Tango Therapeutics Announces First Patient Dosed in TNG456 Phase 1/2 Trial in Patients With MTAP-deleted Glioblastomas and Other Solid Tumors
Tango Therapeutics (NASDAQ: TNGX) has initiated dosing in its Phase 1/2 clinical trial of TNG456, a next-generation, brain-penetrant, MTA-cooperative PRMT5 inhibitor. The trial focuses on patients with MTAP-deleted solid tumors, particularly glioblastoma (GBM). The study (NCT06810544) will evaluate TNG456's safety, pharmacokinetics, pharmacodynamics, and antitumor activity both as monotherapy and in combination with abemaciclib.
The trial's significance is highlighted by the current poor prognosis for GBM patients, who face a five-year survival rate below 10%. Notably, 45% of GBM cases are MTAP-deleted, presenting a substantial potential patient population. Preclinical studies have shown promising results regarding TNG456's potency, MTAP-selectivity, and brain exposure, suggesting potential efficacy in GBM treatment.
Tango Therapeutics (NASDAQ: TNGX) ha iniziato la somministrazione nella sua sperimentazione clinica di fase 1/2 di TNG456, un inibitore PRMT5 di nuova generazione, capace di penetrare nel cervello e cooperare con MTA. Lo studio è rivolto a pazienti con tumori solidi con delezione di MTAP, in particolare il glioblastoma (GBM). La sperimentazione (NCT06810544) valuterà la sicurezza, la farmacocinetica, la farmacodinamica e l'attività antitumorale di TNG456 sia come monoterapia sia in combinazione con abemaciclib.
L'importanza dello studio è sottolineata dalla prognosi attualmente sfavorevole per i pazienti con GBM, che presentano un tasso di sopravvivenza a cinque anni inferiore al 10%. In particolare, il 45% dei casi di GBM presenta delezione di MTAP, rappresentando una significativa popolazione di pazienti potenziali. Studi preclinici hanno mostrato risultati promettenti in termini di potenza, selettività per MTAP ed esposizione cerebrale di TNG456, suggerendo un possibile efficacia nel trattamento del GBM.
Tango Therapeutics (NASDAQ: TNGX) ha iniciado la dosificación en su ensayo clínico de fase 1/2 de TNG456, un inhibidor PRMT5 cooperativo con MTA de nueva generación y capaz de penetrar en el cerebro. El ensayo se centra en pacientes con tumores sólidos con deleción de MTAP, especialmente glioblastoma (GBM). El estudio (NCT06810544) evaluará la seguridad, farmacocinética, farmacodinámica y actividad antitumoral de TNG456 tanto como monoterapia como en combinación con abemaciclib.
La importancia del ensayo se destaca por el pronóstico actualmente desfavorable para los pacientes con GBM, quienes enfrentan una tasa de supervivencia a cinco años inferior al 10%. Notablemente, el 45% de los casos de GBM presentan deleción de MTAP, lo que representa una población potencial considerable. Los estudios preclínicos han mostrado resultados prometedores en cuanto a potencia, selectividad para MTAP y exposición cerebral de TNG456, lo que sugiere una posible eficacia en el tratamiento del GBM.
Tango Therapeutics (NASDAQ: TNGX)는 차세대 뇌 침투형 MTA 협력 PRMT5 억제제인 TNG456의 1/2상 임상 시험에서 투약을 시작했습니다. 이 임상 시험은 MTAP 결손 고형암 환자, 특히 교모세포종(GBM)에 중점을 두고 있습니다. 본 연구(NCT06810544)는 TNG456의 안전성, 약동학, 약력학 및 항종양 활성을 단독 요법과 아베마시클립과의 병용 요법으로 평가할 예정입니다.
이 임상 시험의 중요성은 현재 GBM 환자들의 예후가 매우 좋지 않아 5년 생존율이 10% 미만이라는 점에서 강조됩니다. 특히 GBM 사례의 45%가 MTAP 결손을 가지고 있어 상당한 잠재 환자군을 형성합니다. 전임상 연구에서는 TNG456의 강력한 효능, MTAP 선택성 및 뇌 노출 수준이 유망하게 나타나 GBM 치료에 효과가 있을 것으로 기대됩니다.
