Firm to host investor convention name and webcast on October 17, 2024, at 4:30 pm EDT
BOSTON–(BUSINESS WIRE)–Verastem Oncology (Nasdaq: VS™), a biopharmaceutical firm dedicated to advancing new medicines for sufferers with most cancers, right this moment introduced additional particulars for its late-breaking presentation of mature information from the continuing Part 2 RAMP 201 (ENGOT-ov60/GOG-3052) scientific trial to be offered as an oral presentation at a plenary session on the Worldwide Gynecologic Most cancers Society (IGCS) Annual International Assembly happening October 16-18, 2024 in Dublin, Eire.
The late-breaking summary is embargoed till the morning of the presentation at IGCS. The oral presentation will embrace up to date security and efficacy information from the RAMP 201 trial evaluating the mixture of avutometinib, an oral RAF/MEK clamp, and defactinib, an oral, selective FAK inhibitor, in sufferers with recurrent low-grade serous ovarian most cancers (LGSOC), together with total response fee, development free survival, and period of response.
IGCS Oral Presentation Particulars
- Efficacy and Security of Avutometinib + Defactinib in Recurrent Low Grade Serous Ovarian Most cancers: Main Evaluation of ENGOT-ov60/GOG-3052/RAMP 201
- Session: Plenary 03: Oral Summary Shows
- Date/Time: October 17, 2024, at 11:42 AM ET/4:42 PM Irish time [GMT +1].
- Presenter: Professor Susana N. Banerjee, MBBS, MA PhD, FRCP, international lead investigator of the examine, Guide Medical Oncologist at The Royal Marsden NHS Basis Belief and Crew Chief in Girls’s Cancers at The Institute of Most cancers Analysis, London
Convention Name and Webcast Info
Verastem (NASDAQ:) will maintain an investor convention name and webcast on October 17, 2024 at 4:30 p.m. EDT, to assessment the mature information from the RAMP 201 trial. To entry the convention name, please dial (844) 763-8274 (native) or (412) 717-9224 (worldwide) at the least 10 minutes previous to the beginning time and ask to be joined into the Verastem Oncology convention name. A reside audio webcast of the decision, together with accompanying slides, will likely be accessible below Occasions & Shows within the Buyers & Media part of the corporate’s web site at www.verastem.com.
Concerning the Avutometinib and Defactinib Mixture
Avutometinib is a RAF/MEK clamp that induces inactive complexes of MEK with ARAF, BRAF and CRAF doubtlessly making a extra full and sturdy anti-tumor response by maximal RAS/MAPK pathway inhibition. In distinction to at present accessible MEK-only inhibitors, avutometinib blocks each MEK kinase exercise and the power of RAF to phosphorylate MEK. This distinctive mechanism permits avutometinib to dam MEK signaling with out the compensatory activation of MEK that seems to restrict the efficacy of different MEK-only inhibitors.
Verastem Oncology is at present conducting scientific trials with avutometinib in RAS/MAPK pushed tumors as a part of its Raf And Mek Program or RAMP. Verastem is at present enrolling sufferers and activating websites for RAMP 301 (NCT06072781), a world Part 3 confirmatory trial evaluating the mixture of avutometinib and defactinib, a selective FAK inhibitor, versus customary chemotherapy or hormonal remedy for the remedy of recurrent low-grade serous ovarian most cancers (LGSOC). RAMP 201 (NCT04625270) is a Part 2 registration-directed trial of avutometinib together with defactinib in sufferers with recurrent LGSOC and enrollment has been accomplished for the complete RAMP 201 trial, together with routine choice and enlargement of the go ahead routine.
Verastem initiated a rolling New Drug Utility (NDA) submission in Might 2024 to the U.S. Meals and Drug Administration (FDA) for the investigational mixture of avutometinib and defactinib in adults with recurrent KRAS mutant LGSOC who acquired at the least one prior systemic remedy and expects to finish its NDA submission within the second half of 2024 with a possible FDA determination within the first half of 2025. The FDA granted Breakthrough Remedy Designation of the investigational mixture of avutometinib and defactinib for the remedy of all sufferers with recurrent LGSOC after a number of prior strains of remedy, together with platinum-based chemotherapy. Avutometinib alone or together with defactinib was additionally granted Orphan Drug Designation by the FDA for the remedy of LGSOC.
Verastem Oncology has established scientific collaborations with Amgen (NASDAQ:) and Mirati to judge LUMAKRAS™ (sotorasib) together with avutometinib and defactinib and KRAZATI™ (adagrasib) together with avutometinib in KRAS G12C mutant NSCLC as a part of the RAMP 203 (NCT05074810) and RAMP 204 (NCT05375994) trials, respectively. The RAMP 205 (NCT05669482), a Part 1b/2 scientific trial evaluating avutometinib and defactinib with gemcitabine/nab-paclitaxel in sufferers with front-line metastatic pancreatic most cancers, is supported by the PanCAN Therapeutic Accelerator Award. FDA granted Orphan Drug Designation to avutometinib and defactinib mixture for the remedy of pancreatic most cancers.
About Verastem Oncology
Verastem Oncology (Nasdaq: VS™) is a late-stage improvement biopharmaceutical firm dedicated to the event and commercialization of recent medicines to enhance the lives of sufferers identified with most cancers. Our pipeline is targeted on RAS/MAPK-driven cancers, particularly novel small molecule medicine that inhibit important signaling pathways in most cancers that promote most cancers cell survival and tumor progress, together with RAF/MEK inhibition and FAK inhibition. For extra info, please go to www.verastem.com and observe us on LinkedIn.
