Latest news with #eDSP
Business Wire
6 days ago
- Business
- Business Wire
Quince Therapeutics to Participate at A-T Society's 2025 A-T Clinical Research Conference
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Quince Therapeutics, Inc. (Nasdaq: QNCX), a late-stage biotechnology company dedicated to unlocking the power of a patient's own biology for the treatment of rare diseases, today announced its participation at the upcoming 2025 A-T Clinical Research Conference organized by the A-T Society, a leading Ataxia-Telangiectasia (A-T) patient advocacy group based in the United Kingdom. Taking place June 25-27, 2025 at Loughborough University in the U.K., key opinion leaders (KOLs) will present post hoc data analyses from the company's prior Phase 3 ATTeST clinical trial of its lead asset, eDSP, for the treatment of patients with A-T. Additionally, Quince management will provide an overview of its pivotal Phase 3 NEAT clinical trial. Highlights of A-T Clinical Research Conference Presentations KOLs will present the following data and information at the upcoming A-T Clinical Research Conference: Endocrine and Metabolic Events in Patients with A-T Treated with eDSP: William Whitehouse, M.D., Honorary Clinical Associate Professor of the School of Medicine at the University of Nottingham, England, recently retired Consultant Pediatric Neurologist at Nottingham Children's Hospital, Nottingham University Hospitals NHS Trust, and current Quince Scientific Advisory Board member, will provide a presentation titled Endocrine and Metabolic Events in Children with Ataxia-Telangiectasia Treated Long-term with Erythrocyte-Delivered Encapsulated Dexamethasone Sodium Phosphate (eDSP). The objective of the data analysis was to evaluate metabolic and endocrine adverse events (AEs), growth, and safety laboratory results in patients with A-T treated with eDSP. Key findings reported in Dr. Whitehouse's presentation highlighted that there were no reports of serious metabolic or endocrine events in the 68 patients with A-T treated with eDSP for two years or longer. Growth in height of these patients was also preserved. MiniATM Family Expression in Patients with A-T Treated with eDSP: Michele Menotta, Ph.D., Associate Professor in the Department of Biomolecular Sciences at the University of Urbino in Urbino, Italy, will provide a presentation titled MiniATM Family Expression in ATTeST: Molecular Insights into Unusual ATM Variants in A-T Cells. The objective of the data analysis investigates the potential relationship between miniATM family expression in the blood of patients with A-T who participated in Quince's prior Phase 3 ATTeST clinical trial and their corresponding neurological scores. Additionally, novel functions of the miniATM family were explored in A-T cells and its molecular mechanism of action was investigated. The analysis found that miniATM genes were present in 40% of patients with A-T and were correlated with A-T disease severity at baseline. Lab tests also showed results that may variably influence cell processes, offering new insights for potential treatments. Pivotal Phase 3 NEAT Enrollment Update Quince's management will provide an overview of the company's pivotal Phase 3 NEAT (N eurologic E ffects of e DSP on Subjects with A - T; #IEDAT-04-2022 / NCT06193200) clinical trial and latest enrollment update at the A-T Society meeting. A total of 99 participants have been enrolled to date, including 78 participants in the six to nine year-old primary analysis population and 21 participants aged 10 years or older. All 42 NEAT participants to date have elected to transition to the NEAT open label extension (OLE) study (NCT06664853 / IEDAT-04-2022). Quince is currently enrolling a pivotal Phase 3 NEAT clinical trial, which is an international, multi-center, randomized, double-blind, placebo-controlled clinical trial evaluating the neurological effects of eDSP (previously referred to as EryDex) treatment in patients with A-T. The company expects to report topline results in the first quarter of 2026 with a potential New Drug Application (NDA) submission to the FDA in the second half of 2026, assuming positive study results. Quince was granted Fast Track designation by the FDA for the company's eDSP System for the treatment of patients with A-T based on the potential for eDSP to address a high unmet medical need. About Ataxia-Telangiectasia A-T is an inherited autosomal recessive neurodegenerative and immunodeficiency disorder caused by mutations in the ATM gene, which