05/10/2022 | Press release | Distributed by Public on 05/10/2022 14:12
SAN DIEGO, May 10, 2022 (GLOBE NEWSWIRE) -- Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a clinical-stage precision oncology company designing and developing novel targeted therapies for cancer treatment, today reported financial results for the quarter ended March 31, 2022 and provided operational updates.
"We are pleased with our continued progress led by our topline data for repotrectinib and now our third BTD being granted for our lead asset," said Athena Countouriotis, M.D., President and CEO. "We recently expanded our clinical pipeline with our first in-license of TPX-4589, our potential first-in-class ADC targeting Claudin18.2, which was recently granted Orphan Drug designation by the FDA for both gastric and pancreatic cancers. We continue to advance our pipeline including elzovantinib and look forward to a data-rich second half of the year, including updates from our repotrectinib and elzovantinib programs as well as a first look at our discovery program for KRAS G12D."
First quarter and recent operational highlights include:
REPOTRECTINIB, ROS1/TRK INHIBITOR
Table 1.
TKI-Naïve (EXP-1) Responder Population (n=56 (Phase 1 n=7, Phase 2 n=49)) |
||
Efficacy Parameter | Patients at Risk | DOR Landmark |
% DOR ≥ 6 months 95% CI |
35 |
91% (82, 100) |
% DOR ≥ 9 months 95% CI |
29 |
88% (78, 98) |
% DOR ≥ 12 months 95% CI |
21 |
85% (73, 96) |
% DOR ≥ 18 months 95% CI |
8 |
76% (61, 91) |
Patients at Risk: Patients who have reached the specified timepoint without censoring or an event (progression or death).
Table 2.
TKI-Naïve (EXP-1) Overall Population (n=71 (Phase 1 n=8, Phase 2 n=63)) |
||
Efficacy Parameter | Patients at Risk | PFS Landmark |
% PFS ≥ 6 months 95% CI |
46 |
91% (84, 98) |
% PFS ≥ 9 months 95% CI |
37 |
85% (75, 94) |
% PFS ≥ 12 months 95% CI |
26 |
82% (72, 93) |
% PFS ≥ 18 months 95% CI |
11 |
72% (58, 86) |
Patients at Risk: Patients who have reached the specified timepoint without censoring or an event (progression or death).
ο | In the ROS1-positive advanced NSCLC population pretreated with one prior TKI and prior platinum-based chemotherapy (EXP-2: n=26), the cORR was 42% (95% CI: 23, 63). Duration of response ranged from 3.6 to 18.3+ months. | |
ο | In the ROS1-positive advanced NSCLC population pretreated with two prior TKIs without prior chemotherapy (EXP-3: n=18), the cORR was 28% (95% CI: 10, 54). Duration of response ranged from 1.9+ to 20.3+ months. | |
ο | In the ROS1-positive advanced NSCLC population pretreated with one prior TKI without prior chemotherapy (EXP-4: n=56), the cORR was 36% (95% CI: 23, 50). The cORR does not include two patients with an uPR who both had tumor regressions of -47% on their last scans, both of whom remained on treatment awaiting their next scans as of the data cutoff date. Duration of response ranged from 1.9+ to 17.8 months. |
ELZOVANTINIB (TPX-0022), MET/SRC/CSF1R INHIBITOR
TPX-0046, RET INHIBITOR
TPX-0131, ALK INHIBITOR
TPX-4589, CLAUDIN18.2 ADC
DISCOVERY
Upcoming Milestones
REPOTRECTINIB
ELZOVANTINIB
TPX-0131
TPX-4589
DISCOVERY
First Quarter 2022 Financial Results
About Turning Point Therapeutics Inc.
