On August 9, 2022 BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company focused on developing innovative and affordable oncology medicines to improve treatment outcomes and access for patients worldwide, reported that the global Phase 3 RATIONALE 301 trial with tislelizumab met its primary endpoint of non-inferior Overall Survival (OS) versus sorafenib as a first-line treatment in adult patients with unresectable hepatocellular carcinoma (HCC) (Press release, BeiGene, AUG 9, 2022, View Source [SID1234617938]). The safety profile for tislelizumab was consistent with previous studies and no new safety signals were reported. More than 600 patients in the U.S., Europe, and Asia participated in the study.

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HCC is the sixth most common type of cancer worldwide, accounting for more than 900,000 new cases in 2020i, and despite improvements in screening, surveillance rules, and imaging, more than two-thirds of patients with HCC present with advanced disease at diagnosisii.

"Patients with unresectable HCC face a devastating prognosis, with a median life expectancy of one year. Currently there are few treatment options if patients cannot tolerate TKI therapy or if their condition progresses," said Mark Lanasa M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeiGene. "We are encouraged by the outcome of the final analysis of RATIONALE 301 and look forward to sharing the full safety and efficacy results at an upcoming medical conference."

RATIONALE 301 (NCT03412773) is a global, Phase 3, randomized, open-label study of tislelizumab compared with sorafenib as a first-line treatment in adult patients with unresectable HCC. The primary endpoint of the study is non-inferiority of OS between the two treatment groups. The key secondary endpoint is Overall Response Rate, as assessed by Blinded Independent Review Committee (BIRC) per RECIST v1.1. Other secondary endpoints include other efficacy assessments such as Progression-Free Survival, Durability of Response, and Time to Progression per BIRC, as well as measures of health-related quality of life, and safety and tolerability.

About Tislelizumab

Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors. In pre-clinical studies, binding to Fcγ receptors on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells.

Tislelizumab is the first drug from BeiGene’s immuno-oncology biologics program and is being developed internationally as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers.

The global tislelizumab clinical development program includes more than 11,000 subjects enrolled to-date in 30 countries and regions. BeiGene has initiated or completed 22 registration-enabling clinical trials. More information on the clinical trial program for tislelizumab can be found here.

BeiGene Oncology

BeiGene is committed to advancing best- and first-in-class clinical candidates internally or with like-minded partners to develop impactful and affordable medicines for patients across the globe. We have a growing R&D and medical affairs team of approximately 3,300 colleagues dedicated to advancing more than 100 clinical trials that have involved more than 16,000 subjects. Our expansive portfolio is directed predominantly by our internal colleagues supporting clinical trials in more than 45 countries and regions. Hematology-oncology and solid tumor targeted therapies and immuno-oncology are key focus areas for the Company, with both mono- and combination therapies prioritized in our research and development. BeiGene currently has three approved medicines discovered and developed in our own labs: BTK inhibitor BRUKINSA in the U.S., China, the European Union, Great Britain, Canada, Australia, and additional international markets; and the non-FC-gamma receptor binding anti-PD-1 antibody, tislelizumab, as well as the PARP inhibitor, pamiparib, in China.

BeiGene also partners with innovative companies who share our goal of developing therapies to address global health needs. We commercialize a range of oncology medicines in China licensed from Amgen, Bristol Myers Squibb, EUSA Pharma and Bio-Thera. We also plan to address greater areas of unmet need globally through our other collaborations including with Mirati Therapeutics, Seagen, and Zymeworks.

In January 2021, BeiGene and Novartis announced a collaboration granting Novartis rights to co-develop, manufacture, and commercialize BeiGene’s anti-PD1 antibody, tislelizumab, in North America, Europe, and Japan. Building upon this productive collaboration, BeiGene and Novartis announced an option, collaboration, and license agreement in December 2021 for BeiGene’s TIGIT inhibitor, ociperlimab, that is in Phase 3 development. Novartis and BeiGene also entered into a strategic commercial agreement through which BeiGene will promote five approved Novartis Oncology products across designated regions of China.

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

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On August 9, 2022 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and LIFENET INSURANCE COMPANY (Headquarters: Tokyo, President: Ryosuke Mori, "LIFENET") reported that they have entered into a capital and business alliance agreement to collaborate in dementia and other areas, with the aim of helping reduce the burden of medical and nursing care for people living in Japan’s aging society (Press release, Eisai, AUG 9, 2022, View Source [SID1234617862]).

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New insurance products and services will be developed by mutually leveraging Eisai’s wealth of experience and network in drug discovery and disease awareness activities in the field of dementia, which it has built up over many years, and LIFENET’s know-how and technologies cultivated in insurance products and related services. Furthermore, Eisai and LIFENET will promote the creation of healthcare solutions utilizing various data and customer touchpoint owned by both companies, and expand the ecosystem that contributes to solving social issues. Under the terms of the agreement, Eisai will obtain LIFENET common stock worth 300 million yen through market transaction.

