CMPI Checkmate Pharmaceuticals Inc.

11
+0.04  (+0%)
Previous Close 10.96
Open 10.98
52 Week Low 8.61
52 Week High 16.49
Market Cap $237,056,017
Shares 21,550,547
Float 13,650,941
Enterprise Value $102,302,082
Volume 13,182
Av. Daily Volume 36,590
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Drug Pipeline

Drug Stage Notes
CMP-001 and pembrolizumab
Head and neck squamous cell carcinoma (HNSCC)
Phase 2
Phase 2
Phase 2 trial planned late 2020/early 2021.
CMP-001 and pembrolizumab
Melanoma
Phase 1b
Phase 1b
Phase 1b data presented at SITC meeting November 2020. 17.5% partial response rate for monotherapy, 28% for combo.
CMP-001 and nivolumab
Melanoma
Phase 2
Phase 2
Phase 2 trial is ongoing. Interim data noted pathological Complete Response, or pCR, rate of 62%.

Latest News

  1. CAMBRIDGE, Mass., Nov. 13, 2020 (GLOBE NEWSWIRE) -- Checkmate Pharmaceuticals, Inc. (NASDAQ:CMPI) ("Checkmate"), a clinical stage biotechnology company focused on developing its proprietary technology to harness the power of the immune system to combat cancer, today announced third quarter 2020 financial results and provided an update on recent progress.

    "We are enthusiastic as we advance CMP-001 toward registration in melanoma and expand toward potential proof of concept in additional indications," said Barry Labinger, Chief Executive Officer. "We remain on track to initiate key new clinical trials by late 2020/early 2021 as planned."

    Recent Progress

    • During SITC's 35th Anniversary Annual Meeting, three new data presentations were given…

    CAMBRIDGE, Mass., Nov. 13, 2020 (GLOBE NEWSWIRE) -- Checkmate Pharmaceuticals, Inc. (NASDAQ:CMPI) ("Checkmate"), a clinical stage biotechnology company focused on developing its proprietary technology to harness the power of the immune system to combat cancer, today announced third quarter 2020 financial results and provided an update on recent progress.

    "We are enthusiastic as we advance CMP-001 toward registration in melanoma and expand toward potential proof of concept in additional indications," said Barry Labinger, Chief Executive Officer. "We remain on track to initiate key new clinical trials by late 2020/early 2021 as planned."

    Recent Progress

    • During SITC's 35th Anniversary Annual Meeting, three new data presentations were given evaluating CMP-001, Checkmate's advanced generation Toll-like receptor 9 (TLR9) agonist. These data continue to demonstrate the clinical activity of CMP-001 in combination with anti-PD-1 antibodies in patients with melanoma.
    • Checkmate is actively engaging with potential clinical sites and remains on track to initiate three Phase 2 trials combining CMP-001 with PD-1 blockade by late 2020/early 2021 for the treatment of:
      • First-line head and neck cancer
      • Anti-PD-1 refractory melanoma
      • First-line metastatic or unresectable melanoma

    Third Quarter 2020 Financial Results

    • Cash and cash equivalents: Cash and cash equivalents were $137.3 million as of September 30, 2020.
    • Research and development expenses (R&D): R&D expenses were $6.7 million for the quarter ended September 30, 2020, compared to $5.1 million for the quarter ended September 30, 2019. The increase was primarily attributable to increased headcount and clinical trial expenses in connection with increased patient enrollment in the ongoing clinical trials of CMP-001 and preparations for the initiation of planned additional clinical trials of CMP-001. These increases were partially offset by a decrease in contract manufacturing costs.
    • General and administration expenses (G&A): G&A expenses were $3.2 million for the quarter ended September 30, 2020, compared to $1.2 million for the quarter ended September 30, 2019. The increase was primarily attributable to increases in personnel and other operating expenses incurred in connection with Checkmate beginning to operate as a publicly-traded company.
    • Net loss and comprehensive loss: Net loss and comprehensive loss was $9.8 million for the quarter ended September 30, 2020, compared to $6.2 million for the quarter ended September 30, 2019.

    About Checkmate Pharmaceuticals



    Checkmate Pharmaceuticals is a clinical stage biotechnology company focused on developing its proprietary technology to harness the power of the immune system to combat cancer. Checkmate's product candidate, CMP-001, is an advanced generation TLR9 agonist delivered as a biologic virus-like particle designed to trigger the body's innate immune system to attack tumors in combination with other therapies. Information regarding Checkmate is available at www.checkmatepharma.com.

    Availability of Other Information About Checkmate

    Investors and others should note that we communicate with our investors and the public using our website (www.checkmatepharma.com), our investor relations website (ir.checkmatepharma.com), and on social media (Twitter and LinkedIn), including but not limited to: investor presentations and investor fact sheets, U.S. Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Checkmate posts on these channels and websites could be deemed to be material information. As a result, we encourage investors, the media, and others interested in us to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on our investor relations website and may include additional social media channels. The contents of our website or these channels, or any other website that may be accessed from our website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.

    Forward Looking Statements

    Various statements in this release are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including. Words such as, but not limited to, "anticipate," "believe," "can," "could," "expect," "estimate," "design," "goal," "intend," "may," "might," "objective," "plan," "predict," "project," "target," "likely," "should," "will," and "would," or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. These statements include those regarding our product candidate, including its development and therapeutic potential and the advancement of our clinical and preclinical pipeline; expectations regarding the results and analysis of data; and expectations regarding the timing, initiation, implementation and success of its planned clinical trials for CMP-001.  Forward-looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved. These forward-looking statements are subject to risks and uncertainties, including those related to the development of our product candidate, including any delays in our ongoing or planned preclinical or clinical trials, positive results from a clinical study may not necessarily be predictive of the results of future or ongoing clinical studies, the impact of the ongoing COVID-19 pandemic on our business, operations, clinical supply and plans, the risks inherent in the drug development process, the risks regarding the accuracy of our estimates of expenses and timing of development, our capital requirements and the need for additional financing, and obtaining, maintaining and protecting its intellectual property. These and additional risks are discussed in the sections titled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 dated September 18, 2020, as filed with the Securities and Exchange Commission pursuant to Rule 424(b) under the Securities Act 1933, as amended, which is available on the Securities and Exchange Commission's website at www.sec.gov, and as well as discussions of potential risks, uncertainties and other important factors in the Company's subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information unless required by law.



