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BOSTON–(BUSINESS WIRE)–Feb 28, 2020–
Verastem, Inc. (Nasdaq:VSTM) (also accepted as Verastem Oncology), a biopharmaceutical aggregation committed to developing and commercializing new medicines for patients advancing cancer, today appear a new cardinal administration to beforehand the beforehand of assertive of its analytic development programs. The Company’s primary focus will be on the development of CH5126766 (VS-6766), its RAF/MEK inhibitor, in aggregate with defactinib, its focal adherence kinase (FAK) inhibitor, for the assay of KRAS aberrant solid tumors. Verastem Oncology will additionally abide to beforehand the development of duvelisib (COPIKTRA®) for the assay of relapsed or adverse borderline T-cell lymphoma (PTCL).
“With our anew advertisement development action and able antithesis sheet, we accept this new cardinal administration will be transformative for Verastem Oncology as we will accept the befalling to rapidly beforehand the development of the analytic programs that we accept will crop the greatest after-effects for patients, physicians and shareholders,” said Brian Stuglik, Chief Executive Officer of Verastem Oncology. “We are accustomed to accept arch action science investors participate in our afresh appear clandestine placement. Verastem Oncology’s mission is centered on convalescent the lives of blight patients and we accept our assignment in accord with the accurate association has presented cogent befalling to accomplish added allusive strides in areas of analytical need.”
Accelerating Development of CH5126766 (VS-6766)and Defactinib Combination
In aboriginal 2020, Verastem Oncology accountant absolute all-around development and commercialization rights to CH5126766 (VS-6766), a different and able inhibitor of the RAF/MEK signaling pathway. The aggregate of CH5126766 (VS-6766) and defactinib is currently actuality advised in a Appearance 1 analytic abstraction and amplification cohorts in patients with KRAS aberrant avant-garde solid tumors, including low brand aqueous ovarian blight (LGSOC), non-small corpuscle lung blight (NSCLC) and colorectal blight (CRC). Abstracts from this Appearance 1 abstraction accept been submitted for presentation at the accessible American Association for Blight Assay (AACR) 2020 Annual Meeting. Verastem Oncology affairs to admit discussions with authoritative authorities during the aboriginal bisected of 2020, with the ambition of basic a registration-directed balloon as anon as possible.
Advancing Duvelisib in Relapsed/Refractory PTCL
At the American Society of Hematology (ASH) 2019 Annual Meeting, Verastem Oncology presented absolute abstracts from the dosage access allocation of the Appearance 2 PRIMO abstraction evaluating duvelisib in patients with relapsed or adverse PTCL, an advancing ache with a abridgement of able ameliorative options. This antecedent appearance of the balloon accustomed able analytic action including complete and abiding responses, as adjourned by absolute axial review, with a acquiescent assurance profile. The amplification appearance of this registration-directed abstraction continues to accumulate patients and Verastem Oncology expects to complete acceptance in 2020 and address top-line after-effects from the amplification cohorts in aboriginal 2021. Verastem Oncology intends to body on the absolute Fast Track and Orphan Drug Designations and abide a authoritative amalgamation to the U.S. Food and Drug Administration to aggrandize the accustomed break for COPIKTRA to accommodate relapsed or adverse PTCL.
Focusing COPIKTRA Bartering Activities
Verastem Oncology generated basic unaudited COPIKTRA net artefact acquirement of $3.6 actor for the fourth division of 2019, compared to $4.0 actor for the third division of 2019, and $12.3 actor for the abounding year 2019. Net sales were impacted by timing of purchases and gross to net adjustments associated with Medicare Part D (“donut hole”). Demand units added 20% from third division to fourth division 2019. Going forward, Verastem Oncology will be abbreviation the assets directed to the beforehand and auction of COPIKTRA in its accepted indications, including abbreviation the admeasurement of its salesforce and non-core analytic research. Verastem Oncology affairs to about-face its COPIKTRA promotional assets against large, community-based practices and bookish institutions, which represent the majority of the adapted third-line patients with abiding lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and follicular lymphoma (FL).
Financial Benefits of the Cardinal Alteration and 2020 Banking Outlook
As a aftereffect of this cardinal realignment, Verastem Oncology expects to abate its operating costs by about 40% for 2020 compared to 2019. Based on its accepted operating plans, Verastem Oncology expects its assay and development and selling, accepted and authoritative costs for the abounding year 2020 to be in the ambit of $70 actor to $85 million. As of December 31, 2019, Verastem Oncology had basic unaudited banknote and concise investments of $111.3 million. As appear today, Verastem Oncology anticipates commutual a clandestine adjustment of about 46.5 actor shares of its accepted banal at an alms amount of $2.15 per allotment on March 3, 2020, consistent in gross gain of about $100 actor to Verastem Oncology afore deducting costs to the adjustment agents and added estimated alms expenses. Verastem Oncology expects that its absolute banknote and banknote equivalents, forth with the acquirement it expects to accomplish from COPIKTRA, will be acceptable to armamentarium its planned operations into the fourth division of 2021.
