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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.

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"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.

Inovio’s INO-3112 Shows Robust Immune Responses in Patients With Head & Neck Cancer

On November 05, 2015 Inovio Pharmaceuticals, Inc. (NASDAQ:INO) reported an interim data analysis showing that its INO-3112 DNA-based immunotherapy generated specific T-cell responses and was well tolerated in all evaluable patients with head and neck cancer associated with human papillomavirus (HPV) types 16 and 18 (Press release, Inovio, NOV 5, 2015, View Source;in-Patients-With-Head–Neck-Cancer/default.aspx [SID:1234507968]).

The immunology results show that INO-3112 generated robust HPV16/18 specific CD8+ T cell responses and antibodies against HPV16/18 in all 10 tested patients who received all treatments. These results will be presented today and tomorrow at the 30th Anniversary Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) in National Harbor, MD and on Nov 20-22 at the European Society for Medical Oncology Symposium on Immuno-Oncology in Lausanne, Switzerland.

INO-3112, an active immunotherapy targeting HPV 16/18 combined with a DNA plasmid for IL-12 as an immune activator, is designed to activate patient’s immune responses to specifically kill HPV associated tumors. In this phase I/IIa study, patients with HPV positive head and neck cancer received INO-3112 once every three weeks for a total of four injections.

The characteristics of these immune response data mirror those previously observed in a phase II clinical study of VGX-3100 for HPV-associated cervical dysplasia. In that study, strong CD8+ T cell immune responses were positively correlated with achievement of primary and secondary efficacy endpoints. Data from that trial was recently published in a peer-reviewed article in The Lancet. This publication details that VGX-3100 is the first therapy to demonstrate that activated killer T cells induced in the body have the power to clear neoplastic lesions as well as the virus which caused the disease.

Dr. Charu Aggarwal, MD, MPH, Assistant Professor of Medicine, Medical Oncologist at Abramson Cancer Center, University of Pennsylvania, Philadelphia and the principal investigator of this study said, "These results are in line with our hypothesis that DNA immunotherapy would lead to activation of the immune system. We are excited to follow these patients and learn about long-term results with this immunotherapy."

Dr. J. Joseph Kim, Inovio’s President and CEO, said, "These results demonstrate we’re on the right path using our DNA immunotherapies to fight cancer. In immuno-oncology, it’s all about the T cells. Here we show in cancer patients that we can generate antigen-specific CD8+ killer T cell responses, which are essential to an effective immunotherapy."

This open label study is intended to assess the safety, tolerability, and immunogenicity of INO-3112 in up to twenty five adults with HPV-positive head and neck squamous cell carcinoma. The study (NCT02163057) includes patients who are being treated with INO-3112 before and after resection of their tumor as well as patients being treated with INO-3112 after completion of chemotherapy and radiation therapy. This study currently continues patient enrollment at Abramson Cancer Center of University of Pennsylvania in Philadelphia. In August 2015, Inovio licensed INO-3112 to MedImmune, the global biologics research and development arm of AstraZeneca, for an upfront payment of $27.5 million, $700 million in potential development and commercial milestone payments, and royalties on INO-3112 product sales.

About HPV-Caused Head & Neck Cancer

Human papillomavirus (HPV) is the most common sexually transmitted disease in the United States, infecting 79 million Americans. HPV is known to play a major role in the development of head and neck cancers, which include cancers of the oral cavity, oropharynx, nose/nasal passages and larynx. Head and neck cancers associated with HPV account for nearly 3 percent of all cancers in the United States and are twice as prevalent in men as in women. Incidence rates of HPV-caused head and neck cancers have been on the rise, especially HPV-associated oropharyngeal cancer in men, and are expected to continue growing. By 2025, researchers believe that HPV will be the causative factor of 90% of all head and neck cancers.

10-Q – Quarterly report [Sections 13 or 15(d)]

(Filing, 10-Q, MacroGenics, NOV 4, 2015, View Source [SID:1234507970])

10-Q – Quarterly report [Sections 13 or 15(d)]

(Filing, 10-Q, Immunomedics, NOV 4, 2015, View Source [SID:1234507964])