    CHECKMATE PHARMACEUTICALS, INC.

    SUMMARY STATEMENTS OF OPERATIONS

    (Unaudited)

    (In thousands)

     Three Months Ended 

    September 30,
     Nine Months Ended

    September 30,
      2020   2019   2020   2019 
    Operating expenses:       
    Research and development$6,673  $5,076  $19,462  $17,126 
    General and administrative 3,160   1,208   6,465   3,365 
    Total operating expenses 9,833   6,284   25,927   20,491 
    Loss from operations (9,833)  (6,284)  (25,927)  (20,491)
    Other income (expense), net:       
    Interest income 4   43   32   160 
    Change in fair value of convertible loan notes       (83)   
    Total other income (expense), net 4   43   (51)  160 
    Net loss and comprehensive loss$(9,829) $(6,241) $(25,978) $(20,331)
                    

    CHECKMATE PHARMACEUTICALS, INC.

    SUMMARY BALANCE SHEETS

    (In thousands)

    (Unaudited)

      September 30,  December 31,
       2020   2019 
          
    Cash and cash equivalents $         137,340  $4,185 
    Other current assets               6,725                 941 
    Total assets $         144,065  $         5,126 
          
    Current liabilities $              8,860  $           5,634 
         Total liabilities $                8,860  $         5,634 
          
    Series A redeemable convertible preferred stock                          —            32,482 
    Series B redeemable convertible preferred stock                          —            64,446 
          
    Total stockholders' equity (deficit)                   135,205   (97,436)
    Total liabilities, redeemable convertible preferred stock and stockholders' (deficit) $           144,065  $         5,126 
    Investor Contact
    Kleem Chaudhary
    Chief Business Officer
    
    
    Media Contact
    Karen Sharma
    MacDougall 
    781-235-3060
    

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  2. CMP-001 in combination with pembrolizumab continues to demonstrate durable responses in anti-PD-1 refractory melanoma in ongoing trial

    Encouraging new data on pathological responses and 1-year RFS with neoadjuvant CMP-001 and nivolumab in resectable Stage IIIB/C/D melanoma

    CAMBRIDGE, Mass., Nov. 09, 2020 (GLOBE NEWSWIRE) -- Checkmate Pharmaceuticals, Inc. (NASDAQ:CMPI) ("Checkmate"), a clinical stage biopharmaceutical company focused on developing its proprietary technology to harness the power of the immune system to combat cancer, today announced the presentation of new data from two ongoing clinical trials evaluating CMP-001, Checkmate's Toll-like receptor 9 (TLR9) agonist, in combination with the anti-PD-1 antibodies pembrolizumab (KEYTRUDA®…

    CMP-001 in combination with pembrolizumab continues to demonstrate durable responses in anti-PD-1 refractory melanoma in ongoing trial

    Encouraging new data on pathological responses and 1-year RFS with neoadjuvant CMP-001 and nivolumab in resectable Stage IIIB/C/D melanoma

    CAMBRIDGE, Mass., Nov. 09, 2020 (GLOBE NEWSWIRE) -- Checkmate Pharmaceuticals, Inc. (NASDAQ:CMPI) ("Checkmate"), a clinical stage biopharmaceutical company focused on developing its proprietary technology to harness the power of the immune system to combat cancer, today announced the presentation of new data from two ongoing clinical trials evaluating CMP-001, Checkmate's Toll-like receptor 9 (TLR9) agonist, in combination with the anti-PD-1 antibodies pembrolizumab (KEYTRUDA®) or nivolumab (OPDIVO®), in patients with melanoma.

    "CMP-001 continues to demonstrate clinical benefit, in combination with anti-PD-1 antibodies, with an ORR of 23.5% and median duration of response of 19.9 months in patients with anti-PD-1 refractory melanoma," said Barry Labinger, President and Chief Executive Officer of Checkmate. "We are also encouraged by the maturing data in the anti-PD-1 naïve neoadjuvant study, which has demonstrated a 70% pathological response rate and 1-year relapse free survival of 90% in patients with a pathologic response."

    Intratumoral injection of CMP-001, a Toll-like receptor 9 (TLR9) agonist, in combination with pembrolizumab reversed programmed death receptor 1 (PD-1) blockade resistance in advanced melanoma (Abstract #: 579; NCT02680184)

    In the SITC 2020 Virtual Press Conference, November 9, between 7:45am-9:00am ET, and in the Virtual Poster Hall, November 11-14, 2020 between 9:00am-5:00pm ET, Dr. Mohammed Milhem, Chief, Section of Oncology, and Clinical Professor of Internal Medicine, University of Iowa Healthcare, presents updated data from an ongoing Checkmate-sponsored clinical trial of CMP-001 in combination with pembrolizumab or as a monotherapy.

