Notable Announces Volasertib Phase 2 Programme

Notable advances volasertib phase 2 programme utilizing proprietary PPM platform-guided enrollment

Notable Labs, Ltd., a clinical-stage therapeutics platform company developing a new class of cancer therapies based on its Predictive Precision Medicine Platform (PPMP), announced the advancement of its volasertib phase 2 programme utilizing PPMP to enrich the study population for clinical responders.  Notable is developing its lead drug asset volasertib with its proprietary PPMP for patients with relapsed/refractory acute myelogenous leukaemia (r/r AML).

Notable Labs on volasertib & PPMP report

• “PPMP’s recently reported, 100% accurate prediction of fosciclopirox’s clinical trial outcome has allowed us to eliminate an entire 30-patient cohort from the planned volasertib programme, and further validated our PPMP-guided development strategy to target responding patients, improve patient outcomes and reduce the risk, time, and cost of drug development,” said Thomas Bock, M.D., chief executive officer of Notable Labs.
• “We in-licensed volasertib because of its robust clinical experience in Boehringer Ingelheim’s expansive phases 1-3 programme and our PPMP data that distinguished predicted volasertib-responders from predicted non-responders based on samples from patients with AML. 
• We therefore believe that PPMP will focus volasertib’s development on clinically responding patients, boost its clinical response rate and enhance patient outcomes,” continued Dr. Bock. 
• “The open label design of our Phase 2 trial will enable us to provide frequent data updates, and initiate a subsequent phase 3 trial at the earliest possibility.”

CSO from Notable Labs

• Joseph Wagner, Ph.D., chief scientific officer of Notable, added, In our PPMP-guided phase 2 trial, we are additionally leveraging important learnings from the extensive post-hoc analysis of the original phase 2 and 3 trials. 
• This analysis suggests that standardizing best supportive care and introducing body surface area-based dosing are likely to enhance patient responses and tolerability. We are going to include and evaluate these refinements in a small all-comers dose optimization prelude, expected to begin in Q2 2024 and be completed in Q4 2024, prior to enrolling PPMP-predicted responders.

About Volasertib

• Volasertib is a PLK-1 inhibitor with demonstrated activity in AML and other tumour types, including solid tumours, with significant unmet medical need. 
• Building on the performance of volasertib on PPMP, an important and proprietary step during Notable’s targeted in-licensing strategy and decision making, Notable will utilize PPMP 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 paediatric cancers.

Phase II Study (volasertib+ decitabine)

• Notable’s single-arm, open-label phase 2 study of volasertib combined with decitabine in r/r AML patients is designed to achieve two objectives: 
• i) to confirm the optimized tolerability profile suggested by volasertib’s phase 3 post-hoc analysis through the introduction of body-surface area-based volasertib dosing and standardizing best supportive care, and 
• ii)  to evaluate the clinical impact of volasertib treatment on selectively enrolled r/r AML patients who are predicted to clinically respond, based on PPMP testing of their blood or bone marrow samples (PPMP-predicted responders).  Parallel primary endpoints are i) a positive predicted response rate and ii) a per-protocol response assessment of complete remission and overall survival.
• The phase 2 programme is designed to include a non-selective dose optimization prelude expected to enroll a small cohort of all-comers patients with r/r AML. 
• This dose optimization prelude will evaluate the use of standardized best supportive care and body surface area-based dosing prior to beginning the prospective PPMP-based patient selection. 
• Data on patient safety, tolerability, and efficacy, including overall safety, response and duration of response, will be evaluated.

About Company

Notable Labs is a clinical-stage platform therapeutics company developing predictive precision medicines for patients with cancer.

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