Phase 1 Trial of Nab-Paclitaxel PIPAC (Pressurized Intraperitoneal Aerosolized Chemotherapy) Given in Combination With Second-Line Therapy for Gastric Cancer With Peritoneal Metastases

This phase I trial tests the safety, side effects and best dose of nab-paclitaxel pressurized intraperitoneal aerosolized chemotherapy (PIPAC) in combination with second-line chemotherapy, paclitaxel and ramucirumab, and tests how well they work in treating stomach cancer that has spread from where it first started to the tissue that lines the abdominal wall and organs (peritoneal metastases). Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Nab-paclitaxel is an albumin-stabilized nanoparticle formulation of paclitaxel which may have fewer side effects and work better than other forms of paclitaxel. PIPAC delivers chemotherapy, such as nab-paclitaxel, that has been turned into a fine mist (aerosolized) at a high pressure directly into the abdominal cavity. Aerosolized chemotherapy delivered directly into the peritoneal space has been shown to deliver higher drug concentrations to the tumor. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Giving nab-paclitaxel PIPAC in combination with paclitaxel and ramucirumab may be safe, tolerable, and/or effective in treating gastric cancer patients with peritoneal metastases.

Start Date17 Oct 2025

Sponsor / Collaborator

City of Hope National Medical Center

[+1]

NCT05562297

/ Not yet recruitingPhase 2IIT

A Phase II Study to Evaluate the Safety and Efficacy of Sintilimab Combined with Nab-paclitaxel and Gemcitabine for Neoadjuvant and Adjuvant Therapy of Patients with Resectable and Borderline Resectable Pancreatic Cancer

The purpose of this research is to investigate the activity and safety of the combination of gemcitabine plus nab-paclitaxel and sintilimab as neoadjuvant therapy in treating patients with resectable and borderline resectable pancreatic cancer.
The drugs involved in this study are:
* Sintilimab
* Nab-paclitaxel
* Gemcitabine

Start Date20 Mar 2025

Sponsor / Collaborator

Zhongshan Hospital Fudan University

[+1]

NCT06783140

/ Not yet recruitingPhase 2/3IIT

Comparing Second-Line NABPLAGEM vs. Nab-paclitaxel/Gemcitabine in BRCA1/2 or PALB2 Mutant Metastatic Pancreatic Ductal Adenocarcinoma

This study will compare two different regimens for patients with BRCA1/2 or PALB2 mutated metastatic pancreatic cancer after progression on first-line FOLFIRINOX.

Start Date03 Mar 2025

Sponsor / Collaborator

University Health Network

100 Clinical Results associated with Albumin-Bound Paclitaxel

100 Translational Medicine associated with Albumin-Bound Paclitaxel

100 Patents (Medical) associated with Albumin-Bound Paclitaxel

3,174

Literatures (Medical) associated with Albumin-Bound Paclitaxel

01 Mar 2025·INTERNATIONAL JOURNAL OF BIOLOGICAL MACROMOLECULES

Optimally designed PEGylatied arabinoxylan paclitaxel nano-micelles as alternative delivery for Abraxane®: A potential targeted therapy against breast and lung cancers

Article

Author: Hanafy, Nemany A N

Paclitaxel (PTX) binds to spindle microtubules and inhibits mitotic division leading to cell death. However, its wide distribution, high absorption, and less selectively, minimize its application in cancer clinics. In this study, isolated arabinoxylans were used to encapsulate PTX, and then both were covered by polyethylene glycol conjugated to folic acid (FA), to strengthen its specificity to cancerous cells. Beclin-1 and P21 were significantly overexpressed by (79.6 ± 0.97 %, p ≤ 0.00001, &62.2 ± 1.15 % p ≤ 0.0001 in MCF-7 cells) and (74.8 ± 8.04 %, p ≤ 0.0001 &75.3 ± 2.3 %, p ≤ 0.0001, in NSCLCs) respectively after their incubation for 48 h with nano-targeted PTX NPs. Similarly, P53 and GSK3 beta-pSer9 were significantly increased by (63.5 ± 1 % p ≤ 0.0001, & 87 ± 1 % p ≤ 0.0001, in MCF) respectively and (81.5 ± 6 % p ≤ 0.01, & 84.8 ± 3.8 % p ≤ 0.001, in A549) respectively. The findings confirmed the activation of acidic/neutral autophagosomes in acridine orange/ethidium bromide (AO/EB) and nuclear fragmentation was clearly shown by 4', 6-diamidino-2 phenylindole (DAPI) nuclear stains. The findings provide the basis for the potential application of arabinoxylans as a great vehicle for the encapsulation of chemotherapeutic agents such as PTX for target delivery, and also as an immune mediator.