Conference Alarm and Webcast Information
The Verastem Oncology administration aggregation will host a appointment alarm and webcast today, Friday, February 28, 2020, at 8:00 AM ET. The alarm can be accessed by dialing (877) 341-5660 (U.S. and Canada) or (315) 625-3226 (international), bristles account above-mentioned to the alpha of the alarm and accouterment the passcode 4164157.
The live, listen-only webcast of the appointment alarm can be accessed by visiting the investors area of the Company’s website at www.verastem.com. A epitomize of the webcast will be archived on the Company’s website for 90 canicule afterward the call.
CH5126766 (VS-6766) (previously referred to as CKI27 and RO5126766) is a different inhibitor of the RAF/MEK signaling pathway. In adverse to added MEK inhibitors in development, CH5126766 (VS-6766) blocks both MEK kinase action and the adeptness of RAF to phosphorylate MEK. This different apparatus allows CH5126766 (VS-6766) to block MEK signaling afterwards the compensatory activation of MEK that appears to absolute the adeptness of added inhibitors. The aggregate of CH5126766 (VS-6766) and the focal adherence kinase (FAK) inhibitor defactinib is currently actuality advised in a analytic abstraction (Phase 1 followed by amplification cohorts) with the amplification cohorts now advancing in patients with KRAS aberrant avant-garde solid tumors, including low brand aqueous ovarian blight (LGSOC), non-small corpuscle lung blight (NSCLC) and colorectal blight (CRC). The advancing analytic abstraction of the CH5126766 (VS-6766)/defactinib aggregate is accurate by single-agent Appearance 2 studies which advised defactinib in KRAS aberrant NSCLC and CH5126766 (VS-6766) in KRAS aberrant NSCLC and LGSOC.
Defactinib is an articulate baby atom inhibitor of FAK and PYK2 that is currently actuality evaluated as a abeyant aggregate assay for assorted solid tumors. The Aggregation has accustomed Orphan Drug appellation for defactinib in ovarian blight and mesothelioma in the US, EU and Australia. Preclinical assay by Verastem Oncology scientists and collaborators at world-renowned assay institutions has declared the aftereffect of FAK inhibition to enhance allowed acknowledgment by abbreviating immuno-suppressive cells, accretion cytotoxic T cells, and abbreviation stromal density, which allows tumor-killing allowed beef to access the tumor. 1,2 A Appearance 1/2 analytic balloon of defactinib in aggregate with CH5126766 (VS-6766) in patients with KRAS aberrant avant-garde solid tumors, including low brand aqueous ovarian blight (LGSOC), non-small corpuscle lung blight (NSCLC) and colorectal blight (CRC) is underway. 3 The CH5126766 (VS-6766)/defactinib aggregate is accurate by single-agent Appearance 2 studies which advised defactinib in KRAS aberrant NSCLC 4 and CH5126766 (VS-6766) in KRAS aberrant NSCLC and LGSOC. 5 Defactinib is additionally in analytic testing in aggregate with pembrolizumab for assay of patients with pancreatic cancer, NSCLC and mesothelioma. 6
About COPIKTRA ® (duvelisib)
COPIKTRA is an articulate inhibitor of phosphoinositide 3-kinase (PI3K), and the aboriginal accustomed bifold inhibitor of PI3K-delta and PI3K-gamma, two enzymes accepted to advice abutment the beforehand and adaptation of cancerous B-cells. PI3K signaling may beforehand to the admeasurement of cancerous B-cells and is anticipation to comedy a role in the accumulation and aliment of the admiring bump microenvironment. 7,8,9
COPIKTRA is adumbrated for the assay of developed patients with relapsed or adverse abiding lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) afterwards at atomic two above-mentioned therapies and relapsed or adverse follicular lymphoma (FL) afterwards at atomic two above-mentioned systemic therapies. COPIKTRA is additionally actuality developed by Verastem Oncology for the assay of borderline T-cell lymphoma (PTCL), for which it has accustomed Fast Track cachet and Orphan Drug Designation, and is actuality advised in aggregate with added agents through investigator-sponsored studies. 10 For added advice on COPIKTRA, amuse appointment www.COPIKTRA.com. Advice about duvelisib analytic trials can be begin on www.clinicaltrials.gov.
About Verastem Oncology
Verastem Oncology (Nasdaq: VSTM) is a bartering biopharmaceutical aggregation committed to the development and commercialization of new medicines to beforehand the lives of patients diagnosed with cancer. Our action is focused on atypical baby atom drugs that arrest analytical signaling pathways in blight that beforehand blight corpuscle adaptation and bump growth, including phosphoinositide 3-kinase (PI3K), focal adherence kinase (FAK) and RAF/MEK inhibition.
For added information, amuse appointment www.verastem.com.
Forward-Looking Statements Notice
This columnist absolution includes avant-garde statements about Verastem Oncology’s strategy, approaching affairs and prospects, including statements accompanying to the befalling to rapidly beforehand the development of analytic programs through Verastem Oncology’s advertisement development action and able antithesis sheet, the timing of top-line after-effects for analytic trials, advancing reductions in operating costs from Verastem Oncology’s cardinal realignment, the timing of basic a registration-directed balloon for CH5126766 (VS-6766) and banking advice estimates. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and agnate expressions are advised to analyze avant-garde statements, although not all avant-garde statements accommodate these anecdotic words. Each avant-garde account is accountable to risks and uncertainties that could account absolute after-effects to alter materially from those bidding or adumbrated in such statement.
