A Randomized Study of Andexanet Alfa Compared to Usual Care in Patients Receiving a Factor Xa Inhibitor Who Require Urgent Surgery or Procedure (ANNEXA-RS)

The study will aim to find out if the drug andexanet alfa is safe and effective in preventing major bleeding during urgent surgery or invasive procedures. The study will compare the use of andexanet alfa to the usual care given at the study center.

Start Date20 Oct 2023

Sponsor / Collaborator

AstraZeneca PLC

NCT05898412 / RecruitingNot Applicable

Retrospective Real World Evidence Study to Describe Characteristics and Outcomes in Dutch Patients Admitted to the Hospital With a Factor Xa Inhibitor-associated Bleeding Treated With Andexanet Alfa

This is an observational retrospective database study of hospitalized patients treated with andexanet alfa in approximately 10 Dutch hospitals. Currently there is limited information on the patient characteristics and outcomes of patients who are treated with andexanet alfa in The Netherlands and how it is used. This is of interest for treating clinicians because there is a need for a patient profile, also due to the on par position of andexanet alfa with PCC in the Dutch national guideline.

Start Date06 Oct 2023

Sponsor / Collaborator

AstraZeneca PLC

NCT05548777 / CompletedNot Applicable

Andexanet Alfa and 4F-PCC Use in Patients Hospitalised With an Anticoagulant-related Major Bleed

This is an observational study based on data collected via an audit of electronic medical charts. The study population will include adult US patients treated with andexanet alfa or 4F-PCC during a hospitalization for an anticoagulation-related major bleed, and their characteristics, treatments and outcomes will be described.

Start Date15 Sep 2022

Sponsor / Collaborator

AstraZeneca PLC

[+1]

100 Clinical Results associated with Andexanet alfa

100 Translational Medicine associated with Andexanet alfa

100 Patents (Medical) associated with Andexanet alfa

382

Literatures (Medical) associated with Andexanet alfa

01 Feb 2024·Journal of pharmacy practice

Real-World Reversal of Factor Xa Inhibition in the Setting of Major Life-Threatening Bleeding or Urgent Surgery

Article

Author: Martin, Niels D. ; Hinton, Matthew S. ; Schmidt, Lauren E.

Background: Management of major life-threatening bleeding with factor Xa (FXa) inhibition poses complex challenges involving novel direct reversal agents competing with non-specific preexisting strategies. The recent availability of andexanet alfa (AA) led to a health-system guideline incorporating its use alongside the most commonly used historic agent, four-factor prothrombin complex concentrate (4F-PCC). Objectives: The objective was to characterize the use and efficacy of AA and 4F-PCC for reversal of FXa inhibition after implementation of the health-system guideline. Methods: This multi-hospital, retrospective cohort study included patients aged >18 years administered either AA or 4F-PCC between October 2018 to June 2020 with the indication for urgent reversal of FXa inhibitor-induced coagulopathy. The primary outcome assessed hemostatic efficacy between treatment groups. Secondary outcomes evaluated adjunct blood product administration, incidence of repeat pharmacologic reversal, incidence of thromboembolism, intensive care unit and hospital length of stays, and in-hospital mortality. Results: Eighty-five patients were included; 33 patients received AA and 52 patients received 4F-PCC. Effective hemostasis was achieved at similar rates in both treatment groups (84.8% vs 76.9%; P = .373). Thrombotic events occurring during the observed hospitalization were more frequent among the AA treated group (18% vs 3.8%, P = .027). No differences were observed for other secondary outcomes. Conclusion: Guideline use resulted in similar rates of effective hemostasis with a higher incidence of VTE in patients receiving AA. Further exploration with a larger, prospective study to evaluate these findings is warranted.