01 Feb 2025·Asia-Pacific journal of clinical oncology

C‐reactive protein is a prognostic biomarker in pancreatic ductal adenocarcinoma patients

Article

Author: Waddell, Nicola ; Gebski, Val ; Mukhopadhyay, Pamela ; Kench, James G. ; Bonazzi, Vanessa F. ; Goldstein, David ; Patel, Kalpana ; Gartside, Michael G. ; Lonie, James M. ; Keane, Colm ; Bradford, Julia J. ; Brosda, Sandra ; Loffler, Kelly A. ; Barbour, Andrew P. ; Aoude, Lauren G.

Abstract:

Aim:

The 5‐year survival rate of pancreatic ductal adenocarcinoma (PDAC) is approximately 11% and has only improved marginally over the last three decades. For operable PDAC, resection and adjuvant FOLFIRINOX chemotherapy is standard of care. There is growing interest in perioperative regimens to improve outcomes. The non‐randomized Phase II study “Gemcitabine and Abraxane for resectable Pancreatic cancer” (GAP) demonstrated the feasibility of perioperative gemcitabine/abraxane. Long‐term survival in PDAC requires an effective immune response; hence, we undertook this translational study of the GAP trial cohort to identify immune‐oncology biomarkers for clinical use.

Methods:

We combined Nanostring nCounter technology with immunohistochemistry to investigate the correlation between gene expression and overall patient survival. Findings were investigated in samples from the International Cancer Genome Consortium (ICGC, n = 88) and the Australian Pancreatic Genome Initiative (APGI, n = 227).

Results:

We confirmed that human equilibrative nucleoside transporter 1 (hENT1) expression was not a prognostic marker in PDAC but patients with high levels of hENT1 were more likely to live longer than 24 months post‐surgery. Additionally, CD274 (PD‐L1) and two novel biomarkers of survival, cathepsin W (CTSW) and C‐reactive protein (CRP), were identified in the GAP cohort (n = 19). CRP expression was confirmed in data from the ICGC. Although PD‐L1 and CTSW proteins were not significant across all three cohorts, results show that low CRP mRNA and protein expression are associated with longer overall survival in all three patient groups.

Conclusion:

PDAC patients with long survival have higher hENT1 expression levels. Furthermore, CRP expression is a biomarker of poor prognosis following perioperative chemotherapy and resection in PDAC patients and thus may be useful for identifying patients who could benefit from more aggressive adjuvant strategies.

01 Feb 2025·Biomaterials advances

Tailoring metabolic activity assays for tumour-engineered 3D models

Article

Author: Croagh, Daniel ; Gabrielyan, Anastasiia ; Loessner, Daniela ; Hauser, Sandra ; Curvello, Rodrigo ; Clegg, Julien

Monitoring cell behaviour in hydrogel-based 3D models is critical for assessing their growth and response to cytotoxic treatment. Resazurin-based PrestoBlue and AlamarBlue reagents are frequently used metabolic activity assays when determining cell responses. However, both assays are largely applied to cell monolayer cultures but yet to have a defined protocol for use in hydrogel-based 3D models. The assays' performance depends on the cell type, culture condition and measurement sensitivity. To better understand how both assays perform, we grew pancreatic cancer cells in gelatin methacryloyl and collagen hydrogels and evaluated their metabolic activity using different concentrations and incubation times of the PrestoBlue and AlamarBlue reagents. We tested reagent concentrations of 4 % and 10 % and incubation times of 45 min, 2 h and 4 h. In addition, we co-cultured cancer cells together with cancer-associated fibroblasts and peripheral blood mononuclear cells in gelatin methacryloyl hydrogels and subjected them to gemcitabine and nab-paclitaxel to evaluate how both assays perform when characterising cell responses upon drug treatment. CyQuant assays were conducted on the same samples and compared to data from the metabolic activity assays. In cancer monocultures, higher reagent concentration and incubation time increased fluorescent intensity. We found a reagent concentration of 10 % and an incubation time of 2 h suitable for all cell lines and both hydrogels. In multicellular 3D cultures, PrestoBlue and AlamarBlue assays detected similar cell responses upon drug treatment but overestimated cell growth. We recommend to assess cell viability and growth in conjunction with CyQuant assays that directly measure cell functions.

571

News (Medical) associated with Albumin-Bound Paclitaxel

22 Jan 2025

·www.prnewswire.com

Oncology's Best Minds Set to Meet at Upcoming 2025 ASCO Gastrointestinal Cancers Symposium

