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Xenetic Biosciences, Inc. Announces Update from Collaboration Partner of  First Patient Dosed in Exploratory Clinical Study of DNase I in Combination with FOLFIRINOX for the First Line Treatment of Unresectable, Locally Advanced or Metastatic Pancreatic Cancer
Xenetic Biosciences, Inc. Announces Update from Collaboration Partner of  First Patient Dosed in Exploratory Clinical Study of DNase I in Combination with FOLFIRINOX for the First Line Treatment of Unresectable, Locally Advanced or Metastatic Pancreatic Cancer

Miami Herald

time08-07-2025

  • Business
  • Miami Herald

Xenetic Biosciences, Inc. Announces Update from Collaboration Partner of First Patient Dosed in Exploratory Clinical Study of DNase I in Combination with FOLFIRINOX for the First Line Treatment of Unresectable, Locally Advanced or Metastatic Pancreatic Cancer

Investigator initiated exploratory clinical study being conducted in Israel pursuant to agreement with collaboration partner, PeriNess Company evaluating systemic recombinant human DNase I (DNase I) in combination with chemotherapy and immunotherapy platforms for the treatment of pancreatic carcinoma, colorectal cancer and other locally advanced or metastatic solid tumors FRAMINGHAM, MA / ACCESS Newswire / July 8, 2025 / Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing innovative immuno-oncology technologies addressing difficult to treat cancers, today announced that its collaboration partner, PeriNess Ltd. (PeriNess), has informed the Company that Bnei Zion Medical Center has commenced patient dosing in an exploratory clinical study of systemic DNase I in combination with FOLFIRINOX for the first line treatment of unresectable, locally advanced or metastatic pancreatic cancer. Dr. Abed Agbabrya, head of Oncology at the Bnei Zion Hospital, will act as the principal investigator and all work will be conducted at The Fund for Medical Research, Development of Infrastructure and Health services - Bnei Zion Medical Center in Israel. Dr. Dmitry Genkin, Xenetic Chairman stated, "We are very pleased with the update provided by PeriNess and for the start of patient dosing in this exploratory study. We remain committed to advancing our systemic recombinant human DNase I technology into the clinical stage. The ability of DNase I to degrade neutrophil extracellular traps (NETs) in the pancreatic cancer tumor microenvironment holds promise to improve clinical responses in a critically underserved patient population. We look forward to further exploring the full potential of DNase I." PeriNess has informed the Company that the exploratory study is evaluating the safety, biomarker response, pharmacokinetics (PK) and clinical activity of DNase I in combination with first line regimen of FOLFIRINOX chemotherapy in patients with locally advanced or metastatic pancreatic cancer. All patients will receive intravenous infusions of DNase I on Days 1 and 8 of consecutive 14-day cycles. Safety will be continuously evaluated until the end of the study. DNase I pharmacokinetics will be evaluated on Days 1 and 2 of the first FOLFIRINOX cycle and Days 1 and 2 of the third FOLFIRINOX cycle. Neutrophil extracellular traps biomarkers will be evaluated on Day 1 of the first FOLFIRINOX cycle and every 4 weeks thereafter. Clinical activity will be evaluated by the Objective Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and Progression-Free Survival (PFS). As previously announced, in December 2024, Xenetic entered into a Clinical Trial Services Agreement with PeriNess, under which PeriNess will lead in the regulatory approval, operational execution and management of potential exploratory, investigator initiated studies of recombinant DNase as an adjunctive treatment in patients with pancreatic carcinoma and other locally advanced or metastatic solid tumors receiving chemotherapy and immunotherapy in Israeli medical centers. About Xenetic Biosciences Xenetic Biosciences, Inc. is a biopharmaceutical company focused on advancing innovative immuno-oncology technologies addressing difficult to treat cancers. The Company's DNase technology is designed to improve outcomes of existing treatments, including immunotherapies, by targeting neutrophil extracellular traps (NETs), which are involved in