On October 5, 2022 Translational Drug Development (TD2), a precision oncology contract research organization (CRO), reported the addition of Dr. Alan Miller as their new Chief Medical Officer (Press release, Research Corporation Tech, OCT 5, 2022, View Source [SID1234621724]). Prior to joining TD2, Dr. Miller was Chief Medical Director of Oncology and Associate Chief Medical Director of Clinical Research at SCL Health.

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Dr. Miller obtained his Ph.D. at Roswell Park (SUNY) and his M.D. from the University of Miami School of Medicine. Trained as a medical oncologist, he was also the Associate Senior Vice President for Health Sciences for Tulane Cancer Center, where he navigated the challenges of rebuilding and re-establishing the university and hospital following Hurricane Katrina. He also served as Cancer Center Director of the Baylor Sammons Cancer Center where he brought together a not-for-profit healthcare system and private oncology practices to form an oncology network across north Texas. Additionally, Dr. Miller built a larger system-wide oncology network while at SCL Health and established a system-wide clinical trials infrastructure for a multi-state healthcare system. He also serves as a Board Member for the American Cancer Society Denver and Rocky Mountain Oncology Society.

"Dr. Miller has extensive experience across many cancer types and new medicine development." said Dr. Stephen Gately, President, and CEO of TD2. "He will be an incredible resource to both our internal teams, as well as clients, as we continue our strategic growth."

On October 5, 2022 Prestige Biopharma Limited, a Singapore-based biopharmaceutical company, reported that a team of scientists at Prestige Biopharma Innovative Discovery Centre (IDC) published a study titled ‘PAUF Induces Migration of Human Pancreatic Cancer Cells Exclusively via the TLR4/MyD88/NF‐κB Signalling Pathway’ in the International Journal of Molecular Sciences (Press release, Prestige BioPharma, OCT 5, 2022, View Source [SID1234621723]).

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PAUF (pancreatic adenocarcinoma up‐regulated factor) is a novel secreted protein which is substantially expressed in pancreatic cancer cells. It is known to induce pancreatic cancer progression and metastasis. According to this study, PAUF binds directly to TLR4 (Toll‐like receptor 4), which is identified as a receptor for PAUF, on pancreatic cancer cell surfaces and promote cell migration exclusively through the TLR4/MyD88/NF‐κB pathway.

In addition, the study demonstrated that the knockout of TLR4 led to a marked decrease in the expression of PD‐L1 (Programmed Death‐Ligand 1), an immune checkpoint contributing to cancer immune escape. Accordingly, the scientists are conducting a follow-up study to confirm if combining anti-PAUF treatment with TLR4 inhibitor can enhance treatment efficacy.

The results of this study enhanced the understanding of the mechanism of PAUF‐induced tumour‐promoting effects. Furthermore, it suggests that TLR4 expression on cancer cells may be a critical biomarker for anti‐PAUF treatment, implying a potential clinical application in later phase clinical trials.

Prestige Biopharma has been developing PBP1510 (INN: Ulenistamab), a first-in-class anti-PAUF monoclonal antibody for pancreatic cancer treatment. PBP1510 been granted Orphan Drug Designation (ODD) by the European Medicines Agency (EMA), US Food and Drug Administration (FDA) and Korean MFDS. Currently, it is on Phase 1/2a clinical trial in France, Spain, and US.

Sangseok Koh, President of Prestige Biopharma IDC commented: "Through this study, we found a potential therapeutic biomarker and target for the development of effective pancreatic cancer treatment. We will keep up our research to discover and develop methods to control TLR4 expression and further improve PBP1510’s treatment effect."

Meanwhile, Prestige Biopharma IDC is also undergoing research on technology for diagnosis of pancreatic cancer by detecting PAUF in the body. IDC aims to continue its efforts to enable early diagnosis of fatal diseases as well as effective treatment through innovative drugs.

On October 5, 2022 OncoNano Medicine, Inc. reported it will be presenting data on two development candidates, as well as its ON-BOARD delivery platform, at the 37th Annual Meeting of the Society for Immunology of Cancer (SITC) (Free SITC Whitepaper), taking place November 8-12, 2022 in Boston, Massachusetts (Press release, OncoNano Medicine, OCT 5, 2022, View Source [SID1234621722]).

