On April 6, 2021 Istari Oncology, Inc., a clinical-stage biotechnology company developing PVSRIPO, a novel viral immunotherapy that activates innate and adaptive immunity to facilitate a functional antitumor CD8+ T cell response, reported two upcoming poster presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. The AACR (Free AACR Whitepaper) Annual Meeting will be held virtually April 10-15 and May 17-21, 2021 (Press release, Istari Oncology, APR 6, 2021, View Source [SID1234577606]).

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The full text of the following abstracts will be posted to the AACR (Free AACR Whitepaper) Online Planner at 12:01 a.m. ET on Friday, April 9 at aacr.org and the associated presentations will be made on Saturday, April 10 at the times indicated below. E-posters will be available at on the AACR (Free AACR Whitepaper) website at that time and on istarioncology.com.

Title: LUMINOS-101: Phase 2 study of PVSRIPO with pembrolizumab in recurrent glioblastoma
Abstract #: CT240
Presenter: Andrea True Kelly, Ph.D.
Session Title/Category: PO.CT08.02 – Phase II Clinical Trials in Progress
Date/time: April 10, 2021, 8:30 a.m. – 11:59 p.m. EDT
ClinicalTrials.gov Identifier: NCT04479241

Title: LUMINOS-103: A basket trial evaluating the safety and efficacy of PVSRIPO in patients with advanced solid tumors
Abstract #: CT242
Presenter: Shannon R. Morris, M.D.
Session Title/Category: PO.CT08.02 – Phase II Clinical Trials in Progress
Date/time: April 10, 2021, 8:30 a.m. – 11:59 p.m. EDT
ClinicalTrials.gov Identifier: NCT04690699

For more information about Istari Oncology and their ongoing clinical trials and research in PVSRIPO, visit istarioncology.com.

About PVSRIPO
PVSRIPO is an investigational immunotherapy based on the live attenuated Sabin type 1 poliovirus vaccine that has been genetically modified for safety. PVSRIPO has a distinct target (the poliovirus receptor, CD155), which is expressed on virtually all solid tumors and antigen-presenting cells. Via CD155, PVSRIPO targets tumors with two primary mechanisms: 1) direct damage to and killing of cancerous cells; and 2) engaging innate and adaptive antitumor immune responses via nonlethal infection of antigen presenting cells in the tumor, which stimulates a specific signaling pathway resulting in a sustained, robust type-I/III interferon-dominant response, with minimal release of unwanted cytokines. Its effects are potentiated by prior vaccination against poliovirus. PVSRIPO has been granted Breakthrough Therapy Designation and Orphan Status by the FDA in recurrent glioblastoma. PVSRIPO has also been granted Orphan Status by the FDA for advanced melanoma.

On April 6, 2021 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, reported that the United States Patent and Trademark Office (USPTO) has issued two patents that will enhance its ability to develop blood-based immunotherapy and pipeline testing strategies (Press release, Biodesix, APR 6, 2021, View Source [SID1234577622]). These developments further improve Biodesix’s ability to offer rapid, accurate assessment of patients, which guide physician treatment strategies for their cancer patients.

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U.S. Patent 10,950,348, titled, "Predictive Test for Patient Benefit from Antibody Drug Blocking Ligand Activation of the T-Cell Programmed Cell Death 1 (PD-1) Checkpoint Protein and Classifier Development Methods," covers a test that classifies patients based on their responses, or failures to respond, to immunotherapies. This diagnostic methodology is designed to stratify patients with lung cancer based on their likelihood to respond to immunotherapies.

"Immunotherapy drugs have made tremendous headway in the treatment of many types of cancers, including lung cancer and melanoma," said Robert Georgantas, III, Ph.D., Senior Vice President of Research and Translational Science at Biodesix. "However, only a subset of patients benefits from these treatments. Predicting who will or will not respond to immunotherapy is imperative for better stratification of patients by immune response to foster treatment personalization and optimal outcome. Additionally, response prediction can help our biopharma research partners develop drug regimens to improve patient survival with these types of drugs."

