On June 26, 2025 The Australasian Gastro-Intestinal Trials Group ("AGITG"), the NHMRC Clinical Trials Centre at the University of Sydney, and Lisata Therapeutics, Inc ("Lisata", Nasdaq: LSTA), reported promising positive preliminary Cohort B data from the ASCEND Phase 2b trial (NCT05042128) in metastatic pancreatic cancer, with AGITG sponsoring the study and Lisata providing funding (Press release, Lisata Therapeutics, JUN 26, 2025, View Source [SID1234654134]). Dr. Andrew Dean, Study Chair, is scheduled to present these findings at the European Society for Medical Oncology ("ESMO") Gastrointestinal Cancers Congress in Barcelona, Spain, on 2 July, 2025.

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The ASCEND trial is a 158-patient, double-blind, randomized, placebo-controlled Phase 2b clinical trial evaluating standard-of-care ("SoC") gemcitabine and nab-paclitaxel vs SoC plus certepetide or placebo in patients with metastatic pancreatic ductal adenocarcinoma ("mPDAC"). Participants were enrolled from 24 sites across Australia and Aotearoa New Zealand from May 2022 to December 2023. The study comprises two sequentially enrolled dosing regimens of either certepetide or placebo in combination with SoC. Cohort A employed one 3.2 mg/kg dose of certepetide administered as an IV push over 1 minute immediately after the infusion of gemcitabine and before the infusion of nab-paclitaxel. Cohort B mimicked the dosing regimen of Cohort A; however, it employed an additional dose of certepetide or placebo administered 4 hours after the initial dose.

As announced in January of this year, preliminary Cohort A data was presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium. Those data showed a positive trend in overall survival, including four complete responses in the certepetide-treated group compared to none in the placebo-treated group.

The preliminary data from Cohort B demonstrate a six-month progression-free survival ("6MPFS") of 60.8% for the certepetide-treated group, whereas the 6MPFS in the placebo-treated group was 25%. Median progression-free survival ("mPFS") was 7.5 months for the certepetide-treated group and 4.7 months for the placebo-treated group. Objective response rate ("ORR") was 45.2% for the certepetide-treated group and 19% for the placebo-treated group. Median overall survival ("mOS") was 10.32 months for the certepetide-treated group compared to 9.23 months for the placebo-treated group.

A comparison of data from Cohort A and Cohort B indicates that the addition of two doses of certepetide (Cohort B regimen) to SoC chemotherapy resulted in a clinically meaningful improvement in both PFS and ORR for patients with mPDAC. These clinically significant findings provide compelling support for the continued and expedited investigation of certepetide as a novel therapeutic agent for the treatment of metastatic pancreatic cancer.

Final data and key findings from both cohorts of the ASCEND study are anticipated to be available later this year, with more information to follow as it becomes available.

"We are pleased with the promising Cohort B data of the ASCEND trial. These data, taken with those previously reported for Cohort A, reinforce our confidence in the therapeutic promise of certepetide. Along with its attractive safety profile, we continue to believe that certepetide has the potential to transform the treatment landscape for mPDAC and many other devastating solid tumors", stated David J. Mazzo, PhD, President and Chief Executive Officer of Lisata.

Pancreatic cancer has one of the poorest prognoses among cancers, ranking as the 6th leading cause of cancer mortality worldwide1. In Australia, pancreatic cancer is the 3rd leading cause of cancer-related deaths2. With a five-year survival rate of just 13%, there is a considerable need for new treatment options.

Dr. Dean commented, "The data from ASCEND provides us with critical new knowledge that will significantly enhance our understanding of how to optimally treat patients battling pancreatic cancer. We are excited by the evidence of certepetide’s therapeutic effect and encourage the continued development of this potentially treatment paradigm-changing compound."

We thank the Gut Cancer Foundation for providing funding for trial sites in Aotearoa New Zealand.

1. Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024;74(3):229–63.
2. Australian Institute of Health and Welfare (2024) Cancer data in Australia, AIHW, Australian Government, accessed 13 May 2025.

