On March 25, 2025 Aprea Therapeutics, Inc. (Nasdaq: APRE) ("Aprea", or the "Company"), a clinical-stage biopharmaceutical company developing innovative treatments that exploit specific cancer cell vulnerabilities while minimizing damage to healthy cells, reported financial results for the fourth quarter and full year ended December 31, 2024, and provided a business update (Press release, Aprea, MAR 25, 2025, View Source [SID1234651393]).

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"We made excellent progress across our pipeline in 2024, laying a strong foundation for the year ahead," said Oren Gilad, Ph.D., President and Chief Executive Officer of Aprea. "We continue to enroll patients in the ACESOT-1051 trial evaluating our WEE1 kinase inhibitor, APR-1051, which we believe has best in class potential. The compound appears safe and well tolerated to date with no hematologic toxicity. We look forward to reporting open label data from ACESOT-1051 in the second half of the year. We are also advancing ATRN-119, our highly selective first-in-class macrocyclic ATR inhibitor. The ongoing ABOYA-119 trial is now evaluating ATRN-119 as continuous once daily and twice daily monotherapy in order to maximize therapeutic benefit. Our ultimate goal is to transform the treatment paradigm for difficult to treat cancers by unlocking the full potential of DDR-based therapies."

Key Business Updates and Potential Upcoming Key Milestones

ACESOT-1051: A Biomarkers Focused, Phase 1 Trial of Oral WEE1 inhibitor, APR-1051

● APR-1051 is a potent and selective small molecule that has been designed to potentially solve tolerability challenges of the WEE1 class and may achieve greater clinical activity than other programs currently in development. Aprea is advancing APR-1051 as monotherapy in cancers with Cyclin E over-expression, as well as other biomarkers that may predict sensitivity to WEE1 inhibition. Cancers over-expressing Cyclin E represent a high unmet medical need. Patients with Cyclin E over-expression have poor prognosis and, currently, have no effective therapies available.
● Patients are now being enrolled in Cohort 5 (70 mg dose) of the ACESOT-1051 (A Multi-Center Evaluation of WEE1 Inhibitor in Patients with Advanced Solid Tumors, APR-1051) trial. This Phase 1 clinical trial is evaluating single-agent APR-1051 in advanced solid tumors harboring cancer-associated gene alterations. No hematological toxicities have been observed to date. The primary objectives of the Phase 1 study are to measure safety, dose-limiting toxicities (DLTs), maximum tolerated dose or maximum administered dose (MTD/MAD), and recommended Phase 2 dose (RP2D); secondary objectives are to evaluate pharmacokinetics and preliminary efficacy according to RECIST or PCWG3 criteria; pharmacodynamic parameters are exploratory objectives.

● In October 2024, preliminary findings from the ACESOT-1051 trial were reported in a poster at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics, in Barcelona, Spain. The poster can be viewed on Aprea’s corporate website here.
● Preliminary efficacy data from ACESOT-1051 are expected in the second half of 2025. For more information, refer to ClinicalTrials.gov NCT06260514.

ABOYA-119: Ongoing Clinical Trial Evaluating ATR inhibitor, ATRN-119

● ATRN-119 is a potent and highly selective first-in-class macrocyclic ATR inhibitor, designed to be used in patients with mutations in DDR-related genes. Cancers with mutations in DDR-related genes represent a high unmet medical need. Patients with DDR-related gene mutations have a poor prognosis and, currently, there are no effective therapies available for them.
● ATRN-119 is being evaluated in the open-label Phase 1/2a clinical trial of ABOYA-119 as monotherapy in patients with advanced solid tumors having at least one mutation in a defined panel of DDR-related genes. Patients are currently being enrolled at Dose Level 7, with both 1100 mg once daily and 550 mg twice daily doses being evaluated independently and in parallel. The addition of twice daily dosing was implemented to potentially optimize ATRN-119’s activity across a 24-hour cycle thereby providing better target coverage and maximal clinical benefit. This is expected to increase the likelihood of achieving superior clinical outcomes and may potentially accelerate the path to regulatory approval and commercialization.
● An update from the ABOYA-119 trial was provided in a poster at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics in October, 2024. A copy of the poster can be viewed here.
● For more information on ABOYA-119, please refer to clinicaltrials.gov NCT04905914.

