A Phase 2 Randomized Study of the BER Inhibitor TRC102 in Combination With Standard Pemetrexed-Platinum-Radiation in Stage III Non-Squamous Non-Small Cell Lung Cancer

This phase II trial tests whether TRC102 (methoxyamine hydrochloride) in combination usual care treatment comprised of pemetrexed, cisplatin or carboplatin, and radiation therapy followed by durvalumab works better than the usual care treatment alone to shrink tumors in patients with stage III non-squamous non-small cell lung cancer (NSCLC). TRC102 is in a class of drugs called antineoplastic agents. It blocks the ability of a cell to repair damage to its DNA and may kill cancer cells. It may also help some anticancer drugs work better. Pemetrexed is in a class of medications called antifolate antineoplastic agents. It works by stopping cells from using folic acid to make DNA and may kill cancer cells. Chemotherapy drugs, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy sources to kill tumor cells and shrink tumors. Giving TRC102 in combination with usual care treatment may be more effective than usual care treatment alone in stabilizing and lengthening survival time in patients with stage III non-squamous NSCLC.

Start Date15 Dec 2022

Sponsor / Collaborator

National Cancer Institute

NCT02535312 / Active, not recruitingPhase 1/2IIT

Phase I Study of TRC102 in Combination With Cisplatin and Pemetrexed in Patients With Advanced Solid Tumors / Phase II Study of TRC102 With Pemetrexed in Patients Refractory to Pemetrexed and Cisplatin or Carboplatin

This phase I/II trial studies the side effects and the best dose of methoxyamine when given together with cisplatin and pemetrexed disodium and to see how well it works in treating patients with solid tumors or mesothelioma that have spread to other places in the body and usually cannot be cured or controlled with standard treatment (advanced), or mesothelioma that does not respond to pemetrexed disodium and cisplatin or carboplatin (refractory). Methoxyamine may shrink the tumor and may also help cisplatin and pemetrexed disodium work better by making tumor cells more sensitive to the drugs. Drugs used in chemotherapy, such as cisplatin and pemetrexed disodium, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving methoxyamine together with cisplatin and pemetrexed disodium may be a better treatment for solid tumors or mesothelioma than methoxyamine and pemetrexed disodium.

Start Date08 Mar 2016

Sponsor / Collaborator

National Cancer Institute

NCT02395692 / TerminatedPhase 2IIT

Phase II Study of TRC102 in Combination With Temozolomide for Recurrent Glioblastoma

This phase II trial studies how well methoxyamine works when added to standard temozolomide in treating patients with glioblastoma that has come back. Drugs used in chemotherapy, such as methoxyamine and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Start Date18 Dec 2015

Sponsor / Collaborator

National Cancer Institute

100 Clinical Results associated with Methoxyamine Hydrochloride

100 Translational Medicine associated with Methoxyamine Hydrochloride

100 Patents (Medical) associated with Methoxyamine Hydrochloride

Literatures (Medical) associated with Methoxyamine Hydrochloride

01 Oct 2024·In Vitro Cellular & Developmental Biology - Animal

Effect of transcription factor MEOX on insulin gene expression in glucagon-like peptide 1-secreting cells

Article

Author: Ahmad, Waqas ; Lee, Esder ; Kim, Min Gab ; Ryu, Gyeong Ryul ; Song, Ki-Ho ; Bae, Dongryeoul ; Uddin, Shahab ; Ahn, Gyeongik ; Kim, Woe-Yeon ; Silvano, Kris John ; Meah, Mohammed Sohel ; Cha, Joon-Yung

Currently, the supply of beta cells for islet transplantation in the treatment of type 1 diabetes is limited. Enteroendocrine cells (EECs) are believed to have high potential as stem cells because they share significant developmental similarities with beta cells. In a previous study, we derived EEC cells that secrete individual gut hormones from STC-1 cells. This study aimed to examine intestinal hormone secretion and expression, investigate the expression of developmental-related transcription factors, and analyze the effect of MEOX on insulin gene expression in isolated EECs. The expression and secretion of enteroendocrine hormones were evaluated in L6 and K34 cells from STC-1 cells. Expression patterns of beta cell- and development-related genes in L6 and K34 cells were compared with beta cells. Comparisons of the MEOX-induced expression of Ins in beta cells and GLP-1-secreting cells were investigated. Both L6 and K34 cells predominantly expressed Glp1 and Gip, respectively. The secretion pattern of GLP-1 in L6 cells was similar to that of GLUTag cells. Previous microarray analysis confirmed MEOX as developmentally relevant transcription factors expressed in beta cells. Overexpression of MEOX showed a tendency to increase Ins expression in L6 and GLUTag cells, but not in MIN6 cells. However, when PDX1 and MEOX were co-expressed in GLUTag cells, insulin expression was suppressed, similar to that observed in MIN6 cells. These findings suggest a potential role for MEOX in regulating the expression of the Ins gene in both beta cells and GLP-1-secreting cells. Further studies are warranted to elucidate the underlying mechanism.

