A Phase Ib/II, Multicenter, Open-label, Single-arm Study to Assess the Safety and Efficacy of GFH009 in Combination With Zanubrutinib in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

This is a multicentre, open-label phase Ib/II study. The purpose of the study is to assess the safety and efficacy of GFH009 in combination with Zanubrutinib in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL)

Start Date20 Mar 2024

Sponsor / Collaborator

Zhejiang JinFang Pharmaceutical Co., Ltd.

CTR20240475 / RecruitingPhase 1/2

一项评价GFH009联合泽布替尼治疗复发或难治性弥漫性大B细胞淋巴瘤（DLBCL）患者安全性和有效性的单臂、开放、多中心Ib/II期临床试验

[Translation] A single-arm, open-label, multicenter Phase Ib/II clinical trial evaluating the safety and efficacy of GFH009 combined with zanubrutinib in the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL)

主要目的为评估GFH009联合泽布替尼治疗复发或难治性DLBCL患者的安全性和耐受性，以及初步疗效

[Translation]

The primary objective is to evaluate the safety and tolerability of GFH009 combined with zanubrutinib in the treatment of patients with relapsed or refractory DLBCL, as well as the preliminary efficacy

Start Date12 Mar 2024

Sponsor / Collaborator

Zhejiang JinFang Pharmaceutical Co., Ltd.

CTR20231602 / RecruitingPhase 1/2

一项评估GFH009在复发或难治的外周T细胞淋巴瘤患者中的有效性、安全性/耐受性和药代动力学的多中心、开放标签、Ib/II期临床研究

[Translation] A multicenter, open-label, Phase Ib/II clinical study evaluating the efficacy, safety/tolerability, and pharmacokinetics of GFH009 in patients with relapsed or refractory peripheral T-cell lymphoma

Ib期：主要目的：对GFH009单药在目前最高剂量下治疗复发或难治PTCL受试者进行安全性确认，综合FIH研究中所有数据最终确定II期推荐剂量（RP2D）。次要目的：评估GFH009单药治疗复发或难治PTCL受试者的疗效，评价GFH009的药代动力学（PK）特征。 II期：主要目的：评估GFH009单药治疗复发或难治PTCL受试者的疗效。次要目的：使用其他疗效指标评估GFH009单药治疗PTCL的疗效，进一步评估GFH009单药治疗复发或难治PTCL受试者的安全性，评价GFH009的PK特征。

[Translation]

Phase Ib: Primary purpose: To confirm the safety of GFH009 monotherapy at the highest current dose in the treatment of relapsed or refractory PTCL subjects, and to determine the Phase II recommended dose (RP2D) based on all data from the FIH study. Secondary purpose: To evaluate the efficacy of GFH009 monotherapy in the treatment of relapsed or refractory PTCL subjects, and to evaluate the pharmacokinetic (PK) characteristics of GFH009. Phase II: Primary purpose: To evaluate the efficacy of GFH009 monotherapy in the treatment of relapsed or refractory PTCL subjects. Secondary purpose: To evaluate the efficacy of GFH009 monotherapy in the treatment of PTCL using other efficacy indicators, to further evaluate the safety of GFH009 monotherapy in the treatment of relapsed or refractory PTCL subjects, and to evaluate the PK characteristics of GFH009.

Start Date19 Sep 2023

Sponsor / Collaborator

Zhejiang JinFang Pharmaceutical Co., Ltd.

100 Clinical Results associated with Tambiciclib

100 Translational Medicine associated with Tambiciclib

100 Patents (Medical) associated with Tambiciclib

Literatures (Medical) associated with Tambiciclib

01 Feb 2024·Biomedical chromatography : BMC

Development and validation of a sensitive UPLC–MS/MS analytical method for GFH009 in rat plasma and its application to toxicokinetics studies

Article

Author: Zhao, Jin-Zhu ; Lan, Jiong ; Lu, Qiang ; Ren, Hong-Can ; Zhou, Fu-Sheng ; Liu, Qiang

Abstract:

