On June 23, 2021 Sosei Group Corporation ("the Company"; TSE: 4565) reported that the first healthy subject has been dosed with HTL0022562 in a Phase 1 clinical study (Press release, Sosei, JUN 23, 2021, View Source [SID1234584295]). HTL0022562 (also known as BHV3100) is a novel, small molecule CGRP* receptor antagonist discovered by Sosei Heptares and the lead compound in a portfolio of CGRP antagonists licensed to Biohaven Pharmaceutical Holding Company Ltd. ("Biohaven",NYSE: BHVN) in December 2020 for development as new therapies for CGRP-mediated disorders .

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The trial is a Phase 1, randomized, double-blind, placebo-controlled, first-in-human study to evaluate the safety, tolerability, and pharmacokinetics of a single ascending dose and multiple ascending doses of subcutaneous HTL0022562 in healthy adult subjects. The trial aims to enroll 88 subjects at a single center in the UK and is expected to complete in 2022.

Sosei Heptares has advanced HTL0022562 successfully though a preclinical development program demonstrating its promising and differentiated properties for further investigation in human trials.

Under the global collaboration and license agreement with Biohaven, Sosei Heptares will conduct the Phase 1 clinical trial itself, receiving a milestone payment for its initiation, and is also eligible for development costs for conducting the trial. Biohaven will lead all future studies and development activities and Sosei Heptares will be eligible for further milestone payments and royalties.

Although the event reported today has no significant impact on the consolidated financial results for the accounting period ending 31 December 2021, the Company considers that an important developmental milestone has been achieved with HTL0022562 becoming the tenth drug candidate overall generated from Sosei Heptares’ SBDD platform to enter clinical development, and therefore makes this announcement.

Tim Tasker, Executive Vice President and Chief Medical Officer of Sosei Heptares, said: "We are pleased to initiate this new clinical trial with HTL0022562 following the successful discovery and preclinical development work conducted by Sosei Heptares. We are also delighted at the speed of progress and the positive collaborative approach that has developed between our team and our partners at Biohaven and the confidence they have shown in our early clinical development capabilities. Together, we are committed to developing this novel differentiated agent to treat CGRP-mediated diseases with unmet need."

*Abbreviations used: CGRP – calcitonin gene-related peptide

About the Agreement with Biohaven
Sosei Heptares and Biohaven entered a global collaboration and license agreement in December 2020 under which Biohaven received exclusive global rights to develop, manufacture and commercialize a portfolio of novel, small-molecule CGRP receptor antagonists discovered by Sosei Heptares for the treatment of CGRP-mediated disorders. Sosei Heptares received an upfront payment of US$10 million on signing in cash and Biohaven common shares and is eligible to receive additional research funding, up to US$370 million in development, regulatory and commercialization milestone payments, plus tiered royalties on net sales of products resulting from the collaboration.

About CGRP
CGRP is an important neuropeptide believed to be involved in multiple neuro-inflammatory and neuro-immune diseases. CGRP receptor antagonism interrupts pathologic signals in CGRP-mediated diseases, such as migraine. Following the success of this approach in migraine, Biohaven is exploring the potential of this approach in other neuro-inflammatory and neuro-immune diseases, including COVID-19.

On June 23, 2021 Bionaut Labs, a company focused on revolutionizing the treatment of central nervous system disorders (CNS) with its Bionaut precision medicine treatment modality, reported that the U.S. Food and Drug Administration (FDA) has granted the company orphan drug designation for BNL-101 for the local treatment of all malignant gliomas including diffuse intrinsic pontine glioma in pediatric and adult patients (Press release, Bionaut Labs, JUN 23, 2021, View Source [SID1234584294]). BNL-101 is a drug-device combination comprised of doxorubicin as the active drug component together with the company’s Bionaut microscale robots.

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"The granting of orphan drug designation for BNL-101 represents a significant milestone for Bionaut Labs as it recognizes the potential of our approach to transform the standard of care for devastating CNS diseases like malignant gliomas," said Michael Shpigelmacher, co-founder and CEO, Bionaut Labs. "The award of orphan drug designation is the first step in a program of regulatory optimization that Bionaut Labs has initiated to allow us to move BNL-101 into the clinic in the swiftest and most effective way possible. We believe BNL-101 has the potential to play a significant role in shifting the treatment paradigm for malignant gliomas, and we look forward to continuing to work with the FDA as we fulfill our mission of helping patients suffering from debilitating brain diseases who lack treatment options."

