TPTX Turning Point Therapeutics Inc.

116.93
-4.29  -4%
Previous Close 121.22
Open 119.1
52 Week Low 31.3042
52 Week High 141.3
Market Cap $5,632,804,228
Shares 48,172,447
Float 35,844,285
Enterprise Value $5,132,220,025
Volume 248,089
Av. Daily Volume 278,951
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Upcoming Catalysts

Drug Stage Catalyst Date
TPX-0046
RET-altered NSCLC
Phase 1/2
Phase 1/2
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Repotrectinib (TPX-0005) - TRIDENT-1
Non-small-cell lung cancer (NSCLC) and solid tumors
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
Repotrectinib (TPX-0005) - TRIDENT-2
KRAS mutant NSCLC
Phase 2
Phase 2
Phase 2 trial to be initiated mid-2021.
TPX-0022
Solid tumors
Phase 1
Phase 1
Phase 1 interim data presented at EORTC-NCI-AACR 24 October 2020. 5/10 partial responses among MET TKI-naïve patients, Phase 2 trial to be initiated 2H 2021.

Latest News

    • Continued Strong Enrollment in TRIDENT-1 Registrational Study, with Phase 1/2 Enrollment in EXP-1 Expected to Reach 50 Patients in 2Q; Type B Meeting with FDA Planned in 2Q

    • TPX-0131 Phase 1/2 Study Approved by Australian Ethics Committee; IND Submission Planned in March with Study Activation Anticipated in 2Q

    • Multiple Pipeline Presentations Planned at Medical Conferences in 2Q

    • Cash, Cash Equivalents, and Marketable Securities of $1.1 Billion Expected to Fund Current Operations into 2024

    SAN DIEGO, March 01, 2021 (GLOBE NEWSWIRE) -- Turning Point Therapeutics, Inc. (NASDAQ:TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, today reported financial results and operational updates for the…

    • Continued Strong Enrollment in TRIDENT-1 Registrational Study, with Phase 1/2 Enrollment in EXP-1 Expected to Reach 50 Patients in 2Q; Type B Meeting with FDA Planned in 2Q



    • TPX-0131 Phase 1/2 Study Approved by Australian Ethics Committee; IND Submission Planned in March with Study Activation Anticipated in 2Q



    • Multiple Pipeline Presentations Planned at Medical Conferences in 2Q



    • Cash, Cash Equivalents, and Marketable Securities of $1.1 Billion Expected to Fund Current Operations into 2024

    SAN DIEGO, March 01, 2021 (GLOBE NEWSWIRE) -- Turning Point Therapeutics, Inc. (NASDAQ:TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, today reported financial results and operational updates for the fourth quarter and year ended Dec. 31, 2020.

    "The progress we made during the fourth quarter and in 2020 has set us up for another potentially pivotal year in 2021, with multiple anticipated milestones across our portfolio," said Athena Countouriotis, M.D., president and CEO. "Our growing team continues to execute well as we advance our pipeline of precision oncology drug candidates."

    Fourth quarter 2020 and recent highlights include:

    REPOTRECTINIB, ROS1/TRK Inhibitor

    • Progress in the Phase 2 TRIDENT-1 registrational study of lead drug candidate repotrectinib, where the company in January reported updated interim findings in patients with ROS1-positive TKI-naïve non-small cell lung cancer (NSCLC). As of the Dec. 31, 2020 data cutoff date in 15 patients enrolled in the Phase 2 portion of the TRIDENT-1 study, the preliminary efficacy analysis showed a confirmed objective response rate (ORR) by physician assessment of 93% (95% CI: 68-100), and in 22 patients pooled from the Phase 1 (dosed at or above the Phase 2 dose) and Phase 2 portions, the confirmed ORR was 91% (95% CI: 71-99). As of an Oct. 30, 2020 data cutoff date, the interim safety update in a total of 185 patients from the Phase 1 and Phase 2 portions of the study showed repotrectinib was generally well tolerated.



    • Strong enrollment in the TRIDENT-1 study during the fourth quarter and into 2021, with Turning Point now anticipating enrollment in cohort 1 (EXP-1) to reach 50 patients pooled from the Phase 1 and Phase 2 portions of the study in the second quarter of 2021. The company plans to discuss next steps towards registration of repotrectinib in this patient population at a Type B meeting with the Food and Drug Administration (FDA), also anticipated in the second quarter. In addition, enrollment in the other cohorts within TRIDENT-1 continues to progress, and it is the company's goal to provide an enrollment and clinical data update for other cohorts in the study in the second half.