the progression of many human cancers. Xenetic is currently focused on advancing its systemic DNase I program into the clinic as an adjunctive therapy for pancreatic carcinoma and locally advanced or metastatic solid tumors. For more information, please visit the Company's website at and connect on X, LinkedIn, and Facebook. Forward-Looking Statements This press release contains forward-looking statements that we intend to be subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release other than statements of historical facts may constitute forward-looking statements within the meaning of the federal securities laws. These statements can be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," "remain," "focus", "confidence in", "potential", "look forward", "holds", and other words of similar meaning, including, but not limited to, all statements regarding expectations with respect to the investigator initiated exploratory study being conducted by Bnei Zion Medical Center evaluating the safety, biomarker response, PK and clinical activity of DNase I in combination with first line regimen of FOLFIRINOX chemotherapy in patients with locally advanced or metastatic pancreatic cancer, including the first patient dosing under the exploratory study; all statements regarding expectations with respect to our collaboration with PeriNess; and all statements regarding expectations for our DNase I-based oncology platform, including statements regarding: DNase holding promise to improve clinical responses in a critically underserved patient population, our expectations regarding exploring the full potential of DNase I, our focus on advancing innovative immune-oncology technologies addressing difficult to treat cancers, the DNase I technology improving outcomes of existing treatments, including immunotherapies, by targeting neutrophil extracellular traps (NETs), which are involved in the progression of many human cancers, and our focus on advancing our systemic DNase I program into the clinic as an adjunctive therapy for pancreatic carcinoma and locally advanced or metastatic solid tumors. Any forward-looking statements contained herein are based on current expectations and are subject to a number of risks and uncertainties. Many factors could cause our actual activities, performance, achievements, or results to differ materially from the activities and results anticipated in forward-looking statements. Important factors that could cause actual activities, performance, achievements, or results to differ materially from such plans, estimates or expectations include, among others, (1) the relevance of, or our ability to utilize, the data from the investigator initiated exploratory study, if any, (2)) unexpected costs, charges or expenses resulting from our manufacturing and collaboration agreements, including the Clinical Trial Services Agreement with PeriNess; (3) unexpected costs, charges or expenses resulting from the licensing of the DNase platform; (4) uncertainty of the expected financial performance of the Company following the licensing of the DNase platform; (5) failure to realize the anticipated potential of the DNase technologies; (6) the ability of the Company to obtain funding and implement its business strategy; and (7) other risk factors as detailed from time to time in the Company's reports filed with the SEC, including its annual report on Form 10-K, periodic quarterly reports on Form 10-Q, current reports on Form 8-K and other documents filed with the SEC. The foregoing list of important factors is not exclusive. In addition, forward-looking statements may also be adversely affected by general market factors, general economic and business conditions, including potential adverse effects of public health issues and geopolitical events, such as the conflicts in the Ukraine and Middle East, on economic activity, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new product candidates and indications, manufacturing issues that may arise, patent positions, litigation, and shareholder activism, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and the Company does not undertake any obligation to update forward-looking statements, except as required by law. Contact:JTC Team, LLCJenene Thomas(908) 824-0775xbio@ SOURCE: Xenetic Biosciences, Inc.