GFH009 is a potent, highly selective, small molecule that targets and inhibits the activity of the CDK9/cyclin T1 regulatory complex of P‐TEFb. This study aimed to develop and validate a highly selective and sensitive ultrahigh‐performance liquid chromatography–tandem mass spectrometry (UHPLC–MS/MS) method for precise quantification of GFH009 in rat plasma. This method was subsequently employed for conducting toxicokinetic studies of GFH009 in rats. Plasma was prepared using a simple protein precipitation method by acetonitrile. Chromatographic separation of the analytes was achieved on a BEH C18 analytical column with a rapid 3.0 min run time and a flow rate of 0.5 ml/min. The calibration curves for plasma samples exhibited excellent linearity over a wide concentration range of 1.0–1,000 ng/ml for GFH009. Intra‐ and inter‐day accuracies were within 92.7–105.7%, and precisions were no more than 6.7%. Furthermore, the analyte demonstrated stability under four different storage conditions, with variations of <15.0%. This study pioneers a methodological innovation by introducing a highly reliable, specific and sensitive analytical method for GFH009 in rat plasma. The successful application of this method in toxicokinetic studies further underscores its significance, offering valuable insights for the methodology of clinical pharmacokinetic research.

20 Dec 2023·Oncotarget

The pharmacodynamic and mechanistic foundation for the antineoplastic effects of GFH009, a potent and highly selective CDK9 inhibitor for the treatment of hematologic malignancies

Article

Author: Zhou, Fusheng ; Ge, Mei ; Ren, Jinmin ; Lan, Jiong ; Tang, Lili ; Xie, Fubo ; Cicic, Dragan ; Lu, Qiang ; Le, Siyuan

To evade cell cycle controls, malignant cells rely upon rapid expression of select proteins to mitigate proapoptotic signals resulting from damage caused by both cancer treatments and unchecked over-proliferation. Cyclin-dependent kinase 9 (CDK9)-dependent signaling induces transcription of downstream oncogenes promoting tumor growth, especially in hyperproliferative 'oncogene-addicted' cancers, such as human hematological malignancies (HHMs). GFH009, a potent, highly selective CDK9 small molecule inhibitor, demonstrated antiproliferative activity in assorted HHM-derived cell lines, inducing apoptosis at IC50 values below 0.2 μM in 7/10 lines tested. GFH009 inhibited tumor growth at all doses compared to controls and induced apoptosis in a dose-dependent manner. Twice-weekly injections of GFH009 maleate at 10 mg/kg significantly prolonged the survival of MV-4-11 xenograft-bearing rodents, while their body weight remained stable. There was marked reduction of MCL-1 and c-MYC protein expression post-drug exposure both in vitro and in vivo. Through rapid 'on-off' CDK9 inhibition, GFH009 exerts a proapoptotic effect on HHM preclinical models triggered by dynamic deprivation of crucial cell survival signals. Our results mechanistically establish CDK9 as a targetable vulnerability in assorted HHMs and, along with the previously shown superior class kinome selectivity of GFH009 vs other CDK9 inhibitors, strongly support the rationale for currently ongoing clinical studies with this agent in acute myeloid leukemia and other HHMs.

27 Sep 2023·International journal of molecular sciences

bFGF-like Activity Supported Tissue Regeneration, Modulated Neuroinflammation, and Rebalanced Ca²⁺ Homeostasis following Spinal Cord Injury.

Article

Author: Filippone, Alessia ; Casili, Giovanna ; Repici, Alberto ; Paterniti, Irene ; Bova, Valentina ; Lanza, Marika ; Ardizzone, Alessio ; Esposito, Emanuela

