Tectonic Therapeutic to Host KOL Event on the Unmet Need in Group 2 PH-HFpEF and TX45 as a Potential Treatment on Thursday, December 12, 2024

AVRO 12.03.2024

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WATERTOWN, Mass.,Dec. 03, 2024(GLOBE NEWSWIRE) --Tectonic Therapeutic, Inc.(NASDAQ: TECX) (“Tectonic”) a clinical stage biotechnology company focused on the discovery and development of therapeutic proteins and antibodies that modulate the activity of G-protein coupled receptors (“GPCRs”), today announced it will host a virtual key opinion leader (KOL) event onThursday, December 12, 2024from4:00 PM to 6:00 PM ET. To register,click here.

Key opinion leaders will includeJohn R. Teerlink, MD, FHFSA (University of California San Francisco) andRaymond L. Benza, MD, FACC, FAHA, FACP (Icahn School of Medicine at Mount Sinai),whowill discuss the unmet medical need and current treatment landscape for patients with Group 2 Pulmonary Hypertension due to Heart Failure with Preserved Ejection Fraction (Group 2 PH-HFpEF).

The event will focus on Tectonic’s lead program, TX45, an investigational Fc-relaxin fusion protein with optimized pharmacokinetics and biophysical properties that activates the RXFP1 receptor, the GPCR target of the hormone relaxin. TX45 is being evaluated in patients with Group 2 PH-HFpEF in an ongoing Phase 1b hemodynamic proof-of-concept study and a Phase 2 clinical proof-of-concept study.

A live question and answer session will follow the formal presentations.

About the Key Opinion Leaders:

ProfessorJohn R. Teerlink, MD, FACC, FAHA, FESC, FHFA, FHFSA, FRCP (London)Professor Teerlinkis Professor of Medicine at theUniversity of California San Francisco(UCSF). After graduating fromSwarthmore Collegewith a Religion major, he received an MD fromHarvard Medical Schooland completed his Internal Medicine residency and Cardiovascular Medicine fellowship at UCSF, as well as post-doctoral fellowships in Cardiovascular pharmacology (Hoffman-LaRoche;Basel, Switzerland), echocardiography (UCSF) and heart failure (UCSF-affiliated hospital).

He is actively involved in the design and execution of many heart failure clinical trials, serving on endpoint, data monitoring, steering and executive committees for numerous international studies investigating a variety of new pharmacologic therapies, as well as stem cell and gene therapies, diagnostic modalities and other devices. He was the lead clinical investigator for the serelaxin development program, serving as Principal Investigator for Pre-RELAX-AHF, RELAX-AHF, RELAX-AHF-2 and RELAX-Repeat, and as a steering committee member for RELAX-AHF-Asia.

Dr. Teerlinkhas served on theUS FDA Cardiovascular and Renal Drug Advisory Committee, as well as on other FDA drug, device, diagnostics, and vaccine panels and serves as a consultant on pre-clinical and clinical development programs in multiple areas of cardiology, as well as in non-cardiovascular indications.Dr. Teerlinkwas a founding physician member of theAmerican Association of Heart Failure Nursesand is a Past President of theHeart Failure Society of America. He was an Associate Editor for theJournal of Cardiac Failure, Guest Editor-in-Chief and Associate Editor for JACC: Heart Failure, and is a clinical scholar presenting many lectures and over 300 publications, including a chapter on Acute Heart Failure in Braunwald’s Heart Disease textbook. He was profiled inThe Lancetas an internationally recognized leader in heart failure.

Raymond L. Benza, MD, FACC, FAHA, FACPDr. Benzais a Professor and System Director of Pulmonary Hypertension at theIcahn School of Medicine at Mount Sinai,Mount Sinai Fuster Heart Hospital. He is a fellow of theAmerican College of Physicians, theAmerican Heart Association Council on Clinical Cardiology, theAmerican College of Chest Physiciansand theAmerican College of Cardiology. He is a diplomat of the AmericanBoard of Internal Medicinewith certification in the subspecialties of cardiovascular diseases and advanced heart failure and transplantation.Dr. Benzacurrently holds administrative positions in thePulmonary Vascular Research Instituteand theInternational Society of Heart and Lung Transplantationand is the former treasurer of that society. He served on President Barak Obama’sAdvisory Committee on Organ Transplantation(ACOT) in theHealth Resources and Services Administrationfor 4 years and was knighted in 2015 by his Royal HighnessVittorio EmanueleofItalyfor his philanthropic work in patients with pulmonary arterial hypertension and was admitted to theAssociation of University Cardiologists. He sits on multiple journal editorial committees and is the Steering Committee Chair for several industry trials in PAH. His primary clinical interests are the evaluation and treatment of advanced congestive heart failure, cardiac transplantation, and pulmonary arterial hypertension (PAH). He participates in major clinical studies of new therapies for the treatment of heart failure, mechanical support, and pulmonary hypertension.Dr. Benzais a funded investigator for theNational Institutes of Healthand theAmerican Heart Associationfor his work in pulmonary arterial hypertension focusing on risk stratification, pharmacogenomics and new device therapies for this disease state.

