Open-label, Dose-escalating Trial to Evaluate the Tolerability, Toxicity, Safety, Pharmacokinetics, Pharmacodynamics and Activity of Volasertib Added to the Standard Intensive Salvage Chemotherapy Regimen With Liposomal Daunorubicine, Fludarabine and Cytarabine (DNX-FLA) Followed by Fludarabine and Cytarabine (FLA) in Children From 3 Months to Less Than 18 Years of Age With Acute Myeloid Leukaemia After Failure of the Front-line Therapy

This is an open-label, dose-escalating trial to evaluate the MTD and/or dose to be used for further development by evaluation of DLT in course 1 and the safety of volasertib when added to standard intensive salvage chemotherapy with DNX-FLA in paediatric patients with AML after failure of first-line therapy. Furthermore, data on efficacy and PK/PD of volasertib in paediatric patients with AML when added to standard intensive salvage chemotherapy will be collected.

Start Date01 Nov 2016

Sponsor / Collaborator

Boehringer Ingelheim GmbH

NCT02757248

/ WithdrawnPhase 1

A Phase I Trial of Volasertib Plus Romidepsin in Patients With Relapsed/Refractory Peripheral T Cell and Cutaneous T Cell Lymphoma

This is a phase I study of the combination of volasertib and romidepsin in patients with relapsed/refractory peripheral T cell lymphoma (PTCL) or stage IIB-IV cutaneous T cell lymphoma (CTCL). This study will determine the maximum tolerated dose (MTD) of this combination by treating cohorts of patients at a certain dose combination. The investigators will use a Bayesian design to determine the dose combination for the next cohort of patients and to determine the MTD. Overall response rate as well as adverse events will be monitored and reported.

Start Date01 Nov 2016

Sponsor / Collaborator

Boehringer Ingelheim GmbH

[+1]

NCT02527174

/ WithdrawnPhase 1IIT

A Phase I Study of Volasertib Combined With Standard Induction Chemotherapy for Previously Untreated Patients With Acute Myeloid Leukemia (VIAC)

This is a Phase I clinical trial to determine the maximum tolerated dose (MTD) of the polo-like kinase-1 inhibitor volasertib which can be safely combined with idarubicin plus cytarabine induction chemotherapy for previously untreated patients with acute myeloid leukemia. (AML).

Start Date01 Nov 2016

Sponsor / Collaborator

University of Alberta

100 Clinical Results associated with Volasertib

100 Translational Medicine associated with Volasertib

100 Patents (Medical) associated with Volasertib

360

Literatures (Medical) associated with Volasertib

26 May 2025·ONCOGENE

Cyclin E1 overexpression sensitizes ovarian cancer cells to WEE1 and PLK1 inhibition

Article

Author: Shinozaki-Ushiku, Aya ; Nagai, Saeko ; Osuga, Yutaka ; Kawana, Kei ; Watanabe, Kousuke ; Ka, Mirei ; Tanimoto, Saki ; Oda, Katsutoshi ; Ogawa, Miho ; Katayama, Kazuhiro ; Fukuda, Tomohiko ; Xi, Qian ; Tsuchimochi, Saki ; Ushiku, Tetsuo ; Kunita, Akiko ; Matsunaga, Asami ; Sone, Kenbun ; Kage, Hidenori

Abstract:

Cyclin E1 (CCNE1) amplification is associated with poor prognosis of ovarian carcinomas across histological subtypes. Inhibitors targeting PLK1 or WEE1 are emerging as promising therapeutic agents for cancer treatment that disrupt the critical G2/M checkpoint, leading to cancer cell death. However, biomarkers that predict the response to these inhibitors are not well defined. Here, we evaluated the efficacy of the PLK1 inhibitor, volasertib, and the WEE1 inhibitor, adavosertib, along with the biomarker potential of cyclin E1 in ovarian cancer cells. Both inhibitors suppressed the proliferation of cyclin E1-overexpressing cells to a greater extent than that of cells exhibiting low cyclin E1 expression. TP53 silencing did not increase the sensitivity to these inhibitors. In cyclin E1-overexpressing cells, PLK1 inhibition reduced the proportion of cells in the G1 phase and increased those in the G2/M and sub-G1 phases. WEE1 inhibition reduced G1 phase cells without a clear peak in the S-G2/M phase and increased the sub-G1 phase cells. Both inhibitors suppressed the growth of cyclin E1-overexpressing tumors in vivo. Taken together, cyclin E1 overexpression, regardless of TP53 status, may serve as a predictive biomarker for the efficacy of these inhibitors, offering potential personalized treatment strategies for ovarian cancer.