    • Breakthrough Therapy Designation (BTD) granted by the FDA for the treatment of patients with ROS1-positive metastatic NSCLC who have not been treated with a ROS1 tyrosine kinase inhibitor. BTD is granted by the FDA to expedite the development and regulatory review of an investigational medicine that is intended to treat a serious or life-threatening condition. 



    • Plans to present additional preclinical data highlighting repotrectinib's combination potential in KRAS-mutant disease at a medical conference in the second quarter of 2021.



    • Progress toward initiating the first cohort in the multi-arm Phase 1b/2 TRIDENT-2 repotrectinib combination study in KRAS-mutant solid tumors in mid-2021.

    TPX-0022, MET/ SRC/CSF1R Inhibitor

    • Progress in the Phase 1 SHIELD-1 study of TPX-0022, Turning Point's MET, SRC and CSF1R inhibitor, where initial data reported in October 2020 highlighted preliminary clinical activity, including objective responses across multiple tumor types and a generally well-tolerated safety profile.



      The company continues to enroll patients in the Phase 1 study and is currently evaluating multiple doses and schedules to further characterize the pharmacokinetics, safety and efficacy profile before ultimately determining a recommended Phase 2 dose (RP2D), anticipated in the second quarter. Turning Point plans to proceed directly into Phase 1 dose expansion in multiple patient cohorts after determining RP2D.
    • Additional clinical data update from the Phase 1 dose finding portion of SHIELD-1 planned in the second half of 2021. The company also plans to discuss the ongoing study with the FDA with the goal to modify the study into a registrational Phase 1/2 design and initiate the Phase 2 portion in the second half, pending FDA feedback.



    • Execution of an agreement with Zai Lab in January 2021 to develop and commercialize TPX-0022 in Greater China.

    TPX-0046, RET Inhibitor

    • Progress in the Phase 1 dose finding study of TPX-0046, a novel RET inhibitor, where the company continues to evaluate multiple doses and schedules to further characterize the pharmacokinetics, safety, and efficacy profile. Turning Point plans to provide preliminary data in the second quarter of 2021, which will focus primarily on safety and any early signals of efficacy from initial patients.

    TPX-0131, ALK Inhibitor

    • Approval by the Australian Ethics Committee of the Phase 1/2 clinical study of TPX-0131 focused on ALK-positive TKI-pretreated advanced NSCLC patients. Study initiation is anticipated in the second quarter of 2021.



    • IND submission to the FDA on track for March for TPX-0131, Turning Point's fourth drug candidate, which has a compact macrocyclic structure that has been shown in preclinical studies to potently inhibit wildtype ALK and numerous ALK mutations, and in in-vivo studies has shown significant brain tissue penetration after repeat oral dosing supporting the potential to cross the blood-brain barrier.



    • Presentation of additional preclinical data highlighting the profile of TPX-0131 at a medical conference in the second quarter of 2021.

    Fourth Quarter and Full-Year 2020 Financial Results

    • Revenue: Revenue of $25 million for the year was recognized during the third quarter in connection with the upfront payment from Zai Lab under the company's license agreement for repotrectinib in Greater China.



    • R&D Expenses: Research and development expenses were $34.3 million for the fourth quarter compared to $17.1 million for the fourth quarter of 2019, and $113.4 million for the year compared to $57.9 million for the year ended Dec. 31, 2019. Primary drivers of the year-over-year increase were investments made to develop repotrectinib, TPX-0022, TPX-0046, TPX-0131, discovery efforts and personnel expenses.



    • G&A Expenses: General and administrative expenses were $13.7 million for the fourth quarter compared to $5.9 million for the fourth quarter of 2019, and excluding a one-time non-cash stock-based compensation charge from the first quarter, non-GAAP G&A expenses were $42 million for the year compared to $19.8 million for the year ended Dec. 31, 2019. The increase was primarily attributable to higher personnel expenses as a result of increased employee head count and professional fees for legal and accounting services.