01 Oct 2024·Cell Reports

Base-excision repair pathway regulates transcription-replication conflicts in pancreatic ductal adenocarcinoma

Article

Author: Wang, Yingying ; Li, Tiane ; Kohram, Fatemeh ; Williams, Terence ; Li, Yun R. ; Shen, Binghui ; Feng, Qianhua ; Meng, Fan ; Li, Yun R ; Singh, Anup K ; Raoof, Mustafa ; Singh, Anup K. ; Liu, Yilun ; Attiyeh, Marc

Oncogenic mutations (such as in KRAS) can dysregulate transcription and replication, leading to transcription-replication conflicts (TRCs). Here, we demonstrate that TRCs are enriched in human pancreatic ductal adenocarcinoma (PDAC) compared to other common solid tumors or normal cells. Several orthogonal approaches demonstrated that TRCs are oncogene dependent. A small interfering RNA (siRNA) screen identified several factors in the base-excision repair (BER) pathway as main regulators of TRCs in PDAC cells. Inhibitors of BER pathway (methoxyamine and CRT) enhanced TRCs. Mechanistically, BER pathway inhibition severely altered RNA polymerase II (RNAPII) and R-loop dynamics at nascent DNA, causing RNAPII trapping and contributing to enhanced TRCs. The ensuing DNA damage activated the ATR-Chk1 pathway. Co-treatment with ATR inhibitor (VX970) and BER inhibitor (methoxyamine) at clinically relevant doses synergistically enhanced DNA damage and reduced cell proliferation in PDAC cells. The study provides mechanistic insights into the regulation of TRCs in PDAC by the BER pathway, which has biologic and therapeutic implications.

01 Aug 2024·Clinical Cancer Research

Evaluating the Base Excision Repair Inhibitor TRC102 and Temozolomide for Patients with Recurrent Glioblastoma in the Phase 2 Adult Brain Tumor Consortium Trial BERT

Article

Author: Rogers, Lisa R ; Nabors, Burt ; Peng, Sen ; Takebe, Naoko ; Lesser, Glenn J ; Sloan, Andrew E ; Holdhoff, Matthias ; Lee, Matthew ; Peereboom, David M ; Ozair, Ahmad ; Dhruv, Harshil ; Wen, Patrick Y ; Rath, Sanhita ; Drappatz, Jan ; Couce, Marta ; Grossman, Stuart A ; Berens, Michael E ; Ahluwalia, Manmeet S ; Ye, Xiaobu ; Hao, Yue ; Walbert, Tobias ; Cloughesy, Timothy F

AbstractPurpose:Patients with glioblastoma (GBM) have a dismal prognosis. Although the DNA alkylating agent temozolomide (TMZ) is the mainstay of chemotherapy, therapeutic resistance rapidly develops in patients. Base excision repair inhibitor TRC102 (methoxyamine) reverses TMZ resistance in preclinical glioma models. We aimed to investigate the efficacy and safety of oral TRC102+TMZ in recurrent GBM (rGBM).Patients and Methods:A preregistered (NCT02395692), nonrandomized, multicenter, phase 2 clinical trial (BERT) was planned and conducted through the Adult Brain Tumor Consortium (ABTC-1402). Arm 1 included patients with bevacizumab-naïve GBM at the first recurrence, with the primary endpoint of response rates. If sufficient activity was identified, a second arm was planned for the bevacizumab-refractory patients. The secondary endpoints were overall survival (OS), progression-free survival (PFS), PFS at 6 months (PFS6), and toxicity.Results:Arm 1 enrolled 19 patients with a median of two treatment cycles. Objective responses were not observed; hence, arm 2 did not open. The median OS was 11.1 months [95% confidence interval (CI), 8.2–17.9]. The median PFS was 1.9 months (95% CI, 1.8–3.7). The PFS6 was 10.5% (95% CI, 1.3%–33.1%). Most toxicities were grades 1 and 2, with two grade 3 lymphopenias and one grade 4 thrombocytopenia. Two patients with PFS ≥ 17 months and OS > 32 months were deemed “extended survivors.” RNA sequencing of tumor tissue, obtained at diagnosis, demonstrated significantly enriched signatures of DNA damage response (DDR), chromosomal instability (CIN70, CIN25), and cellular proliferation (PCNA25) in “extended survivors.”Conclusions:These findings confirm the safety and feasibility of TRC102+TMZ in patients with rGBM. They also warrant further evaluation of combination therapy in biomarker-enriched trials enrolling GBM patients with baseline hyperactivated DDR pathways.