USA News Group News Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, Jan. 22, 2025 /PRNewswire/ -- USA News Group News Commentary – Big developments are expected this week at the 2025 ASCO Gastrointestinal Cancers Symposium, running January 23-25 in San Francisco. This year's event is particularly critical as researchers highlight the alarming rise in cancer rates among people under 50, with gastrointestinal cancers leading the increase. Colorectal and pancreatic cancers, two of the top three deadliest cancer types, remain significant concerns as pancreatic cancer mortality continues to climb. Among the innovators presenting at the symposium are Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Agenus Inc. (NASDAQ: AGEN), Guardant Health, Inc. (NASDAQ: GH), Xilio Therapeutics, Inc. (NASDAQ: XLO), and RenovoRx, Inc. (NASDAQ: RNXT). Continue Reading Pelareorep Factsheet (PRNewsfoto/USA News Group) The article continued: According to USD Analytics' recently introduced study, the Global Pancreatic Cancer Treatment Market is expected to soar in the upcoming years, growing at a 7.6% CAGR. Analysts at Precedence Research project that the global stomach cancer treatment market will grow at a 12.54% CAGR to US17.6 billion by 2034. Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today shared details about the data it will present at the ASCO GI symposium. The presentations will highlight pelareorep, an innovative immunotherapy that trains the immune system to target cancer by turning "cold" tumors—typically resistant to treatment—into "hot" tumors that respond better to therapy. In relapsed anal cancer, 4 out of 12 evaluable patients achieved a partial response for a response rate of 33%, and one patient achieved a remarkable complete response, meaning their cancer became undetectable and remained so for over 15 months. To put this into perspective, similar treatments typically achieve response rates of only 10-24%. This underscores pelareorep's potential to deliver life-changing results in some of the toughest-to-treat cancers. "In relapsed anal cancer, the efficacy signal that was initially reported continues to outperform historical control trials with the inclusion of additional patients," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer for Oncolytics Biotech. "Importantly, the complete response we observed previously continued beyond the 12 months initially reported. Together, these results point to a clinically meaningful synergy between pelareorep and checkpoint inhibitors like atezolizumab." In pancreatic cancer, pelareorep has also demonstrated strong potential to improve outcomes for patients with this aggressive disease. The upcoming ASCO GI presentation will feature new safety data showing that pelareorep can be combined with modified FOLFIRINOX, another widely used chemotherapy regimen for patients with pancreatic cancer. "Our new safety data indicate its ability to also be combined with modified FOLFIRINOX, thus expanding its potential to benefit patients with metastatic pancreatic cancer," added Dr. Heineman. "We will continue to provide updates on the safety and efficacy of pelareorep-based combination therapy from these cohorts as they become available." This builds on prior results from the GOBLET study, where pelareorep, combined with atezolizumab, gemcitabine, and nab-paclitaxel, achieved a 62% objective response rate—more than double historical averages of 25%. These findings were pivotal in earning pelareorep FDA Fast Track designation in 2022, highlighting its promise to fill the critical unmet need for more effective pancreatic cancer therapies. The ability to pair pelareorep with modified FOLFIRINOX represents an important step forward in expanding treatment options for metastatic pancreatic cancer. These results not only highlight pelareorep's versatility but also its potential to enhance outcomes across multiple standard-of-care therapies. "I am quite pleased by these recent updates from the GOBLET study as they continue to provide potential new treatment options for patients in need of alternatives while maintaining a manageable safety profile," said Dirk Arnold, M.D., Ph.D., Director of Asklepios Tumorzentrum Hamburg, and primary investigator of the GOBLET trial. "I've been especially impressed with the ability of pelareorep-based therapies to work across multiple challenging cancer indications and with multiple standards of care, including chemotherapy and checkpoint inhibitors, so I look forward to additional data readouts that can help improve the treatment paradigm." As Oncolytics Biotech advances its clinical programs and prepares for pivotal studies, the growing body of evidence continues to solidify pelareorep as a transformative therapeutic option for patients in desperate need of effective treatments. CONTINUED… Read this and more news for Oncolytics Biotech at: In other recent industry developments and happenings in the