is responsible for cell homeostatic and cell division functions including but not limited to double-stranded DNA repair. Typically, A-T is first diagnosed before the age of five as children begin to develop an altered gait and fall with greater frequency. Neurological symptoms worsen and patients with A-T frequently become wheelchair-bound by adolescence. Teenage years for patients with A-T are typically marked by repeated infections, pulmonary impairment, and malignancies. The median lifespan is approximately 25 to 30 years old with mortality due to infections and malignancy. Based on IQVIA Medical Claims (Dx), PharmetricsPlus (P+), and IQVIA Analytics information, there are approximately 4,600 diagnosed patients with A-T in the U.S. Quince estimates that there are approximately 5,000 patients with A-T in the U.K. and EU4 countries. There are currently no approved therapeutic treatments in any global market for A-T. About eDSP for A-T eDSP is comprised of dexamethasone sodium phosphate (DSP) encapsulated in a patient's own red blood cells (autologous erythrocytes). DSP is a corticosteroid well known for its anti-inflammatory properties as well as its dose-limiting toxicity due to adrenal suppression. The eDSP System is designed to provide the efficacy of corticosteroids and to reduce or eliminate the significant adverse effects that accompany chronic use of corticosteroid treatment. eDSP leverages Quince's proprietary Autologous Intracellular Drug Encapsulation, or AIDE, technology platform, which is a novel drug/device combination that uses an automated process designed to encapsulate a drug into the patient's own red blood cells. Red blood cells have several characteristics that make them a potentially effective vehicle for drug delivery, including potentially better tolerability, enhanced tissue distribution, reduced immunogenicity, and prolongation of circulating half-life. Quince's AIDE technology is designed to harness these benefits to allow for the chronic administration of drugs that have limitations due to toxicity, poor biodistribution, suboptimal pharmacokinetics, or immune response. About Quince Therapeutics Quince Therapeutics, Inc. (Nasdaq: QNCX) is a late-stage biotechnology company dedicated to unlocking the power of a patient's own biology for the treatment of rare diseases. For more information on the company and its latest news, visit and follow Quince on social media platforms LinkedIn, Facebook, X, and YouTube. Forward-looking Statements Statements in this news release contain 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995 as contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the 'safe harbor' created by those sections. All statements, other than statements of historical facts, may be forward-looking statements. Forward-looking statements contained in this news release may be identified by the use of words such as 'believe,' 'may,' 'should,' 'expect,' 'anticipate,' 'plan,' 'believe,' 'estimated,' 'potential,' 'intend,' 'will,' 'can,' 'seek,' or other similar words. Examples of forward-looking statements include, among others, statements relating to the timing, success, and reporting of results of the clinical trials and related data, including plans and the ability to enroll participants, impact of closing enrollment, conduct, and/or complete current and additional studies; expected cash position and operating runway; ability to secure additional funding and financial support; current and future clinical development of eDSP, including for the potential treatment of Ataxia-Telangiectasia (A-T), Duchenne muscular dystrophy (DMD), and other potential indications; the strategic development path for eDSP; planned regulatory agency submissions and clinical trials and timeline, prospects, and milestone expectations; and the potential benefits of eDSP and the company's market opportunity. Forward-looking statements are based on Quince's current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict and could cause actual results to differ materially from what the company expects. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, but are not limited to, the risks and uncertainties described in the section titled 'Risk Factors' in the company's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on May 13, 2025, and other reports as filed with the SEC. Forward-looking statements contained in this news release are made as of this date, and Quince undertakes no duty to update such information except as required under applicable law.
