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Bellicum Announces Data Presentations on Lead Product Candidate BPX-501 and CAR-T and TCR Pipeline Programs at the 57th American Society of Hematology (ASH) Annual Meeting

On November 5, 2015 Bellicum Pharmaceuticals, Inc. (Nasdaq:BLCM), a clinical stage biopharmaceutical company focused on discovering and developing novel cellular immunotherapies for cancers and orphan inherited blood disorders, reported that three abstracts on the Company’s lead product candidate, BPX-501, an adjunct T cell therapy for allogeneic hematopoietic stem cell transplantation, were accepted for poster presentation at the 57th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (Press release, Bellicum Pharmaceuticals, NOV 5, 2015, View Source;p=RssLanding&cat=news&id=2107373 [SID:1234507980]). The Company will also highlight data in an oral presentation from a preclinical study with its BPX-401 controllable CAR-T (CIDeCAR) product candidate for the treatment of B cell malignancies. The meeting will be held in Orlando, Florida December 5-8, 2015.

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Investor/Analyst Luncheon

Bellicum will also host an investor and analyst luncheon on Monday, December 7, 2015 from 12:15 – 1:15 p.m. EST at the Hyatt Regency Orlando. Management and select key opinion leaders, including lead Principal Investigator, Professor Francesco Locatelli, M.D., will review the BPX-501 Phase 1/2 clinical study data in pediatric patients with hematologic disorders. The luncheon will be webcast live and may be accessed from the News & Events section of the Bellicum website. An archived version of the webcast will be available for replay for at least two weeks following the event.

Full List of ASH (Free ASH Whitepaper) Presentations on Bellicum Programs

BPX-501:

Poster Presentation: "Clinical Outcome after Adoptive Infusion of BPX-501 Cells (donor T cells transduced with iC9 suicide gene) in Children Given Alpha/Beta T-Cell Depleted HLA-Haploidentical Hematopoietic Stem Cell Transplantation (haplo-HSCT): Preliminary Results of a Phase I-II Trial"

Abstract Number: 1931
Session Name: 722. Clinical Allogeneic Transplantation: Acute and Chronic GVHD, Immune Reconstitution: Poster I
Date: Saturday, December 5, 2015
Presentation Time: 5:30 PM – 7:30 PM EST

Poster Presentation: "Immune Reconstitution after Adoptive Infusion of BPX-501 Cells (donor T cells transduced with iC9 suicide gene) in Children Given Alpha/Beta T-Cell Depleted HLA-Haploidentical Hematopoietic Stem Cell Transplantation (haplo-HSCT): Preliminary Phenotypic and Functional Results of a Phase I-II Trial"

Abstract Number: 3093
Session Name: 703. Adoptive Immunotherapy: Poster II
Date: Sunday, December 6, 2015
Presentation Time: 6:00 PM – 8:00 PM EST

Poster Presentation: "BPX-501 Cells (donor T cells transduced with iC9 suicide gene) Are Able to Clear Life-Threatening Viral Infections in Children with Primary Immune Deficiencies Given Alpha/Beta T-Cell Depleted HLA-Haploidentical Hematopoietic Stem Cell Transplantation (haplo-HSCT)"

Abstract Number: 4299
Session Name: 703. Adoptive Immunotherapy: Poster III
Date: Monday, December 7, 2015
Presentation Time: 6:00 PM – 8:00 PM EST

Additional data on more BPX-501 patients to be presented at ASH (Free ASH Whitepaper).

BPX-401:

Oral Presentation: "Expression of MyD88/CD40 Drives In Vivo Activation and Proliferation of Chimeric Antigen Receptor-Modified T Cells That Can be Effectively Regulated By Inducible Caspase-9"

Abstract Number: 851
Session Name: 703. Adoptive Immunotherapy: Preclinical Studies
Date: Monday, December 7, 2015
Presentation Time: 5:30 PM EST

BPX-601:

Poster Presentation: "Inducible MyD88/CD40 Allows Rimiducid-Dependent Activation to Control Proliferation and Survival of Chimeric Antigen Receptor-Modified T Cells"

Abstract Number: 4295
Session Name: 703. Adoptive Immunotherapy: Poster III
Date: Monday, December 7, 2015
Presentation Time: 6:00 PM – 8:00 PM EST

Enhanced TCRs:

