Aim of this study is to investigate the outcome of NGS MRD based risk stratified treatment for standard risk acute lymphoblastic leukemia in children and adolescents.

开始日期2024-03-05

申办/合作机构

Samsung Medical Center

NCT04293562 / Active, not recruiting临床3期IIT

A Phase 3 Randomized Trial for Patients With De Novo AML Comparing Standard Therapy Including Gemtuzumab Ozogamicin (GO) to CPX-351 With GO, and the Addition of the FLT3 Inhibitor Gilteritinib for Patients With FLT3 Mutations

This phase III trial compares standard chemotherapy to therapy with liposome-encapsulated daunorubicin-cytarabine (CPX-351) and/or gilteritinib for patients with newly diagnosed acute myeloid leukemia with or without FLT3 mutations. Drugs used in chemotherapy, such as daunorubicin, cytarabine, and gemtuzumab ozogamicin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. CPX-351 is made up of daunorubicin and cytarabine and is made in a way that makes the drugs stay in the bone marrow longer and could be less likely to cause heart problems than traditional anthracycline drugs, a common class of chemotherapy drug. Some acute myeloid leukemia patients have an abnormality in the structure of a gene called FLT3. Genes are pieces of DNA (molecules that carry instructions for development, functioning, growth and reproduction) inside each cell that tell the cell what to do and when to grow and divide. FLT3 plays an important role in the normal making of blood cells. This gene can have permanent changes that cause it to function abnormally by making cancer cells grow. Gilteritinib may block the abnormal function of the FLT3 gene that makes cancer cells grow. The overall goals of this study are, 1) to compare the effects, good and/or bad, of CPX-351 with daunorubicin and cytarabine on people with newly diagnosed AML to find out which is better, 2) to study the effects, good and/or bad, of adding gilteritinib to AML therapy for patients with high amounts of FLT3/ITD or other FLT3 mutations and 3) to study changes in heart function during and after treatment for AML. Giving CPX-351 and/or gilteritinib with standard chemotherapy may work better in treating patients with acute myeloid leukemia compared to standard chemotherapy alone.

开始日期2020-07-21

申办/合作机构

The Children's Oncology Group Foundation, Inc.

[+1]

NCT06336395 / Recruiting临床2期IIT

Ma-Spore ALL-Seq 2020: RNA-Seq and IgH/TCR-Seq to Improve Risk Assignment in Childhood, Adolescent and Young Adult Acute Lymphoblastic Leukaemia

The primary objective of this trial is to improve the overall survival rate of children and young adult with B-lineage acute lymphoblastic leukemia (B-ALL) in Singapore and Malaysia in the context of a multicenter cooperative trial using a risk-stratified therapy.

开始日期2020-03-04

申办/合作机构

National University Hospital

100 项与 L-门冬酰胺酶相关的临床结果

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100 项与 L-门冬酰胺酶相关的转化医学

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100 项与 L-门冬酰胺酶相关的专利（医药）

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2,809

项与 L-门冬酰胺酶相关的文献（医药）

2024-04-01·Indian journal of otolaryngology and head and neck surgery : official publication of the Association of Otolaryngologists of India

An Unusual Presentation of Midline Lethal Granuloma

Article

作者: Saniasiaya, Jeyasakthy ; Hitam, Shahrul ; Kah Wai, Ngan ; Chin, Ein Wan ; Hassan, Eyzawiah

Extranodal natural killer T-cell lymphoma, nasal type (ENKTCL), is a rare form of non-Hodgkin lymphoma that is strongly related to Epstein-Barr Virus (EBV) infection and commonly presents as "midline lethal granuloma." Herein, we report a middle-aged lady who presented with a two-week history of fever, sore throat and constitutional symptoms. Intraoral examination revealed a lacerated soft palate with an ulcerated uvula. A diagnosis of ENKTCL was confirmed through deep biopsies under general anaesthesia supplemented with a positive serum EBV genome. Unfortunately, she succumbed due to disease progression with left frontal brain metastasis with concurrent pulmonary tuberculosis before treatment was completed. The recommended treatment is multimodality with L-asparaginase-containing regimes chemotherapy in an advanced stage, relapsed, or refractory ENKTCL for better outcomes. The quantification of circulating plasma EBV deoxyribonucleic acid (DNA) is helpful as the baseline of tumour load and a biomarker for monitoring treatment response and prognostication. We advocate repeated and deeper core tissue biopsies.