PanTher Initiates Phase 1b Clinical Trial of Absorbable, Long-Lasting, High-Dose Chemotherapy Patch for Pancreatic Cancer
PanTher Initiates Phase 1b Clinical Trial of Absorbable, Long-Lasting, High-Dose Chemotherapy Patch for Pancreatic Cancer

Business Wire

time07-07-2025

  • Business
  • Business Wire

PanTher Initiates Phase 1b Clinical Trial of Absorbable, Long-Lasting, High-Dose Chemotherapy Patch for Pancreatic Cancer

AUSTIN, Texas--(BUSINESS WIRE)-- PanTher Therapeutics ('PanTher' or the 'Company'), a clinical-stage company redefining cancer treatment with therapeutics administered continuously and exclusively at the tumor site, today announced that the first patient has been treated with PTM-101 in a Phase 1b clinical trial in pancreatic ductal adenocarcinoma (PDAC). PTM-101 is the most advanced product candidate within PanTher's portfolio of innovative formulations for continuous, high-dose, localized drug administration directly to the site of the tumor. 'The start of this second clinical trial of PTM-101 is an exciting milestone in our journey to transcend the dosing limitations of today's cancer treatments by reimagining how chemotherapy is delivered,' said Laura Indolfi, Ph.D., Chief Executive Officer and Co-founder of PanTher Therapeutics. 'Powerful cancer drugs exist but their toxicity lowers maximum dose and limits dosing frequency — leaving too many opportunities for cancers to continue spreading while patients grapple with debilitating side effects. Our investigational formulations are designed to circumvent the toxic effects of systemic chemotherapy while retaining a much higher dose of the drug exclusively at the tumor, with the goal of shrinking difficult-to-treat tumors and extending patients' lives.' PTM-101 is a polymeric thin film formulation of paclitaxel, a well-established chemotherapy drug, designed to deliver a sustained (~6 weeks) high dose to the tumor site with little to no systemic exposure. A previous first-in-human Phase 1 study (ACTRN12621000881831) of PTM-101 at the 100 mg dose level, combined with standard of care chemotherapy in borderline resectable and locally advanced PDAC, reported promising tumor shrinkage and a favorable safety profile. No paclitaxel was detected systemically at any time. The study additionally demonstrated PTM-101's ability to fit into current PDAC treatment protocols and deliver potential therapeutic benefit early in the clinical paradigm, beginning weeks before intravenous chemotherapy. The ongoing dose escalation and expansion Phase 1b study (NCT06673017) is assessing safety, tolerability, and anti-tumor activity of PTM-101 at two higher dose levels when combined with standard of care neoadjuvant chemotherapy (FOLFIRINOX) in patients with borderline resectable or locally advanced PDAC. The first patient was dosed at Virginia Mason Medical Center in Seattle, Washington, under Drs. Vince Picozzi and William 'Scott' Helton. In addition to Virginia Mason, trial enrollment is presently ongoing at Northwell Health Zuckerberg Cancer Center in Lake Success, New York; Hoag Memorial Hospital Presbyterian in Newport Beach, California; and the Barbara Ann Karmanos Cancer Institute in Detroit, Michigan. This non-randomized, open-label study plans to enroll approximately 30 treatment-naïve patients across multiple clinical sites in the U.S. 'PTM-101 is a novel, innovative approach to treating the primary pancreatic tumor,' said Vince Picozzi, M.D., a medical oncologist and a principal investigator of the Phase 1b clinical trial. 'Doing so successfully is the first step towards curative therapy.' Studies have shown that only about 1% of systemically delivered chemotherapy reaches the tumor, with the remaining 99% of drug producing toxic effects on off-target tissues — including neutropenia, hair loss, nausea and vomiting, and peripheral neuropathy. Additionally, pancreatic cancer is notoriously poorly vascularized, making it extremely difficult for systemic chemotherapy to reach therapeutic levels at the tumor site. 'Targeted cancer treatment is an area of immense interest for oncology,' said Scott Helton, M.D., a pancreatic surgeon in Seattle, Washington. 'The ability of PTM-101 to integrate into our current PDAC care pathway is promising, offering the possibility of transforming a diagnostic step into the start of therapy, weeks before the patient can begin intravenous chemotherapy.' PanTher is additionally developing polymeric drug formulations for the treatment of a range of other solid tumor types. About PTM-101 PanTher's most advanced product candidate, PTM-101, is an absorbable thin film formulation of paclitaxel for non-metastatic pancreatic cancer. PTM-101 is designed to deliver continuous, long-term, high-dose chemotherapy to the tumor with little to no systemic exposure. The product, laparoscopically implanted at the tumor site, easily integrates with common minimally-invasive procedures used in staging pancreatic cancer. PTM-101 is currently being evaluated in a Phase 1b clinical trial (NCT06673017) with support from the Cancer Prevention & Research Institute of Texas (CPRIT) DP220066. About PanTher Therapeutics PanTher Therapeutics is a clinical-stage oncology company leveraging combined expertise in drug formulation and materials science to develop and commercialize potent, localized therapeutic products that can improve outcomes for patients with solid tumors. PanTher's Sagittari™ platform enables the formulation of anti-cancer medicines in a wide range of flexible, polymer-based dosage forms that can be administered to the surface of a cancerous organ or implanted directly into a tumor. The drug product is tunable and engineered to continuously deliver the drug for weeks or months at a desired dose level, avoiding dose-limiting side effects of off-target delivery. The company has offices in Austin, Texas, and Watertown, Massachusetts. For more information, visit