04 Apr 2025·JOURNAL OF PROTEOME RESEARCH

Multiomics Analysis Reveals Neuroblastoma Molecular Signature Predicting Risk Stratification and Tumor Microenvironment Differences

Article

Author: Zhou, Zhaokai ; Zhang, Da ; Wang, Jingyue ; Zhou, Xing ; Fu, Yongcheng ; Qin, Pan ; Cheng, Jian ; Qin, Xiaohan ; Wang, Yuanyuan

Neuroblastoma (NB) remains associated with high mortality and low initial response rate, especially for high-risk patients, thus warranting exploration of molecular markers for precision risk classifiers. Through integrating multiomics profiling, we identified a range of hub genes involved in cell cycle and associated with dismal prognosis and malignant cells. Single-cell transcriptome sequencing revealed that a subset of malignant cells, subcluster 1, characterized by high proliferation and dedifferentiation, was strongly correlated with the hub gene signature and orchestrated an immunosuppressive tumor microenvironment (TME). Furthermore, we constructed a robust malignant subcluster 1 related signature (MSRS), which was an independent prognostic factor and superior to other clinical characteristics and published signatures. Besides, TME differences conferred remarkably distinct therapeutic responses between high and low MSRS groups. Notably, polo-like kinase-1 (PLK1) was one of the most crucial contributors to MSRS and remarkably correlated with malignant subcluster 1, and PLK1 inhibition was effective for NB treatment as demonstrated by in silico analysis and in vitro experiments. Overall, our study constructs a novel molecular model to further guide the clinical classification and individualized treatment of NB.

01 Feb 2025·Cancer research communications

MYC and HSF1 Cooperate to Drive Sensitivity to Polo-like Kinase 1 Inhibitor Volasertib in High-grade Serous Ovarian Cancer

Article

Author: Jothirajah, Pranav ; Ray, Haimanti ; Carpenter, Richard L. ; Delaney, Joe R. ; Walker, Bobby ; Landrum, Lisa M. ; Williams, Imade ; O’Malley, Matthew ; Nephew, Kenneth P. ; Ulhaskumar, Vrushabh ; DeHart, Haddie

Abstract:

Ovarian cancer is a deadly gynecologic disease with frequent recurrence. Current treatments for patients include platinum-based therapy regimens with PARP inhibitors specific for homologous recombination–deficient high-grade serous ovarian cancers (HGSOC). Despite initial effectiveness, patients inevitably develop disease progression as tumor cells acquire resistance. Toward the development of new therapeutic avenues, we describe a gene amplification involving both heat shock factor 1 (HSF1) and MYC, wherein these two genes are co-amplified in more than 30% of patients with HGSOC. We further found that HSF1 and MYC transcriptional activities were highly correlated with human HGSOC tumors and cell lines, suggesting that they may cooperate in the disease. CUT&RUN sequencing for HSF1 and MYC revealed overlapping HSF1 and MYC binding throughout the genome. Moreover, the binding peaks of both transcription factors in HGSOC cells were nearly identical, and a protein–protein interaction between HSF1 and MYC was detected, supporting molecular cooperation. Supporting a functional cooperation of these two transcription factors, the growth of HGSOC cells with the co-amplification was dependent on both HSF1 and MYC. To identify a therapeutic target that could take advantage of this unique HSF1 and MYC dependency, polo-like kinase 1 (PLK1) was correlated with HSF1 and MYC in HGSOC specimens. Targeting PLK1 with volasertib revealed a greater than 200-fold increased potency in HSF1–MYC co-amplified HGSOC cells compared with those with wild-type HSF1 and MYC copy numbers. Although the success of volasertib and other PLK1 inhibitors in clinical trials has been modest, the current study suggests that targeting PLK1 using a precision medicine approach based on HSF1–MYC co-amplification as a biomarker in HGSOC would improve therapy response and patient outcomes.