    • Net Income/Loss: Net loss was $47.4 million for the fourth quarter compared to net loss of $21 million for the fourth quarter of 2019, and excluding a one-time non-cash stock-based compensation charge from the first quarter, non-GAAP net loss was $125.9 million for the year compared to a loss of $72.1 million for the year ended Dec. 31, 2019.



    • Cash position: Cash, cash equivalents and marketable securities at Dec. 31 totaled $1.1 billion, compared to $409.2 million as of Dec. 31, 2019, driven primarily by net proceeds from follow-on public stock offerings in May and October of $351.6 and $433.9 million, respectively, partially offset by cash used in operating activities. Net cash used in operating activities during 2020 was $82.8 million. Turning Point projects its cash position funds current operations into 2024.

    Upcoming Milestones

    Key milestones anticipated in 2021 include:

    Repotrectinib

    • Reach enrollment of 50 patients pooled from the Phase 1 and Phase 2 portions of the TRIDENT-1 study in the ROS1-positive TKI-naïve NSCLC patient cohort (EXP-1) in second quarter



    • Discuss next steps towards registration of repotrectinib in patients with ROS1-positive TKI-naïve NSCLC at a Type B meeting with the FDA in the second quarter



    • Initiate the first cohort of a multi-arm Phase 1b/2 TRIDENT-2 combination study in patients with KRAS-mutant solid tumors mid-year



    • Provide an enrollment and clinical data update in other cohorts of the Phase 2 TRIDENT-1 study in the second half

    TPX-0046

    • Report early interim data from initial patients enrolled in the dose finding portion of the TPX-0046 Phase 1 study in the second quarter

    TPX-0022

    • Provide a clinical data update from the Phase 1 dose finding portion of the SHIELD-1 study in the second half



    • Initiate the Phase 2 portion of the SHIELD-1 study of TPX-0022, pending FDA feedback, in the second half



    • Initiate the Phase 1b/2 SHIELD-2 study of TPX-0022 in combination with an epidermal growth factor receptor (EGFR) targeted therapy in the second half

    TPX-0131

    • Submit the IND for TPX-0131 in the first quarter



    • Initiate the Phase 1/2 clinical study of TPX-0131 focused on ALK-positive TKI-pretreated advanced NSCLC patients in the second quarter

    Preclinical/Research

    • Present multiple preclinical data presentations in the second quarter



    • Outline research strategy in the second half, including focus and anticipated timeline to development candidates.

    Webcast and Conference Call

    Turning Point will webcast its Quarterly Update Conference Call today, March 1 at 4:30 p.m. ET/1:30 p.m. PT. Dr. Countouriotis will host the call, which will be accessible through the "Investors" section of tptherapeutics.com or by dialing (877) 388-2118 (in the United States) or (470) 495-9489 (outside the U.S.) using conference ID 5683087. A replay will be available through the "Investors" section of www.tptherapeutics.com.

    About Turning Point Therapeutics Inc.

    Turning Point Therapeutics is a clinical-stage precision oncology company with a pipeline of internally discovered 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 TPX-0022, 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; and TPX-0131, a next-generation ALK inhibitor currently pending IND submission. Turning Point's next-generation kinase inhibitors are designed to bind to their targets with greater precision and affinity than existing therapies, with a novel, compact structure that has demonstrated an ability to potentially overcome treatment resistance common with other kinase inhibitors. 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.

    Non-GAAP Financial Measures

    In addition to the financial results that are provided in accordance with accounting principles generally accepted in the United States (GAAP), this press release also contains non-GAAP financial measures. When preparing our supplemental non-GAAP financial results, the Company excluded certain GAAP items that management does not consider to be normal. In particular, the non-GAAP measures exclude non-cash stock-based compensation expense relating to a one-time charge of $31.4 million associated with previously disclosed modifications to the vesting of existing stock options, pursuant to the transition agreement with the company's scientific founder. These non-GAAP measures are provided as a complement to results provided in accordance with GAAP as management believes these non-GAAP financial measures are important in comparing current results with prior-period results. A reconciliation of the GAAP financial results to non-GAAP financial results is included in the attached financial information.