2024-03-01·Veterinary clinical pathology

Marked paraneoplastic basophilia in a cat with alimentary T‐cell lymphoma

作者: Serpa, Priscila B S ; Murakami, Masahiro ; Fulkerson, Caroline V ; Fulkerson, Christopher M ; Childress, Michael O ; Dos Santos, Andrea P ; Fourez, Lindsey M ; Strandberg, Natalia J

Abstract:

An 8‐year‐old, spayed female domestic shorthair cat was presented for acute weight loss, hyporexia, intermittent vomiting, and loose stools. A caudal abdominal mass and thickened intestinal loops were palpated on initial examination. An abdominal ultrasound identified a circumferential intramural jejunal mass with complete loss of wall layering, diffuse thickening of the jejunal muscularis, and jejunal and ileocecal lymphadenomegaly. Initial routine bloodwork revealed mild monocytosis and minimal lymphopenia with reactive lymphocytes. Cytologic evaluation of the jejunal mass and enlarged lymph nodes was consistent with lymphoma (intermediate cell size), and PCR for antigen receptor rearrangement revealed a clonal T‐cell receptor rearrangement consistent with T‐cell lymphoma. Chemotherapy (CHOP protocol) was initiated, but despite initial improvement of clinical signs, a repeat ultrasound examination 5 weeks after initiation of treatment revealed no improvement in the lymphadenomegaly or reduction in the size of the jejunal mass. At this visit, the cat also developed a marked basophilia (basophils 12.28 × 103/μL, RI 0.00–0.10) with low numbers of circulating atypical lymphocytes; no concurrent eosinophilia was noted. Heartworm disease, ectoparasites, and allergic diseases were evaluated for and considered unlikely. The chemotherapy protocol was changed to L‐asparaginase, followed by lomustine. The basophilia was significantly reduced 2 days after the initial dose of L‐asparaginase and remained within the reference interval for 40 days before an eventual decline in the cat's health. To the authors' knowledge, this is the first report of paraneoplastic basophilia without concurrent eosinophilia in a cat with T‐cell lymphoma.

2024-02-01·International journal of biological macromolecules

Biochemical characterization of glutaminase-free L-asparaginases from Himalayan Pseudomonas and Rahnella spp. for acrylamide mitigation

Article

作者: Joshi, Robin ; Kumar, Subhash ; Patial, Vijeta ; Singh, Dharam

L-asparaginase having low glutaminase activity is important in clinical and food applications. Herein, glutaminase-free L-asparaginase (type I) coding genes from Pseudomonas sp. PCH182 (Ps-ASNase I) and Rahnella sp. PCH162 (Rs-ASNase I) was amplified using gene-specific primers, cloned into a pET-47b(+) vector, and plasmids were transformed into Escherichia coli (E. coli). Further, affinity chromatography purified recombinant proteins to homogeneity with monomer sizes of ~37.0 kDa. Purified Ps-ASNase I and Rs-ASNase I were active at wide pHs and temperatures with optimum activity at 50 °C (492 ± 5 U/mg) and 37 °C (308 ± 4 U/mg), respectively. Kinetic constant K_m and V_max for L-asparagine (Asn) were 2.7 ± 0.06 mM and 526.31 ± 4.0 U/mg for Ps-ASNase I, and 4.43 ± 1.06 mM and 434.78 ± 4.0 U/mg for Rs-ASNase I. Circular dichroism study revealed 29.3 % and 24.12 % α-helix structures in Ps-ASNase I and Rs-ASNase I, respectively. Upon their evaluation to mitigate acrylamide formation, 43 % and 34 % acrylamide (AA) reduction were achieved after pre-treatment of raw potato slices, consistent with 65 % and 59 % Asn reduction for Ps-ASNase I and Rs-ASNase I, respectively. Current findings suggested the potential of less explored intracellular L-asparaginase in AA mitigation for food safety.

