MediciNova to Present at the Ladenburg Thalmann 2021 Virtual Healthcare Conference

On June 29, 2021 MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), reported that Yuichi Iwaki, MD, PhD, President and Chief Executive Officer, and Geoffrey O’Brien, JD/MBA, Vice President and Executive Officer, will present a corporate overview at the Ladenburg Thalmann 2021 Virtual Healthcare Conference on Tuesday, July 13, 2021 at 4:30 pm ET. MediciNova will be available for one-on-one meetings at this conference and investors may request a one-on-one meeting through Ladenburg Thalmann.

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Foundation Medicine and Flatiron Health Announce First-of-its-Kind Integration of Genomic Profiling Into OncoEMR®

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.

Trillium Therapeutics Announces Dosing of First Patient in Phase 1b/2 Study of TTI-621 in Combination With Doxorubicin in Leiomyosarcoma

On June 29, 2021 Trillium Therapeutics Inc. (NASDAQ/TSX: TRIL), a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported that it has dosed the first patient with TTI-621 (SIRPα-IgG1 Fc), an investigational checkpoint inhibitor of the innate immune system, in combination with doxorubicin in a Phase 1b/2 study in leiomyosarcoma (LMS) (Press release, Trillium Therapeutics, JUN 29, 2021, View Source [SID1234584474]).

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TTI-621 binds CD47, an innate immune checkpoint that binds SIRPα and delivers a "don’t eat me" signal to suppress macrophage phagocytosis. Overexpression of CD47 can allow tumor cells to escape immune surveillance. TTI-621 is a fusion protein consisting of the CD47 binding domain of SIRPα linked to the Fc region of human IgG1. It is designed to enhance phagocytosis and tumor cell destruction by blocking the CD47-SIRPα interaction and delivering an activating ("eat me") signal to macrophages. The IgG1 backbone can also activate NK cell-mediated anti-tumor activity. Published preclinical studies suggest that anti-CD47 agents may exhibit anti-tumor activity against LMS cells.

"The dosing of this patient marks the beginning of the first Phase 1b/2 solid tumor clinical trial for Trillium," commented Dr. Ingmar Bruns, Trillium’s Chief Medical Officer. "We’re committed to exploring solid tumors and build upon our potentially best-in-class initial hematologic malignancy datasets."

For newly diagnosed LMS patients, doxorubicin is considered part of standard of care. In this open-label Phase 1b/2 study, Trillium is adding TTI-621 to frontline doxorubicin and enrolling approximately 60 newly diagnosed LMS patients. The primary endpoints are safety and overall response rate.

"Metastisized LMS, the most common form of soft tissue sarcoma, is a serious disease with significant unmet need. We believe that the combination of TTI-621 and doxorubicin has the potential to provide benefit for these patients where few therapeutic options exist," added Dr. Bruns.

Ixaka and SomaLogic Enter Research Collaboration to Develop Bispecific Agents for Oncology

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.

The first time in China! Two indications of Disitamab Vedotin have been granted breakthrough designations in the United States and China for three times

On June 29, 2021 Remegen reported that National Medical Products Administration (NMPA), China’s first novel antibody-drug conjugate (ADC)- Disitamab vedotin, which was just approved to market has been officially included in the breakthrough treatment category for HER2-positive late-stage breast cancer patients with liver metastasis who have received Trastuzumab and taxane therapy in the past (Press release, RemeGen, JUN 29, 2021, View Source [SID1234594765]). The indication is currently in phase Ⅲ clinical trials in China.

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This is the third time that Disitamab vedotin has been granted breakthrough therapy. In September and December 2020, Disitamab vedotin was granted breakthrough designation by the Food and Drug Administration (FDA) and National Medical Products Administration (NMPA) respectively for the treatment of urothelial cancer, becoming the first ADC drug to be dual recognized by both the US and China as breakthrough therapy and Disitamab vedotin is so far the only ADC from China that recieved breakthrough designation from US FDA .

The criteria for breakthrough designation are significantly higher than the other accelerated review pathways of FDA, such as Fast Track, Accelerated Approval, and Priority Review. However, since breakthrough designation emphasizes on significant improvement over currently available treatment, the application drugs must have clinical data with clear advantages, and approvals in the United States are extremely hard, making it very rare for a single drug to be granted both in the United States and China.