On October 27, 2021 INOVIO (NASDAQ: INO) reported that third quarter 2021 financial results will be released after the market close on November 9, 2021 (Press release, Inovio, OCT 27, 2021, View Source [SID1234592048]). Following the release, INOVIO will host a live conference call and webcast at 4:30 p.m. ET to discuss financial results and provide a general business update regarding its DNA Medicines Platform, including the company’s global Phase 3 efficacy trial (INNOVATE) involving its COVID-19 vaccine candidate, INO-4800.

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A live and archived version of the audio presentation will be available online at View Source This is a listen-only event but will include a live Q&A with analysts.

On October 27, 2021 Together with Imperial College London (‘Imperial’), DNAe reported that it has been awarded a UK Knowledge Transfer Partnership (KTP) by Innovate UK to support development of its next generation sequencing (NGS)-based diagnostic platform for use in cancer monitoring (Press release, Imperial College London, OCT 27, 2021, View Source [SID1234592067]).

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The KTP program connects innovative businesses with academic experts who can help them deliver their ideas. This award formalizes a collaboration between DNAe and Professor Charles Coombes, Professor of Medical Oncology at Imperial. The work of the KTP will build on the existing research partnership between Professor Coombes and Professor Jacqui Shaw, Head of the Department of Genetics and Genome Biology and Professor of Translational Cancer Genetics at the University of Leicester.

The aim of the program is to develop a ‘liquid biopsy’ test based on DNAe’s proprietary "sample to answer" NGS technology, to directly detect and identify biomarkers and mutation hotspots that have been identified in Professors Coombes’ and Shaw’s research. This will enable these markers to be used to monitor treatment and detect early recurrence of breast cancer. Under the terms of the partnership, a post graduate researcher (the KTP Associate) will be based at DNAe to integrate expertise from the academic partners into the development of the test.

Samuel Reed, CEO of DNAe, said: "Recognizing that October is Breast Cancer Awareness Month, we’re delighted to formally announce our collaboration with world experts Professors Coombes and Shaw who bring their extensive knowledge of using circulating tumor DNA to manage the treatment of breast cancers. Through this KTP award, we will be able to harness that deep expertise and combine it with our proven diagnostic technology. Together, we aim to develop a liquid biopsy platform that can deliver accurate and timely results for clinicians and their patients, providing the opportunity for early intervention and much-needed peace of mind."

DNAe’s integrated, sequencing-based technology will bring genomic analysis to the point-of-need, enabling testing to move out of specialist laboratories and closer to the patient. By detecting and sequencing tumor DNA directly from raw blood samples in a matter of hours, DNAe’s platform has the potential to expose unresponsive or recurrent cancer earlier. This approach will enable clinicians to make timely treatment decisions rather than waiting days or weeks for sequencing results.

Professor Charles Coombes, Professor of Medical Oncology, Imperial, and Honorary Consultant Medical Oncologist, Imperial College Healthcare Trust, said: "Cancer monitoring is a vital component of successful treatment. Firstly, we need to ensure a patient’s tumor is responding to the therapy, and secondly, patients in remission must be monitored for signs of recurrence. The current monitoring options are slow, and any delays to appropriate cancer care can lower the chance of survival and increase treatment-associated problems and costs. Although we are at the early stages, I believe that DNAe’s integrated, sequencing-based platform could ultimately provide rapid, actionable information that saves patients’ lives."

Professor Jacqui Shaw, Head of the Department of genetics and genome Biology, University of Leicester, added: "This is an exciting collaboration with DNAe and Imperial, where we will combine our expertise to develop a rapid integrated liquid biopsy platform for management of patients with breast cancer."