项与 L-门冬酰胺酶相关的新闻（医药）

2024-01-09

·Science Daily

The hidden identity of leukemia

Researchers used various sequencing technologies to explore the molecular characteristics of myeloid/natural killer cell precursor acute leukemia (MNKPL). They observed activation of the NOTCH1 and RUNX3 genes, with lower expression of the BCL11B gene. MNKPL cells were also highly sensitive to a drug called L-asparaginase. Collectively, these qualities make MNKPL distinct from other leukemia types. These insights will assist with more accurate clinical diagnoses and therapeutic development for MNKPL. Leukemia is a common term used to refer to a form of blood cancer. However, there are different types of leukemia depending on the cell type involved. One unique form is myeloid/natural killer (NK) cell precursor acute leukemia (MNKPL). Because of its rarity, there is no consensus on the specific characteristics needed to clinically identify this disease. In a recent article published in Science Advances, a team led by researchers at Tokyo Medical and Dental University (TMDU) used various approaches to better assess the molecular pro drug sensitivity characteristics of MNKPL. MNKPL was only first proposed as a leukemia subtype in 1997. Extramedullary involvement is one of the hallmarks of MNKPL. It is prevalent in East Asian countries. Although the immunological phenotype of MNKPL was explored previously, a full genetic characterization of this cancer type had not been performed. These details would help support more accurate diagnoses for patients, which would lead to more appropriate therapeutic decisions. Therefore, the TMDU group aimed to investigate MNKPL on a single-cell level. "A single-cell exploration of MNKPL would not only help us better understand its clinical and genomic features, but also clarify the specific cellular origin of this disease," says Dr. Akira Nishimura, lead author of the study. The team first used what is known as a multiomics approach to investigate MNKPL patient samples. They used various sequencing technologies to determine if there were any relevant mutations in specific genes, look for expression differences in certain signaling pathways at the RNA level, and examine any unique DNA methylation patterns. "Our results demonstrate that MNKPL has molecular qualities that are distinct from other similar cancers, such as acute myeloid leukemia, T-cell acute lymphoblastic leukemia, and mixed-phenotype acute leukemia," explains Dr. Masatoshi Takagi, senior author. "Specific hallmarks of MNKPL include activation of the NOTCH1 and RUNX3, as well as lower expression of the BCL11B." Further work at the single-cell level in MNKPL cells showed that NK cells and myeloid cells come from a common progenitor cell type. The researchers also conducted in vitro drug sensitivity assays where they measured MNKPL cell responses to 79 individual anti-cancer drugs. "We observed that MNKPL cells were highly sensitive to a drug called L-asparaginase, which has already shown clinical effectiveness for this disease," says Dr. Nishimura. "Mechanistically, we found that this was from low expression of asparagine synthetase, a quality that was distinct from other similar types of leukemia." Overall, the robust and comprehensive analysis performed in this study provides crucial molecular details for characterizing MNKPL. This work will undoubtedly help clinicians more effectively diagnose MNKPL and choice of therapeutic option. Additionally, this work provides data that will assist with novel therapeutic target identification and drug development in this leukemia.

