Artios Pharma Announces Details of Presentations at the American Association for Cancer Research (AACR) Annual Meeting 2025

On April 15, 2025 Artios Pharma Limited ("Artios"), a clinical-stage biotech company led by pioneers of DNA damage response ("DDR") drug development, reported that the company’s abstract featuring clinical trial results from its ongoing Phase 1/2a study of ART0380 in combination with low dose irinotecan has been selected for an oral presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) ("AACR") Annual Meeting 2025, taking place in Chicago from April 25 to 30, 2025 (Press release, Artios Pharma, APR 15, 2025, View Source [SID1234651932]). Artios will also present posters on preclinical data from its ART0380 and ART6043 programs.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Details of the oral presentation:

Abstract Title: First results of ART0380 (an ATR kinase inhibitor) with low dose irinotecan in advanced or metastatic tumors

Presenter: Susanna Ulahannan, MD, Associate Professor, Stephenson Cancer Center at the University of Oklahoma/SCRI, OK, USA

Date: Tuesday, April 29, 2025

Time: 3:50 pm – 4:00 pm CDT

Location: Room S406 (Vista Ballroom) – McCormick Place South (Level 4)

Details of the poster presentation on ART0380:

Abstract Title: Combination of the ATR inhibitor, ART0380, with irinotecan for treating ATM-negative tumors

Presenter: Helen M. R. Robinson, VP of Biology, Artios

Session: PO.ET06.02 – DNA Damage Response and Modulation of DNA Repair 1

Date Monday, April 28, 2025

Time: 2:00 pm – 5:00 pm CDT

Location: Section 16

The full poster abstract is available on the AACR (Free AACR Whitepaper) Annual Meeting website.

Details of the poster presentation on ART6043:

Abstract Title: DNA polymerase theta inhibitor, ART6043, potentiates the efficacy of 177Lu- and 225Ac-based radioligand therapies in vitro and in vivo

Presenter: Marco Ranzani, Associate Director, Artios

Session: PO.ET06.02 – DNA Damage Response and Modulation of DNA Repair 1

Date Monday, April 28, 2025

Time: 2:00 pm – 5:00 pm CDT

Location: Section 16

The full poster abstract is available on the AACR (Free AACR Whitepaper) Annual Meeting website.

Toragen, Inc. Provides Update on Phase 1 Clinical Trial of TGN-S11 as Monotherapy and in Combination with Keytruda® in Patients with Stage 4 HPV-Associated Cancers

On April 15, 2025 Toragen, Inc., a San Diego-based clinical-stage biotechnology company focused on developing uniquely selective drugs targeting cancers caused by viruses, reported positive safety data from its Phase 1 trial of TGN-S11, a small molecule inhibitor of the human papillomavirus (HPV) E5 oncogene protein, in patients with cancers associated with HPV (Press release, Toragen, APR 15, 2025, View Source [SID1234651951]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

This Phase 1 trial was an open-label, non-randomized study in multiple cohorts of patients with relapsed, resistant, or metastatic HPV-associated cancers. The study has been conducted in two parts: Part 1 was escalating doses of TGN-S11 as monotherapy and Part 2 was TGN-S11 in combination with Keytruda (pembrolizumab), a PD-1 checkpoint inhibitor. The dose escalation part consisted of four Cohorts of three to six patients on monotherapy with increasing doses of TGN-S11. The Keytruda combination part consisted of three Levels of three to six patients with increasing doses of TGN-S11 and the standard dose of Keytruda.

In Part 1, 18 patients were treated with TGN-S11 as monotherapy in 4 dose cohorts with no serious adverse events identified. In the 4th dose cohort, 2 patients developed non-serious dose-related toxicities; therefore, the maximum tolerated dose (MTD) was determined to be 300mg/day. One-third of the patients who received TGN-S11 monotherapy showed drug activity with decreases in tumor size and decreases in Tumor Tissue Modified Viral (TTMV) HPV DNA as measured by the NavDx test. In addition, 10 patients were treated in Part 2 in 3 dose levels evaluating TGN-S11 in combination with Keytruda with no safety issues. Half of these patients in this portion of the study showed drug activity with decreases in tumor size and/or decreases in TTMV-HPV DNA score. One of these patients had a 92% reduction in TTMV-HPV DNA score and 3 patients remain on treatment.

This Phase 1 trial met both primary endpoints of proving safety and reaching the maximum tolerated dose of TGN-S11. In addition, our data also shows that 53% of patients that reached at least 2 months of treatment showed drug activity.

Dr. Neil Clendeninn, CMO of Toragen, said, "TGN-S11 was well-tolerated as monotherapy and in combination with Keytruda and we are very excited to see evidence of activity based on the reduction in TTMV-HPV DNA score in this study in advanced cancer patients."