01 Feb 2024·British journal of anaesthesia

Comparative analysis of andexanet alfa and prothrombin complex concentrate in reversing anticoagulation by rivaroxaban ex vivo

Article

Author: Schöchl, Herbert ; Deventer, Katharina ; Rayatdoost, Farahnaz ; Rossaint, Rolf ; Grottke, Oliver

BACKGROUND:

The comparative effectiveness of the specific antidote andexanet alfa vs the nonspecific therapy four-factor prothrombin complex concentrates (4F-PCCs) as reversal agents for direct factor Xa (FXa) inhibitors in severely bleeding patients is unclear. We hypothesised that specific reversal using andexanet alfa would be more effective than a high dose of PCC (50 IU kg^-1) for reversing the FXa inhibitor rivaroxaban.

METHODS:

The reversal potential of andexanet alfa, various 4F-PCCs, and activated PCC was investigated ex vivo in human blood anticoagulated with rivaroxaban (37.5, 75, 150, and 300 ng ml^-1) using a panel of coagulation parameters, including conventional coagulation assays, thrombin generation, and a newly developed viscoelastometric device. We simulated in vivo conditions of coagulation activation and fibrin formation using flow chamber experiments of thrombogenicity potential under arterial flow conditions.

RESULTS:

The 4F-PCCs normalised clotting profiles only at low rivaroxaban concentrations, whereas andexanet alfa and activated PCC significantly shortened clotting time at all rivaroxaban concentrations. Only andexanet alfa restored thrombin generation to baseline. Flow chamber results showed that various 4F-PCCs concentration-dependently restored clot formation.

CONCLUSIONS:

In contrast to thrombin generation measurements, haemostatic reversal of rivaroxaban using high-dose 4F-PCCs exhibited similar efficacy as andexanet alfa in flow chamber experiments. The haemostatic effects of 4F-PCCs and andexanet alfa in the context of bleeding patients taking FXa inhibitors requires further study.

01 Jan 2024·Thrombosis and haemostasis

Dose-Related Effectiveness of Andexanet Alfa for Reversal of Apixaban Anticoagulation in a Porcine Polytrauma Model

Article

Author: Braunschweig, Till ; Schöchl, Herbert ; Rayatdoost, Farahnaz ; Rossaint, Rolf ; Grottke, Oliver

Background Andexanet alfa (andexanet) is a reversal agent for use in patients with life-threatening or uncontrolled bleeding treated with oral factor Xa (FXa) inhibitors. There are limited data on the dose–response relationship of andexanet and FXa inhibitor-related bleeding. Objective The aim of this study was to assess the dose-related effectiveness of andexanet in reducing blood loss, improving survival, and reversing apixaban anticoagulation in a porcine polytrauma model. Methods Apixaban was given orally to 40 male pigs for 3 days at a dose of 20 mg/d. On day 3, following bilateral femur fractures and blunt liver injury, animals (n = 8/group) received andexanet (250-mg bolus, 250-mg bolus + 300-mg 2-hour infusion, 500-mg bolus, or 500-mg bolus + 600-mg 2-hour infusion) or vehicle (control). Total blood loss was the primary endpoint. Coagulation parameters were assessed for 300 minutes or until death. Data were analyzed with a mixed-model analysis of variance. Results Administration of 250-mg bolus + 300-mg infusion, andexanet 500-mg bolus, and 500-mg bolus + 600-mg infusion significantly decreased total blood loss by 37, 58, and 61%, respectively (all p < 0.0001), with 100% survival. Andexanet 250-mg bolus was ineffective in reducing total blood loss (6%) and mortality (63% survival) versus controls. Andexanet 500-mg bolus ± infusion neutralized anti-FXa activity to less than 50 ng/mL. Andexanet neutralization of thrombin generation and thromboelastometry parameters was dose and infusion time dependent. Conclusion In a porcine polytrauma model with major bleeding on apixaban, andexanet dose dependently decreased anti-FXa activity. Lower anti-FXa levels (<50 ng/mL) with andexanet 500-mg bolus ± infusion were correlated with 60% less blood loss and 100% survival versus controls.