细胞疗法

2023-05-30

·生物谷

中山大学癌症研究中心李志铭团队揭示了Chiauranib可能为淋巴瘤患者提供一种有前途的治疗方法

结外NK/T细胞淋巴瘤(NKTL)，鼻型(Enkl)，是一种典型的结外淋巴瘤，以血管损伤和破坏、明显坏死、细胞毒表型和EBV相关为特征。中国、日本、韩国和南美部分地区是主要的首选地区。结外NK/T细胞淋巴瘤(NKTL)，鼻型(Enkl)，是一种典型的结外淋巴瘤，以血管损伤和破坏、明显坏死、细胞毒表型和EBV相关为特征。中国、日本、韩国和南美部分地区是主要的首选地区。 NKTL是一种侵袭性淋巴瘤，预后差。到目前为止，能够帮助指导治疗的III期临床试验仍然很少。在复发/难治的患者队列中发现的数据更少。NKTL被证明对CHOP(环磷酰胺、阿霉素、长春新碱和强的松)化疗不敏感，即使在最大剂量强度下也是如此。虽然大约70%-90%的早期患者和15%-65%的晚期患者在初次治疗后获得完全缓解(CR)，但也有一部分患者最终经历了25%至60%的复发，具体取决于治疗方式。目前，晚期NKTL患者的长期存活率仍然较低。因此，迫切需要新的药物和实用的治疗方法。图片来源：https://doi-org.libproxy1.nus.edu.sg/10.1038/s41419-023-05833-w 近日，来自中山大学癌症研究中心李志铭团队的研究者们在Cell Death and Disease杂志上发表了题为“Inhibition of extranodal NK/T-cell lymphoma by Chiauranib through an AIF-dependent pathway and its synergy with L-asparaginase”的文章，该研究首次证实了Chiauranib通过激活AIF依赖的细胞凋亡通路对NKTL的积极疗效。Chiauranib的新颖性和多靶点，以及与L-天冬酰胺酶的协同作用，可能为NKTL患者提供一种有前途的治疗方法。结外NK/T细胞淋巴瘤(NKTL)是一种少见的侵袭性结外淋巴瘤，预后不良。目前，对晚期疾病或复发/复发性疾病的患者的治疗选择非常有限。在本研究中，研究者发现Chiauranib，一种口服的选择性丝氨酸-苏氨酸激酶(极光B，VEGFRs，PDGFR，CSF1R，c-Kit)的小分子抑制剂，与其他类型的癌细胞一样，在体外和体内都能抑制NKTL细胞的增殖，诱导细胞周期停滞，并抑制微血管密度。令人惊讶的是，Chiauranib通过触发AIF依赖的细胞凋亡，而不是传统的Cyt-c/caspase线粒体凋亡途径，展示了一种新的诱导NKTL细胞凋亡的作用。AIF在体外和体内的下调显著阻断了Chiauranib对NKTL的疗效。从机制上讲，AIF从线粒体中的释放是由于AKT-GSK3β途径上调VDAC1和激活钙依赖的m-钙蛋白，从而促进VDAC1的切割，从而允许AIF的释放。值得注意的是，Bax在NKTL细胞和患者组织中的低表达抑制了Cyt-c的释放。其结果是抑制了Cyt-c/caspase线粒体途径，提示针对这一传统途径的药物可能对NKTL无效。此外，研究者还发现L-天冬酰胺酶在NKTL细胞中触发了CD95(Fas/Apo-1)caspase8-caspase3的凋亡通路，并且Chiauranib和L-天冬酰胺酶联合应用具有协同作用，提示两种药物联合治疗NKTL是可行的。 Chiauranib通过诱导AIF依赖性细胞凋亡抑制NKTL生长图片来源：https://doi-org.libproxy1.nus.edu.sg/10.1038/s41419-023-05833-w 从目前的结果，研究者揭示了Chiauranib在治疗NKTL中的潜在作用，这是由于关键靶点的高度符合性和其独特的AIF-凋亡途径，以及与L-天冬酰胺酶的协同作用。本研究的发现可能为NKTL患者提供一种有希望的治疗方法。（生物谷 Bioon.com）参考文献 Tianxiao Gao et al. Inhibition of extranodal NK/T-cell lymphoma by Chiauranib through an AIF-dependent pathway and its synergy with L-asparaginase. Cell Death Dis. 2023 May 9;14(5):316. doi: 10.1038/s41419-023-05833-w.

临床结果细胞疗法

2023-03-22

·BioSpace

ERYTECH Provides Business and Financial Update for the Fourth Quarter and Full Year 2022

