On November 1, 2018 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported publication of an abstract on pelareorep to be presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition taking place December 1-4 in San Diego, California (Press release, Oncolytics Biotech, NOV 1, 2018, View Source [SID1234530637]).

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The abstract, authored by Craig C. Hofmeister, Acting Associate Professor, Department of Hematology and Medical Oncology Emory University School of Medicine, et al., is titled "Oncolytics Virus Replication Using Pelareorep (Reolysin) and Carfilzomib in Relapsed Myeloma Patients Increases PD-L1 Expression with Clinical Responses".

Because immune checkpoint inhibitors can only be effective when tumors express checkpoints such as PD-L1, an industry-wide effort is underway to identify agents that can upregulate the checkpoints on checkpoint-naked tumor cells. The abstract outlines a two-part study that demonstrated an increase in viral infection, viral replication and PD-L1 expression on the surface of myeloma cells for patients undergoing treatment with pelareorep in combination with carfilzomib (Kyprolis), a proteasome inhibitor, while carfilzomib alone has not been shown to induce PD-L1 expression. In part one of the study, six carfilzomib-sensitive patients showed reovirus infection and replication in the post-treatment bone marrow aspirates. In part two of the study, seven carfilzomib-refractory patients were enrolled, and of the three patients processed to date, reovirus infection was detected in myeloma cells of two patients and endothelial cells of one patient.

"With two very good partial responses and two partial responses, the results demonstrate an objective response at the recommended dose, as well as increased viral infection and viral replication," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech. "Most notably, in these myeloma patients receiving a proteasome inhibitor, systemically delivered pelareorep led to increases in PD-L1 expression, making pelareorep an ideal candidate to use in combination with this drug class."

The complete abstract can be found online at View Source Full details from the poster presentation will be announced after it is presented.

Presentation Number: 2655
Title:
Oncolytics Virus Replication Using Pelareorep (Reolysin) and Carfilzomib in Relapsed Myeloma Patients Increases PD-L1 Expression with Clinical Responses
Date: Sunday, December 2
Lecture Time: 6:00 p.m. PT – 8:00 p.m. PT
Location: San Diego Convention Center, Hall GH
Speakers: Craig Hofmeister
Session:
605. Molecular Pharmacology, Drug Resistance—Lymphoid and Other Diseases: Poster II

About Pelareorep
Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

On November 1, 2018 Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a biopharmaceutical company focused on developing and commercializing novel antibiotics to treat life-threatening multidrug-resistant (MDR) infections, reported that company management will host a conference call at 4:30 p.m. ET on Thursday, November 8, 2018 to discuss third quarter financial results and provide a general corporate update (Press release, Tetraphase, NOV 1, 2018, View Source [SID1234530632]).

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The conference call may be accessed by dialing 844-831-4023 (U.S. and Canada) or 731-256-5215 (international) and entering conference ID number 3997765. A live audio webcast of the conference call, or the subsequent archived recording, will be available online from the "Investors – Events & Presentations" section of the Tetraphase website at www.tphase.com.

A replay of the conference call will be available from 7:30 p.m. ET on Thursday, November 8, 2018, through 7:30 p.m. ET on Thursday, November 15, 2018 by dialing 855-859-2056 (U.S. and Canada) and 404-537-3406 for (international) callers. The conference ID number is 3997765. A replay of the webcast will be available for 90 days by visiting Tetraphase’s website.

On November 1, 2018 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported that an abstract describing data from the expansion of the MARIO-1 Phase 1b Study of IPI-549 in combination with nivolumab in advanced solid tumors has been selected as a late-breaking poster presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 33rd Annual Meeting in Washington D.C., November 7 – 11. Details of the presentation are as follows (Press release, Infinity Pharmaceuticals, NOV 1, 2018, View Source [SID1234530631]):

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Title: The first clinical/translational data from the expansion cohorts of a Ph1/1b Study of IPI-549, a tumor macrophage-reprogramming small molecule, in combination with nivolumab in advanced solid tumors
Poster Number: P716; Abstract Number: 10767
Poster Presentation Hours: Saturday, November 10, 2018 at 12:20-1:50 p.m. and 7:00-8:30 p.m.
Poster Hall Location: Hall E
Presenting Author: Ryan J. Sullivan, M.D., Massachusetts General Hospital, PI for the MARIO-1 Study

Infinity will also host a reception for investors and analysts on Saturday, November 10, 2018, from 6:30 a.m. to 7:30 a.m. ET to discuss these results. The event will feature David Hong, M.D., Deputy Chair, Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX. There will also be a panel discussion with David Hong, M.D., and, from Infinity Pharmaceuticals, Sam Agresta, M.D., M.P.H., CMO, and Jeffery Kutok, M.D., Ph.D., CSO.