About Certepetide
Certepetide (formerly LSTA1), an internalizing RGD (arginylglycylaspartic acid or iRGD), cyclic peptide product candidate, is an investigational drug designed to activate a novel uptake pathway that allows co-administered or tethered anti-cancer drugs to target and penetrate solid tumors more effectively. Certepetide actuates this active transport system in a tumor-specific manner, resulting in systemically co-administered anti-cancer drugs more efficiently penetrating and accumulating in the tumor. Certepetide also has been shown to modify the tumor microenvironment resulting in tumors which are more susceptible to immunotherapies. We and our collaborators have amassed significant non-clinical data demonstrating enhanced delivery of a range of emerging anti-cancer therapies, including immunotherapies and RNA-based therapeutics. To date, certepetide has also demonstrated favorable safety, tolerability, and clinical activity in completed and ongoing clinical trials designed to test its ability to enhance the effectiveness of standard-of-care chemotherapy for pancreatic cancer. Lisata is exploring the potential of certepetide to enable a variety of treatment modalities to treat a range of solid tumors more effectively. Certepetide has been awarded Fast Track designation (U.S.) and Orphan Drug Designation for pancreatic cancer (U.S. and E.U.) as well as Orphan Drug Designation for glioma (U.S.) and osteosarcoma (U.S.). Additionally, certepetide has received Rare Pediatric Disease Designation for osteosarcoma (U.S.).

On June 26, 2025 bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on cancer diagnostics and targeted therapeutics, reported it will present findings related to the discovery of a potential broad-spectrum cancer therapy that is the subject of the Company’s recently issued U.S. Patent No. 12,305,171 and the notification of patent grant from the China National Intellectual Property Administration (Press release, BioAffinity Technologies, JUN 26, 2025, View Source [SID1234654150]).

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The presentation at the 2025 RNA Therapeutics Conference, titled "Silencing CD320 and LRP2 by siRNAs selectively kills cancer cells: mechanistic enigmas," highlights a novel therapeutic approach that uses small interfering RNAs (siRNAs) to selectively kill cancer cells by targeting two specific cell surface receptors, CD320 and LRP2. The data demonstrates that dual suppression of these proteins is highly effective in killing cancer cells while sparing normal cells, offering promising potential for the development of new RNA-based therapies. Research is underway to develop a topical treatment for cutaneous malignancies and neoplasms of the skin.

RNA-based cancer therapeutics represent one of the fastest-growing segments within oncology, driven by the urgent need for more targeted and effective treatments. bioAffinity’s approach, utilizing siRNAs to selectively silence cell surface proteins, holds substantial commercial promise due to its broad-spectrum effectiveness demonstrated across multiple tumor types including lung, breast, prostate, brain, and skin cancers. The potential to develop targeted therapies that could significantly enhance patient outcomes positions the Company favorably within this rapidly expanding market.

David Elzi, PhD, Vice President of Product Development, will present the research on behalf of fellow authors, William Bauta, PhD, Chief Science Officer, and Staff Scientist Reggie Jacob, MS.

"Our studies show that silencing the cell surface receptors CD320 and LRP2 using siRNAs selectively kills or halts the growth of cancer cells while leaving normal cells unaffected," Dr. Elzi said. "This effect was observed across multiple cancer types, regardless of mutation status."

"We’re proud to share this research with the scientific, academic and industry leaders who attend the leading conference on RNA innovation," bioAffinity President and CEO Maria Zannes said. "This work reflects our commitment to developing novel, highly selective treatments in the battle against cancer."

The RNA Therapeutics Institute at the University of Massachusetts (UMass) T.H. Chan Medical School in Worcester, MA, leverages RNA biology and clinical research to develop new therapeutics for multiple diseases based on the fundamental mechanisms of cellular RNAs.

On June 26, 2025 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it has filed a regulatory application with the Ministry of Health, Labour and Welfare (MHLW) for an additional indication of its anti-cancer agent/ALK inhibitor Alecensa (generic name: alectinib) for ALK fusion / rearrangement gene-positive unresectable advanced or recurrent solid tumors, including pediatric patients (Press release, Chugai, JUN 26, 2025, View Source [SID1234654135]).