Ahead-Wanting Statements
This press launch contains forward-looking statements about, amongst different issues, Verastem Oncology’s applications and product candidates, technique, future plans and prospects, together with statements associated to the timing and content material of the presentation of the mature information from the continuing Part 2 RAMP 201 (ENGOT-ov60/GOG-3052) scientific trial, the timing, scope and progress of the rolling NDA submission for the avutometinib and defactinib mixture in LGSOC, the construction of our deliberate and pending scientific trials, the potential scientific worth of assorted of the Firm’s scientific trials, together with the RAMP 201 trial, the timing of commencing and finishing trials, together with topline information studies, interactions with regulators, the timeline and indications for scientific improvement, regulatory submissions and the potential for and timing of commercialization of product candidates. The phrases “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” can, promising and comparable expressions are meant to establish forward-looking statements, though not all forward-looking statements comprise these figuring out phrases.
Ahead-looking statements should not ensures of future efficiency and are topic to dangers and uncertainties that might trigger our precise outcomes to vary materially from these expressed or implied within the forward-looking statements we make. Relevant dangers and uncertainties embrace the dangers and uncertainties, amongst different issues, concerning: the success within the improvement and potential commercialization of our product candidates, together with avutometinib together with different compounds, together with defactinib, LUMAKRAS™ and others; the uncertainties inherent in analysis and improvement, equivalent to destructive or sudden outcomes of scientific trials, the incidence or timing of purposes for our product candidates that could be filed with regulatory authorities in any jurisdictions; whether or not and when regulatory authorities in any jurisdictions could approve any such purposes that could be filed for our product candidates, and, if accredited, whether or not our product candidates will likely be commercially profitable in such jurisdictions; our means to acquire, keep and implement patent and different mental property safety for our product candidates; the scope, timing, and consequence of any authorized proceedings; choices by regulatory authorities concerning trial design, labeling and different issues that might have an effect on the timing, availability or business potential of our product candidates; whether or not preclinical testing of our product candidates and preliminary or interim information from scientific trials will likely be predictive of the outcomes or success of ongoing or later scientific trials; that the timing, scope and fee of reimbursement for our product candidates is unsure; that the market alternatives of our drug candidates are based mostly on inside and third-party estimates which can show to be incorrect; that third-party payors (together with authorities companies) could not reimburse; that there could also be aggressive developments affecting our product candidates; that information is probably not accessible when anticipated; that enrollment of scientific trials could take longer than anticipated, which can delay our improvement applications, together with delays in submission or assessment by the FDA of our NDA submission in recurrent KRAS mutant LGSOC if enrollment in our confirmatory trial just isn’t nicely underway on the time of submission, or that the FDA could require the Firm to enroll further sufferers within the Firm’s ongoing RAMP-301 confirmatory Part 3 scientific trial previous to Verastem submitting or the FDA taking motion on our NDA in search of accelerated approval; dangers related to preliminary and interim information, which is probably not consultant of extra mature information, together with with respect to interim period of remedy information; that our product candidates will trigger adversarial security occasions and/or sudden issues could come up from further information or evaluation, or lead to unmanageable security profiles as in comparison with their ranges of efficacy; that we could also be unable to efficiently validate, develop and procure regulatory approval for companion diagnostic checks for our product candidates that require or would commercially profit from such checks, or expertise vital delays in doing so; that the mature RAMP 201 information and related discussions with the FDA could not assist the scope of our rolling NDA submission for the avutometinib and defactinib mixture in LGSOC, together with with respect to KRAS wild sort LGSOC; that our product candidates could expertise manufacturing or provide interruptions or failures; that any of our third occasion contract analysis organizations, contract manufacturing organizations, scientific websites, or contractors, amongst others, who we depend on fail to completely carry out; that we face substantial competitors, which can lead to others growing or commercializing merchandise earlier than or extra efficiently than we do which might lead to diminished market share or market potential for our product candidates; that we’ll be unable to efficiently provoke or full the scientific improvement and eventual commercialization of our product candidates; that the event and commercialization of our product candidates will take longer or price greater than deliberate, together with on account of conducting further research or our choices concerning execution of such commercialization; that we could not have adequate money to fund our contemplated operations, together with sure of our product improvement applications; that we could not appeal to and retain prime quality personnel; that we or Chugai Pharmaceutical Co., Ltd. will fail to completely carry out below the avutometinib license settlement; that the overall addressable and goal markets for our product candidates could be smaller than we’re presently estimating; that we or Secura Bio, Inc. (Secura) will fail to completely carry out below the asset buy settlement with Secura, together with in relation to milestone funds; that we’ll not see a return on funding on the funds we now have and should proceed to make pursuant to the collaboration and possibility settlement with GenFleet Therapeutics (Shanghai), Inc. (GenFleet), or that GenFleet will fail to completely carry out below the settlement; that we could also be unable to acquire ample financing sooner or later by product licensing, co-promotional preparations, public or personal fairness, debt financing or in any other case; that we’ll not pursue or submit regulatory filings for our product candidates; and that our product candidates is not going to obtain regulatory approval, turn into commercially profitable merchandise, or lead to new remedy choices being supplied to sufferers.
Different dangers and uncertainties embrace these recognized below the heading Threat Components within the Firm’s Annual Report on Type 10-Ok for the 12 months ended December 31, 2023 as filed with the Securities and Alternate Fee (SEC) on March 14, 2024 and in any subsequent filings with the SEC. The forward-looking statements contained on this press launch mirror Verastem Oncology’s views as of the date hereof, and the Firm doesn’t assume and particularly disclaims any obligation to replace any forward-looking statements whether or not on account of new info, future occasions or in any other case, besides as required by regulation.
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For Investor and Media Inquiries:
Julissa Viana
Vice President, Company Communications and Investor Relations
buyers@verastem.com or
media@verastem.com
Supply: Verastem Oncology