This company listing is no longer activeThis company may still be operating, however this listing is no longer active. Find out why through their latest events.See Latest EventsAlligator Bioscience（ATORX BTU）株式概要アリゲーター・バイオサイエンス社（Alligator Bioscience AB）は研究開発型のバイオテクノロジー企業で、フィンランドとスウェーデンでがん治療用の抗体医薬を開発している。 詳細ATORX BTU ファンダメンタル分析スノーフレーク・スコア評価2/6将来の成長0/6過去の実績0/6財務の健全性1/6配当金0/6リスク分析キャッシュランウェイが1年未満である 株式の流動性は非常に低い マイナスの株主資本 意味のある時価総額がありません ( SEK9M )+2 さらなるリスクすべてのリスクチェックを見るATORX BTU Community Fair Values Create NarrativeSee what others think this stock is worth. Follow their fair value or set your own to get alerts.Your Fair ValueSEK Current PriceSEK 0.4129.7% 割高 内在価値ディスカウントGrowth estimate overAnnual revenue growth rate5 Yearstime period%/yrDecreaseIncreasePastFuture-248m68m2016201920222025202620282031Revenue SEK 17.2mEarnings SEK 3.1mAdvancedSet Fair ValueView all narrativesAlligator Bioscience AB (publ) 競合他社AptahemSymbol: NGM:APTAMarket cap: SEK 17.6mLipigon PharmaceuticalsSymbol: OM:LPGOMarket cap: SEK 908.9kProstatype GenomicsSymbol: OM:PROGENMarket cap: SEK 28.5mExpreS2ion Biotech HoldingSymbol: OM:EXPRS2Market cap: SEK 6.3m価格と性能株価の高値、安値、推移の概要Alligator Bioscience過去の株価現在の株価SEK 0.4152週高値SEK 0.6552週安値SEK 0.34ベータ1.381ヶ月の変化n/a3ヶ月変化n/a1年変化n/a3年間の変化n/a5年間の変化n/aIPOからの変化9.50%最新ニュースお知らせ • Jan 09Alligator Bioscience to Present New Optimize-1 Data on Mitazalimab at ASCO Gastrointestinal Cancers SymposiumAlligator Bioscience announced that new data from its Phase 1b/2 OPTIMIZE-1 study evaluating mitazalimab in combination with mFOLFIRINOX in previously untreated metastatic pancreatic ductal adenocarcinoma (mPDAC) will be presented at the ASCO Gastrointestinal Cancers Symposium (ASCO GI) in San Francisco, CA, taking place 8-11 January 2026. The presentation will highlight new analyses from OPTIMIZE-1 further characterizing the clinical benefit observed with mitazalimab plus standard chemotherapy in metastatic pancreatic cancer. The data support Alligator's continued preparations for mitazalimab's pivotal development and reinforce the scientific and clinical rationale for CD40 agonism as an immunotherapy approach in this hard-to-treat disease.お知らせ • Dec 20Alligator Bioscience AB (publ) has completed a Composite Units Offering.Alligator Bioscience AB (publ) has completed a Composite Units Offering. Security Name: Units Security Type: Equity/Derivative Unit Securities Offered: 198,725,144 Price\Range: SEK 0.4 Transaction Features: Rights Offeringお知らせ • Jul 11Alligator Bioscience AB (Publ) Appoints Johan Giléus as Chief Financial Officer as of August 12, 2024On June 14, Alligator Bioscience AB (publ) announced the appointment of Johan Giléus as the company's new Chief Financial Officer as of August 12, 2024, to oversee financial strategy and operations.お知らせ • Jul 10Alligator Bioscience Announces Completion of Enrollment in Mitazalimab Optimize-1 StudyAlligator Bioscience announced an update on the on-going OPTIMIZE-1 clinical Phase 2 trial with the company's lead asset, mitazalimab. All patients in the 450 ug/kg back-fill cohort have been enrolled. The additional cohort was enrolled in order to provide further dose characterization following advice from the FDA, to ensure mitazalimab Phase 3 readiness. OPTIMIZE-1, an open-label, single-arm, multicenter, Phase 1b/2 study, assessed the safety and efficacy of mitazalimab (CD40 mAb agonist) in combination with standard of care chemotherapy mFOLFIRINOX in 1st line pancreatic cancer. On June 26, the 18- was reported, demonstrating robust data with month follow-up analysis substantial survival benefits compared to standard of care chemotherapy.お知らせ • Jun 26Alligator Bioscience Announces Results from the Ongoing Optimize-1 TrialAlligator Bioscience announces positive 18-month follow-up data from the OPTIMIZE-1 Phase 2 study of the company's lead asset mitazalimab in 1st line metastatic pancreatic cancer. The open-label, multi-center study assessed the safety and efficacy of mitazalimab (CD40 mAb agonist) in combination with standard of care chemotherapy mFOLFIRINOX, in previously untreated, chemotherapy naïve pancreatic cancer patients. The data demonstrated a near doubling of the 18-month survival rate to 36.2% in patients treated with mitazalimab in combination with mFOLFIRINOX, compared to 18.6% reported with FOLFIRINOX alone. The updated Median Overall Survival (mOS) was 14.9 months, up from 14.3 months at the time of first analysis, comparing favorably to the 11.1 months demonstrated by FOLFIRINOX and more recently by NALIRIFOX. Median follow-up duration for the updated analysis was 18.2 months, indicating the maturity of these outcomes. At the time of the analysis, a total of 17 (30%) patients were still alive, and of these 9 (16% overall) were still on treatment. The longest ongoing treatment duration was 24 months. The follow-up data further demonstrate: An additional late responding patient increased the confirmed Objective Response Rate (ORR; as per the Response Evaluation Criteria in Solid Tumors RECIST 1.1) to 42.1% from the 40.4% reported in the top-line readout, comparing favorably to the ORR of 31.6% reported in a similar patient population treated with FOLFIRINOX alone and an ORR of 42% reported by NALIRIFOX. An increase in the unconfirmed ORR to 54.4% was reported in 57 evaluable patients. The median Duration of Response (DoR) was 12.6 months, an unprecedented outcome in this aggressive disease and much longer compared to 5.9 months with FOLFIRINOX and 7.3 months with NALIRIFOX. Median Progression Free Survival (PFS) was 7.7 months, and a nearly 3-fold increase in the 12-month PFS rate was reported; 35.1% in OPTIMIZE-1 against 12.1% previously reported for FOLFIRINOX.お知らせ • Jun 21Alligator Bioscience AB (publ) to Present Positive Phase 2 Data on Mitazalimab in Pancreatic Cancer at ESMO GI 2024Alligator Bioscience AB (publ) announced it will present positive Phase 2 data on its lead drug candidate mitazalimab in first line metastatic pancreatic cancer at the European Society for Medical Oncology Gastrointestinal Cancers Congress 2024 (ESMO GI 2024), taking place in Munich, Germany from June 26-29. The oral presentation outlines OPTIMIZE-1, an open-label, multicenter, Phase 1b/2 study, assessing the safety and efficacy of mitazalimab (CD40 mAb agonist) in combination with standard of care chemotherapy mFOLFIRINOX. The trial study met its primary endpoint, with mitazalimab showing a manageable safety profile and promising DoR associated with a clinically meaningful survival benefit. Furthermore, there was a significant correlation between treatment-induced increases in natural killer T (NKT) cells and T cells expressing CD38 and depth of response, strongly suggestive of a mitazalimab-dependent contribution to deep anti-tumor responses. The 5-year overall survival rate for metastatic pancreatic ductal adenocarcinoma (mPDAC) is less than 5%, and current systemic therapies are associated with poor outcomes. The OPTIMIZE-1 data have also recently been published in the peer-reviewed The Lancet Oncologyand presented in two posters at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. Alligator expects to report 18-month survival follow-up data from OPTIMIZE-1 at the end of June 2024, and that these will provide further insights into the potential of mitazalimab. Results from the OPTIMIZE-1 trial showed mitazalimab in combination with mFOLFIRINOX had a confirmed ORR of 40.4% in 57 evaluable patients (unconfirmed ORR was 50.9%). Median DoR was 12.5 months and the median OS was 14.3 months. Median Progression Free Survival (PFS) was 7.7 months. These data compare favorably to the historically reported outcomes with FOLFIRINOX (ORR 31.6%, mDoR 5.9 months, mOS 11.1 months and mPFS 6.4 months). The recently approved new treatment regimen of NALIRIFOX was associated with an ORR of 42%, mDoR of 7.3 months, mPFS 7.4 months and a mOS of 11.1 months.