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An oral and poster presentation by Dr. Qiang Feng detail new pre-clinical data for ONM-405, an IL-2-Fc construct formulated with OncoNano’s proprietary ON-BOARD polymeric-micelle delivery system. OncoNano’s lead clinical candidate, pegsitacianine, currently in Phase 2 clinical trials, is formulated with ON-BOARD. The ON-BOARD platform is designed to carry oncology intervention payloads systemically to the tumor microenvironment, minimizing systemic exposure and toxicity.

OncoNano will also present a poster detailing data from studies involving the use of the ON-BOARD platform for encapsulation and delivery of bispecific T cell engagers. In addition, a poster will feature new preclinical data of ONM-501, a novel dual-activating polyvalent STING (STimulator of INterferon Genes) agonist for immuno-oncology applications.

On October 5, 2022 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported the acceptance of two abstracts for poster presentations at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 37th Annual Meeting, which is taking place both virtually and in-person at the Boston Convention and Exhibition Center in Boston, MA, from November 8 – 12, 2022 (Press release, Oncolytics Biotech, OCT 5, 2022, View Source [SID1234621721]).

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Both abstracts will be published by SITC (Free SITC Whitepaper) at 8:00 a.m. ET on November 7, 2022. Additional details on the abstracts and corresponding poster presentations are shown below.

Title: Pelareorep combined with atezolizumab and chemotherapy demonstrates encouraging results as first-line treatment in advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) patients – Interim results from the GOBLET study
Abstract Number: 650
Poster Session Date and Time: November 11, 2022 from 9:00 a.m. – 8:30 p.m. ET
Poster Session Location: Boston Convention and Exhibition Center, Hall C

Title: The oncolytic virus pelareorep in combination with immune checkpoint inhibitor activates T-cell functioning in early breast cancer patients – immunophenotype results from AWARE-1 study
Abstract Number: 548
Poster Session Date and Time: November 11, 2022 from 9:00 a.m. – 8:30 p.m. ET
Poster Session Location: Boston Convention and Exhibition Center, Hall C

Key Opinion Leader Webinar on Pancreatic Cancer and Interim Phase 1/2 GOBLET Study Data
Oncolytics will host a key opinion leader (KOL) webinar to discuss the current treatment landscape and unmet medical need in pancreatic cancer, as well as the interim GOBLET study results that will be presented at the SITC (Free SITC Whitepaper) conference on November 14, 2022 at 10 a.m. ET. The webinar will include both formal presentations and a live question and answer session.

To register for the webinar, please click here.

About GOBLET
The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 14 centers in Germany. The co-primary endpoints of the study are objective response rate (ORR) assessed at week 16 and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers (T cell clonality and CEACAM6). The study employs a Simon two-stage design with Stage 1 comprising four treatment groups expected to enroll a total of approximately 55 patients:

1.Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line advanced/metastatic pancreatic cancer patients (n=12);

2.Pelareorep in combination with atezolizumab in 1st line MSI (microsatellite instability)-high metastatic colorectal cancer patients (n=19);

3.Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients (n=14); and

4.Pelareorep in combination with atezolizumab in 2nd line advanced and unresectable anal cancer patients (n=10).

Any cohort showing an ORR above a pre-specified threshold in Stage 1 may be advanced to Stage 2 and enroll additional patients.

On October 5, 2022 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported that results from the Company’s ongoing preclinical studies evaluating targeted immunotherapy for cancer based on the Manocept platform have been accepted for presentation at the 37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) ("SITC") to be held at the Boston Convention & Exhibition Center in person and virtually November 8-12, 2022 in Boston, MA (Press release, Navidea Biopharmaceuticals, OCT 5, 2022, View Source [SID1234621720]).

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The abstract, "Synthetic CD206 Targeted Constructs Carrying Paclitaxel or Novel Bisphosphonate Payloads Alter Macrophages Towards Pro-inflammatory Phenotypes; The Paclitaxel Construct Improves the Efficacy of anti-CTLA4 in CT26 Tumors" (Abstract #1161), will be presented as a poster on November 10, 9 am to 9 pm in the conference center’s poster hall. Further details of the abstract will be announced in a future press release once the meeting embargo is lifted.

Abstract title and session information can be found on the SITC (Free SITC Whitepaper) Annual Meeting website at: View Source

Dr. Michael Rosol, Chief Medical Officer for Navidea, said, "We are delighted by the opportunity to present these important preclinical results at this internationally recognized meeting." Dr. Rosol continued, "We continue to develop the Manocept platform, using its potent ability to target macrophages, for the development of new immunotherapies for diseases including cancer."