On August 5, 2020 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., reported financial results for the second quarter ended June 30, 2020 (Press release, Tracon Pharmaceuticals, AUG 5, 2020, View Source [SID1234562923]). The Company will host a conference call and webcast today at 4:30 PM Eastern Time / 1:30 PM Pacific Time.
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Recent Corporate Highlights
In July, TRACON filed the ENVASARC pivotal trial protocol with the U.S. Food and Drug Administration (FDA) as part of an Investigational New Drug (IND) application. Following the 30 day FDA review period, TRACON expects to enroll the first patient in the ENVASARC trial evaluating the PD-L1 single domain antibody envafolimab in the soft tissue sarcoma subtypes of undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS) in the fourth quarter of 2020. Key elements of the ENVASARC pivotal tri
Multi-center, open-label, randomized, non-comparative, parallel cohort study.
Eligible patients will have undifferentiated pleomorphic sarcoma (UPS) or myxofibrosarcoma (MFS) and will have received one or two prior lines of cancer therapy, and no prior immune checkpoint inhibitor therapy.
Planned total enrollment of 160 patients, with 80 patients enrolled into cohort A of treatment with single agent envafolimab and 80 patients enrolled in cohort B of treatment with envafolimab and Yervoy.
Primary endpoint of objective response rate (ORR) with duration of response a key secondary endpoint. Nine of 80 objective responses (11.25% ORR) are required to demonstrate an ORR that is statistically higher than the 4% ORR reported for Votrient, the only approved therapy for refractory UPS/MFS, in its package insert.
Open-label format with blinded independent central review of efficacy endpoint data.
In May, TRACON announced positive results for envafolimab at the 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Scientific Program from the Company’s corporate partners, 3D Medicines and Alphamab Oncology, that showed single agent envafolimab demonstrated a 30.0% confirmed ORR in 50 patients with MSI-H/dMMR colorectal cancer (CRC) who failed a fluoropyrimidine, oxaliplatin and irinotecan (n=39) or those with advanced gastric cancer who failed at least one prior systemic treatment (n=11), with at least two on-study tumor assessments. The confirmed ORR in MSI-H/dMMR CRC patients treated with envafolimab who failed a fluoropyrimidine, oxaliplatin and irinotecan was 28.2%, which was nearly identical to the 28% confirmed ORR reported in the Opdivo package insert in MSI-H/dMMR CRC patients who failed a fluoropyrimidine, oxaliplatin, and irinotecan and the 27.9% confirmed ORR reported for Keytruda in MSI-H/dMMR CRC patients who failed a fluoropyrimidine, oxaliplatin and irinotecan in cohort A of KEYNOTE-164.
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In May, TRACON highlighted data at the 2020 ASCO (Free ASCO Whitepaper) Virtual Scientific Program from the Alliance for Clinical Trials in Oncology that showed a 29% confirmed ORR in patients (n=14) with highly refractory UPS who received dual checkpoint inhibition with Opdivo in combination with Yervoy. For reference, cohort B of the ENVASARC pivotal trial will enroll UPS/MFS patients who will receive dual checkpoint inhibition with envafolimab with Yervoy.
In May, positive data were presented from multiple TRC102 clinical trials at the 2020 ASCO (Free ASCO Whitepaper) Virtual Scientific Program. In a Phase 2 trial, two of 14 mesothelioma patients who progressed previously on Alimta had objective responses following treatment with Alimta and TRC102. In a Phase 1 trial, TRC102 in combination with chemo-radiation resulted in an objective response in all 15 patients with locally advanced non-squamous non-small cell lung cancer, including three patients who demonstrated a complete response to treatment. The 100% ORR indicates a significant improvement as compared to historical data of chemoradiation without TRC102 in advanced lung cancer.
"We were excited by the ASCO (Free ASCO Whitepaper) data presented by our corporate partners showing that envafolimab activity was comparable to the activity of the approved products Opdivo and Keytruda in separate trials of MSI-H/dMMR CRC. Moreover, we were encouraged by additional data presented at ASCO (Free ASCO Whitepaper) from the Alliance group which showed an impressive response rate for dual checkpoint inhibition with Opdivo and Yervoy in UPS. Importantly, these data provide the rationale for testing dual checkpoint inhibition using envafolimab and Yervoy in the ENVASARC trial," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "Achieving a 29% response rate in ENVASARC would represent a marked improvement in the treatment of patients with refractory UPS/MFS, where the only approved therapy demonstrated a 4% response rate. We look forward to enrolling the first patient in ENVASARC later this year and plan to provide interim data in 2021, final data in 2022, and assuming positive clinical data and regulatory approval, potentially commercialize envafolimab in 2023."