最新情報をもっと見るRecent updatesお知らせ • Jan 09Alligator Bioscience to Present New Optimize-1 Data on Mitazalimab at ASCO Gastrointestinal Cancers SymposiumAlligator Bioscience announced that new data from its Phase 1b/2 OPTIMIZE-1 study evaluating mitazalimab in combination with mFOLFIRINOX in previously untreated metastatic pancreatic ductal adenocarcinoma (mPDAC) will be presented at the ASCO Gastrointestinal Cancers Symposium (ASCO GI) in San Francisco, CA, taking place 8-11 January 2026. The presentation will highlight new analyses from OPTIMIZE-1 further characterizing the clinical benefit observed with mitazalimab plus standard chemotherapy in metastatic pancreatic cancer. The data support Alligator's continued preparations for mitazalimab's pivotal development and reinforce the scientific and clinical rationale for CD40 agonism as an immunotherapy approach in this hard-to-treat disease.お知らせ • Dec 20Alligator Bioscience AB (publ) has completed a Composite Units Offering.Alligator Bioscience AB (publ) has completed a Composite Units Offering. Security Name: Units Security Type: Equity/Derivative Unit Securities Offered: 198,725,144 Price\Range: SEK 0.4 Transaction Features: Rights Offeringお知らせ • Jul 11Alligator Bioscience AB (Publ) Appoints Johan Giléus as Chief Financial Officer as of August 12, 2024On June 14, Alligator Bioscience AB (publ) announced the appointment of Johan Giléus as the company's new Chief Financial Officer as of August 12, 2024, to oversee financial strategy and operations.お知らせ • Jul 10Alligator Bioscience Announces Completion of Enrollment in Mitazalimab Optimize-1 StudyAlligator Bioscience announced an update on the on-going OPTIMIZE-1 clinical Phase 2 trial with the company's lead asset, mitazalimab. All patients in the 450 ug/kg back-fill cohort have been enrolled. The additional cohort was enrolled in order to provide further dose characterization following advice from the FDA, to ensure mitazalimab Phase 3 readiness. OPTIMIZE-1, an open-label, single-arm, multicenter, Phase 1b/2 study, assessed the safety and efficacy of mitazalimab (CD40 mAb agonist) in combination with standard of care chemotherapy mFOLFIRINOX in 1st line pancreatic cancer. On June 26, the 18- was reported, demonstrating robust data with month follow-up analysis substantial survival benefits compared to standard of care chemotherapy.お知らせ • Jun 26Alligator Bioscience Announces Results from the Ongoing Optimize-1 TrialAlligator Bioscience announces positive 18-month follow-up data from the OPTIMIZE-1 Phase 2 study of the company's lead asset mitazalimab in 1st line metastatic pancreatic cancer. The open-label, multi-center study assessed the safety and efficacy of mitazalimab (CD40 mAb agonist) in combination with standard of care chemotherapy mFOLFIRINOX, in previously untreated, chemotherapy naïve pancreatic cancer patients. The data demonstrated a near doubling of the 18-month survival rate to 36.2% in patients treated with mitazalimab in combination with mFOLFIRINOX, compared to 18.6% reported with FOLFIRINOX alone. The updated Median Overall Survival (mOS) was 14.9 months, up from 14.3 months at the time of first analysis, comparing favorably to the 11.1 months demonstrated by FOLFIRINOX and more recently by NALIRIFOX. Median follow-up duration for the updated analysis was 18.2 months, indicating the maturity of these outcomes. At the time of the analysis, a total of 17 (30%) patients were still alive, and of these 9 (16% overall) were still on treatment. The longest ongoing treatment duration was 24 months. The follow-up data further demonstrate: An additional late responding patient increased the confirmed Objective Response Rate (ORR; as per the Response Evaluation Criteria in Solid Tumors RECIST 1.1) to 42.1% from the 40.4% reported in the top-line readout, comparing favorably to the ORR of 31.6% reported in a similar patient population treated with FOLFIRINOX alone and an ORR of 42% reported by NALIRIFOX. An increase in the unconfirmed ORR to 54.4% was reported in 57 evaluable patients. The median Duration of Response (DoR) was 12.6 months, an unprecedented outcome in this aggressive disease and much longer compared to 5.9 months with FOLFIRINOX and 7.3 months with NALIRIFOX. Median Progression Free Survival (PFS) was 7.7 months, and a nearly 3-fold increase in the 12-month PFS rate was reported; 35.1% in OPTIMIZE-1 against 12.1% previously reported for FOLFIRINOX.お知らせ • Jun 21Alligator Bioscience AB (publ) to Present Positive Phase 2 Data on Mitazalimab in Pancreatic Cancer at ESMO GI 2024Alligator Bioscience AB (publ) announced it will present positive Phase 2 data on its lead drug candidate mitazalimab in first line metastatic pancreatic cancer at the European Society for Medical Oncology Gastrointestinal Cancers Congress 2024 (ESMO GI 2024), taking place in Munich, Germany from June 26-29. The oral presentation outlines OPTIMIZE-1, an open-label, multicenter, Phase 1b/2 study, assessing the safety and efficacy of mitazalimab (CD40 mAb agonist) in combination with standard of care chemotherapy mFOLFIRINOX. The trial study met its primary endpoint, with mitazalimab showing a manageable safety profile and promising DoR associated with a clinically meaningful survival benefit. Furthermore, there was a significant correlation between treatment-induced increases in natural killer T (NKT) cells and T cells expressing CD38 and depth of response, strongly suggestive of a mitazalimab-dependent contribution to deep anti-tumor responses. The 5-year overall survival rate for metastatic pancreatic ductal adenocarcinoma (mPDAC) is less than 5%, and current systemic therapies are associated with poor outcomes. The OPTIMIZE-1 data have also recently been published in the peer-reviewed The Lancet Oncologyand presented in two posters at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. Alligator expects to report 18-month survival follow-up data from OPTIMIZE-1 at the end of June 2024, and that these will provide further insights into the potential of mitazalimab. Results from the OPTIMIZE-1 trial showed mitazalimab in combination with mFOLFIRINOX had a confirmed ORR of 40.4% in 57 evaluable patients (unconfirmed ORR was 50.9%). Median DoR was 12.5 months and the median OS was 14.3 months. Median Progression Free Survival (PFS) was 7.7 months. These data compare favorably to the historically reported outcomes with FOLFIRINOX (ORR 31.6%, mDoR 5.9 months, mOS 11.1 months and mPFS 6.4 months). The recently approved new treatment regimen of NALIRIFOX was associated with an ORR of 42%, mDoR of 7.3 months, mPFS 7.4 months and a mOS of 11.1 months.