Uncategorized – Page 14269 – 1stOncology™: Cancer Intelligence Service

Akoya Biosciences to Showcase New Multiplexed Imaging Data From Its Spatial Biology Platforms at SITC 2019

On November 6, 2019 Akoya Biosciences, Inc., The Spatial Biology Company, reported that data generated with its CODEX and Phenoptics multiplex immunofluorescence platforms will be presented at the 34th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), taking place in National Harbor, MD, from November 6th to 9th (Press release, Akoya Biosciences, NOV 6, 2019, View Source [SID1234550542]).

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Cancer immunotherapy is a transformative treatment modality, but mounting evidence indicates that current biomarkers do not reliably predict treatment response for the majority of patients. As noted in a recent publication, multiplex immunofluorescence and multiplex immunohistochemistry, which preserve critical spatial data about cell proximity and interaction in the tumor microenvironment, offers higher predictive power than traditional immunohistochemistry and emerging genomic biomarkers. The CODEX and Phenoptics Solutions provide industry leading highly multiplexed, spatially resolved biomarker detection for basic, translational, and clinical research.

At SITC (Free SITC Whitepaper) 2019, Akoya and its customers will present results from the latest immuno-oncology studies enabled by these platforms. A sponsored dinner symposium entitled "High-plex Spatial Analysis of the Tumor Microenvironment: Advancements and Applications," will take place at 6:30 pm on Friday, November 8th, at the Gaylord National Convention Center. The featured speakers include Dr. Robert Pierce from the Fred Hutchinson Cancer Research Center as well as Victoria Duckworth, Cliff Hoyt, and Dr. Julia Kennedy-Darling from Akoya. In addition to presenting new workflow innovations, Akoya’s presenters will also share a cross-platform comparison of the CODEX and Vectra Polaris systems that will simplify the translation of biomarkers from discovery to high-throughput validation. Further details can be found at www.akoyabio.com/sitc2019.

Conference attendees can also get hands-on experience with the CODEX and Vectra Polaris systems at the Akoya booth (#330). In-booth software demos will take place during the Friday and Saturday lunch sessions covering these tools:

A preview of the soon-to-be launched Proxima Solution to meet researchers’ data storage, image management and data analysis needs
Akoya’s inForm TissueFinder and phenoptrReports for analyzing and visualizing complex phenotypes and reporting spatial metrics with ease
Visiopharm APP for automated immune infiltrate analysis of unmixed multiplex immunofluorescence imagery
IndicaLab HALO for whole-slide analysis of unmixed multiplex immunofluorescence imagery
The company and its collaborators will also highlight new applications and validation data through the following poster presentations:

#P31: Applying Multispectral Unmixing and Spatial Analyses to Explore Tumor Heterogeneity with a Pre-Optimized 7-Color Immuno-Oncology Workflow
#P34: A Fully Optimized End-To-End Solution for I/O Multiplex Immunofluorescence Staining Using Opal Polaris 7-Color PD1/PD-L1 Panel Kits for Lung Cancer and Melanoma
#P43: A Novel Platform for Highly Multiplexed, Single-Cell Imaging of Cell Suspensions
#P54: Development of a 9-Color Immunofluorescence Assay Using Tyramide Signal Amplification and Multispectral Imaging for High-Throughput Studies on FFPE Tissue Sections
#P59: Highly Consistent Automated Multiplex Immunofluorescence for Immunoprofiling of Solid Tumors in Clinical Trials: Assay Validation Study Using Multispectral Imaging and Digital Analysis.
#P64: Highly Multiplexed Single-Cell Spatial Analysis of FFPE Tumor Tissues Using Codex
Brian McKelligon, Chief Executive Officer of Akoya, commented: "We are excited to share our latest innovations in multiplex immunofluorescence and their application to immunotherapy studies with the SITC (Free SITC Whitepaper) community."