Yahoo
6 days ago
- Health
- Yahoo
Quince Therapeutics to Participate at A-T Society's 2025 A-T Clinical Research Conference
Phase 3 NEAT enrollment momentum continues with 99 total participants enrolled to date SOUTH SAN FRANCISCO, Calif., June 25, 2025--(BUSINESS WIRE)--Quince Therapeutics, Inc. (Nasdaq: QNCX), a late-stage biotechnology company dedicated to unlocking the power of a patient's own biology for the treatment of rare diseases, today announced its participation at the upcoming 2025 A-T Clinical Research Conference organized by the A-T Society, a leading Ataxia-Telangiectasia (A-T) patient advocacy group based in the United Kingdom. Taking place June 25-27, 2025 at Loughborough University in the U.K., key opinion leaders (KOLs) will present post hoc data analyses from the company's prior Phase 3 ATTeST clinical trial of its lead asset, eDSP, for the treatment of patients with A-T. Additionally, Quince management will provide an overview of its pivotal Phase 3 NEAT clinical trial. Highlights of A-T Clinical Research Conference Presentations KOLs will present the following data and information at the upcoming A-T Clinical Research Conference: Endocrine and Metabolic Events in Patients with A-T Treated with eDSP: William Whitehouse, M.D., Honorary Clinical Associate Professor of the School of Medicine at the University of Nottingham, England, recently retired Consultant Pediatric Neurologist at Nottingham Children's Hospital, Nottingham University Hospitals NHS Trust, and current Quince Scientific Advisory Board member, will provide a presentation titled Endocrine and Metabolic Events in Children with Ataxia-Telangiectasia Treated Long-term with Erythrocyte-Delivered Encapsulated Dexamethasone Sodium Phosphate (eDSP). The objective of the data analysis was to evaluate metabolic and endocrine adverse events (AEs), growth, and safety laboratory results in patients with A-T treated with eDSP. Key findings reported in Dr. Whitehouse's presentation highlighted that there were no reports of serious metabolic or endocrine events in the 68 patients with A-T treated with eDSP for two years or longer. Growth in height of these patients was also preserved. MiniATM Family Expression in Patients with A-T Treated with eDSP: Michele Menotta, Ph.D., Associate Professor in the Department of Biomolecular Sciences at the University of Urbino in Urbino, Italy, will provide a presentation titled MiniATM Family Expression in ATTeST: Molecular Insights into Unusual ATM Variants in A-T Cells. The objective of the data analysis investigates the potential relationship between miniATM family expression in the blood of patients with A-T who participated in Quince's prior Phase 3 ATTeST clinical trial and their corresponding neurological scores. Additionally, novel functions of the miniATM family were explored in A-T cells and its molecular mechanism of action was investigated. The analysis found that miniATM genes were present in 40% of patients with A-T and were correlated with A-T disease severity at baseline. Lab tests also showed results that may variably influence cell processes, offering new insights for potential treatments. Pivotal Phase 3 NEAT Enrollment Update Quince's management will provide an overview of the company's pivotal Phase 3 NEAT (Neurologic Effects of eDSP on Subjects with A-T; #IEDAT-04-2022/NCT06193200) clinical trial and latest enrollment update at the A-T Society meeting. A total of 99 participants have been enrolled to date, including 78 participants in the six to nine year-old primary analysis population and 21 participants aged 10 years or older. All 42 NEAT participants to date have elected to transition to the NEAT open label extension (OLE) study (NCT06664853/IEDAT-04-2022). Quince is currently enrolling a pivotal Phase 3 NEAT clinical trial, which is an international, multi-center, randomized, double-blind, placebo-controlled clinical trial evaluating the neurological effects of eDSP (previously referred to as EryDex) treatment in patients with A-T. The company expects to report topline results in the first quarter of 2026 with a potential New Drug Application (NDA) submission to the FDA in the second half of 2026, assuming positive study results. Quince was granted Fast Track designation by the FDA for the company's eDSP System for the treatment of patients with A-T based on the potential for eDSP to address a high unmet medical need. About Ataxia-Telangiectasia A-T is an inherited autosomal recessive neurodegenerative and immunodeficiency disorder caused by mutations in the ATM gene, which is responsible for cell homeostatic and cell division functions including but not limited to double-stranded DNA repair. Typically, A-T is first diagnosed before the age of five as children begin to develop an altered gait and fall with greater frequency. Neurological symptoms worsen and patients with A-T frequently become wheelchair-bound by adolescence. Teenage years for patients with A-T are typically marked by repeated infections, pulmonary impairment, and malignancies. The median lifespan is approximately 25 to 30 years old with mortality due to infections and malignancy. Based on IQVIA Medical Claims (Dx), PharmetricsPlus (P+), and IQVIA Analytics information, there are approximately 4,600 diagnosed patients with A-T in the U.S. Quince estimates that there are approximately 5,000 patients with A-T in the U.K. and EU4 countries. There are currently no approved therapeutic treatments in any global market for A-T. About eDSP for A-T eDSP is comprised of dexamethasone sodium phosphate (DSP) encapsulated in a patient's own red blood cells (autologous erythrocytes). DSP is a corticosteroid well known for its anti-inflammatory properties as well as its dose-limiting toxicity due to adrenal suppression. The eDSP System is designed to provide the efficacy of corticosteroids and to reduce or eliminate the significant adverse effects that accompany chronic use of corticosteroid treatment. eDSP leverages Quince's proprietary Autologous Intracellular Drug Encapsulation, or