お知らせ • May 24Alligator Bioscience to Present Positive Phase 2 Mitazalimab Data in Pancreatic Cancer at 2024 ASCO Annual MeetingAlligator Bioscience AB (publ) announced that two clinical abstracts on its lead drug candidate mitazalimab, a best- in-class CD40 agonist, in first line metastatic pancreatic cancer will be presented (abstracts 2569 and 4133) in a poster presentation session at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place in Chicago, IL and online during May 31-June 4. Data presented at ASCO from the OPTIMIZE-1 study, of mitazalimab in combination with mFOLFIRINOX chemotherapy, showed that pharmacological analyses identified mitazalimab-induced expansion of CD4 effector T cells one week after first administration as a correlate of treatment outcomes. These data suggest the contribution of mitazalimab to tumor responses, and further supports the unique trial design of OPTIMIZE-1. OPTIMIZE-1 achieved its primary endpoint, demonstrating a confirmed Objective Response Rate (ORR) of 40.4%, an unconfirmed ORR of 50.9% and a disease control rate (DCR) of 79% in 57 evaluable patients, as per the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). This compares favorably to the ORR of 31.6% reported in a similar patient population treated with FOLFIRINOX alone. Median Duration of Response (DoR) was 12.5 months, remarkably longer than reported so far with any other approved and investigational therapies. Median Overall Survival (OS) was 14.3 months and the survival estimate from the next planned analysis may further improve. The open-label, multi-center OPTIMIZE-1 study assessed the safety and efficacy of mitazalimab (CD40 mAb agonist) in combination with standard of care chemotherapy mFOLFIRINOX, in previously untreated, chemotherapy naïve patients. More details can be found with the clinicaltrials.gov identifier NCT04888312.お知らせ • May 15Alligator Bioscience Announces Initiation of an Investigator-Initiated Phase 1 Clinical Study of Mitazalimab in Local Advanced Pancreatic CancerAlligator Bioscience announced the initiation of an investigator initiated Phase 1 clinical study (NCT06205849) evaluating the safety and efficacy of the company's lead asset mitazalimab (CD40 mAb agonist) injected intratumorally at the time of surgical irreversible electroporation (IRE) in patients with locally advanced pancreatic cancer (LAPC). The NCI-funded Phase 1a/1b single-center study will enroll up to 18 patients, who will receive a single intratumoral injection of mitazalimab immediately after the surgical IRE, a form of non-thermal ablation that is currently in clinical use for selected patients with LAPC. The study is being conducted by researchers at Moores Cancer Center at UC San Diego. Alligator will supply mitazalimab for the study.お知らせ • May 12+ 1 more updateAlligator Bioscience AB (publ) to Report Nine Months, 2024 Results on Oct 24, 2024Alligator Bioscience AB (publ) announced that they will report nine months, 2024 results on Oct 24, 2024お知らせ • Apr 05Alligator Bioscience AB (Publ) Announces Graham Dixon and Veronica Wallin Not Proposed for Re-Election on BoardAlligator Bioscience AB (publ) at the annual general meeting to be held on 7 May 2024, Graham Dixon and Veronica Wallin are not proposed for re-election on the board.お知らせ • Mar 07Alligator Bioscience and Aptevo Therapeutics Announce Positive Interim Data of Dose Escalation Phase of ALG.APV-527 Phase 1 Study in Solid Tumor Cancers Expressing Tumor Antigen 5T4Alligator Bioscience AB and Aptevo Therapeutics announced positive interim data from the dose escalation phase of their Phase 1 trial evaluating ALG.APV-527 for the treatment of solid tumors likely to express the tumor antigen 5T4. The multi-center, dose escalation trial is now more than 50% enrolled, and preliminary results include: Treatment was overall well-tolerated, and a maximum tolerated dose has not yet been determined, dose-escalation in higher-dose cohorts is ongoing, ALG.APV-527 could be measured in all patients with plasma concentration of ALG.APV-527 consistent with the administered dose, Biomarker analyses indicate the expression of the targets (4-1BB and 5T4) in tumor biopsies and confirm biological activity of ALG.APV-527. Of particular interest, signs of clinical activity were observed for both enrolled patients with heavily pre-treated breast cancer. These patients demonstrated measurable level of drug in circulation (pharmacokinetic) and reproducible elevation of serum pharmacodynamic markers with dosing, suggesting the drug is biologically active. One patient remained on study for seven months and a second remains on study beyond nine months. Both patients achieved best overall response of stable disease. The ALG.APV-527 Phase 1 trial is a multi-center, multi-cohort, open-label trial that will include six cohorts (dose levels) in a 3+3 design. The trial will be conducted at up to 10 sites in the U.S. among adult patients with multiple solid tumor types/histologies likely to express the 5T4 antigen. ALG.APV-527 will be given intravenously once every two weeks. The trial will assess the safety and tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of ALG.APV-527. ALG.APV-527 is a bispecific conditional 4-1BB agonist, only active upon simultaneous binding to 4-1BB and 5T4. This has the potential to be clinically important because 4-1BB can stimulate the immune cells (antitumor-specific T cells and NK cells) involved in tumor control, making 4-1BB a particularly compelling target for cancer immunotherapy. 5T4 is an oncofetal tumor associated antigen overexpressed on numerous solid tumors including non-small-cell lung carcinoma (NSCLC), breast, head and neck, cervical, renal, gastric, and colorectal cancer.お知らせ • Feb 09+ 1 more updateAlligator Bioscience Plans to Adjust Size of Organization with Reduction of Approximately 20% to 25% of Current WorkforceAlligator Bioscience announced that it plans to adjust the size of its organization to reflect the end of the resource-intensive OPTIMIZE-1 Phase 2 clinical trial with its lead asset mitazalimab, and the need for the company to prioritize its preclinical and early-stage assets. The planned restructuring remains subject to negotiation with the relevant trade unions but would result in a reduction of approximately 20% to 25% of the current workforce, which once implemented is expected to reduce operational cash burn with SEK 20 million annually. Alligator will notify the Swedish Public Employment Service (Sw. Arbetsförmedlingen) and seek consultations with trade unions regarding the reorganization. Decisions regarding employee reductions will take place after the change consultations have been concluded according to local regulations.お知らせ • Jan 29Alligator Bioscience Announces Positive Top-Line Results from the Optimize-1 Phase 2 Study of the Company's Lead Asset Mitazalimab in 1st Line Metastatic Pancreatic CancerAlligator Bioscience announced positive top-line results from the OPTIMIZE-1 Phase 2 study of the company’s lead asset mitazalimab in 1st line metastatic pancreatic cancer. The open-label, multi-center study assessed the safety and efficacy of mitazalimab (CD40 mAb agonist) in combination with standard of care chemotherapy mFOLFIRINOX, in previously untreated, chemotherapy naive patients. The study achieved its primary endpoint with the top-line results demonstrating a confirmed Objective Response Rate (ORR) of 40.4%, an unconfirmed ORR of 50.9% and a disease control rate (DCR) of 79% in 57 evaluable patients, as per the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). This compares favorably to the ORR of 31.6% reported in a similar patient population treated with FOLFIRINOX alone. The cut-off time for analysis was November 14, 2023 with a median follow-up duration of 12.7 months. At the time of the analysis, a total of 29 (51%) patients were still alive, of these 18 (32%) were still on treatment. The longest ongoing treatment duration was 23 months. Three patients demonstrated complete remission of their target lesions. The study