On March 26, 2019 Charles River Laboratories International, Inc. (NYSE: CRL) reported that its team of oncology experts will attend the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, with 19 scientific posters and two oral presentations to highlight its enhanced oncology portfolio (Press release, Charles River Laboratories, MAR 26, 2019, View Source [SID1234534645]). The meeting is taking place from March 29-April 3, 2019, at the Georgia World Congress Center in Atlanta, Georgia.

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Charles River’s team of industry-leading oncology experts have been named as co-inventors on more than 60 patents secured by clients for compounds with an oncology indication, including one launched product, and have produced numerous development candidates in this therapeutic area. Additionally, the Company worked on over 85 percent of all oncology therapies approved by the FDA in 2018. At the AACR (Free AACR Whitepaper) Annual Meeting, researchers will present recent work utilizing emerging tools and approaches for cancer research.

Combination Therapies for Breast Cancer

PARP inhibitors have shown promise when used in combination with immunotherapy in women with breast and ovarian cancers who carry the BRCA mutations. In an oral presentation at the AACR (Free AACR Whitepaper) Annual Meeting, Julia Schueler, DVM, PhD, Research Director at Charles River, will discuss the crosstalk identified between PARP inhibitors and immune checkpoint inhibitors in cell and research models expressing the BRCA mutation. The crosstalk suggests this drug combination might be effective in women suffering from BRCA1-driven malignancies.

Monday, April 1, 3:35-3:50 p.m.: Modulation of the tumor infiltrating lymphocyte population by PARP inhibitor Talazoparib in combination with anti-PD1 treatment significantly enhances overall survival in a murine BRCA1-/- breast cancer model
Collaboration in Pediatric Oncology

Cancer remains the leading cause of death from disease among children, making a continued focus on research in this field extremely important. Charles River has partnered with Meds4Kids Pharma (M4K), an organization using open science to revolutionize how affordable new treatments are discovered and developed.

Since 2017, Charles River has donated drug discovery services to M4K, including medicinal and synthetic chemistry. Working collaboratively with M4K and their open science partners, the team has made progress towards the identification of potent, selective, brain-penetrant ALK2 inhibitors.

At the AACR (Free AACR Whitepaper) Annual Meeting, Sue Cramp, PhD, Team Leader, Chemistry at Charles River, will give an oral presentation on work conducted with M4K, the Ontario Institute for Cancer Research, and the Structural Genomics Consortium. She will discuss their combined efforts to generate an orally-available, brain-penetrant therapeutic to treat Diffuse Intrinsic Pontine Glioma (DIPG), a rare, aggressive, and uniformly fatal childhood brain cancer.

Tuesday, April 2, 3:00-5:00 p.m.: Open science medicinal chemistry: Towards a treatment for DIPG
Additionally, Charles River is a part of the Innovative Therapies for Children with Cancer Paediatric Preclinical Proof-of-Concept Platform (ITCC-P4), a public-private partnership with 21 members focused on establishing 400 new patient-derived xenografts (PDX) of high-risk pediatric tumors. By establishing and characterizing these PDXs, the consortium, funded under IMI2 Grant Agreement No. 116064, aims to build a sustainable, comprehensive platform for more translational drug testing.

Tuulia Huhtala, PhD, Head of Biomarkers and Molecular Imaging at Charles River, will present a poster based on the work done in characterizing these PDXs, which demonstrates the essential role of imaging in both clinical diagnosis and monitoring therapy response. The presentation will review volumetric, metabolic, and functional changes in an orthotopic PDX brain tumor model using MRI, MRS, and PET imaging.

Monday, April 1, 1:00-5:00 p.m.: Translational imaging findings in a pediatric patient-derived orthotopic xenograft brain tumor model
Charles River Launches New Drug Discovery Platforms

At the AACR (Free AACR Whitepaper) Annual Meeting Charles River is also launching a new model for oncology research. The HuPBMC-NCG Humanized Model is a humanized, PBMC-engrafted NCG mouse. This study-ready model eliminates the time, energy, and resources spent validating and humanizing a model, enabling researchers to quickly initiate short-term in vivo studies.

Humanized mice, which harbor human immune cells, can be utilized to test the safety and efficacy of compounds that manipulate the immune system to fight cancer. The HuPBMC-NCG Humanized Model will be commercially available in April 2019.

In addition, Distributed Bio scientists will join the Charles River team to highlight their recently announced partnership. A combination of Distributed Bio’s antibody discovery platform and Charles River’s extensive drug development expertise creates an elite end-to-end solution for therapeutic antibody discovery and development. With access to the Distributed Bio’s SuperHuman, AbGenesis, and Tumbler technologies, clients can discover, analyze, and engineer therapeutic antibodies with unprecedented speed.

A full schedule of Charles River’s activities during AACR (Free AACR Whitepaper) 2019 is available online. Reprints of each poster will be available in Booth 2914 during the conference, and Charles River experts will be available for meetings to discuss how an integrated approach can support drug discovery and development programs from hit identification to IND (Investigational New Drug) filing.

Throughout the conference, Charles River will be providing live updates on the Eureka Blog, including reviews of scientific sessions and input on the research being presented.

Approved Quotes

"Cancer remains a leading cause of death by disease across the globe. Our researchers are committed to finding novel treatments by harnessing innovative tools and methodologies." – Birgit Girshick, Corporate Executive Vice President, Discovery & Safety Assessment, Biologics Testing Solutions, and Avian Vaccine Services at Charles River
"The AACR (Free AACR Whitepaper) Annual Meeting affords us a unique opportunity to share our research in oncology and learn from our peers. I am hopeful that our presentation on the use of combination therapies in breast cancer treatment will inspire continued research in this promising area." – Julia Schueler, DVM, PhD, Research Director at Charles River
"For pediatric cancer patients, time is essential. I am proud that Charles River is part of collaborative groups, like M4K and ITCC-P4, that unite the best minds in the industry to focus on finding the most promising targets." – Ian Waddell, PhD, Executive Director, Biology at Charles River

On March 26, 2019 Tarveda Therapeutics, Inc., a clinical stage biopharmaceutical company discovering and developing a new class of potent and selective miniature drug conjugates (Pentarins) for the treatment of patients with a wide range of solid tumors, reported that the company will present nonclinical data on PEN-221 at the 2019 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, occurring March 29 – April 3, 2019 in Atlanta, GA (Press release, Tarveda Therapeutics, MAR 26, 2019, View Source [SID1234534644]).

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PEN-221 is a miniature drug conjugate designed to rapidly penetrate deep into solid tumors where it is highly selective for somatostatin receptor 2 (SSTR2) and accumulates its potent DM1 cytotoxic payload. The presenter will demonstrate the effectiveness of PEN-221 in combination with epigenetic modulation by an HDAC inhibitor in nonclinical models of human cancer. The data show that an HDAC inhibitor increases the tumor expression of SSTR2 with synergy of efficacy.

Details of the poster presentation are as follows:

Title: Epigenetic modulation of SSTR2 expression provides the potential to broaden PEN-221 treatment population
Date: Tuesday, April 2, 2019
Time: 1:00pm Eastern Time
Location: Georgia World Congress Center, Atlanta, GA

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.