On June 29, 2021 eTheRNA immunotherapies NV (‘eTheRNA’), a clinical-stage company developing mRNA-based immunotherapies with in-house GMP certified production and process development capabilities, and Quantoom Biosciences S.A. ("Quantoom"), a biotech company aiming to improve access to essential medicines through innovative bioproduction methods, reported that they are to collaborate on the development of a revolutionary RNA production system (RPS) for both research and GMP-grade material (Press release, eTheRNA, JUN 29, 2021, View Source [SID1234584493]).

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Quantoom and eTheRNA will work together to build an advanced, small footprint technology platform for the production of affordable RNA-based therapies, that can be used either within existing facilities or rapidly deployed to areas of urgent need. Unlike large and costly existing RNA production plants, the RPS will manufacture RNA small modular units, which can be shipped easily across multiple geographic regions. The RPS is intended to be scaled seamlessly from small scale preclinical batches to mass production of GMP-grade RNA. The only requirement will be for the RPS to be located inside a suitable clean room with an uninterrupted utility supply.

Under the terms of the agreement, eTheRNA will transfer manufacturing technology to Quantoom with all materials and data necessary for the development of the novel RPS. Following completion of the RPS, Quantoom will be responsible for commercialization of the system on a worldwide basis, with sales-related royalties payable to eTheRNA. International sales and distribution are expected to commence in 2023 following RPS production in Belgium.

Bernard Sagaert, SVP Manufacturing and COO of eTheRNA, commented: "This cooperation aligns with our goals for RNA production; namely cost reduction, process scalability from small to large scale, portability and process automation. Currently, the global supply of RNA is hampered by the lack of dedicated production facilities and by the cost of constructing new plants. The RPS will revolutionize the way RNA is produced and distributed globally and we are excited to be able to work with a leading developer and manufacturer like Quantoom to bring this vision to the market."

José Castillo, CEO of Quantoom Biosciences, commented: "We are delighted to enter into this collaboration agreement with eTheRNA, which has extensive experience in the field of RNA and like Quantoom, has a mission to change the RNA world. Through our combined knowhow, I am confident that Quantoom will be able to develop an open, integrated RNA platform that will enable manufacture of RNA-based vaccines and therapeutics at scale, resulting in affordable development and production of RNA-based drugs. "

On June 29, 2021 Ixaka Ltd and SomaLogic reported a research collaboration to support the development of aptamer-based bispecific therapeutics (Press release, Ixaka, JUN 29, 2021, View Source [SID1234584492]).

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The collaboration will evaluate the safety and efficacy of antigen-specific SOMAmer reagents (modified aptamers that bind tightly and specifically to protein targets) previously identified and screened by SomaLogic as potential candidates for combination with Ixaka’s anti-CD3 aptamers.

Ixaka is currently developing in vivo CAR-T therapies using its in vivo gene delivery technology, which facilitates in vivo targeting and transduction of patient T cells. The universal in vivo gene modification approach relies on proprietary anti-CD3 aptamers selected by Ixaka as targeting agents, which have been applied to engineer aptamer-based BiTEs (Bi-specific T-cell engagers).

SomaLogic’s antigen-specific SOMAmer reagents will now be evaluated with the intention of improving both the safety and efficacy of antibody-based bispecifics. This follows a recent in vitro proof-of-concept study that successfully highlighted the potential of Ixaka’s cancer specific antigenxCD3 bispecific aptamers as new anticancer agents that can recruit cytotoxic T cells and induce killing of tumor cells.

Cecile Bauche, Vice President and Chief Scientific Officer at Ixaka, commented: "We have made great progress with our anti-CD3 aptamer candidate, with recent positive data demonstrating in vitro proof of concept when combined with a cancer-specific antigenic aptamer. SOMAmer molecules are a promising new class of drug entities with the potential to accelerate development of our aptamer-based BiTEs as anti-cancer agents and help us in our mission to offer new and effective treatments for cancer."

Renaud Vaillant, Vice President, Business Development at Ixaka, commented: "We have been working with aptamers as potential immunotherapies since the inception of the company. We first engaged in discussion with SomaLogic 4 years ago, when the project was just an idea as part of a presentation. I am proud and excited to finally start this collaboration, which is a result of the tremendous work achieved by our team."

In the collaboration, SomaLogic will provide SOMAmers for screening and subsequent evaluation of in vitro cytotoxic properties. Ixaka will lead the experiments to identify and evaluate SOMAmer candidates with high affinity and specificity. Further work will determine functional in vitro properties of bispecific aptamers in human cell cultures and evaluate in vivo anticancer efficacy in murine models.

Nebojsa Janjic, Chief Science Officer of SomaLogic, commented: "The ability of SOMAmer reagents to bind with high specificity and affinity to any target protein makes them ideal for the development of novel therapies for oncology. We hope to expand this collaboration with Ixaka in the future to support new treatments for other therapeutic areas."

