Cedilla Therapeutics | November 17, 2021
Cedilla Therapeutics, a biotechnology company bringing a new dimension to precision oncology, announced appointments across its research and development (R&D) and finance teams, including Joshua Murtie, Ph.D., as Vice President of Biology and Chris Lindblom as Vice President of Finance. These hires are part of an ongoing initiative to expand Cedilla’s leadership and enable future growth as the company progresses its lead programs, conditional inhibitors of TEAD and CDK2, toward the clinic and continues to develop a broad portfolio of small molecule medicines that target key oncogenic drivers.
“We are delighted to expand our team with these key hires, who share our passion and commitment to developing targeted medicines that conditionally modulate proteins in their functional state. We look forward to Joshua and Chris’ many contributions as we continue to explore the power of our novel approach to access historically undruggable cancer drivers, advance our lead conditional inhibitor programs targeting TEAD and CDK2 into clinical development, and ultimately build Cedilla into a fully integrated organization and leader in precision medicine.”
Alexandra Glucksmann, Ph.D., President and Chief Executive Officer of Cedilla Therapeutics
Joshua Murtie, Ph.D., has been appointed Vice President of Biology. Dr. Murtie brings over ten years of industry experience to Cedilla. He worked most recently as Senior Director at Servier Pharmaceuticals, where he oversaw cancer biology, in vivo pharmacology and early-stage program management at the company’s U.S. research site. Earlier, he spent nearly seven years at Agios Pharmaceuticals in roles of increasing responsibility, ultimately serving as Senior Director and Head of Cancer Biology, with responsibility for the strategic oversight of the company’s cancer biology portfolio from early target discovery to translational research. Prior to Agios Pharmaceuticals, Dr. Murtie worked as an investigator at Sanofi and Novartis. He holds a Ph.D. in molecular and cell biology from the Uniformed Services University of the Health Sciences and completed his research fellowship at Harvard Medical School.
“I am thrilled to join Cedilla, particularly as we prepare to advance our lead programs, targeting TEAD and CDK2, into investigational new drug application-enabling studies next year,” said Dr. Murtie. “Both TEAD and CDK2 are well-known yet elusive cancer targets, which, if drugged successfully, could benefit the lives of patients living with a broad range of solid tumors. I am incredibly impressed by the collaborative and innovative culture at Cedilla and look forward to working closely with the team to translate our research efforts into precision therapies for patients in need.”
Chris Lindblom has been appointed Vice President of Finance. Over the course of his 19 years in the biotechnology industry, Mr. Lindblom has crafted long-range financial plans for public and private companies and played a key role in helping companies raise capital through private equity rounds, venture debt deals and public offerings. Prior to joining Cedilla, Mr. Lindblom served as Vice President of Finance at IFM Therapeutics, Cogen Immune Medicine (through its merger with Torque Therapeutics to form Repertoire Immune Medicines) and Warp Drive Bio (through its acquisition by Revolution Medicines). Earlier, Mr. Lindblom held various senior finance roles at Millennium Pharmaceuticals, including through the commercial launch of VELCADE®, and at Infinity Pharmaceuticals. He also served as Vice President of Finance at OvaScience and Senior Vice President of Finance and Administration at BIND Therapeutics. Mr. Lindblom holds an MBA from Boston College and a B.S. in accounting from Syracuse University. He is also a CPA.
“Since its founding, Cedilla has attracted a strong team, including leading scientists and advisors and a robust investor syndicate, to support its mission to bring a new dimension to precision oncology and deliver medicines that can offer profound benefits to patients,” said Mr. Lindblom. “I am honored to take on this role and eager to partner with my new colleagues as we continue building Cedilla for its next phase of growth.”
About Cedilla Therapeutics
Cedilla Therapeutics is bringing a new dimension to precision oncology. We have discovered new ways to selectively inhibit oncogenic drivers with small molecules that conditionally modulate proteins in their functional state. Our conditional inhibitors are unlocking critical and elusive cancer targets including TEAD and CDK2. We are a driven and patient-focused team.
CELL AND GENE THERAPY
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.
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.
Axion BioSystems | February 03, 2022
Axion BioSystems, a leading life sciences tools company focused on advanced bioelectronic assay technologies, announces the acquisition of UK-based printed electronics manufacturer M-Solv Manufacturing Limited, a subsidiary of M-Solv Ltd. The creation of the new division, called Axion BioSystems Manufacturing, UK, Ltd., cements the six-year partnership between the companies and positions Axion for continued growth and innovation.
“The need to control the supply chain has never been more important. This vertical integration not only ensures that our customers have the products they need to conduct critical biomedical research; it also allows us to advance assay plate technologies more rapidly to meet the increasingly complex scientific demands of our users.”
Tom O’Brien, CEO of Axion BioSystems
Since 2017, M-Solv has supplied Atlanta-based Axion BioSystems with high-resolution proprietary printed electronics circuits, a critical consumable used in Axion’s flagship Maestro Pro multielectrode array benchtop instrument. The Maestro Pro system provides pharmaceutical companies, biotechnology firms, and research scientists with a state-of-the-art cell analysis platform for disease modeling and drug discovery. Integrating M-Solv’s development and manufacturing team represents a key step forward in Axion’s continuous efforts to streamline manufacturing and continue its leadership in this space.
“The M-Solv manufacturing team is proud to have played a role supporting Axion’s growth over the last six years,” said Phil Rumsby, CEO of M-Solv Manufacturing Limited. “Now, as part of the Axion Group, we are looking forward to working together even more closely to grow this part of our business as we develop the next generation of bioelectronic assay consumables. Alongside our biosensor business, we will continue to maintain and grow our strong position in touch-panel devices.”
About Axion BioSystems
Axion BioSystems is a leading life science tools company focused on developing and commercializing label-free, bioelectronic assays used to study the function of live cells in vitro for drug discovery and disease modeling. The team at Axion BioSystems is dedicated to continuing the advancement of bioelectronic assay technology that enables the understanding of biological complexity outside of the body. Axion BioSystems is headquartered in Atlanta, Georgia, USA, and also has an office in Shanghai, China. Axion has more than 90 employees across its current locations.
About M-Solv Manufacturing Limited
M-Solv Manufacturing Limited develops and manufactures unique printed electronics, making industrial-grade capacitive touch panels and biosensors at its foundry in Oxford, UK. Prior to acquisition by Axion, the company was part of the M-Solv Ltd. group of companies. M-Solv Ltd. is a world leader in the supply of advanced laser and inkjet digital production tools with teams based in Taiwan, Hong Kong, and Shenzhen, and is ultimately owned by the Hong Kong-based CN Innovations Group.