Selecta Biosciences to Participate at the Raymond James Human Health Innovation Conference

On June 16, 2021 Selecta Biosciences a biotechnology company leveraging its clinically validated ImmTOR platform to develop tolerogenic therapies that selectively mitigate unwanted immune responses, reported that Selecta’s Chief Executive Officer, Carsten Brunn, Ph.D., will provide a corporate update and participate in one-on-one investor meetings at the Raymond James Human Health Innovation Conference to be held virtually, June 21-23, 2021 (Press release, Selecta Biosciences, JUN 16, 2021, View Source [SID1234584062]).

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The presentation on Wednesday, June 23 at 12:00 p.m. ET will be available through the Raymond James conference portal and an archived webcast will also be accessible in the Investors & Media section of the company’s website at www.selectabio.com.

Plus Therapeutics Announces DSMB Approval to Proceed into Eighth Cohort in ReSPECT™ Glioblastoma Trial

On June 16, 2021 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing novel, targeted therapies for rare and difficult to treat cancers, reported that the Data and Safety Monitoring Board recommended the Company proceed to the eighth cohort of the Phase 1 dose escalation ReSPECT trial, which is evaluating the Company’s lead investigational drug, Rhenium NanoLiposome (RNL), in patients with recurrent glioblastoma (GBM)(Press release, Cytori Therapeutics, JUN 16, 2021, View Source [SID1234584066]).

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"We are pleased with the favorable safety profile observed thus far with RNL in recurrent GBM," said Marc Hedrick, M.D., President and Chief Executive Officer of Plus Therapeutics. "Moving to cohort eight will allow us to continue to push the envelope in terms of addressable tumor size and maximum radiation dose delivered."

Twenty-one patients with recurrent GBM have been treated in the ReSPECT trial across seven cohorts to date. In these patients, RNL has had no dose-limiting toxicities observed with absorbed radiation doses of up to 740 Gray per tumor.

The eighth cohort of the ReSPECT trial will implement a 40% increase in total radioactivity. The planned infused dose will be 31.2 millicuries in a volume of 12.3 milliliters (increased from 22.3 millicuries and 8.8 milliliters, respectively, used in cohort seven). The planned maximum flow rate will not change.

RNL 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 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 RNL for the treatment of patients with GBM. Additional details about the ReSPECT trial are available at clinicaltrials.gov (NCT01906385).

The latest corporate information can be found on the Company’s Investor Relations page at ir.plustherapeutics.com/presentations.

PierianDx and Intermountain Healthcare Combine Expertise to Advance Myriad Genetics’ Tumor Test Offering

On June 16, 2021 — PierianDx, the global leader in clinical genomics knowledge, reported that it will work with existing partner, Intermountain Healthcare, to support Myriad Genetics’ comprehensive germline and somatic tumor testing service (Press release, PierianDx, JUN 16, 2021, View Source [SID1234584061]). The PierianDx support will enable Myriad to expand access to the highest quality somatic testing for patients in the U.S. and around the world. Somatic tumor tests performed using Intermountain Healthcare’s TheraMap test will be analyzed and interpreted using the PierianDx Clinical Genomic Workspace and then combined with Myriad’s existing germline and companion diagnostic tests, providing a holistic and integrated view for all oncologists.

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As our knowledge of cancer and the number of therapeutic options grows, oncologists are increasingly seeking both germline and somatic inputs to inform patient treatment. The new service from Myriad Genetics will provide oncologists with a single, easy-to-read report that combines the Myriad myRisk Hereditary Cancer test, which assesses germline alterations in 35 genes associated with increased risk for eight common cancers; its myChoice CDx, a tissue-based companion diagnostic test that assesses a patient’s HRD (homologous recombination repair deficiency) status and predicts the ability to respond to certain PARP (poly adenosine diphosphate-ribose polymerase) inhibitors; and Intermountain’s TheraMap test, which interrogates 523 genes with known relevance to cancer.