SomaLogic’s anti-tumoral SOMAmers demonstrate potential utility as the chemical addition of ‘protein-like’ side chains to the nucleic acid bases that comprise a SOMAmer can be used to develop molecules with high specificity and affinity for any targeted protein, making SOMAmer candidates attractive for novel therapeutic development.

The first application of Ixaka’s TNP technology is the generation of CAR T-cell therapies for haematological malignancies. However, modification of the components offers the potential to target a broad range of therapeutic cells for the treatment of many serious diseases, including cancers, genetic disorders, neurological and ocular diseases.

On June 29, 2021 Foundation Medicine, Inc. reported it’s comprehensive genomic profiling (CGP) tests for their patients without leaving Flatiron Health’s OncoEMR platform (Press release, Foundation Medicine, JUN 29, 2021, View Source [SID1234584491]).

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This integration, the first of a series planned by Flatiron, will support more efficient clinical decision making by allowing electronic ordering, order tracking and receipt of Foundation Medicine’s CGP test results all within the OncoEMR platform. Almost all oncology practices use an electronic medical record (EMR) system to input, view and manage the full patient medical record in a single location, replacing a traditional paper chart with a digital one.1 EMR platforms also support clinical teams by enabling them to more efficiently order and track tests, view results, communicate treatment plans to patients and enable the completion of charting, documentation, and billing.

"With the number of targeted treatments growing exponentially, the opportunity for cancer care transformation has never been greater. Clinicians increasingly rely on genomic insights to guide clinical decision-making, and Foundation Medicine is committed to implementing new solutions that enable widespread access to CGP," said Kathleen Kaa, Interim Chief Commercial Officer at Foundation Medicine. "The integration of Foundation Medicine tests into OncoEMR, and other leading EMR systems to follow, is just one way we’re improving our offerings to fuel precision medicine for cancer patients. The integrations will create efficiencies for oncology healthcare teams to deliver precision treatment plans based on individual genomic insights to their patients."

"We are excited to welcome Foundation Medicine in the first of our planned CGP integrations with OncoEMR," said James Hamrick, MD, MPH, Vice President, Clinical Oncology at Flatiron Health. "This kind of integration marks an important milestone in advancing precision medicine, helping oncologists have access to the information they need to select therapies."

The two companies are planning similar integrations with other CGP platforms and EMRs, respectively, in the oncology space, with the goal of helping every patient to realize the benefit of precision cancer care. These workflow-streamlining integrations are being designed by clinical and product experts in partnership with oncology practices.

On June 29, 2021 I-Mab (the "Company") (Nasdaq: IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, reported its participation in the following conference in July. Details of the conference are as follow:

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CMBI Healthcare Corporate Day (Virtual)

Management participants: Dr. Jingwu Zang, Founder, Chairman and Director, Dr. Joan Huaqiong Shen, Director and Chief Executive Officer, Mr. Jielun Zhu, Director and Chief Financial Officer, and Mr. Tianyi Zhang, Executive Director Investor Relations

One-on-one and small group meetings: July 7-9, 2021

For more information, please contact your CMBI representative.

On June 29, 2021 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, reported that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for its lead investigational drug, Berubicin, for the treatment of patients with recurrent glioblastoma multiforme (GBM) (Press release, CNS Pharmaceuticals, JUN 29, 2021, View Source [SID1234584489]). As previously reported, the Company has also received Orphan Drug Designation from the FDA for Berubicin for the treatment of patients with recurrent GBM.

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"Receiving Fast Track Designation from the U.S. FDA is a huge achievement in our advancement of Berubicin for the treatment of glioblastoma, the most aggressive, deadly and treatment-resistant type of cancer that forms in the brain. If there were ever a disease where the unmet clinical need demands action, it is GBM. Patients have almost no meaningful options and thousands lose their fight against this terrible cancer every year. With this designation, we now have an accelerated pathway to approval for Berubicin and a clear opportunity to more expediently bring this potentially impactful investigational therapy to individuals battling this challenging disease," commented John Climaco, CEO of CNS Pharmaceuticals.

Fast Track Designation enables more frequent interactions with the FDA to expedite the development and review process for drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical need.

CNS recently announced the start of patient enrollment in its potentially pivotal study of Berubicin for the treatment of recurrent glioblastoma multiforme. For more information about this study, please visit ClinicalTrials.gov and reference Identifier NCT04762069.

About Berubicin

Berubicin is an anthracycline, a class of anticancer agents that are among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Anthracyclines are designed to utilize natural processes to induce deoxyribonucleic acid (DNA) damage in targeted cancer cells by interfering with the action of topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin treatment of brain cancer patients appeared to demonstrate positive responses that include one durable complete response in a Phase 1 human clinical trial conducted by Reata Pharmaceuticals, Inc. Berubicin, was developed by Dr. Waldemar Priebe, Professor of Medicinal Chemistry at The University of Texas MD Anderson Cancer Center.