U.S. Patent 10,870,891, "Diagnostic Test System for Specific, Sensitive and Reproducible Detection of Circulating Nucleic Acids in Whole Blood," covers a novel method for detecting fragmented ribonucleic acid (RNA) in whole blood samples. The method uniquely purifies and amplifies RNA once it is isolated and can ultimately be used in tests that identify or quantify tumor genes and mutations in a host of downstream applications.

"This method is especially valuable because it further improves the performance of our blood-based technologies," Gary Pestano, Ph.D., Chief Development Officer at Biodesix, said of the novel diagnostic test method. "The method is incorporated into multiple diagnostic tests, such as the GeneStrat test and other pipeline tests. Specifically, the patented methods have applicability across a number of technologies that purify, transcribe and amplify nucleic acids, including polymerase chain reaction (PCR) and next-generation sequencing (NGS), allowing Biodesix to gather important data in a robust and efficient way that can be used to support physicians and patients in making timely treatment decisions."

"Patents have historically driven the biotechnology industry forward, but conversely have become harder than ever to obtain. Our recent issuances, across diverse technology fields are good news in light of the increasingly fast pace of the diagnostics sector," said Scott Hutton, Chief Executive Officer at Biodesix.

"Patents have historically driven the biotechnology industry forward, but conversely have become harder than ever to obtain. Our recent issuances, across diverse technology fields are good news in light of the increasingly fast pace of the diagnostics sector," said Scott Hutton, Chief Executive Officer at Biodesix. "There is significant ongoing research activity at Biodesix, which will lead to future patent filings that will continue to strengthen and broaden our position in the market."

On April 6, 2021 Istari Oncology, Inc., a clinical-stage biotechnology company developing PVSRIPO, a novel viral immunotherapy that activates innate and adaptive immunity to facilitate a functional antitumor CD8+ T cell response, reported two upcoming poster presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (Press release, Istari Oncology, APR 6, 2021, View Source [SID1234577638]). The AACR (Free AACR Whitepaper) Annual Meeting will be held virtually April 10-15 and May 17-21, 2021.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The full text of the following abstracts will be posted to the AACR (Free AACR Whitepaper) Online Planner at 12:01 a.m. ET on Friday, April 9 at www.aacr.org and the associated presentations will be made on Saturday, April 10 at the times indicated below. E-posters will be available at on the AACR (Free AACR Whitepaper) website at that time and on View Source

Title: LUMINOS-101: Phase 2 study of PVSRIPO with pembrolizumab in recurrent glioblastoma
Abstract #: CT240
Presenter: Andrea True Kelly, Ph.D.
Session Title/Category: PO.CT08.02 – Phase II Clinical Trials in Progress
Date/time: April 10, 2021, 8:30 a.m. – 11:59 p.m. EDT
ClinicalTrials.gov Identifier: NCT04479241

Title: LUMINOS-103: A basket trial evaluating the safety and efficacy of PVSRIPO in patients with advanced solid tumors
Abstract #: CT242
Presenter: Shannon R. Morris, M.D.
Session Title/Category: PO.CT08.02 – Phase II Clinical Trials in Progress
Date/time: April 10, 2021, 8:30 a.m. – 11:59 p.m. EDT
ClinicalTrials.gov Identifier: NCT04690699

For more information about Istari Oncology and their ongoing clinical trials and research in PVSRIPO, visit www.istarioncology.com.

About PVSRIPO
PVSRIPO is an investigational immunotherapy based on the live attenuated Sabin type 1 poliovirus vaccine that has been genetically modified for safety. PVSRIPO has a distinct target (the poliovirus receptor, CD155), which is expressed on virtually all solid tumors and antigen-presenting cells. Via CD155, PVSRIPO targets tumors with two primary mechanisms: 1) direct damage to and killing of cancerous cells; and 2) engaging innate and adaptive antitumor immune responses via nonlethal infection of antigen presenting cells in the tumor, which stimulates a specific signaling pathway resulting in a sustained, robust type-I/III interferon-dominant response, with minimal release of unwanted cytokines. Its effects are potentiated by prior vaccination against poliovirus. PVSRIPO has been granted Breakthrough Therapy Designation and Orphan Status by the FDA in recurrent glioblastoma. PVSRIPO has also been granted Orphan Status by the FDA for advanced melanoma.