Significance::

We show that HSF1 and MYC genes are co-amplified in more than 30% of HGSOC and demonstrate that HSF1 and MYC functionally cooperate to drive the growth of HGSOC cells. This work provides the foundation for HSF1 and MYC co-amplification as a biomarker for treatment efficacy of the polo-like kinase 1 inhibitor volasertib in HGSOC.

News (Medical) associated with Volasertib

30 Aug 2024

·endpts.com

J&J's human resources leader to retire; Amgen becomes the newest pharma with a top AI exec

→ Kristen Mulholland will take over for the retiring Peter Fasolo as chief human resources officer at J&J on Oct. 1. “Peter has led J&J’s talent strategy for the past 16 years including remarkable leadership through the global pandemic and the separation of our consumer health business,” CEO Joaquin Duato said in a statement . “He leaves a legacy of strong leaders, deep bench strength and an inclusive, caring and patient-focused culture.” Fasolo is a Bristol Myers Squibb HR vet who left J&J to become chief talent officer for KKR , only to return in 2010. Mulholland started at J&J in 2005 and has spent nearly five years as head of human resources, global total rewards & enterprise HR functions. → Just do it: Amgen technology chief David Reese said in a LinkedIn post that the pharma giant has appointed Sean Bruich as SVP of artificial intelligence and data. Bruich moves into the pharma world after an 11-year run with Nike , where he vaulted to global VP, insights, data science & analytics. This is the second high-level AI hire by a major pharma in as many weeks — Pfizer just welcomed Berta Rodriguez-Hervas as its new chief AI and analytics officer. → In its biggest personnel news since Doug Williams ’ resignation , Sana Biotechnology has poached Dhaval Patel from UCB as the Seattle biotech awaits data readouts for its CD19-targeted allogeneic CAR-T therapy in a host of indications. Patel had a 10-year career with Novartis before he held the CSO post at UCB for nearly seven years, and he’ll have the same responsibilities at Sana under CEO Steve Harr . Sana said in its second-quarter update that the goal is to reveal data for SC291 in B cell malignancies — and such autoimmune diseases as lupus nephritis, extrarenal lupus and ANCA-associated vasculitis — sometime this year. “His expertise in immunology and autoimmune diseases make[s] him ideally suited to help advance our clinical pipeline,” Harr said in a statement . → Brian Di Donato , the CFO and head of strategy at Immunocore since May 2020 , is stepping down “at the end of the year” to take the CEO job at an unnamed San Diego biotech. Di Donato was the finance leader for Achillion when Alexion scooped it up for $930 million, and he’s also a board member at Jim Wilson joint iECURE , where ex-Achillion chief Joseph Truitt is CEO. → Telix Pharmaceuticals has separated its business into four separate entities: Telix Therapeutics , Telix Precision Medicine (diagnostics), Telix Lightpoint (medtech, from its acquisition of Lightpoint Medical ) and Telix Manufacturing Solutions . With these changes in place, Telix has tapped Richard Valeix as CEO of Telix Therapeutics, Kevin Richardson as Telix Precision Medicine’s chief executive, and Raphael Ortiz as CEO of Telix International . Christian Behrenbruch ’s title has been slightly modified to group CEO. Telix had hoped to join the Nasdaq in June with an IPO around the $200 million mark, but the Melbourne biotech made a gametime decision to pull those plans . → Cambridge, MA-based neuro player Cognito Therapeutics has promoted Christian Howell to CEO. Brent Vaughan had been running Cognito since 2020 after co-founding and leading the autism diagnostic specialist Cognoa , and he hired Howell as his chief commercial officer last October. Howell had a long career with Medtronic and then joined Aetion , where he was elevated to SVP and general manager of the emerging channels group (medical device, diagnostics, digital health, and government) in April 2023. → Elsewhere, Endo is also losing its president and CEO Blaise Coleman . Board member Scott Hirsch will serve in the interim as the company searches