with each of Merck and Genentech, a member of the Roche group, covering three clinical trials. In the first collaboration, Merck will contribute KEYTRUDA (pembrolizumab), its anti-PD-1 therapy, to both Immune Design’s planned G100 Phase 1b/2 clinical trial in patients with Non-Hodgkin’s Lymphoma, as well as anLV305 Phase 1 expansion arm in melanoma patients who have an inadequate response to anti-PD1 therapy. Genentech is providing atezolizumab, its investigational anti-PD-L1 therapy, to Immune Design’s randomized Phase 2 trial for patients with selected soft tissue sarcomas expressing NY-ESO-1. Immune Design is the sponsor of these three clinical trials, and none of the parties to these arrangements have transferred any rights to their products to the other.
Financial Results and Guidance

Third Quarter

Immune Design ended the third quarter of 2015 with $120.5 million in cash and cash equivalents, compared to $75.4 million as of December 31, 2014.

Net loss and net loss per share for the third quarter of 2015 were $7.4 million and $0.37, respectively, compared to $6.7 million and $0.55, respectively, for the third quarter of 2014.

Revenue for the third quarter of 2015 was $4.7 million and was attributable primarily to $3.5 million in license revenue associated with Immune Design’s collaborations with MedImmune and Sanofi, $0.8 million in product sales, and $0.3 million in collaboration revenue associated with the Sanofi G103 collaboration established in the fourth quarter of 2014. Revenue for the third quarter of 2014 was $3.5 million and related to license revenue associated with the company’s collaboration with Sanofi.

Research and development expenses for the third quarter of 2015 were $8.3 million, compared to $6.0 million for the third quarter of 2014. The $2.3 million increase was primarily attributable to research and development and contract manufacturing of Immune Design’s G103 HSV-2 investigational agent, which is almost completely paid for under the Sanofi Pasteur G103 collaboration agreement, and for contract manufacturing and clinical trials for LV305 and CMB305. Additionally, there was an increase in personnel-related expenses, including stock-based compensation, as a result of growth in research and development headcount to support the company’s advancing research and clinical pipeline. Research and development stock-based compensation (a non-cash expense), was $0.5 million for the current quarter and $0.2 million for the same quarter in 2014.

General and administrative expenses for the third quarter of 2015 were $3.5 million, compared to $4.1 million for the third quarter of 2014. This decrease was partially offset by increases in facility-related costs and personnel-related expenses, including stock-based compensation, primarily related to an increase in administrative headcount to support the growth and expansion of the business. General and administrative expenses for stock-based compensation (a non-cash expense), was $0.9 million for the current quarter and $0.2 million for the same quarter in 2014.
Year-to-Date

Net operating cash used in operations through September 2015 was $30.3 million, which excludes the $75.4 million in net proceeds received from the company’s follow-on offering in April 2015.

Net loss and net loss per share for the nine months ended September 30, 2015 were $27.3 million and $1.45, respectively, compared to $21.0 million and $4.85, respectively, for the same period in 2014.

Revenue for the nine months ended September 30, 2015 was $8.4 million and was attributable primarily to $3.9 million in collaboration revenue associated with the Sanofi G103 collaboration established in the fourth quarter of 2014, $3.5 million in license revenue associated with the company’s collaborations with MedImmune and Sanofi, and $0.9 million in product sales. Revenue for the same period in 2014 was $4.6 million and was primarily attributable to $4.5 million in license revenue associated with Immune Design’s collaborations with Sanofi and MedImmune.

Total operating expenses for the nine months ended September 30, 2015 were $35.7 million, compared to $21.4 million for the same period in 2014. The increase in the current period relates primarily to an increase in activities to support research and development and contract manufacturing of G103, which is almost completely paid for under the Sanofi Pasteur G103 collaboration, and for contract manufacturing and clinical trials for LV305 and CMB305. Additionally, there was an increase in personnel-related expenses, including stock-based compensation, as a result of growth and expansion of the business following Immune Design’s initial public offering in July 2014, in professional service fees to support operations as a public company and in facility and office costs. These increases were partially offset by a decrease in legal services related to defending ongoing litigation, patents and corporate legal services.