Under the medium-term business plan"EWAY Future & Beyond", which began in April 2021, Eisai is expanding its main role in healthcare, that is, we should contribute not only to people in the medical domain but also to people in the daily living domain. Eisai aim’s to evolve into a company that empowers them "to realize their fullest life" by creating solutions based on science and data in the fields with high unmet medical needs where Eisai has the greatest strength, through an ecosystem developed in collaboration with other industries. This alliance will accelerate the building of a dementia ecosystem that contributes through prevention, treatment, and aftercare in a comprehensive manner.

LIFENET has worked with other industry partners to provide products and services that meet the needs of the times. Through this alliance, as stated in LIFENET Manifesto, LIFENET will continue providing health and wellness tips beyond the framework of life insurance to create value in our policyholders’ lives, while creating a precedent for future generations as to what life insurance is (and should be) all about.

Eisai and LIFENET will contribute to solving social issues through the creation of an ecosystem while pursuing the possibility of collaborations with other companies and organizations that support the objectives of the two companies’ activities.

On August 9, 2022 The leaders of Case Western Reserve University and Lawrence Livermore National Laboratory (LLNL) reported that signed an agreement today to accelerate their efforts in shared areas of excellence (Press release, Case Western Reserve University, AUG 9, 2022, View Source [SID1234617907]).

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After three years of steadily growing institutional collaboration in such areas as energy, materials science and polymer processing, Case Western Reserve President Eric W. Kaler welcomed Livermore Director Kim Budil to the university’s campus.

"Both of our teams have embraced opportunities to partner with enormous enthusiasm and ingenuity," President Kaler said. "We are grateful to Congresswoman Marcy Kaptur for helping to catalyze this connection, and very much look forward to building on our strong progress to date."

Located less than an hour’s drive from San Francisco, the Livermore Lab is one of 17 laboratories around the country operating under the auspices of the U.S. Department of Energy. Their mission is "to push the boundaries of science, engineering and technology" to advance aspects of the energy department’s mission.

"We’re pleased to continue our successful collaboration with Case Western Reserve," said LLNL Director Kim Budil. "This agreement provides an important framework as we partner to advance some of today’s most transformative science and technology."

In the document signed Tuesday, the two institutions agreed to:

Exchange and share science and technology ideas;
Enable student opportunities and internships; and
Pursue research activities in areas of joint interest and benefit.
Conversations to collaboration
The two organizations began discussions 2019 at the suggestion of U.S. Rep. Kaptur (D-Ohio) and then National Nuclear Security Administration leader Lisa Gordon-Hagerty, said Grant Goodrich, executive director of the university’s Great Lakes Energy Institute.

Case Western Reserve and LLNL officials said the university and lab have benefitted over the last several years as their relationship has grown. LLNL has provided funding and expertise to advance research at the university, and CWRU provided a talent pipeline to LLNL, beginning with five internships over the last few years and the hiring of an employee in 2020.

CWRU and LLNL representatives also visited their counterpart’s campus or held virtual meetings nearly a dozen times over the last several years, including for technical presentations and seminars.

Among the other highlights:

LLNL awarded four research grants totaling more than $2 million to CWRU faculty since 2020 from its research and development arm. It funded or collaborated on research being conducted by Dustin Tyler, the Kent H. Smith II Professor of Biomedical Engineering; Rohan Akolkar, the Milton and Tamar Maltz Professor of Energy Innovation and the Ohio Eminent Scholar in Advance Energy Research at the Case School of Engineering; Matthew Willard, professor of materials science and engineering; and Laura Bruckman, associate professor of materials science and engineering.

The lab awarded a $1.1 million grant to a broad-based team led by Roger French, the Kyocera Professor in the Department of Materials Science and Engineering at the Case School of Engineering and a team of researchers to investigate material degradation and lifetime extension of advanced materials. The lab is also a member of the National Science Foundation-funded Materials Data Science for Reliability Center at CWRU, a joint project with the University of Pittsburgh—also led by French.

Shared research projects among Akolkar and LLNL researcher Scott McCall; and João Maia, a professor of macromolecular science and engineering and director of the Center for Advanced Polymer Processing and LLNL researcher Fei Zhou.

On August 9, 2022 Recursion (Nasdaq: RXRX), the clinical-stage biotechnology company industrializing drug discovery by decoding biology, reported business updates and financial results for its second quarter ending June 30, 2022 (Press release, Recursion Pharmaceuticals, AUG 9, 2022, View Source [SID1234617923]).

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Visualization frames how additional datasets and capabilities compound cycles of discovery to potentially translate novel insights into clinical candidates
Visualization frames how additional datasets and capabilities compound cycles of discovery to potentially translate novel insights into clinical candidates
"Recursion continues to make progress in advancing its clinical programs, including initiating a Phase 2 trial for NF2-mutated meningiomas and receiving U.S. FDA Fast Track and European Commission Orphan Drug designations for REC-4881 for the potential treatment of FAP," said Chris Gibson, Ph.D., Co-Founder & CEO at Recursion. "In the context of continued capital markets friction we are increasingly focusing our pipeline around rapidly deliverable oncology programs. We also continue to lead the digital transformation of drug discovery by building additional capabilities into our Recursion OS platform, including scaling our transcriptomics hit validation platform to up to 13,000 near-whole exomes per week and advancing our ChemOS systems by preparing to install our scalable and automated drug metabolism and pharmacokinetics platform. Across our diverse platform that spans target and hit discovery through optimization and translation, we have now generated and control over 16 petabytes of proprietary biological and chemical data and 2.4 trillion predicted biological and chemical relationships, helping us turn the bespoke, artisanal, and serial process of drug discovery into a search and validation problem."