Poster Presentation: "Inducible MyD88/CD40 Enhances Proliferation and Survival of PRAME-Specific TCR-Engineered T Cells and Increases Anti-Tumor Effects in Myeloma"

Abstract Number: 1886
Session Name: 703. Adoptive Immunotherapy: Poster I
Date: Saturday, December 5, 2015
Presentation Time: 5:30 PM – 7:30 PM EST

Bellicum Program Licensed from Leiden University Medical Center:

Poster Presentation: "T Cell Receptor Gene Therapy Targeting the Intracellular Transcription Factor Bob1 for the Treatment of Multiple Myeloma and Other B Cell Malignancies"

Abstract Number: 3002
Session Name: 652. Myeloma: Pathophysiology and Pre-Clinical Studies, excluding Therapy: Poster II
Date: Sunday, December 6, 2015
Presentation Time: 6:00 PM – 8:00 PM EST

8-K – Current report

On November 5, 2015 Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT, http://www.pvct.com), a clinical-stage oncology and dermatology biopharmaceutical company ("Provectus"), reported its results of operations and financial condition for the third quarter ended September 30, 2015 (Filing, 8-K, Provectus Pharmaceuticals, NOV 5, 2015, View Source [SID:1234507975]).

Provectus will also hold its quarterly business update conference call at 5 p.m. (EST) today to provide a business update on PV-10 and PH-10 to the investment community and answer questions from investors.

Those who wish to participate in the conference call may telephone 877-407-4019 from the U.S. International callers may telephone 201-689-8337 approximately fifteen minutes before the call. A webcast will also be available at www.pvct.com.
A digital replay will be available by telephone approximately two hours after the completion of the call until January 31, 2016 and may be accessed by dialing 877-660-6853 from the U.S. or 201-612-7415 for international callers, and using the Conference ID #13623105.

Third Quarter Financial Results and Balance Sheet Highlights
The Company’s cash and cash equivalents were $18.9 million as of September 30, 2015. This is an increase of $1.5 million from the $17.4 million reported as of December 31, 2014.

Stockholders’ equity at September 30, 2015, was $24,529,437. This compares to stockholders’ equity at December 31, 2014, of $25,189,876.

For additional information regarding Provectus’ results of operations and financial condition for the third quarter ended September 30, 2015, please see Provectus’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 5, 2015.

Global Analysis Of Metastatic Breast Cancer Landscape Reveals Gaps In Patient Care And Support

On November 5, 2015 Pfizer Inc., working collaboratively with the European School of Oncology (ESO), within the scope of the Advanced Breast Cancer Third International Consensus Conference (ABC3), reported the Global Status of Metastatic Breast Cancer (MBC): A 2005 – 2015 Decade Report, which revealed both areas of improvement and substantial gaps in care, access to resources and support, and treatment outcomes for women with MBC (Press release, Pfizer, NOV 5, 2015, View Source [SID:1234507973]).

MBC is the most advanced stage of breast cancer for which there is no cure.1 Further, public health experts estimate there will be a 43 percent increase in breast cancer related deaths globally from 2015 to 2030, the majority of which are a result of metastatic disease.2,3 Previous research has shown that women with MBC have distinct needs that are not often addressed and there are fewer patient and community resources available for these women compared with those for women with early-stage disease.4

Over the past decade – due to the collective efforts of the broader breast cancer community – some progress has been made to address the unique needs of women with MBC.5,6 However, there is still a great deal of improvement that needs to be made in this area. The findings from theGlobal Status of MBC: A Decade Report reinforce the urgent need for change in MBC care, patient support, research and the important role increased disease awareness can play.

This report is the most comprehensive analysis to date of the global advanced and metastatic breast cancer landscape over the past decade, and was developed with guidance from a global steering committee (link is external) of multidisciplinary leaders in the MBC community. Results from the preliminary report were presented today at ABC3 in Lisbon, Portugal.7

As a result of these findings, ESO and members of the breast cancer community are calling for policymakers, advocates and the medical community to unite to develop a global charter as a call-to-action toward changing and improving MBC outcomes by the year 2025.