On April 7, 2021 PsiOxus Therapeutics, Ltd. (PsiOxus) reported an updated agreement to advance its clinical collaboration with Bristol Myers Squibb (NYSE: BMY) to evaluate the safety, tolerability, and preliminary efficacy of PsiOxus’ tumor re-engineering platform, in combination with Bristol Myers Squibb’s PD-1 immune checkpoint inhibitor Opdivo (nivolumab) to treat a range of tumor types in late-stage cancer patients (Press release, PsiOxus Therapeutics, APR 7, 2021, View Source [SID1234577657]).

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The first stage of this collaboration combined Bristol Myers Squibb’s Opdivo with PsiOxus’ enadenotucirev in the Phase 1 SPICE study to determine the safety and tolerability of combining these two agents, and to optimise the combination intravenous dosing regimen. The revised collaboration announced today will build upon the initial study data and will combine Opdivo with PsiOxus’ NG-641.

NG-641, is a tumor re-engineering product using PsiOxus’ proprietary Tumor-Specific Immuno-Gene Therapy (T-SIGn) platform based upon the enadenotucirev vector. NG-641 is a systemically administered product that encodes for the tumor selective delivery of an anti-FAP / anti-CD3 bispecific, interferon alpha, CXCL9 and CXCL10. Fibroblast Activating Protein (FAP) is selectively upregulated on the cancer associated fibroblasts (CAF) that play an important role in the immune suppressive tumor microenvironment found in many stromally dense tumors that are refractory to checkpoint inhibitors. Using a bispecific to drive T-cell mediated killing of CAF is designed to remove stroma and thereby reduce immune suppression within the tumor. A combination of NG-641 and a checkpoint inhibitor such as Opdivo may thus provide an optimal treatment strategy for certain stromally dense tumors.

"We are delighted to continue our collaboration with Bristol Myers Squibb and to investigate the clinical combination of NG-641 with Opdivo in several tumor types," stated John Beadle, M.D., Chief Executive Officer, PsiOxus. "We believe that NG-641 provides a unique combination of tumor modulatory elements that may synergise with the known efficacy of Opdivo to bring patient benefits for a wide range of tumor types."

Opdivo is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers. Opdivo is a registered trademark of Bristol Myers Squibb.

Under the terms of this agreement, PsiOxus will be responsible for conducting the Phase 1 study with patient recruitment expected to start in the third quarter of 2021.

On April 6, 2021 Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with cancer reported that an abstract for SBP-101, a proprietary polyamine analogue, reported that it has been accepted for poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which will be held virtually from June 4-8, 2021 (Press release, Panbela Therapeutics, APR 6, 2021, View Source [SID1234583756]).

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Details of the presentation are as follows:
Poster Presentation

Title: SBP-101, a polyamine metabolic inhibitor, administered in combination with gemcitabine and nab-paclitaxel, shows signals of efficacy as first-line treatment for subjects with metastatic pancreatic ductal adenocarcinoma.

Session Name: Poster Session: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
Additional meeting information can be found on the ASCO (Free ASCO Whitepaper) website at View Source After presenting at ASCO (Free ASCO Whitepaper), the poster will be available on the Company’s website.

About SBP-101

SBP-101 is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for pancreatic ductal adenocarcinoma and other tumors. The molecule has shown signals of tumor growth inhibition in clinical studies of US and Australian metastatic pancreatic cancer patients, suggesting potential complementary activity with an existing FDA-approved standard chemotherapy regimen. In data evaluated from clinical studies to date, SBP-101 has not shown exacerbation of bone marrow suppression and peripheral neuropathy, which can be chemotherapy-related adverse events. Recently observed serious visual adverse evets are being evaluated and the FDA has issued a partial clinical hold for the impacted study, pending Panbela’s evaluation and response. The safety data and PMI profile observed in the current Panbela sponsored current clinical trial generally provides potential support for continued evaluation of the compound in a randomized clinical trial, subject to Panbela’s submission of a complete response and the FDA’s removal of the partial clinical hold. For more information, please visit View Source .