On October 27, 2021 Brickell Biotech, Inc. (Nasdaq: BBI) ("Brickell"), a clinical-stage pharmaceutical company striving to transform patient lives by developing innovative and differentiated prescription therapeutics for the treatment of dermatologic, autoimmune and other debilitating diseases, reported that it has commenced a proposed underwritten public offering of shares of its common stock (Press release, Vical, OCT 27, 2021, View Source [SID1234594012]). In connection with this offering, Brickell expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock at the public offering price, less the underwriting discount. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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Brickell intends to use the net proceeds of this offering for research and development, including clinical trials, working capital, business development and general corporate purposes.
William Blair & Company, L.L.C. and Oppenheimer & Co. Inc. are acting as joint book-running managers for the offering.

The securities are being offered pursuant to a "shelf" registration statement on Form S-3 (File No. 333-254037) filed with the Securities and Exchange Commission ("SEC") and declared effective on March 17, 2021. The offering is being made solely by means of a prospectus. A preliminary prospectus supplement and the accompanying prospectus relating to the offering have been filed with the SEC and are available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and accompanying prospectus, and the final prospectus supplement and accompanying prospectus, when available, may also be obtained from William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, IL 60606, or by calling (800) 621-0687, or emailing [email protected], or from Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad St., 26th Floor, New York, NY 10004, or by calling (212) 667-8055, or emailing [email protected].
This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any offer or sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Any offer, if at all, will be made only by means of the prospectus supplement and accompanying prospectus, which are a part of the effective registration statement.

On October 27, 2021 Race Oncology Limited ("Race") reported it has entered into a research collaboration with Dr Dan Dominissini of the Chaim Sheba Medical Center, Israel to analyse clinical patient samples from the ongoing Zantrene Phase 1b/2 trial in relapsed/refractory Acute Myeloid Leukaemia (R/R AML) for FTO and FTO-related biomarkers (ASX Announcement: 9 August 2021) (Press release, Race Oncology, OCT 27, 2021, View Source [SID1234592003]).

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The biomarker testing will include FTO gene sequencing, FTO protein levels (intracellular staining and flow cytometry), FTO mRNA levels, and analysis of the m6A/A ratio in mRNA from patient tumour samples before, during and after treatment with Zantrene.

Dr Dominissini is a world-renowned expert in RNA methylation and m6A RNA methylation and has authored more than 32 publications in high impact peer-reviewed journals including Nature, Science and Cell.

This research collaboration has strategic importance for Race as the data will advance Race’s ‘Three Pillar’ strategy announced at the 2020 AGM (ASX Announcement: 30 November 2020).

"We are delighted to be extending our successful collaboration with the team at Chaim Sheba to generate important data on the effects of Zantrene on FTO and related molecules. These data will give us the first insights into the effect of Zantrene in patients on FTO and m6A RNA methylation and continues to advance our Three Pillar Strategy."

Race CSO Dr Daniel Tillett
"Conceptual and technological breakthroughs since 2011, by our group and others, have introduced the novel notion that internal chemical modifications of mRNA and long non-coding RNA are abundant, dynamic and sometimes reversible events, which constitute essential regulatory elements in RNA metabolism. Dedicated cellular machineries that install (‘writers’), remove (‘erasers’) and recognize (‘readers’) the various RNA modifications have been discovered, revealing essential roles for mRNA and lncRNA modification in various cellular, developmental and disease processes, and providing avenues for therapeutic intervention. N6-methyladenosine (m6A) is the most prevalent internal mRNA modification, removed by the enzyme FTO, with established key roles in carcinogenesis. We are excited to see these basic discoveries translated into the clinic by the Zantrene study of Race Oncology for relapsed or refractory AML. We hope that our scientific collaboration will advance the understanding of the correlation between FTO and m6A status in AML and response to treatment."

Dr Dominissini from Chaim Sheba
Relapsed or Refractory Acute Myeloid Leukemia
Primary refractory or relapsed acute myeloid leukemia is associated with poor prognosis and remains a major therapeutic challenge. Primary refractory AML is defined by the absence of complete remission (CR), manifested by blast count of ≥5% in bone marrow after one or two cycles of intense induction chemotherapy.

Up to 30% of adults with newly diagnosed AML fail to achieve CR after two courses of intensive chemotherapy.