VBL Therapeutics Announces New IND for an Investigator-Sponsored Phase 2 Trial of VB-111 in Recurrent Glioblastoma

On November 6, 2019 VBL Therapeutics (Nasdaq: VBLT) reported that an investigational new drug (IND) application has received clearance from the U.S. Food and Drug Administration (FDA) (Press release, VBL Therapeutics, NOV 6, 2019, View Source [SID1234550558]). The IND is for a Phase 2 randomized, controlled, clinical trial of VB-111 in rGBM patients undergoing a second surgery. In this new study, VB-111 will be administrated either before and after the surgery (neo-adjuvant and adjuvant therapy) or just after the surgery (adjuvant therapy) and will be compared to a standard of care control cohort. The IND was submitted by Patrick Wen, M.D., Director, Center for Neuro-Oncology, Dana-Farber Cancer Institute, on behalf of a group of top neuro-oncology US medical centers.

"MRI analysis conducted at UCLA of the VB-111 Phase 2 and GLOBE Phase 3 studies demonstrated objective responses to VB-111 monotherapy. Importantly, VB-111 responders had a survival advantage. These clinically meaningful findings suggest that VB-111 should be furthered explored in rGBM," said Timothy Cloughesy, M.D., Director and Professor, UCLA Neuro-Oncology Program and a co-principal investigator of the upcoming study.

A prior Phase 2 study demonstrated a survival benefit for patients with rGBM primed with VB-111 monotherapy that was continued upon progression with a combination of VB-111 and bevacizumab. The primary endpoint of this new study in participants with surgically accessible rGBM is to investigate whether administration of VB-111 as a neo-adjuvant treatment prior to surgery can result in an increase in tumor infiltrating T lymphocyte (TIL) within the tumor and enhance systemic tumor-specific T cell responses. Secondary endpoints will include progression free survival at 6 months (PFS-6) and overall survival (OS).

"This study builds upon our previous positive Phase 2 trial of VB-111 in rGBM and it incorporates lessons learned from the GLOBE study, aiming to optimize the regimen for VB-111 in this deadly tumor," said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. "We look forward to exploring the potential of neo-adjuvant treatment with VB-111 to turn immunologically ‘cold’ GBM tumors ‘hot’."

Additional details about the study will be presented at the 2019 Society for Neuro-Oncology annual meeting, to be held on November 20 – 24, 2019 in Phoenix, Arizona.

Mersana Therapeutics Announces Third Quarter 2019 Financial Results and Provides Business Updates

On November 6, 2019 Mersana Therapeutics, Inc. (NASDAQ:MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported financial results and a business update for the third quarter ended September 30, 2019 (Press release, Mersana Therapeutics, NOV 6, 2019, View Source [SID1234550405]).

"We continue to execute on our 2019 goals and remain on track for near-term proof of concept and the potential for multiple data readouts in 2020. In the third quarter, we made important progress with the initiation of the XMT-1536 expansion study in patients with platinum resistant ovarian cancer and non-small cell lung cancer adenocarcinoma at a dose of 36 mg/m2 as well as the continuation of the dose escalation cohorts," said Anna Protopapas, President and CEO of Mersana Therapeutics. "We are pleased to report that the first three patients in the 43 mg/m2 dose escalation cohort have experienced no dose limiting toxicities. We are encouraged that the safety and efficacy profile of XMT-1536 continues to be promising."

Recent Highlights and Updates

Clinical Program

Expansion portion of the XMT-1536 Phase 1 study initiated. In August 2019, Mersana announced that it had dosed the first patient in the expansion study on the 36 mg/m2 once-every-four-week dose regimen. The Company continues to add sites and enroll platinum-resistant ovarian cancer patients who have failed standard therapy and non-small cell lung cancer (NSCLC) adenocarcinoma patients who have failed front line platinum-based chemotherapy with anti-PD-1 or anti-PD-L1 therapy or have exhausted targeted therapies.

Phase 1 dose escalation of XMT-1536 remains ongoing. In August 2019, Mersana announced that the 36 mg/m2 once-every-four-week dosing cohort cleared safety review and the Company initiated a 43 mg/m2 once-every-four-week dose escalation cohort. The Safety Review Committee has evaluated three patients on the 43 mg/m2 dose level and concluded that no patients experienced dose limiting toxicities and the dose has been well-tolerated to date. The Company plans to continue to enroll and evaluate additional patients at this dose level before deciding next steps for dose escalation and expansion.