AIDE, technology platform, which is a novel drug/device combination that uses an automated process designed to encapsulate a drug into the patient's own red blood cells. Red blood cells have several characteristics that make them a potentially effective vehicle for drug delivery, including potentially better tolerability, enhanced tissue distribution, reduced immunogenicity, and prolongation of circulating half-life. Quince's AIDE technology is designed to harness these benefits to allow for the chronic administration of drugs that have limitations due to toxicity, poor biodistribution, suboptimal pharmacokinetics, or immune response. About Quince Therapeutics Quince Therapeutics, Inc. (Nasdaq: QNCX) is a late-stage biotechnology company dedicated to unlocking the power of a patient's own biology for the treatment of rare diseases. For more information on the company and its latest news, visit and follow Quince on social media platforms LinkedIn, Facebook, X, and YouTube. Forward-looking Statements Statements in this news release contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 as contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the "safe harbor" created by those sections. All statements, other than statements of historical facts, may be forward-looking statements. Forward-looking statements contained in this news release may be identified by the use of words such as "believe," "may," "should," "expect," "anticipate," "plan," "believe," "estimated," "potential," "intend," "will," "can," "seek," or other similar words. Examples of forward-looking statements include, among others, statements relating to the timing, success, and reporting of results of the clinical trials and related data, including plans and the ability to enroll participants, impact of closing enrollment, conduct, and/or complete current and additional studies; expected cash position and operating runway; ability to secure additional funding and financial support; current and future clinical development of eDSP, including for the potential treatment of Ataxia-Telangiectasia (A-T), Duchenne muscular dystrophy (DMD), and other potential indications; the strategic development path for eDSP; planned regulatory agency submissions and clinical trials and timeline, prospects, and milestone expectations; and the potential benefits of eDSP and the company's market opportunity. Forward-looking statements are based on Quince's current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict and could cause actual results to differ materially from what the company expects. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, but are not limited to, the risks and uncertainties described in the section titled "Risk Factors" in the company's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on May 13, 2025, and other reports as filed with the SEC. Forward-looking statements contained in this news release are made as of this date, and Quince undertakes no duty to update such information except as required under applicable law. View source version on Contacts Media & Investor Contact: Stacy RoughanQuince Therapeutics, President, Corporate Communications & Investor Relationsir@
Business Wire
18-06-2025
- Business
- Business Wire
Quince Therapeutics Announces Closing of Up to $22 Million Private Placement of Securities
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Quince Therapeutics, Inc. (Nasdaq: QNCX) ('Quince' or the 'Company'), a late-stage biotechnology company dedicated to unlocking the power of a patient's own biology for the treatment of rare diseases, today announced the closing of its previously announced sale and issuance to certain institutional and accredited investors, of its common stock (or pre-funded warrants in lieu thereof), and accompanying common warrants ('Warrants') that resulted in approximately $11.5 million in upfront proceeds and potential additional proceeds of up to $10.4 million if the accompanying Warrants are exercised in full for cash, before deducting placement agent fees and other private placement expenses. The private placement priced at a premium and was led by healthcare-focused institutional investor Nantahala Capital with participation from existing Quince stockholders including ADAR1 Capital Management, along with members of Quince's senior management. Dirk Thye, M.D., Quince's Chief Executive Officer and Chief Medical Officer, said, 'We are pleased to secure additional financing that allows us to complete enrollment of our pivotal Phase 3 NEAT clinical trial and extend our cash runway beyond topline results. This transaction reflects a significant commitment from high caliber healthcare investors who believe in our technology platform and Phase 3 asset, eDSP. Success in our lead indication of Ataxia-Telangiectasia (A-T) would demonstrate our ability to deliver corticosteroid efficacy without toxicity and would expand opportunities for pursuing additional indications for both rare and non-rare diseases.' Quince intends to use the net proceeds of this offering for working capital and general corporate purposes, including funding the ongoing enrollment of the Company's pivotal Phase 3 NEAT (N eurological E ffects of e DSP on Subjects with A - T; NCT06193200 / IEDAT-04-2022) clinical trial in A-T, research and development expenses, general and administrative expenses and capital expenditures. The net upfront proceeds from the private placement, combined with Quince's current cash, cash equivalents, and short-term investments of $31.6 million as of March 31, 2025, are expected to fund the Company's operations into the second quarter of 2026, or the second half of 2026 if the Warrants are exercised in full for cash. In addition, the Company expects to use proceeds to continue to expand and accelerate its development pipeline by funding new program expansion into Duchenne muscular dystrophy and other high priority rare disease indications for its lead asset eDSP. The Company continues to make meaningful progress in enrolling participants in its pivotal Phase 3 