Corporate

● Aprea engaged Philippe Pultar, MD in October 2024 as senior medical advisor to support the development and advancement of APR-1051. Dr. Pultar is a seasoned pharmaceutical executive with extensive experience in oncology. He was most recently employed at Zentalis Pharmaceuticals where he played a key role in the strategy and execution of the global clinical development of azenosertib, a WEE1 inhibitor.

Select Financial Results for the Fourth Quarter ended December 31, 2024

● For the quarter ended December 31, 2024, the Company reported an operating loss of $3.2 million, compared to an operating loss of $3.7 million in the fourth quarter of 2023.
● Research and Development (R&D) expenses were $2.4 million for the quarter ended December 31, 2024, compared to $2.0 million for the fourth quarter of 2023. The increase in R&D expense was primarily related to an increase in personnel costs primarily related to new hires and severance.
● General and Administrative (G&A) expenses were $1.1 million for the quarter ended December 31, 2024, compared to $1.6 million for the comparable period in 2023.
● The Company reported a net loss of $2.9 million ($0.49 per basic share) on approximately 6.0 million weighted-average common shares outstanding for the quarter ended December 31, 2024, compared to a net loss of $3.4 million ($0.92 per basic share) on approximately 3.7 million weighted average common shares outstanding for the comparable period in 2023.

Select Financial Results for the Year ended December 31, 2024

● As of December 31, 2024, the Company reported cash and cash equivalents of $22.8 million compared to $21.6 million as of December 31, 2023. The Company believes its cash and cash equivalents as of December 31, 2024 will be sufficient to meet its currently projected operating expenses and capital expenditure requirements into the first quarter of 2026.
● For the year ended December 31, 2024, the Company reported an operating loss of $14.3 million, compared to an operating loss of $15.5 million for the year ended December 31, 2023.
● R&D expenses were $9.4 million for the year ended December 31, 2024, compared to $7.6 million for the year ended December 31, 2023. The increase in R&D expense was primarily related to the ABOYA-119 clinical trial to evaluate ATRN-119, the initiation of the ACESOT-1051 clinical trial to evaluate APR-1051 and an increase in personnel costs primarily related to new hires and severance.
● G&A expenses were $6.5 million for the year ended December 31, 2024, compared to $8.4 million for the year ended December 31, 2023. The decrease in G&A expenses was primarily due to a decrease in personnel costs primarily related to severance expense for former executives and insurance premiums.
● The Company reported a net loss of $13.0 million ($2.35 per basic share) on approximately 5.5 million weighted-average common shares outstanding for the year ended December 31, 2024, compared to a net loss of $14.3 million ($3.95 per basic share) on approximately 3.6 million weighted average common shares outstanding for the comparable period in 2023.

On March 25, 2025 Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company developing novel small molecule therapeutics to treat unmet needs in immune-mediated diseases, reported positive topline results from the PORTOLA Phase 2a clinical trial evaluating zetomipzomib, a novel, first-in-class selective immunoproteasome inhibitor, in patients with autoimmune hepatitis (AIH) and reported fourth quarter and year end 2024 financial results (Press release, Kezar Life Sciences, MAR 25, 2025, View Source [SID1234651404]).
"We are pleased to announce these exciting results from the PORTOLA trial, the first successful randomized study in treatment-refractory AIH," said Chris Kirk, CEO and co-founder of Kezar. "We are encouraged by the safety and efficacy data in this difficult-to-treat patient population, specifically durable and steroid-sparing remissions experienced by patients treated with zetomipzomib. We are eager to work with the FDA Division of Hepatology and Nutrition to remove the partial clinical hold and align on an appropriate trial design to demonstrate the clinical benefit of zetomipzomib in AIH. I’d like to thank the team at Kezar, the physicians and staff at our clinical trial sites, and most importantly, the patients and their caregivers, for their participation, sacrifice and hard work."