A spinal cord injury (SCI) is a well-defined debilitating traumatic event to the spinal cord that usually triggers permanent changes in motor, sensory, and autonomic functions. Injured tissue becomes susceptible to secondary mechanisms caused by SCIs, which include pro-inflammatory cytokine release, the activation of astrocytes and microglia, and increased neuronal sensibility. As a consequence, the production of factors such as GFAP, IBA-1, TNF-α, IL-1β, IFN-γ, and S100-β slow down or inhibit central nervous system (CNS) regeneration. In this regard, a thorough understanding of the mechanisms regulating the CNS, and specifically SCI, is essential for the development of new therapeutic strategies. It has been demonstrated that basic fibroblast growth factor (bFGF) was successful in the modulation of neurotrophic activity, also promoting neurite survival and tissue repair, thus resulting in the valuable care of CNS disorders. However, bFGF therapeutic use is limited due to the undesirable effects developed following its administration. Therefore, the synthetic compound mimetic of bFGF, SUN11602 (with chemical name 4-[[4-[[2-[(4-Amino-2,3,5,6-tetramethylphenyl)amino]acetyl]methylamino]-1-piperidinyl]methyl]benzamide), has been reported to show neuroprotective activities similar to those of bFGF, also demonstrating a good pharmacokinetic profile. Here, we aimed to investigate the neuroprotective activity of this bFGF-like compound in modulating tissue regeneration, neuroinflammation, and Ca²⁺ overload by using a subacute mouse model of SCI. SUN11602 (1, 2.5, and 5 mg/kg) was administered orally to mice for 72 h daily following the in vivo model of SCI, which was generated by the extradural compression of the spinal cord. The data obtained demonstrated that SUN11602 treatment considerably decreased motor alteration and diminished the neuroinflammatory state through the regulation of glial activation, the NF-κB pathway, and kinases. Additionally, by controlling Ca²⁺-binding proteins and restoring neurotrophin expression, we showed that SUN11602 therapy restored the equilibrium of the neuronal circuit. Because of these findings, bFGF-like compounds may be an effective tool for reducing inflammation in SCI patients while enhancing their quality of life.

News (Medical) associated with Tambiciclib

25 Jun 2024

·www.globenewswire.com

SELLAS Announces U.S. FDA Rare Pediatric Disease Designation Granted to SLS009 for the Treatment of Pediatric Acute Lymphoblastic Leukemia

- Acute Lymphoblastic Leukemia (ALL) is the Most Common Type of Cancer in Children – - Rare Pediatric Disease Designation (RPDD) Provides Eligibility for SLS009 to Receive a Priority Review Voucher (PRV) Upon Marketing Approval that can be Transferred/Sold to Other Parties – - Past Sales of PRVs Have Averaged More Than $100 Million - June 24, 2024 -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS” or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) to SLS009, a highly selective CDK9 inhibitor, for the treatment of pediatric acute lymphoblastic leukemia (ALL). “We are pleased that the FDA has granted Rare Pediatric Disease Designation to SLS009 for the treatment of pediatric ALL, the most common cancer diagnosed in children,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. ”We remain steadfast in our commitment to advancing SLS009 through the clinical development process across multiple indications and striving to improve the lives of patients, including children, and their families affected by ALL. We look forward to exploring SLS009 as a potential treatment option in pediatric ALL and this designation will significantly help expedite clinical development.” Childhood ALL is a life-threatening disease with a high unmet medical need. Despite significant advances in the treatment of pediatric ALL, relapse continues to be the most common cause of treatment failure. There are patient subpopulations with high-risk and very high-risk features in need of less toxic therapies that would ultimately extend their long-term event-free survival (EFS) which remains around 50% for very high-risk groups. In clinical trials, SLS009 has demonstrated a very favorable safety profile with complete absence, to date, of any non-hematologic clinical higher-grade toxicities. Rare Pediatric Disease (RPD) Designation is granted by the FDA for serious or life-threatening diseases that affect fewer than 200,000 people in the United States, and in which the serious or life-threatening manifestations primarily affect individuals less than 18 years of age. If, in the future, a New Drug Application (NDA) for SLS009 for the treatment of pediatric AML is approved by the FDA, SELLAS might be eligible to receive a Priority Review Voucher (PRV) that could be redeemed to receive a priority review for any subsequent marketing application. PRVs may be used by the sponsor or sold to another sponsor for their use and have recently sold for approximately $100 million. SELLAS is a late-stage clinical biopharmaceutical company focused on the development of novel therapeutics for a broad range of cancer indications. SELLAS’ other lead product candidate, GPS, is licensed from Memorial Sloan Kettering Cancer Center and targets the WT1 protein, which is present in an array of tumor types. GPS has the potential as a monotherapy and combination with other therapies to address a broad spectrum of hematologic malignancies and solid tumor indications. The Company is also developing SLS009 (formerly GFH009) - potentially the first and best-in-class differentiated small molecule CDK9 inhibitor with reduced toxicity and increased potency compared to other CDK9 inhibitors. Data suggests that SLS009 demonstrated a high response rate in AML patients with unfavorable prognostic factors including ASXL1 mutation, commonly associated with poor prognosis in various myeloid diseases. For more information on SELLAS, please visit www.sellaslifesciences.com. The content above comes from the network. if any infringement, please contact us to modify.

