TANGO THERAPEUTICS, INC. – Phase 1/2 trial of TNG908, a synthetic lethal PRMT5 inhibitor, for the treatment of MTAP-deleted solid tumors open for enrollment –
– Declared TNG462 as a development candidate - a next-generation PRMT5 inhibitor for MTAP-deleted solid tumors –
– Declared TNG260 as a development candidate - an inhibitor of an undisclosed synthetic lethal target that reverses the immune evasion effect of STK11 loss-of-function mutations –
– Strong cash position of
“We’ve had a strong start to 2022, including IND clearance and Fast Track Designation from the FDA for TNG908, our lead PRMT5 inhibitor program. We are making good progress advancing TNG908 into the clinic and expect to dose our first patient in the Phase 1/2 clinical trial for the treatment of MTAP-deleted solid tumors in the second quarter of this year,” said
Recent Business Highlights
- TNG908 IND cleared and granted Fast Track Designation (FTD); first-in-human clinical trial is now open for enrollment. As disclosed in
February 2022 , theU.S. Food and Drug Administration (FDA) granted FTD to TNG908, a synthetic lethal small molecule inhibitor of protein arginine methyltransferase 5 (PRMT5) designed to selectively kill cancer cells with methylthioadenosine phosphorylase (MTAP) deletions. FTD is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fulfill an unmet medical need, with the potential to allow drugs to reach more patients faster.
As disclosed inJanuary 2022 , the FDA cleared the Investigational New Drug (IND) application for TNG908. The Phase 1/2 clinical trial is now open for enrollment and the Company expects to have initial safety and efficacy data in the 1H 2023. Enrollment is limited to patients with confirmed MTAP-deleted solid tumors. MTAP deletions occur in approximately 10% - 15% of all human cancers, including non-small cell lung cancer, mesothelioma, cholangiocarcinoma and glioblastoma.
- TNG462, a next-generation PRMT5 inhibitor, declared a development candidate in 2Q 2022: Given the large number of patients with MTAP-deleted cancers, Tango is investing in a PRMT5 franchise by developing a product candidate with increased potency, MTAP-deletion selectivity and longer target coverage. TNG462, a next-generation PRMT5 inhibitor, is 45-fold more potent in cells with MTAP deletions than those without and induces deep tumor regressions in preclinical models of multiple cancer types. The Company plans to file an IND for TNG462 in the first half of 2023. The clinical development path for TNG462 is expected to be similar to TNG908, evaluating safety and efficacy in multiple tumor types in a Phase 1/2 clinical trial. Glioblastoma will be excluded from the clinical trial as TNG462 does not cross the blood-brain barrier in preclinical non-human primate models.
- TNG260, an inhibitor that reverses the immune evasion effect of STK11 mutations, declared a development candidate in 2Q 2022: Inhibiting Target 3, an undisclosed synthetic lethal target, reverses the immune evasion effect of serine-threonine kinase 11 (STK11) loss-of-function mutations in cancer models. In syngeneic models with an STK11 mutation and an intact immune system, the combination of TNG260 with an anti-PD1 antibody resulted in sustained complete tumor regressions and the induction of immune memory against re-implantation of tumors. Tango expects to file an IND for this program in 2023. STK11 mutations occur in approximately 15% of non-small cell lung cancers, 15% of cervical cancers, 10% carcinoma of unknown primary, 5% of breast cancers and 3% of pancreatic cancers.
- Presented preclinical data on TNG908, USP1 inhibitor program and discovery platform at 2022
American Association for Cancer Research (AACR) Annual Meeting. Last month, the Company presented three posters at the 2022 AACR Annual Meeting. The posters highlight the potential applicability of synthetic lethal drugs targeting across a range of cancer types, including TNG908 and the USP1 (ubiquitin-specific protease 1) program.
- Presented preclinical TNG908 combination data at 2022
European Society for Medical Oncology (ESMO) Targeted Anticancer Therapies Congress . In March, the Company presented at the 2022ESMO Targeted Anticancer Therapies Congress . The posters highlight the synergy between TNG908 and the KRAS inhibitor, sotorasib, in xenograft models with MTAP deletion and a KRAS G12C mutation.