Turning Point Therapeutics is a clinical-stage precision oncology company with a pipeline of investigational drugs designed to address key limitations of existing cancer therapies. The company's lead drug candidate, repotrectinib, is a next-generation kinase inhibitor targeting the ROS1 and TRK oncogenic drivers of non-small cell lung cancer and advanced solid tumors. Repotrectinib, which is being studied in a registrational Phase 2 study in adults and a Phase 1/2 study in pediatric patients, has shown antitumor activity and durable responses among kinase inhibitor treatment-naïve and pre-treated patients. The company's pipeline of drug candidates also includes elzovantinib, targeting MET, CSF1R and SRC, which is being studied in a Phase 1 trial of patients with advanced or metastatic solid tumors harboring genetic alterations in MET; TPX-0046, targeting RET, which is being studied in a Phase 1/2 trial of patients with advanced or metastatic solid tumors harboring genetic alterations in RET; TPX-0131, a next-generation ALK inhibitor, which is being studied in a Phase 1/2 trial of previously treated patients with ALK-positive advanced or metastatic non-small cell lung cancer; and TPX-4589 (LM-302), a novel ADC targeting Claudin18.2 which is being studied in a Phase 1 study in gastrointestinal cancers. The company is driven to develop therapies that mark a turning point for patients in their cancer treatment. For more information, visit www.tptherapeutics.com.
Forward Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "plans", "will", "believes," "anticipates," "expects," "intends," "goal," "potential" and similar expressions are intended to identify forward-looking statements. Such forward-looking statements include statements regarding, among other things, the efficacy, safety and therapeutic potential of Turning Point Therapeutics' drug candidates, repotrectinib, elzovantinib, TPX-0046, TPX-0131, and TPX-4589, the results, conduct, progress and timing of Turning Point Therapeutics' research and development programs and clinical trials, plans regarding future data presentations, clinical trials, regulatory meetings and regulatory submissions, the regulatory approval path for repotrectinib, and the strength of Turning Point Therapeutics' balance sheet, and financial guidance regarding the adequacy of cash on hand. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon Turning Point Therapeutics' current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with Turning Point Therapeutics' business in general, risks and uncertainties related to the impact of the COVID-19 pandemic to Turning Point Therapeutics' business and the other risks described in Turning Point Therapeutics' filings with the Securities and Exchange Commission (SEC), including its annual report on Form 10-K filed with the SEC on February 28, 2022. All forward-looking statements contained in this press release speak only as of the date on which they were made. Turning Point Therapeutics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
TURNING POINT THERAPEUTICS, INC.
Balance Sheet Data
(In thousands)
(unaudited)
March 31, | December 31, | |||||||
2022 | 2021 | |||||||
Balance Sheet Data: | ||||||||
Cash, cash equivalents and marketable securities | $ | 918,187 | $ | 981,582 | ||||
Working capital | 881,865 | 945,373 | ||||||
Total assets | 938,786 | 1,003,463 | ||||||
Accumulated deficit | (591,172 | ) | (516,727 | ) | ||||
Total stockholders' equity | $ | 891,347 | $ | 954,425 |
TURNING POINT THERAPEUTICS, INC.
Statements of Operations and Comprehensive Loss
(In thousands, except share and per share amounts)
(unaudited)
Three Months Ended March 31, | ||||||||
2022 | 2021 | |||||||
Revenue | $ | 429 | $ | 25,205 | ||||
Operating expenses: | ||||||||
Research and development | 55,050 | 41,263 | ||||||
General and administrative | 20,314 | 19,991 | ||||||
Total operating expenses | 75,364 | 61,254 | ||||||
Loss from operations | (74,935 | ) | (36,049 | ) | ||||
Other income, net | 490 | 545 | ||||||
Net loss | (74,445 | ) | (35,504 | ) | ||||
Unrealized loss on marketable securities | (4,118 | ) | (186 | ) | ||||
Comprehensive loss | $ | (78,563 | ) | $ | (35,690 | ) | ||
Net loss per share, basic and diluted | $ | (1.50 | ) | $ | (0.73 | ) | ||
Weighted-average common shares outstanding, basic and diluted | 49,611,492 | 48,920,403 |
Contact:
Adam D. Levy, Ph.D., M.B.A.
[email protected]
858-867-6366
Source: Turning Point Therapeutics, Inc.