further demonstrated: Median Overall Survival (mOS) of 14.3 months at the time of analysis and expected to improve as majority of the patients remain alive, comparing favorably to the 11.1 months demonstrated by FOLFIRINOX[1], and more recently by NALIRIFOX in the NAPOLI 3 Phase 3 trial. An unprecedented median Duration of Response (DoR) of 12.5 months, compared to 5.9 months with FOLFIRINOX[1], and the 7.3 months demonstrated by NALIRIFOX The 12-month survival rate was 59.3% compared to 48.1% for FOLFIRINOX and 45.6% for NALIRIFOX Median Progression Free Survival (PFS) of 7.7 months, compared to 6.4 months with FOLFIRINOX[1], and the 7.4 months demonstrated by NALIRIFOX. Mitazalimab's manageable safety and tolerability profile supporting long-term administration in combination with mFOLFIRINOX was confirmed. As the majority of patients remain alive at the time of analysis, Overall Survival and Durability of Response are expected to improve further with ongoing treatment and follow-up. Alligator Bioscience has undertaken discussions with the US Food and Drug Administration (FDA) and has been able to establish a clear development and approval pathway for mitazalimab in pancreatic cancer. Based on the emerging data from the OPTIMIZE-1 study, FDA has provided additional guidance and has endorsed OPTIMIZE-1 as a Phase 3 enabling study. Consequently, mitazalimab can proceed directly to a global Phase 3 registration study, which Alligator is preparing to initiate in early 2025.お知らせ • Nov 07Alligator Bioscience AB (Publ) Appoints Bertil Brinck as Chairman of the Nomination CommitteeAlligator Bioscience AB (publ) announced that Bertil Brinck has been appointed Chairman of the Nomination Committee.お知らせ • Oct 13Alligator Bioscience Grants New Composition of Matter Patent in Europe for MitazalimabAlligator Bioscience announced that the European Patent Office (EPO) has granted the company a new patent based on EP Patent No. 3323834 covering its lead drug candidate= mitazalimab, a CD40 monoclonal antibody currently being evaluated in a Phase 2 study in 1st line metastatic pancreatic cancer. Mitazalimab is being evaluated in combination with chemotherapy, mFOLFIRINOX, in the OPTIMIZE-1 Phase 2 study in 1st line metastatic pancreatic cancer. The study is progressing and is on track for top-line readout in early first quarter of 2024.お知らせ • Aug 18Alligator Bioscience AB (publ) Announces Resignation of Malin Carlsson as Chief Operating Officer At the End of OctoberAlligator Bioscience AB (publ) announced the resignation of Malin Carlsson as the company's Chief Operating Officer (COO). Dr Carlsson will leave her role at the end of October to assume an executive role in a global pharma company. Dr Carlsson’s responsibilities will be transferred to other members of the Management team.お知らせ • Jul 06Alligator Bioscience AB (Publ) Announces Executive ChangesAlligator Bioscience AB (publ) announced that Anette Sundstedt, PhD, Principal Scientist at Alligator, has been appointed as employee representative, and Karin Nordbladh, Director Clinical Operations at Alligator, as deputy employee representative at the Alligator Bioscience AB's Board of Directors, effective July 5, 2023. Anette Sundstedt, who joined Alligator in 2021, replaces Tova Landström, who resigned on May 26, 2023, for personals reasons.お知らせ • Jul 01Alligator Bioscience AB (publ) Announces Phase II Results Indicate Durability of Response for Alligator's CD40 AgonistAlligator Bioscience AB (publ) has presented a second round of interim results from a phase II trial with mitazalimab in pancreatic cancer patients. The follow-up evaluation on the first 23 patients shows an objective response rate of 57% - up from 52% at the first evaluation reported in January. The evaluation on the full set of 57 patients reveals an objective response rate of 44% - also susceptible to an increase as the study progresses. More data points indicate that mitazalimab provides a durable response in combination with standard of care chemotherapy.お知らせ • Jun 27Alligator Bioscience Announces Positive Second Interim Results from the Ongoing Optimize-1 Phase 2 Study of the Lead Asset Mitazalimab in 1st Line Metastatic Pancreatic CancerAlligator Bioscience announced positive second interim results from the ongoing OPTIMIZE-1 Phase 2 study of the company's lead asset mitazalimab in 1st line metastatic pancreatic cancer. The open-label, multi-center study is assessing the safety and efficacy of mitazalimab (CD40 mAb agonist) in combination with chemotherapy, mFOLFIRINOX, in previously untreated patients with metastatic pancreatic ductal adenocarcinoma. The second interim analysis conducted on the 23 patients included in the interim analysis, with a follow-up period of nine to 17 months, reported in January 2023. demonstrated the following: Tumor responses deepened and the Objective Response Rate (ORR) increased to 57% (from 52%), suggesting a durable benefit for patients. Of the 13 patients achieving an objective response, seven (54%) were still ongoing in treatment for longer than 10 months with a maintained response, with the longest being 17 months. The interim analysis conducted on all 57 evaluable patients with a follow-up periodof two to 17 months demonstrated the following: 25 patients responded to treatment resulting in an interim ORR of 44%. Median Duration of Response (DoR) was 8.7 months compared to 5.9 reported for FOLFIRINOX alone in other studies, indicating an immunostimulatory effect of mitazalimab and potential Progression Free Survival (PFS) and survival benefits. In addition, 19 patients (33%) achieved stable disease resulting in a 77% disease control rate (DCR) Furthermore, mitazalimab's manageable safety and tolerability profile in combination with mFOLFIRINOX was confirmed. These data compare favorably to the ORR of 31.6%, mPFS of 6.4 months and DoR of 5.9 months reported in similar patient populations treated with standard of care FOLFIRINOX alone. Completion of, and patient enrolment in OPTIMIZE-1 was reported in April 2023 in May 2023, mitazalimab was granted Orphan Drug Designation by the U. S. Food and Drug Administration for the treatment of pancreatic cancer.お知らせ • Jun 06Alligator Bioscience to Present Latest Clinical Data from Mitazalimab Optimize-1 Phase 2 Trial in Pancreatic Cancer At Asco Annual Meeting 2023Alligator Bioscience announces that data from the ongoing OPTIMIZE-1 Phase 2 study of the company's lead asset mitazalimab in 1st line metastatic pancreatic cancer will be presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, being held in Chicago, June 2-6. The data presented at ASCO demonstrate that mitazalimab in combination with mFOLFIRINOX is a feasible treatment regimen for 1st line pancreatic cancer patients with encouraging interim efficacy and well-manageable safety profile, consistent with mFOLFIRINOX monotherapy. Combination with mFOLFIRINOX had no impact on mitazalimab pharmacokinetics and the pharmacodynamic biomarker profile in peripheral blood confirmed the immune activation profile typical of mitazalimab. When administered at 900 µg/kg in combination with mFOLFIRINOX, mitazalimab showed robust anti-tumor activity in 23 mPDAC patients, meriting continued development. An objective response rate (ORR) of 52% was demonstrated with clinically meaningful tumor reduction in 12 of the 23 evaluable patients, which compares favorably to the 31.6%[1] reported with FOLFIRINOX in a similar patient population. The analysis also revealed: 8 patients achieved stable disease resulting in a 91% disease control rate (DCR), 6 of the 7 patients who began treatment at least 6 months prior to the interim analysis cutoff were still on treatment, and of these, 2 patients had been receiving treatment for over 11 months.