    Key highlights from these clinical data as of the data cut-off of September 30, 2020 include:

    CMP-001 in combination with pembrolizumab

    • In patients treated with CMP-001 PS20 0.01% in combination with pembrolizumab, the best ORR by RECIST v1.1 was 23.5% (23/98), including 7 complete responses and 16 partial responses, and 27.6% (27/98) including patients with responses after initial progressive disease.
    • The Kaplan Meier estimate for median duration of response across all patients was 19.9 months for both RECIST v1.1 responders and RECIST v1.1 responders plus post-progressive disease responders.
    • The mean regression in injected and non-injected target lesions was similar in responding patients.
    • Most treatment related adverse events (TRAEs) were Grade 1 or 2 and included flu-like symptoms, including chills, fever, fatigue, nausea, vomiting, and headache, and injection site pain. The most common treatment-related Grade 3 or 4 adverse events were hypotension (6.3%) and hypertension (5.0%). No Grade 5 treatment-related adverse events were reported.

    CMP-001 monotherapy

    • Of the 40 patients treated with CMP-001 monotherapy, 7 patients (17.5%) achieved a partial response by RECIST v1.1, and the median duration of response was 5.6 months.
    • Most treatment-related adverse events were Grade 1 or 2 and included flu-like symptoms including chills, fever, nausea, fatigue, and headache. The only treatment-related Grade 3 adverse event in more than 1 patient was hypotension (n=2, 5.0%). No Grade 4 or 5 treatment-related adverse events were reported.

    "The response rate, duration of response, and adverse event profile are encouraging given that 93% of the patients had progressive disease as the last response to anti-PD-1 antibodies at study entry," said Dr. Milhem. "We need new treatment approaches for patients who progress after anti-PD-1 antibodies, and I'm excited to move this regimen forward into a potentially registrational study in patients with confirmed disease progression on PD-1 blockade."

    Phase II Trial of Neoadjuvant Nivolumab (Nivo) and Intra-Tumoral (IT) CMP-001 in High-Risk Resectable Melanoma (Neo-C-Nivo) (Abstract #: 612; NCT03618641)

    In a Virtual Oral Presentation on Wednesday, November 11, 2020 at 5:30pm ET, Dr. Diwakar Davar, Assistant Professor of Medicine at the University of Pittsburgh School of Medicine, presents data from an investigator-sponsored trial evaluating neoadjuvant treatment with CMP-001 in combination with nivolumab in patients with Stage IIIB/C/D Melanoma.

    Key highlights from these clinical data included:

    • 30 patients were evaluable for efficacy per protocol.
      • Pathological responses were observed in 70% of patients, and the primary outcome measure of major pathological response rate was 60%. The response breakdown was as follows:
        • Pathological Complete Response (pCR = 15/30; 50%)
        • Pathological Major Response (pMR = 3/30; 10%)
        • Pathological Partial Response (pPR = 3/30; 10%)
    • The median RFS has not been reached.
      • 1-year RFS was 89% in patients with major pathological response (pCR and pMR) and 90% in patients with any pathological response (pCR, pMR, and pPR).
    • 31 patients were evaluable for safety per protocol.
      • CMP-001 in combination with nivolumab was generally well-tolerated with an acute toxicity profile consisting predominantly of Grade 1/2 TRAEs. The only treatment-related Grade 3 adverse event in more than 1 patient was hypertension (n=3, 9.7%). No Grade 4/5 TRAEs were reported.
      • There were no dose limiting toxicities or delays in surgery related to neoadjuvant treatment.
    • Response was associated with evidence of intratumoral and peripheral immune activation.

    "The pathological response rate in this study is among the highest reported for treatment that includes a PD-1 blocking antibody in neoadjuvant treatment of Stage III melanoma, and compares favorably with the reported data for neoadjuvant PD-1/CTLA-4 Opacin-Neo," said Dr. Davar. "We are encouraged by the relapse free survival, and I'm particularly excited by our data demonstrating the activation of pDCs and infiltration of T cells in many of the responding tumors, which provides further support for the mechanism of action of CMP-001."

    Intravenous CMP-001, a CpG-A Toll-like receptor 9 (TLR9) agonist delivered via a virus-like particle, causes tumor regression in syngeneic Hepa1-6 mouse models of hepatocellular carcinoma (Abstract #: 418)

    In the Virtual Poster Hall, November 11-14, 2020 between 9:00am-5:00pm ET, Dr. Arthur M. Krieg, Founder and Chief Scientific Officer of Checkmate Pharmaceuticals, presents data from a preclinical study of CMP-001 plus PD-1 blocking antibody in mouse models of hepatocellular carcinoma.

    In orthotopic mouse models of HCC, the antitumor activity of intravenous CMP-001 was greater than PD-1 blockade and comparable to sorafenib. CMP-001 intravenous was more active than CMP-001 subcutaneous in this model, consistent with increased liver exposure with intravenous infusion. CMP-001 intravenous may be a promising treatment option to explore in future clinical research for patients with primary or metastatic liver cancers.

    About CMP-001

    CMP-001 comprises a virus-like particle utilizing a CpG-A oligonucleotide. It is designed to trigger the body's innate immune system via TLR9 and infiltrate the tumor microenvironment by the subsequent induction of both innate and adaptive anti-tumor immune responses. Checkmate believes CMP-001 is the only compound utilizing a CpG-A class TLR9 agonist in clinical development. For information on CMP-001 trials that are currently recruiting patients, please visit www.clinicaltrials.gov.

    About Checkmate Pharmaceuticals

    Checkmate Pharmaceuticals is a clinical stage biotechnology company focused on developing proprietary technology to harness the power of the immune system to combat cancer. Checkmate's product candidate, CMP-001, is a differentiated TLR9 agonist delivered as a biologic virus-like particle designed to trigger the body's innate immune system to attack tumors in combination with other therapies. Checkmate's goal is to leverage its proprietary technology to discover, develop and commercialize transformative treatments to fight cancer. Information regarding Checkmate is available at www.checkmatepharma.com.