Tango Therapeutics (NASDAQ : TNGX) a commencé l'administration dans son essai clinique de phase 1/2 de TNG456, un inhibiteur PRMT5 coopératif avec MTA, de nouvelle génération et capable de pénétrer dans le cerveau. L'essai cible des patients atteints de tumeurs solides avec délétion de MTAP, en particulier le glioblastome (GBM). L'étude (NCT06810544) évaluera la sécurité, la pharmacocinétique, la pharmacodynamie et l'activité antitumorale de TNG456, à la fois en monothérapie et en combinaison avec l'abémaciclib.
L'importance de cet essai est soulignée par le pronostic actuellement défavorable des patients atteints de GBM, qui présentent un taux de survie à cinq ans inférieur à 10 %. Notamment, 45 % des cas de GBM présentent une délétion de MTAP, ce qui représente une population de patients potentielle importante. Les études précliniques ont montré des résultats prometteurs concernant la puissance, la sélectivité MTAP et l'exposition cérébrale de TNG456, suggérant une efficacité possible dans le traitement du GBM.
Tango Therapeutics (NASDAQ: TNGX) hat mit der Dosierung in seiner Phase-1/2-Studie von TNG456 begonnen, einem next-generation, gehirngängigen, MTA-kooperativen PRMT5-Inhibitor. Die Studie richtet sich an Patienten mit MTAP-deleierten soliden Tumoren, insbesondere Glioblastom (GBM). Die Studie (NCT06810544) wird die Sicherheit, Pharmakokinetik, Pharmakodynamik und antitumorale Aktivität von TNG456 sowohl als Monotherapie als auch in Kombination mit Abemaciclib bewerten.
Die Bedeutung der Studie wird durch die derzeit schlechte Prognose für GBM-Patienten unterstrichen, die eine Fünf-Jahres-Überlebensrate von unter 10 % aufweisen. Bemerkenswert ist, dass 45 % der GBM-Fälle MTAP-deleiert sind, was eine große potenzielle Patientengruppe darstellt. Präklinische Studien zeigten vielversprechende Ergebnisse hinsichtlich der Wirksamkeit, MTAP-Selektivität und Gehirnexposition von TNG456, was auf eine mögliche Wirksamkeit bei der GBM-Behandlung hindeutet.
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BOSTON, May 21, 2025 (GLOBE NEWSWIRE) -- Tango Therapeutics, Inc. (NASDAQ: TNGX), a clinical-stage biotechnology company committed to discovering the next generation of precision cancer medicines, today announced that the first patient has been dosed in the TNG456 Phase 1/2 trial in patients with MTAP-deleted solid tumors, with a focus on glioblastoma (GBM). TNG456 is a next-generation, brain-penetrant, MTA-cooperative PRMT5 inhibitor.
“Dosing the first patient in the TNG456 Phase 1/2 trial marks a significant step for us and for patients with MTAP-deleted GBM,” said Adam Crystal, M.D., Ph.D., President, Research and Development of Tango Therapeutics. “People with GBM currently have few treatment options and a five-year survival rate below
The Phase 1/2 clinical trial (NCT06810544) is evaluating the safety, pharmacokinetics, pharmacodynamics and antitumor activity of TNG456 as a monotherapy and in combination with abemaciclib. We are currently enrolling patients with TNG456 monotherapy in dose escalation focused on GBM.
About Tango Therapeutics
Tango Therapeutics is a clinical-stage biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer. Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at critical targets in cancer. For more information, please visit www.tangotx.com.
