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

Syros Pharmaceuticals has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Syros Pharmaceuticals, 2017, NOV 14, 2016, View Source [SID1234521272]).

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Argos Therapeutics Reports Third Quarter 2016 Financial Results and Recent Operational Highlights

On November 14, 2016 Argos Therapeutics, Inc. (Nasdaq:ARGS), an immuno-oncology company focused on the development and commercialization of individualized immunotherapies for the treatment of cancer based on the Arcelis technology platform, reported financial results for the third quarter ended September 30, 2016 and reported on the company’s corporate and operational highlights (Press release, Argos Therapeutics, NOV 14, 2016, View Source [SID1234516560]).

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"During the third quarter, we further strengthened our management team and financial position," said Jeff Abbey, president and chief executive officer. "As we previously announced, Dr. Richard Katz joined us as chief financial officer in July. Rich has already played an instrumental role by driving the most recent financing, in which we raised gross proceeds of $50 million. In addition, he has initiated the transformation of our finance structure towards that of a commercial stage company."

"Our Phase 3 ADAPT study of AGS-003 in advanced renal cell carcinoma continues to progress and we look forward to the next Independent Data Monitoring Committee meeting in February, followed by anticipated top-line data in the first half of 2017," Mr. Abbey stated. "In addition, in July the first patient was dosed in Stage 2 of the investigator-initiated adult HIV eradication trial of AGS-004 in combination with the latency reversing drug vorinostat being conducted at the University of North Carolina, Chapel Hill. This is the first clinical trial evaluating the ‘kick and kill’ approach employing an HIV latency-reversing drug combined with an individualized immunotherapy. This is an exciting step, as it represents another promising opportunity to demonstrate the versatility of our Arcelis platform technology."

Third Quarter 2016 and Recent Operational Highlights:

In July 2016, Richard D. Katz, MD, joined the company as chief financial officer
In July 2016, the first patient was dosed in Stage 2 of the investigator-initiated adult HIV eradication trial of AGS-004
In August 2016, the company completed an equity financing with gross proceeds of $50 million
Selected Third Quarter 2016 Financial Results

Net loss for the three months ended September 30, 2016 was $12.2 million, or $0.32 per share, compared to a net loss of $20.1 million, or $0.97 per share, for the same period in 2015. Net loss for the nine months ended September 30, 2016 was $37.7 million, or $1.30 per share, compared to a net loss of $57.2 million, or $2.81 per share, for the same period in 2015.

Revenue for the three months ended September 30, 2016 totaled $0.1 million compared to $0.2 million for the same period in 2015. Revenue for the nine months ended September 30, 2016 totaled $0.8 million compared to $0.4 million for the same period in 2015.

Research and development expense for the three months ended September 30, 2016 totaled $9.3 million compared to $17.2 million for the same period in 2015. Research and development expense for the nine months ended September 30, 2016 totaled $28.0 million compared to $48.1 million for the same period in 2015.

General and administrative expense for the three months ended September 30, 2016 totaled $3.0 million compared to $2.7 million for the same period in 2015. General and administrative expense for the nine months ended September 30, 2016 totaled $9.4 million compared to $8.0 million for the same period in 2015.

As of September 30, 2016, cash and cash equivalents totaled $69.3.

Upcoming Investor Day

As previously announced, the company will host an Investor Day on Wednesday, December 7, 2016 from 8:00-11:00 a.m. Eastern Time at NASDAQ MarketSite in New York City. A live and archived audio webcast of the Investor Day can be accessed through the Investors section of the company’s website at www.argostherapeutics.com.

Argos’ management will review the scientific, clinical and commercial opportunity behind the company’s lead product candidate, AGS-003, which is currently being evaluated in the pivotal ADAPT Phase 3 clinical trial for the treatment of advanced renal cell carcinoma. Gerald Linette, MD, PhD, chief medical officer for cancer immunotherapy at the University of Pennsylvania Abramson Cancer Center, and Christopher Wood, MD, FACS, professor of urology, division of surgery at the University of Texas MD Anderson Cancer Center will join management in discussing AGS-003 and the treatment landscape.

Third Quarter 2016 Financial Results Conference Call and Webcast Details

Argos management will host a conference call beginning at 8:30 a.m. Eastern Time today to discuss these results and to answer questions.

To participate by telephone, please dial (855) 433-0930 (Domestic) or (484) 756-4271 (International). The conference ID number is 15427740. A live and archived audio webcast can be accessed through the Investors section of the company’s website at www.argostherapeutics.com. The archived webcast will remain available on the company’s website for twelve (12) months following the call.

About the Arcelis Technology Platform
Arcelis is a precision immunotherapy technology that captures both mutated and variant antigens that are specific to each patient’s individual disease. It is designed to overcome immunosuppression by producing a specifically targeted, durable memory T-cell response without adjuvants that may be associated with toxicity. The technology is potentially applicable to the treatment of a wide range of different cancers and infectious diseases, and is designed to overcome many of the manufacturing and commercialization challenges that have impeded other personalized immunotherapies. The Arcelis process uses only a small disease sample or biopsy as the source of disease-specific antigens, and the patient’s own dendritic cells, which are optimized from cells collected by a leukapheresis procedure. The proprietary process uses RNA isolated from the patient’s disease sample to program dendritic cells to target disease-specific antigens. These activated, antigen-loaded dendritic cells are then formulated with the patient’s plasma, and administered via intradermal injection as an individualized immunotherapy.