News (Medical) associated with Andexanet alfa

05 Feb 2024

·www.globenewswire.com

Lexeo Therapeutics Strengthens Clinical Development Leadership with New Executive Appointments

NEW YORK, Feb. 05, 2024 (GLOBE NEWSWIRE) -- Lexeo Therapeutics, Inc. (Nasdaq: LXEO), a clinical stage genetic medicine company dedicated to pioneering treatments for genetically defined cardiovascular diseases and APOE4-associated Alzheimer's disease, today announced new executive appointments to lead the evolution of the company’s pipeline into late-stage clinical development. “The accumulating talent bench at Lexeo has overseen some of the most transformative clinical development programs, drug approvals and product launches in rare disease and precision cardiovascular medicine,” said R. Nolan Townsend, Chief Executive Officer of Lexeo Therapeutics. “We look forward to benefiting from this group’s thought leadership and operational experience as we progress the Lexeo pipeline towards late-stage studies.” The appointments include: Sandi See Tai, MD, has been promoted to Chief Development Officer. Prior to Lexeo, Dr. See Tai was VP & Development Head for Rare Disease at Pfizer, responsible for setting the Rare Disease internal portfolio strategy and delivering its clinical development portfolio of investigational products and in-line assets. She served as the Medicine Team Lead for clinical programs across multiple therapeutic areas including Rare Cardiovascular, Neurology, Renal and Pulmonary disease areas. During her tenure, Dr. See Tai led the late-stage clinical development program of tafamidis for ATTR cardiomyopathy (ATTR-ACT), which achieved global regulatory approvals, and the Phase 3 LMNA dilated cardiomyopathy clinical program. In addition to late-stage clinical development, Dr. See Tai was responsible for strategic clinical planning for early-stage development candidates such as those for other genetic cardiomyopathies and Duchenne Muscular Dystrophy. With almost 20 years of experience in the pharmaceutical industry, Dr. See Tai held multiple roles of increased scope and responsibility across Global Medical Affairs in Transplantation at Wyeth Pharmaceuticals before moving into clinical development at Pfizer. Prior to joining the pharmaceutical industry, Dr. See Tai was Assistant Professor of Pediatrics at Drexel University College of Medicine and Attending Physician in Pediatric Nephrology at St. Christopher’s Hospital for Children, Philadelphia, where she also completed her General Pediatrics residency and Pediatric Nephrology fellowship. She received her MD from Tufts University School of Medicine, Boston.Eric Adler, MD, has been appointed Chief Medical Officer & Head of Research. As a pioneer and thought leader in cardiovascular gene therapy, Dr. Adler formerly served as Chief Scientific Officer at Lexeo since joining in 2022. Prior to this role, Dr. Adler served as Professor of Medicine, head of the Heart Failure Section, Director of the Strauss Center for Cardiomyopathy, and the Czarina and Humberto S. Lopez Chancellor’s Endowed Chair in Cardiology at the University of California, San Diego (UCSD). Dr. Adler’s work has led to the development of a novel cardiovascular gene therapy candidate entering late-stage clinical development. His research is focused on the study and treatment of cardiomyopathy, and he has published over 100 papers in peer reviewed journals on the topic. Dr. Adler is currently an associate editor of Circulation Hearth Failure and has served on leadership, grant review, and guidelines committees for the American Heart Association, the Heart Failure Society of America, the International Society of Heart and Lung Transplant, and the National Institute of Health. Dr. Adler earned his medical degree from the Boston