Expected Upcoming Milestones
Completion of the 30 day FDA review period for the ENVASARC protocol, a pivotal trial in the sarcoma subtypes of UPS and MFS, that was submitted to the FDA on July 16, 2020.
Enroll the first patient in ENVASARC during the fourth quarter of 2020.
Submission of the envafolimab BLA with the National Medical Products Association in China (NMPA) by our partners, 3D Medicines and Alphamab Oncology.
Report top-line data from the Phase 1 dose escalation study of TJ4309, a CD73 antibody, as a single agent and in combination with Tecentriq (a PD-L1 antibody being supplied by Roche), in the second half of 2020.
Second Quarter 2020 Financial Results
Cash and cash equivalents were $14.5 million at June 30, 2020, compared to $16.4 million at December 31, 2019. We expect our current cash and cash equivalents to fund operations into the second quarter of 2021. If the remaining $11.7 million available under the Aspire Capital agreement as of June 30, 2020 were fully utilized, cash runway would extend late into the third quarter of 2021.
Research and development expenses for the second quarter of 2020 were $2.2 million, compared to $4.3 million for the second quarter of 2019. The decrease was primarily attributable to lower manufacturing expenses and clinical trial expenses due to the discontinuation of the Phase 3 TRC105 program.
General and administrative expenses for the second quarter of 2020 were $2.1 million, compared to $1.9 million for the second quarter of 2019.
Net loss for the second quarter of 2020 was $4.5 million, compared to $6.3 million for the second quarter of 2019.
About Envafolimab
Envafolimab (KN035), a novel, single-domain antibody against PD-L1, is the first subcutaneously injected PD-(L)1 inhibitor to be studied in registrational trials. Envafolimab is currently dosing in a Phase 2 registration trial as a single agent in MSI-H/dMMR advanced solid tumor patients and a Phase 3 registration trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients in China. 3D Medicines and Alphamab Oncology, TRACON’s corporate partners for this program, plan to submit a BLA to the NMPA in China for envafolimab in 2020 based on the ORR in MSI-H/dMMR advanced solid tumor patients. The confirmed ORR in MSI-H/dMMR colorectal cancer patients treated with envafolimab who failed a fluoropyrimidine, oxaliplatin and irinotecan reported at ASCO (Free ASCO Whitepaper) 2020 was 28.2%, which was nearly identical to the 28% confirmed ORR reported in the Opdivo package insert in MSI-H/dMMR colorectal cancer patients who failed a fluoropyrimidine, oxaliplatin, and irinotecan and the 27.9% confirmed ORR reported for Keytruda in MSI-H/dMMR CRC patients who failed a fluoropyrimidine, oxaliplatin and irinotecan in cohort A of KEYNOTE-164.
About TRC102
TRC102 (methoxyamine) is a novel, small molecule inhibitor of the DNA base excision repair pathway, which is a pathway that causes resistance to alkylating and antimetabolite chemotherapeutics. TRC102 is currently being studied in multiple Phase 1 and Phase 2 clinical trials sponsored by the National Cancer Institute or Case Comprehensive Cancer Center.
About TRC253
TRC253 is a Phase 3 ready novel, orally bioavailable small molecule drug that is a potent, high affinity competitive inhibitor of the androgen receptor (AR) and AR mutations, including the F877L mutation. The AR F877L mutation results in an alteration in the AR ligand binding domain that confers resistance to therapies for prostate cancer. Therapies targeting the AR have demonstrated clinical efficacy by extending time to disease progression, and in some cases, the survival of patients with metastatic castration-resistant prostate cancer. However, resistance to these agents is often observed and several molecular mechanisms of resistance have been identified, including gene amplification, overexpression, alternative splicing, and point mutation of the AR. TRC253 recently completed a Phase 1/2 clinical trial in prostate cancer conducted by TRACON. TRACON believes TRC253 can be developed and commercialized successfully in China and is actively seeking a strategic collaboration.
About TJ004309
TJ004309 is a novel, humanized antibody against CD73, an ecto-enzyme expressed on stromal cells and tumors that converts extracellular adenosine monophosphate (AMP) to adenosine, which is highly immunosuppressive. TJ004309 is currently being studied in a Phase 1 trial to assess safety and preliminary efficacy as a single agent and when combined with the PD-L1 checkpoint inhibitor Tecentriq in patients with advanced solid tumors.