"Gliomas remain some of the most devastating tumors for which there are few, if any, effective treatment options and for which there remains significant unmet medical need," said Alex Kiselyov, chief science officer, Bionaut Labs. "Receiving orphan drug designation from the FDA is an important regulatory milestone as we believe it validates our Bionaut-based approach. We look forward to advancing our BNL-101 therapeutic program into the clinic."

The FDA’s Office of Orphan Drug Products grants orphan drug status to support development of drugs and biologics intended for the safe and effective treatment, diagnosis or prevention of rare diseases or conditions affecting fewer than 200,000 people in the United States. Orphan drug designation provides benefits to drug developers designed to support the development of drugs and biologics for small patient populations with unmet medical needs. These benefits include assistance in the drug development process, tax credits for clinical costs, exemptions from certain FDA fees, and seven years of marketing exclusivity.

About Bionaut Treatment
A Bionaut is a novel treatment modality that uses remote-controlled microscale robots to deliver biologics, nucleic acids, small molecule, gene or cellular therapies locally to targeted CNS disease areas. Through precise targeting, Bionaut therapeutics could offer better efficacy and safety that cannot be achieved by other traditional treatment or delivery modalities.

Bionauts can be constructed in different designs with custom geometries and surface characteristics. Smaller than a millimeter, they contain moving parts controlled remotely by a magnetic controller, allowing them to safely reach the target and release a therapeutic payload from the cargo compartment. Engineering flexibility provides a broad foundation for designing Bionaut therapies for nearly any disease of interest.

Bionaut Labs has demonstrated safe and controlled navigation of its therapeutic Bionaut to and from the treatment locus in the brain, in a large animal in vivo model. Furthermore, the Company has successfully treated human glioma tumors established in mice, utilizing guided delivery of therapeutic cargos directly into these tumors to eliminate systemic toxicity. These results pave the way to the clinical trials of the Bionaut platform.

On June 23, 2021 xCures Inc., the leader in the patient-centric use of artificial intelligence (AI) and predictive modeling, reported that it has raised $12.69 million in Series A funding (Press release, xCures, JUN 23, 2021, View Source [SID1234584293]). This investment, led by Boehringer Ingelheim Venture Fund and joined by Vanedge Capital, Harmonix Fund, Metaplanet, as well as other investors, will be used to accelerate adoption and further development of xCures’ AI-Powered platform for precision oncology decision making.

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We’re confident that xCures will continue to develop their platform and work to make a meaningful impact for patients

The xCures platform transforms complex unstructured medical data directly from the patient’s medical records into structured data suitable for analysis and machine learning. The AI engine then actively cross-references this data against a vast digital library of oncology data to match patients with potential treatments and predict outcomes, thereby empowering patients as well as their oncologists to make more informed and effective treatment decisions.

"This new investment enables us to leverage our experience in helping over 1000 patients on our platform to dramatically increase both platform usage and the insights we are generating," stated Mika Newton, CEO of xCures. "Working with the Boehringer Ingelheim Venture Fund and our other investors, we are leading the field of patient-centric research, AI-powered clinical decision support, and prospectively generating regulatory-grade real-world evidence."

xCures has developed the infrastructure and products to directly engage patients and access their raw unstructured medical records from anywhere in the United States. These records are then processed into structured data and stored in a HIPAA and CFR Part 11 compliant system. Patients and their physicians receive a crisp summary of their case in the form of a Cancer Journey. The platform then integrates knowledge and insights from this real-world evidence into xINFORM, providing powerful AI-driven clinical decision support tools. Also, the acquired real-world evidence is helpful for biopharmaceutical companies and payors to accelerate novel therapies and guide the optimization of precision medicine approaches to cancer treatment.