News (Medical) associated with Methoxyamine Hydrochloride

11 Jun 2024

·www.globenewswire.com

TRACON Announces Publication in Clinical Cancer Research of Phase 2 Clinical Data for TRC102, a DNA Damage Repair Inhibitor, in Recurrent Glioblastoma Patients

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 100% response rate (including a 20% complete response rate) in a Phase 1 clinical trial combining TRC102 with pemetrexed, cisplatin and radiation therapy in 15 patients with stage III non-squamous non-small cell lung cancer (https://pubmed.ncbi.nlm.nih.gov/34740922), TRC102 is currently being studied in a randomized Phase 2 clinical trial in combination with chemotherapy (pemetrexed, cisplatin or carboplatin) and radiation therapy for stage III non-squamous non-small cell lung cancer (NCT05198830: https://clinicaltrials.gov/study/NCT05198830?intr=TRC102&rank=6). This trial is sponsored by the National Cancer Institute (NCI) through a Cooperative Research and Development Agreement (CRADA). Determination of the primary endpoint of progression free survival is expected in 2025. TRACON and the NCI have a longstanding history of partnership to develop TRC102, whereby the NCI has funded six Phase 1 or Phase 2 trials through the CRADA. 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 TheuerBrian RitchieChief Executive OfficerLifeSci Advisors LLC(858) 550-0780(212) 915-2578ctheuer@traconpharma.combritchie@lifesciadvisors.com

Phase 2Phase 1Orphan DrugRadiation TherapyClinical Result

14 May 2024

·www.globenewswire.com

TRACON Pharmaceuticals Reports First Quarter 2024 Financial Results and Provides Corporate Update

