Tango Therapeutics Announces Discontinuation of TNG348 Program
Tango Therapeutics (NASDAQ: TNGX) has discontinued its TNG348 program following Phase 1/2 trial results indicating liver toxicity in patients. The company emphasizes patient safety as the primary reason for halting the development of TNG348, a USP1 inhibitor. This decision will allow Tango Therapeutics to redirect resources toward its PRMT5 and CoREST clinical programs, which remain on track. The company has extended its cash runway into 2027 and plans to provide a comprehensive clinical update on TNG908 and TNG462 in the latter half of the year.
- Redirection of resources to more promising programs: PRMT5 and CoREST.
- Cash runway extended into 2027, suggesting strong financial planning.
- Commitment to patient safety by discontinuing TNG348 due to observed liver toxicity.
- Planned clinical updates on TNG908 and TNG462 in the second half of the year indicate ongoing progress.
- Discontinuation of TNG348 due to liver toxicity in Phase 1/2 trial.
- Grade 3/4 liver function abnormalities observed in patients after eight weeks.
- No patient had yet received a combination of TNG348 and olaparib, meaning incomplete data for combination therapy.
- Potential investor concern over the termination of a key program.
Insights
The discontinuation of TNG348 due to liver toxicity underscores the complexity and risks inherent in developing new cancer therapies. Liver toxicity is a severe side effect that can compromise patient safety. Given that the observed toxicity arose in initial study cohorts, it indicates that the drug might not be viable for further development. This also suggests a need to revisit and perhaps reformulate the therapeutic approach towards USP1 inhibition.
Interestingly, the company has chosen to focus on other programs, such as PRMT5. This shift in priorities might also point towards those programs showing more promise with fewer adverse effects. For stakeholders, it's important to note that shifting focus is a typical response to trial failures in biotech, aiming to optimize resources and focus on more promising avenues.
Tango Therapeutics' decision to halt the TNG348 program will likely have mixed financial implications. On the one hand, discontinuing a program due to toxicity can be seen as a setback, potentially affecting the company's stock price negatively in the short term. Clinical trial failures can erode investor confidence, especially in early-stage biotech firms.
However, the extension of the cash runway into
It’s also worth mentioning that the company’s confidence in delivering clinical updates in the second half of the year could be an optimistic sign for future milestones, potentially stabilizing or even boosting investor sentiment in the longer term.
The termination of the TNG348 program due to liver toxicity emphasizes the importance of patient safety in clinical research. The failure in the early phase signals significant setbacks in understanding the safety profile of USP1 inhibitors. It's important for stakeholders to understand that early-phase trials are designed to identify these kinds of toxicities. This data is invaluable, as it informs future drug development and safety protocols.
Moreover, the company's strategic focus shift towards the PRMT5 program, which remains on track, suggests that this program has shown a safer and potentially more effective profile so far. Investors should pay attention to upcoming data releases related to TNG908 and TNG462, as these could offer significant insights into the future potential of Tango Therapeutics' pipeline.
– The phase 1/2 clinical trial of TNG348, a USP1 inhibitor, is being terminated due to toxicity observed in the initial study cohorts –
– Cash runway extended into 2027, PRMT5 and CoREST clinical programs remain on track –
“Patient safety is always our first priority and based on emerging data from the TNG348 dose escalation study, we have made the decision to discontinue further development of this molecule due to liver toxicity experienced by patients in the trial. While disappointing, we believe this is the right decision given the data at hand,” said Barbara Weber, M.D., President and Chief Executive Officer of Tango Therapeutics. “We will focus resources and capital on our existing portfolio, particularly our PRMT5 program. We remain committed to and confident in our ability to deliver a comprehensive clinical update on TNG908 and TNG462 in the second half of this year.”
TNG348 was being studied in a phase 1/2 clinical trial evaluating safety, pharmacokinetics, pharmacodynamics and efficacy as a single agent and in combination with olaparib, a PARP inhibitor, in patients with BRCA1/2-mutant and other HRD+ (homologous recombination deficient) cancers. Grade 3/4 liver function abnormalities were observed in patients remaining on study longer than eight weeks, leading to the decision to terminate the program. No patient had yet received a combination of TNG348 and olaparib.
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), 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 include, but are not limited to, the following: statements regarding Tango’s plans to progress its TNG908 and TNG462 programs, including timing and expectations to provide an update related thereto; and Tango’s expectations regarding its use of capital and the extension of its cash runway. 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 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 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 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 results (including final, initial or additional 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 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, initiation of dose expansion, 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; 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 ODD or Fast Track designation (and such designations may not advance any anticipated approval timelines); 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); government regulation may negatively impact the Company’s business, including the potential approval of the BIOSECURE Act; 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 SEC, including the risk factors referenced in Tango’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240523266195/en/
Investor Contact:
Sam Martin/Andrew Vulis
Argot Partners
tango@argotpartners.com
Media Contact:
Amanda Brown Galgay
SVP, Corporate Communications, Tango Therapeutics
media@tangotx.com
Source: Tango Therapeutics
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