Priority ReviewNDA

17 Jun 2024

·www.biospace.com

SELLAS Life Sciences Announces Positive Recommendation from the Independent Data Monitoring Committee of the Phase 3 REGAL Trial in Acute Myeloid Leukemia

– The Independent Data Monitoring Committee (IDMC) Recommends Continuation of Phase 3 REGAL Trial Without Any Modifications – – No Safety or Futility Concerns Were Raised Based on theEfficacy and Safety Assessment of All REGAL Patients – – Interim Analysis Anticipated by Q4 2024 – NEW YORK, June 17, 2024 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced a positive review of the ongoing Phase 3 REGAL clinical trial of galinpepimut-S (GPS) in acute myeloid leukemia (AML) by the Independent Data Monitoring Committee (IDMC). The IDMC conducted a prespecified risk-benefit assessment of unblinded data from the study and has recommended that the trial continue without modifications. Based on a detailed analysis of all unblinded data, the IDMC projects with a high level of confidence that the interim analysis (60 events) will occur by the fourth quarter of 2024. “We are encouraged with another positive review and the IDMC’s recommendation to continue the Phase 3 REGAL trial in AML without any modifications,” said Angelos Stergiou, MD, ScD hc, President and Chief Executive Officer of SELLAS. “The committee’s review did not raise any safety or futility concerns, further strengthening our confidence in the potential of GPS as a safe and effective treatment option for AML patients. This is the first time the IDMC has provided guidance regarding the timing of the expected interim analysis, by the fourth quarter of this year, based on their thorough analysis of the REGAL trial data.” “As a principal investigator from a high enrolling REGAL study site, I am of course delighted to learn that the interim analysis, a key milestone, is upcoming,” said Panagiotis Tsirigotis, MD, Professor of Medicine at the University of Athens and Chief of Leukemia at Attikon University Hospital. “What makes me equally and perhaps even more excited is that now with the REGAL study enrollment completed and upcoming efficacy read-out, I am looking forward to the potential expansion of GPS into other settings, beyond maintenance of second remissions in patients with AML, as it could function as a treatment modality in patients in first remission as well as post bone marrow transplant.” REGAL is a Phase 3 open-label registrational clinical trial for GPS in AML patients who have achieved complete remission following second-line salvage therapy (CR2 patients). The primary endpoint is overall survival. The IDMC is an independent group of medical, scientific, and biostatistics experts responsible for reviewing and evaluating patient safety and efficacy data for REGAL, and for monitoring quality and overall conduct to ensure the study's validity, scientific and clinical merits. The IDMC charter provides for periodic reviews of safety, efficacy, and futility in addition to the interim and final analyses. About SELLAS Life Sciences Group, Inc. SELLAS is a late-stage clinical biopharmaceutical company focused on the development of novel therapeutics for a broad range of cancer indications. SELLAS’ other lead product candidate, GPS, is licensed from Memorial Sloan Kettering Cancer Center and targets the WT1 protein, which is present in an array of tumor types. GPS has the potential as a monotherapy and combination with other therapies to address a broad spectrum of hematologic malignancies and solid tumor indications. The Company is also developing SLS009 (formerly GFH009), a small molecule, highly selective CDK9 inhibitor, which is licensed from GenFleet Therapeutics (Shanghai), Inc., for all therapeutic and diagnostic uses in the world outside of Greater China. For more information on SELLAS, please visit . Forward-Looking Statements This press release contains forward-looking statements. All statements other than statements of historical facts are “forward-looking statements,” including those relating to future events. In some cases, forward-looking statements can be identified by terminology such as “plan,” “expect,” “anticipate,” “may,” “might,” “will,” “should,” “project,” “believe,” “estimate,” “predict,” “potential,” “intend,” or “continue” and other words or terms of similar meaning. These statements include, without limitation, statements related to the GPS clinical development program, including the REGAL study and the timing of future milestones related thereto. These forward-looking statements are based on current plans, objectives, estimates, expectations and intentions, and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties with oncology product development and clinical success thereof, the uncertainty of regulatory approval, and other risks and uncertainties affecting SELLAS and its development programs as set forth under the caption “Risk Factors” in SELLAS’ Annual Report on Form 10-K filed on March 28, 2024 and in its other SEC filings. Other risks and uncertainties of which SELLAS is not currently aware may also affect SELLAS’ forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. The forward-looking statements herein are made only as of the date hereof. SELLAS undertakes no obligation to update or supplement any forward-looking statements to reflect actual results, new information, future events, changes in its expectations or other circumstances that exist after the date as of which the forward-looking statements were made. Investor Contact Bruce Mackle Managing Director LifeSci Advisors, LLC SELLAS@lifesciadvisors.com

