On January 27, 2025 RenovoRx, Inc. ("RenovoRx" or the "Company") (Nasdaq: RNXT), a life sciences company developing novel targeted oncology therapies and commercializing RenovoCath, a novel, FDA-cleared delivery platform, reported an abstract presentation highlighting promising pharmacokinetic (known as PK) data from the use of RenovoRx’s patented Trans-Arterial Micro-Perfusion (TAMP) therapy platform in treating locally advanced pancreatic cancer (LAPC) (Press release, Renovorx, JAN 27, 2025, View Source [SID1234649899]).

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The abstract was presented at the ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO GI) 2025, by Paula Novelli, MD, University of Pittsburgh Medical Center, which is currently underway in San Francisco, CA.

Dr. Novelli, together with her co-authors, presented "Intra-arterial Gemcitabine Versus Intravenous Gemcitabine: Pharmacokinetic Sub-study of the TIGeR-PaC Phase 3 Clinical Trial," a sub-study of RenovoRx’s ongoing pivotal Phase III TIGeR-PaC clinical trial in LAPC. In this sub-study, PK analyses were performed on a sample of participants across TIGeR-PaC study clinical sites. These analyses compared treatment with intra-arterial gemcitabine (IAG), using the RenovoCath delivery system via TAMP, versus systemic intravenous gemcitabine, which is the current standard of care for patients with LAPC.

Results of the sub-study showed RenovoRx’s IAG approach to drug delivery via TAMP decreased systemic levels of gemcitabine versus standard of care. In addition to providing increased local drug potency, the IAG approach may also be beneficial to decreasing gemcitabine-related systemic side effects. TAMP is designed to ensure precise therapeutic delivery across the arterial wall near the tumor site to bathe the target tumor, while potentially minimizing a therapy’s toxicities versus systemic intravenous therapy.

"Pancreatic cancer remains one of the most challenging cancers to treat, and this new data further highlights the potential of RenovoRx’s TAMP therapy platform as a transformative therapeutic option," said Paula Novelli MD, TIGeR-PaC Principal Investigator at University of Pittsburgh Medical Center. "TAMP is intended to direct a drug and more effectively target the tumor while minimizing systemic impact, and this sub-study shows that despite delivering more gemcitabine in a shorter time, the total systemic drug exposure was significantly lower compared to intravenous treatment. This data further demonstrates that TAMP has the potential to deliver gemcitabine to the tumor more efficiently, enhancing local treatment effectiveness while reducing the broader impact on the body, ultimately minimizing the systemic side effects of chemotherapy."

About the TIGeR-PaC Clinical Trial

TIGeR-PaC is an ongoing Phase III randomized multi-center study evaluating the proprietary TAMP (Trans-Arterial Micro-Perfusion) therapy platform for the treatment of locally advanced pancreatic cancer (LAPC.) RenovoRx’s first product candidate using the TAMP technology, is a novel investigational oncology drug-device combination utilizing RenovoRx’s FDA-cleared RenovoCath device for the intra-arterial administration of chemotherapy, gemcitabine.

The first interim analysis in the Phase III clinical trial was completed in March 2023, with the Data Monitoring Committee recommending a continuation of the study. The study’s primary endpoint is an Overall Survival benefit with secondary endpoints including reduced side effects versus standard of care. The second interim analysis for this study will be triggered by the 52nd event (i.e., patient death), which is estimated to occur in early 2025. The second interim data readout is anticipated to occur by the end of the first half of 2025, with the timing for such readout, however, being dependent on customary factors such as time needed for analysis. RenovoRx is also aiming to complete patient enrollment in the TIGeR-PaC study in the first half of 2025.

About RenovoCath

Based on its FDA clearance, RenovoCath is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to selected sites in the peripheral vascular system. RenovoCath is also indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. For further information regarding our RenovoCath Instructions for Use ("IFU"), please see: IFU-10004-Rev.-F-Universal-IFU.pdf.

On January 27, 2025 Sapience Therapeutics, Inc., a clinical-stage biotechnology company focused on the discovery and development of peptide therapeutics to address oncogenic and immune dysregulation that drive cancer, reported that it presented Phase 1 safety and biomarker data on ST316, a novel peptide antagonist of β-catenin, during a poster session at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal (GI) Cancers Symposium (Press release, Sapience Therapeutics, JAN 27, 2025, View Source [SID1234649898]).