ERYTECH Provides Business and Financial Update for the Fourth Quarterand Full Year 2022 Combination with Pherecydes announced, intending to create a global leader in extended phage therapies targeting antimicrobial resistant pathogenic bacteria Deep restructuring implemented; team size reduced by approximately 75% since start of 2022 Cash and cash equivalents of €38.8 million ($41.5 million) at the end of December 2022 Cambridge, MA (U.S.) and Lyon (France),March 22, 2023– Erytech Pharma Inc. (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, today provided a business and financial update for the fourth quarter and full year of 2022. “After the disappointing results of our Phase 3 trial in pancreatic cancer, we have pursued during 2022 a consistent strategy to maximize the remaining value for our shareholders through strategic partnering. We sold our US manufacturing site, sharply reduced our cash burn, focused on our most promising preclinical programs, and relentlessly pursued partnering options”,said Gil Beyen, Chief Executive Officer of ERYTECH.“We are very pleased this resulted in the recently announced strategic combination with Pherecydes to build on complementary expertise and capabilities of both companies and create a global leader in phage therapy to address the increasingly alarming health context caused by antimicrobial-resistant bacteria.” Business Highlights U.S. cell therapy manufacturing facility sold to Catalent for a total consideration of USD 44.5 million Following the disappointing results of the Company’s Phase 3 trial in pancreatic cancer, ERYTECH in April 2022 sold its state-of-the-art commercial-scale cell therapy manufacturing facility in Princeton, New Jersey, to Catalent for a total consideration of $44.5 million. ERYTECH’s staff at the site of approximately 40 people has been transferred to Catalent. Graspa® program halted and focused shifted to preclinical RBC vesicles program After FDA feedback on the envisaged BLA submission for Graspa® in hypersensitive ALL setback, and a non-conclusive early readout of first patients in a Phase 2 trial in TNBC, with the same product candidate, ERYTECH decided in September 2022 to halt further development of Graspa®, L-asparaginase encapsulated in donor red blood cells. Erytech decided to focus its development efforts on its most promising preclinical programs, the vesiculation of red blood cells that have already been loaded with active therapeutics to produce cargo-loaded RBC-derived extracellular vesicles, for the development of novel therapeutic approaches. Deep restructuring implemented Linked to the halt of the Company’s lead program Graspa®, a restructuring program was initiated in May 2022. Combined with the approximately 40 people who transferred to Catalent after the sale of the Company’s manufacturing facility in Princeton, the global team size will be less than 25% compared to the start of this year. The Company has retained its R&D team and its expertise in key functional areas to keep the ability to restart a pipeline of partnered development programs and maintain a fully operational dual-listed company. Combination with Pherecydes announced On February 15, 2023, the Company announced the strategic combination with Pherecydes, a biotechnology company specializing in precision phage therapy to treat resistant and/or complicated bacterial infections, with the ambition to create a global leader in extended phage therapy and accelerate the development of a portfolio of phage candidates targeting pathogenic bacteria. The proposed transaction seeks to leverage ERYTECH’s financial resources and teams to both accelerate and expand PHERECYDES’ existing phage development programs and reinforce efforts to advance novel phage candidates. ERYTECH and PHERECYDES intend to merge their operations and relocate all teams to ERYTECH’s premises in Lyon, where they will benefit from presence in a major European hub for infectious diseases. The combined company’s cash runway would extend into Q3 2024, with a consolidated cash position of approximately €41 million as of December 31, 2022, and would enable funding of existing and novel programs through multiple clinical milestones. The proposed transaction is structured as a merger of PHERECYDES into ERYTECH, pursuant to which the shareholders of PHERECYDES would receive newly issued ERYTECH ordinary shares in consideration of the contribution of the assets and liabilities of PHERECYDES. The extraordinary general meetings of ERYTECH and PHERECYDES will be called upon to vote on the proposed merger, currently expected to be convened at the end of June of 2023. The proposed transaction is expected to close shortly after the approval by the EGM. Full Year 2022 Financial Results Key financial figures for the twelve months of 2022 compared with the same period of the previous year are summarized below: In thousands of euros Q42022 (12 months) Q42021 (12 months) Revenues — — Other income 6,647 4,180 Net gain on asset sale 24,351 — Operating income 30,998 4,180 Research and development (19,907) (45,100) General and administrative (13,887) (15,595) Operating expenses (33,793) (60,696) Operating income (loss) (2,796) (56,517) Financial income 4,453 5,422 Financial expenses (1,364) (2,702) Financial income (loss) 3,089 2,720 Income tax (521) (2) Net loss (227) (53,798) Net loss for the full year of 2022 was €0.2 million, a €53.7 million improvement year-over-year, reflecting the €24.4 million net gain on the sale of the Princeton facility, and the further decrease in operating expenses, which, at €33.8 million of expenses at the end of 2022, were also showing an accelerated decrease of €26.9 million (-44%) year-over-year, with a €25.2 million decrease in R&D expenses (-56%), related to the termination of clinical programs, and a €1.7 million decrease (-11%) in G&A. Other income included the €4.9 million debt extinguishment related to the conditional advance on the Tedac R&D program, owing to the termination of developments on the Graspa® platform, and €1.5M for the R&D tax credit. Total operating expenses of €33.8 million included an impairment charge of €2.4 million on the Lyon production facility, related to the end of eryaspase operations, and a one-off €1.8 million cost of restructuring, related to the resizing of French operations and staff. Income tax expense in 2022 was €0.5 million, reflecting the expected tax impacts of the capital gain from the sale of the Princeton facility. As of December 31, 2022, ERYTECH had