University School of Medicine.Rajiv Patni, MD, has been appointed Senior Advisor to the Chief Executive Officer and Board of Directors of Lexeo. Dr. Patni was formerly Chief Research and Development Officer at Reata Pharmaceuticals (acquired by Biogen for $7.3 billion), a commercial-stage biopharmaceutical company that received approval for Skyclarys, the first FDA-approved therapy for Friedreich’s ataxia. Prior to this role, Dr. Patni served as Chief Medical Officer at several public, small-cap, commercial-stage biopharmaceutical companies including Portola (acquired by Alexion for $1.4 billion) and Global Blood Therapeutics (acquired by Pfizer for $5.4 billion) and at those companies, Dr. Patni oversaw the clinical studies leading to the approvals of Andexxa and Oxbryta. Dr. Patni joined these companies at inflection points in their research and development growth trajectories and significantly supported their successful acquisitions. Over his 24-year industry tenure in global product development, Dr. Patni has contributed to the development of 21 new chemical entities in several therapeutic areas including cardiology, diabetology, hepatology, neurology, and benign hematology. His experience in fostering successful teams from 35 to 250 colleagues contributed to the approval of 11 medicines from the US FDA, EMA, and other regulatory agencies. The recent approvals include medicines for several rare diseases such as pulmonary arterial hypertension, advanced Parkinson’s disease, sickle cell disease, and Friedrich’s ataxia. Dr. Patni received his MD from the Mount Sinai School of Medicine in New York City as part of an accelerated BS/MD Program. He completed his internal medicine residency and adult cardiology fellowship at the Albert Einstein College of Medicine, also in New York City, where he continued as an attending physician-scientist before joining the biopharmaceutical industry. Jenny R. Robertson has been appointed Chief Business and Legal Officer. Ms. Robertson formerly served as Chief Legal and Administrative Officer at Lexeo, leading legal, human resources, information technology, information security, and facilities strategies and activities. Prior to Lexeo, Ms. Robertson served as Chief Counsel to Pfizer’s Oncology Business Unit and held other senior legal roles including Chief Counsel for Pfizer’s Rare Disease Business Unit, where she led the global legal team for five years. Across positions at Pfizer, Ms. Robertson counseled clients on a range of business and legal matters including commercialization, disclosure, business development, alliance management, clinical development, intellectual property issues and litigation. Before joining Pfizer in 2010, Ms. Robertson spent 10 years in private practice with a large international law firm in New York and Washington, D.C., engaged in complex commercial litigation with a healthcare focus. Ms. Robertson holds a Bachelor of Arts Degree in Political Science from Southern Illinois University and a J.D. from the Georgetown University Law Center, where she co-founded and served as Editor-in-Chief of The Georgetown Journal of Gender and the Law. About Lexeo TherapeuticsLexeo Therapeutics is a New York City-based, clinical stage genetic medicine company dedicated to transforming healthcare by applying pioneering science to fundamentally change how genetically defined cardiovascular diseases and APOE4-associated Alzheimer’s disease are treated. Using a stepwise development approach, Lexeo is leveraging early proof-of-concept functional and biomarker data to advance a pipeline of cardiovascular and APOE4-associated Alzheimer’s disease programs. Media Response:Janine Bogris(201) 245-6838janine.bogris@canalecomm.com Investor Response:Laurence Watts(619) 916-7620laurence@gilmartinir.com