market include: Agenus Inc. (NASADAQ: AGEN), a leader in immuno-oncology, recently announced it too will share five presentations at ASCO GI's symposium featuring botensilimab (BOT, an Fc-enhanced anti-CTLA-4 antibody) plus balstilimab (BAL, an anti-PD-1 antibody), and showcasing BOT/BAL's consistent activity in microsatellite stable (MSS) colorectal cancer (CRC), which accounts for over 80% of CRC cases and has limited treatment options, as well as its efficacy in microsatellite instability-high (MSI-H) CRC. Additionally, one presentation will feature BOT/BAL and invariant natural killer T cells (iNKTs) in patients with refractory gastric cancer. "These presentations will highlight BOT/BAL's potential to benefit patients across colorectal cancer treatment settings, including the neoadjuvant, late-line, and first-line settings," said Dr. Garo Armen, Chairman and CEO of Agenus. "We aim to transform outcomes at every stage of disease and deliver renewed hope for patients worldwide." ALX Oncology Holdings Inc. (NASDAQ: ALXO), a clinical-stage biotechnology company advancing therapies that boost the immune system to treat cancer and extend patients' lives, also recently announced that updated results from its Phase 2 ASPEN-06 clinical trial were accepted for oral presentation at ASCO GI 2025. ASPEN-06 is a global clinical trial testing evorpacept, ALX Oncology's innovative therapy designed to block the "don't eat me" signal used by cancer cells to evade the immune system. The study is evaluating evorpacept in combination with trastuzumab, CYRAMZA® (ramucirumab), and paclitaxel (a combination known as TRP) compared to TRP alone in patients with HER2-positive gastric or gastroesophageal junction cancer who have previously received anti-HER2 treatments. This approach aims to enhance the effectiveness of existing therapies and improve outcomes for patients with this aggressive cancer type. Xilio Therapeutics, Inc. (NASDAQ: XLO), a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology therapies for people living with cancer, recently announced its plans to present initial data from its ongoing Phase 2 trial for vilastobart (XTX101), a tumor-activated, Fc-enhanced, high affinity binding anti-CTLA-4, in combination with atezolizumab (Tecentriq®) in patients with metastatic microsatellite stable colorectal cancer (MSS CRC) at the ASCO GI Symposium. In addition, the company also announced preliminary data from Phase 1 dose escalation for XTX301, an investigational tumor-activated IL-12. "We are encouraged by the early evidence of responses in patients with cold tumors, including MSS colorectal cancer, reported for the combination of vilastobart and atezolizumab in Phase 1C dose escalation earlier this year, and we look forward to sharing initial Phase 2 data for the combination in MSS CRC at ASCO GI in January," said Katarina Luptakova, M.D., Chief Medical Officer of Xilio. "In addition, the preliminary Phase 1 data we reported today for XTX301, our tumor-activated IL-12, highlight its promising clinical profile, including no dose-limiting toxicities reported to date and consistent interferon gamma signaling observed throughout treatment cycles." RenovoRx, Inc. (NASDAQ: RNXT), a life sciences company developing novel targeted oncology therapies and commercializing RenovoCath®, a novel, FDA-cleared delivery platform, also announced that three of its abstracts were accepted to be presented at several upcoming industry conferences, including ASCO GI 2025. RenovoRx is pioneering a novel therapy platform called TAMP, which delivers chemotherapy directly to the tumor through the arterial wall, potentially reducing side effects and improving treatment effectiveness compared to standard intravenous therapy. Their ongoing Phase III TIGeR-PaC trial, evaluating this approach with their FDA-cleared RenovoCath device, is expected to complete patient enrollment and a key interim analysis by mid-2025. "These abstracts support the potential for our TAMP therapy platform to provide a meaningful advancement in the standard of care for cancer treatment," said Ramtin Agah, MD, Chief Medical Officer and Founder of RenovoRx. "TAMP focuses on drug concentration optimization in tumors by delivering therapies with our RenovoCath delivery system. This targeted approach to cancer treatment is designed to enable physicians to isolate segments of the vascular anatomy closest to tumors and ensure precise therapeutic delivery, while potentially minimizing a therapy's toxicities versus the standard of care. Specifically, our approach enables physicians to utilize RenovoCath to use pressure to force chemotherapy across the arterial wall near the tumor site to bathe the target tumor." Source: CONTACT: USA NEWS GROUP [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment. Infographic - Logo - SOURCE USA News Group WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ImmunotherapyPhase 1ASCOPhase 2Phase 3