Oncolytics Biotech® Strengthens Its Pipeline in 2025 with Key Pancreatic and Anal Cancer Advances in Addition to Metastatic Breast Cancer
Oncolytics Biotech® Strengthens Its Pipeline in 2025 with Key Pancreatic and Anal Cancer Advances in Addition to Metastatic Breast Cancer

Globe and Mail

time18-02-2025

  • Business
  • Globe and Mail

Oncolytics Biotech® Strengthens Its Pipeline in 2025 with Key Pancreatic and Anal Cancer Advances in Addition to Metastatic Breast Cancer

Recent clinical data presentations in these two hard-to-treat GI cancers, coupled with strong efficacy signals in breast cancer, demonstrate the potential of pelareorep across very different tumor types SAN DIEGO and CALGARY, AB , Feb. 18, 2025 /CNW/ -- Oncolytics Biotech ® Inc. ( NASDAQ : ONCY ) ( TSX : ONC ), a leading clinical-stage company specializing in immunotherapy for oncology, continues to make good progress in 2025 with key regulatory and clinical advancements, reinforcing pelareorep's potential in hard-to-treat cancers. Oncolytics is pleased to highlight two significant developments for its immunotherapy , pelareorep : the safety and regulatory clearance to advance enrollment in its pancreatic cancer study and the recent presentation of new efficacy and safety data at the 2025 American Society of Clinical Oncology ( ASCO ) Gastrointestinal Cancers Symposium in late January. "We're hitting critical milestones that validate our progress and set the stage for what we believe will be an exciting year," said Wayne Pisano , Interim CEO and Chair of Oncolytics' Board of Directors. "With positive feedback from regulators in place, we're advancing our pancreatic cancer study toward full enrollment, and our ASCO GI presentations highlighted pelareorep's strong safety and efficacy results in two hard-to-treat cancers. We remain focused on bringing new treatment options to patients while creating value for shareholders as we move forward in 2025." German Regulatory Agency Gives Green Light for Pancreatic Cancer Study to Continue as Planned Approval to Fully Enroll the Cohort Secured: Germany's Paul-Ehrlich-Institute (PEI) has given Oncolytics the go-ahead to continue enrolling patients in its pancreatic cancer trial (GOBLET Cohort 5) after a positive safety review. What This Means: Pelareorep, in combination with modified FOLFIRINOX with and without atezolizumab, is now progressing toward full enrollment, with 30 patients set to participate in Stage 1 across the two treatment arms. Next Steps: Oncolytics will continue to collect safety data, and an initial efficacy readout is expected later this year. ASCO GI 2025 Data Confirms Pelareorep's Potential in Pancreatic and Anal Cancers At ASCO GI 2025, Oncolytics presented new clinical results demonstrating pelareorep's potential in two challenging cancer types: Anal Cancer: Patients receiving pelareorep + atezolizumab continue to show stronger responses than expected based on published studies with checkpoint inhibitors alone. Pancreatic Cancer: Pelareorep previously demonstrated a strong efficacy signal when administered with gemcitabine, nab-paclitaxel, and atezolizumab. The most recent data supports a favorable safety profile when combining pelareorep with a different chemotherapy regimen (modified FOLFIRINOX) with and without the checkpoint inhibitor atezolizumab, potentially expanding its treatment applications. Why This Matters: These findings further de-risk