株主還元ATORX BTUSE BiotechsSE 市場7D9.2%3.7%4.3%1Yn/a29.5%14.4%株主還元を見る業界別リターン: ATORX BTUがSwedish Biotechs業界に対してどのようなパフォーマンスを示したかを判断するにはデータが不十分です。リターン対市場: ATORX BTU Swedish市場に対してどのようなパフォーマンスを示したかを判断するにはデータが不十分です。価格変動Is ATORX BTU's price volatile compared to industry and market?ATORX BTU volatilityATORX BTU Average Weekly Movementn/aBiotechs Industry Average Movement9.3%Market Average Movement6.3%10% most volatile stocks in SE Market13.5%10% least volatile stocks in SE Market3.7%安定した株価: ATORX BTUの株価は、 Swedish市場と比較して過去 3 か月間で変動しています。時間の経過による変動: 過去 1 年間のATORX BTUのボラティリティの変化を判断するには データが不十分です。会社概要設立従業員CEO（最高経営責任者ウェブサイト200013Søren Bregenholtwww.alligatorbioscience.seアリゲーター・バイオサイエンス社（Alligator Bioscience AB）は研究開発型のバイオテクノロジー企業で、フィンランドとスウェーデンでがん治療用の抗体医薬を開発している。同社はCD40を標的とする刺激性抗体Mitazalimabを開発しており、膵臓癌を含む固形転移性腫瘍の治療薬として第2相臨床試験中である。また、固形転移性腫瘍の治療薬として前臨床段階にある、免疫療法のためのNeo-X-Prime技術プラットフォームを用いて開発された腫瘍指向性二重特異性抗体ATOR-4066も開発している。また、4-1BBと5T4分子を標的とする二重特異性抗体ALG APV-527は固形転移性腫瘍の治療薬として臨床第1相試験中であり、ATOR-1017は腫瘍内のT細胞とNK細胞上の4-1BB受容体を刺激するモノクローナル抗体で、固形転移性癌の治療薬として臨床第1相試験中である。さらに、独自のヒト抗体ライブラリーであるALLIGATOR-GOLD、創薬に最適な特性を持つ複数の足場を構築し、生成される抗体の構造多様性をさらに高めるALLIGATOR-FAB、抗体やその他のタンパク質の最適化のための分子進化技術であるFIND、二特異性抗体フォーマットであるRUBYなどの技術プラットフォームを用いた製品開発も行っている。さらに、Aptevo Therapeutics, Inc.、Orion Corporation、BioArctic AB、Abclon Inc.と共同研究および導出契約を結んでいる。同社は2000年に設立され、スウェーデンのルンドに本社を置いている。もっと見るAlligator Bioscience AB (publ) 基礎のまとめAlligator Bioscience の収益と売上を時価総額と比較するとどうか。ATORX BTU 基礎統計学時価総額SEK 8.68m収益（TTM）-SEK 77.72m売上高(TTM)SEK 46.22m0.2xP/Sレシオ-0.1xPER（株価収益率ATORX BTU は割高か？公正価値と評価分析を参照収益と収入最新の決算報告書（TTM）に基づく主な収益性統計ATORX BTU 損益計算書（TTM）収益SEK 46.22m売上原価SEK 106.63m売上総利益-SEK 60.41mその他の費用SEK 17.31m収益-SEK 77.72m直近の収益報告Sep 30, 2025次回決算日Feb 12, 2026一株当たり利益（EPS）-1.77グロス・マージン-130.70%純利益率-168.15%有利子負債／自己資本比率0%ATORX BTU の長期的なパフォーマンスは？過去の実績と比較を見るView Valuation企業分析と財務データの現状データ最終更新日（UTC時間）企業分析2026/01/15 15:45終値2026/01/13 00:00収益2025/09/30年間収益2024/12/31データソース企業分析に使用したデータはS&P Global Market Intelligence LLC のものです。本レポートを作成するための分析モデルでは、以下のデータを使用しています。データは正規化されているため、ソースが利用可能になるまでに時間がかかる場合があります。パッケージデータタイムフレーム米国ソース例会社財務10年損益計算書キャッシュ・フロー計算書貸借対照表SECフォーム10-KSECフォーム10-Qアナリストのコンセンサス予想+プラス3年予想財務アナリストの目標株価アナリストリサーチレポートBlue Matrix市場価格30年株価配当、分割、措置ICEマーケットデータSECフォームS-1所有権10年トップ株主インサイダー取引SECフォーム4SECフォーム13Dマネジメント10年リーダーシップ・チーム取締役会SECフォーム10-KSECフォームDEF 14A主な進展10年会社からのお知らせSECフォーム8-K* 米国証券を対象とした例であり、非米国証券については、同等の規制書式および情報源を使用。特に断りのない限り、すべての財務データは1年ごとの期間に基づいていますが、四半期ごとに更新されます。これは、TTM（Trailing Twelve Month）またはLTM（Last Twelve Month）データとして知られています。詳細はこちら。分析モデルとスノーフレーク本レポートを生成するために使用した分析モデルの詳細は当社のGithubページでご覧いただけます。また、レポートの使用方法に関するガイドやYoutubeのチュートリアルも掲載しています。シンプリー・ウォールストリート分析モデルを設計・構築した世界トップクラスのチームについてご紹介します。業界およびセクターの指標私たちの業界とセクションの指標は、Simply Wall Stによって6時間ごとに計算されます。アナリスト筋Alligator Bioscience AB (publ) 1 これらのアナリストのうち、弊社レポートのインプットとして使用した売上高または利益の予想を提出したのは、 。アナリストの投稿は一日中更新されます。2 アナリスト機関Carl RamaniusRedeyeFilip LindkvistRedeye
お知らせ • Jan 09Alligator Bioscience to Present New Optimize-1 Data on Mitazalimab at ASCO Gastrointestinal Cancers SymposiumAlligator Bioscience announced that new data from its Phase 1b/2 OPTIMIZE-1 study evaluating mitazalimab in combination with mFOLFIRINOX in previously untreated metastatic pancreatic ductal adenocarcinoma (mPDAC) will be presented at the ASCO Gastrointestinal Cancers Symposium (ASCO GI) in San Francisco, CA, taking place 8-11 January 2026. The presentation will highlight new analyses from OPTIMIZE-1 further characterizing the clinical benefit observed with mitazalimab plus standard chemotherapy in metastatic pancreatic cancer. The data support Alligator's continued preparations for mitazalimab's pivotal development and reinforce the scientific and clinical rationale for CD40 agonism as an immunotherapy approach in this hard-to-treat disease.
お知らせ • Dec 20Alligator Bioscience AB (publ) has completed a Composite Units Offering.Alligator Bioscience AB (publ) has completed a Composite Units Offering. Security Name: Units Security Type: Equity/Derivative Unit Securities Offered: 198,725,144 Price\Range: SEK 0.4 Transaction Features: Rights Offering
お知らせ • Jul 11Alligator Bioscience AB (Publ) Appoints Johan Giléus as Chief Financial Officer as of August 12, 2024On June 14, Alligator Bioscience AB (publ) announced the appointment of Johan Giléus as the company's new Chief Financial Officer as of August 12, 2024, to oversee financial strategy and operations.
お知らせ • Jul 10Alligator Bioscience Announces Completion of Enrollment in Mitazalimab Optimize-1 StudyAlligator Bioscience announced an update on the on-going OPTIMIZE-1 clinical Phase 2 trial with the company's lead asset, mitazalimab. All patients in the 450 ug/kg back-fill cohort have been enrolled. The additional cohort was enrolled in order to provide further dose characterization following advice from the FDA, to ensure mitazalimab Phase 3 readiness. OPTIMIZE-1, an open-label, single-arm, multicenter, Phase 1b/2 study, assessed the safety and efficacy of mitazalimab (CD40 mAb agonist) in combination with standard of care chemotherapy mFOLFIRINOX in 1st line pancreatic cancer. On June 26, the 18- was reported, demonstrating robust data with month follow-up analysis substantial survival benefits compared to standard of care chemotherapy.
お知らせ • Jun 26Alligator Bioscience Announces Results from the Ongoing Optimize-1 TrialAlligator Bioscience announces positive 18-month follow-up data from the OPTIMIZE-1 Phase 2 study of the company's lead asset mitazalimab in 1st line metastatic pancreatic cancer. The open-label, multi-center study assessed the safety and efficacy of mitazalimab (CD40 mAb agonist) in combination with standard of care chemotherapy mFOLFIRINOX, in previously untreated, chemotherapy naïve pancreatic cancer patients. The data demonstrated a near doubling of the 18-month survival rate to 36.2% in patients treated with mitazalimab in combination with mFOLFIRINOX, compared to 18.6% reported with FOLFIRINOX alone. The updated Median Overall Survival (mOS) was 14.9 months, up from 14.3 months at the time of first analysis, comparing favorably to the 11.1 months demonstrated by FOLFIRINOX and more recently by NALIRIFOX. Median follow-up duration for the updated analysis was 18.2 months, indicating the maturity of these outcomes. At the time of the analysis, a total of 17 (30%) patients were still alive, and of these 9 (16% overall) were still on treatment. The longest ongoing treatment duration was 24 months. The follow-up data further demonstrate: An additional late responding patient increased the confirmed Objective Response Rate (ORR; as per the Response Evaluation Criteria in Solid Tumors RECIST 1.1) to 42.1% from the 40.4% reported in the top-line readout, comparing favorably to the ORR of 31.6% reported in a similar patient population treated with FOLFIRINOX alone and an ORR of 42% reported by NALIRIFOX. An increase in the unconfirmed ORR to 54.4% was reported in 57 evaluable patients. The median Duration of Response (DoR) was 12.6 months, an unprecedented outcome in this aggressive disease and much longer compared to 5.9 months with FOLFIRINOX and 7.3 months with NALIRIFOX. Median Progression Free Survival (PFS) was 7.7 months, and a nearly 3-fold increase in the 12-month PFS rate was reported; 35.1% in OPTIMIZE-1 against 12.1% previously reported for FOLFIRINOX.