SAN DIEGO, May 14, 2024 (GLOBE NEWSWIRE) -- TRACON Pharmaceuticals, Inc. (Nasdaq: TCON), a clinical stage biopharmaceutical company utilizing 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, today announced financial results for the first quarter ended March 31, 2024. The Company will host a conference call and webcast today at 4:30 PM Eastern Time / 1:30 PM Pacific Time. “With ENVASARC fully enrolled we are focused on leveraging our Product Development Platform to generate non-dilutive capital through either an additional license or by replacing a CRO and executing clinical trials for partners at a lower cost compared to a CRO but still at a premium to our costs using a pay for performance model,” said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. “We look forward to reporting the final response assessment data in all patients from the ENVASARC Phase 2 pivotal trial, which are expected in the third quarter.” Recent Corporate Highlights In April, we announced updated interim safety and efficacy data from the ENVASARC Phase 2 pivotal trial in 73 patients treated with single agent envafolimab. The objective response rate (ORR) was 11% by investigator review and 5.5% by blinded independent central review (BICR), all of which were confirmed responses. Envafolimab monotherapy was generally well tolerated and median duration of response by BICR was greater than six months. The primary endpoint of the study is achievement of an ORR by BICR in nine of 82 patients (11%) treated with envafolimab and median duration of response of greater than six months is a key secondary endpoint. In April, the Company announced that the Nasdaq Hearings Panel granted the Company’s request for an extension to demonstrate compliance with all applicable criteria for continued listing on The Nasdaq Capital Market, including the $1.00 bid price and $2.5 million stockholders’ equity requirements, through June 3, 2024, provided the Company execute a reverse stock split and file an S-1, both of which the Company executed in April. The Company continues to consider alternatives to address the $2.5 million stockholders’ equity requirement on or before June 3, 2024. Expected Upcoming Milestone Report the final response assessment data including duration of response in all patients from the ENVASARC Phase 2 pivotal trial, which are expected in the third quarter of 2024. First Quarter 2024 Financial Results Cash, cash equivalents and restricted cash were $8.0 million at March 31, 2024, compared to $8.6 million at December 31, 2023, which is expected to fund the Company late into the third quarter of 2024. Research and development expenses for the first quarter of 2024 were $1.9 million, compared to $5.0 million for the first quarter of 2023. The decrease was primarily related to completing enrollment of the ENVASARC Phase 2 pivotal trial in 2024. General and administrative expenses for the first quarter of 2024 were $1.4 million, compared to $2.3 million for the first quarter of 2023. Net loss for the first quarter of 2024 was $3.2 million, compared to $8.5 million for the first quarter of 2023. Conference Call Details To access the call by phone, please register using this link and you will be provided with dial-in details. A live webcast of the conference call will be available online from the Investor/Events and Presentation page of the Company’s website at www.traconpharma.com. After the live webcast, a replay will remain available on TRACON’s website for 60 days. About Envafolimab Envafolimab (KN035), a single-domain antibody against PD-L1 invented by Alphamab Oncology and licensed by TRACON, is the first approved subcutaneously injected PD-(L)1 inhibitor. Envafolimab was approved by the Chinese NMPA in November 2021 in adult patients with MSI-H/dMMR advanced solid tumors who failed systemic treatment and have no satisfactory alternative treatment options. In December 2019, Alphamab Oncology, 3D Medicines and TRACON entered into a collaboration whereby TRACON has the right to develop and commercialize envafolimab in soft tissue sarcoma in North America. Envafolimab is currently being studied in the ENVASARC Phase 2 pivotal trial in the United States sponsored by TRACON and a Phase 3 pivotal trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients in China sponsored by TRACON’s corporate partners, Alphamab Oncology and 3D Medicines. TRACON has received orphan drug designation from the U.S. Food and Drug Administration for envafolimab for patients with soft tissue sarcoma and fast track designation from the U.S. Food and Drug Administration for envafolimab (KN035) for patients with locally advanced, unresectable or metastatic undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS) who have progressed on one or two prior lines of chemotherapy. About ENVASARC (NCT04480502) The ENVASARC Phase 2 pivotal trial is a multicenter, open label, randomized, non-comparative, parallel cohort study at 30 top cancer centers in the United States and the United Kingdom that began dosing in December 2020. TRACON enrolled patients in ENVASARC with UPS or MFS who have progressed following one or two lines of prior treatment and have not received an immune checkpoint inhibitor. A total of 82 evaluable patients have received treatment with single agent envafolimab at 600 mg every three weeks. The primary endpoint is objective response rate by central review in nine of 82 patients (11%) with duration of response a key secondary endpoint. About TRACON TRACON is a clinical-stage biopharmaceutical company utilizing 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. The Company’s clinical-stage pipeline includes: Envafolimab, a PD-L1 single-domain antibody given by rapid subcutaneous injection that is being studied in the pivotal ENVASARC trial for sarcoma; YH001, a potential best-in-class CTLA-4 antibody in Phase 1 development; and TRC102, a Phase 2 small molecule drug candidate for the treatment of lung cancer. TRACON is actively seeking additional corporate partnerships through a profit-share or revenue-share partnership, or through franchising TRACON’s product development platform. TRACON believes it can serve as a solution for companies without clinical and commercial capabilities in the United States or who wish to become CRO-independent. To learn more about TRACON and its product pipeline, 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, TRACON’s plans to further develop product candidates; TRACON’s ability to regain compliance with Nasdaq continued listing standards and maintain the listing of its securities on a national securities exchange; TRACON’s plans to further license out its platform or replace CROs and generate non-dilutive capital; expectations regarding the timing and scope of clinical trials and availability of clinical data, including the timing and results of accrual and data from TRACON’s ENVASARC Phase 2 pivotal trial; expected development, regulatory and commercial milestones and timing thereof; potential utility of product candidates; TRACON’s cash runway; and TRACON’s business development strategy and goals, including the ability to enter into additional collaborations or licensing arrangements. Risks that could cause actual results to differ from those expressed in these forward‐looking statements include: the risk that TRACON needs substantial additional capital to continue as a going concern and to enroll or complete its ongoing clinical trials as currently planned, if at all; risks associated with clinical development and regulatory approval of novel pharmaceutical 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 geopolitical and macroeconomic events; the fact that future preclinical studies and clinical trials, including ENVARSAC, may not be successful or otherwise consistent with results from prior studies; the fact that TRACON has limited control over whether or when third party collaborators complete on-going trials or initiate additional trials of TRACON’s product candidates; the fact that TRACON’s collaboration agreements are subject to early termination; whether TRACON will be able to enter into additional collaboration agreements or licensing arrangements or arrangements whereby TRACON replaces CROs on favorable terms or at all; 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; whether TRACON will experience unanticipated costs or other events that cause TRACON’s cash runway to not extend late into the third quarter of 2024; whether TRACON will remain listed on Nasdaq; 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. TRACON Pharmaceuticals, Inc.Unaudited Condensed Consolidated Statements of Operations(in thousands, except share and per share data) Three Months EndedMarch 31, 2024 2023 Revenue$100 $— Operating expenses: Research and development 1,878 4,969 General and administrative 1,434 2,344 Total operating expenses 3,312 7,313 Loss from operations (3,212) (7,313)Total other income (expense) 44 (1,191)Net loss$(3,168) $(8,504) Loss per share, basic and diluted$(1.33) $(6.76)Weighted-average common shares outstanding, basic and diluted 2,389,519 1,258,096 TRACON Pharmaceuticals, Inc.Unaudited Condensed Consolidated Balance Sheets(in thousands) March 31, December 31, 2024 2023 Assets Current assets: Cash and cash equivalents$7,891 $8,564 Prepaid and other assets 511 526 Total current assets 8,402 9,090 Property and equipment, net 33 37 Restricted Cash 73 73 Other assets 847 905 Total assets$9,355 $10,105 Liabilities and Stockholders’ Deficit Current liabilities: Accounts payable and accrued expenses$10,036 $9,755 Accrued compensation and related expenses 414 427 Total current liabilities 10,450 10,182 Other long-term liabilities 667 732 Commitments and contingencies Stockholders’ deficit: Common stock 3 2 Additional paid-in capital 241,902 239,688 Accumulated deficit (243,667) (240,499)Total stockholders’ deficit (1,762) (809)Total liabilities and stockholders’ deficit$9,355 $10,105 Company Contact:Investor Contact:Charles TheuerBrian RitchieChief Executive OfficerLifeSci Advisors LLC(858) 550-0780(212) 915-2578ctheuer@traconpharma.combritchie@lifesciadvisors.com