Forward-Looking Statements
Certain statements in this press release may be considered forward-looking statements. Forward-looking statements generally relate to future events, Tango’s future operating performance and goals, the anticipated benefits of therapies and combination therapies (that include a Tango pipeline product), as well as the expectations, beliefs and development objectives for Tango’s product pipeline and clinical trials. In some cases, you can identify forward-looking statements by terminology such as “may”, “should”, “expect”, “intend”, “will”, “goal”, “estimate”, “anticipate”, “believe”, “predict”, “designed,” “potential” or “continue”, or the negatives of these terms or variations of them or similar terminology. For example, implicit or explicit statements concerning the following include or constitute forward-looking statements: the potential benefits of TNG456; a substantial number of patients have the potential to benefit from TNG456; the brain exposure of TNG456 has the potential to be sufficient for meaningful efficacy in GBM;; and the expected timing of: (i) development candidate declaration for certain targets; (ii) initiating IND-enabling studies; (iii) filing INDs; (iv) clinical trial initiation, dose escalation and dose expansion (including for combination studies); (v) disclosing initial, interim, updated, additional and final clinical trial results (including for combination studies); and (vi) the expected benefits of the Company's development candidates and other product candidates. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Tango and its management, are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: the benefits of product candidates (including TNG456) seen in preclinical tests and analyses may not be evident when tested in later preclinical studies or in clinical trials or when used in broader patient populations (if approved for commercial sale); Tango has limited experience conducting clinical trials (and does and will continue to rely on a third party to operate its clinical trials) and may not be able to commence its clinical trials (including opening clinical trial sites, dosing the first patient, and continued enrollment and dosing of an adequate number of clinical trial participants) when expected, may not be able to continue dosing, initiate dose escalation and/or dose expansion on anticipated timelines, and may not generate or report clinical trial results (including final, initial, interim, updated clinical trial results or additional safety and efficacy data and the establishment of proof-of-mechanism and proof-of-concept) in the anticipated timeframe (or at all); future clinical trial data releases may differ materially from initial or interim data from our current and future clinical trials; Tango’s pipeline products may not be safe and/or effective in humans; Tango has a limited operating history and has not generated any revenue to date from product sales, and may never become profitable; other companies may be able to identify and develop product candidates more quickly than the Company and commercially introduce the product prior to the Company;; the Company may not be able to identify development candidates on the schedule it anticipates due to technical, financial or other reasons; the Company may not be able to file INDs for development candidates on time, or at all, due to technical or financial reasons or otherwise; the Company may utilize cash resources more quickly than anticipated; Tango will need to raise capital in the future and if we are unable to raise capital when needed or on attractive terms, we would be forced to delay, scale back or discontinue some of our development programs or future commercialization efforts (which may delay filing of INDs, dosing patients, initiation of dose expansion, reporting clinical trial results and filing new drug applications); the Company may be unable to advance our preclinical development programs into and through the clinic for safety or efficacy reasons or commercialize our product candidates or we may experience significant delays in doing so as a result of factors beyond Tango’s control; the Company may not be able to realize the benefits of orphan drug or Fast Track designation (and such designations may not advance any anticipated approval timelines); the expected benefits of our product candidates in patients as single agents and/or in combination may not be realized; the Company may experience delays or difficulties in the initiation, enrollment, or dosing of patients in clinical trials or the announcement of clinical trial results, Tango may not identify or discover additional product candidates or may expend limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success; the Company’s product candidates may cause adverse or other undesirable side effects (or may not show requisite efficacy) that could, among other things, delay or prevent regulatory approval; our dependence on one or a limited number third parties for conducting clinical trials and producing drug substance and drug product (including drug substance, which is currently sole sourced) increases the risk that we will not have sufficient quantities of our product candidates or products or at an acceptable cost; government regulation may negatively impact the Company’s business, including the potential approval of the BIOSECURE Act; our business, financial condition and results of operations may be negatively impacted by global economic conditions, including trade restrictions and tariffs, legal actions or enforcement and inflation rates; inadequate funding for or disruptions at the U.S. Food and Drug Administration or other government agencies may slow the time necessary for new drugs to be reviewed and/or approved or prevent these agencies from performing business functions on which the operation of our business may rely (which could negatively impact our business); uncertainty around the U.S. presidential administration's approach to governmental agencies and/or product candidate approvals may present challenges for our business or create a more costly environment in which to pursue the development of new therapeutic candidates; and our ability to obtain and maintain patent and other intellectual property protection for our technology and product candidates or the scope of intellectual property protection obtained is not sufficiently broad. Additional information concerning risks, uncertainties and assumptions can be found in Tango’s filings with the Securities and Exchange Commission (SEC), including the risk factors referenced in Tango’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024, as supplemented and/or modified by its most recent Quarterly Report on Form 10-Q. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. Tango specifically disclaims any duty to update these forward-looking statements.
Investors and Media:
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media@tangotx.com
FAQ
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