NEAT clinical trial. Key highlights to date include: A total of 95 participants have been enrolled, including 77 participants in the six to nine year-old primary analysis population and 18 participants aged 10 years or older. All 39 NEAT participants to date have elected to transition to the NEAT open label extension (OLE) study (NCT06664853 / IEDAT-04-2022). Participants who complete the full treatment period, complete study assessments, and provide informed consent are eligible to transition to the OLE study. Quince expects to report topline results from the Phase 3 NEAT clinical trial in the first quarter of 2026. Assuming positive study results, the Company plans to submit a New Drug Application to the U.S. Food and Drug Administration (FDA) in the second half of 2026. Quince was granted FDA Fast Track designation for the Company's eDSP System for the treatment of patients with A-T based on the potential for eDSP to address a high unmet medical need. NEAT is an international, multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the neurological effects of Quince's lead asset, eDSP (dexamethasone sodium phosphate [DSP] encapsulated in autologous red blood cells; previously referred to as EryDex) in patients with A-T. Participants are randomized (1:1) between eDSP or placebo and treatment consists of six infusions scheduled once every 21 to 30 days. The primary efficacy endpoint will be measured by the change from baseline to last efficacy visit in the rescored modified International Cooperative Ataxia Rating Scale (RmICARS) compared to placebo. About the Private Placement At the closing, the Company issued to the investors an aggregate of 6,671,928 shares of common stock, 2,000,000 pre-funded warrants and accompanying Warrants to purchase an aggregate of 8,671,928 shares of common stock (or pre-funded warrants in lieu thereof), at a combined purchase price of $1.325 per share (or $1.324 per pre-funded warrant) and accompanying Warrant (representing a 10% premium over the $1.20 closing price per share of the Company's common stock on June 11, 2025). The accompanying Warrants have an exercise price of $1.20 per share and are exercisable immediately. The Warrants will expire five years from the date of issuance. Citizens Capital Markets acted as the lead placement agent for the private placement. Maxim Group LLC and Brookline Capital Markets, a division of Arcadia Securities, LLC, acted as co-placement agents for the private placement. The securities issued in connection with the private placement described above were offered in a private placement and were not registered under the Securities Act of 1933, as amended (the 'Securities Act'), or any state or other applicable jurisdictions' securities laws, and were not offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions' securities laws. This news release does not constitute an offer to sell or the solicitation of an offer to buy the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. About Quince Therapeutics Quince Therapeutics, Inc. (Nasdaq: QNCX) is a late-stage biotechnology company dedicated to unlocking the power of a patient's own biology for the treatment of rare diseases. For more information on the Company and its latest news, visit and follow Quince on social media platforms LinkedIn, Facebook, X, and YouTube. Forward-looking Statements Statements made in this news release that are not statements of historical or current facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that statements in this news release regarding the receipt of additional gross proceeds if the accompanying Warrants are exercised in full; the achievement of positive clinical trial results and approval of the eDSP by the FDA; the Company's intended use of the proceeds from the private placement, including the expected funding of new program expansion into Duchenne muscular dystrophy and other high priority rare disease indications for its lead asset eDSP; the potential for expanded opportunities for pursuing additional indications for both rare and non-rare diseases if A-T is successful; the Company's expectation that the net proceeds from the closing of the private placement, combined with its current cash, cash equivalents and marketable securities, will fund its operating and capital expenditures into the second quarter of 2026, or the second half of 2026 if all Warrants are exercised for cash; and the Company's strategy, future operations, future financial position, projected expenses, expected timing and results of clinical trials, prospects, plans and objectives of management constitute forward-looking statements that involve risks and uncertainties, including, without limitation, risks and uncertainties related to: cost, timing, progress and results of the pivotal Phase 3 NEAT clinical trial in A-T indication and potential future trials in other indications; the Company's ability to obtain FDA approval and successfully commercialize its product candidate; the satisfaction of customary closing conditions related to the proposed private placement and the impact of general economic, industry or political conditions in the United States or internationally, the current or evolving effects of macroeconomic conditions, on Quince's business operations and activities. There can be no assurance that the Company will be able to complete the proposed private placement on acceptable terms, or at all. Quince's actual results, performance, or achievements could differ materially from those expressed or implied by the forward-looking statements as a result of a number of factors, including the risks discussed under the heading "Risk Factors" discussed under the caption "Item 1A. Risk Factors" in Part I of Quince's most recent Annual Report on Form 10-K or any updates discussed under the caption "Item 1A. Risk Factors" in Part II of its Quarterly Reports on Form 10-Q and in the Company's other filings with the SEC. Quince undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise that occur after that date, except as required by law.
