TPTX Turning Point Therapeutics Inc.

64.96
+0.18  (+0%)
Previous Close 64.78
Open 65.25
52 Week Low 51.56
52 Week High 141.3
Market Cap $3,192,839,866
Shares 49,150,860
Float 40,764,132
Enterprise Value $2,349,887,190
Volume 741,845
Av. Daily Volume 455,801
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Upcoming Catalysts

Drug Stage Catalyst Date
TPX-0022 ( SHIELD-1)
Solid tumors
Phase 1
Phase 1
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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
TPX-0131 - FORGE-1
Non-small cell lung cancer
Phase 1/2
Phase 1/2
Phase 1/2 trial initiation announced April 12, 2021.
Repotrectinib (TPX-0005) - TRIDENT-2
KRAS mutant NSCLC
Phase 2
Phase 2
Phase 2 trial to be initiated mid-2021.
TPX-0046
RET-altered NSCLC
Phase 1/2
Phase 1/2
Phase 1/2 interim data noted 3/14 partial responses - April 5, 2021.

Latest News

    • FDA Type B Meeting Feedback Supports Discussion of Topline BICR Results for Repotrectinib in TKI-Naïve ROS1+ NSCLC Patients After 6 Months or Greater Follow-up; FDA Meeting Anticipated in 1Q 2022
    • Investigational New Drug Application Cleared for Combination of Repotrectinib and MEK-inhibitor Trametinib in KRAS-Driven Tumors; TRIDENT-2 Study on Track to Initiate Mid-Year

    • TPX-0022 SHIELD-1 Study Progressing Toward Recommended Phase 2 Dose

    • TPX-0131 Phase 1/2 FORGE-1 Study Initiated

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

    SAN DIEGO, May 05, 2021 (GLOBE NEWSWIRE) -- Turning Point Therapeutics, Inc. (NASDAQ:TPTX), a precision oncology company developing next-generation therapies that…

    • FDA Type B Meeting Feedback Supports Discussion of Topline BICR Results for Repotrectinib in TKI-Naïve ROS1+ NSCLC Patients After 6 Months or Greater Follow-up; FDA Meeting Anticipated in 1Q 2022
    • Investigational New Drug Application Cleared for Combination of Repotrectinib and MEK-inhibitor Trametinib in KRAS-Driven Tumors; TRIDENT-2 Study on Track to Initiate Mid-Year



    • TPX-0022 SHIELD-1 Study Progressing Toward Recommended Phase 2 Dose



    • TPX-0131 Phase 1/2 FORGE-1 Study Initiated



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

    SAN DIEGO, May 05, 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 first quarter ended March 31, 2021.

    "Our team continues to execute well and has achieved multiple key milestones, including completing a Type B meeting with the FDA for our lead drug candidate, repotrectinib, as well as clearing our fourth IND and initiating our fourth clinical study in less than 2 years," said Athena Countouriotis, M.D., president and CEO. "We are pleased with the feedback from the Type B meeting and look forward to the discussion with the FDA about the topline results from patients treated within cohort 1 of our TRIDENT-1 study, which we anticipate in the first quarter of next year."

    First quarter and recent highlights include:

    REPOTRECTINIB, ROS1/TRK Inhibitor

    • Completion of a Type B meeting with the Food and Drug Administration (FDA) to discuss potential next steps for repotrectinib in patients treated within cohort 1 (EXP-1) of the registrational TRIDENT-1 study. The FDA guided that a meeting should be requested to discuss topline blinded independent central review (BICR) results when responders have been followed for at least six months past onset of response. Turning Point believes it may be in a position to discuss the topline results from patients treated within EXP-1 with the FDA during the first quarter of 2022.



    • Clearance of an investigational new drug (IND) application for the combination of repotrectinib and MEK-inhibitor trametinib in KRAS-driven tumors. The company anticipates the first cohort of its planned Phase 1b/2 TRIDENT-2 study will examine the safety, tolerability, pharmacokinetics, and any early signals of efficacy of repotrectinib in combination with trametinib in patients with KRAS mutant G12D advanced solid tumors. The study is planned for initiation in mid-2021.



    • Presentation of preclinical data at the American Association for Cancer Research (AACR) annual meeting demonstrating that repotrectinib in combination with trametinib was more effective than single-agent treatment of either repotrectinib or trametinib in patient-derived KRAS mutant G12D/V lung and G12D/V/R pancreatic cancer models.



