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/.

On October 27, 2021 Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, reported that the first patient has been dosed in its open-label dose-escalation Phase 1b clinical trial evaluating camsirubicin for the treatment of advanced soft tissue sarcoma (ASTS) (Press release, Monopar Therapeutics, OCT 27, 2021, View Source [SID1234592049]).

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"We are very pleased to have dosed our first patient so quickly after trial initiation and so soon following our FDA allowance to proceed in early August. The strong interest and support we are seeing within the oncology community for this study adds to our hopeful excitement and anticipation of the potential impact that escalating doses of camsirubicin may have on improving patient outcomes," said Chandler Robinson, MD, Monopar’s Chief Executive Officer.

"We are excited to participate in this clinical trial that addresses a high unmet medical need in a cancer which carries a tragic 12 to 15-month life expectancy. There have been no advances in first-line therapies for decades in this patient population, and today’s first camsirubicin treatment in this trial marks an encouraging milestone for the thousands of ASTS patients who may potentially benefit from this drug," said Dr. Sant Chawla, Principal Investigator, Sarcoma Oncology Research Center in Santa Monica, CA.

An estimated 21 patients will be enrolled in the Phase 1b clinical trial, which is active and recruiting in the US. Further information about the camsirubicin trial is available at www.ClinicalTrials.gov under study identifier NCT 05043649.

About Camsirubicin

Camsirubicin is a novel proprietary analog of the widely used cancer drug doxorubicin. It has been investigated previously in ASTS patients in a Phase 1 and a single arm Phase 2 clinical trial. In these studies, no patients developed the irreversible cardiotoxicity common to doxorubicin at higher cumulative doses. The most frequent adverse event observed in the Phase 1 study was neutropenia, which was mitigated in the Phase 2 study through the use of prophylactic G-CSF. Based on encouraging clinical results to date, the current Phase 1b trial is designed to test camsirubicin at even higher doses than previously administered while using concomitant prophylactic G-CSF to prevent neutropenia.

About Soft Tissue Sarcoma

Soft tissue sarcomas (STS) are a diverse type of cancer that typically develop in the connective tissue of the body. According to the American Cancer Society, in 2021, an estimated 13,460 new STS cases will be diagnosed in the US alone, and about 5,350 people will not survive their disease. These tend to be the advanced cases – those with sarcomas that are unresectable and/or have metastasized. The average life expectancy from time of diagnosis for those patients with advanced disease (ASTS) is about 12 to 15 months. Doxorubicin is the current standard of care in the 1st-line setting for ASTS, and has been for decades, as there have been no 1st-line therapeutic advancements that have improved overall survival for this patient population.

On October 27, 2021 Rheos Medicines, a biopharmaceutical company bringing molecular targeting and precision treatment to autoimmune and inflammatory disease, reported a research collaboration with the French non-profit research organization CRYOSTEM (Press release, Rheos Medicines, OCT 27, 2021, View Source [SID1234592068]). The goal of the research collaboration is to provide biological resources from HSCT (Hematopoietic Stem Cell Transplantation) patients in order to evaluate MALT1-targeted therapeutics, including Rheos’s lead product candidate, RHX-317, for Graft-versus-Host Disease (GvHD), based on functional immunologic profiling of patients and identification of molecular signatures for MALT1 activity. This collaboration supports a precision medicine approach to enable the treatment of GvHD, by defining the predominant metabolic pathways in the anabolic hub that drive key pathogenic pathways in GvHD patient subsets.

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"CRYOSTEM chose to establish this collaborative research program with Rheos because it aligns with our mission to promote our collection of biological resources to help scientists accelerate innovation and extract new knowledge to allow better prevention, diagnosis and treatment of GvHD as one of the HSCT major complications that is a barrier to effective stem cell transplants for patients," said Professor Régis PEFFAULT de LATOUR, co-founder and scientific coordinator of CRYOSTEM.

The research program brings together the collaborators’ two domains of expertise to address the challenge of treating GvHD, a major cause of post-transplant morbidity and mortality in patients who undergo allogeneic HSCT. With its proprietary technology platform, Rheos brings insights from studies showing that MALT1 activity underpins the activation of multiple cell types and signaling pathways within a metabolic hub that is dysregulated in GvHD, as well as approaches to predict and stratify patient response to treatment. CRYOSTEM operates through a national biobanking network bringing together transplant units and Biological Resources Centers to accelerate research in the area of complications of HSCT, housing the first and unique collection in Europe dedicated to HSCT complications. This collection of approximately 200,000 biological samples, taken from patients before and after transplant, support research projects that meet rigorous selection criteria by a world-renowned scientific committee.