"As members of the global breast cancer community, we need to change the way we comprehend, research and prioritize metastatic breast cancer, a disease that is highly complex clinically and emotionally, yet has received far less attention than other forms of breast cancer," said Fatima Cardoso, MD, director, Breast Cancer Unit at Champalimaud Clinical Center in Lisbon. "The Global Status of MBC: A Decade Report underscores the great challenges that continue to exist in the metastatic breast cancer landscape, and the need for worldwide unity in support of the hundreds of thousands of women living with the disease today."8,9,10,11

The report includes three newly commissioned primary surveys examining current perceptions of the state of breast cancer in 34 countries around the world, including the first survey of global public perceptions of MBC. Secondary analyses were also conducted, and included an analysis of existing breast cancer resources and more than 3,000 previously published articles and abstracts, to determine the global landscape of MBC over the past decade. This analysis examined several key areas of MBC patient care and contains the first comprehensive analysis of the MBC scientific landscape.

"While significant progress has been made in the past few decades in our understanding of breast cancer, there is an unquestionable need for more research surrounding metastatic breast cancer worldwide," said Liz Barrett, global president and general manager, Pfizer Oncology. "Through our work, we hope to leverage our scientific expertise and partnerships with the global breast cancer community to ultimately make metastatic breast cancer a chronic disease where patients can live with their condition and thrive as active contributors to their families and society."

Beyond the results highlighted in the preliminary report, there is ongoing analysis of the policy and socioeconomic aspects of MBC, and additional findings will be presented in 2016.

For more information on the Global Status of MBC: A Decade Report, including methodology, please visit:www.BreastCancerVision.com (link is external).

Primary Survey Highlights

Three new studies evaluating the current state of breast cancer from the perspective of breast cancer care centers, patient support organizations and the general population found:

More than half of 582 surveyed oncologists and other healthcare practitioners in the U.S., Europe, Latin America and Australia, report that they have not been trained on how to effectively deliver difficult information to their patients and have a desire for more training.12

The majority of the 50 interviewed patient support organizations in North America, Europe, Asia Pacific, Latin America, Africa and the Middle East, recognize women with MBC require more support than those with early-stage disease, but report a range of barriers that can impact efforts to meet patient needs, including limited resources, cultural views and logistics.13

There is a global lack of familiarity with metastatic or advanced breast cancer among the general public leading to widespread misperceptions about the disease, according to a survey of more than 14,000 people in 14 countries throughout Europe, Latin America, the Middle East, Africa and the Asia Pacific.14

The survey also found that among the general public, approximately 1 out of 5 people believe that those with metastatic breast cancer should keep their diagnosis a secret and not discuss their disease with anyone other than their physician, potentially contributing to the stigma that is associated with MBC and leading to feelings of isolation by the patient.13,15

These findings reinforce results from a 2014 survey conducted by Pfizer and breast cancer leaders in the United States that found the majority of Americans (60%) know little to nothing about MBC.16

Secondary Analysis Highlights

An analysis of more than 3,000 previously published articles and abstracts identified key limitations to progress for women with MBC over the past decade relating to patient care, the environmental landscape and scientific research, including:

Despite the benefits of supportive and palliative care to the quality of life for patients, implementation of supportive care has been variable across certain countries and significant gaps remain.17,18,19,20,21
Better psychological support for women with MBC is needed to ease the end-of-life care experience, particularly when it comes to anxieties about what they may experience.22,23
There has not been a significant improvement in the quality of life for women with MBC in more than a decade, and there has even been a slight decrease since 2004.24,25,26,27,28,29
The pace of innovation in MBC appears to have slowed in recent years with treatment advances, clinical research, publications and guideline development, particularly when compared with other tumor types, such as melanoma and lung cancer.30,31,32

About Metastatic Breast Cancer

MBC occurs when cancer spreads beyond the breast to other parts of the body, including the bones, lungs, liver and brain.1 An estimated 1.7 million new cases of breast cancer are diagnosed globally each year.7 Globally, five to 10 percent of newly diagnosed breast cancer patients will present with metastatic disease, however, in low- and middle-income countries 50-80 percent are initially diagnosed with advanced disease.8 In developed countries, approximately 20-30 percent of women diagnosed with early breast cancer progress to MBC, and this number may be higher in less developed countries.9,10

OncoMed Pharmaceuticals Reports Third Quarter 2015 Financial Results

On November 05, 2015 OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED), a clinical-stage company developing novel cancer stem cell (CSC) and immuno-oncology therapeutics, reported financial results for the quarter ended September 30, 2015 (Press release, OncoMed, NOV 5, 2015, View Source [SID:1234507972]). The company ended the third quarter with $175.2 million in cash, cash equivalents, and short term investments.