Yahoo
03-06-2025
- Business
- Yahoo
Quince Therapeutics Exceeds 75% Enrollment in Pivotal Phase 3 NEAT Clinical Trial in Ataxia-Telangiectasia
SOUTH SAN FRANCISCO, Calif., June 03, 2025--(BUSINESS WIRE)--Quince Therapeutics, Inc. (Nasdaq: QNCX), a late-stage biotechnology company dedicated to unlocking the power of a patient's own biology for the treatment of rare diseases, today announced that its pivotal Phase 3 NEAT (Neurological Effects of eDSP on Subjects with A-T; NCT06193200/IEDAT-04-2022) clinical trial in the rare neurodegenerative disease Ataxia-Telangiectasia (A-T) has reached an important milestone as enrollment now exceeds 75% with a total of 65 participants randomized in the study's targeted 86 participants in the six to nine year-old primary analysis population. Key Phase 3 NEAT clinical trial enrollment highlights to date include: A total of 76 participants have been enrolled, including 65 participants in the six to nine year-old primary analysis population and 11 participants aged 10 years or older. Study powering based on currently enrolled participants is approximately 80%. The rate of screening and randomization activities has materially increased with the recent activation of all study sites. A total of 108 NEAT participants have been screened to date with a low screen failure rate of 10%. All 37 NEAT participants to date have elected to transition to the NEAT open label extension (OLE) study (NCT06664853/IEDAT-04-2022). Participants who complete the full treatment period, complete study assessments, and provide informed consent are eligible to transition to the OLE study. Assuming positive study results, the company plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the second half of 2026. Quince was granted FDA Fast Track designation for the company's eDSP System for the treatment of patients with A-T based on the potential for eDSP to address a high unmet medical need. NEAT is an international, multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the neurological effects of Quince's lead asset, eDSP (dexamethasone sodium phosphate [DSP] encapsulated in autologous red blood cells; previously referred to as EryDex) in patients with A-T. Participants are randomized (1:1) between eDSP or placebo and treatment consists of six infusions scheduled once every 21 to 30 days. The primary efficacy endpoint will be measured by the change from baseline to last efficacy visit in the rescored modified International Cooperative Ataxia Rating Scale (RmICARS) compared to placebo. About Ataxia-Telangiectasia A-T is an inherited autosomal recessive neurodegenerative and immunodeficiency disorder caused by mutations in the ATM gene, which is responsible for cell homeostatic and cell division functions including but not limited to double-stranded DNA repair. Typically, A-T is first diagnosed before the age of five as children begin to develop an altered gait and fall with greater frequency. Neurological symptoms worsen and patients with A-T frequently become wheelchair-bound by adolescence. Teenage years for patients with A-T are typically marked by repeated infections, pulmonary impairment, and malignancies. The median lifespan is approximately 25 to 30 years old with mortality due to infections and malignancy. Based on IQVIA Medical Claims (Dx), PharmetricsPlus (P+), and IQVIA Analytics information, there are approximately 4,600 diagnosed patients with A-T in the U.S. Quince estimates that there are approximately 5,000 patients with A-T in the U.K. and EU4 countries. There are currently no approved therapeutic treatments in any global market for A-T. About eDSP for A-T eDSP is comprised of dexamethasone sodium phosphate (DSP) encapsulated in a patient's own red blood cells (autologous erythrocytes). DSP is a corticosteroid well known for its anti-inflammatory properties as well as its dose-limiting toxicity due to adrenal suppression. The eDSP System is designed to provide the efficacy of corticosteroids and to reduce or eliminate the significant adverse effects that accompany chronic use of corticosteroid treatment. eDSP leverages Quince's proprietary Autologous Intracellular Drug Encapsulation, or AIDE, technology platform, which is a novel drug/device combination that uses an automated process designed to encapsulate a drug into the patient's own red blood cells. Red blood cells have several characteristics that make them a potentially effective vehicle for drug delivery, including potentially better tolerability, enhanced tissue distribution, reduced immunogenicity, and prolongation of circulating half-life. Quince's AIDE technology is designed to harness these benefits to allow for the chronic administration of drugs that have limitations due to toxicity, poor biodistribution, suboptimal pharmacokinetics, or immune response. About