for a permanent successor. Hirsch joined Endo’s board in April, around the same time that the company sued the FDA over its approval of a generic version of Endo’s drug Adrenalin . Hirsch is the former CEO of Solta Medical and also held the roles of president of Ortho Dermatologics and CBO of Bausch Health / Bausch + Lomb . → Thomas Bock has handed in his resignation as CEO of Notable Labs , and CSO Joseph Wagner will take over the top spot on an interim basis. This isn’t uncharted territory for Wagner: He’s the former CEO of Oncocyte (2011-15) and Canadian I/O biotech BriaCell Therapeutics (2015-16). Notable Labs merged with VBL Therapeutics in February 2023 and will start enrolling patients in its Phase 2 study of the ex- Boehringer Ingelheim drug volasertib for acute myeloid leukemia “in the coming months,” the company said in July. → Delfi Diagnostics marked the beginning of the year with a new CEO it hired away from Illumina . Now, the competitor to Grail has brought on Thomas Russo as finance chief. Russo served in the same role at Icosavax and Assembly Biosciences . During his time at Icosavax, Russo helped with the company’s growth until its $838 million upfront acquisition by AstraZeneca . → Marea Therapeutics , the Third Rock upstart led by ex- Graphite Bio CEO Josh Lehrer , has selected Ian Clements as CFO. Clements resigned from the same post at Livmarli maker Mirum Pharmaceuticals in May 2023 after four years overall with the company, and he’s the ex-VP of investor relations for Dermira . Marea launched in June with $190 million in “combined Series A and B” funding, testing an ex-Novartis monoclonal antibody that targets ANGPTL4 in adults with metabolic dysfunction. → With ex- Synlogic CEO Aoife Brennan at the controls, a seemingly rejuvenated Eliem Therapeutics has named Brett Kaplan as COO and Nishi Rampal as SVP, clinical development. Kaplan had been president and chief financial & corporate development officer for epigenetic editing upstart Chroma Medicine , and he was also the finance chief at Prevail until Eli Lilly bought the gene therapy biotech for $1 billion. An Alexion vet, Rampal also handled the role of global development and strategy lead for the neuromyelitis optica spectrum disorder (NMOSD) treatment Uplizna as an executive director with Horizon /Amgen. Eliem’s hunt for strategic alternatives ended with the acquisition of Tenet Medicines and its anti-CD19 antibody budoprutug , once known as TNT119 . → Backed by RA Capital and Forbion , Navigator Medicines disclosed its $100 million Series A this week and the recruitment of Dana McClintock as CMO. McClintock spent six years in the same position at Alladapt Immunotherapeutics and was global head of the Office of I2O Innovation for Genentech . Navigator also said that Forbion general partner Wouter Joustra and RA Capital managing director Andrew Levin have made their way to the board of directors. → Alex Bastian has been named VP, commercial strategy at Swiss-based Memo Therapeutics , reuniting with CEO Erik van den Berg . Toward the end of van den Berg’s tenure as CEO of AM-Pharma , Bastian was the Dutch biotech’s VP, commercial & patient access. He also worked for Galapagos as VP, head of value & market access. → Structure Therapeutics , one of many biotechs developing a GLP-1 drug for obesity, has elected ex- Shire CEO Angus Russell to the board of directors. The 68-year-old Russell has chaired the board at Daxxify maker Revance Therapeutics since 2014 and has a board seat at Lineage Cell Therapeutics . → Ex- Vividion CEO Jeff Hatfield has joined the board of directors at Gate Bioscience , a California drug developer that launched last November with a $60 million Series A from several blue-chip investors. Hatfield chairs the board at Vividion and Rome Therapeutics . → Opna Bio has made room for Inozyme co-founder and former CEO Axel Bolte on the board of directors. The South San Francisco biotech also announced that it had dosed the first patient in a Phase 1 trial of its multiple myeloma candidate OPN-6602 and appointed Myeloma Investment Fund managing director Stephanie Oestreich as a board observer.