Executive ChangeAcquisitionDrug ApprovalPhase 3

17 Jan 2024

·pipelinereview.com

Tr1X, Inc. Announces $75 Million Series A Financing to Develop Best-in-Class Universal Allogeneic Regulatory T (Treg) and CAR-Treg Cell Therapies to Treat and Potentially Cure Autoimmune and Inflammatory Diseases

SAN DIEGO, CA, USA I January 17, 2024 I Tr1X, Inc. today announced its emergence from stealth with a $75 million Series A financing to bring universal allogeneic regulatory T (Treg) and CAR-Treg cell therapies to the clinic to treat and potentially cure autoimmune and inflammatory diseases. The financing was led by Bay Area-based The Column Group, with participation from NEVA SGR and Alexandria Ventures. The Company appointed William Lis Chief Executive Officer, strengthened its leadership team with other biopharma industry veterans, and announced members of the Board of Directors and Scientific Advisory Board. "We are thrilled to partner with Bill Lis, Maria Grazia Roncarolo and Tr1X's world-class team to revolutionize the field through its innovative, breakthrough science," said Leon Chen, Ph.D., MBA, Partner at The Column Group and Tr1X Board Member. "With its experienced management team at the helm, we are confident in Tr1X's ability to bring curative cell therapies to patients who currently require life-long treatment and management." Science and Pipeline The Company's science is primarily based on the work of Tr1X's Scientific Founder Maria Grazia Roncarolo, M.D., the discoverer of Type 1 regulatory T (Tr1) cells, which have features that can benefit patients with autoimmune and inflammatory diseases. Tr1 cells, a differentiated subpopulation of regulatory T cells, are crucial for maintaining homeostasis and tolerance in healthy individuals and have several important functions. These include dampening of local inflammation and downregulation of the inflammasome, suppression of pathogenic effector T cell responses, and induction of long-term tolerance as observed in preclinical models and patients. Tr1X's proprietary technology enables the conversion of CD4 + T cells isolated from healthy donors into Treg-like cells that have a similar function and profile to naturally occurring Tr1 cells. These cells can be further engineered to target specific tissues or organs to enable local, targeted immunomodulation. With a proprietary, GMP-grade, closed-loop system that provides consistency, quality and reliability at scale, Tr1X can enable production of its products at commercial volume. Currently, Tr1X is working on its first investigational Tr1 cell therapy, TRX103, which it plans to evaluate in a Phase 1 trial to prevent Graft versus Host Disease (GvHD) in patients undergoing mismatched hematopoietic stem cell transplant. The Company is developing additional pipeline programs to treat inflammatory bowel disease, Type 1 diabetes and multiple B-cell mediated autoimmune diseases. "The ability to develop a pipeline of medicines based on our work on regulatory T cells represents the culmination of decades of discovery and research into the underpinnings of immunological tolerance and autoimmunity," said Dr. Roncarolo, Scientific Founder, President and Head of R&D at Tr1X. "Tr1 cells have unique properties and represent the ideal therapeutic platform from which to develop 'immune reset' products. Our two platforms have the required attributes to address a broad set of indications, including dual targeting of pathogenic T and B cells. These engineered cells have the potential to induce tolerance, which could transform the lives of people living with chronic autoimmune diseases by providing them with a cure instead of ongoing treatment." Proven Leadership Team, Board of Directors and Scientific Advisory Board Tr1X is led by industry veterans with cell therapy expertise who have a track record of discovery, development and commercialization of more than a dozen novel first- or best-in-class medicines. Chief Executive Officer William "Bill" Lis has more than 25 years of biotech executive leadership experience in building companies and product pipelines from R&D stage through commercialization. He most recently served as Chairman and interim CEO of Jasper Therapeutics, Inc., from 2019 to 2022, where he led the company's Series A and follow-on financings and successful brequilimab Phase 1 study readouts in hematopoietic stem cell