pelareorep's development and could pave the way for larger registration-enabling clinical trials in these indications. Looking Ahead: More Catalysts in 2025 Oncolytics is entering a pivotal year with multiple upcoming milestones, including: Additional data readouts from ongoing trials in gastrointestinal cancers, including translational results that further characterize pelareorep's mechanism of action. Interactions with Regulatory Agencies that could accelerate future trials and move pelareorep closer to potential registration-enabling studies in breast cancer and gastrointestinal cancers. "We're seeing clinical validation across multiple studies," added Pisano. "With encouraging regulatory interactions in hand and data readouts ahead, 2025 is shaping up to be an exciting year for Oncolytics and our investors. As we have shown in GOBLET, BRACELET-1, and numerous previous studies, pelareorep has a favorable safety profile and efficacy signals across multiple indications with a high unmet need. We are excited about the potential for moving to a registration-enabling study in breast cancer and advancing our clinical program in gastrointestinal cancers." About GOBLET The GOBLET (G astrointestinal tum O rs exploring the treatment com B inations with the oncolytic reovirus pe L ar E orep and an T i-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 and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers. Favorable safety and positive clinical efficacy signals have been seen in the pancreatic and anal cancer cohorts. About GOBLET Cohort 5 The modified FOLFIRINOX (mFOLFIRINOX) cohort of the Phase 1/2 GOBLET study is designed to evaluate newly diagnosed metastatic pancreatic ductal adenocarcinoma patients treated with pelareorep + mFOLFIRINOX with or without atezolizumab. A three-patient safety run-in was incorporated to evaluate the safety and tolerability of each treatment arm: pelareorep + mFOLFIRINOX + atezolizumab and pelareorep + mFOLFIRINOX. A total of fifteen evaluable patients will be randomized to each arm in Stage 1 of this Simon two-stage study. The co-primary endpoints are objective response rate and safety. If Stage 1 success criteria are met, one or both treatment arms may be expanded to Stage 2, in which 17 additional evaluable patients per arm will be enrolled. Blood and tumor samples will also be collected for translational evaluations. 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 prepares for 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. 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 advance our pancreatic cancer study toward full enrollment; our focus on bringing new treatment options to patients while creating value for shareholders as we move forward in 2025; our plans to continue to collect safety data; the anticipated timing of an initial efficacy readout; our belief that our new clinical results in anal and pancreatic cancer further de-risk pelareorep's development and could pave the way for larger registration-enabling clinical trials in these indications; our upcoming milestones, including additional data readouts and interactions with regulatory agencies; our belief that pelareorep is poised to advance 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 jpatton@ Investor Relations for Oncolytics Timothy McCarthy LifeSci Advisors +1-917-679-9282 tim@ Media Contact for Oncolytics Michael Rubenstein LifeSci Communications mrubenstein@