Executive ChangePhase 1AcquisitionIPO

29 Aug 2024

·www.globenewswire.com

Notable Labs to Present Data on September 4th at SOHO 2024

Society of Hematologic Oncology (SOHO) session to highlight volasertib program Phase 2 volasertib AML program expected to begin in the coming months FOSTER CITY, Calif., Aug. 29, 2024 (GLOBE NEWSWIRE) -- Notable Labs, Ltd. (Nasdaq: NTBL) (“Notable”, “Notable Labs” or the “Company”), a clinical-stage precision oncology company developing new cancer therapies identified by its Predictive Medicine Platform (PMP), announced that the Company will present an overview of the Phase 2 program and additional data from preclinical studies evaluating volasertib for acute myeloid leukemia (AML) at the twelfth annual meeting of the Society for Hematologic Oncology (SOHO 2024), being held from September 4th-7th 2024. Presentation details: Poster:Revival of the polo-like kinase 1 (PLK1) inhibitor volasertib in relapsed/refractory acute myeloid leukemiaAuthors:G. Michelson, S. Houston, C. Leonardi, C. Gu, M. Lacher, and J. WagnerPoster Session:Wednesday, September 4th at 6:15 PM CDT About Volasertib Volasertib is a PLK-1 inhibitor with demonstrated activity in AML and other tumor types with significant unmet medical need, including solid tumors. Building on the performance of volasertib on PMP, an important and proprietary step during Notable’s targeted in-licensing strategy and decision making, Notable will utilize its PMP to predict volasertib-responsive patients prior to their treatment, with the goal of selectively enrolling and treating those predicted responders, increasing volasertib’s response rates and overall patient outcomes, and fast-tracking volasertib’s remaining clinical development. Volasertib was originally developed and manufactured by Boehringer Ingelheim and previously granted Breakthrough Therapy Designation by the FDA. Notable in-licensed volasertib and has exclusive worldwide development and commercialization rights, except for certain rare pediatric cancers. About Notable Labs, Ltd. Notable Labs, Ltd. is a clinical-stage platform therapeutics company developing predictive medicines for patients with cancer. Through its proprietary Predictive Medicine Platform (PMP), Notable aims to predict whether or not a patient is likely to respond to a specific therapeutic. The PMP is designed to identify and select clinically responsive patients prior to their treatment, potentially fast-tracking clinical development. By continually advancing and expanding the reach of the PMP across diseases and predicted medical outcomes, Notable aims to be the leader in predictive medicine and revolutionize the way patients seek and receive treatments that work best for them. Notable believes the use of PMP also provides the Company with a more targeted and de-risked in-licensing strategy to deliver a product’s medical impact and commercial value faster, with a greater likelihood of success, than traditional drug development. By transforming historical standards of care, Notable aims to create a dramatically positive impact for patients and the healthcare community. Notable is headquartered in Foster City, California. Learn more at the Company’s website: https://notablelabs.com/ and follow us @notablelabs. Forward Looking StatementsThis press release contains “forward-looking statements” within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including but not limited to, express or implied statements regarding Notable’s future operations and goals; the potential benefits of any therapeutic candidates or platform technologies of Notable; the timing of any clinical milestones of Notable’s therapeutic candidates; the cash runway of the Company; and other statements that are not historical fact. All statements other than statements of historical fact contained in this communication are forward-looking statements. These forward-looking statements are made as of the date they were first issued, and are based on the then-current expectations, estimates, forecasts, and projections, as well as the beliefs and assumptions of management. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond Notable’s control. Notable’s actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to (i) uncertainties associated with Notable’s platform technologies, as well as risks associated with the clinical development and regulatory approval of product candidates, including potential delays in the commencement, enrollment and completion of clinical trials; (ii) risks related to the inability of Notable to obtain sufficient additional capital to continue to advance these product candidates and any preclinical programs; (iii) uncertainties in obtaining successful clinical results for product candidates and unexpected costs that may result therefrom; (iv) risks related to the failure to realize any value from product candidates and preclinical programs being developed and anticipated to be developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; (v) risks associated with Notable’s future financial and operating results, including its ability to become profitable; (vi) Notable’s ability to retain key personnel; (vii) Notable’s ability to manage the requirements of being a public company; (viii) uncertainties relating to the Israel-Hamas war; (ix) Notable’s ability to obtain orphan drug designation, and the associated benefits, for any of its drug candidates; (x) Notable’s inability to obtain regulatory approval for any of its drug candidates; and (xi) changes in, or additions to international, federal, state or local legislative requirements, such as changes in or additions to tax laws or rates, pharmaceutical regulations, and other regulations. 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. These and other risks and uncertainties are more fully described in periodic filings with the U.S. Securities and Exchange Commission (“SEC”), including the factors described in the section titled “Risk Factors” in the Annual Report on Form 10-K of Notable Labs, Ltd. for the year ended December 31, 2023 as filed with the SEC, and in other subsequent filings with the SEC. You should not place undue reliance on these forward-looking statements, which are made only as of the date hereof or as of the dates indicated in the forward-looking statements. Notable expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. CONTACTS: Investor Relations: Daniel FerryLifeSci Advisors+1 (617) 430-7576daniel@lifesciadvisors.com

