UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): February 9, 2017
TRACON Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
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Delaware |
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001-36818 |
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34-2037594 |
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(State or other jurisdiction |
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(Commission File Number) |
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(IRS Employer Identification No.) |
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of incorporation) |
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8910 University Center Lane, Suite 700 San Diego, California |
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92122 |
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(Address of principal executive offices) |
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Registrant’s telephone number, including area code: (858) 550-0780
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 8.01Other Events.
On February 9, 2017, the Company issued a press release announcing top-line results from a randomized Phase 2 clinical trial of TRC105 in recurrent glioblastoma (GBM) funded and conducted by the Clinical Therapy Evaluation Program (CTEP) of the National Cancer Institute (NCI).
In the trial, TRC105 combined with Avastin® (bevacizumab) was compared to single agent Avastin in a total of 101 patients with recurrent GBM following chemoradiation. The trial was designed to detect a three-month improvement in progression free survival (PFS), the primary endpoint, from the expected value of 3.45 months with single agent Avastin. Top-line data indicate that the combination of TRC105 and Avastin did not improve median PFS versus single agent Avastin in recurrent GBM patients, although the combination was associated with a non-significant increase in overall survival. Detailed data and the associated correlative analyses are expected to be presented at an oncology conference later this year.
The press release issued on February 9, 2017 is attached hereto as Exhibit 99.1
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
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Exhibit No. |
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DDescription |
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99.1 |
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Press release issued by TRACON Pharmaceuticals, Inc. dated February 9, 2017. |
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Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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TRACON Pharmaceuticals, Inc. |
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Dated: February 9, 2017 |
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By: |
/s/ Charles P. Theuer, M.D., Ph.D. |
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Charles P. Theuer, M.D., Ph.D. |
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President and Chief Executive Officer |
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EXHIBIT INDEX
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Exhibit No. |
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Description |
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99.1 |
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Press release issued by TRACON Pharmaceuticals, Inc. dated February 9, 2017.
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Exhibit 99.1
TRACON Pharmaceuticals Announces Top-line Results from NCI-Sponsored Phase 2 Trial of TRC105 in Recurrent Glioblastoma
Combination of TRC105 and Avastin did not improve the median progression free survival versus single agent Avastin in recurrent glioblastoma patients
Combination was associated with a non-significant increase in overall survival
San Diego, CA – February 9, 2017 – TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer, wet age-related macular degeneration and fibrotic diseases, today reported top-line results from a randomized Phase 2 clinical trial of TRC105 in recurrent glioblastoma (GBM) funded and conducted by the Clinical Therapy Evaluation Program (CTEP) of the National Cancer Institute (NCI).
In the trial, TRC105 combined with Avastin® (bevacizumab) was compared to single agent Avastin in a total of 101 patients with recurrent GBM following chemoradiation. The trial was designed to detect a three-month improvement in progression free survival (PFS), the primary endpoint, from the expected value of 3.45 months with single agent Avastin. Top-line data indicate that the combination of TRC105 and Avastin did not improve median PFS versus single agent Avastin in recurrent GBM patients, although the combination was associated with a non-significant increase in overall survival. Detailed data and the associated correlative analyses are expected to be presented at an oncology conference later this year.
“Glioblastoma is a very challenging indication for drug development,” said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. “We are grateful to the National Cancer Institute for sponsoring the trial and to the patients and providers who participated, and look forward to the detailed survival analysis from this trial, as well as data from multiple company-sponsored trials of TRC105 in other indications later this year.”
About TRC105 and other Endoglin Antibodies
TRC105 is a novel, clinical stage antibody to endoglin, a protein overexpressed on proliferating endothelial cells that is essential for angiogenesis, the process of new blood vessel formation. TRC105 is currently being studied in one Phase 3 and multiple Phase 2 clinical trials sponsored by TRACON or the National Cancer Institute for the treatment of solid tumor types in combination with VEGF inhibitors. The ophthalmic formulation of TRC105, DE-122, is currently in a Phase 1/2 trial for patients with wet AMD. TRC205, a second generation antibody to endoglin, is undergoing preclinical testing in models of fibrosis. For more information about the clinical trials, please visit TRACON’s website at http://www.traconpharma.com/clinical_trials.php.
About TRACON
TRACON develops targeted therapies for cancer, ophthalmic and fibrotic diseases. The Company’s clinical-stage pipeline includes: TRC105, an endoglin antibody that is being developed for the treatment of multiple cancers; DE-122, the ophthalmic formulation of TRC105 that is being developed in wet AMD through a collaboration with Santen Pharmaceutical Company Ltd.; and TRC102, a small molecule that is
8910 University Center Lane ● Suite 700 ● San Diego, California 92122 ● P: 858.550.0780 ● F: 858.550.0786
URL: www.traconpharma.com
being developed for the treatment of lung cancer and glioblastoma. To learn more about TRACON and its product candidates, visit TRACON's website at www.traconpharma.com.
Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding expected timing of data from on-going clinical trials of TRC105, the future presentation of detailed results from the Phase 2 clinical trial in glioblastoma, and other development plans and potential benefits of TRACON’s product candidates. Forward-looking statements speak only as of the date of this press release and TRACON does not undertake any obligation to update or revise these statements, except as may be required by law. These forward-looking statements are based on management's expectations and assumptions as of the date of this press release and actual results may differ materially from those in these forward-looking statements as a result of various factors. These factors include, but are not limited to, the fact that results of subsequent studies may not be consistent with results of prior studies, TRACON’s and NCI’s ability to identify and enroll patients in on-going and planned clinical trials, potential delays in completing on-going clinical trials and initiating new clinical trials, whether TRACON’s product candidates will be shown to be safe and effective in subsequent studies, and TRACON’s and NCI’s ability and willingness to fund additional clinical development of TRACON’s product candidates. For a further description of these and other risks facing TRACON, please see the risk factors described in TRACON’s filings with the United States Securities and Exchange Commission, including those factors discussed under the caption "Risk Factors" in those filings. Forward-looking statements speak only as of the date of this press release and TRACON undertakes no obligation to update or revise these statements, except as may be required by law.
Company Contact:Investor Contact:
Casey LoganAndrew McDonald
Chief Business OfficerLifeSci Advisors LLC
(858) 550‐0780 ext. 236646-597-6987
clogan@traconpharma.comAndrew@lifesciadvisors.com