Quince Therapeutics Quince Therapeutics, Inc. (Nasdaq: QNCX) is a late-stage biotechnology company dedicated to unlocking the power of a patient's own biology for the treatment of rare diseases. For more information on the company and its latest news, visit and follow Quince on social media platforms LinkedIn, Facebook, X, and YouTube. Forward-looking Statements Statements in this news release contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 as contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the "safe harbor" created by those sections. All statements, other than statements of historical facts, may be forward-looking statements. Forward-looking statements contained in this news release may be identified by the use of words such as "believe," "may," "should," "expect," "anticipate," "plan," "believe," "estimated," "potential," "intend," "will," "can," "seek," or other similar words. Examples of forward-looking statements include, among others, statements relating to the timing, success, and reporting of results of the clinical trials and related data, including plans and the ability to enroll participants, impact of closing enrollment, conduct, and/or complete current and additional studies; current and future clinical development of eDSP, including for the potential treatment of Ataxia-Telangiectasia (A-T), Duchenne muscular dystrophy (DMD), and other potential indications; the strategic development path for eDSP; planned regulatory agency submissions, including NDAs, and clinical trials and timeline, prospects, and milestone expectations; and the potential benefits of eDSP and the company's market opportunity. Forward-looking statements are based on Quince's current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict and could cause actual results to differ materially from what the company expects. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, but are not limited to, the risks and uncertainties described in the section titled "Risk Factors" in the company's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on May 13, 2025, and other reports as filed with the SEC. Forward-looking statements contained in this news release are made as of this date, and Quince undertakes no duty to update such information except as required under applicable law. View source version on Contacts Media & Investor Contact: Stacy RoughanQuince Therapeutics, President, Corporate Communications & Investor Relationsir@ Sign in to access your portfolio
Business Wire
03-06-2025
- Business
- Business Wire
Quince Therapeutics Exceeds 75% Enrollment in Pivotal Phase 3 NEAT Clinical Trial in Ataxia-Telangiectasia
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Quince Therapeutics, Inc. (Nasdaq: QNCX), a late-stage biotechnology company dedicated to unlocking the power of a patient's own biology for the treatment of rare diseases, today announced that its pivotal Phase 3 NEAT (N eurological E ffects of e DSP on Subjects with A - T; NCT06193200 / IEDAT-04-2022) clinical trial in the rare neurodegenerative disease Ataxia-Telangiectasia (A-T) has reached an important milestone as enrollment now exceeds 75% with a total of 65 participants randomized in the study's targeted 86 participants in the six to nine year-old primary analysis population. Key Phase 3 NEAT clinical trial enrollment highlights to date include: A total of 76 participants have been enrolled, including 65 participants in the six to nine year-old primary analysis population and 11 participants aged 10 years or older. Study powering based on currently enrolled participants is approximately 80%. The rate of screening and randomization activities has materially increased with the recent activation of all study sites. A total of 108 NEAT participants have been screened to date with a low screen failure rate of 10%. All 37 NEAT participants to date have elected to transition to the NEAT open label extension (OLE) study (NCT06664853 / IEDAT-04-2022). Participants who complete the full treatment period, complete study assessments, and provide informed consent are eligible to transition to the OLE study. Assuming positive study results, the company plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the second half of 2026. Quince was granted FDA Fast Track designation for the company's eDSP System for the treatment of patients with A-T based on the potential for eDSP to address a high unmet medical need. NEAT is an international, multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the neurological effects of Quince's lead asset, eDSP (dexamethasone sodium phosphate [DSP] encapsulated in autologous red blood cells; previously referred to as EryDex) in patients with A-T. Participants are randomized (1:1) between eDSP or placebo and treatment consists of six infusions scheduled once