Phase 2Orphan DrugPhase 1Fast TrackClinical Result

07 May 2024

·www.globenewswire.com

TRACON to Report First Quarter 2024 Financial Results and Provide Corporate Update on May 14, 2024

SAN DIEGO, May 07, 2024 (GLOBE NEWSWIRE) -- TRACON Pharmaceuticals, Inc. (Nasdaq: TCON), a clinical stage biopharmaceutical company utilizing 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, announced today that it will report its first quarter 2024 financial and operating results after the close of U.S. financial markets on Tuesday, May 14, 2024. In addition, management will host a conference call to provide an update on corporate activities and discuss the financial results. Date:May 14, 2024Time:4:30 pm Eastern Time (1:30 pm Pacific Time)Conference Call:In order to participate in the live conference call, you must register in advance here: registration link. After registering, you will receive an email with dial-in details and a unique conference call access code required to join the live call. To ensure you are connected prior to the beginning of the call, the Company suggests registering a minimum of 10 minutes before the start of the call. For those not planning to ask a question of management, the Company recommends listening via the webcast.Webcast:https://traconpharma.com/events-presentations/ A replay of the webcast will be available for 60 days on the website. About TRACON TRACON is a clinical-stage biopharmaceutical company utilizing 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. The Company’s clinical-stage pipeline includes: Envafolimab, a PD-L1 single-domain antibody given by rapid subcutaneous injection that is being studied in the pivotal ENVASARC trial for sarcoma; YH001, a potential best-in-class CTLA-4 antibody in Phase 1 development; and TRC102, a Phase 2 small molecule drug candidate for the treatment of lung cancer. TRACON is actively seeking additional corporate partnerships through a profit-share or revenue-share partnership, or through franchising TRACON’s product development platform. TRACON believes it can serve as a solution for companies without clinical and commercial capabilities in the United States or who wish to become CRO-independent. To learn more about TRACON and its product pipeline, visit TRACON’s website at www.traconpharma.com. Company Contact:Investor Contact:Charles TheuerBrian RitchieChief Executive OfficerLifeSci Advisors LLC(858) 550-0780(212) 915-2578ctheuer@traconpharma.combritchie@lifesciadvisors.com

Phase 1Financial StatementPhase 2

100 Deals associated with Methoxyamine Hydrochloride

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KEGG	Wiki	ATC	Drug Bank
-	Methoxyamine Hydrochloride	-	DB06328