    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. Such forward-looking statements include statements regarding, among other things, the efficacy, safety and therapeutic potential of Turning Point Therapeutics' drug candidates, repotrectinib, TPX-0022, TPX-0046 and TPX-0131, the results, conduct, progress and timing of Turning Point Therapeutics' research and development programs and clinical trials, including the TRIDENT-1 clinical study of repotrectinib, the SHIELD-1 clinical study of TPX-0022 and the Phase 1/2 clinical study of TPX-0046, plans regarding future data presentations, clinical trials and regulatory submissions, the regulatory approval path for repotrectinib, and the strength of Turning Point Therapeutics' balance sheet and 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. Words such as "plans", "will", "believes," "anticipates," "expects," "intends," "goal," "potential" and similar expressions are intended to identify 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's business and the other risks described in Turning Point Therapeutics' filings with the SEC. 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)

      December 31,  December 31, 
      2020  2019 
    Balance Sheet Data:        
    Cash, cash equivalents, and marketable securities $1,122,508  $409,151 
    Working capital  1,106,287   400,915 
    Total assets  1,136,713   422,202 
    Accumulated deficit  (280,176)  (122,884)
    Total stockholders' equity $1,109,898  $404,351 



    TURNING POINT THERAPEUTICS, INC.

    STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

    (In thousands, except share and per share amounts)

    (unaudited)

      Three Months Ended

    December 31,
      Year Ended

    December 31,
     
      2020  2019  2020  2019 
    Revenue $-   -  $25,000  $- 
    Operating expenses:                
    Research and development  34,275   17,141   113,411   57,943 
    General and administrative  13,664   5,924   73,425   19,781 
    Total operating expenses  47,939   23,065   186,836   77,724 
    Loss from operations  (47,939)  (23,065)  (161,836)  (77,724)
    Other income, net  563   2,106   4,544   5,593 
    Net loss  (47,376)  (20,959)  (157,292)  (72,131)
    Unrealized gain (loss) on marketable securities, net of tax  (203)  (50)  (62)  271 
    Comprehensive loss $(47,579) $(21,009) $(157,354) $(71,860)
    Net loss per share, basic and diluted $(1.02) $(0.58) $(3.85) $(2.99)
    Weighted-average common shares outstanding, basic and diluted  46,588,835   35,851,252   40,843,782   24,124,924 



    TURNING POINT THERAPEUTICS, INC.

    Reconciliation of GAAP to Non-GAAP Financial Results

    (In thousands)

    (unaudited)

      Three Months Ended December 31,  Year Ended December 31, 
      2020  2019  2020  2019 
    GAAP Net Loss $(47,376) $(20,959) $(157,292) $(72,131)
    Adjustments:                
    Share-based compensation expense (1)        31,405    
    Non-GAAP Net Loss $(47,376) $(20,959) $(125,887) $(72,131)



      Three Months Ended December 31,  Year Ended December 31, 
      2020  2019  2020  2019 
    GAAP General & Administrative Expenses $(13,664) $(5,924) $(73,425) $(19,781)
    Adjustments:                
    Share-based compensation expense (1)        31,405    
    Non-GAAP General & Administrative Expenses $(13,664) $(5,924) $(42,020) $(19,781)

    (1)   During the first quarter of 2020, the Company recognized in non-cash stock-based compensation expense a one-time charge of $31.4 million associated with previously disclosed modifications to the vesting of existing stock options, pursuant to the transition agreement with the company's scientific founder.



    Contact:

    Jim Mazzola



    858-342-8272



    Primary Logo

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  1. SAN DIEGO, Feb. 18, 2021 (GLOBE NEWSWIRE) -- Turning Point Therapeutics, Inc. (NASDAQ:TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, will report fourth quarter and year ended Dec. 31, 2020 financial results following the close of U.S. financial markets on March 1. The company will host a conference call at 1:30 p.m. PT/4:30 p.m. ET to discuss the results and provide operational updates. President and CEO Athena Countouriotis, M.D., will host the call, which will include a question and answer session.

    The update will be accessible via audio webcast through the "Investors" section of www.tptherapeutics.com or by dialing (877) 388-2118 (in the United States) or (470) 495-9489 (outside…

    SAN DIEGO, Feb. 18, 2021 (GLOBE NEWSWIRE) -- Turning Point Therapeutics, Inc. (NASDAQ:TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, will report fourth quarter and year ended Dec. 31, 2020 financial results following the close of U.S. financial markets on March 1. The company will host a conference call at 1:30 p.m. PT/4:30 p.m. ET to discuss the results and provide operational updates. President and CEO Athena Countouriotis, M.D., will host the call, which will include a question and answer session.

