TRACON Announces Publication in Clinical Cancer Research of Phase 2 Clinical Data for TRC102, a DNA Damage Repair Inhibitor, in Recurrent Glioblastoma Patients
TRACON Pharmaceuticals (NASDAQ: TCON) announced the publication of Phase 2 clinical data on its DNA damage repair inhibitor, TRC102, in recurrent glioblastoma patients.
Published in Clinical Cancer Research, the study evaluated TRC102 combined with Temodar in 19 patients who had progression following initial treatment.
Results showed extended survival in two patients, with progression-free survival of at least 17 months and overall survival over 32 months. Both patients had enriched DNA damage response pathways prior to treatment.
The study confirms the safety and feasibility of TRC102 with Temodar and suggests further trials in biomarker-enriched glioblastoma patients may be warranted.
Additionally, TRC102 is being studied in a Phase 2 trial for non-small cell lung cancer, with primary endpoint determination expected in 2025.
- Publication of Phase 2 data in a reputable journal boosts credibility.
- Extended survival noted in patients with specific biomarkers (≥ 17 months PFS, > 32 months OS).
- Study confirms safety and feasibility of TRC102 combined with Temodar.
- 100% response rate in a Phase 1 trial for non-squamous non-small cell lung cancer.
- Ongoing Phase 2 trial for non-small cell lung cancer, primary endpoint expected in 2025.
- Only two patients showed significantly extended survival.
- sample size of 19 patients in the Phase 2 trial.
- Further trials are needed, indicating current data is not conclusive.
- Results are specific to patients with particular biomarkers, limiting broader applicability.
Insights
The new clinical data indicating the effectiveness of TRC102 combined with Temodar for recurrent glioblastoma patients stands out. Glioblastoma, a highly aggressive brain tumor, has limited treatment options and poor prognosis. The Phase 2 trial showing extended survival in certain patients is a significant finding. Specifically, patients with enriched DNA damage response (DDR) pathways prior to treatment had better outcomes, highlighting the potential of personalized medicine. The confirmation of safety and feasibility of this combination therapy also opens pathways for further studies in newly diagnosed patients. It's important for investors to note that the field of oncology often demands substantial evidence through multiple phases of trials before drugs can receive regulatory approval.
From a financial perspective, this data publication can positively influence TRACON Pharmaceuticals' stock. Positive clinical trial results often lead to an increase in stock prices, reflecting market optimism. However, it's essential to consider the long development cycle and the need for further trials before commercialization. Investors should be aware of the costs associated with such trials and weigh them against the potential market size for glioblastoma treatments. Additionally, the mention of partnerships with the National Cancer Institute (NCI) via the CRADA is noteworthy. This not only provides funding but also validates the scientific merit of the drug. Monitoring upcoming trial results and regulatory milestones is key for understanding long-term financial impact.
The publication in a reputable journal like Clinical Cancer Research underscores the scientific community's interest in TRC102. The evidence of effectiveness, particularly in patients with hyperactivated DDR pathways, suggests TRC102 could play a critical role in targeted therapies. Investors should recognize the importance of such biomarkers in developing precision medicine. Additionally, the ongoing randomized Phase 2 trials in non-small cell lung cancer (NSCLC) sponsored by the NCI are significant, as successful results here could diversify and further validate TRC102's applicability. Understanding the competitive landscape of DDR inhibitors and ongoing research in this field can provide insights into the potential market positioning of TRC102.
Publication Highlights Activity of the Combination of TRC102 and Temodar (Temozolomide) in Patients who Progressed Following Initial Treatment with Surgical Resection, Temodar and External Beam Radiotherapy
Consistent with the TRC102 Mechanism of Action, Extended Survival was Demonstrated in Patients with Activation of DNA Damage Response Pathways Prior to TRC102 Treatment
SAN DIEGO, June 11, 2024 (GLOBE NEWSWIRE) -- TRACON Pharmaceuticals (NASDAQ: TCON), a clinical stage biopharmaceutical company utilizing a cost-efficient, CRO-independent Product Development Platform (PDP) to advance its pipeline of novel targeted cancer therapeutics and to partner with other life science companies, today announced the publication of Phase 2 clinical data of its DNA damage repair inhibitor drug candidate, TRC102, in patients with glioblastoma in Clinical Cancer Research. The article, entitled, “Evaluating the Base Excision Repair Inhibitor TRC102 and Temozolomide for patients with Recurrent Glioblastoma in the Phase 2 Adult Brain Tumor Consortium Trial BERT,” highlights the activity of TRC102 given in combination with Temodar chemotherapy in patients with recurrent glioblastoma: https://pubmed.ncbi.nlm.nih.gov/38836759/
TRC102 was evaluated in a Phase 2 trial in combination with Temodar in 19 patients with progressive or recurrent glioblastoma following surgical resection, Temodar and external beam radiotherapy. Extended survival was observed in two patients (progression-free survival ≥ 17 months and overall survival > 32 months), both of whom demonstrated significantly enriched signatures of DNA damage response (DDR), chromosomal instability, and cellular proliferation by RNA sequencing prior to initiating treatment with Temodar and TRC102. The study was completed by the Adult Brain Tumor Consortium and led by Manmeet Alhuwalia, MD while he was Chair of Neuro-Oncology at Cleveland Clinic prior to his appointment as Chief of Medical Oncology, Chief Scientific Officer, and Deputy Director of the Miami Cancer Institute. The authors concluded the study findings confirm the safety and feasibility of TRC102 given with Temodar for recurrent glioblastoma patients and warrant further evaluation of combination therapy in biomarker-enriched trials enrolling glioblastoma patients with baseline hyperactivated DDR pathways.