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"I am very pleased that Alecensa has reached the regulatory application stage as a tumor-agnostic treatment for ALK fusion / rearrangement gene-positive solid tumors. This application represents an important step in expanding the treatment potential of Alecensa beyond non-small cell lung cancer and anaplastic large cell lymphoma, a hematological malignancy, for which it has already been approved, to various solid tumors with ALK fusion / rearrangement genes. We will work toward obtaining approval to deliver Alecensa as a new treatment option to patients with various cancer types as quickly as possible." said Chugai’s President and CEO, Dr. Osamu Okuda.

The application for this additional indication is based on the results of the TACKLE study, an investigator initiated Japanese Phase II clinical study evaluating the efficacy and safety of Alecensa in pediatric and adult patients with rare cancers harboring ALK gene abnormalities (fusion / rearrangement genes, activating mutations, and gene copy number amplification) in unresectable advanced or recurrent settings. In this study, the objective response rate as assessed by the central review committee, which was the primary endpoint, was 76.5% (95% CI: 50.1%-93.2%) (13/17 patients) in the ALK fusion / rearrangement gene-positive subpopulation. The incidence of adverse events was 73.1% (19/26 patients), with the main adverse reactions being lymphocyte count decreased, and neutrophil count decreased at 23.1% each (6/26 patients), anemia at 19.2% (5/26 patients), and blood creatinine increased at 15.4% (4/26 patients). The safety profile observed in this study was similar to the previously established safety profile of Alecensa, with no new safety signals identified.

Chugai Pharmaceutical, a leading company in the oncology field, remains committed to addressing unmet medical needs in cancer treatment with innovative medicines for patients and healthcare professionals.

About the TACKLE study

The TACKLE study (NCCH1712/MK003, jRCT2091220364) is an investigator initiated, multicenter, open-label, single-arm, Japanese Phase II clinical study evaluating the efficacy and safety of Alecensa in pediatric and adult patients with unresectable rare cancers harboring ALK gene abnormalities (fusion / rearrangement genes, activating mutations, gene copy number amplification). In this study, safety and efficacy were evaluated in 26 patients. The primary endpoint was objective response rate, and secondary endpoints included progression-free survival, overall survival, and safety. The TACKLE study is being conducted as a substudy of the MASTER KEY project,1 which promotes the development of treatments for rare cancers through industry-academia collaboration with the National Cancer Center Hospital.

About ALK fusion / rearrangement gene-positive solid tumors
ALK fusion / rearrangement genes are abnormal genes created when the ALK (anaplastic lymphoma kinase) gene fuses with other genes (such as EML4, NPM) as a result of chromosomal translocation.2,3 ALK fusion / rearrangement proteins produced from these fusion / rearrangement genes are thought to promote cancer cell proliferation. ALK fusion / rearrangement genes have been identified in patients with inflammatory myofibroblastic tumors, lung cancer, breast cancer, colorectal cancer, and other cancers.2,4,5

About Alecensa
Alecensa is a highly selective, central nervous system-active, oral medicine created at Chugai Pharmaceutical Co., Ltd. for people with non-small cell lung cancer (NSCLC) whose tumors are identified as anaplastic lymphoma kinase (ALK) positive. ALK fusion / rearrangement gene-positive lung cancer is found in approximately 3-5% of NSCLC cases.4 Alecensa is already approved in over 100 countries as an initial (first-line) and second-line treatment for ALK fusion / rearrangement gene-positive metastatic NSCLC, including in the United States, Europe, Japan, China, and Taiwan. For adjuvant therapy of ALK fusion / rearrangement gene-positive NSCLC, Alecensa received approval in the United States in April 2024, followed by Europe in June 2024, and Japan in August 2024. In Japan, Alecensa has also been approved for the treatment of recurrent or refractory ALK fusion / rearrangement gene-positive anaplastic large cell lymphoma.