Discovery Pipeline Progress

Mersana presented preclinical data from a research collaboration that investigated NaPi2b expression in NSCLC emphasizing correlations to histology. In a poster titled "NaPi2b expression in a large surgical non-small cell lung cancer cohort," investigators

concluded that in a large early-stage surgical NSCLC cohort, a high level of NaPi2b expression was seen with adenocarcinoma subtypes and tumors harboring EGFR and KRAS mutations.

Mersana remains on track to disclose its next ADC clinical candidate around year end, further strengthening its scientific leadership in ADC development. The Company is targeting the filing of its next Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) in the first half of 2020.

Mersana presented preclinical data from the Company’s novel Immunosynthen platform at the 10th Annual World ADC conference. Data supports the potential for the development of a STING agonist ADC that can address the challenge of systemic delivery and tolerability of immunomodulatory payloads.

Upcoming Events

The Company will present preclinical data from its novel Immunosynthen platform in a poster session at the 34th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) from November 6 – 10, 2019, in National Harbor, MD. Details of the poster session are as follows:

Poster Title: "Tumor targeting of a STING agonist with an antibody drug conjugate elicits potent anti-tumor immune responses"

Date/Time: November 8, 2019 from 8 AM – 8 PM

Abstract/Poster #: P695

2019 Financial Results

Cash, cash equivalents and marketable securities as of September 30, 2019, were $112.0 million, compared to $70.1 million as of December 31, 2018. On March 5, 2019 the Company completed a public equity offering with gross proceeds of $97.8 million. On May 8, 2019, the Company completed a non-dilutive debt financing with Silicon Valley Bank (SVB) that provides Mersana with the ability to draw up to $20.0 million. The Company drew $5.0 million upon the execution of the agreement. The Company used net cash of $16.3 million in operations in the third quarter of 2019. The Company expects that its cash, cash equivalents and marketable securities will enable it to fund its operating plan into at least mid-2021.

Third Quarter 2019

Collaboration revenue for the third quarter 2019 was approximately $0.8 million, compared to $2.2 million for the same period in 2018. The decrease in collaboration revenue was primarily as a result of a decrease in services performed in support of partner’s programs.

Research and development expenses for the third quarter 2019 were approximately $13.7 million, compared to $15.2 million for the same period in 2018. The decrease was primarily due to decreased manufacturing costs for XMT-1536 and XMT-1522, offset by increased manufacturing costs for preclinical studies and discovery efforts associated with the Company’s next ADC clinical candidate, advancement of companion diagnostics development efforts for the NaPi2b biomarker and a milestone paid on the initiation of the expansion cohort.

General and administrative expenses for the third quarter 2019 remained flat at $4.4 million, compared to the same period in 2018.

Net loss for the third quarter 2019 was $16.8 million, or $0.35 per share, compared to a net loss of $17.1 million, or $0.74 per share, for the same period in 2018. Weighted average common shares outstanding for the quarters ended September 30, 2019 and September 30, 2018, were 47,833,607 and 23,152,019 respectively.

Conference Call

Mersana Therapeutics will host a conference call and webcast today at 8:00 a.m. ET to report financial results for the third quarter of 2019 and provide certain business updates. To access the call, please dial 877-303-9226 (domestic) or 409-981-0870 (international) and provide the Conference ID 459394. A live webcast of the presentation will be available on the Investors & Media section of the Mersana website at www.mersana.com.