    The update will be accessible via audio webcast through the "Investors" section of www.tptherapeutics.com or by dialing (877) 388-2118 (in the United States) or (470) 495-9489 (outside the U.S.) using conference ID 5683087. A replay will be available through the "Investors" section of www.tptherapeutics.com.

    About Turning Point Therapeutics Inc.

    Turning Point Therapeutics is a clinical-stage precision oncology company with a pipeline of internally discovered 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 TPX-0022, 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; and TPX-0131, a next-generation ALK inhibitor currently pending IND submission. Turning Point's next-generation kinase inhibitors are designed to bind to their targets with greater precision and affinity than existing therapies, with a novel, compact structure that has demonstrated an ability to potentially overcome treatment resistance common with other kinase inhibitors. 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. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as "plans", "will", "believes," "anticipates," "expects," "intends," "goal," "potential" and similar expressions are intended to identify 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's business and the other risks described in Turning Point Therapeutics' filings with the SEC. 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.

    Contact:

    Jim Mazzola



    858-342-8272



    Primary Logo

    View Full Article Hide Full Article
  2. SAN DIEGO, Feb. 04, 2021 (GLOBE NEWSWIRE) -- Turning Point Therapeutics, Inc. (NASDAQ:TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, today announced that President and CEO Athena Countouriotis, M.D., will participate in the Guggenheim Healthcare Talks 2021 Oncology Days conference on Feb. 11-12.

    Dr. Countouriotis is scheduled to participate in two question-and-answer sessions: a joint discussion with Zai Lab Founder, Chairperson and CEO Dr. Samantha Du on Feb. 12 at 8:30 a.m. ET, and a company focused discussion at 11:00 a.m. ET, both accessible via webcast through the Investors page of www.tptherapeutics.com.

    About Turning Point Therapeutics Inc.
    Turning Point Therapeutics is…

    SAN DIEGO, Feb. 04, 2021 (GLOBE NEWSWIRE) -- Turning Point Therapeutics, Inc. (NASDAQ:TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, today announced that President and CEO Athena Countouriotis, M.D., will participate in the Guggenheim Healthcare Talks 2021 Oncology Days conference on Feb. 11-12.

    Dr. Countouriotis is scheduled to participate in two question-and-answer sessions: a joint discussion with Zai Lab Founder, Chairperson and CEO Dr. Samantha Du on Feb. 12 at 8:30 a.m. ET, and a company focused discussion at 11:00 a.m. ET, both accessible via webcast through the Investors page of www.tptherapeutics.com.

    About Turning Point Therapeutics Inc.

    Turning Point Therapeutics is a clinical-stage precision oncology company with a pipeline of internally discovered 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 TPX-0022, 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; and TPX-0131, a next-generation ALK inhibitor currently pending IND submission. Turning Point's next-generation kinase inhibitors are designed to bind to their targets with greater precision and affinity than existing therapies, with a novel, compact structure that has demonstrated an ability to potentially overcome treatment resistance common with other kinase inhibitors. 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. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as "plans", "will", "believes," "anticipates," "expects," "intends," "goal," "potential" and similar expressions are intended to identify 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's business and the other risks described in Turning Point Therapeutics' filings with the SEC. 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.

    Contact:

    Jim Mazzola



    858-342-8272



    Primary Logo

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    • Phase 2 Confirmed Objective Response Rate is 93% (95% CI: 68-100); Pooled Phase 1/2 Confirmed Objective Response Rate is 91% (95% CI: 71-99)

    • Approximately 40 Patients with ROS1-Positive TKI-Naive Non-Small Lung Cancer Now Enrolled in Phase 1/2 TRIDENT-1 Study

    • Company Plans to Conduct Type B Meeting with Food and Drug Administration in 1H 2021 to Discuss Regulatory Path

    SAN DIEGO, Jan. 29, 2021 (GLOBE NEWSWIRE) -- Turning Point Therapeutics, Inc. (NASDAQ:TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, announced updated interim findings from the ongoing TRIDENT-1 registrational study of lead drug candidate repotrectinib in patients with ROS1-positive TKI-naïve non-small cell lung cancer…

    • Phase 2 Confirmed Objective Response Rate is 93% (95% CI: 68-100); Pooled Phase 1/2 Confirmed Objective Response Rate is 91% (95% CI: 71-99)



    • Approximately 40 Patients with ROS1-Positive TKI-Naive Non-Small Lung Cancer Now Enrolled in Phase 1/2 TRIDENT-1 Study



    • Company Plans to Conduct Type B Meeting with Food and Drug Administration in 1H 2021 to Discuss Regulatory Path

    SAN DIEGO, Jan. 29, 2021 (GLOBE NEWSWIRE) -- Turning Point Therapeutics, Inc. (NASDAQ:TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, announced updated interim findings from the ongoing TRIDENT-1 registrational study of lead drug candidate repotrectinib in patients with ROS1-positive TKI-naïve non-small cell lung cancer (NSCLC).