Financial Results
As of
Collaboration revenue was
Research and development expenses were
General and administrative expenses were
Net loss for the three months ended
About
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, 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”, “predict”, “potential” or “continue”, or the negatives of these terms or variations of them or similar terminology. For example, statements concerning the following include or constitute forward-looking statements: the Company believes that it has sufficient cash balances to fund operations (including to support advancing discovery and its clinical pipeline) into the second half of 2024; anticipated milestones in the Company’s research and development programs; a Phase 1/2 study for TNG908 is now open for enrollment and we expect to dose a patient in second quarter of 2022; expectations regarding progressing Company development candidates in 2022 and beyond, including TNG462 and TNG260; the Company anticipates having preliminary safety and efficacy data in the TNG908 Phase 1/2 study in the first half of 2023; FTD has the potential to allow drugs to reach patients earlier; the planned clinical development path for TNG462 (expected to be similar to TNG908); Tango plans to evaluate TNG908 in GBM; the expected benefits of TNG908 and the Company's other development candidates and other product candidates; and 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 preliminary and final clinical trial results. 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: Tango has limited experience conducting clinical trials (and will rely on a third party to operate the clinical trial for TNG908) and may not be able to commence the clinical trial when expected and may not generate results (including final or preliminary safety and efficacy data) in the anticipated timeframe (or at all); benefits of product candidates seen in preclinical analyses may not be evident when tested in clinical trials or when used in broader patient populations (if approved for commercial sale); the benefits of Tango pipeline products, development candidates and potential combination therapies that are seen in pre-clinical experiments may not be present in clinical trials or in use commercially or may not be safe and/or effective in humans (and Tango or a third-party may not be able to obtain approval or commercial sales of any combination therapies); Tango has a limited operating history and has not generated any revenue to date from drug sales, and may never become profitable; 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 and, if so, may not have sufficient cash to fund operations to the second half of 2024; 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; we 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 fast track designation (and such designation may not advance any anticipated approval timelines); 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; our products 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
Investor Contact:
tango@argotpartners.com
Media Contact:
tango@argotpartners.com
Consolidated Statements of Operations
(In thousands, except share and per share data)
| Three Months Ended | |||||||
| 2022 | 2021 | ||||||
| Collaboration revenue | $ | 5,758 | $ | 6,386 | |||
| Operating expenses: | |||||||
| Research and development | 24,330 | 15,000 | |||||
| General and administrative | 6,807 | 3,467 | |||||
| Total operating expenses | 31,137 | 18,467 | |||||
| Loss from operations | (25,379 | ) | (12,081 | ) | |||
| Other income (expense): | |||||||
| Interest income | 218 | 104 | |||||
| Other expense, net | (47 | ) | (55 | ) | |||
| Total other income, net | 171 | 49 | |||||
| Loss before income taxes | (25,208 | ) | (12,032 | ) | |||
| Provision for income taxes | - | (74 | ) | ||||
| Net loss | $ | (25,208 | ) | $ | (12,106 | ) | |
| Net loss per common share – basic and diluted | $ | (0.29 | ) | $ | (0.29 | ) | |
| Weighted average number of common shares outstanding – basic and diluted | 87,670,653 | 41,575,143 | |||||
Consolidated Balance Sheets
(In thousands)
2022 | 2021 | ||||||
| Assets | |||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 99,909 | $ | 142,745 | |||
| Marketable securities | 349,976 | 342,510 | |||||
| Accounts receivable | 2,000 | 2,000 | |||||
| Restricted cash | 567 | 567 | |||||
| Prepaid expenses and other current assets | 8,202 | 4,516 | |||||
| Total current assets | 460,654 | 492,338 | |||||
| Property and equipment, net | 6,538 | 4,832 | |||||
| Operating lease right-of-use assets | 894 | 1,254 | |||||
| Restricted cash, net of current portion | 3,423 | 1,712 | |||||
| Other assets | 16 | 19 | |||||
| Total assets | $ | 471,525 | $ | 500,155 | |||
| Liabilities and Stockholders' Equity | |||||||
| Current liabilities: | |||||||
| Accounts payable | $ | 3,367 | $ | 3,226 | |||
| Accrued expenses and other current liabilities | 9,693 | 9,887 | |||||
| Operating lease liabilities | 1,075 | 1,503 | |||||
| Deferred revenue | 25,024 | 26,022 | |||||
| Income tax payable | 52 | 52 | |||||
| Total current liabilities | 39,211 | 40,690 | |||||
| Operating lease liabilities, net of current portion | — | — | |||||
| Deferred revenue, net of current portion | 111,958 | 114,718 | |||||
| Other long-term liabilities | — | — | |||||
| Total liabilities | 151,169 | 155,408 | |||||
| Total stockholders’ equity | 320,356 | 344,747 | |||||
| Total liabilities and stockholders’ equity | $ | 471,525 | $ | 500,155 | |||
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