Phase 3

11 Jun 2024

·www.globenewswire.com

SELLAS Announces Completion of Enrollment and Initial Positive Data in Phase 2a Trial of SLS009 in r/r AML

- 30 Patients Relapsed or Refractory to Venetoclax-Based Regimens Enrolled Ahead of Schedule - - Overall Response Rate (ORR) of 33% and 50% Achieved to Date in 60 mg QW and 30 mg BIW Cohorts, Respectively - - 45 mg (Safety Dose) Once a Week of SLS009 Showed a Median Overall Survival (OS) of 5.4 Months vs. 2.5 Months with Standard of Care; 60 mg Once a Week and 30 mg Twice a Week Median OS Have Not Been Reached Yet - - 100% Overall Response Rate in Patients with ASXL1 Mutation in the 30 mg BIW Cohort to Date - - Trial Continues with Two Expansion Cohorts of Patients with ASXL1 Mutations and Myelodysplasia-Related Molecular Mutations Other Than ASXL1; Additional Update Expected in Q3 2024 - June 10, 2024 -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS” or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced the completion of enrollment as well as positive initial data from the ongoing Phase 2a trial of SLS009, a highly selective CDK9 inhibitor, in relapsed/refractory acute myeloid leukemia (r/r AML). “We are pleased to announce the completion of enrollment in the initial portion of our Phase 2a trial representing a significant milestone in the development of SLS009 in AML,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. “There has been a high level of enthusiasm from the clinical sites, trial investigators, and patients, reflecting the significant unmet need in the AML patient population previously treated with venetoclax-based regimens. We are extremely grateful to everyone who has helped us achieve this important milestone ahead of schedule.” Dr. Stergiou continued: “In addition, we are excited to share very promising initial data from this Phase 2a trial. Efficacy was demonstrated across all cohorts far exceeding the targeted ORR of 20% and median overall survival (mOS) of 3 months. The results also showed that SLS009 was well-tolerated across all doses. These data give us increased confidence in SLS009 as a potential new treatment for AML. We remain committed to advancing the treatment landscape for this underserved patient population and we look forward to continuing the trial, mainly the expansion cohorts, and reporting additional study updates and data in Q3 of this year.” Thirty heavily pretreated patients were recruited in 5 centers across the US, reflecting the high unmet need of this refractory/relapsed patient population. Except for one, all patients in this Phase 2a trial had unfavorable/poor cytogenetic and/or molecular genetics risk (97%) and were treated with continued venetoclax – azacytidine combination therapy after having failed it or similar venetoclax combinations, often more than once. The expected overall survival in those patients is approximately 2.5 months. The Phase 2a clinical trial of SLS009 is an open-label, single-arm, multi-center study designed to evaluate the safety, tolerability, and efficacy of SLS009 in combination with venetoclax and azacitidine at two dose levels, 45 and 60 mg. In the 60 mg dose cohort patients were randomized into either a 60 mg dose once per week or a 30 mg dose two times per week. The target response rate at the optimal dose level is 20% with a target median survival of at least 3 months. In addition, the study aims to identify biomarkers for the target patient population and enrichment for further trials. For more information on the study, visit clinicaltrial.gov identifier NCT04588922. SELLAS is a late-stage clinical biopharmaceutical company focused on the development of novel therapeutics for a broad range of cancer indications. SELLAS’ other lead product candidate, GPS, is licensed from Memorial Sloan Kettering Cancer Center and targets the WT1 protein, which is present in an array of tumor types. GPS has the potential as a monotherapy and combination with other therapies to address a broad spectrum of hematologic malignancies and solid tumor indications. The Company is also developing SLS009 (formerly GFH009), a small molecule, highly selective CDK9 inhibitor, which is licensed from GenFleet Therapeutics (Shanghai), Inc., for all therapeutic and diagnostic uses in the world outside of Greater China. For more information on SELLAS, please visit www.sellaslifesciences.com. The content above comes from the network. if any infringement, please contact us to modify.