    Availability of Other Information About Checkmate

    Investors and others should note that we communicate with our investors and the public using our website (www.checkmatepharma.com), our investor relations website (ir.checkmatepharma.com), and on social media (Twitter and Linkedin), including but not limited to: investor presentations and investor fact sheets, U.S. Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Checkmate posts on these channels and websites could be deemed to be material information. As a result, we encourage investors, the media, and others interested in us to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on our investor relations website and may include additional social media channels. The contents of our website or these channels, or any other website that may be accessed from our website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.

    Forward Looking Statements

    Various statements in this release are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including. Words such as, but not limited to, "anticipate," "believe," "can," "could," "expect," "estimate," "design," "goal," "intend," "may," "might," "objective," "plan," "predict," "project," "target," "likely," "should," "will," and "would," or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. These statements include those regarding our product candidate, including its development and therapeutic potential and the advancement of our clinical and preclinical pipeline; expectations regarding the results and analysis of data.  Forward-looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved. These forward-looking statements are subject to risks and uncertainties, including those related to the development of our product candidate, including any delays in our ongoing or planned preclinical or clinical trials; the risk that positive results from a clinical study may not necessarily be predictive of the results of future or ongoing clinical studies; the risk that data updates and interim results may not be predictive of future results; the impact of the ongoing COVID-19 pandemic on our business, operations, clinical trials, clinical supply and plans; the risks inherent in the drug development process; the risks regarding the accuracy of our estimates of expenses and timing of development, our capital requirements and the need for additional financing; and obtaining, maintaining and protecting our intellectual property. These and additional risks are discussed in the sections titled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in our quarterly report on Form 10-Q for the quarter ended June 30, 2020, as filed with the U.S. Securities and Exchange Commission (SEC), as well as subsequent filings and reports filed with the SEC, which are available on the SEC's website at www.sec.gov.

    All registered trademarks are the property of their respective owners.

    Investor Contact
    Kleem Chaudhary 
    Chief Business Officer 
    
    
    Media Contact
    Karen Sharma 
    MacDougall 
    781-235-3060 
    

    Primary Logo

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  3. CAMBRIDGE, Mass., Nov. 03, 2020 (GLOBE NEWSWIRE) -- Checkmate Pharmaceuticals, Inc. (NASDAQ:CMPI) ("Checkmate"), a clinical stage biotechnology company focused on developing proprietary technology to harness the power of the immune system to combat cancer, today announced that Barry Labinger, CEO, will present at the upcoming Jefferies Virtual London Healthcare Conference. The presentation is scheduled for 6:45 – 7:15am ET on Tuesday, November 17, 2020 and will be webcast.

    A live webcast of the presentation can be accessed under "Events & Presentations" in the Investors section of the Checkmate website. An archived copy of the webcast will be available on the Checkmate website for approximately 45 days after the event.

    About Checkmate Pharmaceuticals

    CAMBRIDGE, Mass., Nov. 03, 2020 (GLOBE NEWSWIRE) -- Checkmate Pharmaceuticals, Inc. (NASDAQ:CMPI) ("Checkmate"), a clinical stage biotechnology company focused on developing proprietary technology to harness the power of the immune system to combat cancer, today announced that Barry Labinger, CEO, will present at the upcoming Jefferies Virtual London Healthcare Conference. The presentation is scheduled for 6:45 – 7:15am ET on Tuesday, November 17, 2020 and will be webcast.

    A live webcast of the presentation can be accessed under "Events & Presentations" in the Investors section of the Checkmate website. An archived copy of the webcast will be available on the Checkmate website for approximately 45 days after the event.

    About Checkmate Pharmaceuticals



    Checkmate Pharmaceuticals is a clinical stage biotechnology company focused on developing proprietary technology to harness the power of the immune system to combat cancer. Checkmate's product candidate, CMP-001, is a differentiated TLR9 agonist delivered as a biologic virus-like particle designed to trigger the body's innate immune system to attack tumors in combination with other therapies. Checkmate's goal is to leverage its proprietary technology to discover, develop and commercialize transformative treatments to fight cancer. Information regarding Checkmate is available at www.checkmatepharma.com

    Forward Looking Statements

    Various statements in this release are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including. Words such as, but not limited to, "anticipate," "believe," "can," "could," "expect," "estimate," "design," "goal," "intend," "may," "might," "objective," "plan," "predict," "project," "target," "likely," "should," "will," and "would," or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. These statements include those regarding our product candidate, including its development and therapeutic potential, the advancement of our clinical and preclinical pipeline and expectations regarding the results and analysis of data.  Forward-looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved. Positive results from a clinical study may not necessarily be predictive of the results of future or ongoing clinical studies. These forward-looking statements are subject to risks and uncertainties, including those related to the development of our product candidate, including any delays in our ongoing or planned preclinical or clinical trials, the impact of the ongoing COVID-19 pandemic on our business, operations, clinical supply and plans, the risks inherent in the drug development process, the risks regarding the accuracy of our estimates of expenses and timing of development, our capital requirements and the need for additional financing, and obtaining, maintaining and protecting its intellectual property. These and additional risks are discussed in the sections titled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in our prospectus dated August 6, 2020, as filed with the Securities and Exchange Commission ("SEC") pursuant to Rule 424(b) under the Securities Act 1933, as amended, which is available on the SEC's website at www.sec.gov, and in the Company's subsequent filings with the SEC.