Phase 2ASHOrphan DrugBreakthrough TherapyASCO

26 Aug 2024

·www.globenewswire.com

Notable Labs Announces CEO Transition

Thomas Bock, MD resigns as CEO; Joseph Wagner, PhD, CSO, appointed interim CEO Company affirms plan to initiate volasertib Phase 2 program in the coming months FOSTER CITY, Calif., Aug. 26, 2024 (GLOBE NEWSWIRE) -- Notable Labs, Ltd. (Nasdaq: NTBL) (“Notable”, “Notable Labs” or the “Company”), a clinical-stage precision oncology company developing new cancer therapies identified by its Predictive Medicine Platform (PMP), announced that Thomas A. Bock, MD has resigned from his positions as Chief Executive Officer (CEO) and member of the Board of Directors of the Company, effective today. Joseph Wagner, PhD, the Company’s Chief Scientific Officer (CSO), has been appointed as interim CEO. The Board of Directors has initiated a search process for Dr. Bock’s successor. “On behalf of the Board and the entire Notable team, I want to extend our deepest gratitude to Thomas for his visionary leadership and tireless dedication to the Company. Under his leadership, Notable transformed from a private diagnostic start-up to a publicly-traded clinical-stage therapeutic-focused leader in Predictive Medicine and delivered industry-leading results from platform-validating clinical trials in hematologic cancers. We are confident that the strong foundation Thomas built will lead to continued progress, starting with the initiation of the Phase 2 clinical program for volasertib, expected in the coming months,” said Tuomo Pätsi, Chairman of the Board. “As we search for Thomas’ successor, we look forward to working with Joe to continue Notable’s work to revolutionize the use of predictive medicine in cancer care.” “I am especially proud of Notable’s world-class team and how far the Company has come in developing PMP as a novel precision medicine tool. I believe the re-designed volasertib development program, which merges biology and technology through enhanced trial design and the use of PMP, has the potential to improve treatment outcomes for patients with AML,” said Dr. Bock. “With our FDA-cleared Phase 2 program nearing significant clinical milestones, I am optimistic for Notable’s future and thankful to our team, Board, investors, advisors, and all partners for their shared commitment and the sense of urgency that patients deserve.” Dr. Bock will continue as a consultant to the Company, advising the Board of Directors and offering his expertise and guidance on the Company’s next phase. About Volasertib Volasertib is a PLK-1 inhibitor with demonstrated activity in AML and other tumor types, including solid tumors, with significant unmet medical need. Building on the performance of volasertib on PMP, an important and proprietary step during Notable’s targeted in-licensing strategy and decision making, Notable will utilize its PMP to predict volasertib-responsive patients prior to their treatment, with the goal of selectively enrolling and treating those predicted responders, increasing volasertib’s response rates and overall patient outcomes, and fast-tracking volasertib’s remaining clinical development in this patient population. Volasertib was originally developed and manufactured by Boehringer Ingelheim and previously granted Breakthrough Therapy designation by the FDA. Notable in-licensed volasertib and obtained exclusive worldwide development and commercialization rights, except for certain rare pediatric cancers. About Notable Labs, Ltd. Notable Labs, Ltd. is a clinical-stage platform therapeutics company developing predictive medicines for patients with cancer. Through its proprietary Predictive Medicine Platform (PMP), Notable aims to predict whether or not a patient is likely to respond to a specific therapeutic. The PMP is designed to identify and select clinically responsive patients prior to their treatment, potentially fast-tracking clinical development. By continually advancing and expanding the reach of the PMP across diseases and predicted medical outcomes, Notable aims to be the leader in predictive medicine and revolutionize the way patients seek and receive treatments that work best for them. Notable believes it has created a targeted and de-risked in-licensing strategy to deliver a product’s medical impact and commercial value faster, with a greater likelihood of success, than traditional drug development. By transforming historical standards of care, Notable aims to create a dramatically positive impact for patients and the healthcare community. Notable is headquartered in Foster City, California. Learn more at our website and follow us @notablelabs. Forward Looking StatementsThis press release contains “forward-looking statements” within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including but not limited to, express or implied statements regarding Notable’s future operations and goals; the potential benefits of any therapeutic candidates or platform technologies of Notable; the timing of any clinical milestones of Notable’s therapeutic candidates; the cash runway of the company; and other statements that are not historical fact. All statements other than statements of historical fact contained in this communication are forward-looking statements. These forward-looking statements are made as of the date they were first issued, and are based on the then-current expectations, estimates, forecasts, and projections, as well as the beliefs and assumptions of management. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond Notable’s control. Notable’s actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to (i) uncertainties associated with Notable’s platform technologies, as well as risks associated with the clinical development and regulatory approval of product candidates, including potential delays in the commencement, enrollment and completion of clinical trials; (ii) risks related to the inability of Notable to obtain sufficient additional capital to continue to advance these product candidates and any preclinical programs; (iii) uncertainties in obtaining successful clinical results for product candidates and unexpected costs that may result therefrom; (iv) risks related to the failure to realize any value from product candidates and preclinical programs being developed and anticipated to be developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; (v) risks associated with Notable’s future financial and operating results, including its ability to become profitable; (vi) Notable’s ability to retain key personnel; (vii) Notable’s ability to manage the requirements of being a public company; (viii) uncertainties relating to the Israel-Hamas war; (ix) Notable’s ability to obtain orphan drug designation, and the associated benefits, for any of its drug candidates; (x) Notable’s inability to obtain regulatory approval for any of its drug candidates; and (xi) changes in, or additions to international, federal, state or local legislative requirements, such as changes in or additions to tax laws or rates, pharmaceutical regulations, and other regulations. 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. These and other risks and uncertainties are more fully described in periodic filings with the U.S. Securities and Exchange Commission (“SEC”), including the factors described in the section titled “Risk Factors” in the Annual Report on Form 10-K of Notable Labs, Ltd. for the year ended December 31, 2023 as filed with the SEC, and in other subsequent filings with the SEC. You should not place undue reliance on these forward-looking statements, which are made only as of the date hereof or as of the dates indicated in the forward-looking statements. Notable expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. CONTACTS: Investor Relations: Daniel FerryLifeSci Advisors+1 (617) 430-7576daniel@lifesciadvisors.com

