On November 5, 2019 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported that interim data on TK216 – an investigational targeted small molecule inhibitor of ETS transcription factor oncoproteins – will be presented at the Connective Tissue Oncology Society (CTOS) 2019 Annual Meeting in Tokyo, Japan, on November 16, 2019 (Press release, Oncternal Therapeutics, NOV 5, 2019, View Source [SID1234550355]). The oral presentation (abstract 3250355) titled "A Phase 1 Dose Escalation Study of Intravenous TK216 in Patients with Relapsed or Refractory Ewing Sarcoma" will be given by Paul A. Meyers, M.D., Chief, Pediatric Sarcoma Service and Vice Chair for Clinical Affairs of Memorial Sloan Kettering Cancer Center.

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About TK216

TK216 is an investigational, potentially first-in-class small molecule that is designed to inhibit the biological activity of E26 transformation-specific (ETS) transcription factor oncoproteins, including fusion proteins. Tumorigenic gene fusions involving ETS factors are frequently found in tumors such as Ewing sarcoma and prostate cancer, and ETS factors are often overexpressed in many other tumors, including prostate cancer and acute myeloid leukemia (AML). TK216 was developed based on discoveries of Jeffrey Toretsky, M.D., and his team at Georgetown University, who discovered inhibitors of EWS-FLI1 using a novel chemical screening assay. In preclinical models, TK216 binds to EWS-FLI1 and blocks the interaction between ETS family members and RNA helicase A leading to tumor cell apoptosis.

About the Study

TK216 is being evaluated in a Phase 1 clinical study as a single agent and in combination with vincristine in patients with relapsed or refractory Ewing sarcoma, a rare pediatric cancer that has historically been very challenging to treat effectively, particularly for recurrent and metastatic disease. A dose-finding arm of this study is nearing completion, after which Oncternal intends to begin enrolling patients in an expansion cohort of the study to evaluate the clinical response of treatment with TK216 in combination with vincristine, an approved chemotherapy agent. This multi-center study is actively enrolling patients at six clinical trial centers across the U.S. Additional information about the TK216 study may be accessed at ClinicalTrials.gov (NCT02657005).

On November 5, 2019 Akoya Biosciences, The Spatial Biology Company reported a strategic alliance with Precision for Medicine (formerly ApoCell), a pioneer in customized biomarker solutions, to develop proprietary liquid biopsy and tissue biomarker tests using Akoya’s Vectra Polaris System (Press release, Akoya Biosciences, NOV 5, 2019, View Source [SID1234550371]). By combining the Vectra Polaris system with Precision for Medicine’s ApoStream technology, the collaboration is designed to advance immuno-oncology candidates in clinical trials using both tumor biopsies and liquid biopsies to generate data required for assessing drug efficacy and validation of companion diagnostics (CDx).

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"We are very excited to be the first commercial laboratory to launch the Vectra Polaris system for image analysis of circulating tumor cells following ApoStream’s isolation and enrichment functionality," said Darren Davis, PhD, Precision for Medicine Senior Vice President. "Together, these technologies will enable accelerated drug development through detection of biomarkers in liquid biopsies. These tools have enabled our scientists to better understand the biological correlation of circulating metastatic cancer cells with cancer cells present in the tumor tissue."

Circulating tumor cells (CTCs) have long been known to exist in cancer patients’ blood. However, the promise of clinical application of CTCs as a liquid biopsy has not born fruit because these cells are difficult to detect using current molecular biology techniques. Precision for Medicine’s proprietary ApoStream technology captures significant quantities of rare circulating cancer cells from whole blood for characterization using Akoya’s Opal technology and Vectra Polaris imaging platform. ApoStream has been used in more than 80 clinical trials, including several ongoing phase III studies for CDx development.

Akoya’s Vectra Polaris Automated Quantitative Pathology System, part of the company’s Phenoptics 2.0 next-generation biomarker multiplexing platform, enables researchers to gain a deeper level of understanding of disease mechanisms related to new cancer immunotherapy approaches. The Vectra Polaris system integrates high throughput, seven-color multispectral imaging with whole-slide scanning in a simplified digital pathology workflow to support the quantification and analysis of tissue sections discernible with Opal detection kits. A recent meta-analysis of several studies showed that incorporating spatial information using Akoya’s multiplexed immunofluorescence technology is important for improving the predictive accuracy of immuno-oncology biomarkers.

The Phenoptics portfolio is capable of interrogating multiple protein markers on any tissue or cytology slide preparation. Precision for Medicine has validated several immune biomarker panels across various therapeutic applications using both types of preparation. These immune panels are currently being used to monitor immune cell infiltration including cancer, psoriasis, lupus and atomic dermatitis.

"The Vectra Polaris imaging system offers an innovative approach to assessing immunotherapy candidates in translational and clinical research," said Dr. Cliff Hoyt, Akoya Vice President of Translational and Scientific Affairs. "We are pleased to see this technology paired with ApoStream for a comprehensive method of imaging CTCs and improving our understanding of disease mechanisms in cancer."