Cyclacel Pharmaceuticals Reports Third Quarter 2015 Financial Results

On November 12, 2015 Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP) ("Cyclacel" or the "Company"), a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious disorders, reported its financial results and business highlights for the third quarter ended September 30, 2015 (Press release, Cyclacel, NOV 12, 2015, View Source [SID:1234508218]).

The Company’s net loss applicable to common shareholders for the third quarter ended September 30, 2015 was $2.8 million, or $0.08 per basic and diluted share, compared to a net loss applicable to common shareholders of $5.0 million, or $0.22 per basic and diluted share for the third quarter ended September 30, 2014. As of September 30, 2015, cash and cash equivalents totaled $22.7 million.

"SEAMLESS continues to progress towards final data read-out," said Spiro Rombotis, President and Chief Executive Officer of Cyclacel. "There are now approximately 8% of events remaining to occur and we anticipate reporting top-line data during the first half of 2016. Following unblinding and analysis of the data, we will review the results to determine their suitability for submission to regulators. Our CDK2/9 programs made significant progress over the quarter. The CYC065 Phase 1 trial in solid tumor and lymphoma patients has started and the mechanistic rationale for CDK2/9 inhibition in targeted solid tumors and hematological malignancies is supported by multiple presentations at scientific conferences. Seliciclib was administered to the first patients with Cushing’s disease in an investigator-sponsored trial. We and our investigators are excited about the prospects of CDK2/9 inhibitors and we look forward to keeping you apprised as to our progress."

Business Highlights

Sapacitabine in SEAMLESS, pivotal, Phase 3 study for first-line treatment in elderly patients with acute myeloid leukemia (AML):

Continued follow-up with 8% of events remaining before analyzing mature data and reporting top-line results. The SEAMLESS study is powered at 90% to detect a 27.5% improvement of survival between the experimental and control arms.
Cyclin Dependent Kinase (CDK) Inhibitor Programs

Presented the molecular rationale for clinical development of CYC065 for the treatment of solid tumors at the AACR (Free AACR Whitepaper)-NCI-EORTC International Conference: Molecular Targets and Cancer Therapeutics

Dosed the first patient in a first-in-human, Phase 1 trial of CYC065, the Company’s second-generation CDK2/9 inhibitor, in solid tumor and lymphoma patients to evaluate the safety, tolerability and pharmacokinetic profile of CYC065

Presented the molecular rationale for clinical development of CYC065 for the treatment of leukemias and lymphomas at the Society of Hematologic Oncology (SOHO) 2015 Annual Meeting
Dosed the first patient in a Phase 2 investigator-sponsored trial (IST) evaluating seliciclib as a potential treatment for Cushing’s disease.

CYC065 data to be presented at the upcoming 2015 San Antonio Breast Cancer Symposium in Texas and at the 4th Neuroblastoma Symposium in Newcastle Upon Tyne, United Kingdom
Third Quarter 2015 Financial Results

Revenue

Revenue was $0.7 million for both the three months ended September 30, 2014 and 2015. Revenue is mainly related to grants from the European Union and the Biomedical Catalyst of the United Kingdom government. The Company recognized $0.3 million from its license and supply agreement with ManRos during the three months ended September 30, 2015.

Research and Development Expenses

Research and development expenses were $2.9 million for the three months ended September 30, 2015, compared to $5.0 million for the same period in the previous year. The decrease was primarily a result of reduced expenditures in study and site startup costs associated with the SEAMLESS Phase 3 study this quarter compared to the same period last year.

General and Administrative Expenses

General and administrative expenses for the three months ended September 30, 2015 were $1.2 million compared to $1.4 million for the same period in 2014. The decrease was primarily the result of lower patent-related and stock-based compensation costs.