"This research collaboration with the world-class experts at CRYOSTEM will enable us to significantly build on our existing work in immune cells from healthy donors, and now study GvHD patient samples to evaluate the effect of inhibiting a key drug target on the activation state of multiple immune cells and the specific pathways that are dysregulated in GvHD," said Dania Rabah, Ph.D., Chief Scientific Officer of Rheos Medicines. "We believe the data generated under this collaboration can validate our precision medicine approach to identify novel patient subsets in autoimmune and inflammatory diseases, while also informing the clinical development plan for RHX-317, our novel MALT1 inhibitor drug candidate to treat GvHD."

Under the terms of the research collaboration, CRYOSTEM will provide Rheos with biological resources for post-transplant patients in three categories: those who developed acute GvHD, those who developed chronic GVHD, and those who did not develop GvHD. Rheos will evaluate therapeutic targets for GvHD through these study methods:

Measure the effectiveness of MALT1 inhibition against disease-relevant functions of immune cells, comparing results across the three different categories of patient samples to determine sensitivity of MALT1 inhibitor drug response and target validation in chronic GvHD.
Perform multi-omic analyses of patient samples to define signatures reflecting MALT1 therapeutic activity.
Upon successful completion of these initial studies, both parties may agree to expand the research to include larger GvHD patient cohorts and additional evaluation of patient subsets to predict therapeutic response for a potential precision medicine approach to GvHD.

"As with many diseases that have an aberrant immune response, today’s treatments for GvHD involve broad immunosuppression, and we lack molecularly-targeted medicines that target disease pathways," said Robert Zeiser, M.D., Head of Tumor Immunology and Immune Modulation and professor at the University of Freiburg Medical Center in Germany. "Rheos’s therapeutic approach to target MALT1 for the treatment of GvHD is built on compelling findings that MALT1 activates cellular activity and signaling pathways that are dysregulated in GvHD. I look forward to continued progress with this MALT1 inhibitor that offers a promising new approach for patients with GvHD."

About MALT1

MALT1 (mucosa-associated lymphoid tissue lymphoma translocation protein 1) is a dual-function scaffolding molecule and paracaspase that is expressed preferentially in immune cells. In addition to its role in NF-κB mediated lymphocyte activation and proliferation, Rheos has shown that MALT1 activity is central to the anabolic shift that fuels pathogenic functions of immune cells. Inhibiting MALT1 attenuates the activity of multiple immune cell types simultaneously to dampen the inflammatory response in the activated immune system. Because of its role in cellular metabolism, the effects of MALT1 inhibition can be monitored by metabolite signatures, opening an opportunity to monitor disease and evaluate activity of therapeutics in patients and patient subsets.

On October 27, 2021 CohBar, Inc. (NASDAQ: CWBR) (the "Company"), a clinical stage biotechnology company developing mitochondria based therapeutics to treat chronic diseases and extend healthy lifespan, reported a proposed underwritten public offering of shares of the Company’s common stock and accompanying warrants to purchase common stock (Press release, CohBar, OCT 27, 2021, View Source [SID1234592122]). Each warrant will be exercisable for 5 years from the closing date of the offering. All of the securities to be sold in the offering are being offered by the Company. 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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Cantor Fitzgerald & Co. is acting as sole book-running manager for the offering, and Brookline Capital Markets, a division of Arcadia Securities, LLC, is acting as co-manager.

CohBar intends to use the net proceeds from the offering, together with its existing cash resources, for general corporate purposes, which may include funding preclinical and clinical development of its peptides, increasing working capital, operating expenses and capital expenditures.

The securities will be issued pursuant to an effective shelf registration statement filed with the Securities and Exchange Commission (SEC) on August 24, 2020. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. When available, copies of the prospectus supplement, together with the accompanying prospectus, can be obtained at the SEC’s website at www.sec.gov or from Cantor Fitzgerald & Co., Attn: Capital Markets, 499 Park Ave., 4th Floor, New York, New York 10022, or by e-mail at [email protected].

This press release does not and shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of these securities in any state or other 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 other jurisdiction. Any offer, if at all, will be made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement.

Eli Lilly has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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