Mateon Provides Corporate Update and Reports Third Quarter 2016 Financial Results

On November 14, 2016 Mateon Therapeutics, Inc. (Nasdaq:MATN), a biopharmaceutical company developing vascular disrupting agents (VDAs) for the treatment of orphan oncology indications, reported a corporate update and reported financial results for the third quarter of 2016 (Press release, Mateon Therapeutics, NOV 14, 2016, View Source [SID1234516590]).

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Recent Corporate Highlights

Entered into a collaboration with U.S. Oncology Research for their participation in Mateon’s Phase 2/3 FOCUS Study evaluating CA4P in combination with bevacizumab (Avastin) and chemotherapy for the treatment of patients with platinum-resistant ovarian cancer.
Continued to expand the number of U.S. investigator sites participating in the FOCUS Study.
Expanded the FOCUS Study into Europe, with sites in Belgium now actively recruiting patients.
Completed enrollment in the second cohort and initiated the third cohort of OX1222, an open-label dose-ranging study of OXi4503 in combination with cytarabine, in patients with relapsed/refractory acute myeloid leukemia (AML).
Received an issued patent for pre-clinical cathepsin-inhibiting compounds from the U.S. Patent and Trademark Office.
Expanded Board of Directors with appointment of two experienced biopharmaceutical executives.
"I am pleased that our most advanced clinical trial, the FOCUS Study, remains on track and now has 20 investigator sites qualified to enroll patients," stated William D. Schwieterman, M.D., Mateon’s President and Chief Executive Officer. "Importantly, we are seeking to demonstrate improvement over the current standard of care in platinum-resistant ovarian cancer, and positive results from this trial could ultimately change the treatment paradigm in ovarian cancer, as well as the much broader field of vascular-targeted therapy in a variety of other solid tumor cancers. Therefore, the results of this clinical trial are critical to our goal of creating long-term shareholder value."

Financial Results for the Third Quarter of 2016

For the third quarter of 2016, Mateon reported a net loss of $3.2 million compared to a net loss of $3.6 million for the third quarter of 2015. R&D expenses decreased to $2.1 million in the third quarter of 2016, compared to $2.5 million in the third quarter of 2015, while general and administrative expenses increased to $1.2 million for the third quarter of 2016 compared to $1.1 million for the third quarter of 2015.

At September 30, 2016, Mateon had cash, cash equivalents and short-term investments of $16.3 million, which the Company currently believes is sufficient to fund operations through the availability of key clinical data from the FOCUS Study, which is expected in the second half of 2017.

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

CohBar has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, CohBar, 2017, NOV 14, 2016, View Source [SID1234521275]).

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New Study Demonstrates Anti-Tumor Advantages for Combination Treatment Featuring Peregrine Pharmaceuticals’ PS-Targeting Antibodies in a Preclinical Melanoma Model

On November 14, 2016 Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM) (NASDAQ:PPHMP), a biopharmaceutical company committed to improving patient lives by manufacturing high quality products for biotechnology and pharmaceutical companies and advancing its proprietary R&D pipeline, reported the presentation of positive data from multiple new preclinical studies of the company’s phosphatidylserine (PS)-targeting antibodies (Press release, Peregrine Pharmaceuticals, NOV 14, 2016, View Source [SID1234516592]). Study results highlight that PS-targeting antibodies similar to bavituximab synergize with checkpoint inhibitors and radiation to improve anti-tumor activity in various animal tumor models. Importantly, the improved anti-tumor activity seen in these studies was even greater when PS-targeting therapy was a part of triple combination treatment including anti-PD-1 and another therapy. Data were presented by Peregrine scientists, as well as researchers from Memorial Sloan Kettering Cancer Center (MSK), at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2016 Annual Meeting, which was held November 9-13, 2016 in National Harbor, MD.

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Initial results from Peregrine’s ongoing collaboration with MSK researchers were featured in a poster presented by Sadna Budhu, Ph.D., at SITC (Free SITC Whitepaper) 2016. A team of MSK researchers led by cancer immunotherapy thought-leaders, Taha Merghoub, Ph.D. and Jedd D. Wolchok, M.D., Ph.D., evaluated the effects of combining PS-targeting, anti-PD-1 and radiation therapies in the mouse B16 melanoma model. Study data showed that PS-targeting antibodies synergize with both anti-PD-1 and radiation therapy to improve anti-cancer activity. PS-targeting treatment in combination with radiation, as well as triple combination of PS-targeting treatment, anti-PD-1 and radiation, led to a reduction in tumor burden. Median survival for the triple combination treatment still had not been reached at the end of the 80-day observation period with other arms in the study showing median survival that ranged from 24-70 days.