About XMT-1536

XMT-1536 is a first-in-class ADC targeting the sodium-dependent phosphate transport protein (NaPi2b) and utilizing the Dolaflexin platform to deliver an average of 10-15 DolaLock payload molecules per antibody. The NaPi2b antigen is broadly expressed in non-small cell lung cancer (NSCLC) adenocarcinoma and ovarian cancer. XMT-1536 is in Phase 1 clinical trials in patients with tumors expressing NaPi2b, including ovarian cancer and NSCLC adenocarcinoma. More information on the ongoing Phase 1 clinical trial can be found at clinicaltrials.gov (NCT03319628).

argenx to Present Data at Upcoming 61st American Society of Hematology (ASH) Annual Meeting

On November 6, 2019 argenx (Euronext & Nasdaq: ARGX), a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, reported three presentations at the the upcoming 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting being held from December 7-10, 2019 in Orlando, FL (Press release, argenx, NOV 6, 2019, View Source [SID1234550437]). The presentations will include preclinical translational data highlighting the multiple modes of action of cusatuzumab to target leukemic stem cells, potential synergies of cusatuzumab in combination with a BCL-2 antagonist, and previously announced data from the Company’s completed Phase 2 trial of efgartigimod for primary immune thrombocytopenia (ITP).

Details for the oral presentations are as follows:

Title: Targeting CD70 with Cusatuzumab Eliminates Acute Myeloid Leukemia Stem Cells in Humans

Oral Session: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Novel Targets and Combinations

Date and Time: Saturday, December 7, 3:15 p.m. ET

Location: Orange County Convention Center, Chapin Theater, W320

Presenter: Dr. Adrian Ochsenbein, M.D., University of Bern

Title: Phase 2 Study of Efgartigimod, a Novel FcRn Antagonist, in Adult Patients with Primary Immune Thrombocytopenia

Oral Session: 311. Disorders of Platelet Number or Function: Advances in ITP Therapy

Date and Time: Monday, December 9, 6:15 p.m. ET

Location: Orange County Convention Center, W307

Presenter: Dr. Adrian Newland, M.D., The Royal London Hospital

Details for the poster presentation are as follows:

Title: The Combination of the BCL-2 Antagonist Venetoclax with the CD70-Targeting Antibody Cusatuzumab Synergistically Eliminates Primary Human Leukemia Stem Cells

Session: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Poster III

Date & Time: Monday, December 9, 2019, 6:00 p.m. – 8:00 p.m. ET

Location: Orange County Convention Center, Hall B

Presenter: Dr. Carsten Riether, Ph.D., University of Bern

Curis Abstracts for Fimepinostat and CA-4948 Accepted for Presentation at the 61st Annual Meeting of the American Society of Hematology

On November 6, 2019 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported that abstracts for both fimepinostat and CA-4948 were accepted for presentation at the 61st Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) which will be held December 7-10, 2019, in Orlando, FL (Press release, Curis, NOV 6, 2019, View Source [SID1234550454]).

"We are pleased to announce that abstracts for two of our first-in-class cancer therapeutics, fimepinostat and CA-4948, were accepted for presentation at ASH (Free ASH Whitepaper)," said James Dentzer, President and Chief Executive Officer of Curis. "In addition to the data published in the abstracts this morning, we look forward to providing updated clinical data on both programs at ASH (Free ASH Whitepaper)."

Curis’ abstracts are listed below and are available on the ASH (Free ASH Whitepaper) conference website: www.hematology.org/Annual-Meeting/.

Poster Presentation:

Presentation Title:

A Multi-Center Dose-Finding Study to Assess Safety, Tolerability,
Pharmacokinetics and Preliminary Efficacy of Fimepinostat (CUDC-907) in
Combination with Venetoclax in Patients with Relapsed/Refractory (R/R)
Lymphoma

Session:

626. Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive
B-Cell Non-Hodgkin Lymphomas)—Results from Prospective Clinical
Trials: Poster III

Viewing Date/Time:

Monday, December 9, 2019, 10:00 a.m. – 8:00 p.m. ET

Presentation Date/Time:

Monday, December 9, 2019, 6:00 p.m. – 8:00 p.m. ET

Location:

Hall B, Orange County Convention Center

Online Abstract:

Abstract Title:

Phase 1 Dose-Finding Study Investigating CA-4948, an IRAK4 Kinase
Inhibitor, in Patients with R/R NHL: Report of Initial Efficacy and Updated
Safety Information