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): June 13, 2018
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TRACON Pharmaceuticals, Inc. |
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(Exact name of registrant as specified in its charter) |
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Delaware |
001-36818 |
34-2037594 |
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(State or other jurisdiction |
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(IRS Employer Identification No.) |
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of incorporation) |
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4350 La Jolla Village Drive, Suite 800 San Diego, California |
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(Address of principal executive offices) |
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Registrant’s telephone number, including area code: (858) 550-0780 _______________________________________________________________________________________ |
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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)) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒
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On June 13, 2018, TRACON Pharmaceuticals, Inc. (“TRACON”) issued a press release announcing preclinical data from TRC105, TRACON’s endoglin antibody, in combination with a PD-1 antibody, that were discussed in an oral presentation at the 2018 International Cancer Microenvironment Society meeting.
A copy of this press release is attached as Exhibit 99.1 hereto and incorporated by reference herein.
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Item 9.01 |
Financial Statements and Exhibits. |
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(d) |
Exhibits. |
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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: June 13, 2018 |
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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 99.1
TRACON Announces Presentation of Preclinical Data from Studies of TRC105 in Combination with a PD-1 Antibody in Murine Models of Colorectal Cancer
San Diego, CA – June 13, 2018 – 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 announced that positive preclinical data from TRC105, TRACON’s endoglin antibody, in combination with a PD-1 antibody, were discussed in an oral presentation at the 2018 International Cancer Microenvironment Society meeting.
Dr. Mark Schoonderwoerd of Leiden University presented data from multiple murine models assessing the activity of TRC105 in combination with a PD-1 antibody. The individual antibodies as well as the combination were studied in two separate models. In the first, immunocompetent mice were implanted with a syngeneic colorectal cancer subcutaneously to mimic metastatic colorectal cancer. In the second, immunocompetent mice were implanted orthotopically to mimic advanced colorectal cancer.
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In both models, treatment with either TRC105 or a PD-1 antibody alone decreased tumor volume compared to IgG control antibody to a similar degree. However, combined treatment with TRC105 and the PD-1 antibody significantly reduced tumor volume compared to treatment with TRC105 or PD-1 treatment alone. |
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Treatment with either TRC105 or a PD-1 antibody improved survival to a similar degree compared to control antibody. However, survival was significantly improved with combination treatment versus the individual therapies, with long-term survival demonstrated in 30% to 60% of animals. Combination treatment also increased tumor specific T cells, indicating stimulation of an immune response. |
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The activity of TRC105 given as a single agent or combined with a PD-1 antibody was diminished following CD8+ T cell depletion, indicating that TRC105 activity was mediated through an immunologic mechanism. |
In a separately reported third preclinical study, an endoglin antibody specific for mouse endoglin that mimics TRC105 activity in mice, M1043, was studied in a chemically induced colorectal cancer model of early-stage colorectal cancer.
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Combined treatment with M1043 and a PD-1 antibody significantly reduced tumor volume compared to treatment with M1043 or PD-1 treatment alone. Combination treatment also significantly reduced the number of tumors that formed in response to the chemically induced carcinogenesis. |
TRC105 is currently being studied in the ongoing pivotal randomized Phase 3 TAPPAS trial in angiosarcoma (NCT02979899), the randomized Phase 2 TRAXAR trial in renal cell carcinoma (NCT01806064), a Phase 1/2 trial in patients with hepatocellular carcinoma (NCT02560779), and a Phase 1 trial studying the combination of TRC105 and nivolumab (Opdivo) in patients with non-small cell lung cancer (NCT03181308).
4350 La Jolla Village Drive ● Suite 800 ● San Diego, California 92122 ● P: 858.550.0780 ● F: 858.550.0786
URL: www.traconpharma.com
TRACON develops targeted therapies for cancer and ophthalmic 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.; TRC102, a small molecule being developed for the treatment of lung cancer and glioblastoma; and TRC253, a small molecule being developed for the treatment of prostate cancer. To learn more about TRACON and its product candidates, visit TRACON's website at www.traconpharma.com.
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Company Contact: |
Investor Contact: |
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Patricia Bitar |
Andrew McDonald |
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Chief Financial Officer |
LifeSci Advisors LLC |
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(858) 550‐0780 ext. 223 |
646-597-6987 |
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pbitar@traconpharma.com |
Andrew@lifesciadvisors.com |