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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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.

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.

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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On November 12, 2016 Aduro Biotech, Inc. (Nasdaq:ADRO) reported highlights from a poster presentation at the Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) being held in National Harbor, Maryland on the preliminary safety and efficacy of its novel immunotherapy, CRS-207, being evaluated in unresectable malignant pleural mesothelioma (Press release, Aduro BioTech, NOV 12, 2016, View Source;p=RssLanding&cat=news&id=2221888 [SID1234516505]). These data were from the second cohort of patients in an ongoing Phase 1b clinical trial of CRS-207 in combination with standard of care chemotherapy and immune-modulating doses of cyclophosphamide (Cy) as a first-line treatment.

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Preliminary results as of October 2016 from the 22 patients in the second cohort in the Phase 1b clinical study (Abstract #261) showed that 82 percent (18/22) of patients had disease control, with 55 percent (12/22) of patients achieving a partial response (PR) and 27 percent (6/22) with stable disease. Tumor shrinkage was observed in 77 percent (17/22) of patients. Of these patients, 36 percent (8/22) experienced tumor shrinkage after two doses of immunomodulatory doses of cyclophosphamide combined with CRS-207 (Cy/CRS-207), but prior to initiation of standard of care chemotherapy. Fourteen percent (3/22) of these patients achieved a partial response. No treatment-related serious adverse events or unexpected toxicities were observed. Median duration on study was 9.7 months at the time of data cutoff. Treatment continues, with immune response evaluations and survival follow up ongoing.

Of note, analysis of paired tumor biopsies obtained from two patients showed a marked infiltration of immune effector cells into the tumor microenvironment (TME) following two doses of Cy/CRS-207, as compared to baseline. Post-therapeutic changes included an increase in CD8+ cytotoxic T cells as well as an increase in other immune cell types that are thought to be essential for effective immunotherapy, including dendritic cells and natural killer cells. Together, these data suggest that the Cy/CRS-207 remodeling of the TME may be an important component of the clinical responses observed in this cohort of patients.

"The data from the second cohort, which is a patient population with more advanced disease compared to the first cohort, demonstrate that the addition of immunomodulatory doses of cyclophosphamide, which has been shown to inhibit negative regulatory T cell populations, to the combination of CRS-207 and chemotherapy results in encouraging disease control and tolerability for patients with mesothelioma," said Dirk G. Brockstedt, Ph.D., executive vice president of research and development of Aduro. "Importantly, we believe these data, together with the results from the first cohort, support further investigation of CRS-207 in mesothelioma, and we intend to initiate a Phase 2 study of CRS-207 used in combination with an anti-PD-1 therapy as an immune-modulator in patients with mesothelioma who have failed at least one prior therapy."

Additional Data on STING, pLADD Platform Technologies

A poster presentation highlighting preclinical data on the potential mechanism of action of ADU-S100 (also known as MIW315) therapy for treating cancer (Abstract #399) was given yesterday. The data showed that injection of ADU-S100 directly into the tumor microenvironment induces a systemic tumor-specific T cell response that leads to durable anti-tumor immunity. The data demonstrate that TNF-alpha and neutrophil recruitment mediate the primary tumor shrinkage following injection with ADU-S100, while CD8-alpha+ cells and natural killer cells mediate durable anti-tumor immunity. Anti-tumor efficacy was enhanced by combining ADU-S100 with anti-PD-1 or anti-CTLA4 checkpoint inhibitors. An ongoing Phase 1 clinical study is ongoing evaluating the safety and tolerability and possible anti-tumor effects of ADU-S100 in patients with cutaneously-accessible non UV-induced and UV-induced malignancies.

An additional poster presentation highlighting preclinical data on a personalized, live, attenuated double-deleted Listeria monocytogenes (pLADD) immunotherapy (Abstract #366) will be given today at 11:45 a.m. ET. pLADD is a patient-specific immunotherapy based on Aduro’s LADD platform. To design the individualized pLADD immunotherapy, tumor-specific mutations, called neoantigens, are identified through a comparison of tumor and normal tissue sequences. Aduro then constructs a LADD strain encoding patient-specific neoantigens that will be administered to the patient. Preclinical data included in the poster presentation demonstrate that a mouse tumor-specific pLADD induces a robust neoantigen-specific response and survival benefit in two mouse models of cancers when combined with anti-PD-1 checkpoint modulation.

About LADD and CRS-207
LADD is Aduro’s proprietary platform of live, attenuated double-deleted Listeria monocytogenes strains that have been engineered to generate a potent innate immune response and to express tumor-associated antigens to induce tumor-specific T cell-mediated immunity.

CRS-207 is one of a family of product candidates based on Aduro’s LADD immunotherapy platform that has been engineered to express the tumor-associated antigen mesothelin, which is over-expressed in many cancers including mesothelioma and pancreatic, non-small cell lung, ovarian, endometrial and gastric cancers.

About STING Pathway Activator Platform
The Aduro-proprietary STING Pathway Activator product candidates, including ADU-S100 (MIW815), are synthetic small molecule immune modulators that are designed to target and activate human STING. STING is generally expressed at high levels in immune cells, including dendritic cells. Once activated, the STING receptor initiates a profound innate immune response through multiple pathways, inducing the expression of a broad profile of cytokines, including interferons and chemokines. This subsequently leads to the development of a systemic tumor antigen-specific T cell adaptive immune response.

About pLADD
Aduro’s pLADD platform is a highly-personalized immunotherapy based on the live, attenuated double-deleted Listeria monocytogenes (LADD) platform. The pLADD approach leverages the immune activating activity of the Listeria bacterial vector in combination with patient-specific neoantigens, or an individual’s own cancer mutations, derived from a patient’s own tumor cells. Once administered, pLADD therapies are designed to mobilize the immune system through: 1.) an immediate recognition of the presence of Listeria as being foreign, and 2.) a specific and customized immune attack on cells containing the tumor neoantigens presented by pLADD. Aduro plans to initiate a Phase 1 clinical trial to evaluate the safety and immunogenicity of pLADD in patients with advanced gastrointestinal cancers in 2017.