Phase 2Executive ChangeBreakthrough Therapy

100 Deals associated with Volasertib

External Link

KEGG	Wiki	ATC	Drug Bank
D10182	Volasertib	-	DB12062

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acute Myeloid Leukemia	Phase 3	United States	Boehringer Ingelheim GmbH	29 Jan 2013
Acute Myeloid Leukemia	Phase 3	Japan	Boehringer Ingelheim GmbH	29 Jan 2013
Acute Myeloid Leukemia	Phase 3	Argentina	Boehringer Ingelheim GmbH	29 Jan 2013
Acute Myeloid Leukemia	Phase 3	Austria	Boehringer Ingelheim GmbH	29 Jan 2013
Acute Myeloid Leukemia	Phase 3	Belgium	Boehringer Ingelheim GmbH	29 Jan 2013
Acute Myeloid Leukemia	Phase 3	Brazil	Boehringer Ingelheim GmbH	29 Jan 2013
Acute Myeloid Leukemia	Phase 3	Canada	Boehringer Ingelheim GmbH	29 Jan 2013
Acute Myeloid Leukemia	Phase 3	Czechia	Boehringer Ingelheim GmbH	29 Jan 2013
Acute Myeloid Leukemia	Phase 3	Finland	Boehringer Ingelheim GmbH	29 Jan 2013
Acute Myeloid Leukemia	Phase 3	France	Boehringer Ingelheim GmbH	29 Jan 2013