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"I am impressed by the totality of efficacy and safety data from the PORTOLA study," said Gideon Hirschfield, Chair of Autoimmune Liver Disease Research and Director of the Francis Family Liver Clinic, at the Toronto General Hospital. "Zetomipzomib represents a potent and targeted therapy for patients, and I believe these results will positively contribute to the design of a registrational trial of zetomipzomib in AIH, where patients are in need of better treatment options."
PORTOLA is a placebo-controlled, randomized, double-blind Phase 2a clinical trial evaluating the efficacy and safety of zetomipzomib in patients with AIH that are insufficiently responding to standard of care or

have relapsed from a previous CR. The trial enrolled 24 patients, randomized (2:1) to receive 60 mg of zetomipzomib or placebo in addition to background therapy for 24 weeks, with a protocol-suggested steroid taper. All patients were required to receive a starting daily steroid dose of 20-40 mg/day of prednisone (or budesonide equivalent) and physicians were encouraged to taper daily steroid usage to 5 mg/day consistent with AIH treatment guidelines established by the American Association for the Study of Liver Diseases (AASLD).
The primary efficacy endpoint of PORTOLA, which was not powered for efficacy, evaluated the proportion of patients who achieved a CR by Week 24, measured as normalization of alanine aminotransferase (ALT), aspartate aminotransferase (AST) and Immunoglobulin G (IgG) values (if elevated at baseline), with steroid dose levels not higher than baseline. A key secondary endpoint was the proportion of patients who achieved a CR by Week 24 with a steroid dose of 5 mg/day or less. The PORTOLA trial included a pre-specified subgroup analysis of patients who were on steroid-based therapy at the time of screening, which represents a patient population with unmet medical needs for a potential future registrational study. Additional exploratory endpoints included changes in histologic assessment of AIH as measured in biopsies taken within six months of screening and repeated at Week 24 of the trial.
Summary of Topline Results
PORTOLA enrolled 24 patients as the ITT population. Consistent with the AASLD treatment goals, zetomipzomib treatment resulted in higher rates of complete biochemical responses (CR) combined with reduction of steroid dosage to 5 mg/day or less, compared to placebo. In the ITT population:
•Without regard to steroid taper, 50.0% (8 of 16) of zetomipzomib patients achieved a CR, compared to 37.5% (3 of 8) of placebo patients.
•31.3% (5 of 16) of zetomipzomib patients achieved both a CR and steroid taper to 5 mg/day or less, compared to 12.5% (1 of 8) of placebo patients.
•18.8% (3 of 16) of zetomipzomib patients achieved both a CR and complete steroid withdrawal to zero mg/day, compared to 0% (0 of 8) of placebo patients.
•Median duration of response in zetomipzomib patients achieving a CR was 27.6 weeks (including the ongoing open-label extension), and no disease flares were reported in any zetomipzomib-treated patient achieving CR. Disease flares were defined as a sustained increase in ALT values to 25% above the CR value or 1.25-fold higher than the upper limit of normal for more than one week and requiring a restart or increase in steroid dose.
In the pre-specified subgroup analysis, 21 of the 24 patients entered the study on a steroid-based therapy at the time of screening. One patient in the placebo arm and two patients in the zetomipzomib arm were not receiving steroids at screening. All patients on study were required to initiate treatment with an initial prednisone dose of 20–40 mg/day. Of the 21 patients in this subgroup analysis:
•Median steroid use at screening was 20 mg/day for patients enrolled in the zetomipzomib arm, compared to 10 mg/day in the placebo arm, indicating that the zetomipzomib-treated arm was more refractory than the placebo arm.
•Without regard to steroid taper, 57.1% (8 of 14) of zetomipzomib patients achieved a CR, compared to 28.6% (2 of 7) of placebo patients.