As a long-standing partner of PierianDx, Intermountain Healthcare already uses PierianDx Clinical Genomics Workspace to analyze results from the TheraMap test. The platform enables them to rapidly and accurately classify and interpret variants and produce a physician-ready report. Now, Clinical Genomics Workspace will enable Intermountain Healthcare to accommodate test volumes generated through Myriad’s global reach.

"We are pleased to enhance our partnership with PierianDx to provide comprehensive genomic test results to Myriad’s cancer testing service, thereby helping to improve outcomes for patients," says Lincoln Nadauld, Vice President and Chief of Precision Medicine and Genomics at Intermountain Healthcare.

"To advance precision oncology, we must collaborate across the healthcare ecosystem, combining capabilities from leading partners to increase access to genetic testing and provide better outcomes for all patients," states Paul J. Diaz, President and CEO, Myriad Genetics. "Our collaboration with Intermountain Healthcare, and the resulting use of Clinical Genomics Workspace, will enable us to provide a complete genetic picture to oncologists."

"We are thrilled to deepen our relationship with Intermountain Healthcare to provide comprehensive genomic test results as part of Myriad’s expanding cancer testing service," states Mark McDonough, PierianDx CEO. "Our contribution to Myriad’s enhanced testing service aligns with our mission to help catalyze the democratization of clinical genomics by partnering with leading-edge healthcare organizations like Intermountain Healthcare and Myriad to optimally serve patients and physicians."

OncoArendi executes the strategy for 2021-2025 in the area of R&D platform for developing small molecules modulating RNA function

On June 16 2021, The agreement signed between OncoArendi and IIMCB launches a new, strategic area of research cooperation (Press release, OncoArendi Therapeutics, JUN 16, 2021, View Source;utm_medium=rss&utm_campaign=oncoarendi-executes-the-strategy-for-2021-2025-in-the-area-of-rd-platform-for-developing-small-molecules-modulating-rna-function [SID1234584060]). It focuses on the development of the SMR Platform, i.e. the platform of small molecules targeting RNA. Discovery and development of small molecule drugs modulating RNA function with the use of innovative bioinformatic tools is one of the three key R&D areas of the Company’s strategy for growth in 2021-2025.

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This cooperative research will include enhancement and optimization of the Bioinformatics Platform and the embedded computer programs, which will be used to discover new small molecules. Under this agreement OncoArendi will finance research at IIMCB in the net amount of 2.5 million PLN. The agreement also stipulates that OncoArendi will spend at least 2 million PLN covering its internal R&D expenses.

– The mRNA technology has the potential to become a breakthrough therapeutic approach in the treatment of previously incurable diseases. It will open access to new biological targets hidden in the sequence of human RNA, which were previously inaccessible to conventional medicines – we are talking about thousands of new possible interactions for drugs of the future, which we plan to develop. Moreover, by interfering with the RNA function, we can obtain a therapeutic effect at an early stage of the disease, before the synthesis of pathogenic proteins occurs. Therefore, we will strike directly at the source of the disease, before its irreversible consequences occur – says Rafał Kamiński, Member of the Board, Scientific Director (CSO) of OncoArendi Therapeutics S.A.

At the same time, OncoArendi and IIMCB entered into exclusive negotiations to in-license the Bioinformatics Platform, which will enhance and accelerate the process of screening for and designing new drugs in the Company’s SMR Platform. A six-month period of exclusivity has been agreed by the parties until the signing the License Execution Agreement.

During this period of exclusive negotiations, due diligence will be conducted on the scope of the licensed IP and know-how and the functionality of the Bioinformatics Platform will be validated for in silico predictions of the binding of small molecules to RNA fragments. IIMCB will receive from OncoArendi a one-off, non-refundable exclusivity fee in the net amount of 100.000 PLN.

The solutions and software subject to licensing were developed by the Laboratory of Bioinformatics and Protein Engineering (LBIB), headed by prof. Janusz Bujnicki at IIMCB. LBIB will also be responsible for the execution of the research tasks assigned to IIMCB under the cooperation agreement. Prof. Janusz Bujnicki is one of the pioneers and leaders of bioinformatics in Poland and an outstanding scientist exploring the structure of RNA and its interactions with other molecules. The scientific group of prof. Bujnicki has created globally unique algorithms and bioinformatics software, which are an important element in the discovery of new drugs targeting RNA. The innovativeness of the Bioinformatics Platform and the extensive RNA structure and function knowledge of prof. Bujnicki’s team offer a technological competitive advantage over other international companies developing small molecule drugs modulating RNA function.