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ST316 is a first-in-class antagonist of β-catenin and its co-activator, BCL9, that is designed to selectively shut down the Wnt/β-catenin signaling pathway. The Phase 1 Dose Escalation study enrolled patients with advanced solid tumors likely to harbor abnormalities in the Wnt/β-catenin pathway to assess the safety, pharmacokinetics (PK), biomarker and preliminary activity of ST316, and to recommend a Phase 2 dose.

"With signals of anti-tumor activity, strong pharmacodynamic data, and a clean safety profile, we are pleased that the ST316 Phase 1 Dose Escalation study demonstrated clinical proof-of-concept as a single agent, in a patient population in which single agent response is limited," commented Dr. Abi Vainstein-Haras, Sapience’s Chief Medical Officer. "ST316’s tolerability as a single agent, together with the biomarker data from its Phase 1 study, are encouraging for its continued development in our ongoing Phase 2 Dose Expansion study, which is evaluating ST316 across multiple combinations and lines of treatment in colorectal cancer (CRC)."

Summary of Phase 1 Dose Escalation Results:

ST316 disrupts the interaction of β-catenin with BCL9 to result in Wnt/β-catenin pathway inhibition.
ST316 was shown to be safe and well tolerated at all doses tested.
The prolonged stable disease noted with single agent ST316 is consistent with early signals of anti-tumor activity.
ST316 demonstrates tumor uptake and target engagement, as shown by a shift in the localization of β-catenin from nucleus to cytoplasm/membrane following treatment in 4 of 7 patients assessed.
ST316 significantly reduced the expression of immunosuppressive polymorphonuclear myeloid-derived suppressor cells (PMN-MDSCs) in all Phase I patients that displayed elevated baseline levels (n=7).
Based on the safety and pharmacodynamic effects that are consistent with the mechanism of action, ST316 is now being tested in combination with chemotherapy in advanced colorectal cancer patients across different lines of treatment.
Poster Presentation:

Title: "Safety and biomarker assessment of ST316, a novel peptide antagonist of ß-catenin, in patients with advanced solid tumors"
Session: Poster Session C: Cancers of the Colon, Rectum and Anus
Date/Time: Saturday, January 25, 2025, 7:00 am to 7:55 am PST
Abstract Number: 286
Presenting Author: Anthony El-Khoueiry, MD

More information can be found on the ASCO (Free ASCO Whitepaper) GI website.

About ST316
ST316 is a first-in-class antagonist of the interaction between β-catenin and its co-activator, BCL9, a complex responsible for driving oncogene expression and immune exclusion in multiple cancers where aberrant Wnt/β-catenin pathway signaling is observed. ST316 exposure in cancer cells prevents BCL9-driven nuclear localization of β-catenin and inhibits formation of the Wnt enhanceosome protein complex. Disruption of this interaction selectively suppresses the transcription of oncogenic Wnt target genes that regulate proliferation, migration, invasion and the metastatic potential of tumor cells, as well as genes that regulate the immunosuppression of the tumor microenvironment. ST316 creates a pro-immune tumor microenvironment and in preclinical models has shown to be synergistic with checkpoint inhibition. Due to its selectivity and downstream modulation of the Wnt/β-catenin pathway, ST316 presents an opportunity to safely and effectively target Wnt/β-catenin driven pathologies without the toxicities previously seen with other Wnt pathway agents.

ST316-101 (NCT05848739) is a first-in-human, open-label, Phase 1-2 Dose Escalation and Expansion study designed to determine the safety, tolerability, PK, PD and early efficacy of ST316. The Phase 1 Dose Escalation portion of the study tested various dose levels of ST316 in patients with select advanced solid tumors that are known to harbor abnormalities of the Wnt/β-catenin signaling pathway, including CRC. ST316 is currently being tested in the Phase 2 portion of the study in CRC patients in combination with relevant standards of care and in multiple lines of treatment. The U.S. FDA has granted Orphan Drug Designation to ST316 for the treatment of familial adenomatous polyposis (FAP).

On January 27, 2025 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported its participation in the upcoming investor relations events (Press release, Ideaya Biosciences, JAN 27, 2025, View Source [SID1234649897]).