    In a total of 15 patients enrolled in the Phase 2 portion of the TRIDENT-1 study, the preliminary efficacy analysis showed the confirmed objective response rate (ORR) by physician assessment was 93% (95% CI: 68-100) and in 22 patients pooled from the Phase 1 (dosed at or above the Phase 2 dose) and Phase 2 portions, the confirmed ORR was 91% (95% CI: 71-99).

    The findings will be presented in a mini-oral presentation by Dr. Byoung Chul Cho, Division of Medical Oncology, Yonsei Cancer Center at Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea, at the International Association for the Study of Lung Cancer 2020 World Conference on Lung Cancer.

    "These interim data confirm our belief that repotrectinib has the potential to be the best-in-class treatment for patients with ROS1-positive TKI-naïve advanced non-small cell lung cancer," said Mohammad Hirmand, M.D., chief medical officer. "To date, we have enrolled approximately 40 ROS1-positive TKI-naïve patients in the Phase 1 and 2 portions of the TRIDENT-1 study dosed at or above the Phase 2 dose-- an encouraging increase in enrollment following our data update from last August—and we look forward to discussing next steps towards registration of repotrectinib in this patient population at a Type B meeting with the FDA anticipated in the first half of the year."

    Interim Update

    Utilizing a Dec. 31, 2020 cutoff date, the TRIDENT-1 preliminary interim efficacy update includes 22 ROS1-positive TKI-naïve NSCLC patients pooled from the Phase 1 portion of the study (dosed at or above the Phase 2 dose) with patients from the Phase 2 portion who had at least two post-baseline scans. Responses for patients in the Phase 2 portion of the study were determined by physician assessment. The interim safety update includes a total of 185 patients from the Phase 1 and Phase 2 portions of the study utilizing an Oct. 30, 2020 cutoff date.

    • 14 of 15 patients treated in the Phase 2 portion achieved a confirmed ORR of 93% (95% CI: 68-100). At the time of the data cut-off, the one non-responder remained on treatment and in stable disease with a 13% tumor reduction. In addition, one of the 14 patients in a partial response at the time of the data cutoff date has since achieved a confirmed complete response.



    • Duration of response ranged from 1.3+ to 7.4+ months, and the duration of treatment ranged from 3.7+ to 10.9+ months with 14 of the 15 patients remaining on treatment. As of the cutoff date, one additional patient (not included in the confirmed ORR calculation) had an unconfirmed partial response and was on treatment awaiting a confirmatory scan. The company's prior Phase 2 update with the data cutoff date of July 10, 2020 in 7 total patients, showed a confirmed ORR of 86% and a wider 95% confidence interval of 42 to 100.



    • 20 of 22 patients pooled from Phase 1 and Phase 2 achieved a confirmed ORR of 91% (95% CI: 71-99). In the 7 patients from the Phase 1 portion dosed at or above the Phase 2 dose, duration of treatment ranged from 10.9 to 37.3 months with a median of 30.9 months, with four patients receiving treatment for longer than 30 months.



    • Repotrectinib was generally well tolerated in 185 patients treated in the Phase 1 and Phase 2 portions of the study.



    • Treatment-emergent adverse events (TEAE) found in greater than 15 percent of patients were dizziness (58%), dysgeusia (43%), constipation (32%), dyspnea (31%), fatigue (27%), paresthesia (25%), anemia (22%), nausea (20%), and muscular weakness (16%).



    • There were four cases of Grade 3 dizziness (2%) and no cases of dizziness have led to treatment discontinuation. Dose modifications due to TEAEs were infrequent, including 18% that led to dose reduction and 9% that led to drug discontinuation.