On June 26, 2025 I-Mab (NASDAQ: IMAB) (the "Company"), a U.S.-based, global biotech company, focused on the development of precision immuno-oncology agents for the treatment of cancer, reported publication of ESMO (Free ESMO Whitepaper) Gastrointestinal Cancers Congress 2025 (ESMO GI 2025) abstract #388MO related to positive data from a Phase 1b study evaluating givastomig in combination with nivolumab and mFOLFOX6 chemotherapy for metastatic gastric cancers. An objective response rate (ORR) of 71% (12/17) was observed across all dose levels with an ORR of 83% (10/12) observed at dose levels selected for the ongoing dose expansion study (8 and 12 mg/kg) (Press release, I-Mab Biopharma, JUN 26, 2025, View Source [SID1234654136]). Responses were rapid and deepened over time, and were observed in tumors with low levels of PD-L1 expression and/or low levels of Claudin 18.2 (CLDN18.2) expression. There was a favorable safety profile, with low incidence of GI and liver toxicities. I-Mab intends to host a virtual investor event on Tuesday, July 8th (register here) to recap the data being presented at ESMO (Free ESMO Whitepaper) GI.

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The abstract is based on the results of the dose escalation part of a Phase 1b study (NCT04900818) evaluating the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of givastomig used in combination with nivolumab and mFOLFOX6 as first line therapy (1L) in patients with Claudin 18.2-positive gastric cancers (≥1+ intensity in ≥1% of cells). The primary endpoint is safety. The study only enrolled patients in the U.S.

"We are excited to share positive initial data from the Phase 1b dose escalation study of givastomig in gastric cancers at ESMO (Free ESMO Whitepaper) GI 2025. Givastomig shows promising activity in the first line setting, with responses that are both rapid onset and durable, deepening over time. This is the first study to evaluate givastomig in combination with immunochemotherapy and we are very pleased by the overall tolerability, consistent pharmacokinetic data and soluble 4-1BB induction. We look forward to sharing the data with the oncology and investment communities at ESMO (Free ESMO Whitepaper) GI 2025 on July 2nd," said Phillip Dennis, MD, PhD, Chief Medical Officer of I-Mab.

"Givastomig’s strong response data and favorable safety profile are encouraging. I look forward to presenting the data for this novel Claudin 18.2 targeted therapy next week at ESMO (Free ESMO Whitepaper) GI and discussing with colleagues," said Samuel J Klempner, MD, Associate Professor of Medicine at Massachusetts General Hospital. "Gastroesophageal cancers continue to be a significant unmet medical need, and novel combination approaches are critical. On behalf of the study team, I am enthusiastic to continue to support the givastomig clinical program."

ESMO GI Presentation Details:

Title: Preliminary Safety and Efficacy of Givastomig, a Novel Claudin 18.2/4-1BB Bispecific Antibody, in Combination with Nivolumab and mFOLFOX in Metastatic Gastroesophageal Carcinoma (mGEC)

Speaker: Samuel J. Klempner, MD, Associate Professor of Medicine, Massachusetts General Hospital

Presentation Number: 388MO

Date and Time: Wednesday, July 2nd at 16:50 CEST (10:50am EST)

Givastomig Phase 1b Dose Escalation Data Summary in 1L Gastric Cancers

•
17 advanced metastatic gastric cancer patients were treated with givastomig across the 5 mg/kg (n=5), 8 mg/kg (n=6), and 12 mg/kg (n=6) dose levels as of the February 28, 2025, data cutoff. All patients were efficacy evaluable

Patient Characteristics:

•
The 17 patients enrolled in the study were treatment naïve metastatic gastric, esophageal or gastroesophageal adenocarcinomas
•
Patients were HER2-negative, Claudin 18.2-positive (defined as >1+ intensity in >1% of tumor cells) regardless of PD-L1 expression levels
•
All patients were enrolled at sites within the United States

Efficacy Results:

•
Objective Response Rates (ORRs):
o
71% of patients (12/17) achieved a partial response (PR) per RECIST v1.1
▪
5 mg/kg (2/5)
▪
8 mg/kg (5/6)
▪
12 mg/kg (5/6), with one unconfirmed response as of the data cutoff
o
At the doses selected for dose expansion (8 and 12 mg/kg), 83% (10/12) of patients achieved PRs
o
80% of patients (4/5) with CLDN18.2 expression below 75% (CLDN-Low) achieved a PR. The CLDN-Low response rate increased to 100% of patients (3/3) in the doses selected for expansion (8 and 12 mg/kg)
•
The disease control rate (DCR) was 100% across the three dose levels
•
Dose-dependent PK was observed, similar to monotherapy PK.
•
Patients also experienced a dose dependent induction of soluble 4-1BB, a positive indicator of T cell activation and engagement