every 21 to 30 days. The primary efficacy endpoint will be measured by the change from baseline to last efficacy visit in the rescored modified International Cooperative Ataxia Rating Scale (RmICARS) compared to placebo. About Ataxia-Telangiectasia A-T is an inherited autosomal recessive neurodegenerative and immunodeficiency disorder caused by mutations in the ATM gene, which is responsible for cell homeostatic and cell division functions including but not limited to double-stranded DNA repair. Typically, A-T is first diagnosed before the age of five as children begin to develop an altered gait and fall with greater frequency. Neurological symptoms worsen and patients with A-T frequently become wheelchair-bound by adolescence. Teenage years for patients with A-T are typically marked by repeated infections, pulmonary impairment, and malignancies. The median lifespan is approximately 25 to 30 years old with mortality due to infections and malignancy. Based on IQVIA Medical Claims (Dx), PharmetricsPlus (P+), and IQVIA Analytics information, there are approximately 4,600 diagnosed patients with A-T in the U.S. Quince estimates that there are approximately 5,000 patients with A-T in the U.K. and EU4 countries. There are currently no approved therapeutic treatments in any global market for A-T. About eDSP for A-T eDSP is comprised of dexamethasone sodium phosphate (DSP) encapsulated in a patient's own red blood cells (autologous erythrocytes). DSP is a corticosteroid well known for its anti-inflammatory properties as well as its dose-limiting toxicity due to adrenal suppression. The eDSP System is designed to provide the efficacy of corticosteroids and to reduce or eliminate the significant adverse effects that accompany chronic use of corticosteroid treatment. eDSP leverages Quince's proprietary Autologous Intracellular Drug Encapsulation, or AIDE, technology platform, which is a novel drug/device combination that uses an automated process designed to encapsulate a drug into the patient's own red blood cells. Red blood cells have several characteristics that make them a potentially effective vehicle for drug delivery, including potentially better tolerability, enhanced tissue distribution, reduced immunogenicity, and prolongation of circulating half-life. Quince's AIDE technology is designed to harness these benefits to allow for the chronic administration of drugs that have limitations due to toxicity, poor biodistribution, suboptimal pharmacokinetics, or immune response. About Quince Therapeutics Quince Therapeutics, Inc. (Nasdaq: QNCX) is a late-stage biotechnology company dedicated to unlocking the power of a patient's own biology for the treatment of rare diseases. For more information on the company and its latest news, visit and follow Quince on social media platforms LinkedIn, Facebook, X, and YouTube. Forward-looking Statements Statements in this news release contain 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995 as contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the 'safe harbor' created by those sections. All statements, other than statements of historical facts, may be forward-looking statements. Forward-looking statements contained in this news release may be identified by the use of words such as 'believe,' 'may,' 'should,' 'expect,' 'anticipate,' 'plan,' 'believe,' 'estimated,' 'potential,' 'intend,' 'will,' 'can,' 'seek,' or other similar words. Examples of forward-looking statements include, among others, statements relating to the timing, success, and reporting of results of the clinical trials and related data, including plans and the ability to enroll participants, impact of closing enrollment, conduct, and/or complete current and additional studies; current and future clinical development of eDSP, including for the potential treatment of Ataxia-Telangiectasia (A-T), Duchenne muscular dystrophy (DMD), and other potential indications; the strategic development path for eDSP; planned regulatory agency submissions, including NDAs, and clinical trials and timeline, prospects, and milestone expectations; and the potential benefits of eDSP and the company's market opportunity. Forward-looking statements are based on Quince's current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict and could cause actual results to differ materially from what the company expects. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, but are not limited to, the risks and uncertainties described in the section titled 'Risk Factors' in the company's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on May 13, 2025, and other reports as filed with the SEC. Forward-looking statements contained in this news release are made as of this date, and Quince undertakes no duty to update such information except as required under applicable law.