Alligator Bioscience Reports Incremental Overall Survival Benefit of Mitazalimab Combined with mFOLFIRINOX Based on Literature-based Indirect Comparison of Outcomes
Alligator Bioscience Reports Incremental Overall Survival Benefit of Mitazalimab Combined with mFOLFIRINOX Based on Literature-based Indirect Comparison of Outcomes

Yahoo

time27-01-2025

  • Business
  • Yahoo

Alligator Bioscience Reports Incremental Overall Survival Benefit of Mitazalimab Combined with mFOLFIRINOX Based on Literature-based Indirect Comparison of Outcomes

LUND, SE / ACCESSWIRE / January 27, 2025 / Alligator Bioscience (STO:ATORX) Indirect Comparison shows significant improvement of OS of mitazalimab + mFOLFIRINOX, compared to known FOLFIRINOX and NALIRIFOX outcomes The data substantiates the potential of this regimen in the context of the upcoming randomized Phase 3 trial Lund, Sweden - Alligator Bioscience (Nasdaq Stockholm: ATORX) today announces positive outcomes from adjusted indirect treatment comparison studies, demonstrating that mitazalimab + mFOLFIRINOX shows significantly better Overall Survival (OS) compared to FOLFIRINOX-based and NALIRIFOX treatment regimens for the frontline treatment of metastatic pancreatic adenocarcinoma cancer (mPDAC). As the OPTIMIZE-1 trial for mitazalimab did not include a control group, these indirect treatment comparisons are a means to establish the relative efficacy of mitazalimab in combination with mFOLFIRINOX compared to existing treatment regimens. A robust comparison was achieved using published literature from randomized Phase 2/3 studies in frontline mPDAC with mitazalimab + mFOLFIRINOX (18-month follow-up analysis), FOLFIRINOX, mFOLFIRINOX and NALIRIFOX regimens, after applying the ITC methodologies. The results demonstrated a significantly better Overall Survival (OS) potential for mitazalimab in combination with mFOLFIRINOX compared to FOLFIRINOX-based regimens (hazard ratio 0.64, 95% CI 0.46 - 0.87) and FOLFIRINOX-based plus NALIRIFOX regimens (hazard ratio 0.68, 95% CI 0.47 - 0.99). This outcome will not only inform preparation of the mitazalimab Phase 3 trial but is also valuable in the context of mitazalimab confirmatory development from both a regulatory and partnering standpoint. These analyses were conducted by an independent clinical research organization in collaboration with expert pancreatic cancer clinicians and results were presented on January 24 at the 2025 ASCO Gastrointestinal (GI) Cancers Symposium in San Francisco, California by Professor Eileen O´Reilly in a presentation titled " Evaluating the relative treatment efficacy of CD40 agonist mitazalimab in combination with mFOLFIRINOX in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) using unanchored indirect treatment comparisons (ITCs) ". "These results further underscore the consistently positive clinical data delivered by mitazalimab, reaffirming its potential to transform the treatment landscape for metastatic pancreatic cancer," said Søren Bregenholt, CEO of Alligator Bioscience. "It is yet another milestone in mitazalimab's development, as we prepare to advance into the Phase 3 trial and continue our mission to bring innovative therapies to patients with urgent unmet needs. We eagerly anticipate the 24-month follow-up data, expected later this quarter, which will further inform the potential of mitazalimab in this critical patient population." "ITC is an acknowledged methodology in the context of health outcomes research, and particularly relevant for a disease like pancreatic cancer with short overall survival" said Dr. Zev Wainberg, Professor of Medicine at University of California, Los Angeles (UCLA) and co-director of the UCLA Gastrointestinal (GI) Oncology Program. "The improvement in survival indicated by these results substantiate the potential for mitazalimab combined with chemotherapy as a frontline therapy, to be evaluated in the upcoming phase 3 study." The encouraging survival benefits demonstrated through this analysis contribute to the growing body of evidence supporting mitazalimab's potential in treating metastatic pancreatic cancer. These findings provide further momentum as Alligator works toward refining standards of care and improving outcomes for patients facing this devastating disease. About the methodologyBy leveraging the published data from randomized Phase 2/3 studies and applying robust indirect treatment comparison methodologies, valuable insights can be gained to support both clinical and regulatory decisions. Matching-adjusted indirect comparison (MAIC) and simulated treatment comparison (STC) adjust for observed heterogeneity of potential effect modifiers across the study populations by utilising propensity score weighting methods and regression methods, respectively. Age, gender, presence of liver metastases and the ECOG performance status were adjusted using these standard methods. These methods, commonly referred to as indirect treatment comparison (ITC), are standard in the context of health outcomes research, and pricing & reimbursement considerations. For further information, please contact: Søren Bregenholt, CEOE-mail: +46 (0) 46 540 82 00 About Alligator Bioscience Alligator is a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs focused on the CD40 receptor. This validated approach promotes priming of tumor-specific T cells and reversing the immunosuppressive nature of the tumor microenvironment, with significant potential benefits for cancer patients across multiple types of cancer. The Company's lead drug candidate mitazalimab, is currently in preparation for Phase 3 development, and has previously presented unprecedented survival data at 18-months follow up in first-line metastatic pancreatic cancer patients in the Phase 2 trial OPTIMIZE-1. Alligator is listed on Nasdaq Stockholm (ATORX) and headquartered in Lund, Sweden. For more information, please visit . Attachments Alligator Bioscience Reports Incremental Overall Survival Benefit of mitazalimab combined with mFOLFIRINOX based on Literature-based Indirect Comparison of Outcomes SOURCE: Alligator Bioscience View the original press release on ACCESS Newswire Sign in to access your portfolio

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