    Investor Contact
    Kleem Chaudhary
    Chief Business Officer
    
    
    Media Contact
    Karen Sharma
    MacDougall 
    781-235-3060
    

    Primary Logo

    View Full Article Hide Full Article
  4. CMP-001 in combination with pembrolizumab continues to demonstrate durable responses in anti-PD-1 refractory melanoma

    Encouraging new data on pathological responses and 1-year RFS with neoadjuvant CMP-001 and nivolumab in resectable Stage III melanoma

    CAMBRIDGE, Mass., Oct. 15, 2020 (GLOBE NEWSWIRE) -- Checkmate Pharmaceuticals, Inc. (NASDAQ:CMPI) ("Checkmate"), a clinical stage biotechnology company focused on developing proprietary technology to harness the power of the immune system to combat cancer, today announced new data presentations evaluating CMP-001, Checkmate's Toll-like receptor 9 (TLR9) agonist, at The Society for Immunotherapy of Cancer (SITC) 35th Anniversary Annual Meeting to be held virtually November 9-14, 2020.

    The abstracts…

    CMP-001 in combination with pembrolizumab continues to demonstrate durable responses in anti-PD-1 refractory melanoma

    Encouraging new data on pathological responses and 1-year RFS with neoadjuvant CMP-001 and nivolumab in resectable Stage III melanoma

    CAMBRIDGE, Mass., Oct. 15, 2020 (GLOBE NEWSWIRE) -- Checkmate Pharmaceuticals, Inc. (NASDAQ:CMPI) ("Checkmate"), a clinical stage biotechnology company focused on developing proprietary technology to harness the power of the immune system to combat cancer, today announced new data presentations evaluating CMP-001, Checkmate's Toll-like receptor 9 (TLR9) agonist, at The Society for Immunotherapy of Cancer (SITC) 35th Anniversary Annual Meeting to be held virtually November 9-14, 2020.

    The abstracts for these presentations appeared briefly on the SITC website in error prior to their intended release on November 9, 2020, and as a result are provided in full below.

    "These data continue to demonstrate the compelling clinical activity and manageable safety profile of CMP-001 in combination with anti-PD-1 antibodies in patients with melanoma," said Dr. James Wooldridge, Chief Medical Officer at Checkmate Pharmaceuticals. "Of particular note, we are encouraged by the maturing results in the neoadjuvant study that will be presented by Dr. Davar, including a pathological response rate (pCR, pMR, pPR) of 70%, and a 1-year relapse-free survival of 82%, which trended higher in patients achieving a pathological response."

    Presentation Details (presented without modification below):

    Title: Intratumoral injection of CMP-001, a Toll-like receptor 9 (TLR9) agonist, in combination with pembrolizumab reversed programmed death receptor 1 (PD-1) blockade resistance in advanced melanoma

    Presenting Author: Mohammed Milhem

    Abstract #: 579

    Location: Virtual Poster Hall November 11-14, 9:00am – 5:00pm ET

    Full abstract:

    Background: Therapeutic options are limited for patients with advanced melanoma that is refractory to PD-1 blockade. This study was performed in this patient population to assess the safety and antitumor activity of CMP-001, a CpG-A TLR9 agonist packaged within a virus-like particle.

    Methods: Patients were eligible for this 2-part, open-label, multicenter, phase 1b study if they had metastatic/unresectable melanoma and stable disease after ≥12 weeks or progressive disease (PD) on/after anti−PD-1 therapy. Part 1 evaluated CMP-001 plus pembrolizumab dose-escalation and dose-expansion. Part 2 evaluated CMP-001 monotherapy. Accessible lesion(s) were injected intratumorally with CMP-001, at a polysorbate 20 (PS20) concentration of either 0.01% or 0.00167%. The Part 1 primary objective was to identify the recommended phase 2 dose (RP2D) and schedule of CMP-001 plus pembrolizumab, while the Part 2 primary objective was to assess the safety of CMP-001 monotherapy. Secondary objectives for both parts were a preliminary assessment of antitumor activity of CMP-001 plus pembrolizumab and CMP-001 monotherapy, and the overall safety profile and pharmacodynamics of the combination.

    Results: In Part 1 (N=159) and Part 2 (N=40), 93.1% and 80.0% of patients had PD as their last response to prior anti–PD-1 therapy, respectively. The most common treatment-related adverse events (TRAEs; >25%) were flu-like symptoms (Parts 1 and 2) and injection-site reactions (Part 1). Grade 3/4 TRAEs were reported in 36.5% (Part 1) and 22.5% (Part 2) of patients, the most common being hypotension (Part 1: 6.9%; Part 2: 5.0%). No Grade 5 TRAEs were observed.

    In Part 1, the best objective response rate (ORR; RECIST v1.1) in patients treated with pembrolizumab and CMP-001 (PS20 0.01%) was 23.5% (23/98), while CMP-001 PS20 (0.00167%) resulted in a lower ORR of 11.5% (7/61). Seven additional patients had a delayed response after initial PD (Table). The median duration of response was >1 year. In the 37 RECIST v1.1 and post-progression responders, the mean regression in injected and noninjected target lesions was 54.7% and 52.7%, respectively. In Part 2, the best ORR with CMP-001 monotherapy was 17.5% (7/40 patients); the response duration was shorter than in Part 1. Intratumoral CMP-001 PS20 0.01% 10 mg was selected as the RP2D.

    Conclusion: Intratumoral CMP-001 was well-tolerated and provided both local and distant responses in patients with advanced melanoma with disease progression on prior PD-1 blockade. CMP-001 monotherapy induced systemic tumor regression in some patients, but duration of response was substantially increased by the addition of pembrolizumab.