お知らせ • Jun 21Alligator Bioscience AB (publ) to Present Positive Phase 2 Data on Mitazalimab in Pancreatic Cancer at ESMO GI 2024Alligator Bioscience AB (publ) announced it will present positive Phase 2 data on its lead drug candidate mitazalimab in first line metastatic pancreatic cancer at the European Society for Medical Oncology Gastrointestinal Cancers Congress 2024 (ESMO GI 2024), taking place in Munich, Germany from June 26-29. The oral presentation outlines OPTIMIZE-1, an open-label, multicenter, Phase 1b/2 study, assessing the safety and efficacy of mitazalimab (CD40 mAb agonist) in combination with standard of care chemotherapy mFOLFIRINOX. The trial study met its primary endpoint, with mitazalimab showing a manageable safety profile and promising DoR associated with a clinically meaningful survival benefit. Furthermore, there was a significant correlation between treatment-induced increases in natural killer T (NKT) cells and T cells expressing CD38 and depth of response, strongly suggestive of a mitazalimab-dependent contribution to deep anti-tumor responses. The 5-year overall survival rate for metastatic pancreatic ductal adenocarcinoma (mPDAC) is less than 5%, and current systemic therapies are associated with poor outcomes. The OPTIMIZE-1 data have also recently been published in the peer-reviewed The Lancet Oncologyand presented in two posters at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. Alligator expects to report 18-month survival follow-up data from OPTIMIZE-1 at the end of June 2024, and that these will provide further insights into the potential of mitazalimab. Results from the OPTIMIZE-1 trial showed mitazalimab in combination with mFOLFIRINOX had a confirmed ORR of 40.4% in 57 evaluable patients (unconfirmed ORR was 50.9%). Median DoR was 12.5 months and the median OS was 14.3 months. Median Progression Free Survival (PFS) was 7.7 months. These data compare favorably to the historically reported outcomes with FOLFIRINOX (ORR 31.6%, mDoR 5.9 months, mOS 11.1 months and mPFS 6.4 months). The recently approved new treatment regimen of NALIRIFOX was associated with an ORR of 42%, mDoR of 7.3 months, mPFS 7.4 months and a mOS of 11.1 months.
お知らせ • Jan 09Alligator Bioscience to Present New Optimize-1 Data on Mitazalimab at ASCO Gastrointestinal Cancers SymposiumAlligator Bioscience announced that new data from its Phase 1b/2 OPTIMIZE-1 study evaluating mitazalimab in combination with mFOLFIRINOX in previously untreated metastatic pancreatic ductal adenocarcinoma (mPDAC) will be presented at the ASCO Gastrointestinal Cancers Symposium (ASCO GI) in San Francisco, CA, taking place 8-11 January 2026. The presentation will highlight new analyses from OPTIMIZE-1 further characterizing the clinical benefit observed with mitazalimab plus standard chemotherapy in metastatic pancreatic cancer. The data support Alligator's continued preparations for mitazalimab's pivotal development and reinforce the scientific and clinical rationale for CD40 agonism as an immunotherapy approach in this hard-to-treat disease.
お知らせ • Dec 20Alligator Bioscience AB (publ) has completed a Composite Units Offering.Alligator Bioscience AB (publ) has completed a Composite Units Offering. Security Name: Units Security Type: Equity/Derivative Unit Securities Offered: 198,725,144 Price\Range: SEK 0.4 Transaction Features: Rights Offering
お知らせ • Jul 11Alligator Bioscience AB (Publ) Appoints Johan Giléus as Chief Financial Officer as of August 12, 2024On June 14, Alligator Bioscience AB (publ) announced the appointment of Johan Giléus as the company's new Chief Financial Officer as of August 12, 2024, to oversee financial strategy and operations.
お知らせ • Jul 10Alligator Bioscience Announces Completion of Enrollment in Mitazalimab Optimize-1 StudyAlligator Bioscience announced an update on the on-going OPTIMIZE-1 clinical Phase 2 trial with the company's lead asset, mitazalimab. All patients in the 450 ug/kg back-fill cohort have been enrolled. The additional cohort was enrolled in order to provide further dose characterization following advice from the FDA, to ensure mitazalimab Phase 3 readiness. OPTIMIZE-1, an open-label, single-arm, multicenter, Phase 1b/2 study, assessed the safety and efficacy of mitazalimab (CD40 mAb agonist) in combination with standard of care chemotherapy mFOLFIRINOX in 1st line pancreatic cancer. On June 26, the 18- was reported, demonstrating robust data with month follow-up analysis substantial survival benefits compared to standard of care chemotherapy.
お知らせ • Jun 26Alligator Bioscience Announces Results from the Ongoing Optimize-1 TrialAlligator Bioscience announces positive 18-month follow-up data from the OPTIMIZE-1 Phase 2 study of the company's lead asset mitazalimab in 1st line metastatic pancreatic cancer. The open-label, multi-center study assessed the safety and efficacy of mitazalimab (CD40 mAb agonist) in combination with standard of care chemotherapy mFOLFIRINOX, in previously untreated, chemotherapy naïve pancreatic cancer patients. The data demonstrated a near doubling of the 18-month survival rate to 36.2% in patients treated with mitazalimab in combination with mFOLFIRINOX, compared to 18.6% reported with FOLFIRINOX alone. The updated Median Overall Survival (mOS) was 14.9 months, up from 14.3 months at the time of first analysis, comparing favorably to the 11.1 months demonstrated by FOLFIRINOX and more recently by NALIRIFOX. Median follow-up duration for the updated analysis was 18.2 months, indicating the maturity of these outcomes. At the time of the analysis, a total of 17 (30%) patients were still alive, and of these 9 (16% overall) were still on treatment. The longest ongoing treatment duration was 24 months. The follow-up data further demonstrate: An additional late responding patient increased the confirmed Objective Response Rate (ORR; as per the Response Evaluation Criteria in Solid Tumors RECIST 1.1) to 42.1% from the 40.4% reported in the top-line readout, comparing favorably to the ORR of 31.6% reported in a similar patient population treated with FOLFIRINOX alone and an ORR of 42% reported by NALIRIFOX. An increase in the unconfirmed ORR to 54.4% was reported in 57 evaluable patients. The median Duration of Response (DoR) was 12.6 months, an unprecedented outcome in this aggressive disease and much longer compared to 5.9 months with FOLFIRINOX and 7.3 months with NALIRIFOX. Median Progression Free Survival (PFS) was 7.7 months, and a nearly 3-fold increase in the 12-month PFS rate was reported; 35.1% in OPTIMIZE-1 against 12.1% previously reported for FOLFIRINOX.
お知らせ • Jun 21Alligator Bioscience AB (publ) to Present Positive Phase 2 Data on Mitazalimab in Pancreatic Cancer at ESMO GI 2024Alligator Bioscience AB (publ) announced it will present positive Phase 2 data on its lead drug candidate mitazalimab in first line metastatic pancreatic cancer at the European Society for Medical Oncology Gastrointestinal Cancers Congress 2024 (ESMO GI 2024), taking place in Munich, Germany from June 26-29. The oral presentation outlines OPTIMIZE-1, an open-label, multicenter, Phase 1b/2 study, assessing the safety and efficacy of mitazalimab (CD40 mAb agonist) in combination with standard of care chemotherapy mFOLFIRINOX. The trial study met its primary endpoint, with mitazalimab showing a manageable safety profile and promising DoR associated with a clinically meaningful survival benefit. Furthermore, there was a significant correlation between treatment-induced increases in natural killer T (NKT) cells and T cells expressing CD38 and depth of response, strongly suggestive of a mitazalimab-dependent contribution to deep anti-tumor responses. The 5-year overall survival rate for metastatic pancreatic ductal adenocarcinoma (mPDAC) is less than 5%, and current systemic therapies are associated with poor outcomes. The OPTIMIZE-1 data have also recently been published in the peer-reviewed The Lancet Oncologyand presented in two posters at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. Alligator expects to report 18-month survival follow-up data from OPTIMIZE-1 at the end of June 2024, and that these will provide further insights into the potential of mitazalimab. Results from the OPTIMIZE-1 trial showed mitazalimab in combination with mFOLFIRINOX had a confirmed ORR of 40.4% in 57 evaluable patients (unconfirmed ORR was 50.9%). Median DoR was 12.5 months and the median OS was 14.3 months. Median Progression Free Survival (PFS) was 7.7 months. These data compare favorably to the historically reported outcomes with FOLFIRINOX (ORR 31.6%, mDoR 5.9 months, mOS 11.1 months and mPFS 6.4 months). The recently approved new treatment regimen of NALIRIFOX was associated with an ORR of 42%, mDoR of 7.3 months, mPFS 7.4 months and a mOS of 11.1 months.