    • The majority of treatment related AEs (TRAEs) were Grade 1 or 2 and there were no Grade 4 or Grade 5 TRAEs.

    About Turning Point Therapeutics Inc.

    Turning Point Therapeutics is a clinical-stage precision oncology company with a pipeline of internally discovered 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 TPX-0022, 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; and TPX-0131, a next-generation ALK inhibitor currently pending IND submission. Turning Point's next-generation kinase inhibitors are designed to bind to their targets with greater precision and affinity than existing therapies, with a novel, compact structure that has demonstrated an ability to potentially overcome treatment resistance common with other kinase inhibitors. 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. Such forward-looking statements include statements regarding, among other things, the efficacy, safety and therapeutic potential of repotrectinib, the results, conduct, progress and timing of the TRIDENT-1 clinical study, plans regarding future regulatory submissions, and the regulatory approval path for repotrectinib. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as "plans", "will", "believes," "anticipates," "expects," "intends," "goal," "potential" and similar expressions are intended to identify 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's business and the other risks described in Turning Point Therapeutics' filings with the SEC. 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.

    Contact:

    Jim Mazzola



    858-342-8272



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    • Present Updated Data from TRIDENT-1 Study in TKI-Naive Patients with ROS1-Positive Non-Small Cell Lung Cancer Jan. 31 at World Conference on Lung Cancer

    • Provide TRIDENT-1 Study Timeline in First Quarter

    • Provide Clinical Data Interim Updates from Multiple Studies, including Phase 1/2 TRIDENT-1, Phase 1 SHIELD-1 and Phase 1 Study of TPX-0046

    • Submit Fourth Drug Candidate IND in First Quarter

    • Initiate Combination Studies for Repotrectinib and TPX-0022

    • Outline Precision Therapy Research Vision in Second Half

    • Company also Updates Cash, Cash Equivalents, and Marketable Securities as of Dec. 31, 2020; Approximately $1.1 Billion Expected to Fund Current Operations into 2024

    SAN DIEGO, Jan. 11, 2021 (GLOBE NEWSWIRE) -- Turning Point Therapeutics, Inc. (NASDAQ…

    • Present Updated Data from TRIDENT-1 Study in TKI-Naive Patients with ROS1-Positive Non-Small Cell Lung Cancer Jan. 31 at World Conference on Lung Cancer



    • Provide TRIDENT-1 Study Timeline in First Quarter



    • Provide Clinical Data Interim Updates from Multiple Studies, including Phase 1/2 TRIDENT-1, Phase 1 SHIELD-1 and Phase 1 Study of TPX-0046



    • Submit Fourth Drug Candidate IND in First Quarter



    • Initiate Combination Studies for Repotrectinib and TPX-0022



    • Outline Precision Therapy Research Vision in Second Half



    • Company also Updates Cash, Cash Equivalents, and Marketable Securities as of Dec. 31, 2020; Approximately $1.1 Billion Expected to Fund Current Operations into 2024

    SAN DIEGO, Jan. 11, 2021 (GLOBE NEWSWIRE) -- Turning Point Therapeutics, Inc. (NASDAQ:TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, today announced 2021 milestone targets for its pipeline of four drug candidates, including data updates from multiple clinical studies and the initiation of new clinical studies. The company also updated its cash position as of Dec. 31, 2020.

    "Following a pivotal year in 2020, we believe we have even greater opportunities in 2021 to further advance our pipeline by potentially modifying our SHIELD-1 study to a registrational Phase 1/2 design, adding three new clinical trials, including two anticipated combination studies and a Phase 1 study of our fourth drug candidate, our novel ALK-inhibitor TPX-0131, and reporting initial or updated data from our three clinical stage drug candidates," said Athena Countouriotis, M.D., president and chief executive officer. "At the same time, we have continued to invest in our discovery engine and look forward to the second half of the year when we plan to outline our focus and goals to further expand the pipeline."

    2020 Achievements and 2021 Milestone Targets

    Repotrectinib, ROS1 and TRK Inhibitor

    In 2020, repotrectinib was granted breakthrough-therapy designation (BTD) and received its second and third fast-track designations. In addition, the company signed an exclusive license agreement with Zai Lab to develop and commercialize repotrectinib in greater China and reported early interim data from the Phase 2 TRIDENT-1 registrational study.