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Malignant Solid Neoplasm	Phase 2	US	National Cancer Institute	08 Mar 2016
Peritoneal Diseases	Phase 2	US	National Cancer Institute	08 Mar 2016
Refractory Malignant Solid Neoplasm	Phase 2	US	National Cancer Institute	08 Mar 2016
Unresectable Solid Neoplasm	Phase 2	US	National Cancer Institute	08 Mar 2016
Granulosa Cell Tumor of the Ovary	Phase 2	US	National Cancer Institute	12 Jul 2013
Lymphoma	Phase 2	US	National Cancer Institute	12 Jul 2013
Metastatic colon cancer	Phase 2	US	National Cancer Institute	12 Jul 2013
Relapsed Solid Neoplasm	Phase 2	US	National Cancer Institute	12 Jul 2013
Lung Cancer	Phase 2	US	TRACON Pharmaceuticals, Inc.	-
Recurrent Glioblastoma	Preclinical	US	National Cancer Institute	18 Dec 2015

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02535312 (CTgov)	Phase 1/2	Refractory Malignant Solid Neoplasm \| Peritoneal Diseases \| Malignant Mesothelioma of Peritoneum \| Malignant Pleural Mesothelioma \| Advanced Malignant Solid Neoplasm \| Unresectable Solid Neoplasm	30	TRC102+Cisplatin (Arm A, Dose Level 1 - 50mg TRC102, 60mg/m^2 Cisplatin (Phase I))	beisxonuhh(ixatyssxtu) = zjntqhiafj famaqhwkom (qftybeuphw, jtllmahmns - fbdjpbuudl) View more	-	25 Apr 2024
NCT02535312 (CTgov)	Phase 1/2		30	TRC102+Cisplatin (Arm A, Dose Level 2 - 75mg TRC102, 60mg/m^2 Cisplatin (Phase I))	beisxonuhh(ixatyssxtu) = muoeueqgle famaqhwkom (qftybeuphw, xujkxlbaoz - gawagcfdxp) View more	-	25 Apr 2024
NCT01851369 (ASCO2023) Manual	Phase 1/2	Granulosa Cell Tumor	8	temozolomide 150 mg/m^2+TRC102 125 mg	(osayedeziz) = fatigue, myelosuppression, nausea, and vomiting qngmxusdwl (lbigzgsuaw ) View more	Positive	26 May 2023
NCT02535312 (ASCO2020) Manual	Phase 2	Mesothelioma \| HR-positive/HER2-low Solid Tumors	-	TRC102+cisplatin+pemetrexed	(mvkoiktpmq) = gvhfkcovsh llnhifrwpk (jdsfqmslnb, 1.4 - 6.8) View more	Positive	29 May 2020
NCT02535325 (ASCO2020)	Phase 1	Locally Advanced Lung Non-Squamous Non-Small Cell Carcinoma	15	TRC102	(pnetljkoxa) = ymwljgxdmd avmjxqeklw (txbmfyubcq ) View more	Positive	25 May 2020
NCT01851369 (ASCO2017) Manual	Phase 1	Solid tumor \| Lymphoma	52	methoxyamine HCl+temozolomide	(fjtwgdkaij) = neutropenia (13%), anemia (the DLT;10%), thrombocytopenia (7%), hemolysis (5%) or hypophosphatemia (3%) jnkkcbmsnl (ivqfqvwgzs )	Positive	05 Jun 2017
NCT01851369 (ASCO2016)	Phase 1	Solid tumor \| Lymphoma	37	TRC102 + TMZ	(wvtubjzpvz) = 8% attddibcfi (rwgsgucdue ) View more	Positive	20 May 2016
NCT00692159 (Pubmed \| Invest New Drugs)	Phase 1	HR-positive/HER2-low Solid Tumors	28	TRC102	(vrbuundjwh) = nngyloxbgo liexlghjsq (vuehqfxaym ) View more	-	01 Jun 2013
ASCO2010	Phase 1	Brain Cancer	4	Methoxyamine-HCl (TRC102; MX)	(txqgpctnil) = One grade 3 toxicity possibly treatment related (hallucinations in one patient with progressive disease and on opioids) zxsqbepkjj (xjzlqraycl )	-	20 May 2010
ASCO2010	Phase 1	Refractory Cancer	28	TRC102	(ooqdnhzgzl) = ncxwajiecv bxcxqvdbcd (sippiwyrcg ) View more	-	20 May 2010

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