cash and cash equivalents totaling €38.8 million (approximately $41.5 million), compared with €33.7 million as of December 31, 2021. The €5.1 million net increase in cash position during the twelve months of 2022 was the result of the net cash of €37.6 million received from the sale of the Princeton facility, a €31.3 million net cash utilization in operating activities and investing activities (excluding the sale of the Princeton facility) and €1.8 million used in financing activities, while the variation of the U.S. dollar against the euro led to a €0.5 million positive currency exchange impact. Earlier this year, the company initiated a deep restructuring and cost reduction program, then further intensified with the halt of the Graspa® program and BLA process. Considering this ongoing reduction in operating expenses, the Company believes that its current cash position can fund its current activities and planned operating expenses to the second half of 2024. Filing of 2022 Universal Registration Document and 2022 Annual Report on Form 20-F The Company’s 2022 Universal Registration Document for the year ended December 31, 2022, including the management report and the annual financial report, and its Annual Report on Form 20-F for the year ended December 31, 2022, will be filed with the “Autorité des Marchés Financiers” (AMF) and with the U.S. Securities and Exchange Commission (SEC), respectively, on March 27, 2023. These documents will be accessible on the Investors section of the Company’s corporate website ( ). In addition, the Universal Registration Document will be available on the website of the AMF ( ) and the Annual Report on Form 20-F will also be available on the website of the SEC ( ). Printed copies of these documents will also be available free of charge, by sending a postal request to the registered offices of ERYTECH Pharma, Bâtiment Bioserra, 60 Avenue Rockefeller, 69008 in Lyon (France). 2023 Financial Calendar* Business Update and Financial Highlights for the First Quarter of 2023: May 9, 2023 (after U.S. market close), followed by a conference call & webcast on May 10, 2023 (2:30pm CET/8:30am ET) Shareholders’ Meeting: June 23, 2023 at 9.30am CET - Paris Business Update and Financial Highlights for the Second Quarter & First Half of 2023: September 11, 2023 (after U.S. market close), followed by a conference call & webcast on September 12, 2023 (2:30pm CET/8:30am ET) Business Update and Financial Highlights for the Third Quarter of 2023: November 6, 2023 (after U.S. market close), followed by a conference call & webcast on November 7, 2023 (2:30pm CET/8:30am ET) (*): Information subject to change. About ERYTECH ERYTECH is a biopharmaceutical company developing innovative red blood cell-based therapeutics for severe forms of cancer and orphan diseases. Leveraging its proprietary ERYCAPS® platform, which uses a novel technology to encapsulate drug substances inside red blood cells, ERYTECH is developing a pipeline of product candidates for patients with high unmet medical needs. On February 15 2023, ERYTECH announced its intended strategic combination with PHERECYDES to create a global player in extended phage. More detail can be found in the press release. ERYTECH is listed on the Nasdaq Global Select Market in the United States (ticker: ERYP) and on the Euronext regulated market in Paris (ISIN code: FR0011471135, ticker: ERYP). ERYTECH is part of the CAC Healthcare, CAC Pharma & Bio, CAC Mid & Small, CAC All Tradable, EnterNext PEA-PME 150 and Next Biotech indexes. For more information, please visit CONTACTS ERYTECH Eric Soyer CFO & COO NewCap Mathilde Bohin / Louis-Victor Delouvrier Investor relations Nicolas Merigeau Media relations +33 4 78 74 44 38 investors@erytech.com +33 1 44 71 94 94 erytech@newcap.eu Forward-looking information This press release contains forward-looking statements, forecasts and estimates with respect to the clinical results from and the development plans of eryaspase, business and regulatory strategy and anticipated future performance of ERYTECH and of the market in which it operates. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will” and “continue” and similar expressions. All statements contained in this press release other than statements of historical facts are forward-looking statements, including, without limitation, statements regarding ERYTECH’s business and regulatory strategy and its evaluation of potential strategic transactions. Such statements, forecasts and estimates are based on various assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable when made but may or may not prove to be correct. Actual events are difficult to predict and may depend upon factors that are beyond ERYTECH's control. Therefore, actual results may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Important factors that could cause actual results and outcomes to differ materially from those indicated in the forward-looking statements include, among others, the following: (1) the failure to achieve certain regulatory and commercial milestones; (2) the inability to maintain the listing of ERYTECH’s shares on the Nasdaq Global Select market and the Euronext regulated market; (3) changes in applicable laws or regulations; (4) the possibility that ERYTECH may be adversely affected by other economic, business and/or competitive factors; (5) the inability to agree to terms on a long-term supply agreement with Catalent; and (6) other risks and uncertainties indicated from time to time in ERYTECH’s regulatory filings. Further description of these risks, uncertainties and other risks can be found in the Company’s regulatory filings with the French Autorité des Marchés Financiers (AMF), the Company’s Securities and Exchange Commission (SEC) filings and reports, including in the Company’s 2021 Universal Registration Document (Document d’Enregistrement Universel) filed with the AMF on April 27, 2022 and in the Company’s Annual Report on Form 20-F filed with the SEC on April 28, 2022 and future filings and reports by the Company. Given these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. Readers are cautioned not to place undue reliance on any of these forward-looking statements. ERYTECH disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any change in ERYTECH’s expectations with regard thereto, or any change in events, conditions or circumstances on which any such statement, forecast or estimate is based, except to the extent required by law. Attachment ERYTECH_PR_Q4_FY_2022_EN_vf