transplantation. Before that, he served as Chief Executive Officer and a Director of Portola Pharmaceuticals, Inc. from 2008 to 2018 after serving as Chief Operating Officer, where he built the company from a private research-stage startup into a multi-billion dollar public company that launched Andexxa ® and Bevyxxa ® . Portola was acquired by Alexion Pharmaceuticals, Inc. in 2020. Previously, Mr. Lis held executive positions at Scios, Inc. (a Johnson & Johnson company) where he last served as Senior Vice President of New Product Development and Business Development, leading in-licensing efforts, development and commercial P&L operations for Xarelto ® and the company's therapeutics pipeline. Earlier in his career, he held positions at Millennium Pharmaceuticals, Inc., COR Therapeutics, Inc. and Rhone Poulenc Rorer. He is a director of Zai Laboratories, Inc. Scientific Founder, President and Head of R&D Dr. Maria Grazia Roncarolo is the George D. Smith Professor in Stem Cell and Regenerative Medicine, Professor of Pediatrics and Medicine, Founder of the Center for Definitive and Curative Medicine, and former Co-Director of the Institute for Stem Cell Biology and Regenerative Medicine at Stanford University. Dr. Roncarolo has spent her career translating discoveries in immune-mediated diseases and regenerative medicine into novel patient therapies. She and her team were the first to discover Type 1 regulatory T cells in patients and the first to develop curative treatments for ADA-SCID. A pediatric immunologist by training, she was instrumental in bringing novel cell and gene therapies to market, including Strimvelis ® and Libmeldy ® . She is a Co-Founder of the gene-editing companies Graphite Bio and Kamau Therapeutics. Co-Founder and Chief Operating Officer David de Vries has over a decade of experience founding and scaling companies at the intersection of healthcare, biology and technology. Prior to Tr1X, he was Co-Founder and Chief Operating Officer of Arine, a medication intelligence and therapeutic optimization company he helped start, launch and scale to serve millions of patients, working with some of the largest healthcare organizations in the U.S. Previously, he worked at Proteus Digital Health, an innovative drug-device company and the first in the field to obtain FDA approval for a digital medicine, Abilify MyCite ® . "Tr1X is committed to bringing cures to millions of patients suffering from autoimmune diseases through our scalable, universal allogeneic cell therapy process that has been demonstrated to yield billions of cells in a single run," said Mr. Lis, CEO of Tr1X. "In just 18 months, the Tr1X team has successfully closed a Series A financing and extension, assembled an experienced leadership team, board of directors and scientific advisory board, and established a scalable GMP-grade manufacturing process. We are well positioned to advance our pipeline of first-of-their kind allogeneic engineered Treg and CAR-Treg cell therapies that have the potential to address the significant limitations of current cell therapies for autoimmune diseases, which include, among others, poor trafficking, lack of stability, limited persistence and induction of cytokine-associated toxicities, at a fraction of the cost per dose." In addition to Mr. Lis, Dr. Roncarolo and Mr. de Vries, the Tr1X leadership team includes Xavier Paliard, Pharm.D., Ph.D., Chief Scientific Officer; James Adams, MBA, Chief Technical Officer; Jonathan Perrin, J.D., Co-Founder and General Counsel; and Erik Poulsen, M.S., Head of Regulatory Affairs. Joining Mr. Lis and Dr. Roncarolo on Tr1X's Board of Directors are: Tr1X has recruited experts in immunology, stem cell and gene therapy, T-cell biology and immune-mediated diseases to join its Scientific Advisory Board. They include: About Tr1X Tr1X is a privately held biotechnology company focused on engineering cures for immune and inflammatory diseases. Founded by industry veterans, including the scientists behind the discovery of Tr1 cells, the company's pipeline of universal allogeneic cell therapies is being developed for diseases with high unmet medical need. The company is headquartered in San Diego, has developed a robust intellectual property portfolio, and is backed by leading investors, including The Column Group, NEVA SGR and Alexandria Ventures. For more information visit: www.tr1x.bio . SOURCE: Tr1X