On November 5, 2019 Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) reported that members of its senior management team will present at the upcoming investor conferences (Press release, Arena Pharmaceuticals, NOV 5, 2019, View Source [SID1234550504]):

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Credit Suisse 28th Annual Healthcare Conference – Presenting on Tuesday, November 12, at 10:00 AM ET (8:00 AM MT)
Guggenheim Healthcare Talks | Idea Forum | Neuro/Immunology Day – Presenting on Monday, November 18, at 1:45 PM ET
A live audio webcast of each presentation will be available under the investor relations section of Arena’s website at www.arenapharm.com. A replay of each presentation will be available for 30 days following the event.

On November 5, 2019 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on harnessing the body’s immune system in the fight against cancer, reported that the United States Patent and Trademark Office (USPTO) has issued US Patent No. 10,463,724 titled "Breast Cancer Vaccine (Press release, Anixa Biosciences, NOV 5, 2019, View Source [SID1234550308])."

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The lead inventor on the patent is Dr. Vincent Tuohy of the Department of Inflammation and Immunity at the Cleveland Clinic’s Lerner Research Institute and also the Mort and Iris November Distinguished Chair in Innovative Breast Cancer Research. The patent is assigned to the Cleveland Clinic and Anixa Biosciences is the exclusive world-wide licensee. This patent is one of several patents and patent applications in the portfolio licensed to Anixa Biosciences from the Cleveland Clinic, covering the innovative breast cancer vaccine technology.

"We are pleased that this key patent has been issued for technology, which we hope may eliminate breast cancer," stated Dr. Amit Kumar, Chief Executive Officer of Anixa. "This patent covers Dr. Tuohy’s method of protecting women from developing breast cancer by vaccinating against a protein that is "retired" from service after a woman has stopped lactating, only to reappear later in life in many forms of breast cancer, especially triple negative breast cancer (TNBC), the most lethal form of the disease. We look forward to progressing towards major breakthroughs in the prevention of breast cancer."

On November 5, 2019 Forbius, a clinical-stage protein engineering company that develops biotherapeutics to treat fibrosis and cancer, reported that it will present the first clinical data from its Phase 1a oncology trial with AVID200 in a late-breaking poster presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting 2019in National Harbor, Maryland (Nov. 6-10) (Press release, Forbius, NOV 5, 2019, View Source [SID1234550324]).

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AVID200 is a first-in-class, selective inhibitor of TGF-beta 1 & 3, the main pathogenic TGF-beta isoforms. AVID200 spares TGF-beta 2 for optimal safety.

The presentation will feature results from a Phase 1a monotherapy dose-escalation trial in patients with advanced solid tumor malignancies (AVID200-03, NCT03834662). The highest tested dose level was 30 mg/kg (1100 mg/m2)administered iv q3w, and the maximum tolerated dose (MTD) was not reached. Pharmacokinetics (PK), target engagement results as well as preliminary clinical efficacy will also be disclosed in the poster presentation.

Details of the Presentation:

Title:

AVID200, first-in-class TGF-beta 1 and beta 3 selective inhibitor: Results of a Phase 1 monotherapy dose escalation study in solid tumors and evidence of target engagement in patients (Abstract # P856)

Presenter:

Dr. Timothy Yap, Associate Professor, Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, MD Anderson Cancer Center

Poster Viewing:

Friday, Nov. 8 / 12:30 – 2:00 p.m. and 6:30 – 8:00 p.m.

Saturday, Nov. 9 / 12:35 – 2:05 p.m. and 7:00 – 8:30 p.m.

Location:

Prince George’s Exhibition Halls AB

About TGF-beta 1 & 3

TGF-beta 1 & 3 are the main oncogenic TGF-beta isoforms expressed by many solid tumors. They are believed to play a major role in T-cell suppression, fibrosis and resistance to anti-PD-(L)1 therapies such as nivolumab (Opdivo) and pembrolizumab (Keytruda) (Chakravarthy, Nature Comm., 2018; Tauriello, Nature, 2018; Mariathasan, Nature, 2018).

About AVID200 and the AVID200-03 Trial (NCT03834662)

AVID200 is an isoform-selective and highly potent inhibitor of TGF-beta 1 & 3 undergoing Phase 1 clinical testing in solid tumors and fibrotic diseases. TGF-beta 1 & 3 are the principal disease-driving isoforms, while TGF-beta 2 is responsible for normal cardiac function and hematopoiesis.

AVID200’s selectivity for TGF-beta 1 & 3 was designed to achieve optimal efficacy while circumventing cardiac and other safety issues that have limited the applicability of earlier-generation, non-selective TGF-beta inhibitors. Therefore, AVID200 is positioned to be an effective and well-tolerated therapeutic in a variety of clinical settings, including in combination with anti-PD-(L)1 therapy.

AVID200-03 (NCT03834662) is an open label, multicenter, dose-escalation study to evaluate the safety, pharmacokinetics, pharmacodynamics and antitumor effects of AVID200 in patients with advanced or metastatic solid tumor malignancies.