Cancer drugs lift AstraZeneca, aiding turnaround

biopharmadive | April 26, 2019

Years after defending AstraZeneca from a Pfizer takeover bid, CEO Pascal Soriot has finally delivered the return to growth he promised in staving off what would have been a $120 billion buyout. Sales last year rose by 4% — the first annual increase since 2014 — and the pharma expects that figure to rise even higher this year. Results from the first three months of the year so far support that hope, and showcase the success AstraZeneca has had in rebuilding a business in oncology. Together, the company's cancer drugs Tagrisso (osimertinib), Imfinzi (durvalumab) and Lynparza (olaparib) earned $700 million in additional sales over last year's first quarter numbers.

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This video about the plant biotechnology development process.

Spotlight

This video about the plant biotechnology development process.

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INDUSTRIAL IMPACT

Palantir and Dewpoint Therapeutics Announce Strategic Partnership

Palantir Technologies Inc. | December 21, 2021

Palantir Technologies Inc. a leading builder of operating systems for the modern enterprise, and Dewpoint Therapeutics the leading biomolecular condensates company, announced a partnership for Palantir’s Foundry platform to help power Dewpoint’s efforts to discover treatments and cures for the most challenging diseases. Palantir Foundry will help to enable researchers at Dewpoint to further their understanding of condensates biology by analyzing lab data along with other data sources, including data from the published literature and databases, to identify new compounds and therapeutic approaches. Dewpoint will also use Foundry as the primary platform for its centralized knowledge repository, helping it contextualize its experimental results and prioritize the most viable outcomes. This multi-year agreement marks one of Palantir’s most comprehensive partnerships with a biotechnology company. Palantir Foundry is designed to integrate disparate and siloed information sources to lead to data-driven analysis and decision making. It allows users to track lineage across systems, making it particularly suited for work in life sciences and the biotechnology sector, where data sources come from several unique and separate systems. At Dewpoint, Foundry will be able to work seamlessly with the existing systems in its laboratories to provide researchers with a comprehensive foundation for exploration and analysis. “We think Dewpoint is changing the way the world approaches drug design by exploring new frontiers of disease biology, requiring a game changing solution that goes beyond just cloud and infrastructure to drive their R&D and scale with their vision as they grow. We are proud to partner with Dewpoint and share their passion of working on one of the most exciting translational medicine approaches of our time.” Lalarukh Haris Shaikh, Palantir’s Head of Biotech Foundry will help researchers make decisions around compound and target viability and streamline experiments and automate analysis by creating a digital twin of the research environment. One concrete example of Foundry’s use at Dewpoint Therapeutics is the expansion of the data foundation to include advanced genetic analysis for disease association and correlation with condensate content, empowering future discoveries. “Key to our approach has been creating a seamless connection between our wet-lab and dry-lab capabilities, with machine learning and AI at the center. Foundry has provided us with a solid foundation for us to fully connect and operationalize our entire lab to enterprise and enable the discovery and development of new drugs,” said Dewpoint CEO Ameet Nathwani. About Biomolecular Condensates Biomolecular condensates, formed through a process called phase separation, are membraneless droplets inside cells that facilitate molecular interactions and help cells perform vital functions. Condensates have been shown to play a critical role in key biological processes and in serious, intractable diseases across areas including neurodegeneration, cancer, inflammation, infectious disease, metabolic disease, and rare genetic disorders. The first condensates were observed more than 100 years ago. It is only in the last dozen years, though, that scientists—including Dewpoint founders Tony Hyman of the Max Planck Institute in Dresden and Rick Young of the Whitehead Institute—have begun to understand the dynamic nature and function of condensates. Dewpoint develops drugs that exploit this biology. About Dewpoint Therapeutics Dewpoint Therapeutics is the first company to apply the emerging understanding of biomolecular condensates to drug discovery. Dewpoint believes that a vast range of conditions have pathways that are regulated by condensates or arise from the dysfunction of condensates — including cancer, neurodegeneration, infectious disease, and metabolic disease. Dewpoint scientists work in Boston, Dresden, and Berlin to translate condensate biology into treatments for the toughest diseases. About Palantir Technologies Inc. Palantir Technologies Inc. builds and deploys operating systems for the modern enterprise.