22 Jan 2025

·www.prnewswire.com

Oncolytics Biotech® to Present Compelling New Efficacy and Safety Data in Anal and Pancreatic Cancers at 2025 ASCO GI Symposium

Pelareorep combination therapy shows continued meaningful improvement over checkpoint inhibitors alone in anal cancer patients Pelareorep-based therapy demonstrates strong safety profile with new chemotherapy regimen in pancreatic cancer patients SAN DIEGO and CALGARY, AB, Jan. 22, 2025 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today provided details from the abstracts featuring pelareorep that are being presented at the 2025 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium in San Francisco January 23-25, 2025. Thomas Heineman, M.D., Ph.D., Chief Medical Officer for Oncolytics Biotech, commented, "The posters that will be presented at the symposium later this week continue to show pelareorep's compelling potential in gastrointestinal cancers. In relapsed anal cancer, the efficacy signal that was initially reported continues to outperform historical control trials with the inclusion of additional patients. Importantly, the complete response we observed previously continued beyond the 12 months initially reported. Together, these results point to a clinically meaningful synergy between pelareorep and checkpoint inhibitors like atezolizumab. In pancreatic cancer, pelareorep previously demonstrated a strong efficacy signal when administered with gemcitabine, nab-paclitaxel and atezolizumab. Our new safety data indicate its ability to also be combined with modified FOLFIRINOX, thus expanding its potential to benefit patients with metastatic pancreatic cancer. We will continue to provide updates on the safety and efficacy of pelareorep-based combination therapy from these cohorts as they become available." "I am quite pleased by these recent updates from the GOBLET study as they continue to provide potential new treatment options for patients in need of alternatives while maintaining a manageable safety profile," said Dirk Arnold, M.D., Ph.D., Director of Asklepios Tumorzentrum Hamburg, and primary investigator of the GOBLET trial. "I've been especially impressed with the ability of pelareorep-based therapies to work across multiple challenging cancer indications and with multiple standards of care, including chemotherapy and checkpoint inhibitors, so I look forward to additional data readouts that can help improve the treatment paradigm." Abstract Number: 6 Title: GOBLET platform study: Preliminary safety and tumor response results for the relapsed anal carcinoma cohort in patients treated with pelareorep and atezolizumab. Presentation Type: Poster Session Title: Poster Session C: Cancers of the Colon, Rectum, and Anus Session Date and Time: January 25, 2025, 7:00 - 7:55 a.m. PT The fourth cohort of the GOBLET study is evaluating pelareorep combined with the checkpoint inhibitor atezolizumab in patients with second-line or later unresectable squamous cell carcinoma of the anal canal (SCCA). The treatment combination met the pre-defined efficacy success criteria for Stage 1 of its Simon two-stage design, and Stage 2 enrollment of 18 additional evaluable patients has begun. Updated results from this cohort show that four of twelve evaluable patients achieved a partial response for an objective response rate of 33%. This includes one patient with a prolonged complete response that persisted for over 15 months. This is notable because historical response rates to checkpoint inhibitor monotherapy are low, generally 10-24%1-3. There continue to be no safety concerns with the treatment regimen. At treatment cycle four, tumor-infiltrating lymphocyte (TIL) clonal expansion has been observed in the three responding patients for which data is available. It is anticipated that the additional data from Stage 2 of this cohort will provide a sufficiently strong efficacy signal to move this treatment regimen into a registration-enabling study. Abstract Number: 730 Title: GOBLET study: Results of the safety run-in for first-line metastatic pancreatic ductal adenocarcinoma (PDAC) patients treated with pelareorep + modified FOLFIRINOX +/- atezolizumab. Presentation Type: Poster Session Title: Poster Session B: Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract Session Date and Time: January 24, 2025, 11:30 a.m. – 1:00 p.m. PT A promising efficacy signal in metastatic pancreatic ductal adenocarcinoma (PDAC) was previously observed for the combination of pelareorep, gemcitabine, nab-paclitaxel, and atezolizumab. To expand the potential of pelareorep to benefit PDAC patients, and after discussion with key opinion leaders, a cohort was added to the GOBLET study to evaluate pelareorep combined with modified FOLFIRINOX (mFOLFIRINOX) both with and without atezolizumab. This cohort is being funded by a US$5 million grant from the Pancreatic Cancer Action Network (PanCAN). The three-patient safety run-in for each treatment arm has completed enrollment, and patients have completed the necessary evaluation period. The safety data have been reviewed by the Data Safety Monitoring Board (DSMB) and Paul Ehrlich Institute (PEI), Germany's medical regulatory body, and they have recommended patient enrollment continue without modification. Abstracts from the ASCO Gastrointestinal Cancers Symposium are currently available on the event website, which can be accessed by clicking here. References Rao S, et al. Phase II study of retifanlimab in patients (pts) with squamous carcinoma of the anal canal (SCAC) who progressed following platinum-based chemotherapy. Annals of Oncology. 2020 September. doi: . Marabelle A, et al. Pembrolizumab for previously treated advanced anal squamous cell carcinoma: results from the non-randomised, multicohort, multicentre, phase 2 KEYNOTE-158 study. Lancet Gastroenterol Hepatol. 2022 May;7(5):446-454. doi: 10.1016/S2468-1253(21)00382-4. Lonardi S, et al. Randomized phase II trial of avelumab alone or in combination with cetuximab for patients with previously treated, locally advanced, or metastatic squamous cell anal carcinoma: the CARACAS study. J Immunother Cancer. 2021 November;9(11):e002996. doi: 10.1136/jitc-2021-002996. PMID: 34815354; PMCID: PMC8611452. About GOBLET The GOBLET ( Gastrointestinal tum Ors exploring the treatment com Binations with the oncolytic reovirus pe Lar Eorep and an Ti-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 17 centers in Germany and is being managed by AIO-Studien-gGmbH. The co-primary endpoints of the study are objective response rate (ORR) and/or disease control rate assessed at week 16 and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers. The study comprises five treatment groups: Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line advanced/metastatic pancreatic cancer patients; Pelareorep in combination with atezolizumab in 1st line MSI (microsatellite instability)-high metastatic colorectal cancer patients; Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients Pelareorep in combination with atezolizumab in 2nd line advanced and unresectable anal cancer patients; and Pelareorep in combination with mFOLFIRINOX with and without atezolizumab in newly diagnosed metastatic PDAC patients. Any cohort meeting pre-specified efficacy criteria in Stage 1 may be advanced to Stage 2 and enroll additional patients. About AIO AIO-Studien-gGmbH (AIO) emerged from the study center of the medical oncology working group within the German Cancer Society (DKG). AIO operates with a non-profit purpose of promoting science and research with a focus on medical oncology. Since its foundation, AIO has become a successful sponsor and study management company and has established itself both nationally and internationally. About Oncolytics Biotech Inc. Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and Phase 1 and 2 studies in pancreatic cancer. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers. Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA. For further information, please visit: or follow the company on social media on LinkedIn and on X @oncolytics. Tecentriq® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group. This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential, mechanism of action and benefits of pelareorep as a cancer therapeutic; our plans to provide updates on the safety and efficacy of pelareorep-based combinations therapy; our expectation that additional data from the fourth cohort of our Stage 2 GOBLET study will provide a sufficiently strong efficacy signal to move the treatment regimen into a registration-enabling study; our plans to advance pelareorep to registration-enabling studies for the treatment of breast and pancreatic cancers; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. We may incur expenses or delays relating to events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws. Company Contact Jon Patton Director of IR & Communication [email protected] Investor Relations for Oncolytics Timothy McCarthy LifeSci Advisors +1-917-679-9282 [email protected] Media Contact for Oncolytics Michael Rubenstein LifeSci Communications [email protected] Logo - SOURCE Oncolytics Biotech® Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultImmunotherapyASCOPhase 2Fast Track