    2021 Milestone Targets:

    • Present updated data from the TRIDENT-1 study in TKI-naive patients with ROS1-positive advanced non-small cell lung cancer (NSCLC) in a mini-oral presentation on Jan. 31 at the World Conference on Lung Cancer



    • Provide an update on the overall Phase 2 TRIDENT-1 registrational study timeline in the first quarter



    • Initiate the Phase 2 TRIDENT-2 combination study in patients with KRAS mutant NSCLC mid-year



    • Provide clinical data updates from certain cohorts of the Phase 2 TRIDENT-1 study in the second half

    TPX-0022, MET/SRC/CSF1R Inhibitor

    In 2020, Turning Point advanced its clinical development of TPX-0022 and reported initial data from the Phase 1 SHIELD-1 study in an oral presentation during the plenary session at the EORTC-NCI-AACR medical symposium.

    Earlier today, the company announced the broadening of its collaboration with Zai Lab to include an exclusive licensing agreement for TPX-0022 in greater China.

    2021 Milestone Targets:

    • Initiate the Phase 2 portion of SHIELD-1, pending FDA feedback, in the second half



    • Initiate the Phase 2 SHIELD-2 study of TPX-0022 in combination with an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor in the second half



    • Provide a clinical data update from the Phase 1 portion of the SHIELD-1 study in the second half

    TPX-0046, RET Inhibitor

    In 2020, Turning Point presented preclinical data highlighting the potent inhibition of TPX-0046 against wildtype RET and RET mutations, and continued its ongoing Phase 1 study of TPX-0046.

    2021 Milestone Target:

    • Report early interim data from initial patients enrolled in the dose finding portion of the TPX-0046 Phase 1 study in the first half

    TPX-0131, ALK Inhibitor

    In 2020, Turning Point nominated TPX-0131 as its ALK inhibitor drug candidate, advanced its IND enabling studies, and presented preclinical data highlighting its ability to overcome ALK resistant mutations refractory to approved ALK inhibitors.

    2021 Milestone Targets:

    • Submit the IND for TPX-0131 in the first quarter
    • Initiate a Phase 1 clinical study of TPX-0131 in the first half

    Early Discovery Pipeline

    In 2020, Turning Point named Siegfried Reich as chief scientific officer and made investments to advance its research strategy.

    2021 Milestone Target:

    • Outline research strategy, focus and milestones for future development candidates in the second half

    Financial

    In 2020, Turning Point completed follow-on stock offerings generating gross proceeds of $374 million and $460 million. The company enters 2021 with approximately $1.1 billion in cash, cash equivalents and marketable securities as of Dec. 31, 2020, which is expected to fund operations into 2024.

    About Turning Point Therapeutics Inc.

    Turning Point Therapeutics is a clinical-stage precision oncology company with a pipeline of internally discovered 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 called TRIDENT-1 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 TPX-0022, targeting MET, CSF1R and SRC, which is in a Phase 1 study called SHIELD-1 in patients with advanced or metastatic solid tumors harboring genetic alterations in MET; RET-inhibitor TPX-0046, which is in a Phase 1/2 study of patients with advanced or metastatic solid tumors harboring genetic alterations in RET; and ALK-inhibitor TPX-0131, which is in IND-enabling studies. Turning Point's next-generation kinase inhibitors are designed to bind to their targets with greater precision and affinity than existing therapies, with a novel, compact structure that has demonstrated an ability to potentially overcome treatment resistance common with other kinase inhibitors. 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. Such forward-looking statements include statements regarding, among other things, the efficacy, safety and therapeutic potential of Turning Point Therapeutics' drug candidates repotrectinib, TPX-0022, TPX-0046 and TPX-0131, the results, conduct, progress and timing of Turning Point Therapeutics' research and development programs and clinical trials including the Phase 2 TRIDENT-1 clinical study, the Phase 1 SHIELD-1 clinical study of TPX-0022 and the Phase 1/2 clinical study of TPX-0046, plans regarding future clinical trials and regulatory submissions, the regulatory approval path for repotrectinib, and the strength of Turning Point Therapeutics' balance sheet and 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. Words such as "plans", "will", "believes," "anticipates," "expects," "intends," "goal," "potential" and similar expressions are intended to identify 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's business and the other risks described in Turning Point Therapeutics' filings with the SEC. 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.

    Contact:

    Jim Mazzola



    858-342-8272 



    Primary Logo

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