"Our internally discovered research and development pipeline continues to advance, with both demcizumab and tarextumab in two randomized Phase 2 clinical trials each," said Paul J. Hastings, Chairman and Chief Executive Officer. "We now have seven product candidates in 17 clinical trials, and are advancing two additional immuno-oncology product candidates to IND filings."

Pipeline Update

Demcizumab (anti-DLL4, OMP-21M18)

Enrollment continues in the randomized Phase 2 YOSEMITE pancreatic cancer and Phase 2 DENALI non-small cell lung cancer (NSCLC) trials.

Planning advances for a Phase 1b trial testing combination of demcizumab with pembrolizumab (an anti-PD1 antibody). Participating institutions include Memorial Sloan Kettering Cancer Center, Columbia University, Royal Marsden Hospital.
Tarextumab (anti-Notch 2/3, OMP-59R5)

Completed enrollment in the randomized Phase 2 ALPINE pancreatic cancer trial in August. A readout of the trial data, including overall survival results from both intent-to-treat and Notch3 biomarker populations, is anticipated in the second half of 2016.
Enrollment continues in the randomized Phase 2 PINNACLE small cell lung cancer (SCLC) trial.

Presented Notch3 biomarker results at the World Congress on Lung Cancer in September highlighting the role of overexpression of Notch3 as a poor prognostic factor in SCLC patients and as a potential biomarker for tarextumab treatment. Updated survival data continued to suggest greater benefit of tarextumab in a dose-dependent fashion, with median overall survival not yet reached in patients with high Notch3 tumors receiving higher doses of tarextumab.

Wnt Pathway Programs

Reached an agreement with Bayer to enroll up to 24 additional subjects, including some subjects who will undergo serial tumor biopsies, in the Phase 1b clinical trial of vantictumab (anti-Fzd7, OMP-18R5) in breast cancer and the Phase 1b clinical trial of ipafricept (Fzd8-Fc, OMP-54F28) in ovarian cancer, to further elucidate the profile of these product candidates and generate additional data to inform Bayer’s opt-in decisions. Bayer has agreed to reimburse OncoMed for all out-of-pocket expenses to support this additional patient enrollment. Delivery of opt-in packages to Bayer for both vantictumab and ipafricept is now anticipated in late 2016/early 2017.

Brontictuzumab (anti-Notch1, OMP-52M51)

De-prioritized and discontinued the Phase 1a hematologic malignancy trial to focus on solid tumor indications in biomarker selected populations. Data will be presented at an upcoming medical meeting.

Data to be presented on November 8, 2015 at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) Meeting in November in Boston show single-agent activity of brontictuzumab in Notch1 biomarker positive solid tumor subjects.

Advanced plans to clinically test brontictuzumab in combination with standard-of-care in solid tumor indications with a focus on patients whose tumors overexpress the active form of Notch1.
Anti-DLL4/VEGF (OMP-305B83) and Anti-RSPO3 (OMP-131R10)

Enrollment continues in Phase 1a study of anti-DLL4/VEGF bispecific in solid tumors.
Presented pre-clinical data at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) of the immune mediated anti-cancer effects of OncoMed’s anti-DLL4/VEGF bispecific antibody.

Advance plans to study anti-DLL4/VEGF in Phase 1b in combination with standard-of-care.
Enrollment continues in Phase 1a/b study of anti-RSPO3 in solid tumors.

Immuno-oncology Research

Presented new data for GITRL-Fc showing potent single-agent anti-tumor activity and activity in combination with checkpoint inhibitors at the Inaugural International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) in September. OncoMed is advancing GITRL-Fc into IND-enabling studies with the goal of ultimately filing an Investigational New Drug (IND) application with the U.S. Food and Drug Administration.

Advanced preclinical testing of an immuno-oncology antibody under the collaboration with Celgene with goal of achieving formal designation as a clinical development candidate in the collaboration by the end of 2015 followed by an IND filing in 2016.

Third Quarter 2015 Financial Results

Cash, cash equivalents and short-term investments totaled $175.2 million as of September 30, 2015, compared to $200.2 million as of June 30, 2015.

Revenues for the third quarter 2015 totaled $4.7 million, as compared to $19.0 million in the third quarter of 2014. Revenues were higher in the third quarter of 2014 primarily due to milestone revenues from the GlaxoSmithKline and Bayer collaborations achieved during that period.