22 Jan 2025

·ir.lisata.com

Lisata Therapeutics Reports Encouraging Preliminary Cohort A Data from the AGITG-led Phase 2 ASCEND Trial Evaluating Certepetide with Standard-of-Care Chemotherapy in Metastatic Pancreatic Ductal Adenocarcinoma

Cohort A data to be presented in a poster session at the 2025 American Society of Clinical Oncology Gastrointestinal Cancers Symposium Data reported positive trend in overall survival, including 4 complete responses observed in the certepetide treatment group compared to none in placebo group Data from Cohort B expected in the coming months, with full data from both cohorts to be reported thereafter BASKING RIDGE, N.J., Jan. 22, 2025 (GLOBE NEWSWIRE) -- 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, today announced preliminary Cohort A data from the ongoing Phase 2 ASCEND trial (NCT05042128) being conducted at 25 sites across Australia and New Zealand led by the Australasian Gastro-Intestinal Trials Group (AGITG) and coordinated by the National Health and Medical Research Council (NHMRC) Clinical Trial Centre at the University of Sydney. The data will be presented in a poster session, entitled, “AGITG ASCEND: Randomized, double-blind Phase II study of certepetide or placebo added to gemcitabine plus nab-paclitaxel in patients with untreated metastatic pancreatic ductal adenocarcinoma: Initial results,” at the 2025 American Society of Clinical Oncology Gastrointestinal (ASCO GI) Cancers Symposium on Friday, January 24th at 11:30 a.m. - 1:00 p.m. (PST) in San Franscisco, California. For a detailed summary of the poster presentation, please see the abstract available on the ASCO GI website: meetings.asco.org/abstracts-presentations/241497. The Phase 2 double-blind, randomized (2:1 ratio), placebo-controlled trial is evaluating certepetide, Lisata's proprietary investigational iRGD cyclic peptide product candidate, in combination with standard-of-care (SoC) chemotherapy (gemcitabine and nab-paclitaxel) for the treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC). Following the acquisition of Cend Therapeutics, Lisata collaborated with AGITG to amend the inherited trial’s protocol to ensure it respected international regulatory standards and was optimized to generate clinically meaningful data that would effectively guide the next stages of development. The amended protocol is designed to assess the efficacy of two different dosing regimens of certepetide in two separate treatment cohorts: Cohort A, with 95 patients receiving a single intravenous (IV) dose of certepetide 3.2 mg/kg or placebo in combination with SoC, and Cohort B, with 63 patients receiving two IV doses of certepetide 3.2 mg/kg or placebo administered 4 hours apart in combination with SoC. Cohort A of the ASCEND trial completed enrollment in the third quarter of 2023. The preliminary data from Cohort A demonstrate a median overall survival (mOS) of 12.68 months for the certepetide treated group, compared to 9.72 months for the placebo treated group. Despite a numerical trend in 6-month PFS favoring the certepetide treatment group, no significant improvement in median PFS was observed (mPFS of 5.5 months in both groups). However, the observed mOS and objective response rate (ORR) benefit are positive with 4/65 (6.2%) complete responses in the certepetide treated group, compared to 0/28 (0%) the placebo treated group. “The data from Cohort A are as we expected and corroborate our decision to add Cohort B to the ASCEND protocol,” stated Kristen K. Buck, M.D., Executive Vice President of Research and Development and Chief Medical Officer of Lisata. “The increase in overall survival and the observation of 4 complete responses in the certepetide-treated group compared to none in the placebo group for Cohort A, coupled with our expectation of even better outcomes in Cohort B, where we believe early indications show a strong separation in mPFS benefiting patients treated with certepetide, support our plans to advance certepetide development to Phase 3 in early 2026.” 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.). About Lisata Therapeutics Lisata Therapeutics is a clinical-stage pharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies for the treatment of advanced solid tumors and other major diseases. Lisata’s cyclic peptide product candidate, certepetide, is an investigational drug designed to activate a novel uptake pathway that allows co-administered or tethered anti-cancer drugs to selectively target and penetrate solid tumors more effectively. Lisata has already established noteworthy commercial and R&D partnerships based on its CendR Platform® technology. The Company expects to announce numerous milestones over the next 1.5 years and believes that its projected capital will fund operations into early 2026, encompassing anticipated data milestones from its ongoing and planned clinical trials. Learn more about certepetide’s mechanism of action in our short film. For more information on the Company, please visit www.lisata.com. Forward-Looking Statements This communication contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this communication regarding the Company’s clinical development programs are forward-looking statements. In addition, when or if used in this communication, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to Lisata or its management, may identify forward-looking statements. Examples of forward-looking statements include, but are not limited to, the potential efficacy of certepetide as a treatment for patients with metastatic pancreatic ductal adenocarcinoma and other solid tumors; statements relating to Lisata’s continued listing on the Nasdaq Capital Market; expectations regarding the capitalization, resources and ownership structure of Lisata; the approach Lisata is taking to discover and develop novel therapeutics; the adequacy of Lisata’s capital to support its future operations and its ability to successfully initiate and complete clinical trials; and the difficulty in predicting the time and cost of development of Lisata’s product candidates. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: results observed from a single patient case study are not necessarily indicative of final results and one or more of the clinical outcomes may materially change following more comprehensive reviews of the data and as more patient data becomes available, including the risk that unconfirmed responses may not ultimately result in confirmed responses to treatment after follow-up evaluations; the risk that product candidates that appeared promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later clinical trials; the safety and efficacy of Lisata’s product candidates, decisions of regulatory authorities and the timing thereof, the duration and impact of regulatory delays in Lisata’s clinical programs, Lisata’s ability to finance its operations, the likelihood and timing of the receipt of future milestone and licensing fees, the future success of Lisata’s scientific studies, Lisata’s ability to successfully develop and commercialize drug candidates, the timing for starting and completing clinical trials, rapid technological change in Lisata’s markets, the ability of Lisata to protect its intellectual property rights; and legislative, regulatory, political and economic developments. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in Lisata’s Annual Report on Form 10-K filed with the SEC on February 29, 2024, and in other documents filed by Lisata with the Securities and Exchange Commission. Except as required by applicable law, Lisata undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events, or otherwise. Lisata Therapeutics Contact: Investors: Lisata Therapeutics John Menditto Vice President, Investor Relations and Corporate Communications Phone: 908-842-0084 Email: jmenditto@lisata.com Media: ICR Healthcare Elizabeth Coleman Account Supervisor Phone: 203-682-4783 Email: elizabeth.coleman@icrhealthcare.com This press release was published by a CLEAR® Verified individual.