      In earlier preclinical studies, repotrectinib's inhibition of SRC, FAK and JAK2 at therapeutically relevant concentrations in combination with trametinib demonstrated a synergistic effect over either single agent by reducing tumor cell growth and enhancing tumor cell death in a KRAS mutant G12D lung cancer model.
    • Progress in the ongoing Phase 1/2 CARE study in pediatric and young adult patients with advanced solid tumors harboring ALK, ROS1 or NTRK alterations. The company plans to report initial data from the study in the second half of 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 the company continues to enroll patients and evaluate multiple doses and schedules to further characterize the pharmacokinetics, safety and efficacy profile before determining a recommended Phase 2 dose (RP2D), anticipated in the second quarter of 2021. Turning Point plans to proceed directly into multiple Phase 1 dose expansion cohorts after determining the RP2D and to prepare for an end of Phase 1 meeting in the second half of 2021.



    • Presentation of preclinical data at AACR demonstrating potential utility of TPX-0022 in combination with immune checkpoint inhibitors. In a syngeneic xenograft tumor model, TPX-0022 downregulated immunosuppressive cytokines, increased anti-tumor M1 macrophages, and enriched levels of CD8-positive cytotoxic T cells. TPX-0022 had single agent in vivo efficacy and enhanced the efficacy of an anti-PD-1 inhibitor. The company is evaluating a clinical combination study of TPX-0022 and an anti-PD-1 checkpoint inhibitor.

    TPX-0046, RET Inhibitor

    • Reporting initial data from the Phase 1 dose finding portion of the Phase 1/2 SWORD-1 study, which showed preliminary clinical activity, including objective responses and a generally well-tolerated safety profile in patients with RET-positive non-small cell lung cancer (NSCLC) and medullary thyroid carcinoma.



    • Progress in the ongoing dose-finding portion of the study, where the company continues to evaluate multiple doses and schedules to further characterize the pharmacokinetics, safety, and efficacy profile before determining the RP2D. The company has revised the study protocol to include multiple Phase 1 dose expansion cohorts following determination of the RP2D.

    TPX-0131, ALK Inhibitor

    • Clearance of the IND for TPX-0131, the company'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 brain tissue penetration after repeat oral dosing.



    • Initiation of the Phase 1/2 FORGE-1 study of TPX-0131 in patients with locally advanced or metastatic TKI-pretreated ALK-positive NSCLC. The study endpoints include safety and tolerability, determination of the maximum tolerated dose and/or the recommended Phase 2 dose, and objective response rate by RECIST 1.1.



    • Presentation of preclinical data at AACR demonstrating the potential for TPX-0131 to cross the blood-brain barrier in vivo, and potency against wild type ALK (IC50=0.4 nM) and a broad spectrum of acquired ALK resistance mutations, including the G1202R solvent front mutation (IC50=0.2 nM), L1196M gatekeeper mutation (IC50=0.5 nM), and multiple compound mutations (IC50< 1 nM) based on cell proliferation assays.

    First Quarter Financial Results

    • Revenue: Revenue of $25.2 million recognized during the quarter included a $25 million upfront payment from Zai Lab (Shanghai) Co. Ltd., under the company's license agreement for TPX-0022 in Greater China, and $0.2 million from clinical drug supply to Zai Lab under the company's repotrectinib license agreement.



    • R&D Expenses: Research and development expenses were $41.3 million in the quarter, compared to $22.8 million in the first quarter of 2020. The $18.5 million increase was primarily driven by the year-over-year increase in investments to develop repotrectinib, TPX-0022, TPX-0046 and TPX-0131, discovery efforts and personnel expenses.



    • G&A Expenses: General and administrative expenses were $20 million compared to $39.9 million in the first quarter of 2020. Excluding a one-time non-cash stock-based compensation charge from the first quarter of 2020, non-GAAP G&A expenses increased by $11.5 million, primarily related to higher personnel expenses from an increase in head count and professional services.



    • Net Income/Loss: Net loss was $35.5 million compared to a net loss of $60.7 million for the first quarter of 2020, and excluding the one-time non-cash stock-based compensation charge from the first quarter of 2020, non-GAAP net loss increased by $6.2 million.