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Oppenheimer 35th Annual Healthcare Life Sciences Conference
Tuesday, February 11th, 2025 at 1:20 PM ET

Fireside chat with Yujiro S. Hata, President and Chief Executive Officer, hosted by Matthew Biegler, Executive Director and Senior Analyst

Citi’s 2025 Virtual Oncology Leadership Summit
Wednesday, February 19th, 2025 at 12:00 PM ET

Fireside chat with Yujiro S. Hata, President and Chief Executive Officer, hosted by Yigal D. Nochomovitz, Ph.D., Director, SMid Cap Biotech Analyst

A live audio webcast of the conference event, as permitted by the conference host, will be available under the "Investors/Events" section of the IDEAYA website at View Source and/or through the conference host. A replay of the webcast will be accessible for 30 days following the live event.

On January 27, 2025 Cambium Oncology reported that their lead drug candidate, ANT308, recently demonstrated outstanding single-agent efficacy and safety in preclinical studies (Press release, Cambium Oncology, JAN 27, 2025, View Source [SID1234649896]). The drug is mutation-agnostic, and the company observes no toxicity-limiting dosages. In addition to their Fast-Track SBIR NIH grant recently being funded for $2.4M, they have received a significant investment from OEP Innovations of Taiwan.

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ANT308 is a FIRST-IN-CLASS immunotherapeutic with broad therapeutic potential across hematologic malignancies and solid tumors with the potential to enhance response rates in cancers that are resistant to other treatments. The intellectual property portfolio is expansive and solid. We have no debt.

MULTIPLE PROOFS-OF-CONCEPT: Leukemia and Pancreatic Cancers
(1)Leukemia
ANT308 has shown strong single-agent anti-leukemia activity in 2 mouse models.
(2) Pancreatic cancer
ANT308 has shown synergistic effects with anti-PD-1 checkpoint inhibitors in 3 pancreatic cancer models.

ANT308 is a proprietary small-molecule antagonist that blocks VIP-receptor signaling on human T cells, overcoming immune suppression in the tumor microenvironment.

On January 27, 2025 Triumvira Immunologics, a clinical-stage company developing novel, targeted autologous and allogeneic T cell therapeutics that co-opt the natural biology of T cells to treat patients with solid tumors, reported an abstract at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium, which was held in San Francisco, California, from January 23-25, 2025 (Press release, Triumvira Immunologics, JAN 27, 2025, View Source [SID1234649895]). The company showcased updated clinical data from its ongoing Phase I/II TACTIC-3 study investigating the safety and efficacy of autologous TAC-T cells in subjects with Claudin 18.2+ advanced solid tumors (TACTIC-3 /NCT05862324).

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The poster presentation, titled "A Phase 1/2 Study Evaluating the Safety and Efficacy of Autologous TAC-T Cells in Subjects with Claudin 18.2+ Advanced Solid Tumors", provided an in-depth look at interim results from the Phase I study. Key highlights included:

Patient Demographics and Characteristics: The study included subjects with multiple types of Claudin 18.2 positive advanced solid tumors, such as pancreatic, gastric, and esophageal cancers. .
Safety Data: TAC01-CLDN18.2 demonstrated a favorable safety and tolerability profile. Two grade 3 events, gastritis and gastric hemorrhage, were observed in the same dose-level 3 (DL3) patient, and resolved within 4 days with supportive care. One Grade 1 immune-effector cell-associated neurotoxicity (ICAN) event resolved within 24 hours without intervention. Low-grade cytokine release syndrome (CRS) events were resolved with standard treatment.
Preliminary Efficacy: Early clinical activity was observed, with a confirmed, ongoing partial response in a dose-level 1 (DL1) subject with stage IV pancreatic cancer, and an unconfirmed partial response in a heavily pretreated subject with esophageal adenocarcinoma (DL3). The disease control rate (DCR) was 70%, with an objective response rate (ORR) of 20% in a patient population that was not restricted based Claudin 18.2 expression levels, tumor burden, or location of metastatic disease.
The TAC technology platform, exemplified by TAC01-CLDN18.2, reprograms T cells to co-opt the natural T cell receptor (TCR) signaling complex, providing precise tumor targeting and reduced systemic toxicity compared to conventional engineered T cell therapies.