财报临床3期临床2期细胞疗法

100 项与 L-门冬酰胺酶相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L01XX02	DB00023

研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
急性淋巴细胞白血病	日本	Kyowa Kirin Co., Ltd.	1971-06-25
淋巴瘤	日本	Kyowa Kirin Co., Ltd.	1971-06-25

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临床结果

适应症

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ASH2023	N/A	-	-	Ancestral L-ASNase candidates	憲鹽繭網醖醖膚簾顧鹽(醖鏇顧膚壓襯觸憲鑰願) = 遞膚顧淵簾襯願簾壓範艱餘簾製蓋範蓋夢蓋構 (鬱鏇鬱襯構壓淵獵選壓 )	-	2023-12-11
ASH2023	临床1/2期	结外NK-T细胞淋巴瘤	34	Brentuximab vedotin in combination with methotrexate, L-asparaginase, and dexamethasone (B-MAD)	範構夢網膚網築鹹醖衊(構壓繭襯範遞鹽鹹遞鏇) = 蓋膚鑰襯餘壓襯淵蓋鹹鑰鹽壓願獵願糧構積範 (製襯夢鏇膚範鏇鬱蓋壓 )	-	2023-12-11
EHA2021	N/A	急性淋巴细胞白血病	316	L-asparaginase	艱願願糧獵製願顧齋膚(廠繭蓋構齋淵壓淵膚鬱) = 壓膚廠淵顧淵窪壓鹹廠艱襯廠範衊壓醖築築簾 (餘夢糧簾衊鬱範餘獵蓋 ) 更多	-	2021-06-09
ISTH2020	N/A	急性淋巴细胞白血病	-	L-Asparaginase	壓齋簾鏇獵獵齋齋壓艱(蓋願衊醖顧簾鹽壓獵廠) = 繭繭夢艱壓淵衊淵醖糧繭簾艱艱鏇範築鬱膚餘 (廠齋廠餘壓憲淵襯選壓 ) 更多	-	2020-07-12
NCT01371981 (AAML1031, CTgov)	临床3期	髓系肿瘤 \| 急性髓性白血病 \| 皮肤淋巴瘤 ... 更多	1,645	Quality-of-Life Assessment+Etoposide+Mitoxantrone Hydrochloride+Asparaginase+Cytarabine+Daunorubicin Hydrochloride (Arm A)	範憲膚築鹽膚淵遞遞壓(選遞製壓齋窪鬱廠製鏇) = 憲廠壓醖鏇製衊壓鏇範願構蓋遞顧餘醖壓夢憲 (積衊範觸糧選繭膚遞築, 窪壓簾蓋願夢觸窪觸壓 ~ 鏇選餘積鬱遞壓獵衊醖) 更多	-	2020-07-07
NCT01371981 (AAML1031, CTgov)	临床3期	髓系肿瘤 \| 急性髓性白血病 \| 皮肤淋巴瘤 ... 更多	1,645	Quality-of-Life Assessment+Etoposide+Mitoxantrone Hydrochloride+Asparaginase+bortezomib+Cytarabine+Daunorubicin Hydrochloride (Arm B)	範憲膚築鹽膚淵遞遞壓(選遞製壓齋窪鬱廠製鏇) = 繭網鑰鏇襯醖艱顧窪鑰願構蓋遞顧餘醖壓夢憲 (積衊範觸糧選繭膚遞築, 鑰夢淵鹹夢顧憲築廠廠 ~ 鑰製淵範遞顧窪淵壓衊) 更多	-	2020-07-07
Peking University Cancer Hospital (ICML2017)	N/A	结外NK-T细胞淋巴瘤一线	196	L-asparaginase	夢襯醖夢夢繭構糧憲糧(簾遞顧淵範艱壓網醖積) = 鑰簾鹹鹹鏇醖壓廠鹽繭獵醖鬱鑰鬱餘艱襯願構 (築獵壓繭夢願鬱蓋觸製 ) 更多	积极	2017-06-07
Peking University Cancer Hospital (ICML2017)	N/A	结外NK-T细胞淋巴瘤一线	196	L-asparaginase	夢襯醖夢夢繭構糧憲糧(簾遞顧淵範艱壓網醖積) = 願餘醖餘糧觸積鹽構構獵醖鬱鑰鬱餘艱襯願構 (築獵壓繭夢願鬱蓋觸製 ) 更多	积极	2017-06-07