•35.7% (5 of 14) of patients on the zetomipzomib arm achieved a CR and steroid taper to 5 mg/day or less, compared to 0% (0 of 7) of placebo patients.
•21.4% (3 of 14) of patients on the zetomipzomib arm achieved a CR and complete steroid withdrawal to zero mg/day, compared to 0% (0 of 7) of placebo patients.
Safety
Treatment-emergent adverse events (TEAEs) were seen in all patients, with injection site reactions (ISRs) being the most commonly reported TEAE in both arms. Systemic injection reactions (SIRs), with onset occurring 8 to 24 hours post-dose and usually resolving within 48 hours, were all Grade 1 and Grade 2. SIRs are a protocol-defined set of specific adverse events (AEs) consisting of one or more of the following signs/symptoms: hypotension, tachycardia, nausea, vomiting, dizziness, headache, pyrexia, rigors and/or chills.
Three patients experienced treatment-emergent serious adverse events (SAEs): one in the placebo arm, a Grade 3 variceal bleeding with hematemesis and atrial fibrillation; and two in the zetomipzomib arm, a Grade 3 fever occurring after the Week 24 liver biopsy, and a Grade 3 influenza infection that fully resolved during study. All SAEs were considered unrelated to study treatment, and all three patients completed the double-blind treatment period. Infectious AEs were reported in 85.7% (6 of 7) of patients in the placebo arm and 56.3% (9 of 16) of patients in the zetomipzomib arm. One patient discontinued from the placebo arm for a UTI requiring antibiotic treatment prior to receiving a dose on study, and three patients discontinued on the zetomipzomib arm for a Grade 1 fatigue, Grade 2 hives and a Grade 2 AIH disease flare. The safety population (n=23) includes all patients who received at least one dose of study treatment:

Placebo Zetomipzomib
n=7 n=16
Adverse Events in Double-blind Treatment Period n (%) n (%)
Participants with at least 1 Treatment Emergent Adverse Event (TEAE) 7 (100.0) 16 (100.0)
Most common TEAE:
Injection Site Reaction (ISR) 4 (57.1) 15 (93.8)
Systemic Injection Reaction (SIR) 1 (14.3) 12 (75.0)
TEAE leading to study drug discontinuation 0 (0) 3 (18.8)
Grade 3 TEAE (no Grade 4 or 5 TEAEs reported) 1 (14.3)
3 (18.8)
Serious TEAE 1 (14.3) 2 (12.5)
Infectious TEAE 6 (85.7) 9 (56.3)
Grade ≥3 Infectious TEAE 0 (0) 1 (6.3)
Opportunistic Infections 0 (0) 0 (0)
Death 0 (0) 0 (0)

Financial Results
•Cash, cash equivalents and marketable securities totaled $132.2 million as of December 31, 2024, compared to $201.4 million as of December 31, 2023. The decrease was primarily attributable to cash used in operations to advance clinical-stage programs.
•Revenue decreased by $7.0 million in 2024 compared to 2023 due to the October 2023 upfront payment received under the collaboration and license agreement with Everest Medicines.