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CELL AND GENE THERAPY

Imara Announces Primary Endpoint Change in the Ardent Phase 2b Clinical Trial of Tovinontrine (IMR-687) in Sickle Cell Disease

Imara | November 22, 2021

Imara Inc. a clinical-stage biopharmaceutical company dedicated to developing and commercializing novel therapeutics to treat patients suffering from rare inherited genetic disorders of hemoglobin and other serious diseases, today announced a change to the primary endpoint for the Ardent clinical trial, a Phase 2b study of tovinontrine (IMR-687) in patients with sickle cell disease (SCD), based on the recommendation of the U.S. Food and Drug Administration (FDA). Imara requested feedback from the FDA on the draft statistical analysis plan (SAP) for the Ardent trial in which fetal hemoglobin (HbF) response was the primary endpoint and annualized rate of vaso-occlusive crises (VOCs) was the key secondary endpoint. In reviewing the Ardent draft SAP and prior to any database lock for analysis, the FDA recommended that Imara change the primary endpoint to be annualized rate of VOCs. HbF response will continue to be evaluated as a key secondary endpoint. The endpoint revisions do not affect the conduct of the trial or operational aspects of the study. As part of its recommendation, the FDA suggested further interactions regarding the revised SAP and engagement on the potential of the current program for regulatory decision-making. “We welcome the FDA’s recommendations and are in the process of changing the primary endpoint of the Ardent trial to be annualized rate of VOCs and moving HbF response to be a key secondary endpoint. A reduction in VOC rate is an established approval endpoint, and we are engaging the FDA further on this and related topics, including possible streamlined paths to registration.” Rahul Ballal, Ph.D., President and Chief Executive Officer of Imara Dr. Ballal continued, “In light of this endpoint revision, the previously planned fourth quarter interim analysis will no longer occur. That interim analysis had been designed to have a focus on safety and pharmacodynamic biomarkers, including HbF, but did not include a review of VOCs. The first review of data from the Ardent trial, including annualized VOC rate, will be conducted when all subjects have completed assessment at Week 24 or terminated early, and is planned for the first quarter of 2022, subject to our upcoming discussions with the FDA. Final data analysis from the Ardent trial remains on track for the second half of 2022. In June 2021, we reported promising data from our Phase 2a and open label extension clinical trials in SCD that demonstrated reduced annualized rates of VOCs in patients treated with tovinontrine versus placebo. We expect to present updated 12-month VOC data from our ongoing Phase 2a open label extension clinical trial at the American Society of Hematology Annual Meeting in December 2021.” About the Ardent Phase 2b Clinical Trial The Ardent Phase 2b clinical trial is a fully-enrolled, global, randomized, double-blind, placebo-controlled, multicenter study with approximately 115 adult patients with sickle cell disease (SCD) enrolled. The planned primary efficacy objective will be to evaluate the annualized rate of vaso-occlusive crises (VOCs) in patients dosed with tovinontrine (IMR-687) as compared to placebo. A key secondary endpoint will be to evaluate the proportion of all patients with fetal hemoglobin (HbF) response, defined as an absolute increase from baseline of at least 3% in HbF, as compared to placebo. Additional endpoints include the evaluation of the effect of tovinontrine versus placebo on other VOC-related outcome measures, HbF-associated biomarkers, markers of red blood cell hemolysis, white blood cell adhesion markers and quality of life measures over the course of a one-year treatment period. The FDA has granted Orphan Drug, Fast Track and Rare Pediatric Disease designations and the European Commission has granted Orphan Drug designation for tovinontrine for the treatment of SCD. About Tovinontrine (IMR-687) Tovinontrine is a highly selective and potent small molecule inhibitor of phosphodiesterase-9 (PDE9). PDE9 selectively degrades cyclic guanosine monophosphate (cGMP), an active signaling molecule that plays a role in vascular biology and hemoglobin production in red blood cells. Lower levels of cGMP are found in people with sickle cell disease (SCD) and beta-thalassemia and are associated with reduced blood flow, increased inflammation, greater cell adhesion and reduced nitric oxide mediated vasodilation. Blocking PDE9 acts to increase cGMP levels, which is associated with several benefits including the potential reactivation of fetal hemoglobin (HbF), a natural hemoglobin produced during fetal development. Increased levels of HbF in RBCs have been demonstrated to improve symptomology and substantially lower disease burden in both patients with SCD and patients with beta-thalassemia. About Sickle Cell Disease Sickle cell disease (SCD), a hemoglobinopathy, is a rare inherited red blood cell disorder. The disease causes structural abnormalities in hemoglobin that cause red blood cells to become inflexible and elongated, ultimately blocking blood flow to organs, which can lead to vaso-occlusive crises (VOCs). SCD is characterized by debilitating pain, progressive multi-organ damage and early death. The global prevalence of SCD is estimated to be approximately 4.4 million patients, including an estimated 100,000 patients in the United States and 134,000 patients in the European Union. About Imara Imara Inc. is a clinical-stage biotechnology company dedicated to developing and commercializing novel therapeutics to treat patients suffering from rare inherited genetic disorders of hemoglobin and other serious diseases. Imara is advancing tovinontrine (IMR-687), a highly selective, potent small molecule inhibitor of PDE9 that is an oral, potentially disease-modifying treatment currently in clinical development for sickle cell disease and beta-thalassemia and preclinical development for heart failure with preserved ejection fraction, or HFpEF. Imara is also advancing IMR-261, an oral activator of nuclear factor erythroid 2–related factor 2, or Nrf2. Cautionary Note Regarding Forward-Looking Statements Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to (i) the Company’s plans to change the primary and secondary endpoints for the Ardent Phase 2b clinical trial of tovinontrine (IMR-687), (ii) the timing for reporting of additional data from the Ardent Phase 2b and open label extension clinical trials of tovinontrine in patients with sickle cell disease and (iii) the Company’s planned discussions with the FDA regarding the regulatory pathway for tovinontrine. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the impact of extraordinary external events, such as the risks and uncertainties resulting from the impact of the COVID-19 pandemic on the Company’s business, operations, strategy, goals and anticipated milestones, including its ongoing and planned research activities and ability to readout data from the Ardent Phase 2b and open label extension clinical trials of tovinontrine in sickle cell disease; the Company’s ability to advance the development of tovinontrine under the timelines it projects in current and future clinical trials, demonstrate in any current and future clinical trials the requisite safety and efficacy of tovinontrine; and other factors discussed in the “Risk Factors” section of the Company’s most recent Quarterly Report on Form 10-Q, which is on file with the Securities and Exchange Commission and in other filings that the Company makes with the Securities and Exchange Commission in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