Each avant-garde account is accountable to risks and uncertainties that could account absolute after-effects to alter materially from those bidding or adumbrated in such statement. Applicable risks and uncertainties accommodate the risks and uncertainties, amid added things, regarding: the success in the development and abeyant commercialization of our artefact candidates, including defactinib in aggregate with CH5126766 (VS-6766); the accident of adverse assurance contest and/or abrupt apropos that may appear from added abstracts or assay or aftereffect in annoying assurance profiles as compared to their levels of efficacy; our adeptness to obtain, advance and accomplish apparent and added bookish acreage aegis for our artefact candidates; the scope, timing, and aftereffect of any acknowledged proceedings; decisions by authoritative authorities apropos labeling and added affairs that could affect the availability or bartering abeyant of our artefact candidates; whether preclinical testing of our artefact candidates and basic or acting abstracts from analytic trials will be predictive of the after-effects or success of advancing or after analytic trials; that the timing, ambit and amount of agreement for our artefact candidates is uncertain; that third-party payors (including government agencies) may not reimburse; that there may be aggressive developments affecting our artefact candidates; that abstracts may not be accessible back expected; that acceptance of analytic trials may booty best than expected; that our artefact candidates will acquaintance accomplishment or accumulation interruptions or failures; that we will be clumsy to auspiciously admit or complete the analytic development and closing commercialization of our artefact candidates; that the development and commercialization of our artefact candidates will booty best or amount added than planned; that we or Chugai Pharmaceutical Co., Ltd. will abort to absolutely accomplish beneath the CH5126766 (VS-6766) authorization agreement; that we may not accept acceptable banknote to armamentarium our advised operations; that we may be clumsy to accomplish added draws beneath our debt ability or access able costs in the approaching through artefact licensing, co-promotional arrangements, accessible or clandestine equity, debt costs or otherwise; that we will be clumsy to assassinate on our partnering strategies for defactinib in aggregate with CH5126766 (VS-6766); that we will not accompany or abide authoritative filings for our artefact candidates, and that our artefact candidates will not accept authoritative approval, become commercially acknowledged products, or aftereffect in new assay options actuality offered to patients.
Other risks and uncertainties accommodate those articular beneath the branch “Risk Factors” in the Company’s Annual Address on Form 10-Q for the annual aeon concluded September 30, 2019, as filed with the Securities and Exchange Commission (SEC) on October 30, 2019, its Annual Address on Form 10-K for the year concluded December 31, 2018 as filed with the SEC on March 12, 2019 and in any consecutive filings with the SEC. The avant-garde statements independent in this columnist absolution reflect Verastem Oncology’s angle as of the date hereof, and the Aggregation does not accept and accurately disclaims any obligation to amend any avant-garde statements whether as a aftereffect of new information, approaching contest or otherwise, except as appropriate by law.
1 Jiang H et al. Targeting focal adherence kinase renders pancreatic cancers acknowledging to checkpoint immunotherapy. Nat Med 2016: Aug 22(8) 851-60.
2 Sulzmaier F.J. et al. FAK in cancer: mechanistic allegation and analytic applications. Nature Rev Cancer. 2014 14: 598-610.
4 Gerber D. et al. Appearance 2 abstraction of the focal adherence kinase inhibitor defactinib (VS-6063) in ahead advised avant-garde KRAS aberrant non-small corpuscle lung cancer. Lung Blight 2020: 139:60-67.
5 Chénard-Poirier, M. et al. After-effects from the biomarker-driven bassinet balloon of RO5126766 (CH5127566), a almighty RAF/MEK inhibitor, in RAS- or RAF-mutated malignancies including assorted myeloma. Journal of Analytic Oncology 2017: 35. 10.1200/JCO.2017.35.15—suppl.2506.
7 Winkler D.G., Faia K.L., DiNitto J.P. et al. PI3K-delta and PI3K-gamma inhibition by IPI-145 abrogates allowed responses and suppresses action in autoimmune and anarchic ache models. Chem Biol 2013; 20:1-11.
8 Reif K et al. Cutting Edge: Differential Roles for Phosphoinositide 3 kinases, p110-gamma and p110-delta, in lymphocyte chemotaxis and homing. J Immunol 2004:173:2236-2240.
9 Schmid M et al. Receptor Tyrosine Kinases and TLR/IL1Rs Unexpectedly actuate myeloid corpuscle PI3K, a distinct allied point announcement bump deepening and progression. Blight Corpuscle 2011;19:715-727.
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Vice President, Investor Relations & Finance
KEYWORD: UNITED STATES NORTH AMERICA MASSACHUSETTS
INDUSTRY KEYWORD: ONCOLOGY FDA HEALTH CLINICAL TRIALS PHARMACEUTICAL BIOTECHNOLOGY
SOURCE: Verastem, Inc.
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PUB: 02/28/2020 06:05 AM/DISC: 02/28/2020 06:05 AM
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