1stOncology™: Cancer Intelligence Service – Page 478 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Lisata Therapeutics and Catalent Announce Global Antibody-Drug Conjugate (ADC) License Agreement

On October 8, 2025 Lisata Therapeutics, Inc. (Nasdaq: LSTA) ("Lisata" or the "Company"), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, and Catalent, Inc. ("Catalent"), a leader in enabling the development and supply of better treatments for patients worldwide, reported a global product license agreement that allows Catalent to incorporate Lisata’s certepetide into antibody-drug conjugates ("ADCs") developed using Catalent’s SMARTag technology platform (Press release, Catalent, OCT 8, 2025, https://www.catalent.com/media-advisories/lisata-therapeutics-and-catalent-announce-global-antibody-drug-conjugate-adc-license-agreement/ [SID1234656506]). Certepetide, a proprietary, internalizing RGD (arginyl-glycyl-aspartic acid) or "iRGD" cyclic peptide, is being tested by Lisata as a cancer therapeutic to be used in combination with other anti-cancer agents to enhance tumor targeting and penetration and improve treatment outcomes.

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!

Under the licensing agreement, Catalent gains worldwide, non-exclusive rights to develop and commercialize bioconjugate products containing certepetide and its analogs, including the ability to partner with third parties. As part of this collaboration, Catalent will have the right to evaluate certepetide and its analogs as SMARTag payloads in clinical studies across multiple ADCs targeting difficult-to-treat diseases, with the goal of creating a new class of targeted bioconjugate therapies. Lisata is eligible to receive over $10 million in tiered study initiation milestone payments plus revenue sharing on future sales and partnerships.

"This collaboration is based on positive preclinical results generated by Catalent’s use of an iRGD peptide as part of its SMARTag ADC platform," stated Kristen K. Buck, M.D., Executive Vice President of Research and Development and Chief Medical Officer of Lisata. "It underscores our mutual belief in certepetide’s broad potential and is another significant step forward in Lisata’s mission to bring transformative therapies to patients. Catalent’s technology and innovative approach are a perfect complement to certepetide’s biology." Preclinical work supporting incorporation of iRGD peptides into the SMARTag ADC platform will be highlighted at this November’s World ADC conference in San Diego.

"We are excited about the opportunity to explore iRGD biology as it relates to ADC delivery to the tumor microenvironment. Early data suggest that incorporating iRGD peptides into ADCs improves efficacy and pharmacokinetics, leading us to be optimistic about the potential of iRGD as a novel payload class," said Penelope Drake, Head of R&D, Bioconjugates at Catalent.

Alligator announces publication of OPTIMIZE-1 biomarker analysis in Cell Reports Medicine supporting mitazalimab and mFOLFIRINOX in metastatic pancreatic cancer

On October 8, 2025 Alligator Bioscience (Nasdaq Stockholm: ATORX), a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs, reported the publication of a peer-reviewed article in Cell Reports Medicine, a Cell Press journal (Press release, Alligator Bioscience, OCT 8, 2025, View Source [SID1234656505]). The paper presents biomarkers associated with clinical efficacy endpoints from the Phase 1b/2 OPTIMIZE-1 trial evaluating Alligator’s CD40 agonist mitazalimab in combination with mFOLFIRINOX chemotherapy in patients with untreated metastatic pancreatic ductal adenocarcinoma (mPDAC).

The publication, titled "CD40 agonist mitazalimab with mFOLFIRINOX in untreated metastatic pancreatic cancer: biomarkers associated with outcomes from OPTIMIZE-1", provides mechanistic insights into determinants of clinical response and offers translational support for a planned randomized Phase 3 trial.

Key findings from the publication include:

Clinical efficacy: The OPTIMIZE-1 study met its primary endpoint, with a confirmed objective response rate of 42.1% in the Phase 2 cohort. Median duration of response was 12.6 months, progression-free survival 7.7 months, and overall survival 14.9 months. The survival rate at 24 months was 29.4%, triple that of chemotherapy alone.
Tumor gene signature linked to outcome: Baseline expression of a tumor-intrinsic fibrotic gene signature, directly linked to the mode of action of mitazalimab, was associated with improved overall survival.
Peripheral immune activation: Mitazalimab-induced increases in circulating activated immune cells correlated with better clinical outcomes.
Intratumoral immune activation: Patients with objective clinical responses displayed mitazalimab-induced immune activation supporting mitazalimab’s contribution to clinical outcomes
Translational impact: strongly supports mitazalimabs contribution to the improved clinical outcomes observed in OPTIMIZE-1 and supports future development of predictive biomarkers for mitazalimab.
"These data provide important guidance for understanding which patients may benefit most from mitazalimab-based immunotherapy in pancreatic cancer, and provides further evidence for mitazalimab’s contribution to the sustained clinical benefit observed in the OPTIMIZE-1 trial" said Søren Bregenholt, CEO of Alligator Bioscience. "The integration of biomarker-driven insights into our clinical development strategy strengthens the foundation for the next phase of mitazalimab’s evaluation in this high-need indication."

Oncoinvent Reports Positive Final Data from Phase 1 Trial of Radspherin® to Treat Ovarian Cancer

On October 8, 2025 Oncoinvent reported new data highlight continued potential of Radspherin to prevent disease progression Oncoinvent ASA, a clinical-stage radiopharmaceutical company developing innovative treatments for solid cancers, announced positive final 24-month follow-up results from its Phase 1 clinical trial (RAD-18-001) evaluating Radspherin in patients with platinum-sensitive recurrent ovarian cancer and peritoneal carcinomatosis (Press release, Oncoinvent, OCT 8, 2025, https://www.oncoinvent.com/press-release/oncoinvent-reports-positive-final-data-from-phase-1-trial-of-radspherin-to-treat-ovarian-cancer/?utm_source=mailpoet&utm_medium=email&utm_source_platform=mailpoet [SID1234656487]). Radspherin, direct intraperitoneal targeting with the alpha-emitter radium-224, aims to eliminate post-surgery micro-metastases and thereby prevent or delay peritoneal recurrence.