Even when CR is achieved through intense chemotherapy, approximately half of the younger and 80% of the older patient’s relapse. In both clinical situations, refractory and/or relapsed AML, active disease remains a major therapeutic challenge despite recent advances.

Study Design
Samples will be taken from patients participating in the existing study, "An open-label, Phase 1b/2 study of intravenous FluCloZan (fludarabine, clofarabine, Zantrene (bisantrene dihydrochloride)" in cohorts of adult patients with R/R AML using a Simon’s 2-stage design: a Phase 1b lead-in dose escalation stage to establish the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of FluCloZan and a Phase 2 expansion stage to determine efficacy and confirm safety of the FluCloXan regimen at the RP2D in up to 17 subjects.

On October 27, 2021 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, reported data at the American Society for Radiation Oncology (ASTRO) 2021 Annual Meeting indicating Rhenium-186 NanoLiposome (186RNL) delivered to patients with recurrent glioblastoma (GBM) through convection enhanced delivery results in predictable distribution and stable retention to the targeted tissues, providing days of sustained, localized radiation treatment to the tumor (Press release, Cytori Therapeutics, OCT 27, 2021, View Source [SID1234592024]).

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Data from the ePoster titled "Image-guided Rhenium-186 NanoLiposome (186RNL) brachytherapy in the treatment of recurrent glioblastoma: technique, image analysis, dosimetry, and monitoring" demonstrated the following:

Mean locoregional retention in the brain volume at the end of infusion (85.9% ± 17.1% ID, n=18) and at eight days post-infusion (46.6% ± 16.7% ID, n=17).
Following dose escalation, the mean radiation absorbed dose in the two most recent cohorts to the tumor volume was 354.7 ± 144.0 Gy, to the whole brain was 1.32 ± 1.06 Gy, and to the whole body was 0.16 ± 0.04 Gy (n=6), establishing evidence of a high radiation absorbed dose to the tumor with minimal brain and whole body radiation exposure.
"We’re very encouraged by this latest data supporting investigational 186RNL for the treatment of recurrent glioblastoma, specifically underscoring its potential to effectively treat difficult to reach brain tumors, without harming surrounding tissue," said John Floyd, M.D., University of Texas Health Science Center San Antonio, study investigator, and presenter of the ePoster. "Coupled with state-of-the-art imaging technology tools, treatment with 186RNL has shown to be highly precise, which may give reassurance to patients living with recurrent glioblastoma and advance understanding of convection therapy and targeted radiation for healthcare providers treating this unforgiving disease."

In addition, the analysis shows image monitoring can provide a predictive tool to evaluate therapy delivery and treatment effectiveness. In this study, up to four catheters showed to have effectively enhanced locoregional drug distribution and tumor volume coverage, supporting that the 3D dose distribution calculation leads to convenient dose and therapy evaluation, and application of additional therapy for better tumor control.

"This presentation documents the potential safety and utility of locoregional radiotherapeutic delivery to the brain or any organ or tissue in the body," said Marc Hedrick, M.D., President and Chief Executive Officer of Plus Therapeutics. "We are committed to further investigating the potential of 186RNL in hopes of offering a novel treatment to patients in need of minimally invasive and convenient therapeutic options for recurrent GBM and other difficult to treat cancers. This new data builds on existing evidence and reinforces the clinical promise of providing precise, targeted radiotherapeutics for cancer."

186RNL is under investigation as a potentially safe, effective and convenient way to deliver a very high dose of radiation, possibly over 20 times greater than traditional external beam radiation therapy. This trial is supported by the U.S. National Institutes of Health/National Cancer Institute at three trial sites in the U.S., including UT Health Science Center San Antonio, UT Southwestern Medical Center Dallas and UT MD Anderson Cancer Center Houston.

The U.S. Food and Drug Administration has granted both Orphan Drug designation and Fast Track designation to 186RNL for the treatment of patients with GBM. Additional details about the ReSPECT trial are available at clinicaltrials.gov (NCT01906385).

A copy of the poster will be available under the Presentations tab of the Investors section of the Company’s website at ir.plustherapeutics.com/.