Cell TherapyExecutive ChangePhase 1ImmunotherapyGene Therapy

17 Oct 2023

·www.globenewswire.com

Olema Oncology Appoints Oncology Biotech Executive Scott Garland to Board of Directors

Mr. Garland brings significant industry expertise with a long track record of successful launchesSAN FRANCISCO, Oct. 17, 2023 (GLOBE NEWSWIRE) -- Olema Pharmaceuticals, Inc. (“Olema” or “Olema Oncology,” Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women’s cancers, today announced the appointment of Scott Garland to the company’s Board of Directors. Mr. Garland brings more than 30 years of biopharmaceutical industry experience with deep commercial and executive leadership expertise. “We are delighted to have Scott join our Board of Directors at such an exciting time for Olema,” said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. “His broad experience on the frontlines of the biopharmaceutical industry, leading the commercialization of groundbreaking therapies, will be crucial as we enter the late-stage development of palazestrant.” Mr. Garland most recently served as CEO of PACT Pharma, an immuno-oncology company that was focused on developing cell therapies for solid tumors. Prior to PACT, Mr. Garland was president and chief executive officer of Portola Pharmaceuticals where he led the company through the commercial launch of Andexxa® and a successful acquisition by Alexion. Before joining Portola, he served first as chief commercial officer of Relypsa and then as president of the U.S. organization after the company was acquired by Vifor Pharma. Mr. Garland has held numerous other commercial leadership roles at Exelixis (leading the launch of cabozantinib), Genentech, Amgen, and Merck, including leading the commercial franchises for two multi-billion-dollar therapies – Avastin® and Rituxan®. Mr. Garland currently serves as a board member for ALX Oncology and Day One Biopharmaceuticals. He received a B.S. from California Polytechnic State University-San Luis Obispo and an MBA from the Fuqua School of Business at Duke University. “Olema is well along the path of advancing their mission to transform the standard of care for women living with breast cancer, and I am excited to contribute as palazestrant moves into Phase 3 and new pipeline assets are announced,” said Mr. Garland. “As Olema continues to advance its pipeline, I believe that Olema’s science, the management team’s track record of success, and its strong financial foundation positions the company well to define the next generation of targeted therapies for women’s cancers.” “On behalf of Olema’s Board of Directors, I would like to welcome Scott to the Board, and we look forward to benefiting from his unique perspective and counsel as we navigate this pivotal moment in Olema’s history,” Ian Clark, Chairman of Olema’s Board of Directors. About Olema OncologyOlema Oncology is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women’s cancers. Olema’s lead product candidate, palazestrant (OP-1250), is a proprietary, orally-available small molecule with dual activity as both a complete estrogen receptor (ER) antagonist (CERAN) and a selective ER degrader (SERD). It is currently being evaluated both as a single agent in an ongoing Phase 2 clinical trial, and in combination with CDK4/6 inhibitors (palbociclib and ribociclib) and a PI3Ka inhibitor (alpelisib), in patients with recurrent, locally advanced or metastatic ER-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. Palazestrant has been granted FDA Fast Track designation for the treatment of ER+/HER2- metastatic breast cancer that has progressed following one or more lines of endocrine therapy with at least one line given in combination with a CDK4/6 inhibitor. Olema is headquartered in San Francisco and has operations in Cambridge, Massachusetts. For more information, please visit us at www.olema.com, or follow us on Twitter and LinkedIn. Forward Looking Statements Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Words such as “anticipate,” “expect,” “will,” “may,” “goal,” “potential” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These statements include those related to the potential beneficial characteristics of palazestrant (OP-1250), including the potential to become best-in-class or transform the standard of care for women living with ER+/HER2- metastatic breast cancers, the capabilities of Olema’s executive management team and board of directors, the clinical timeline and status for palazestrant, and Olema’s preclinical and clinical pipeline. Because such statements deal with future events and are based on Olema’s current expectations, they are subject to various risks and uncertainties, and actual results, performance or achievements of Olema could differ materially from those described in or implied by the statements in this press release. These forward-looking statements are subject to risks and uncertainties, including, without limitation, those discussed in the section titled “Risk Factors” in Olema’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2023, and future filings and reports that Olema makes from time to time with the U.S. Securities and Exchange Commission. Except as required by law, Olema assumes no obligation to update these forward-looking statements, including in the event that actual results differ materially from those anticipated in the forward-looking statements. Contact:Geoffrey Mogilner, Vice President, Investor Relations and Communicationsir@olema.com