•Research and development (R&D) expenses for the fourth quarter of 2024 decreased by $6.6 million to $16.0 million, compared to $22.6 million in the fourth quarter of 2023. Full year R&D expenses decreased by $20.0 million to $65.7 million in 2024, compared to $85.7 million in 2023. This decrease was primarily due to the Company’s strategic restructuring in October 2023 to prioritize its clinical-stage programs, reducing personnel-related costs and spending in its early-stage research activities, and a $5.0 million milestone payment made in 2023 under Kezar’s exclusive license agreement with Onyx Therapeutics. The decrease was partially offset by the increased clinical trial costs related to the PALIZADE and PORTOLA trials.
•General and administrative (G&A) expenses for the fourth quarter of 2024 decreased by $0.3 million to $5.5 million compared to $5.8 million in the fourth quarter of 2023. Full year G&A expenses decreased by $3.1 million to $23.4 million in 2024, compared to $26.5 million in 2023. The decrease was primarily due to a decrease in legal and professional service expenses and non-cash stock-based compensation.
•Restructuring and impairment charges decreased by $4.7 million to $1.5 million in 2024, compared to $6.2 million in 2023. The decrease was primarily related to one-time severance-related costs made in 2023 and higher impairment costs recognized in 2023 than 2024 on the right-of-use asset for the vacated floor in the leased office facility and certain equipment no longer utilized.
•Net loss for the fourth quarter of 2024 was $20.2 million, or $2.77 per basic and diluted common share, compared to a net loss of $32.3 million, or $4.44 per basic and diluted common share, for the fourth quarter of 2023. Net loss for 2024 was $83.7 million, or $11.49 per basic and diluted common share, compared to a net loss of $101.9 million, or $14.04 per basic and diluted common share in 2023. The weighted-average shares used to compute net loss per basic and diluted common share have been retroactively adjusted to reflect the one-for-ten reverse stock split completed on October 29, 2024.
•Total shares of common stock outstanding was 7.3 million shares as of December 31, 2024, after taking into effect the one-for-ten reverse stock split completed on October 29, 2024.
Conference Call and Webcast
Kezar Life Sciences will host a webcast and conference call today, March 25, 2025, at 8:00 a.m. ET to discuss topline results from the PORTOLA Phase 2a clinical trial. To access the live audio webcast with slides and dial-in information as needed, please register here: View Source
A live webcast of the event can also be found on the Kezar website at View Source A replay of the event will be available for 90 days following the presentation.

On March 25, 2025 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company") reported that the Company has received a clinical trial notice approving the investigational new drug application for a radionuclide-drug conjugate (RDC) drug SKB107 (formerly TBM-001) from the Center for Drug Evaluation of the National Medical Products Administration (Press release, Kelun, MAR 25, 2025, View Source [SID1234651429]). SKB107 is the first company RDC drug clinical project.

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SKB107 is jointly developed by the Company and Professor Chen Yue’s team of the Affiliated Hospital of Southwest Medical University (the "Affiliated Hospital of SMU"). It utilizes a small molecule as the targeting ligand, combined with a suitable conjugation technology, chelator, and therapeutic radionuclide, and is intended to be used for treatment of bone metastases in solid tumors. Compared with traditional external radiation therapy, the RDC drug SKB107 can benefit patients with systemic multiple bone metastases and is highly targeted, which can reduce the damage to normal tissues, and is expected to show good safety; and compared with traditional bone-modifying drugs, it can effectively kill tumor cells with bone metastases, and is expected to have potential for the treatment of bone metastases efficacy. The Company entered into an exclusive license agreement with the Affiliated Hospital of SMU for a RDC drug SKB107 on Sept. 14, 2023.

About Bone Metastasis of Malignant Tumors

Bone is the most common site of metastasis in advanced malignant tumors, and about 70%~80% of patients with advanced malignant tumors will eventually develop bone metastasis. Among common tumors, prostate cancer, breast cancer, thyroid cancer, lung cancer and kidney cancer have a higher incidence of bone metastasis, accounting for more than 80% of all bone metastatic tumors[1]. Bone metastasis can lead to serious complications such as severe bone pain and bone-related events, such as pathologic fracture and spinal cord compression, which can seriously reduce patients’ quality of life and increase the risk of death. Currently, treatments for bone metastases of malignant tumors mainly include comprehensive treatments such as analgesic therapy, radiation therapy, bone-modifying drug therapy, and surgery. However, these treatments are still limited in improving patients’ quality of life, delaying or avoiding the occurrence of SREs, and prolonging patients’ survival, and the development of new mechanisms of action and safer and more effective drugs is imminent.

On March 25, 2025 NHS Lothian, Scotland’s second largest health authority providing a comprehensive range of primary, community-based and acute hospital services, and Nucleix, a liquid biopsy company revolutionizing cancer treatment by detecting the disease earlier, reported data from an abstract featuring Nucleix’s Bladder EpiCheck test presented at the 46th Annual European Association of Urology (EAU) Congress (Press release, Nucleix, MAR 25, 2025, View Source [SID1234651445]).