お知らせ • May 24Alligator Bioscience to Present Positive Phase 2 Mitazalimab Data in Pancreatic Cancer at 2024 ASCO Annual MeetingAlligator Bioscience AB (publ) announced that two clinical abstracts on its lead drug candidate mitazalimab, a best- in-class CD40 agonist, in first line metastatic pancreatic cancer will be presented (abstracts 2569 and 4133) in a poster presentation session at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place in Chicago, IL and online during May 31-June 4. Data presented at ASCO from the OPTIMIZE-1 study, of mitazalimab in combination with mFOLFIRINOX chemotherapy, showed that pharmacological analyses identified mitazalimab-induced expansion of CD4 effector T cells one week after first administration as a correlate of treatment outcomes. These data suggest the contribution of mitazalimab to tumor responses, and further supports the unique trial design of OPTIMIZE-1. OPTIMIZE-1 achieved its primary endpoint, demonstrating a confirmed Objective Response Rate (ORR) of 40.4%, an unconfirmed ORR of 50.9% and a disease control rate (DCR) of 79% in 57 evaluable patients, as per the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). This compares favorably to the ORR of 31.6% reported in a similar patient population treated with FOLFIRINOX alone. Median Duration of Response (DoR) was 12.5 months, remarkably longer than reported so far with any other approved and investigational therapies. Median Overall Survival (OS) was 14.3 months and the survival estimate from the next planned analysis may further improve. The open-label, multi-center OPTIMIZE-1 study assessed the safety and efficacy of mitazalimab (CD40 mAb agonist) in combination with standard of care chemotherapy mFOLFIRINOX, in previously untreated, chemotherapy naïve patients. More details can be found with the clinicaltrials.gov identifier NCT04888312.
お知らせ • May 15Alligator Bioscience Announces Initiation of an Investigator-Initiated Phase 1 Clinical Study of Mitazalimab in Local Advanced Pancreatic CancerAlligator Bioscience announced the initiation of an investigator initiated Phase 1 clinical study (NCT06205849) evaluating the safety and efficacy of the company's lead asset mitazalimab (CD40 mAb agonist) injected intratumorally at the time of surgical irreversible electroporation (IRE) in patients with locally advanced pancreatic cancer (LAPC). The NCI-funded Phase 1a/1b single-center study will enroll up to 18 patients, who will receive a single intratumoral injection of mitazalimab immediately after the surgical IRE, a form of non-thermal ablation that is currently in clinical use for selected patients with LAPC. The study is being conducted by researchers at Moores Cancer Center at UC San Diego. Alligator will supply mitazalimab for the study.
お知らせ • May 12+ 1 more updateAlligator Bioscience AB (publ) to Report Nine Months, 2024 Results on Oct 24, 2024Alligator Bioscience AB (publ) announced that they will report nine months, 2024 results on Oct 24, 2024
お知らせ • Apr 05Alligator Bioscience AB (Publ) Announces Graham Dixon and Veronica Wallin Not Proposed for Re-Election on BoardAlligator Bioscience AB (publ) at the annual general meeting to be held on 7 May 2024, Graham Dixon and Veronica Wallin are not proposed for re-election on the board.
お知らせ • Mar 07Alligator Bioscience and Aptevo Therapeutics Announce Positive Interim Data of Dose Escalation Phase of ALG.APV-527 Phase 1 Study in Solid Tumor Cancers Expressing Tumor Antigen 5T4Alligator Bioscience AB and Aptevo Therapeutics announced positive interim data from the dose escalation phase of their Phase 1 trial evaluating ALG.APV-527 for the treatment of solid tumors likely to express the tumor antigen 5T4. The multi-center, dose escalation trial is now more than 50% enrolled, and preliminary results include: Treatment was overall well-tolerated, and a maximum tolerated dose has not yet been determined, dose-escalation in higher-dose cohorts is ongoing, ALG.APV-527 could be measured in all patients with plasma concentration of ALG.APV-527 consistent with the administered dose, Biomarker analyses indicate the expression of the targets (4-1BB and 5T4) in tumor biopsies and confirm biological activity of ALG.APV-527. Of particular interest, signs of clinical activity were observed for both enrolled patients with heavily pre-treated breast cancer. These patients demonstrated measurable level of drug in circulation (pharmacokinetic) and reproducible elevation of serum pharmacodynamic markers with dosing, suggesting the drug is biologically active. One patient remained on study for seven months and a second remains on study beyond nine months. Both patients achieved best overall response of stable disease. The ALG.APV-527 Phase 1 trial is a multi-center, multi-cohort, open-label trial that will include six cohorts (dose levels) in a 3+3 design. The trial will be conducted at up to 10 sites in the U.S. among adult patients with multiple solid tumor types/histologies likely to express the 5T4 antigen. ALG.APV-527 will be given intravenously once every two weeks. The trial will assess the safety and tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of ALG.APV-527. ALG.APV-527 is a bispecific conditional 4-1BB agonist, only active upon simultaneous binding to 4-1BB and 5T4. This has the potential to be clinically important because 4-1BB can stimulate the immune cells (antitumor-specific T cells and NK cells) involved in tumor control, making 4-1BB a particularly compelling target for cancer immunotherapy. 5T4 is an oncofetal tumor associated antigen overexpressed on numerous solid tumors including non-small-cell lung carcinoma (NSCLC), breast, head and neck, cervical, renal, gastric, and colorectal cancer.
お知らせ • Feb 09+ 1 more updateAlligator Bioscience Plans to Adjust Size of Organization with Reduction of Approximately 20% to 25% of Current WorkforceAlligator Bioscience announced that it plans to adjust the size of its organization to reflect the end of the resource-intensive OPTIMIZE-1 Phase 2 clinical trial with its lead asset mitazalimab, and the need for the company to prioritize its preclinical and early-stage assets. The planned restructuring remains subject to negotiation with the relevant trade unions but would result in a reduction of approximately 20% to 25% of the current workforce, which once implemented is expected to reduce operational cash burn with SEK 20 million annually. Alligator will notify the Swedish Public Employment Service (Sw. Arbetsförmedlingen) and seek consultations with trade unions regarding the reorganization. Decisions regarding employee reductions will take place after the change consultations have been concluded according to local regulations.