In this Phase 1 trial, 10 out of 21 patients received the highest and recommended intraperitoneal dose of 7 MBq Radspherin after dose escalation (1, 2, 4 and 7 MBq). The final 24-month data still reports that only 1 of these 10 patients had peritoneal recurrence, and peritoneal recurrence rate remains at 10%. Two additional patients were reported with lymph node metastases outside of the peritoneum, giving an overall recurrence rate of 30%. In similar populations, approximately 55-60% of patients receiving best standard of care would expect disease recurrence at this time point[1],[2],[3].

"These highly encouraging results conclude our Phase 1 program for Radspherin and fuel our determination to advance Radspherin as an innovative treatment for patients with peritoneal metastases as quickly as possible," said Oystein Soug, CEO of Oncoinvent. "We are profoundly grateful to the patients, investigators, and the team for their invaluable contributions and look forward to interim results from our Phase 2 study next year."

"Peritoneal metastases remain a defining challenge in ovarian cancer, often driving recurrence," said Dr. Luis Chiva, Principal Investigator and Director of Department of Obstetrics and Gynecology, Clinica Universidad de Navarra, Spain. "These final results are truly encouraging, suggesting that Radspherin could help delay disease progression and offer patients hope for longer, healthier lives. It is particularly promising to see that the new recurrences were limited to lymph nodes, which are typically associated with longer survival compared to peritoneal relapses.

About RAD-18-001

RAD-18-001 was an open label Phase 1 trial conducted in patients with peritoneal metastases in platinum-sensitive recurrent ovarian cancer. The trial was designed to evaluate dosing, safety and tolerability, and signal of efficacy of intraperitoneally administered Radspherin following complete surgical resection. A total of 21 patients were enrolled across sites in Norway, Belgium and Spain.

AbCellera to Participate at Upcoming Investor Conferences in November and December 2025

On October 7, 2025 AbCellera (Nasdaq: ABCL) reported that the Company will participate in the following investor conferences (Press release, AbCellera, OCT 7, 2025, View Source [SID1234656501]):

Truist Securities BioPharma Symposium, November 6, 2025
Stifel Healthcare Conference, November 11-13, 2025
Jefferies Global Healthcare Conference, November 18-20, 2025
Piper Sandler 37th Annual Healthcare Conference, December 2-4, 2025

Kernal Bio Awarded up to $48 Million from ARPA-H to Develop Lower Cost in vivo CAR T-cell Therapies for Hematological Cancers and Autoimmune Disease

On October 7, 2025 Kernal Biologics, Inc., a venture-backed TechBio company pioneering novel therapeutics to program human cells directly inside the body, reported that it has been awarded up to $48 million in funding by the Advanced Research Projects Agency for Health (ARPA-H) (Press release, Kernal Biologics, OCT 7, 2025, View Source [SID1234656500]). This project is to be funded by ARPA-H’s EMBODY program, which focuses on the engineering of immune cells inside the body. EMBODY is led by ARPA-H Program Manager Daria Fedyukina, Ph.D.

The funds will be used to support the clinical development of Kernal Bio’s in vivo mRNA-encoded CAR T-cell program, KR-402, which targets multiple sclerosis and B-cell malignancies, including acute lymphoblastic leukemia, large B-cell lymphoma and chronic lymphocytic leukemia. As part of this project, Kernal Bio will collaborate with sub-awardees – Stanford University School of Medicine, Dana-Farber Cancer Institute, and The Jackson Laboratory – to engineer targeted, mRNA-encoded CARs, as well as develop novel manufacturing strategies and preclinical models for testing these therapies.

"We’re honored to join the elite cohort of ARPA-H awardees," said Yusuf Erkul, M.D., MBA., cofounder and chief executive officer of Kernal Bio. "Current CAR-T therapies heralded a true revolution in cancer treatment. Yet, they have their limitations, including a three-week vein-to-vein turnaround time, tumor resistance leading to relapse, and side effects such as cytokine release syndrome or secondary T-cell malignancies. At Kernal Bio, we believe that we have the tools to evolve the CAR-T modality towards in vivo therapies."

KR-402 is a next-generation CAR-T therapy program developed using Kernal Bio’s mRNA 2.0 platform. This platform achieves exceptional precision using a unique two-pronged strategy. First, it uses a highly selective mRNA that only translates in specific cells — intelligently designed by analyzing thousands of multi-omics datapoints across various cell types. Second, this RNA is delivered by a targeted lipid nanoparticle (LNP) delivery vehicle decorated with antibodies that allow it to home in directly on target T cells.

By reprogramming T cells inside the body with this approach, KR-402 is positioned to be a differentiated in vivo CAR-T therapy that minimizes the risk of genomic integration, while offering tremendous cost efficiencies over traditional ex vivo therapies. Furthermore, the in vivo CAR-T approach may also improve patients’ treatment journey by eliminating the need for additional toxic procedures, such as lymphodepletion agents.

"Manufacturing ex vivo CAR-T therapies is a complex and expensive process. However, with our proprietary platform, there is a potential of reducing the cost of manufacturing in vivo CAR T-cell therapies by as much as 100-fold," commented Burak Yilmaz, president of Kernal Bio. "In addition, chemotherapy drugs used for lymphodepletion prior to CAR-T therapies carry significant toxicity, making these therapies viable for just a small group of patients. We believe that with our technology and the support of our partners and ARPA-H, we can greatly transform access to this category of therapies."