Phase 2Clinical Result

100 Deals associated with Tambiciclib

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diffuse large B-cell lymphoma recurrent	Phase 2	CN	Zhejiang JinFang Pharmaceutical Co., Ltd.	12 Mar 2024
Diffuse large B-cell lymphoma refractory	Phase 2	CN	Zhejiang JinFang Pharmaceutical Co., Ltd.	12 Mar 2024
Peripheral T-Cell Lymphoma	Phase 2	CN	Zhejiang JinFang Pharmaceutical Co., Ltd.	06 Sep 2023
Recurrent Hematologic Malignancy	Phase 2	US	SELLAS Life Sciences Group, Inc.	10 May 2021
Recurrent Hematologic Malignancy	Phase 2	CN	SELLAS Life Sciences Group, Inc.	10 May 2021
Acute Myeloid Leukemia	Phase 2	CN	Genfleet Therapeutics (Shanghai), Inc.Startup	-
Hematologic Neoplasms	Phase 2	US	Genfleet Therapeutics (Shanghai), Inc.Startup	-
Prostatic Cancer	Preclinical	US	SELLAS Life Sciences Group, Inc.	24 Aug 2022

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04588922 (GlobeNewswire) Manual	Phase 2	Acute Myeloid Leukemia	30	SLS009 30 mg BIW	xsnvjdbjph(jnoyrgxkts) = none fphecgegwl (xkulmhpwce )	Positive	10 Jun 2024
				SLS009 45 mg QW
NCT04588922 (GlobeNewswire) Manual	Phase 1/2	Acute Myeloid Leukemia ASXL1 Mutation	-	GFH009+venetoclax+azacitidine	oaqkmbnavd(icqzpozncg) = uxqyxitgdm tlvaiqipyd (dqxdpmhlgc ) View more	Positive	01 May 2024
GlobeNewswire Manual	Phase 2	Acute Myeloid Leukemia	21	SLS009 45 mg+azacitidine+venetoclax	grzxiuuccc(uhqalqtlck) = rhwxnmspdv qfbdpthisa (lqsfgyqdbe )	Positive	26 Mar 2024
				SLS009 60 mg QW+azacitidine+venetoclax	grzxiuuccc(uhqalqtlck) = rkcdkhkccl qfbdpthisa (lqsfgyqdbe )
Biospace Manual	Phase 1	Peripheral T-Cell Lymphoma	-	SLS009	wkkrwxrqmu(izmpyztuey) = pgyzmyjzcx webxbkamvx (hropavfknr )	Positive	21 Dec 2023
				belinostat	wkkrwxrqmu(izmpyztuey) = dcdjctlifr webxbkamvx (hropavfknr )
NCT04588922 (Biospace) Manual	Phase 1	Hematologic Neoplasms	11	SLS009	hvtlypwthp(fhgrsqirqf) = tluxelzmet gzmcivrney (wwtdrdgtng )	Positive	30 Oct 2023
Corporate Publications Manual	Phase 2	Acute Myeloid Leukemia	5	SLS00945 mg (patients with r/r AML who failed venetoclax-based therapies)	xvjlobnjlw(slgfswmyhi) = krrrwyuues qwrykmijgj (drctqvkjrf )	Positive	16 Oct 2023
NCT04588922 (ASH2022) Manual	Phase 1	Hematologic Neoplasms	30	GFH009	fqqlpjatuc(bicaklrcdn) = wwaasaqqmc zxbfwxyemd (sbjnaviked ) View more	Positive	12 Dec 2022
NCT04588922 (Corporate Publications) Manual	Phase 1	Acute Myeloid Leukemia \| Lymphoma	50	GFH009 (AML group)	jnwuyhfvmx(egenzuxzai) = In patients with lymphoma and acute myeloid leukemia, dose-limiting toxicity was not observed at all dose levels studied to date nrqhoqktoj (otbooqjxdm )	Positive	27 Jun 2022
				GFH009 (lymphoma group)

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