– A key element of our cooperation with OncoArendi is to apply computer methods developed by my team to study the interaction of small chemical molecules with RNA. We have a unique software and appropriate know-how to find the right molecules that bind to the desired targets in RNA and to study the influence of this binding on the RNA structure. Together with OncoArendi, we aim to identify molecules binding to RNA and exerting an appropriate functional effect – says prof. Janusz Bujnicki, head of the Laboratory of Bioinformatics and Protein Engineering at the International Institute of Molecular and Cell Biology in Warsaw.

– Collaboration in the area of the SMR Platform gives us a unique opportunity to discover and develop breakthrough therapies of the future, which, by interacting directly with RNA structures, can be used to cure numerous diseases. This is a new hot trend in the biopharmaceutical industry, with many companies seeing an opportunity for breakthrough in the pharmacological treatment of millions of patients with uncurable diseases. By expanding our collaboration in this area, we capitalize on the synergy between the unique knowledge and groundbreaking results of the Institute’s basic research, the know-how of the bioinformatics laboratory of Prof. Bujnicki and our years of experience and proven commercial success in the development of small molecules that interact with new biological targets. The International Institute of Molecular and Cell Biology in Warsaw is one of the leaders, not only in Poland but also worldwide, when it comes to research and publications on RNA biology. Our collaboration will be very significant in the long-term development of OncoArendi and we are convinced that it will contribute to the discovery and development of innovative drugs that interact with RNA – says Marcin Szumowski, President of the Management Board and Chief Executive Officer of OncoArendi Therapeutics S.A.

– The mission of IIMCB is to conduct basic research aimed at understanding the basis of human diseases at the molecular and cellular level. This knowledge can be applied to create innovative therapeutic and diagnostic methods. Studies of structure and functions of various types of RNA are the main area of activity of several research groups at the Institute, and our scientists are among world leaders in this field. To ensure that the results of our research are translated into clinical applications, IIMCB’s long-term priority is to cooperate with the pharmaceutical and biotechnology industry to strengthen the potential of Polish companies by sharing resources and expertise. Thus, the current cooperation with OncoArendi is in line with the IIMCB mission and development strategy – says prof. Marta Miączyńska, Director of the International Institute of Molecular and Cell Biology in Warsaw.

Circle Pharma raises $66 Million in Series C Financing

On June 16, 2021 Circle Pharma, Inc., a macrocycle drug discovery and development company focused on intractable cancer targets, reported that it has raised $66 million in an oversubscribed Series C financing(Press release, Circle Pharma, JUN 16, 2021, View Source [SID1234584063]).

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The financing was co-led by The Column Group and Nextech Invest. All investors from the prior round participated in the Series C, including Pandect Bioventures, together with new investors including Euclidean Capital, Pavillion Capital, Hartford HealthCare Endowment and Eli Lilly and Company.

Proceeds from the financing will be used to advance the Company’s wholly-owned cyclin-targeted programs towards the clinic, with potential applications in Rb-dysregulated cancers such as small cell lung cancer and cyclin E dependent malignancies, including ovarian cancer. In addition, the Company will apply its macrocycle platform to other precision oncology targets that have a clear therapeutic rationale but are considered undruggable with small molecules.

"Circle has made excellent progress since its Series B financing last year and we are very pleased to have co-led this round with Nextech Invest," said Peter Svennilson, managing partner at The Column Group. "We look forward to seeing Circle’s pioneering macrocycle platform bring highly innovative, first-in-class therapies to patients."

"We are deeply appreciative of the continuing support of our existing investors and welcome the support of a strong group of new investors in this financing," said David J. Earp, J.D., Ph.D., Circle’s President and CEO. "The funding will help drive our progress to the clinic and support the addition of new pipeline programs.