    • Cash position: Cash, cash equivalents and marketable securities at March 31, 2021 totaled $1.1 billion, compared to $1.1 billion as of Dec. 31, 2020, driven primarily by $25.2 million in revenue, partially offset by cash used in operating activities. Net cash used in operating activities during the first quarter was $15.7 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



    • Initiate the first cohort of a multi-arm Phase 1b/2 TRIDENT-2 combination study in patients with KRAS mutant G12D advanced solid tumors mid-year



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



    • Report initial clinical data from the ongoing Phase 1/2 CARE study in pediatric and young adult patients in the second half

    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

    Preclinical/Research

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

    Webcast and Conference Call

    Turning Point will webcast its Quarterly Update Conference Call today, May 5 at 5:00 p.m. ET/2:00 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 7397513. 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, 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. 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, 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 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

    TURNING POINT THERAPEUTICS, INC.

    Balance Sheet Data

    (In thousands)

    (unaudited)

      March 31,  December 31,  
      2021  2020  
    Balance Sheet Data:         
    Cash, cash equivalents, and marketable securities $1,114,777  $1,122,508  
    Working capital  1,097,541   1,106,287  
    Total assets  1,127,584   1,136,713  
    Accumulated deficit  (315,680)  (280,176) 
    Total stockholders' equity $1,101,165  $1,109,898  



    TURNING POINT THERAPEUTICS, INC.


    STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

    (In thousands, except share and per share amounts)

    (unaudited)

      Three Months Ended March 31,  
      2021  2020  
    Revenue $25,205   -  
    Operating expenses:         
    Research and development  41,263   22,769  
    General and administrative  19,991   39,857  
    Total operating expenses  61,254   62,626  
    Loss from operations  (36,049)  (62,626) 
    Other income, net  545   1,908  
    Net loss  (35,504)  (60,718) 
    Unrealized loss on marketable securities  (186)  (316) 
    Comprehensive loss $(35,690) $(61,034) 
    Net loss per share, basic and diluted $(0.73) $(1.69) 
    Weighted-average common shares outstanding, basic and diluted  48,920,403   35,919,358  
              



    TURNING POINT THERAPEUTICS, INC.

    Reconciliation of GAAP to Non-GAAP Financial Results

    (In thousands)

    (unaudited)

      Three Months Ended March 31,  
      2021  2020  
    GAAP Net Loss $(35,504) $(60,718) 
    Adjustments:         
    Share-based compensation expense (1)     31,405  
    Non-GAAP Net Loss $(35,504) $(29,313) 
              



      Three Months Ended March 31,  
      2021  2020  
    GAAP General & Administrative $(19,991) $(39,857) 
    Adjustments:         
    Share-based compensation expense (1)     31,405  
    Non-GAAP General & Administrative $(19,991) $(8,452) 



    (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.


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  1. SAN DIEGO, April 26, 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 first quarter financial results following the close of U.S. financial markets on May 5. The company will host a conference call at 2:00 p.m. PT/5:00 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…

    SAN DIEGO, April 26, 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 first quarter financial results following the close of U.S. financial markets on May 5. The company will host a conference call at 2:00 p.m. PT/5:00 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 7397513. 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, 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. 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



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  2. Investigational New Drug Application Cleared

    Study Initiated in Australia, with U.S. Site Activations Now Planned

    SAN DIEGO, April 12, 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 initiation of its Phase 1/2 FORGE-1 study of TPX-0131, a potent inhibitor of the anaplastic lymphoma kinase (ALK) and multiple resistant mutations of ALK.

    The investigational new drug (IND) application for TPX-0131 is Turning Point's third IND to be cleared by the FDA in less than 2 years, and FORGE-1 is the company's fourth clinical study to initiate during the same period of time.

    The study was initiated…

    Investigational New Drug Application Cleared

    Study Initiated in Australia, with U.S. Site Activations Now Planned

    SAN DIEGO, April 12, 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 initiation of its Phase 1/2 FORGE-1 study of TPX-0131, a potent inhibitor of the anaplastic lymphoma kinase (ALK) and multiple resistant mutations of ALK.

    The investigational new drug (IND) application for TPX-0131 is Turning Point's third IND to be cleared by the FDA in less than 2 years, and FORGE-1 is the company's fourth clinical study to initiate during the same period of time.

    The study was initiated in Australia, with U.S. site activations now planned.