お知らせ • Jan 29Alligator Bioscience Announces Positive Top-Line Results from the Optimize-1 Phase 2 Study of the Company's Lead Asset Mitazalimab in 1st Line Metastatic Pancreatic CancerAlligator Bioscience announced positive top-line results from the OPTIMIZE-1 Phase 2 study of the company’s lead asset mitazalimab in 1st line metastatic pancreatic cancer. The open-label, multi-center study assessed the safety and efficacy of mitazalimab (CD40 mAb agonist) in combination with standard of care chemotherapy mFOLFIRINOX, in previously untreated, chemotherapy naive patients. The study achieved its primary endpoint with the top-line results demonstrating a confirmed Objective Response Rate (ORR) of 40.4%, an unconfirmed ORR of 50.9% and a disease control rate (DCR) of 79% in 57 evaluable patients, as per the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). This compares favorably to the ORR of 31.6% reported in a similar patient population treated with FOLFIRINOX alone. The cut-off time for analysis was November 14, 2023 with a median follow-up duration of 12.7 months. At the time of the analysis, a total of 29 (51%) patients were still alive, of these 18 (32%) were still on treatment. The longest ongoing treatment duration was 23 months. Three patients demonstrated complete remission of their target lesions. The study further demonstrated: Median Overall Survival (mOS) of 14.3 months at the time of analysis and expected to improve as majority of the patients remain alive, comparing favorably to the 11.1 months demonstrated by FOLFIRINOX[1], and more recently by NALIRIFOX in the NAPOLI 3 Phase 3 trial. An unprecedented median Duration of Response (DoR) of 12.5 months, compared to 5.9 months with FOLFIRINOX[1], and the 7.3 months demonstrated by NALIRIFOX The 12-month survival rate was 59.3% compared to 48.1% for FOLFIRINOX and 45.6% for NALIRIFOX Median Progression Free Survival (PFS) of 7.7 months, compared to 6.4 months with FOLFIRINOX[1], and the 7.4 months demonstrated by NALIRIFOX. Mitazalimab's manageable safety and tolerability profile supporting long-term administration in combination with mFOLFIRINOX was confirmed. As the majority of patients remain alive at the time of analysis, Overall Survival and Durability of Response are expected to improve further with ongoing treatment and follow-up. Alligator Bioscience has undertaken discussions with the US Food and Drug Administration (FDA) and has been able to establish a clear development and approval pathway for mitazalimab in pancreatic cancer. Based on the emerging data from the OPTIMIZE-1 study, FDA has provided additional guidance and has endorsed OPTIMIZE-1 as a Phase 3 enabling study. Consequently, mitazalimab can proceed directly to a global Phase 3 registration study, which Alligator is preparing to initiate in early 2025.
お知らせ • Nov 07Alligator Bioscience AB (Publ) Appoints Bertil Brinck as Chairman of the Nomination CommitteeAlligator Bioscience AB (publ) announced that Bertil Brinck has been appointed Chairman of the Nomination Committee.
お知らせ • Oct 13Alligator Bioscience Grants New Composition of Matter Patent in Europe for MitazalimabAlligator Bioscience announced that the European Patent Office (EPO) has granted the company a new patent based on EP Patent No. 3323834 covering its lead drug candidate= mitazalimab, a CD40 monoclonal antibody currently being evaluated in a Phase 2 study in 1st line metastatic pancreatic cancer. Mitazalimab is being evaluated in combination with chemotherapy, mFOLFIRINOX, in the OPTIMIZE-1 Phase 2 study in 1st line metastatic pancreatic cancer. The study is progressing and is on track for top-line readout in early first quarter of 2024.
お知らせ • Aug 18Alligator Bioscience AB (publ) Announces Resignation of Malin Carlsson as Chief Operating Officer At the End of OctoberAlligator Bioscience AB (publ) announced the resignation of Malin Carlsson as the company's Chief Operating Officer (COO). Dr Carlsson will leave her role at the end of October to assume an executive role in a global pharma company. Dr Carlsson’s responsibilities will be transferred to other members of the Management team.
お知らせ • Jul 06Alligator Bioscience AB (Publ) Announces Executive ChangesAlligator Bioscience AB (publ) announced that Anette Sundstedt, PhD, Principal Scientist at Alligator, has been appointed as employee representative, and Karin Nordbladh, Director Clinical Operations at Alligator, as deputy employee representative at the Alligator Bioscience AB's Board of Directors, effective July 5, 2023. Anette Sundstedt, who joined Alligator in 2021, replaces Tova Landström, who resigned on May 26, 2023, for personals reasons.
お知らせ • Jul 01Alligator Bioscience AB (publ) Announces Phase II Results Indicate Durability of Response for Alligator's CD40 AgonistAlligator Bioscience AB (publ) has presented a second round of interim results from a phase II trial with mitazalimab in pancreatic cancer patients. The follow-up evaluation on the first 23 patients shows an objective response rate of 57% - up from 52% at the first evaluation reported in January. The evaluation on the full set of 57 patients reveals an objective response rate of 44% - also susceptible to an increase as the study progresses. More data points indicate that mitazalimab provides a durable response in combination with standard of care chemotherapy.
お知らせ • Jun 27Alligator Bioscience Announces Positive Second Interim Results from the Ongoing Optimize-1 Phase 2 Study of the Lead Asset Mitazalimab in 1st Line Metastatic Pancreatic CancerAlligator Bioscience announced positive second interim results from the ongoing OPTIMIZE-1 Phase 2 study of the company's lead asset mitazalimab in 1st line metastatic pancreatic cancer. The open-label, multi-center study is assessing the safety and efficacy of mitazalimab (CD40 mAb agonist) in combination with chemotherapy, mFOLFIRINOX, in previously untreated patients with metastatic pancreatic ductal adenocarcinoma. The second interim analysis conducted on the 23 patients included in the interim analysis, with a follow-up period of nine to 17 months, reported in January 2023. demonstrated the following: Tumor responses deepened and the Objective Response Rate (ORR) increased to 57% (from 52%), suggesting a durable benefit for patients. Of the 13 patients achieving an objective response, seven (54%) were still ongoing in treatment for longer than 10 months with a maintained response, with the longest being 17 months. The interim analysis conducted on all 57 evaluable patients with a follow-up periodof two to 17 months demonstrated the following: 25 patients responded to treatment resulting in an interim ORR of 44%. Median Duration of Response (DoR) was 8.7 months compared to 5.9 reported for FOLFIRINOX alone in other studies, indicating an immunostimulatory effect of mitazalimab and potential Progression Free Survival (PFS) and survival benefits. In addition, 19 patients (33%) achieved stable disease resulting in a 77% disease control rate (DCR) Furthermore, mitazalimab's manageable safety and tolerability profile in combination with mFOLFIRINOX was confirmed. These data compare favorably to the ORR of 31.6%, mPFS of 6.4 months and DoR of 5.9 months reported in similar patient populations treated with standard of care FOLFIRINOX alone. Completion of, and patient enrolment in OPTIMIZE-1 was reported in April 2023 in May 2023, mitazalimab was granted Orphan Drug Designation by the U. S. Food and Drug Administration for the treatment of pancreatic cancer.
お知らせ • Jun 06Alligator Bioscience to Present Latest Clinical Data from Mitazalimab Optimize-1 Phase 2 Trial in Pancreatic Cancer At Asco Annual Meeting 2023Alligator Bioscience announces that data from the ongoing OPTIMIZE-1 Phase 2 study of the company's lead asset mitazalimab in 1st line metastatic pancreatic cancer will be presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, being held in Chicago, June 2-6. The data presented at ASCO demonstrate that mitazalimab in combination with mFOLFIRINOX is a feasible treatment regimen for 1st line pancreatic cancer patients with encouraging interim efficacy and well-manageable safety profile, consistent with mFOLFIRINOX monotherapy. Combination with mFOLFIRINOX had no impact on mitazalimab pharmacokinetics and the pharmacodynamic biomarker profile in peripheral blood confirmed the immune activation profile typical of mitazalimab. When administered at 900 µg/kg in combination with mFOLFIRINOX, mitazalimab showed robust anti-tumor activity in 23 mPDAC patients, meriting continued development. An objective response rate (ORR) of 52% was demonstrated with clinically meaningful tumor reduction in 12 of the 23 evaluable patients, which compares favorably to the 31.6%[1] reported with FOLFIRINOX in a similar patient population. The analysis also revealed: 8 patients achieved stable disease resulting in a 91% disease control rate (DCR), 6 of the 7 patients who began treatment at least 6 months prior to the interim analysis cutoff were still on treatment, and of these, 2 patients had been receiving treatment for over 11 months.
