On March 26, 2019 Akoya Biosciences, Inc., reported that data from its new line of multiplex immunofluorescence imaging platforms for high-parameter, spatially resolved biomarker analysis will be presented at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019. The meeting runs March 29 – April 3, 2019 in Atlanta, Georgia (Press release, Akoya Biosciences, MAR 26, 2019, View Source [SID1234534643]).

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The company will feature data from its new products in an Exhibitor Spotlight Theater presentation on Sunday, March 31, from 1:30-2:30 PM titled "Pushing the frontiers of immuno-oncology with multiplex immunofluorescence" with speakers David Rimm, MD, PhD, Professor of Pathology at Yale University School of Medicine and Julia Kennedy-Darling, PhD, Director of R&D at Akoya Biosciences. During the presentation, Dr. Rimm will discuss the results from a Multi-institutional TSA-amplified Multiplexed Immunofluorescence Reproducibility Evaluation (MITRE Study) which assessed the reproducibility of Akoya’s automated multiplexed immunofluorescence slide staining, imaging, and analysis workflow.

"The exciting results from our MITRE Study demonstrate that multiplexed immunofluorescence methods can be analytically robust enough to support translation into large scale trials and eventual clinical practice," said Clifford Hoyt, Vice President, Translational and Scientific Affairs at Akoya Biosciences. "In addition, we’ve provided a template for other investigative teams to use for assessing reproducibility of their multiplex panels. The next step in this multi-site project will be to apply this assay retrospectively to discover and develop predictive biomarkers for PD1 and PDL1 therapies. We at Akoya are very grateful for the significant technical and scientific contributions from participants, who share a mission to ultimately deploy these methods for the benefit of patients."

Accepted abstracts will feature data from the new CODEX System, which can transform existing fluorescence microscopes into high-quality multiplexed tissue imagers for more than 40 biomarkers. Data will also be presented from the company’s new Phenoptics 2.0 platform, which includes the Vectra Polaris imaging system, Opal detection reagents, and inForm analysis software. Phenoptics 2.0 now also includes the company’s proprietary MOTiF technology, which acquires multispectral images on whole-slide tissue sections using up to seven colors simultaneously, and at speeds 20 times faster than previously possible.

Akoya’s abstracts include:

Multi-institutional TSA-amplified Multiplexed Immunofluorescence Reproducibility Evaluation (MITRE Study) – Reproducibility assessment of an automated multiplexed immunofluorescence slide staining, imaging, and analysis workflow
Poster # 9, Section 42, Presentation LB318
Wednesday, April 3 from 8 AM to 12 PM
Highly multiplexed single-cell spatial analysis of tissue specimens using CODEX
Poster #3, Section 20, Presentation 490
Sunday, March 31 from 1 to 5 PM
Quantifying tumor heterogeneity and mapping complex immune cell interactions with high-throughput, 7-color multispectral slide scans
Poster #30, Section 6, Presentation 153
Sunday, March 31 from 1 to 5 PM
In addition, several leading pharmaceutical companies and academic medical centers will be presenting data from studies using the company’s multiplex immunofluorescence technology including:

Tumor heterogeneity and its impact on immunoprofiling data: Whole tumor vs regions of interest (ROI) analysis of multiplex immunofluorescence in four carcinoma types
Poster #4, Section 20, Presentation 491
Sunday, March 31 from 1 to 5 PM
Impact of the spatial analysis of tumor-associated lymphocytes and tumor-associated macrophages on recurrence at early stage of non-small cell lung carcinoma
Poster #7, Section 9, Presentation 1180
Monday, April 1 from 8 AM to 12 PM
Multiplexed immunofluorescence and multispectral imaging-based quantification of tumor and immune cell populations reveals spatial relationships in oral cavity squamous cell carcinoma
Poster #4, Section 7, Presentation 1132
Monday, April 1 from 8 AM to 12 PM
IL17 signaling modulates tumor microenvironment in pancreatic cancer
Poster #29, Section 3, Presentation 4575
Wednesday, April 3 from 8 AM to 12 PM
The company will also be providing demos in its booth (#4243) on Tuesday afternoon, April 2. For specific topics and times, see: View Source

On March 26, 2019 Lipella Pharmaceuticals Inc., a clinical stage biopharmaceutical company based in Pittsburgh, PA, reported the investigational new drug (IND) approval for a phase-2a, multi-center, double-blind, placebo-controlled clinical study measuring the safety and efficacy of LP-10 for cancer survivors with hemorrhagic cystitis resulting from pelvic radiation therapy and/or systemic chemotherapy (Press release, Lipella Pharmaceuticals, MAR 26, 2019, View Source [SID1234534642]).

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Cancer survivorship is becoming an important priority for patients, caregivers and health care providers. Radiation used to treat prostate, colon, uterine, cervical and other pelvic cancers, in approximately 12% of patients, leads to chronic hemorrhagic cystitis that can be severe and uncontrollable. Certain chemotherapy agents can also cause hemorrhagic cystitis. There are no approved therapies to treat hemorrhagic cystitis, which can severely diminish a patient’s quality of life, and, in some cases lead to death.