About IPI-549 and the Ongoing Phase 1/1b Study
IPI-549 is an investigational first-in-class, oral, immuno-oncology product candidate targeting tumor-associated myeloid cells through selective phosphoinositide-3-kinase-gamma (PI3K-gamma) inhibition, thereby reducing pro-tumor macrophage function and increasing anti-tumor macrophage function. In preclinical studies, IPI-549 demonstrated the ability to reprogram macrophages from a pro-tumor (M2), immune suppressive function, to an anti-tumor (M1) immune activating function and enhance the activity of, and overcome resistance to, checkpoint inhibitors.i ii As such, IPI-549 may have the potential to treat a broad range of solid tumors and represents a potentially additive or synergistic approach to restoring anti-tumor immunity in combination with other immunotherapies such as checkpoint inhibitors.

The ongoing Phase 1/1b study being conducted by Infinity is designed to evaluate the safety, tolerability, activity, pharmacokinetics and pharmacodynamics of IPI-549 as a monotherapy and in combination with nivolumab (Opdivo) in approximately 200 patients with advanced solid tumors.iii The study includes monotherapy and combination dose-escalation components, in addition to monotherapy expansion and combination expansion components. The monotherapy dose-escalation and expansion components are complete. The combination dose-escalation component is also complete, and combination expansion cohorts are enrolling.

The combination expansion component of the study includes multiple cohorts designed to evaluate IPI-549 in patients with specific types of cancer, including patients with non-small cell lung cancer (NSCLC), melanoma and head and neck cancer whose tumors show initial resistance or initially respond to but subsequently develop resistance to immune checkpoint blockade therapy. The combination expansion component also includes a cohort of patients with triple negative breast cancer (TNBC) who have not been previously treated with immune checkpoint blockade therapy, a cohort of patients with mesothelioma, a cohort of patients with adrenocortical carcinoma and a cohort of patients with high baseline blood levels of MDSCs.

IPI-549 is an investigational compound and its safety and efficacy has not been evaluated by the U.S. Food and Drug Administration or any other health authority.

On November 1, 2018 Quanterix Corporation (NASDAQ:QTRX), a company digitizing biomarker analysis to advance the science of precision health, reported financial results for the three months and nine months ended September 30, 2018 (Press release, Quanterix, NOV 1, 2018, View Source [SID1234530628]).

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"This third quarter has been an incredibly productive one for our company, as we continue to achieve strong momentum and hit important milestones, including gaining back unrestricted rights to our Simoa technology for the in vitro diagnostics (IVD) markets," said Kevin Hrusovsky, Chief Executive Officer, President and Chairman. "Our Simoa technology is at the bleeding edge of the biomarker revolution, which has gained considerable traction recently as biomarkers are increasingly being recognized for their abilities to transform treatment options by accelerating development of more effective and safer drugs for all disease categories, and then longer-term, enabling and empowering individuals to take control of their lives and prevent disease."

Third Quarter 2018 Financial Highlights

Key financial results for the third quarter are shown below:

· Q3 revenue of $10.6M versus prior year Q3 of $5.7M, an increase of 85%.

· Q3 product revenue was $6.0M versus prior year Q3 of $3.3M, an increase of 82%.

· Q3 Service and Other revenue totaled $3.0M versus prior year Q3 of $2.2M, an increase of 36%.

Q3 2018 revenue includes a one-time item of $1.3M related to termination of a licensing agreement with bioMérieux for the Simoa technology. Revenue growth would have been 61% excluding this item.

YTD 2018 Financial Highlights

Key financial results for 2018 YTD are shown below:

· YTD revenue of $26.8M versus prior year $16.3M, an increase of 64%.

· YTD product revenue of $15.9M versus prior year $10.1M, an increase of 57%.

·YTD Service and Other revenue of $8.7M versus prior year $5.4M, an increase of 61%.

Excluding the $1.3M one-time item, total YTD revenue growth would have been 56%.

Third Quarter 2018 Business Highlights

· Gained unrestricted rights back for its Simoa technology in IVD markets with the termination of a license agreement with bioMérieux.

· Cadence of publications continued to increase with more than 40 new publications featuring Simoa technology in Q3 alone, bringing the total to approximately 300.

· Major presence at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Congress with a record number of posters/presentations mentioning the use of Quanterix’ serum neurofilament light (NfL) assay for a wide range of clinical studies in multiple sclerosis (MS) disease progression and monitoring.

