On November 6, 2019 LIDDS AB (publ) reported that it has received approval from authorities in Lithuania to conduct its Phase I study, NZ-DTX-001 (Press release, Lidds, NOV 6, 2019, View Source [SID1234555903]). Previously the phase I study is approved in Sweden and Denmark .

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The aim of the phase I dose escalation clinical trial is to assess the tolerability and safety of intratumoral injections of NanoZolid with docetaxel, a well-established cytostatic used in the treatment of cancer with an estimated global market of over USD 1 billion.

LIDDS enrolled the first patient in spring and further patients are planned to be treated in Q4, 2019.

– This is very exciting as we hope that NanoZolid combined with docetaxel will decrease the tumor size and improve surgery and radiation therapy outcomes. In the Phase I study, LIDDS aims to demonstrate that intratumoral injections with cytostatics are safe and we expect that following this study a wide range of different indications and NanoZolid combinations using chemotherapy drugs will emerge, says Monica Wallter, CEO.

– Our goal is to deliver drugs directly into the cancer tumor and thereby limit the severe side effects for cancer sufferers receiving systemic chemotherapy treatments which affect all cells in the body including the immune system, says Monica Wallter.

NZ-DTX-001 study description:
A phase Ia/Ib, first-in-human, open label, multicenter, dose-escalation and dose-expansion study of a novel NanoZolid-docetaxel depot formulation (NZ-DTX Depot) given as an intratumoral injection in patients with advanced solid tumors.

On November 6, 2019 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) reported that it will report its third quarter 2019 financial and operating results on Wednesday, November 13, 2019, after the close of the U.S. financial markets (Press release, Y-mAbs Therapeutics, NOV 6, 2019, View Source [SID1234550642]). The announcement will be followed by a conference call and webcast with the investment community at 4:30 p.m. ET. Participating on the call from Y-mAbs will be Thomas Gad, Founder, Chairman and President; Dr. Claus Moller, Chief Executive Officer; and Bo Kruse, Chief Financial Officer.

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Conference call and webcast details:

Investors (domestic): 877-407-0792
Investors (international): 201-689-8263
Conference ID: 13696442

To access a live webcast of the update, please use the following link:
View Source

On November 6, 2019 Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to address unmet medical needs, reported the presentation of preclinical data for TransCon Toll-like Receptor (TLR) 7/8 Agonist, an oncology product candidate designed to provide sustained local release of resiquimod, a small molecule with immune-activating and anti-tumor properties, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting in National Harbor, Maryland (Press release, Ascendis Pharma, NOV 6, 2019, View Source [SID1234551452]). The poster will be presented on Saturday, November 9, 2019.

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"Our preclinical data showed that TransCon TLR7/8 Agonist, administered as a single intratumoral injection in animal studies, delivered sustained local release of resiquimod over weeks directly to the tumor site and demonstrated potent anti-tumor activity as a monotherapy, as well as in combination with interleukin-2 (IL-2). This highlights the potential for TransCon technologies to improve the safety and efficacy of validated therapeutic candidates in oncology," said Juha Punnonen, M.D., Ph.D., Ascendis Pharma’s Senior Vice President and Head of Oncology. "Presenting these results for the first time at a premier scientific meeting is significant for us, reinforcing the potential applicability of TransCon technologies in the field of oncology."

TransCon TLR7/8 Agonist is a long-acting prodrug of resiquimod that is transiently conjugated to a hydrogel carrier via a TransCon linker. Administered as an intratumoral injection, TransCon TLR7/8 Agonist is designed to provide sustained release of unmodified resiquimod directly to the tumor. In preclinical studies, the effective half-life of resiquimod released from TransCon TLR7/8 Agonist has been found to be approximately 25-fold longer than the parent drug, resiquimod.

Presentation Details

Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2019
Title Date/Time
P676: Intratumoral delivery of TransCon TLR7/8 Agonist provides potent anti-tumor activity as a monotherapy and in combination with IL-2 while minimizing systemic cytokine induction

Saturday, November 9, 2019

Following the session, the poster will also be available on the company’s website under Selected Publications in the Pipeline section.

About TransCon Oncology Programs
Ascendis Pharma is working to create potentially best-in-class oncology therapies by applying systemic and intratumoral TransCon technologies for clinically validated pathways to improve outcomes currently limited by suboptimal efficacy and systemic toxicity. Three oncology programs are currently in preclinical studies: TransCon TLR7/8 Agonist, TransCon IL-2 b/g and TransCon Vascular Endothelial Growth Factor-Tyrosine Kinase Inhibitor (VEGF-TKI).

About TransCon Technology
TransCon is short for "transient conjugation." The proprietary TransCon platform is an innovative technology to create new therapies that optimize therapeutic effect, including efficacy, safety and dosing frequency. TransCon molecules have three components: an unmodified parent drug, an inert carrier that protects it, and a linker that temporarily binds the two. When bound, the carrier inactivates and shields the parent drug from clearance. When injected into the body, physiologic pH and temperature conditions initiate the release of the active, unmodified parent drug in a predictable manner. Because the parent drug is unmodified, its original mode of action is expected to be maintained. TransCon technology can be applied broadly to a protein, peptide or a small molecule in multiple therapeutic areas, and can be used systemically or locally.

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."