Based on these positive results, Toragen plans to proceed with the development of its second-generation inhibitor of the E5 oncogene protein, TGN-S15, which has demonstrated increased efficacy and decreased side effects in preclinical testing. TGN-S15 will advance to IND-enabling studies to support a first in human study in healthy volunteers and Phase 2 clinical trials targeting HPV-associated cancers.

InnoCare Announces the Acceptance of New Drug Application for pan-TRK Inhibitor Zurletrectinib in China

On April 15, 2025 InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, reported that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) accepted a New Drug Application (NDA) for its new generation pan-TRK inhibitor zurletrectinib (ICP-723) for the treatment of adult and adolescent patients (12 to 18 years old) with advanced solid tumors harboring NTRK gene fusions (Press release, InnoCare Pharma, APR 15, 2025, View Source [SID1234651952]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

In the registrational trial for adult and adolescent patients with NTRK fusion-positive solid tumors, zurletrectinib demonstrated outstanding efficacy with a good safety profile. Zurletrectinib was also shown to overcome acquired resistance to the first-generation TRK inhibitors.

Meanwhile, the Company is accelerating the registrational trial for pediatric patients (2 to 12 years old).

Dr. Jasmine Cui, the co-founder, chairwoman and CEO of InnoCare, said, "Zurletrectinib has demonstrated outstanding efficacy and safety profile in adult, adolescent, and pediatric patients with tumors harboring NTRK fusion genes, bringing better treatment options for patients with solid tumors. The Company is expanding the scope of its solid tumor pipelines through a combination of targeted therapies, immune-oncology approaches, and cutting-edge ADC technology, looking forward to meeting the unmet needs of patients with solid tumors early."

NTRK fusion genes occur in various types of adult and pediatric tumors. In some rare tumors, such as salivary gland carcinoma, secretory breast cancer, and infantile fibrosarcoma, the incidence of NTRK gene fusion exceeds 90%1. It is estimated that there are about 6,500 new cases of NTRK fusion-positive solid tumors are diagnosed, in China each year. There are highly unmet clinical needs in this area due to lack of effective treatment options.

SECuRE trial update: First patient treated in the Phase II Cohort Expansion

On April 15, 2025 Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for patients with cancer, reported the treatment of the first participant with their first dose of 8 GBq of 67Cu-SAR-bisPSMA in the Cohort Expansion Phase of the SECuRE trial (NCT04868604) (Press release, Clarity Pharmaceuticals, APR 15, 2025, View Source [SID1234651939]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The dosing of this participant follows the recent successful completion of the Dose Escalation Phase (Phase I) of the trial and subsequent SRC recommendation to progress to the Cohort Expansion Phase (Phase II) at the 8 GBq dose level, with an increase in the total number of cycles from up to 4 to up to 6. This recommendation is based on the favourable safety profile and efficacy of 67Cu-SAR-bisPSMA observed to date.

This participant will be receiving the combination of 8 GBq of 67Cu-SAR-bisPSMA and enzalutamide (ARPI), allowed by a recent protocol amendment. This amendment incorporated an increase in the number of participants in this cohort from 14 to 24, in which a subset of participants will receive this combination therapy. These changes are aligned with the positive results from the Enza-p trial3 and the ongoing discussions with and advice from key global medical experts in the field of prostate cancer, including the Company’s Clinical Advisory Board members, Prof Louise Emmett and Prof Oliver Sartor, as well as the SRC.

The recently amended SECuRE trial protocol will also focus on the evaluation of metastatic castration-resistant prostate cancer (mCRPC) participants in the pre-chemotherapy setting. This aligns with Clarity’s strategy of bringing 67Cu-SAR-bisPSMA to earlier stages of the disease and is based on its promising safety and efficacy data, especially in pre-chemotherapy participants treated in the SECuRE trial to date. In the Dose Escalation Phase, preliminary data showed that 92% of pre-chemotherapy participants (12/13) demonstrated prostate-specific antigen (PSA) drops greater than 35%, PSA reductions greater than 50% were reached in 61.5% (8/13) of participants, and reductions of 80% or more were achieved in 46.2% (6/13) of participants. These outstanding results were achieved despite many of the 13 pre-chemotherapy participants having considerable disease burden, being heavily pre-treated, and the majority of them only receiving a single dose of 67Cu-SAR-bisPSMA2.

In preparation for the Cohort Expansion Phase, Clarity rolled out its improved 67Cu-SAR-bisPSMA product formulation. The enhanced formulation allows for room temperature stability, supply and scalability, which are essential for late-stage clinical trials and streamlined commercial-scale manufacture.

Clarity’s Executive Chairperson, Dr Alan Taylor, commented, "We are incredibly excited about the progress we’ve achieved in the SECuRE trial to date and look forward to continuing to generate promising data in the Cohort Expansion Phase.