    Title: Phase II Trial of Neoadjuvant Nivolumab (Nivo) and Intra-Tumoral (IT) CMP-001 in High-Risk Resectable Melanoma (Neo-C-Nivo)

    Presenting Author: Diwakar Davar

    Abstract #: 612

    Location: Virtual Oral Presentation November 11, 5:30 – 6:30pm ET

    Full Abstract:

    Background: Neoadjuvant PD-1 blockade produces major pathological responses (MPR) in ~30% of patients (pts) with high-risk resectable melanoma (MEL) with durable relapse-free benefit, and increased circulating activated CD8+ T cells [1,2]. CMP-001 is a type A CpG packaged within a virus-like particle that activates tumor-associated plasmacytoid dendritic cells (pDC) via TLR9 inducing type I interferons and anti-tumor CD8+ T cells. CMP-001/pembrolizumab produces durable anti-tumor responses in PD-1 refractory melanoma [3]. We previously reported preliminary evidence of efficacy of neoadjuvant IT CMP/Nivo in high-risk resectable MEL; and herein present final results on 30 evaluable patients.

    Methods: 30 pts with stage III B/C/D MEL were enrolled. Pre-operatively, CMP-001 was dosed at 5mg subcutaneous (SC, 1st), then 10mg IT (2nd-7th) weekly; and Nivo was dosed 240mg q2weeks for 3 doses – both over a 7-week period. Post-operatively, Nivo was dosed 480mg q4weeks with CMP-001 5mg q4 weeks SC for 48 weeks. Primary endpoints included major pathologic response (MPR) rate, and incidence of dose-limiting toxicities (DLT). Secondary endpoints were radiographic response, relapse-free survival (RFS) and overall survival (OS). Pathological response was scored by blinded pathologist based on residual volume of tumor (RVT) using prior cutoffs [4-6]: 0% (complete response, pCR); 0%<RVT<10% (major response, pMR); 10%<RVT<50% (partial response, pPR) and RVT>50% (non-response, pNR). Radiographic response was assessed using RECIST v1.1. Sequential blood draws and tumor biopsies were collected and analyzed for CD8+ T cell infiltrate (TIL), multiparameter flow cytometry (MFC) and multiplex immunofluorescence (mIF).

    Results: 30 pts with advanced MEL were enrolled, and staged as: IIIB (57%), IIIC (37%), IIID (7%). 29/30 (97%) of pts completed 7 weeks of neoadjuvant Nivo/CMP; while 1 pt had a delay in surgery related to a pre-operative infection unrelated to therapy. No DLTs were reported; although grade 3/4 irAE were reported in 3 pts (11%) leading to CMP-001 discontinuation in 2 pts (7%). Radiographic responses seen in 13 pts (43%), while 9 pts (30%) had stable disease and 8 pts (27%) had progressive disease. Pathological responses (RVT <50%) were seen in 70% of pts: pCR 15 (50%), pMR 3 (10%), 3 pPR (10%); while 9 (30%) had pNR. Pathological responders (pCR/pMR) had increased CD8+ TIL and CD303+ pDC intra-tumorally by mIF; and activated PD1+/Ki67+ CD8+ T cells by MFC peripherally.

    Conclusions: Neoadjuvant CMP/Nivo has an acceptable toxicity profile and promising efficacy. MPR rate is 60% in 30 pts. 1-year RFS was 82% (all pts) and 89% (pCR/pMR); and median RFS is 9 months (pNR/pPR) and unreached (pCR/pMR). Response is associated with evidence of immune activation intra-tumorally and peripherally. IT CMP001 together increases clinical efficacy of PD-1 blockade alone with minimal additional toxicity in neoadjuvant MEL.

    Title: Intravenous CMP-001, a CpG-A Toll-like receptor 9 (TLR9) agonist delivered via a virus-like particle, causes tumor regression in syngeneic Hepa1-6 mouse models of hepatocellular carcinoma

    Presenting Author: Arthur M. Krieg

    Abstract #: 418

    Location: Virtual Poster Hall November 11-14, 9:00am – 5:00pm ET

    Full Abstract:

    Background: Therapeutic options are limited for patients with liver metastases and hepatocellular carcinoma (HCC). Intratumoral and subcutaneous injections of CMP-001, a CpG-A TLR9 agonist packaged within a virus-like particle, have shown evidence of antitumor activity in patients with melanoma refractory to PD-1 blockade. In mice, CMP-001 intravenous distributes primarily to the liver, while CMP-001 subcutaneous is found mostly in local tissues and draining lymph nodes. The antitumor activity of CMP-001 intravenous and subcutaneous were compared with PD-1 blockade or sorafenib in two Hepa1-6 orthotopic mouse models of HCC.

    Methods: Groups of 10-15 C57BL/6J mice were orthotopically implanted with syngeneic murine hepatoma cells using two different models. Model 1 used 1.5 x 106 Hepa1-6 cells injected into the spleen following a partial hepatectomy; Model 2 used 1 x 106 Hepa1-6-Luc cells injected into the upper left lobe of intact liver. Treatment was initiated 3-7 days later with either CMP-001 intravenous or subcutaneous Q4-5Dx3-4 doses, PD-1 blocking antibody intraperitoneal Q3-4Dx2 (Bio X Cell clone RPM1-14), or sorafenib QD oral. Antitumor activity was assessed by tumor imaging, liver weight, and/or survival.

    Results: CMP-001 was compared with PD-1 blocking antibody therapy in Model 1, the more aggressive model. All animals were sacrificed at day 15 due to institutional welfare requirements. Tumor growth inhibition (TGI) was assessed by comparison of liver weight to body weight ratios, which relative to untreated control mice showed that CMP-001 intravenous achieved 85% mean TGI compared with 63% mean TGI for CMP-001 subcutaneous and 15% mean TGI for PD-1 blocking antibody intraperitoneal (Table 1). CMP-001 intravenous was compared to sorafenib oral in Model 2, which utilized an engineered Hepa1-6 cell line that expresses luciferase to enable noninvasive monitoring of liver tumor growth. CMP-001 intravenous was active, with a 67% mean TGI, and survival that was comparable to sorafenib (Table 2; Figure 1).