Clinical ResultOrphan DrugFast TrackImmunotherapyPhase 2

100 Deals associated with Albumin-Bound Paclitaxel

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Indication	Country/Location	Organization	Date
Pancreatic adenocarcinoma metastatic	US	Teva Pharmaceuticals, Inc.	11 May 2023
Pancreatic adenocarcinoma	US	Bristol Myers Squibb Co.	06 Sep 2013
Non-Small Cell Lung Cancer	JP	Taiho Pharmaceutical Co., Ltd.	23 Jul 2010
Pancreatic Cancer	JP	Taiho Pharmaceutical Co., Ltd.	23 Jul 2010
Stomach Cancer	JP	Taiho Pharmaceutical Co., Ltd.	23 Jul 2010
Breast Cancer	CN	Abraxis BioScience, Inc.	30 Jun 2008
Metastatic breast cancer	US	Bristol Myers Squibb Co.	07 Jan 2005

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced breast cancer	Phase 3	CN	CSPC Ouyi Pharmaceutical Co., Ltd.	27 Apr 2023
PD-L1 positive Triple Negative Breast Cancer	Phase 3	AR	Hoffmann-La Roche, Inc.	17 Dec 2019
PD-L1 positive Triple Negative Breast Cancer	Phase 3	CL	Hoffmann-La Roche, Inc.	17 Dec 2019
PD-L1 positive Triple Negative Breast Cancer	Phase 3	CZ	Hoffmann-La Roche, Inc.	17 Dec 2019
PD-L1 positive Triple Negative Breast Cancer	Phase 3	FR	Hoffmann-La Roche, Inc.	17 Dec 2019
PD-L1 positive Triple Negative Breast Cancer	Phase 3	HU	Hoffmann-La Roche, Inc.	17 Dec 2019
PD-L1 positive Triple Negative Breast Cancer	Phase 3	IT	Hoffmann-La Roche, Inc.	17 Dec 2019
PD-L1 positive Triple Negative Breast Cancer	Phase 3	MX	Hoffmann-La Roche, Inc.	17 Dec 2019
PD-L1 positive Triple Negative Breast Cancer	Phase 3	PE	Hoffmann-La Roche, Inc.	17 Dec 2019
PD-L1 positive Triple Negative Breast Cancer	Phase 3	PL	Hoffmann-La Roche, Inc.	17 Dec 2019