Executive ChangePhase 2Fast TrackAcquisition

100 Deals associated with Andexanet alfa

External Link

KEGG	Wiki	ATC	Drug Bank
D11029	Andexanet alfa	V03AB38	DB14562

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Hemorrhage	US	Portola Pharmaceuticals LLC	03 May 2018
Hemorrhage	US	AstraZeneca AB	03 May 2018

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ISTH2023	Not Applicable	Hemorrhage factor Xa (FXa) inhibitors rivaroxaban \| apixaban	-	Andexanet alfa	uytnbdfgvm(hnavvesexw) = kqdfsiwxjh bltwcjysci (sylcxzwsjl ) View more	-	24 Jun 2023
				4-factor prothrombin complex concentrate	uytnbdfgvm(hnavvesexw) = bvbvmvzfdr bltwcjysci (sylcxzwsjl ) View more
ISTH2023	Not Applicable	Hemorrhage	-	Andexanet alfa	bcyprinnky(snllbjvyel) = ilmbuvcdzj sippipnkrt (ofickeywso )	-	24 Jun 2023
				4-Factor Prothrombin Complex Concentrate (4F-PCC)	bcyprinnky(snllbjvyel) = fmezcdmuvk sippipnkrt (ofickeywso )
NCT02329327 (ANNEXA-4, Pubmed)	Phase 3	Hemorrhage	479	Andexanet alfa	hxgscdmnrl(woubywmpcu) = aetekruapc tkywctyhrx (yemduimywf, 10.0)	-	20 Feb 2023
ISTH2022	Not Applicable	-	-	Unfractionated Heparin (UFH)	kfzxmqqtbe(cemixvjryi) = bqvqawdidc qwwcqgqpij (vtkmrjwsvf )	-	09 Jul 2022
				Enoxaparin	kfzxmqqtbe(cemixvjryi) = crovyfnous qwwcqgqpij (vtkmrjwsvf )
ISTH2022	Not Applicable	-	-	Andexanet alfa	kbmemmzvqa(qpzmokmsae) = uvrauuubyj nypbczcxui (rhwoevxrkx )	-	09 Jul 2022
				4F-PCC	kbmemmzvqa(qpzmokmsae) = mggcwcnjwz nypbczcxui (rhwoevxrkx )
NCT02329327 (Pubmed)	Phase 3	Intracranial Hemorrhages	-	Andexanet alfa	crxtzrfbhq(ydtfqbfymh) = mnuoqmlnvn hbgumhauwb (lyrzxxsgvo ) View more	-	16 Jun 2022
				Four-factor prothrombin complex concentrate (4F-PCC)	crxtzrfbhq(ydtfqbfymh) = cupxszoyde hbgumhauwb (lyrzxxsgvo ) View more
AAN2022	Not Applicable	Cerebral Hemorrhage DOAC type	43	Andexanet alfa	oktbtxgalj(fzuhyzhsnz) = nxyjpqmveo vfzabpezgg (bbfreyuzgp )	-	03 May 2022
ISTH2021	Not Applicable	-	-	Anti-Xa agents (oral)	xnyjdcenwt(eijxxiovxk) = vdmsdxlqqn ddvzfzrstb (rhbogusiji )	-	17 Jul 2021
				Anti-Xa agents (parenteral)	xnyjdcenwt(eijxxiovxk) = oeljozqtmz ddvzfzrstb (rhbogusiji )
ISC2021	Not Applicable	Hemorrhage	-	Idarucizumab	zxdzlxgfgn(szykgzbjpr) = ykqzmtiqbz fgdzwlttoq (kkbgtowdfp )	-	01 Mar 2021
				Andexanet Alfa	zxdzlxgfgn(szykgzbjpr) = jtigrsifvb fgdzwlttoq (kkbgtowdfp )
ISC2021	Not Applicable	Cerebral Hemorrhage	604	Andexanet alfa	nouhaethbs(lglytrhkzx) = pxcdvqshva ffdwcnuwwh (xjgdqqopbz, 3 - 8)	-	01 Mar 2021

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