    Conclusion: In orthotopic mouse models of HCC, the antitumor activity of CMP-001 intravenous was greater than PD-1 blockade and comparable to sorafenib. CMP-001 intravenous was more active than CMP-001 subcutaneous in this model, which we hypothesize is due to increased liver exposure with intravenous infusion. Antitumor activity of CMP-001 monotherapy may be increased by combining it with standard of care or other therapies, as observed relative to historical benchmarks in ongoing CMP-001 clinical trials in patients with melanoma. CMP-001 intravenous may be a promising treatment option for patients with primary or metastatic liver cancers.

    About CMP-001

    CMP-001 comprises a virus-like particle utilizing a CpG-A oligonucleotide. It is designed to trigger the body's innate immune system via TLR9 and infiltrate the tumor microenvironment by the subsequent induction of both innate and adaptive anti-tumor immune responses. Checkmate believes CMP-001 is the only compound utilizing a CpG-A class TLR9 agonist in clinical development. For information on CMP-001 trials that are currently recruiting patients, please visit www.clinicaltrials.gov.

    About Checkmate Pharmaceuticals

    Checkmate Pharmaceuticals is a clinical stage biotechnology company focused on developing proprietary technology to harness the power of the immune system to combat cancer. Checkmate's product candidate, CMP-001, is a differentiated TLR9 agonist delivered as a biologic virus-like particle designed to trigger the body's innate immune system to attack tumors in combination with other therapies. Checkmate's goal is to leverage its proprietary technology to discover, develop and commercialize transformative treatments to fight cancer. Information regarding Checkmate is available at www.checkmatepharma.com.

    Forward Looking Statements

    Various statements in this release are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including. Words such as, but not limited to, "anticipate," "believe," "can," "could," "expect," "estimate," "design," "goal," "intend," "may," "might," "objective," "plan," "predict," "project," "target," "likely," "should," "will," and "would," or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. These statements include those regarding our product candidate, including its development and therapeutic potential and the advancement of our clinical and preclinical pipeline; expectations regarding the results and analysis of data.  Forward-looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved. These forward-looking statements are subject to risks and uncertainties, including those related to the development of our product candidate, including any delays in our ongoing or planned preclinical or clinical trials, positive results from a clinical study may not necessarily be predictive of the results of future or ongoing clinical studies, the impact of the ongoing COVID-19 pandemic on our business, operations, clinical supply and plans, the risks inherent in the drug development process, the risks regarding the accuracy of our estimates of expenses and timing of development, our capital requirements and the need for additional financing, and obtaining, maintaining and protecting its intellectual property. These and additional risks are discussed in the sections titled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in our prospectus dated August 6, 2020, as filed with the Securities and Exchange Commission pursuant to Rule 424(b) under the Securities Act 1933, as amended, which is available on the SEC's website at www.sec.gov.

    Investor Contact
    Kleem Chaudhary
    Chief Business Officer
    
    
    Media Contact
    Karen Sharma
    MacDougall 
    781-235-3060
    

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  5. - Longitude Venture Partners IV will build on the Firm's commitment to improve clinical outcomes, enhance patient quality of life, and drive efficiency in healthcare delivery -

    - In 2020 to date, Longitude portfolio companies announced 4 IPOs and 3 M&A transactions -

    MENLO PARK, Calif. and GREENWICH, Conn. and BOSTON, Sept. 23, 2020 (GLOBE NEWSWIRE) -- Longitude Capital, a leading healthcare venture capital firm, today announced the closing of Longitude Venture Partners IV, L.P. ("LVP4"), with $585 million in capital commitments. LVP4, the largest fund that Longitude Capital has raised to date, will build on the proven strategy of its predecessor funds by investing in biotechnology, medical technology, and health solutions companies that…

    - Longitude Venture Partners IV will build on the Firm's commitment to improve clinical outcomes, enhance patient quality of life, and drive efficiency in healthcare delivery -

    - In 2020 to date, Longitude portfolio companies announced 4 IPOs and 3 M&A transactions -

    MENLO PARK, Calif. and GREENWICH, Conn. and BOSTON, Sept. 23, 2020 (GLOBE NEWSWIRE) -- Longitude Capital, a leading healthcare venture capital firm, today announced the closing of Longitude Venture Partners IV, L.P. ("LVP4"), with $585 million in capital commitments. LVP4, the largest fund that Longitude Capital has raised to date, will build on the proven strategy of its predecessor funds by investing in biotechnology, medical technology, and health solutions companies that seek to transform the healthcare industry.

    "We are in the golden era of medical and biological innovation. The significant unmet clinical needs and the inefficiencies of our current healthcare system are driving meaningful scientific breakthroughs and creative solutions," said Patrick Enright, co-founder and Managing Director of Longitude Capital. Since inception in 2006, Longitude Capital has raised nearly $2 billion in cumulative capital commitments and managed over 30 company exits. "We are fortunate to have helped build many successful healthcare companies and look forward to working alongside the next wave of entrepreneurs and scientists to advance critical medicines, devices, and health solutions to the marketplace."

    Juliet Bakker, co-founder and Managing Director of Longitude Capital, added, "We are thankful for the continued support of, and partnerships with, our investors who value our differentiated venture growth investing approach, experienced team, and passion for forging new frontiers in healthcare."

    LVP4 will invest opportunistically across all stages of a company's development through a variety of approaches that include traditional venture capital investing and special situations such as spin-outs, equity-linked transactions, and private investments in public equities. Many of these investments stem from Longitude's proprietary research of targeted healthcare sectors, therapeutic areas, and technologies of interest.