· Led webinar alongside world-renowned researchers on how Simoa technology is enabling advances in drug development through the use of digital biomarkers; presented at MedCity

CONVERGE describing the power of predictive biomarkers for the diagnosis of cancer; delivered presentations at several leading investor conferences and garnered additional analyst coverage; featured in leading publications, including Forbes, Bloomberg and Digital Biotech.

Conference Call

In conjunction with this announcement, Quanterix Corporation will host a conference call on November 1, 2018, at 4:30 p.m. EDT to discuss the Company’s financial results and business outlook. To access this call, dial (833) 686-9351 for domestic callers, or (612) 979-9890 for international callers. Please reference the following conference ID: 2573579.

On November 1, 2018 Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company focused on the development and commercialization of precisely targeted oncology therapies, reported financial results for the third quarter ended September 30, 2018, and provided a business update (Press release, Corvus Pharmaceuticals, NOV 1, 2018, View Source [SID1234530625]).

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"We continue to make significant progress in the clinic both with CPI-444 and with CPI-006," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "We are encouraged by ongoing presentation of data related to both programs at medical meetings and in peer-reviewed journals. This includes biomarker data for CPI-444 that our team presented at the ESMO (Free ESMO Whitepaper) 2018 Congress on October 22, 2018. We also are looking forward to presenting additional new clinical and biomarker data for both programs at the SITC (Free SITC Whitepaper) annual meeting on November 9 and 10, 2018. Our progress continues to demonstrate that we are a leader in designing and developing medicines that modulate the adenosine pathway and that have demonstrated efficacy as monotherapies and in combination with other agents. We are also advancing our ITK inhibitor, CPI-818, toward the clinic and expect to initiate a clinical trial in early 2019."

Recent Achievements
CPI-444: A2A Receptor Antagonist of Adenosine

Continued enrollment of up to 50 patients with renal cell cancer (RCC) in an amended Phase 1/1b clinical trial evaluating CPI-444, the Company’s lead product candidate, administered alone and in combination with Genentech’s Tecentriq (atezolizumab), an anti-PD-L1 antibody. Patients in the study have failed no more than two prior treatment regimens, which must have included an anti-PD-(L)1 and a tyrosine kinase inhibitor, compared to having failed up to five (median three) prior treatment regimens in prior CPI-444 studies.
Continued enrollment of up to 60 patients with non-small cell lung cancer (NSCLC) in a Phase 1b/2 trial being conducted by Genentech as part of their MORPHEUS platform. The study is evaluating CPI-444 and Tecentriq in patients who have failed no more than two prior regimens.
CPI-444 preclinical study results were published in and featured on the cover of the October issue of the journal Cancer Immunology Research, which is an official journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper). The results demonstrated that CPI-444 induces dose dependent anti-tumor responses as a monotherapy and in combination with anti-PD-1, anti-PD-L1 and anti-CTLA-4 therapies.
Presented new data on the "adenosine gene signature," a biomarker associated with patient response to therapy with CPI-444, in a poster presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress.
CPI-006: Anti-CD73 Antibody

Continued enrollment of up to 350 patients with advanced cancer in a Phase 1/1b clinical trial evaluating CPI-006 as a single agent and in combination with CPI-444, and in combination with an anti-PD-1. The trial is designed to select the dose and evaluate the safety, pharmacokinetics, immune biomarkers and efficacy in patients with NSCLC, RCC, and other cancers who have failed standard therapies.
CPI-818: A small molecule ITK inhibitor

Plan to submit an Investigational New Drug (IND) filing for CPI-818, the Company’s interleukin-2-inducible kinase (ITK) inhibitor, in early 2019.
Preclinical data on CPI-818 to be presented by Douglas H. Thamm, VMD, DACVIM (Oncology) at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Molecular Targets and Cancer Therapeutics Symposium, November 13 through 16, 2018 in Dublin, Ireland.
Financial Results

As of September 30, 2018, Corvus had cash, cash equivalents and marketable securities totaling $122.6 million. This compared to cash, cash equivalents and marketable securities of $90.1 million at December 31, 2017.

Research and development expenses for the three months ended September 30, 2018 totaled $8.4 million compared to $10.7 million for the same period in 2017. The decrease of $2.3 million was primarily due to a decrease in CPI-444 clinical trial expenses.

General and administrative expenses for the three months ended June 30, 2018 totaled $2.8 million compared to $2.2 million for the same period in 2017. The increase of $0.6 million was primarily due to an increase of $0.3 million in patent and public company expenses, and an increase of $0.2 million in personnel costs.

The net loss for the three months ended September 30, 2018 was $10.5 million compared to $12.7 million for the same period in 2017. Total stock compensation expense for the three months ended September 30, 2018 was $1.8 million compared to $1.5 million for the same period in 2017.