Research and development (R&D) expenses for the third quarter 2015 were $24.7 million compared with $21.0 million for the same period in 2014. Increases in R&D expenditures in the three months ended September 30, 2015 were primarily attributable to increased personnel expenses, increased program costs associated with the advancement of demcizumab and tarextumab into randomized Phase 2 trials, as well as increased costs related to advancement of our anti-DLL4/VEGF and anti-RSPO3 programs into clinical development.

General and administrative (G&A) expenses for the quarter ended September 30, 2015 were $4.5 million, compared to $3.5 million for the same three-month period in 2014. The increased costs during the third quarter 2015 were attributable to higher employee-related costs, increased patent expenses, and financial expenses related to the June 2015 S-3 shelf registration filing.

Net loss for the third quarter 2015 was $24.5 million ($0.81 per share), compared to $5.5 million ($0.18 per share) for the same three-month period of 2014. The change in net loss for the third quarter of 2015 was primarily due to an increase in operational expenses and lower milestone revenues.

Oncolytics Biotech® Inc. Announces 2015 Third Quarter Results

On November 5, 2015 Oncolytics Biotech Inc. (TSX:ONC, OTCQX:ONCY) ("Oncolytics" or the "Company") reported its financial results and operational highlights for the third quarter ended September 30, 2015 (Press release, Oncolytics Biotech, NOV 5, 2015, View Source [SID:1234507971]).

"During the quarter, we announced exciting initial clinical data from our multiple myeloma study showing statistically significant increases in the production of caspase-3 and upregulation of PD-L1 along with an early objective response rate of 100%," said Dr. Brad Thompson, President and CEO of Oncolytics. "We also announced one and two-year survival data versus historical controls from our pancreatic (REO 017) cancer trial. This data is very often suggestive of broader immune system involvement which led us to file a US Phase 1b study in pancreatic adenocarcinoma; the first to examine REOLYSIN in combination with the checkpoint inhibitor KEYTRUDA."

Selected Highlights

Since July 1, 2015, selected highlights announced by the Company include:

Clinical Program

A poster presentation at the 15th International Myeloma Workshop titled "Combination Carfilzomib and the Viral Oncolytic Agent REOLYSIN in Patients with Relapsed Multiple Myeloma: A Pilot Study Investigating Viral Proliferation," highlighting data including 100% of patients (8 of 8) experiencing an objective response as measured by changes in blood monoclonal protein and significant increases in the production of caspase-3 (p=0.005) and upregulation of PD-L1 (p=0.005);

An oral presentation at the International Association for the Study of Lung Cancer (IASLC) 16th World Conference on Lung Cancer titled "Oncolytic Reovirus in Combination with Paclitaxel/Carboplatin in NSCLC Patients with Ras Activated Malignancies, Long Term Results," covering updated results, including one- and two-year survival data, from the Company’s REO 016 Phase 2 study in Non-Small Cell Lung Cancer (NSCLC);

Presentation of final data from a single arm clinical study examining the use of REOLYSIN in combination with gemcitabine in patients with advanced pancreatic cancer (REO 017), which showed an increase in median overall survival, as well as an approximate two-fold increase in one-year survival rates, and a five-fold increase in two-year survival rates when compared to gemcitabine therapy alone as seen in historical data;

Completion of enrollment in two randomized Phase 2 studies sponsored and conducted by the NCIC Clinical Trials Group; IND 211 is a study of REOLYSIN in combination with chemotherapy in patients with previously treated advanced or metastatic non-small cell lung cancer and IND 209 is a study of REOLYSIN in combination with chemotherapy in patients with recurrent or metastatic castration resistant prostate cancer;

Subsequent to quarter end, confirmation that, following submission to the U.S. Food and Drug Administration ("FDA") for review, the Investigational New Drug Application containing the protocol titled "A Phase Ib study of pembrolizumab (KEYTRUDA) in combination with REOLYSIN (pelareorep) and chemotherapy in patients with advanced pancreatic adenocarcinoma", the Company’s first trial examining REOLYSIN in combination with a checkpoint inhibitor, was active; and

Financial

At September 30, 2015 the Company reported $30.0 million in cash, cash equivalents and short-term investments. At November 5, 2015, the Company had approximately $28.7 million in cash, cash equivalents and short-term investments, which is expected to provide sufficient funds to support several small early-stage immunotherapy combination studies as well as both a run-in and a registration study in muscle invasive bladder cancer.