LP-10 is a liposomal tacrolimus formulation under development for the treatment of hemorrhagic cystitis, an orphan indication with no currently approved therapies. "The approved protocol allows for dose escalation as well as a lipid vehicle control arm," stated Jonathan Kaufman, PhD, Chief Executive Officer of Lipella. "We are looking forward to the collection of additional human data, as we seek opportunities for future collaboration. Oncology supportive care is an important strategic direction for us, and we are excited to advance our clinical pipeline."

About LP-10

LP-10 is a proprietary product developed for intravesical delivery to hemorrhagic cystitis patients. LP-10 has received US FDA Orphan Designation.

Caution: LP-10 is currently not approved for commercial use in any indication in the United States and is limited by U.S. federal law to investigational use only.

On March 26, 2019 IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical stage immuno-oncology corporation, reported preliminary data from the phase 2 cohort of the DECIDE clinical study (Press release, IMV, MAR 26, 2019, View Source [SID1234534641]). Six patients receiving DPX-Survivac monotherapy with intermittent low-dose cyclophosphamide (mCPA) have reached the first CT scan assessment with key related findings as follows:

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83% of the subjects (5 of 6) show stable disease (SD), including two tumor regressions
80% (4 of 5) with stable disease are in subjects with a lower baseline tumor burden (BTB), which also includes the two tumor regressions
"This initial phase 2 data confirms the earlier trends we saw in the phase 1b portion of the study," said Frederic Ors, Chief Executive Officer. "It supports the potential of DPX-Survivac as a monotherapy and the use of our patient selection strategy. We are encouraged by these early initial results and are committed to advancing this program quickly with the goal of providing an additional treatment option to patients with advanced ovarian cancer."

Importantly, in earlier stages of this trial, durable clinical responses occurred after 140 days, and have now lasted for 20 months or more. Additional data at the 140 day mark of this cohort will be available by the end of the first half of 2019.

This amended phase 2 study evaluates the safety and efficacy of DPX-Survivac monotherapy with mCPA in patients with advanced recurrent ovarian cancer. As of the March 25, 2019 data cut-off date, 13 patients have been enrolled in the phase 2 portion of the trial in addition to the 53 enrolled in the phase 1b cohort. Five patients were randomized into the DPX-Survivac monotherapy cohort. Seven patients had been randomized into DPX-Survivac/mCPA in combination with epacadostat before the phase 2 protocol was amended to stop enrollment in the combination arm. One of the patients in the combination arm elected to switch to the monotherapy arm of the trial. Positive data from the phase 1b portion of the trial led IMV to amend the study to monotherapy in patients with lower tumor burden.

The amended phase 2 cohort of the DECIDE trial is targeting an enrollment of at least additional 16 patients in the population with a lower tumor burden. Enrollment is ongoing at multiple sites in the U.S. and Canada.

On March 26, 2019 Exicure, Inc. (OTCQB: XCUR), the pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA) constructs, reported that its CFO, David Snyder, will give a company presentation on Tuesday, April 2, 2019 at 9:30 am ET at the Spring Investor Summit (Press release, Exicure, MAR 26, 2019, View Source [SID1234534640]). The presentation will be made at the Essex House in New York City.

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A live audio webcast will be available on the Investors section of Exicure’s website: www.exicuretx.com. The webcast will be archived for approximately 30 days following the event.

On March 26, 2019 Ichor Medical Systems, Inc. (Ichor) reported that it has entered into a collaboration and research license agreement with AstraZeneca (LSE, SSE, NYSE: AZN) for the development and clinical assessment of plasmid DNA constructs (Press release, Ichor Medical Systems, MAR 26, 2019, View Source [SID1234534639]). The plasmids will encode monoclonal antibodies developed by AstraZeneca and will be delivered using Ichor’s TriGrid Delivery System. Under the terms of the agreement, Ichor will receive upfront and annual payments along with development milestones.

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The development and optimization of in vivo expression of DNA-encoded antibodies delivered by the TriGrid is a particularly attractive product strategy in the recombinant monoclonal antibody market. Utilizing this approach, the TriGrid platform works to deliver DNA-encoding monoclonal antibodies directly into a person, after which that person’s own cells can begin to manufacture the antibodies.

"We are very excited to be working alongside AstraZeneca in this burgeoning field. Our goal is ultimately to increase access to antibody therapies for a wide range of disease indications affecting diverse global populations, thereby expanding new patient markets," said Ichor CEO Bob Bernard.

Ichor’s patented TriGrid system uses electroporation, a potent delivery method in which brief electrical pulses are applied to a target tissue to facilitate entry of plasmid DNA into cells, resulting in high expression of genes encoded on the plasmid. The TriGrid has been utilized in numerous clinical studies of prophylactic and therapeutic DNA vaccines. Improved vaccine potency with TriGrid delivery versus conventional injection, as well as induction of antibody and T cell responses, has been demonstrated in humans.