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03240016 (ABLE, CTgov)	Phase 2	Advanced Urothelial Carcinoma	36	Abraxane+pembrolizumab	sqcfwtikmu(bsfsilhpbr) = pfoxjzatfe tfdswehuub (gkgctkpckd, lbaloiexmr - jmiejniwnn) View more	-	16 Jan 2025
NCT05244993 (NEWS) Manual	Phase 2	Advanced Triple-Negative Breast Carcinoma First line	43	安罗替尼 +派安普利单抗 +白蛋白紫杉醇	genhomrwcs(stsdzmjmxe) = lsztpqzxll bxkaiwzkuy (nyslrgzbmd ) View more	Positive	14 Dec 2024
NEWS Manual	Phase 3	Breast Cancer	-	SYHX2011	kgkndyxjlb(sdfonwnnzr): HR = 1.38 (95% CI, 1.040 - 1.842) View more	Positive	10 Dec 2024
				紫杉醇（白蛋白结合型）
NCT05659056 (SABCS2024) Manual	Phase 2	HER2 Positive Breast Cancer Neoadjuvant HER2 Positive	52	pyrotinib + trastuzumab + nab-paclitaxel	rzzaelhkxh(ubxhnhtnpy) = nafxkttunc sbihdqlfwc (oidipdelfk, 29.0 - 56.7) View more	Positive	10 Dec 2024
				pyrotinib + trastuzumab + nab-paclitaxel (HER2-enriched subtype)	rzzaelhkxh(ubxhnhtnpy) = exjivrnaut sbihdqlfwc (oidipdelfk, 37.9 - 73.2)
NCT02754726 (CTgov)	Phase 2	Metastatic Pancreatic Ductal Adenocarcinoma	35	nivolumab+albumin-bound paclitaxel+Gemcitabine+Paricalcitol+cisplatin	rllfndzmfx(cgtuwbkplj) = whjpdepneu ctkdrlkqce (wcyiyzdwsc, peyocgzigj - rzgvqmqjjm) View more	-	10 Dec 2024
ESMO_ASIA2024	Not Applicable	Neoadjuvant neutrophil-to-lymphocyte ratio (NLR)	142	nab-paclitaxel (Low NLR (<2.1))	uxkffieefz(rmuduvckxt) = DFS in the low NLR group was longer than in the high NLR group yirqmexcfh (ttpxxpyvld )	-	07 Dec 2024
				nab-paclitaxel (High NLR (≥2.1))
NCT03768414 (SWOG 1815, CTgov)	Phase 3	Unresectable Intrahepatic Cholangiocarcinoma \| Advanced biliary tract cancer \| Gallbladder Neoplasms ... View more	452	Nab-paclitaxel+Gem+Cisplatin (Gem+Cisplatin+Nab-paclitaxel)	cncyjlchlz(bowkbzvwra) = epsrdoaxnr pzudocqgrm (jtlklbxplu, mqdhobngwz - ogbleopeps) View more	-	22 Oct 2024
				Gemcitabine+Cisplatin (Gemcitabine + Cisplatin)	cncyjlchlz(bowkbzvwra) = dbyjogcvml pzudocqgrm (jtlklbxplu, anzsmhtclt - jwchssukoc) View more
NCT04964960 (CTgov)	Phase 2	Metabolic Syndrome \| Non-Small Cell Lung Cancer \| Brain metastases	3	nab paclitaxel+Carboplatin+Paclitaxel+Pembrolizumab+Pemetrexed	tddaehmgyz(zrbhdleejm) = dnbgrvzbrj puwccgwogv (upzpfjpshs, adfztflclk - qbiucfyszn) View more	-	21 Oct 2024
ASTRO2024	Not Applicable	Locally Advanced Esophageal Squamous Cell Carcinoma Neoadjuvant	136	Weekly cisplatin/nab-paclitaxel	eiaeciecmb(xpkqjimlwf) = wwmklewwmw ssxnehrtss (fxwpdfehow ) View more	Positive	01 Oct 2024
				Tri-weekly cisplatin/nab-paclitaxel	eiaeciecmb(xpkqjimlwf) = lmvcbraswj ssxnehrtss (fxwpdfehow ) View more
NCT05821556 (VESPA, Pubmed \| BMC Cancer)	Phase 2	Pancreatic adenocarcinoma metastatic CA 19.9	240	VPA/SIM plus gemcitabine/nab-paclitaxel-based regimens	rowawefslh(comkoypnwy) = xhpmctieqm adnzkdrtul (vfnflhwrpl )	-	19 Sep 2024
				Chemotherapy alone	rowawefslh(comkoypnwy) = zbrmcnafxb adnzkdrtul (vfnflhwrpl )

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