    Longitude Capital's recent Initial Public Offerings (IPOs) and exits include 89bio (NASDAQ:ETNB), Aimmune (NASDAQ:AIMT, recently agreed to be acquired by Nestlé Health Science))), Axonics Modulation Technologies (NASDAQ:AXNX), Checkmate Pharmaceuticals (NASDAQ:CMPI), Inflazome (acquired by Roche), Inozyme Pharma (NASDAQ:INZY), KaNDy Therapeutics (acquired by Bayer), Molecular Templates (NASDAQ:MTEM), Poseida Therapeutics (NASDAQ:PSTX), and Vaxcyte (NASDAQ:PCVX).

    About Longitude Capital

    Longitude Capital is a leading healthcare venture capital firm, that invests in transformative biotechnology, medical technology, and health solutions companies seeking to improve clinical outcomes, enhance quality of life, and drive efficiency of healthcare delivery. Founded in 2006, Longitude Capital invests in both privately held and publicly traded companies through a variety of investment approaches. Longitude Capital has offices in Menlo Park, CA, Greenwich, CT, and Boston, MA. For more information, including a complete listing of investments, please visit www.longitudecapital.com.

    About Longitude Capital Recent IPOs and Exits

    • 89bio is a biopharmaceutical company developing and commercializing innovative therapies for the treatment of liver and cardio-metabolic diseases. 89bio was originally spun out of Teva Pharmaceuticals in 2018 by founding investors Longitude Capital and OrbiMed, and completed its IPO in November 2019. www.89bio.com.



    • Aimmune is a biopharmaceutical company developing and commercializing treatments for potentially life-threatening food allergies. Aimmune's PALFORZIA® is the world's first approved treatment for peanut allergy. Longitude Capital was the founding institutional investor of Aimmune. In 2020, Aimmune agreed to be acquired by Nestlé Health Science for $34.50 per share in cash, representing a total equity value of $2.6 billion. www.aimmune.com.



    • Axonics Modulation Technologies is a medical technology company developing and commercializing novel implantable rechargeable sacral neuromodulation (SNM) devices for patients with urinary and bowel dysfunction. In 2018, Longitude Capital led a $40 million financing that preceded the company's IPO later that year. www.axonics.com.



    • Checkmate Pharmaceuticals is a clinical-stage biopharmaceutical company developing proprietary technology to harness the power of the immune system to combat cancer. In 2020, Longitude Capital and Novo Holdings led the company's $85 million Series C financing that preceded the company's IPO later in the year. www.checkmatepharma.com.



    • Inflazome is a biotechnology company developing small molecules that block harmful inflammation by targeting inflammasomes, protein complexes that generate signals in order to activate an immune response. In 2020, Inflazome announced its acquisition by Roche for an upfront payment of €380 million, and potential predetermined milestone payments. www.inflazome.com.



    • Inozyme Pharma is a rare disease pharmaceutical company developing novel therapeutics for the treatment of diseases of abnormal mineralization. Longitude Capital led Inozyme's $49 million Series A financing in 2017, and was joined by New Enterprise Associates, Novo Holdings, and Sanofi Ventures. Inozyme completed its initial public offering in 2020. www.inozyme.com.



    • KaNDy Therapeutics was a UK-based clinical-stage company focused on optimizing the potential of its unique NK-1,3 receptor antagonist NT-814 to treat common, chronic debilitating conditions related to menopause. In 2020, KaNDy Therapeutics was acquired by Bayer Pharmaceuticals for an upfront payment of $425 million, and a potential $450 million in R&D, regulatory milestones and additional commercial milestones.



    • Molecular Templates is a clinical-stage company focused on the discovery and development of targeted biologic therapeutics. In 2017, Longitude Capital led Molecular Template's $40 million PIPE (private investment into public equity) financing. Molecular Templates now has strategic collaborations with Takeda Pharmaceuticals and Vertex Pharmaceuticals. www.mtem.com.



    • Poseida Therapeutics is a clinical-stage biopharmaceutical company dedicated to utilizing its proprietary gene engineering platform technologies to create next generation cell and gene therapeutics with the capacity to cure various cancers. Longitude Capital led Poseida's $30 million Series B financing in 2018. Poseida completed its IPO in 2020. www.poseida.com.



    • Vaxcyte is a next-generation vaccine company seeking to improve global health by developing superior and novel vaccines designed to prevent or treat some of the most common and deadly infectious diseases worldwide. Longitude Capital invested in Vaxcyte's $22 million Series A financing and served on the Board of the company through its IPO in 2020. www.vaxcyte.com.

    About Longitude Capital Recent Investments

    • Eargo is a medical device company dedicated to improving the quality of life of people with hearing loss. Longitude Capital and Gilde Healthcare led Eargo's $81 million Series E financing in 2020. www.eargo.com.



    • Epirium Bio is a clinical-stage biopharmaceutical company that uses insights related to the biology of mitochondrial function and tissue regeneration to pursue novel and clinically significant therapeutic approaches for neuromuscular, neurodegenerative, and mitochondrial disorders. Longitude Capital and ARCH Venture Partners led Epirium's $85 million Series A financing in 2019. www.epirium.com.



    • Polares Medical is a clinical-stage medical technology company focused on the development of a unique trans-catheter mitral valve hemi-replacement system to treat patients suffering from mitral regurgitation (MR). Longitude Capital led Polares Medical's $40 million Series B financing in 2020. www.polaresmedical.com.



    • WelbeHealth is a services company dedicated to unlocking the full potential of vulnerable seniors through PACE (Program of All-Inclusive Care for the Elderly), a comprehensive medical and social care model. Longitude Capital and .406 Ventures led WelbeHealth's $30 million Series C in 2020. www.welbehealth.com.

    Source: Longitude Capital

    Contact Information
    
    Maggie Jamison
    Longitude Capital
    650-854-5700 
    

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