EHA2017	N/A	急性淋巴细胞白血病	280	Low-molecular weight heparin	齋築壓壓夢鏇醖遞鏇蓋(遞鑰繭蓋壓鏇衊選獵製) = 1 patient with ALL and hemostasis alteration had intracerebral hemorrhage (ICH) with rapid progressive neurological deterioration to death 壓遞衊艱壓餘範齋構鹹 (觸襯繭鏇鑰遞鬱蓋壓構 ) 更多	-	2017-05-18
NCT00610883 (CTgov)	临床2期	非霍奇金淋巴瘤	17	LSA4+Cyclophosphamide+Daunomycin+BCNU+Methotrexate	鏇鑰糧網窪憲憲鬱範製(繭觸選夢築淵築選選網) = 構遞膚餘製窪觸窪齋獵糧鬱蓋鬱遞築憲鬱築遞 (願齋鏇繭糧糧廠鬱觸糧, 鏇淵餘壓鏇鏇觸製簾選 ~ 願顧選襯醖網衊窪選襯) 更多	-	2016-01-25
NCT00372593 (AAML0531, CTgov)	临床3期	急性髓性白血病	1,070	etoposide+mitoxantrone hydrochloride+asparaginase+cytarabine+daunorubicin hydrochloride (Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome)	鹽齋餘衊選簾積構壓齋(範獵夢淵鬱淵鹹鏇願齋) = 壓窪齋夢鏇構築鑰鬱構網願繭鏇鬱齋餘艱蓋製 (鏇膚壓鏇鏇網遞壓壓窪, 鏇網選襯衊遞膚繭夢齋 ~ 餘膚淵範願廠蓋鏇鹹簾) 更多	-	2015-01-13
NCT00372593 (AAML0531, CTgov)	临床3期	急性髓性白血病	1,070	etoposide+gemtuzumab ozogamicin+mitoxantrone hydrochloride+asparaginase+cytarabine+daunorubicin hydrochloride (Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome)	鹽齋餘衊選簾積構壓齋(範獵夢淵鬱淵鹹鏇願齋) = 窪艱鏇築襯網製積鏇鹹網願繭鏇鬱齋餘艱蓋製 (鏇膚壓鏇鏇網遞壓壓窪, 遞獵鏇廠膚顧鹹獵鏇簾 ~ 範範範艱夢鑰齋淵糧糧) 更多	-	2015-01-13
NCT00004228 (CTgov)	临床3期	淋巴母细胞淋巴瘤	393	asparaginase+CYCLOPHOSPHAMIDE+Prednisone+doxorubicin hydrochloride+thioguanine+mercaptopurine+Dexamethasone+vincristine sulfate+Methotrexate+cytarabine+daunorubicin hydrochloride (A0 (Localized Disease Stg I/II) Modified CCG BFM)	遞簾願積餘鏇顧願選願(廠簾鏇餘齋鑰夢遞窪鑰) = 網糧醖網蓋醖構範蓋築鑰鹹糧鹹積範遞鏇餘夢 (繭壓鹽鏇憲膚鏇鹽鑰觸, 餘顧網醖積構顧淵鑰觸 ~ 鏇鏇遞願構願鑰範夢襯) 更多	-	2013-12-05
NCT00004228 (CTgov)	临床3期	淋巴母细胞淋巴瘤	393	asparaginase+CYCLOPHOSPHAMIDE+Prednisone+doxorubicin hydrochloride+thioguanine+mercaptopurine+Dexamethasone+vincristine sulfate+Methotrexate+cytarabine+daunorubicin hydrochloride (A1 (Disseminated, No CNS - CCG Mod BFM w/Out Intens)	遞簾願積餘鏇顧願選願(廠簾鏇餘齋鑰夢遞窪鑰) = 襯願範淵憲簾鏇範餘艱鑰鹹糧鹹積範遞鏇餘夢 (繭壓鹽鏇憲膚鏇鹽鑰觸, 鬱鏇衊簾鏇遞廠顧鏇範 ~ 繭糧鹹廠鹽鹹夢遞廠觸) 更多	-	2013-12-05