    "With a lack of available therapies to address a broad spectrum of ALK resistant mutations, we are encouraged by the preclinical potency for TPX-0131, particularly against the G1202R solvent front mutation which is reported to occur in more than 40% of biopsies with resistance mutations," said Ben Solomon, M.D., principal investigator for the FORGE-1 study, a medical oncologist and group leader of the Molecular Therapeutics and Biomarkers Laboratory at the Peter MacCallum Cancer Centre in Melbourne, Australia. "In addition, TPX-0131 has been shown preclinically to penetrate the central nervous system, which is important in the treatment of patients with ALK-positive non-small cell lung cancer as the disease often progresses in the brain."

    ALK alterations are estimated to be responsible for 3% to 5% of non-small cell lung cancer (NSCLC) cases annually in the U.S. and EU5 countries. In preclinical studies, TPX-0131 potently inhibits wildtype ALK and is more potent in comparison to approved ALK inhibitors against many clinically observed resistance mutations, including the G1202R solvent front mutation, L1196M gatekeeper mutation, and multiple compound mutations. In addition, TPX-0131 has shown brain tissue penetration after repeat oral dosing.

    "Our clinical study of TPX-0131 will begin with a Phase 1 dose finding portion in patients previously treated with up to 2 prior ALK tyrosine kinase inhibitors, a population we believe is underserved today by available therapies that are less potent against known resistant mutations of ALK," said Mohammad Hirmand, M.D., chief medical officer of Turning Point Therapeutics.

    The Phase 1 dose finding portion of the FORGE-1 study will enroll patients with locally advanced or metastatic TKI-pretreated ALK-positive NSCLC. Patients with up to 2 prior ALK TKIs and 1 prior platinum-based chemotherapy will be enrolled. The study endpoints include safety and tolerability, determination of the maximum tolerated dose and/or the recommended Phase 2 dose, and objective response rate by RECIST 1.1.

    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, 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. 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 candidate TPX-0131, the results, conduct, progress and timing of Turning Point Therapeutics' pre-clinical studies and clinical trials and plans regarding future clinical trials. 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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  3. SAN DIEGO, April 09, 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 new preclinical data supporting the ongoing development of three of its drug candidates, repotrectinib, TPX-0022 and TPX-0131. The findings will be presented this weekend at the American Association for Cancer Research (AACR) annual meeting, which is convening virtually through April 14.

    For lead drug candidate, repotrectinib, poster presentations will highlight new preclinical combination data with MEK and MEK/Raf inhibitors, as well as repotrectinib's potency against wildtype and mutant TRKA/B/C as compared to approved TRK inhibitors…

    SAN DIEGO, April 09, 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 new preclinical data supporting the ongoing development of three of its drug candidates, repotrectinib, TPX-0022 and TPX-0131. The findings will be presented this weekend at the American Association for Cancer Research (AACR) annual meeting, which is convening virtually through April 14.

    For lead drug candidate, repotrectinib, poster presentations will highlight new preclinical combination data with MEK and MEK/Raf inhibitors, as well as repotrectinib's potency against wildtype and mutant TRKA/B/C as compared to approved TRK inhibitors. The preclinical studies found that repotrectinib combinations with approved MEK inhibitor, trametinib, or investigational MEK/Raf inhibitor, VS-6766, were more effective than single-agent treatment in patient-derived KRAS mutant G12D/V lung and G12D/V/R pancreatic cancer models. Based on the findings and additional preclinical support presented previously, Turning Point anticipates the first cohort of its planned Phase 1/2 TRIDENT-2 study will examine the safety, tolerability, pharmacokinetics, and any early signals of efficacy of repotrectinib in combination with trametinib in patients with KRAS mutant G12D advanced solid tumors.

    "We are encouraged by the new preclinical data our research team has generated in support of our ongoing development of repotrectinib, TPX-0022 and TPX-0131," said Athena Countouriotis, M.D., president and CEO. "In particular, our preclinical models continue to suggest that the combination of repotrectinib with MEK inhibitors can suppress mutant KRAS signaling to achieve more potent and durable anti-tumor activity. We look forward to studying this further in the first cohort of our planned TRIDENT-2 combination study.

    "In addition, preclinical studies show repotrectinib is highly potent against wild type TRK fusions and is less affected by NTRK resistance mutations than approved therapies, with strong potency in both in vitro and in vivo studies. We look forward to sharing additional clinical data from our TRIDENT-1 study of repotrectinib in the second half of the year."