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The abstract titled "Bladder EpiCheck triggered Photodynamic Diagnosis biopsies detect High Grade recurrences missed by White Light Cystoscopy"i describes the implications of implementing the Bladder EpiCheck urine test as an adjunct to routine surveillance by white light cystoscopy in all high-risk non-muscle invasive bladder cancer (NMIBC) patients. In 316 patients undergoing surveillance from July 2023 until August 2024, 38 cancers were detected, of which 29 were high-grade and 13 were carcinoma in situ (CIS), an aggressive form of bladder cancer often missed by white light cystoscopy, that can progress to muscle-invasive cancer if left untreated. White light cystoscopy detected 17 (59%) of the high-grade cases and 4 (31%) of the CIS cases versus 28 (97%) and 12 (92%), respectively, detected by Bladder EpiCheck and confirmed by photodynamic diagnosis (PDD) biopsies. Specificity was 97% (261/270) for cystoscopy and 94% (253/270) for Bladder EpiCheck. Additionally, Bladder EpiCheck was able to detect 65% more high-grade disease recurrences compared to white light cystoscopy (28 vs. 17), by performing biopsy under PDD in patients with a negative white light cystoscopy and a positive Bladder EpiCheck result. Nine of the 16 (56%) patients that were missed by white light cystoscopy but detected with Bladder EpiCheck and PDD had CIS.

The abstract was presented by Professor Param Mariappan, Consultant Urological Surgeon at Western General Hospital, Edinburgh (NHS Lothian) and member of the European Non-Muscle Invasive Bladder Cancer (NMIBC) and Muscle Invasive Bladder Cancer (MIBC) Guidelines Committees. Professor Mariappan established the Edinburgh Bladder Cancer Surgery (EBCS) Effectiveness and Efficiency Programme (EBCS-EEP) in 2006 to improve the care of patients with bladder cancer by implementing evidence-based interventions in a systematic manner while using real-world data to inform outcomes and process. Adding Bladder EpiCheck to routine high-risk NMIBC surveillance is part of this ongoing project to improve early detection of high-grade disease recurrences.

"The ability of Bladder EpiCheck, a non-invasive urine test, to precisely identify the patients whose cancer is missed by cystoscopy, and refer them for additional workup, makes it a very effective tool for the NHS," said Professor Mariappan. "This allows us to detect and treat aggressive disease early, while containing budget and resources that are limited. Early detection allows us to treat such patients conservatively and potentially to improve patient outcome and avoid significant costs of late treatment, such as cystectomies."

"These data add an important new layer to the robust and constantly growing body of real-world evidence of Bladder EpiCheck performance and clinical utility in NMIBC monitoring," said Dr. Aharona Shuali, Vice President of Medical at Nucleix. "We are proud that leading centers, such as NHS Lothian, are choosing this test to enhance patient care."

These results are consistent with a recently published paper by Fleshner et al. in the journal Bladder Cancerii, that described a strong anticipatory positive signal for Bladder EpiCheck in NMIBC surveillance patients with a negative cystoscopy and cytology, showing a five times higher risk of recurrence in 12 months in patients who had a positive Bladder EpiCheck result versus a negative result.

On March 25, 2025 Promontory Therapeutics Inc., a clinical stage pharmaceutical company advancing immunogenic small molecule approaches in oncology, reported the company will present immuno-profiling data from two Phase 2 studies of PT-112 monotherapy at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, which will be held from April 25 – 30, 2025 at the McCormick Place Convention Center in Chicago, IL (Press release, Promontory Therapeutics, MAR 25, 2025, View Source [SID1234651471]).

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The poster will present immune activation effects observed with PT-112 monotherapy in patients with pretreated thymic epithelial tumors and late-line metastatic castration-resistant prostate cancer, including increases in activated T cells and NK cells, modulation of blood cytokines, and the emergence of novel T cell clones.

Poster Session Details

Title: Anti-Cancer Immune Effects of PT-112 Monotherapy Across Two Disease Indications
Location: Poster Section 28, McCormick Place Convention Center, Chicago, Illinois
Poster Board Number: C128
Published Abstract Number: 5819
Session: Immune Response to Therapies
Session date + time: 4/29/2025 2-5PM CDT