Summary of Business Highlights

Internal Pipeline
Cerebral cavernous malformation (CCM) (REC-994): In March 2022, we announced the initiation of our Phase 2 SYCAMORE clinical trial, which is a double-blind, placebo-controlled safety, tolerability and exploratory efficacy study of this drug candidate in 60 participants with CCM. At this time, we continue to actively enroll participants.
Neurofibromatosis type 2 (NF2) (REC-2282): In June 2022 at the Children’s Tumor Foundation NF Conference, we announced the initiation of our Phase 2/3 POPLAR clinical trial, which is a parallel group, two stage, randomized, multicenter study of this drug candidate in approximately 90 participants with progressive NF2-mutated meningiomas. At this time, we continue to actively enroll participants.
Familial adenomatous polyposis (FAP) (REC-4881): We are on track to initiate a Phase 2, randomized, double-blind, placebo-controlled study to evaluate safety, pharmacokinetics and exploratory efficacy of this drug candidate in FAP in the third quarter of 2022. Recently, the U.S. Food and Drug Administration (FDA) granted Recursion Fast Track designation and the European Commission granted Recursion Orphan Drug Designation for REC-4881 for the potential treatment of FAP.
Clostridium difficile colitis (REC-3964): We made progress in IND-enabling studies for REC-3964 and are on track to initiate a Phase 1 study in the second half of 2022.
Oncology pipeline: We continue to focus our pipeline on oncology and oncology-like programs while advancing numerous programs discovered using our next generation mapping and navigating technology, including programs focused on novel targets and polypharmacology.
Transformational Collaborations
We continue to advance efforts to discover new potential therapeutics with our strategic partners in the areas of fibrotic disease (Bayer) as well as neuroscience and a single indication in gastrointestinal oncology (Roche and Genentech).
Recursion OS
ChemOS: We are preparing to install our automated and scalable drug metabolism and pharmacokinetics (DMPK) platform which will allow for the processing and evaluation of compounds for protein plasma binding, microsomal stability, and cell permeability. Such continuous chemical data generation will help enable us to build machine learning approaches that predict properties for our and our partners’ growing libraries of chemical compounds. Furthermore, we are implementing a unified workflow for medicinal and computational chemists to seamlessly access assay data, design molecules, and perform predictive analyses to support our internal and partnership programs.
Machine Learning: We continue to improve the ease, scale, and biological relevance of our machine learning models and added new benchmarking flows to evaluate how well our models recapitulate known biological relationships associated with protein complexes and pathways. We improved our machine learning models to achieve state-of-the-art results in 9 of 22 absorption, distribution, metabolism, excretion, and toxicity (ADMET) benchmark tasks from Therapeutic Data Commons and we are leveraging them for our oncology programs.
Transcriptomics: We continued building out our scaled transcriptomics platform, with infrastructure, automation, and operational processes that will enable the robust validation of inferences from our maps of biology and chemistry. We have now been able to carry out and analyze up to 13,000 near-whole exomes per week, creating another growing relatable dataset that we can integrate in our Recursion OS for continued improvement of our inferences across compounds and biology at scale.
Compounding Cycles of Discovery: The visualization below frames how additional datasets and capabilities compound cycles of discovery to potentially translate novel insights into clinical candidates. In this technology stack graphic, bold text signifies capabilities that have been built to some meaningful scale already, italic text signifies capabilities that are in the process of being built, and standard text signifies capabilities that Recursion intends to incorporate in the future.
Second Quarter 2022 Financial Results

Cash Position: Cash, cash equivalents, and investments were $515.4 million as of June 30, 2022.
Revenue: Total revenue, consisting primarily of revenue from collaborative agreements, was $7.7 million for the second quarter of 2022, compared to $2.5 million for the second quarter of 2021. The increase was due to revenue recognized from our Roche-Genentech collaboration.
Research and Development Expenses: Research and development expenses were $38.4 million for the second quarter of 2022, compared to $29.6 million for the second quarter of 2021. The increase in research and development expenses was primarily due to an increased number of pre-clinical assets being validated and increased clinical costs as studies progressed.
General and Administrative Expenses: General and administrative expenses were $21.2 million for the second quarter of 2022, compared to $13.9 million for the second quarter of 2021. The increase in general and administrative expenses was due to the growth in size of the company’s operations, including an increase in salaries and wages of $1.8 million, a fixed asset write-down of $2.8 million, increased rent expense of $1.0 million, and other administrative costs associated with operating a public company.
Net Loss: Net loss was $65.6 million for the second quarter of 2022, compared to a net loss of $43.4 million for the second quarter of 2021.