    TPX-0022, MET, SRC, CSF1R Inhibitor

    For MET/SRC/CSF1R inhibitor TPX-0022, the company will present preclinical data demonstrating potential utility in combination with immune checkpoint inhibitors. In a syngeneic xenograft tumor model, TPX-0022 treatment downregulated immunosuppressive cytokines, increased anti-tumor M1 macrophages, and enriched levels of CD8+ cytotoxic T cells. TPX-0022 had single agent in vivo efficacy and enhanced the efficacy of an anti-PD-1 inhibitor. With the new data, Turning Point is evaluating a potential additional combination study of TPX-0022 and an anti-PD-1 checkpoint inhibitor. In the second half of 2021, the company plans to provide a clinical data update from the Phase 1 dose finding portion of its ongoing SHIELD-1 study and initiate its planned Phase 1b/2 SHIELD-2 clinical study of TPX-0022 in combination with an EGFR targeted therapy.

    TPX-0131, ALK Inhibitor

    For its ALK-inhibitor, TPX-0131, Turning Point will present preclinical data showing its potential to cross the blood-brain barrier and its potency against wild type ALK and a broad spectrum of acquired ALK resistance mutations, including the G1202R solvent front mutation, L1196M gatekeeper mutation, and the G1202R/L1196M and /L1198F compound mutations. Turning Point plans to initiate a Phase 1/2 study in patients with ALK-positive TKI-pretreated advanced non-small cell lung cancer in the second quarter of 2021.

    AACR plans to make poster presentations available via its website on Saturday, April 10. The four posters to be presented are:

    Title: Repotrectinib increases effectiveness of MEK inhibitors in KRAS mutant cancer models

    Abstract Number: 1104

    Title: Molecular characteristics of repotrectinib that enable potent inhibition of TRK fusion proteins and broad mutant selectivity

    Abstract Number: 1119

    Title: TPX-0022, a potent MET/SRC/CSF1R inhibitor that modulates the tumor immune microenvironment in preclinical models

    Abstract Number: 1444

    Title: TPX-0131, a potent inhibitor of wild type ALK and a broad spectrum of both single and compound ALK resistance mutations

    Abstract Number: 1469

    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. 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, the results, conduct, progress and timing of Turning Point Therapeutics' pre-clinical studies and plans regarding future development activities. 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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    • Preliminary Clinical Activity Shown, With Tumor Regression in 4 of 5 TKI-Naïve Patients Including 2 Confirmed Partial Responses

    • Preliminary Clinical Activity Shown, With Tumor Regression in 3 of 9 TKI-Pretreated Patients

    • Across 6 Dose Finding Cohorts, Generally Well Tolerated Preliminary Safety Profile

    • Continued Dose Finding with Phase 1 Dose Expansion Planned

    • Conference Call Scheduled for 4:30 p.m. Eastern Time

    SAN DIEGO, April 05, 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 initial clinical data from the ongoing Phase 1/2 SWORD-1 study of its RET inhibitor drug candidate, TPX-0046.

    The initial…

    • Preliminary Clinical Activity Shown, With Tumor Regression in 4 of 5 TKI-Naïve Patients Including 2 Confirmed Partial Responses



    • Preliminary Clinical Activity Shown, With Tumor Regression in 3 of 9 TKI-Pretreated Patients



    • Across 6 Dose Finding Cohorts, Generally Well Tolerated Preliminary Safety Profile



    • Continued Dose Finding with Phase 1 Dose Expansion Planned



    • Conference Call Scheduled for 4:30 p.m. Eastern Time

    SAN DIEGO, April 05, 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 initial clinical data from the ongoing Phase 1/2 SWORD-1 study of its RET inhibitor drug candidate, TPX-0046.

    The initial data from the Phase 1 dose finding portion of the study showed preliminary clinical activity, including objective responses and a generally well-tolerated safety profile. Turning Point continues to evaluate doses and schedules to determine a recommended Phase 2 dose, and plans to revise the study protocol to include Phase 1 expansion cohorts at the recommended Phase 2 dose.

      

    "RET-driven cancers affect nearly 10,000 patients annually in the U.S. and E.U., and patients who progress following treatment with a selective RET inhibitor remain particularly underserved," said Alexander Drilon, M.D., chief, Early Drug Development Service, Memorial Sloan Kettering Cancer Center. "While we continue to evaluate TPX-0046, the initial preliminary data are encouraging, with a generally tolerable safety profile and early signals of activity."

