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.

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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 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 PCI Biotech (OSE: PCIB), a clinical-stage biopharma company developing innovative therapeutics that address significant unmet medical needs in cancer reported that it will present at the European Biotech Investor Days 2021, a US based online event taking place April 7-8, 2021 and hosted by Goodwin, Solebury Trout, Deutsche Bank and Nasdaq (Press release, PCI Biotech, APR 6, 2021, View Source [SID1234585154]).

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On Thursday, April 8, 2021 at 15:00 (CEST), Dr. Per Walday, CEO, will present an overview of PCI Biotech’s proprietary platform technology via a general company presentation.

The presentation can be accessed live through this link View Source

The presentation slides will be made available on PCI Biotech’s website (www.pcibiotech.com) under "Other presentations" after the event.

On April 6, 2021 Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, and Catalent, Inc. (NYSE: CTLT), the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, reported the expansion of their strategic collaboration to dedicate a new high-speed vial filling line for the manufacture of the Moderna COVID-19 Vaccine and potentially other investigational programs in Moderna’s pipeline, at Catalent’s biologics facility in Bloomington, Indiana (Press release, Moderna Therapeutics, APR 6, 2021, View Source [SID1234577639]).

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In June 2020, Catalent and Moderna announced that Catalent would provide aseptic vial filling and packaging from its Bloomington site, including additional staffing required for 24×7 manufacturing to support production of an initial 100 million doses of Moderna’s vaccine. On March 29, Moderna announced that this significant milestone was achieved.

As part of this expanded agreement, Catalent will now dedicate to Moderna’s use a new high-speed filling line at the site through June 2023, which can be used to manufacture the COVID-19 vaccine and potentially additional investigational programs in Moderna’s large clinical pipeline. Catalent will also provide inspection, labeling, cartoning, and final packaging for these programs.

"We appreciate this expanded collaboration with Catalent and the dedication of their team," said Juan Andres, Moderna’s Chief Technical Operations and Quality Officer. "This additional fill-finish capacity will be important for not only our COVID-19 vaccine, but also potentially for other programs in our clinical development pipeline."

"Catalent’s partnership with Moderna began in 2016, when we had only glimpsed the potential applications of mRNA and could not have guessed how pivotal mRNA would become in the fight against COVID-19," commented Alessandro Maselli, Catalent’s President and Chief Operating Officer. "We are proud to announce this extension of our companies’ strategic collaboration, and we look forward to further demonstrating our commercial manufacturing expertise as we help supply more vaccine doses."

Catalent announced in September 2020 its $50 million investment into this third high-speed vial filling line at Bloomington. Due to the company’s considerable experience in facility and capacity expansion, it was able to accelerate the overall project from a typical 18-month timeframe to approximately 10 months, including construction, procurement, installation, and CGMP qualification of the line, which will be completed in April 2021. Furthermore, the ability to dedicate this new line to Moderna will enable the site to free-up capacity on existing lines for other important customer programs.

On April 6, 2021 Bridge Biotherapeutics Inc.(288330 KQ), a clinical-stage biotech company headquartered in Seongnam, Republic of Korea, reported that the company has initiated the Phase 1/2 clinical trial assessing safety, tolerability, and anti-tumor activity of BBT-176 in non-small cell lung cancer (NSCLC) patients who acquired osimertinib-resistant EGFR triple mutations (Press release, Bridge Biotherapeutics, APR 6, 2021, View Source [SID1234577641]).

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BBT-176, a novel epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) is designed to inhibit the signaling pathway of EGFR with C797S mutations, which arises due to osimertinib (Tagrisso)-resistant mutations in NSCLC. The mutation results in a cysteine to serine change on amino acid 797 within the kinase domain sequence of the EGFR. From the pre-clinical studies, BBT-176 exhibited anti-tumor efficacy in mouse xenograft models and anti-brain metastases in patient-derived orthotopic xenograft models.

The Phase 1/2 study, an open-label study to assess the safety, tolerability, pharmacokinetics, and anti-tumor activity of BBT-176 in patients with NSCLC who progressed following prior therapy with an EGFR TKI agent (NCT identifier: NCT04820023), is expected to enroll approximately 90 participants separated into two parts: a dose escalation phase (Part 1) and a dose expansion phase (Part 2). In the first part of the study, which has been initiated in the Republic of Korea, the RP2D (Recommended Phase 2 Dose) will be identified based on the evaluation of drug safety and tolerability in the treatment group. In the subsequent part of the study, which will be conducted both in the U.S. and Korea this year, primary and secondary outcome measures will include assessments of overall anti-tumor activity with objective response rate (ORR), duration of response (DoR), and progression-free survival (PFS), based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. In addition, detailed mutation profiles collected through liquid and tumor biopsy procedures will be analyzed after the study.

"We are highly encouraged to be able to initiate the first-in-patient study of BBT-176, which is expected to address high unmet medical needs of advanced NSCLC patients with C797S mutations across the globe," and "our Business Development team will be exploring strategic partnership opportunities as the clinical study progresses," said James Lee, CEO of Bridge Biotherapeutics.

Additional information about the clinical trial may be found at ClinicalTrials.gov, using identifier NCT: 04820023.

Lung cancer is the leading cause of cancer death, accounting for about one-fifth of all cancer deaths. Lung cancer is classified into two main groups: non-small cell lung cancers (NSCLC) and small cell lung cancers (SCLC), where NSCLC accounts for approximately 85% of all lung cancer diagnoses. In 2019, there were a combined 0.79 million diagnosed cases of NSCLC in men and women, aged 18 years and older, across the US, France, Germany, Italy, Spain, the UK, Japan, and urban China. The incidence of NSCLC is expected to increase at an annual growth rate (AGR) of 3.01% from 2019 to 2029, reaching 1.03 million cases in 2029[1].