"The Boehringer Ingelheim Venture Fund sees the potential of the xCures platform to provide valuable options for advanced cancer patients, while at the same time, generating real-world evidence that could lead to important therapeutic insights," said Mark Ralph, Executive Director of the Boehringer Ingelheim Venture Fund focused on Digital Health Investments, and who is joining the xCures Board of Directors. "We’re confident that xCures will continue to develop their platform and work to make a meaningful impact for patients."

On June 23, 2021 Arcus Biosciences, Inc. (NYSE:RCUS), an oncology-focused biopharmaceutical company working to create best-in-class cancer therapies, reported that, at the first interim analysis of the three-arm randomized Phase 2 ARC-7 study, both arms with domvanalimab-based combinations showed encouraging clinical activity (measured by overall response rate; ORR) when given as an initial treatment (first-line) to people with metastatic, PD-L1≥50% non-small cell lung cancer (NSCLC) (Press release, Arcus Biosciences, JUN 23, 2021, View Source [SID1234584292]). The zimberelimab monotherapy arm showed activity similar to that of marketed anti-PD-1 antibodies studied by other companies in this setting. At the time of data cut off, no unexpected safety signals were observed; and the current safety profile for each arm of the study appears to be consistent with known immune checkpoint inhibitors in this setting. All three arms of the ARC-7 trial, and the ongoing ARC-10 Phase 3 registrational study, will continue to enroll as planned; and ARC-7 data will be submitted later this year for presentation at a medical conference."

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Our partner Gilead Sciences has an exclusive option to co-develop and co-commercialize domvanalimab and is anticipated to make a decision regarding opting into the anti-TIGIT program later this year. Arcus and Gilead will continue preparations for additional Phase 3 studies of domvanalimab-based combinations and explore development plans for combinations including domvanalimab and etrumadenant.

"This analysis of the dataset for the ongoing ARC-7 study revealed encouraging clinical activity for the anti-TIGIT domvanalimab-based combinations, and furthermore, that the anti-PD-1 zimberelimab monotherapy arm showed activity similar to that of marketed anti-PD-1 antibodies studied in this setting," said Bill Grossman, M.D., Ph.D., Chief Medical Officer of Arcus. "Next steps are to complete enrollment in all our open domvanalimab studies, execute on our broader plans for Phase 3 studies for domvanalimab across multiple cancer types, and further explore combinations with domvanalimab and etrumadenant."

Conference call details

Arcus will host a conference call and live webcast today, Wednesday, June 23, 2021 at 2:00 p.m. Pacific Time/5:00 p.m. Eastern Time to provide an update on its ongoing domvanalimab program. Investors interested in listening to the conference call may do so by dialing (877) 209-6698 in the U.S. or (825) 312-2373 internationally, using Conference ID: 6891607. In addition, the live webcast and accompanying slides will be available on the "Investors" section of the Arcus website at www.arcusbio.com. Following the live webcast, a replay will be available on the Company’s website for approximately 30 days.

About ARC-7 and the domvanalimab Development Program

ARC-7 is an open-label randomized Phase II study evaluating the safety and efficacy of domvanalimab plus zimberelimab (anti-PD1 antibody) vs. zimberelimab alone vs. domvanalimab plus zimberelimab and etrumadenant (dual adenosine A2a/A2b receptor antagonist) in 150 people as a first-line treatment for PD-L1 ≥ 50% and EGFR/ALK wild-type, metastatic NSCLC. Participants are being randomized 1:1:1 across three study arms and treated until disease progression or loss of clinical benefit. Co-primary endpoints are objective response rate (ORR) and progression-free survival (PFS). Secondary endpoints include safety, duration of response and disease control rates. In this first interim analysis, data were not mature, and PFS was not assessed.

In addition to ARC-7, domvanalimab is currently being evaluated in ARC-10, an ongoing registrational Phase 3 study evaluating domvanalimab plus zimberelimab vs. zimberelimab alone vs. chemotherapy in first-line locally advanced or metastatic, PD-L1>50% NSCLC. Based on the ARC-7 data, additional Phase 3 studies are planned for domvanalimab-based combination across various cancer types.