    TPX-0046 Initial Clinical Data

    Twenty-one patients enrolled in the study including 10 with non-small cell lung cancer (NSCLC) and 11 with medullary thyroid carcinoma (MTC) who were treated from December 2019 to the data cut-off date of March 10, 2021. Patients included those with RET-altered TKI-naïve NSCLC (n=3; all previously treated with platinum-based chemotherapy and immunotherapy) and MTC (n=2), and TKI-pretreated NSCLC (n=7) and MTC (n=9).  

    All 16 TKI-pretreated patients were previously treated with a selective RET TKI and 9 patients (56%) were treated with more than 1 prior TKI. Ninety-one percent of patients (19/21) had a baseline ECOG performance score of 1, and nearly half (10/21) received 3 or more prior therapies.

    Preliminary efficacy data by investigator assessment was available for 14 evaluable patients with baseline measurable disease and at least one post-baseline assessment per RECIST v1.1, including TKI-naïve NSCLC (n=3) and MTC (n=2), and TKI-pretreated NSCLC (n=4) and MTC (n=5).

    As of the March 10, 2021 data cut-off date:

    Preliminary Safety and Pharmacokinetic Results

    • A total of 21 patients with RET-altered NSCLC or MTC were treated with TPX-0046 across multiple doses and schedules from 10mg once daily (QD) to 30mg QD
    • TPX-0046 was generally well tolerated, with the most frequent treatment emergent adverse event (TEAE) being Grade 1 or 2 dizziness
    • The maximum tolerated dose had not been determined, with 1 dose-limiting toxicity of treatment-related Grade 2 gait disturbance at 30 mg QD
    • TEAEs reported in greater than 20 percent of patients were dizziness (43%); fatigue (38%); alkaline phosphatase increase, constipation, decreased appetite, dry mouth, hyperphosphataemia, lipase increase (29% each); and alanine aminotransferase increase, dehydration, and muscular weakness (24% each)
    • There were infrequent dose reductions or drug discontinuations due to TEAEs
    • The majority of treatment related adverse events (TRAEs) were Grade 1 or 2 and there were no Grade 4 or 5 TRAEs
    • There were no treatment related Grade 3 or greater ALT/AST elevations, any grade of hypertension, hemorrhagic events or QT prolongation, and no interstitial lung disease or pneumonitis
    • Preliminary pharmacokinetic data indicates exposure increases in a dose dependent manner

    Preliminary Efficacy Results

    • Of 5 RET TKI-naïve patients, 4 showed tumor regressions of -42%, -37%, -23%, and -3%, including 2 patients dosed at 30 mg QD who achieved confirmed partial responses with duration of responses of 5.6 and 5.8+ months, respectively. Three of the 4 patients with regressions remained on treatment awaiting their next scan
    • Of 9 TKI-pretreated patients, 3 patients (2 treated with only 1 prior selective RET TKI) achieved tumor regressions of -44%, -27% and -17%. All 3 patients remained on treatment awaiting their next scan
    • Of the 14 evaluable patients, 7 (50%) remained on treatment with duration of treatment ranging from 5.1 to 51+ weeks

    "Given the encouraging data we have seen, we plan to modify the SWORD-1 study to include a dose expansion portion utilizing additional clinical sites," said Mohammad Hirmand, M.D., executive vice president and chief medical officer of Turning Point Therapeutics. "We look forward to advancing our development of TPX-0046 in both the RET-positive TKI-naïve and less heavily pretreated TKI-pretreated settings."

    After determination of the recommended Phase 2 dose, Turning Point plans to study TPX-0046 in multiple Phase 1 dose expansion cohorts in up to 75 patients with RET-altered malignancies prior to an end of Phase 1 meeting with the Food and Drug Administration.

    Webcast and Conference Call

    Turning Point will host a webcast and conference call accompanied by a slide presentation to discuss the results at 4:30 p.m. ET today. Athena Countouriotis, M.D., president and chief executive officer, will host the call, which will also include Dr. Hirmand.

    The discussion 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 9939858. 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. 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 TPX-0046, the results, conduct, progress and timing of the Phase 1/2 clinical study of TPX-0046, plans regarding future clinical studies and regulatory discussions, and the regulatory approval path for TPX-0046. 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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