Tango Therapeutics Announces First Patient Dosed in Phase 1/2 Trial of TNG348 in Patients with BRCA1/2-Mutant and Other HRD+ Cancers
- TNG348 has shown strong anti-tumor activity in preclinical models and has demonstrated synergy with PARP inhibitors in cancer models with acquired resistance to PARP inhibitors.
- The Fast Track designation granted by the U.S. FDA indicates the potential of TNG348 to address unmet medical needs in the treatment of HRD+ cancers.
- The dosing of the first patient in the phase 1/2 trial marks a significant milestone for Tango Therapeutics in advancing its clinical-stage pipeline.
- None.
Insights
The initiation of a phase 1/2 trial for TNG348 by Tango Therapeutics represents a significant step in the exploration of new treatments for HRD+ cancers. These cancers, characterized by a deficiency in homologous recombination, a DNA damage repair pathway, are a considerable subset of several cancer types, including ovarian and breast cancers. The combination of TNG348 with olaparib, a PARP inhibitor, could address a critical need for patients with advanced cancers harboring BRCA1/2 mutations or other HRD+ phenotypes.
The pharmacodynamics and anti-tumor activity of TNG348, as observed in preclinical models, suggest a promising therapeutic potential, especially in synergy with PARP inhibitors. This combination could offer a novel treatment avenue, potentially overcoming acquired resistance to PARP inhibitors, which is a notable challenge in clinical oncology. The impact of this trial will be closely watched, as positive outcomes could lead to advancements in precision medicine for cancer patients.
Tango Therapeutics' TNG348 entering phase 1/2 trials is a pivotal event in the company's clinical development pipeline. The FDA's Fast Track designation indicates the agency's recognition of the drug's potential to address an unmet medical need. In terms of investment, the progress of TNG348 through clinical trials could significantly affect Tango Therapeutics' valuation, contingent on trial outcomes. The drug's success in early trials could lead to increased investor confidence and potentially drive up the company's stock price.
However, investors should be aware of the inherent risks associated with clinical trials, including the possibility of adverse effects, lack of efficacy, or regulatory setbacks. Long-term implications for stakeholders will hinge on the comprehensive data from the trial, which will inform the drug's safety profile, efficacy and market potential. Given the prevalence of HRD+ cancers, a successful treatment could capture a substantial market share, thus benefiting the company's financial outlook.
The market for cancer therapeutics is highly competitive, with numerous companies vying for a share in the precision medicine space. Tango Therapeutics' foray into this market with TNG348, especially targeting HRD+ cancers, taps into a segment with high incidence rates and a clear need for innovative treatments. The prevalence of HRD+ cancers provides a substantial target patient population, which could translate into a significant market opportunity should TNG348 prove to be safe and effective.
Moreover, the ability of TNG348 to potentially resensitize tumors to PARP inhibitors can set a new standard for combination therapies in oncology. Close monitoring of the trial's progression and results will be crucial for forecasting the drug's competitive edge in the market. A successful trial outcome could position Tango Therapeutics as a key player in the precision oncology field and influence the strategic decisions of competitors and potential collaborators.
BOSTON, Jan. 03, 2024 (GLOBE NEWSWIRE) -- Tango Therapeutics, Inc. (NASDAQ: TNGX), a clinical-stage biotechnology company committed to discovering and delivering the next generation of precision cancer medicines, today announced that the first patient has been dosed in the phase 1/2 trial evaluating TNG348 as a single agent and in combination with olaparib, a PARP inhibitor, in patients with BRCA1/2-mutant or other HRD+ (homologous recombination deficient) cancers. TNG348 is a novel, selective inhibitor of USP1 (ubiquitin-specific protease 1). The U.S. FDA granted TNG348 Fast Track designation in September 2023.
“Dosing the first patient in the TNG348 phase 1/2 trial is an important milestone for us and for patients with advanced ovarian, breast and certain other cancers. TNG348 has the potential to become a meaningful treatment for cancers caused by DNA damage repair pathways defects,” said Barbara Weber, M.D., President and Chief Executive Officer of Tango Therapeutics. “As we begin 2024, we are hopeful for the impact we believe we can make for patients by advancing multiple synthetic lethality programs across our clinical-stage pipeline.”
The phase 1/2 trial will evaluate the safety, pharmacokinetics, pharmacodynamics and efficacy of TNG348 as a single agent and in combination with olaparib, a PARP inhibitor, in patients with BRCA1/2-mutant and other HRD+ cancers. HRD+ cancers, including BRCA1/2 mutations, represent up to
USP1 is an essential enzyme for the survival and proliferation of HRD+ cancer cells. In preclinical models, TNG348 has strong anti-tumor activity, inducing cell death and tumor growth inhibition in multiple xenograft models. Preclinically, TNG348 has strong synergy with PARP inhibitors in BRCA1/2-mutant or other HRD+ cancer models, as evidenced by marked tumor regressions and the ability to restore sensitivity to PARP inhibition in models of acquired resistance to PARP inhibitors.
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. This includes expanding the universe of precision oncology targets into novel areas such as tumor suppressor gene loss and their contribution to the ability of cancer cells to evade immune cell killing. 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), 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”, “opportunity”, “committed” “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: dosing of the first patient in the TNG348 trial is an important milestone for the Company and for patients with certain cancers; TNG348 has the potential to become a meaningful treatment for cancers caused by DNA damage repair pathways defects; we are hopeful for the impact we believe we can make for patients by advancing multiple synthetic lethality programs across our clinical-stage pipeline; the TNG348 phase 1/2 trial will evaluate the safety, pharmacokinetics, pharmacodynamics and efficacy of TNG348 as a single agent and in combination with olaparib; the expected timing of: (i) development candidate declaration for certain targets, (ii) initiating IND-enabling studies; (iii) filing INDs; (iv) clinical trial initiation and (v) disclosing initial, interim and final clinical trial results; and 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: benefits of product candidates seen in preclinical analyses may not be evident when tested in later pre-clinical 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 will rely on a third party to operate its clinical trials) and may not be able to commence the clinical trial (including opening clinical trial sites, dosing the first patient, and enrolling and dosing an adequate number of clinical trial participants) when expected, may not be able to continue dose escalation on anticipated timelines, and may not generate results (including final or initial safety, efficacy data and proof-of-mechanism and proof-of-concept) in the anticipated timeframe (or at all); 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 expected benefits of a product candidate may not be realized when tested in clinical trials; the Company’s proprietary discovery platform is novel and may not identify any synthetic lethal targets for future development; 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, reporting clinical trial results and filing new drug applications); Tango’s approach to the discovery and development of product candidates is novel and unproven, which makes it difficult to predict the time, cost of development, and likelihood of successfully developing any products; 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 third parties for conducting clinical trials and producing drug product; 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; and delays and other impacts on product development and clinical trials from the COVID-19 pandemic. Additional information concerning risks, uncertainties and assumptions can be found in Tango’s filings with the SEC, including the risk factors referenced in Tango’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022, 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 presentation, 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.
Investor Contact:
Sam Martin/Andrew Vulis
Argot Partners
tango@argotpartners.com
Media Contact:
Amanda Galgay
SVP, Corporate Communications, Tango Therapeutics
media@tangotx.com
FAQ
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