Researchers also evaluated the impact of the PS-targeting and radiation combination treatment on the level and type of immune activity. These results demonstrated that the combination led to a change in the tumor microenvironment, shifting it from immunosuppressive in which tumors are protected to immune active in which tumors are more susceptible to treatment. Analysis of local immune responses in the tumors of the treated animals showed that the combination treatment increased the number of tumor associated macrophages and shifted the macrophage polarization from the immunosuppressive M2 type to the immune active M1 type. When systemic immune responses were analyzed following triple combination of PS-targeting treatment, anti-PD-1 and radiation, researchers also saw evidence of increased immune activity. This was illustrated by key indicators of immune activity, including increases in CD8+ T-cell activation, effector cytokine production and differentiation into effector memory cells.
"Based on these study results, we believe that the targeting of PS is having meaningful activity within the tumor microenvironment in the B16 melanoma model," stated Dr. Wolchok. "It appears that this activity creates a more immune active environment in which other treatments, including radiation, are able to have a greater anti-tumor impact."

"We have noted that the combination of PS-targeting treatment and radiation, as well as triple combination of PS-targeting treatment, radiation and anti-PD-1, resulted in clear advantages in anti-tumor activity in the mouse B16 melanoma model," said Taha Merghoub, Ph.D., co-director of the Ludwig Collaborative Laboratory at MSK. "We believe that these findings suggest the potential benefit of combining these agents to improve the outcomes of patients with cancer. With this in mind, we think this research may play an important role in designing future clinical trials of PS-targeting agents in melanoma and other cancers."
A second study, conducted by Peregrine, evaluated the effects of combining PS-targeting, anti-PD-1 and anti-LAG3 therapies in the E0771 triple negative breast cancer (TNBC) model. Initial findings from this study were previously reported and demonstrated that eight of the ten (80%) animals receiving the PS-targeting, anti-PD-1 and anti-LAG3 treatment combination experienced complete tumor regressions, whereas there were no animals (0/10) in the anti-PD-1 and anti-LAG3 combination treatment arm that had a complete regression. New data presented for the first time at SITC (Free SITC Whitepaper) demonstrated that the triple combination established a specific and prolonged anti-tumor immune response which protected those eight animals that achieved a complete tumor regression against a re-challenge with the same E0771 TNBC model tumor cells. This sustained anti-tumor response demonstrates the ability of the triple combination treatment to trigger immune system memory and support adaptive immune responses against reemerging disease in the E0771 TNBC model.

Further highlighting the immune impact of the PS-targeting/anti-PD-1/anti-LAG3 treatment combination were initial results of a new analysis from this study using the nCounter PanCancer Immune Profiling Panel from NanoString Technologies. Data from the analysis demonstrated that the triple combination induced a greater shift in the tumor microenvironment from immunosuppressive to immune active as compared to all other treatment groups. This was evidenced by greater increases in the activity of several critical immune activating pathways, including presentation and processing of antigens and signaling and activation of T-cells, for the triple combination as compared to all other treatments.

"It is very encouraging to see the consistent increase in anti-tumor activity triggered by triple combination treatments that combine PS-targeting agents and anti-PD-1 with other cancer treatments. By demonstrating this activity across multiple studies in multiple tumor models, we are continuing to build scientific support for the therapeutic potential of adding PS-targeting therapies in combination with other cancer treatments, including checkpoint inhibitors such as anti-PD-1," said Jeff T. Hutchins, Ph.D., Peregrine’s vice president, preclinical research. "As cancer research continues to explore the potential of combination treatments that marry complementary mechanisms, we are pleased to see that our efforts continue to generate data supporting the role that PS-targeting agents such as bavituximab may play in this area."

Bavituximab is an investigational monoclonal antibody that targets PS. Signals from PS inhibit the ability of immune cells to recognize and fight tumors. Bavituximab is believed to override PS mediated immunosuppressive signaling by blocking the engagement of PS with its receptors as well as by sending an alternate immune activating signal. Previous studies demonstrated PS-targeting antibodies shift the functions of immune cells in tumors, resulting in multiple signs of immune activation and anti-tumor responses. Peregrine continues to support and guide clinical development through the evaluation of the preclinical equivalent of bavituximab, ch1N11, in animal model studies.

Peregrine’s clinical development strategy for bavituximab currently focuses on small, early-stage, proof-of-concept trials evaluating the drug in combination with other cancer treatments. This approach includes the recently announced grants awarded by the National Comprehensive Cancer Network (NCCN) to support three different clinical trials of bavituximab treatment combinations. These trials will evaluate novel bavituximab combinations in glioblastoma, head and neck cancer, and hepatocellular carcinoma including an immunotherapy combination. Additionally, Peregrine continues to advance its pre-clinical collaboration with Memorial Sloan Kettering Cancer Center with the goal of evaluating combinations of bavituximab with other checkpoint inhibitors and immune stimulatory agents. The intent behind this strategy is to focus our research and development spending to further validate bavituximab’s combination potential as we seek to advance the program though a pharmaceutical or biotechnology partner.