About TX45, a long-acting Fc-relaxin fusion proteinTX45 is an investigational Fc-relaxin fusion protein with optimized pharmacokinetics and biophysical properties that activates the RXFP1 receptor, the G-protein coupled receptor target of the hormone relaxin. Relaxin is an endogenous protein, expressed at low levels in both men and women that is a pulmonary and systemic vasodilator with lusitropic, anti-fibrotic and anti-inflammatory activity. In normal human physiology, relaxin is upregulated during pregnancy where it exerts vasodilative effects, reduces systemic and pulmonary vascular resistance and increases cardiac output to accommodate the increased demand for oxygen and nutrients from the developing fetus. Relaxin also exerts anti-fibrotic effects on pelvic ligaments to facilitate delivery of the baby.

About Group 2 Pulmonary Hypertension in HFpEFTheWorld Health Organizationhas defined five groups of pulmonary hypertension (“PH”). Tectonic is focused on the Group 2 subtype, a condition that develops due to left-sided heart disease, specifically pulmonary hypertension secondary to left heart failure with preserved ejection fraction (“PH-HFpEF”). In patients with PH-HFpEF, chronic heart failure leads to increased blood pressure in the pulmonary arteries, exerting severe strain on the right side of the heart, which adapts poorly to the increased pressure. This increased pulmonary pressure gradually causes worsening exercise capacity, shortness of breath and right-sided heart failure which can lead to death. Although several Group 1 PH (Pulmonary Arterial Hypertension, PAH) medications have been explored in Group 2 PH, to date, no medications have been approved for its treatment.

About TectonicTectonicis a biotechnology company focused on the discovery and development of therapeutic proteins and antibodies that modulate the activity of G-protein coupled receptors (“GPCRs”). Leveraging its proprietary technology platform called GEODeTM (GPCRs Engineered for Optimal Discovery), Tectonic is focused on developing biologic medicines that overcome the existing challenges of GPCR-targeted drug discovery and harness the human body to modify the course of disease. Tectonic focuses on areas of significant unmet medical need, often where therapeutic options are poor or nonexistent, as these are areas where new medicines have the potential to improve patient quality of life. Tectonic is headquartered inWatertown, Massachusetts. For more information, please visitwww.tectonictx.comand follow onLinkedIn.

Forward-Looking StatementsThis press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. All statements in this press release other than statements of historical facts are “forward-looking statements. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include statements regarding: the design, objectives, initiation, timing, progress and results of clinical trials of Tectonic’s product candidates, including the ongoing Phase 1b and Phase 2 clinical trials for TX45 in Group 2 PH-HFpEF; and the potential properties and benefits of TX45. These forward-looking statements are based on Tectonic’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties that could cause Tectonic’s clinical development programs, future results or performance to differ materially from those expressed or implied by the forward-looking statements. Many factors may cause differences between current expectations and actual results, including: the potential that success in preclinical testing and earlier clinical trials does not ensure that later clinical trials will generate the same results or otherwise provide adequate data to demonstrate the efficacy and safety of a product candidate; the impacts of macroeconomic conditions, including the conflict inUkraineand the conflict in theMiddle East, heightened inflation and uncertain credit and financial markets, on Tectonic’s business, clinical trials and financial position; unexpected safety or efficacy data observed during preclinical studies or clinical trials; clinical trial site activation or enrollment rates that are lower than expected; Tectonic’s ability to realize the benefits of its collaborations and license agreements; changes in expected or existing competition; changes in the regulatory environment; the uncertainties and timing of the regulatory approval process; and unexpected litigation or other disputes. Other factors that may cause Tectonic’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are identified under the heading “Risk Factors” in Tectonic’s quarterly report on Form 10-Q filed with theSEConNovember 12, 2024, and in other filings that Tectonic makes and will make with theSECin the future. Tectonic expressly disclaims any obligation to update any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law. For more information, please visitwww.tectonictx.comand follow onLinkedIn.

Source:Tectonic Therapeutic

Contacts:Investors:Dan FerryLifeSci Advisors(617) 430-7576daniel@lifesciadvisors.comMedia:Kathryn MorrisThe Yates Network(914) 204-6412kathryn@theyatesnetwork.com

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Source: Tectonic Therapeutic

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