"With the latest protocol amendments ensuring that we are utilising the most recent advances and knowledge in the radiopharmaceutical space, we continue to be driven by the highest standards of clinical trial management and research. At Clarity, we are committed to working with various key opinion leaders in the field and incorporating the most recent findings into our study design to maximise the probability of clinical trial success and positive patient outcomes. As a result, we are focused on bringing 67Cu-SAR-bisPSMA to earlier lines of prostate cancer therapy, especially in the pre-chemotherapy setting, where we have seen very promising safety and efficacy to date. We are also investigating the benefits of combination therapy, where SECuRE participants are being treated with 67Cu-SAR-bisPSMA and enzalutamide based on the results from Prof Emmett’s Enza-p trial and in consultation with global thought leaders in the prostate cancer space.

"We are committed to continuously improving our product and took the opportunity to advance our 67Cu-SAR-bisPSMA formulation prior to dosing our first patients in the Cohort Expansion Phase of the trial. The improvements also help us prepare for the large-scale manufacture in a potential Phase III trial and during commercialisation, allowing for room temperature stability with considerable advantages for supply and scalability. The ability to manufacture 67Cu-SAR-bisPSMA under room temperature reduces the likelihood of batch failures which lead to common supply issues and subsequent product shipment delays. Through the improvements in formulation, we hope that no patient is left waiting for their 67Cu-SAR-bisPSMA treatments.

"We thank our community, our team, Principal Investigators, members of the SRC, and especially the participants who have contributed to the SECuRE study so far. Armed with favourable safety and efficacy data from the Dose Escalation cohorts and with 3 US Food and Drug Administration (FDA) Fast Track Designations for the SAR-bisPSMA molecule, 1 for therapy and 2 for diagnostics, we are closer than ever to delivering on our ultimate goal of improving treatment outcomes for people with cancer."

About the SECuRE trial
The SECuRE trial (NCT04868604)1 is a Phase I/IIa theranostic trial for identification and treatment of participants with PSMA-expressing mCRPC using 64Cu/67Cu-SAR-bisPSMA. 64Cu-SAR-bisPSMA is used to visualise PSMA-expressing lesions and select candidates for subsequent 67Cu-SAR-bisPSMA therapy. The trial is a multi-centre, single arm, dose escalation study with a cohort expansion involving approximately 54 participants in the US and Australia. The overall aim of the trial is to determine the safety and efficacy of 67Cu-SAR-bisPSMA for the treatment of prostate cancer.

About SAR-bisPSMA
SAR-bisPSMA derives its name from the word "bis", which reflects a novel approach of connecting two PSMA-targeting agents to Clarity’s proprietary sarcophagine (SAR) technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-bisPSMA is a Targeted Copper Theranostic (TCT) that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu) for therapy.

Avistone Announces Preclinical Results for ANS03, a Novel Type II ROS1/NTRK Inhibitor in Overcoming Clinically Relevant ROS1/NTRK Resistance Mutations at AACR Annual Meeting 2025

On April 15, 2025 Avistone Biotechnology Co., Ltd ("Avistone"), an innovative biotechnology company focused on precision oncology therapeutics, reported that the preclinical data for ANS03, its novel, orally bioavailable Type II ROS1/NTRK tyrosine kinase inhibitor (TKI), will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025 (Press release, Avistone Pharmaceuticals, APR 15, 2025, View Source [SID1234651953]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The details of the poster presentation are provided below:

Poster title: ANS03, a novel, orally bioavailable small-molecule type II ROS1/NTRK inhibitor, effectively overcomes clinically relevant ROS1/NTRK resistance mutations and exhibits potent antitumor activity in preclinical tumor models
Abstract Number: 828
Session: Targeted Therapies and Combinations 1 (Clinical Research)
Location: Poster section 34, Board 16
Session Date/Time: April 27, 2025 | 2:00-5:00 PM CDT

The battle against ROS1 and NTRK fusion-positive cancers has seen major advances with next-generation tyrosine kinase inhibitors (TKIs) like repotrectinib, taletrectinib, which effectively suppress the recurrent resistance mutations such as G2032R (ROS1 SF mutation). However, the emergence of new resistance mechanisms, such as ROS1 L2086F (Cβ6) mutation, presents a growing clinical challenge and unmet need.

Non-clinical studies of ANS03 showed it was a potent, orally bioavailable Type II ROS1/NTRK inhibitor with remarkable activity against various pathogenetic ROS1/NTRK alterations (including ROS1: G2032R, D2033N, L2086F; NTRK: G667C, G595R-G667C) and with favorable absorption, distribution, pharmacokinetics, efficacy, and tolerability profiles.

"These findings suggest ANS03 could become the preferred therapeutic option for patients developing resistance to current ROS1/NTRK inhibitors," said Dr. Hepeng Shi, CEO of Avistone. "Its distinct Type II binding mode provides comprehensive coverage of clinically-relevant mutations while maintaining good CNS activity, which offers the potential to be explored as frontline therapy."

ANS03 is currently being evaluated in a global phase I study (NCT06716138) in adult patients with locally advanced or metastatic solid tumors harboring with ROS1 alterations, and in adult and pediatric patients (aged≥12 years) with NTRK alterations.