About domvanalimab and Arcus’ anti-TIGIT program

Domvanalimab, Arcus’ most advanced anti-TIGIT candidate, is an Fc-silent investigational monoclonal antibody that binds to TIGIT, a protein receptor on immune cells that acts as a brake on the immune response. Cancer cells can exploit TIGIT to avoid detection by the immune system. Domvanalimab binds to TIGIT to free up immune activating pathways and activate immune cells to attack and kill cancer cells.

Arcus is developing a second anti-TIGIT candidate, AB308, an Fc-enabled investigational monoclonal antibody in clinical development, with a potential focus on hematological malignancies. AB308 is currently in Phase I studies for advanced malignancies.

On June 23, 2021 BioAffinity Technologies, a privately held biotech company, reported that it will present the Company’s discoveries in the field of cancer diagnostics and therapeutics at the RNA Therapeutics Institute’s 2021 RNA Therapeutics Symposium June 23 – 25, 2021, and the International Conference on Porphyrins and Phthalocyanines (ICPP) June 28 – July 3, 2021 (Press release, BioAffinity Technologies, JUN 23, 2021, View Source [SID1234584291]).

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"The presentation describes the novel mechanism by which the porphyrin TCPP, which is used in bioAffinity Technologies’ non-invasive test for the early detection of lung cancer, is incorporated into cancer cells"

bioAffinity Senior Vice President of Therapeutics, William Bauta, Ph.D., will present "Selective Cancer Cell Killing by Dual siRNA Knockdown of CD320 and LRP2 Receptors" on June 23 at the RNA Therapeutics Institute’s Symposium sponsored by the University of Massachusetts Medical School. Dr. Bauta will discuss how bioAffinity has successfully used RNA interference to knock down expression of two genes that results in killing cancer cells with little or no effect on normal cells. Dr. Bauta’s live presentation will be Wednesday, June 23, from 3:30 p.m. to 4:15 p.m. EDT. A video presentation by bioAffinity Vice President of Research, David Elzi, Ph.D., also will be available throughout the conference for viewing by conference participants.

"bioAffinity’s discovery of a fundamental vulnerability of cancer opens the way to new therapies that kill cancer without harm to normal tissue," Dr. Bauta said. "In particular, bioAffinity’s research shows how the Company has designed and used siRNAs to kill multiple cancers at the cellular level including prostate, lung, breast, brain and skin cancers without harm to normal cells."

"Recent scientific discoveries and their application in medicine related to RNAs has been astonishing, leading to life-saving therapies including the use of mRNA vaccines to eradicate the SARS-Cov-2 virus causing the COVID-19 pandemic," said bioAffinity President and CEO Maria Zannes. "We are honored to be part of the 2021 RNA Symposium that brings together leaders in the field to discuss what the world is witnessing – that RNA can be the future of therapeutics."

Dr. Bauta also will present the poster "Meso-tetra (4-carboMeso-tetra (4-carboxyphenyl) porphyrin (TCPP) is taken up in cancer cells by the CD320 receptor" at the International Conference on Porphyrins and Phthalocyanines (ICPP) ICPP-11 from June 28 through July 3.

"The presentation describes the novel mechanism by which the porphyrin TCPP, which is used in bioAffinity Technologies’ non-invasive test for the early detection of lung cancer, is incorporated into cancer cells," Ms. Zannes said. "Our discoveries have furthered the understanding of TCPP for use in diagnostics, including the Company’s first product, CyPath Lung, a flow cytometry test used to diagnose lung cancer at early stage."

A test validation trial comparing people at high risk for lung cancer to patients with the disease resulted in CyPath Lung sensitivity of 92% and specificity of 87% for individuals with nodules less than 20 mm.

Precision Pathology Services, a CAP/CLIA laboratory in San Antonio, Texas, is completing validation of CyPath Lung as a Laboratory Developed Test for sale to physicians who will order the test for their patients suspected of having lung cancer. Patients collect a sputum sample non-invasively at home and ship the sample overnight to the laboratory where it is analyzed for cell types and populations indicating a tumor in the lung.

"CyPath Lung is a well-balanced, highly accurate test allowing patients to collect their sample in the privacy of their own home," Ms. Zannes said. "Precision Pathology’s commercial validation of the test is going very well and expected to be complete this summer."