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INDUSTRIAL IMPACT

Kane Biotech Announces New Collaboration Agreements for Prosthetic Joint Infection, expanding its DispersinB® applications

Kane Biotech Inc. | February 11, 2022

Kane Biotech Inc. announces that it has signed collaboration agreements with Dr. James Doub, MD, Assistant Professor of Medicine, University of Maryland School of Medicine’s Institute of Human Virology, and the University of Texas Medical Branch (UTMB) to study the use of DispersinB® with Prosthetic Joint Infection (PJI) patients. The group is securing funding from the National Institutes of Health (NIH) for pre-clinical work to be done by Josh Wenke, a Professor in the Department of Orthopedic Surgery and Rehabilitation at UTMB. PJI’s are one of the most serious complications of joint replacement surgery. Conservative estimates are that approximately 1–2% of all prostheses will become infected over the life of the implant [1]. The financial burden of treating these infections is staggering. It is estimated that they will cost the US healthcare system $1.62 billion in 2020 [1]. In addition, patients have significant morbidity and mortality as a direct result of our current medical and surgical management to treat these infections [2]. In one study, the five-year mortality for prosthetic joint infections is over 20% [2]. “These collaborations are of utmost importance given our shared strategies for managing complex musculoskeletal infections and finding cures for the debilitating morbidity associated with PJI. We are highly optimistic of advancing this field scientifically and clinically for the benefit of patients across the globe” Marc Edwards, CEO of Kane Biotech “The Institute of Human Virology has been testing the use of bacteriophage therapeutics in treating recalcitrant PJIs with some early signals of success,” explained Dr. Doub, who is also Director of Infectious Diseases Ambulatory Practice at the University of Maryland Medicine Center. “However, DispersinB®, has properties that bacteriophages do not have which include superior application as a preventative therapeutic, broader spectrum of activity, and a much easier regulatory (FDA) path.” Dr. Doub is a consultant for Kane Biotech. Dr. Nanda Yakandawala, Vice President of Research and Development at Kane, in collaboration with Dr. Doub and Josh Wenke, Ph. D, recently submitted a R-21 grant application to NIH to fund pre-clinical work to be performed by Dr. Wenke. About University of Texas Medical Department Established in 1891 as the University of Texas Medical Department, UTMB was the nation's first public medical school and hospital under unified leadership and has evolved into a modern academic health science center with multiple campus locations and almost 1,000 faculty members educating approximately 3,500 students. Since the beginning, UTMB has been at the forefront of medical research, with researchers studying the viruses common to a sub-tropical island climate. Today, our world-renowned investigators generate a portfolio exceeding $160 million, and work in state-of-the-art laboratories developing diagnostic tools, cures and vaccines to benefit the global community. About Kane Biotech Kane Biotech is a biotechnology company engaged in the research, development, and commercialization of technologies and products that prevent and remove microbial biofilms. The company has a portfolio of biotechnologies, intellectual property (81 patents and patents pending, trade secrets, and trademarks) and products developed by the company's own biofilm research expertise and acquired from leading research institutions. StrixNB™, DispersinB®, Aledex™, bluestem™, bluestem®, silkstem™, goldstem™, coactiv+™, coactiv+®, DermaKB™ and DermaKB Biofilm™ are trademarks of Kane Biotech Inc.

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