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


SOHO2024	Not Applicable	Relapsing acute myeloid leukemia	-	Volasertib + Decitabine	snhkflzxoc(bzytrigvgq) = about 30% ofgqrsbzie (szitsaabql ) View more	-	04 Sep 2024
NCT01721876 (CTgov)	Phase 3	Acute Myeloid Leukemia	666	Placebo+Cytarabine (Placebo + Low-dose Cytarabine)	ncpwqfmpct = pexbnijhuy pvrdqicmuq (nernvkobjl, xzzuigulwz - znipdiepgq) View more	-	19 Nov 2021
				Volasertib+Cytarabine (Volasertib + Low-dose Cytarabine)	ncpwqfmpct = dazebousea pvrdqicmuq (nernvkobjl, xrhaxuojbw - crvdtssgyk) View more
NCT01721876 (Pubmed) Manual	Phase 3	Acute Myeloid Leukemia	666	cytarabine+Volasertib	oguavhksbd(cardnshpwn) = udoofrkadq dsqbpexchs (tiglykvscc ) View more	Negative	02 Aug 2021
				cytarabine+Placebo	oguavhksbd(cardnshpwn) = rgepitmzrb dsqbpexchs (tiglykvscc ) View more
NCT01957644 (CTgov)	Phase 1	Chronic Myelomonocytic Leukemia \| Myelodysplastic Syndromes	16	Volasertib+Azacitidine (Volasertib 250 mg + Azacitidine (Escalation Cohort)-Part 1)	qszdljrtio = qjecabeonr jokpcsnjkx (nfuvcrglvl, wfkvttvxqc - bcvufiddts) View more	-	08 Feb 2019
				Volasertib+Azacitidine (Volasertib 300 mg + Azacitidine (Escalation Cohort)- Part 1)	qszdljrtio = lmvpybembh jokpcsnjkx (nfuvcrglvl, lsayuayaxy - uclbufnleg) View more
NCT01206816 (CTgov)	Phase 1	Advanced Malignant Solid Neoplasm	57	Volasertib150+Afatinib (Volasertib150 mg+Afatinib 30 mg (Schedule A))	elqrdzpwzk = mzshamjxdv qzihoofvtv (vwovlnwbqf, jljgjylzwi - sfyuyvfemn) View more	-	01 Feb 2019
				Afatinib+Volasertib (Volasertib 225 mg+Afatinib 30 mg (Schedule A))	elqrdzpwzk = uxsgpejphl qzihoofvtv (vwovlnwbqf, oaaemtudxo - rjljfgjese) View more
NCT02003573 (CTgov)	Phase 1	Acute Myeloid Leukemia \| Refractory acute myeloid leukemia	13	decitabine iv+volasertib iv infusion	drxhvzmnkc = cecxkxdanh ijxahowcev (xhfidfkcmx, xqaxexyino - nfazlyzbpb)	-	31 Jan 2019
NCT01145885 (CTgov)	Phase 1	Solid tumor \| Advanced Malignant Solid Neoplasm	7	Volasertib (Volasertib 14C 300 mg)	njxoyzwovm(eikpwwdzuw) = auomytoqfa ifgspdcjwo (xxdksnzttd, 18.0) View more	-	31 Jan 2019
				Volasertib (Volasertib 300mg)	xobkaltsem = zcgeabixhn edqhihjkgp (apvfggtqrm, nqajyqvxru - kdjqepwdbo) View more
NCT01348347 (CTgov)	Phase 1	Advanced Malignant Solid Neoplasm	15	Volasertib (Volasertib 200 mg Cohort)	srhtfvnahq = otshgdhyvg dhekuljqlw (lpxytmycip, nmmkojgucn - ajgfobmqlg) View more	-	06 Aug 2018
				Volasertib (Volasertib 300 mg Cohort)	srhtfvnahq = dsdiesxbfy dhekuljqlw (lpxytmycip, jhaxhknqqw - ymhkvpzkzs) View more
NCT01662505 (CTgov)	Phase 1	Acute Myeloid Leukemia	19	Volasertib	eunakzpjuw = webxbchtvl qchflzvonz (mnlqtkbwhj, zqpwaumchn - ualsaulhke)	-	30 Jul 2018

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