“We believe that the data generated to date provides a strong rationale for studying TRC102 in combination with Temodar and radiotherapy in newly diagnosed patients with malignant glioma,” said James Freddo, M.D., Chief Medical Officer of TRACON. “The Clinical Cancer Research publication supports prior data published in Cancer Cell (https://pubmed.ncbi.nlm.nih.gov/33217343) that patients whose cancers demonstrate activation of DDR pathways may be particularly sensitive to the pharmacologic effects of TRC102.”
Based on a
About TRC102
TRC102 (methoxyamine) is a novel, clinical-stage 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 randomized Phase 2 clinical trial entitled Testing the Addition of an Anti-Cancer Drug, TRC102, to the Usual Chemotherapy Treatment (Pemetrexed, Cisplatin or Carboplatin) During Radiation Therapy for Stage III Non-Squamous Non-Small Cell Lung Cancer (NCT05198830) that is sponsored by the NCI through a CRADA. TRC102 was granted orphan drug designation by the US FDA for the treatment of malignant glioma in 2020. For more information about the clinical trials, please visit TRACON’s website at www.traconpharma.com/clinical-trials.
About Malignant Glioma and Glioblastoma
Glioblastoma (GBM) is a rapidly growing malignant glioma that develops from glial cells (astrocytes and oligodendrocytes) that support the health of the nerve cells within the brain. GBM is the most invasive type of glial tumors, rapidly growing and commonly invading into nearby brain tissue. The National Cancer Institute estimates that approximately 22,850 adults are diagnosed with brain and other nervous system cancers annually in the U.S. and approximately 15,320 of these diagnoses will result in death. GBM has an incidence of two to three per 100,000 adults per year in the U.S., and accounts for 52 percent of all primary brain tumors.
About TRACON
TRACON utilizes a cost-efficient, CRO-independent, product development platform to advance its pipeline of novel targeted cancer therapeutics and to partner with other life science companies. TRACON believes it can serve as a solution for companies without clinical capabilities who wish to become CRO-independent. To learn more about TRACON, visit TRACON’s website at www.traconpharma.com.
Forward-Looking Statements
Statements made 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. Such statements include, but are not limited to, statements regarding TRACON’s and the NCI’s plans to further develop product candidates, expectations regarding clinical trials, development and regulatory plans, the potential benefits of TRC102, the potential for TRC102 to become a treatment option for patients with the glioblastoma or lung cancer, market estimates regarding annual diagnoses of brain and other nervous system cancer, and TRACON’s business development strategy and goals. Risks that could cause actual results to differ from those expressed in these forward‐looking statements include: risks associated with TRACON’s ability to remain listed on a national securities exchange, risks associated with clinical development and regulatory approval of pharmaceutical product candidates, including the results of clinical trials involving TRC102 and whether the results of earlier studies or trials will be consistent with or otherwise achieved in later trials; risks relating to TRACON’s ability to continue as a going concern; risks relating to other therapies that are being developed and compete with TRACON’s product candidates; whether TRACON or others will be able to complete or initiate clinical trials on TRACON’s expected timelines, if at all, including due to risks associated with macroeconomic and geopolitical events; potential changes in regulatory requirements in the United States and foreign countries; TRACON’s reliance on third parties for the development of its product candidates, including the conduct of its clinical trials and manufacture of its product candidates; whether TRACON will be able to obtain additional financing on favorable terms or at all; and other risks described in TRACON’s filings with the Securities and Exchange Commission under the heading “Risk Factors”. All forward‐looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. TRACON undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made except as required by law.
| Company Contact: | Investor Contact: |
| Charles Theuer | Brian Ritchie |
| Chief Executive Officer | LifeSci Advisors LLC |
| (858) 550-0780 | (212) 915-2578 |
| ctheuer@traconpharma.com | britchie@lifesciadvisors.com |
FAQ
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