ORR: % (n)

All

(n=17)

Cohorts Chosen for expansion

(8 and 12 mg/kg)

(n=12)

PD-L1

Any

71 (12/17)

83 (10/12)

≥5

82 (9/11)

89 (8/9)

<5

50 (3/6)

67 (2/3)

≥1

73 (11/15)

82 (9/11)

<1

50 (1/2)

100 (1/1)

CLDN18.2

≥75

67 (8/12)

78 (7/9)

<75

80 (4/5)

100 (3/3)

Durability:

•
8 of 17 patients remained on study treatment and the longest treatment duration was 11.3 months as of the data cutoff

Safety:

•
No dose limiting toxicities (DLT) were observed and a maximum tolerated dose (MTD) was not reached
•
Common treatment related adverse events (TRAEs, ≥10% of patients) were generally Grade 1 or Grade 2 including nausea, vomiting, infusion related reaction, fatigue, decreased appetite, diarrhea, abdominal pain, chills, dyspepsia and gastritis
•
Grade 3 TRAEs attributed to givastomig were rare, with single cases of abdominal pain, ALT/AST increases, gastritis, and infusion related reaction
•
No Grade 4 or Grade 5 TRAEs were reported

Virtual Investor Event:

Register for the Post-ESMO GI 2025 Investor Event here. A replay of the webinar will be accessible on the News & Events page of the I-Mab website for 90 days.

About Givastomig

Givastomig (TJ033721 / ABL111) is a bispecific antibody targeting Claudin 18.2 (CLDN18.2)-positive tumor cells. It conditionally activates T cells through the 4-1BB signaling pathway in the tumor microenvironment where CLDN18.2 is expressed. Givastomig is being developed for first line (1L) metastatic gastric cancers, with further potential in other solid tumors. In Phase 1 trials, givastomig has shown promising anti-tumor activity attributable to a potential synergistic effect of proximal interaction between CLDN18.2 on tumor cells and 4-1BB on T cells in the tumor microenvironment, while minimizing toxicities commonly seen with other 4-1BB agents.

An ongoing Phase 1b study is evaluating givastomig for the treatment of gastric cancer in the 1L setting in combination with standard of care, nivolumab (an anti-PD-1 checkpoint inhibitor) plus chemotherapy, in dose escalation and dose expansion cohorts. Dose escalation is complete, and enrollment in the first dose expansion cohort (n=20) finished ahead of schedule. Enrollment continues to progress ahead of schedule in the second dose expansion cohort (n=20). The study builds on positive Phase 1 monotherapy data.

Givastomig is being jointly developed through a global partnership with ABL Bio, in which I-Mab is the lead party and shares worldwide rights, excluding Greater China and South Korea, equally with ABL Bio.

On June 26, 2025 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, and Nusano, a physics company transforming the production of radioisotopes, reported the signing of a multi-year supply agreement in which Nusano will provide Cellectar with iodine-125 (I-125) and actinium-225 (Ac-225) for its clinical studies and future commercial needs (Press release, Nusano, JUN 26, 2025, View Source [SID1234654137]).

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"Securing a reliable supply of both iodine-125 and actinium-225 is a critical milestone in advancing our targeted radiotherapy programs," said James Caruso, chief executive officer of Cellectar. "This agreement ensures uninterrupted access to these essential isotopes, providing the necessary clinical development supply for our innovative clinical stage programs, including CLR 125 for triple negative breast cancer and CLR 225 for pancreatic cancer. We look forward to partnering with Nusano to support our mutual vision to deliver new radiotherapeutics to patients in critical need of novel treatment options. I-125 and Ac-225 will be produced at Nusano’s next-generation radioisotope production facility in Utah. This production platform enables the creation of rare and hard-to-produce medical radioisotopes in quantities needed for commercial-stage therapeutics and diagnostics."

"The power and flexibility of the Nusano production platform is designed to solve the critical supply chain challenges and enable innovation across multiple industries," said Chris Lowe, chief executive officer of Nusano. "We’re proud to support Cellectar with critical isotope supplies so they can advance their product pipeline and create new, personalized cancer treatments."