LONDON and REDWOOD CITY, Calif. and BOSTON, Jan. 13, 2020 /PRNewswire/ — Mereo BioPharma Group plc (NASDAQ: MREO, AIM: MPH), “Mereo” or the “Company,” and Oncologie, Inc. (“Oncologie”) today appear a all-around authorization acceding (the “License Agreement”) for the development and commercialization of navicixizumab, an anti-DLL4/VEGF bispecific antibiotic currently actuality evaluated in an advancing Phase 1b abstraction in accumulated with paclitaxel in patients with avant-garde heavily pretreated ovarian cancer. Navicixizumab ahead completed a Phase 1a monotherapy abstraction in patients with assorted types of adverse solid tumors and is one of two artefact candidates Mereo acquired through its 2019 alliance with OncoMed Pharmaceuticals, Inc. In October 2019, the U.S. Food and Drug Administration (“FDA”) accepted Fast Track appellation to navicixizumab and has agreed in assumption on the architecture of a abstraction that could potentially abutment accelerated approval for navicixizumab in a heavily pretreated, platinum-resistant ovarian blight accommodating population.
Under the acceding of the Authorization Agreement, Oncologie will accept an absolute accepted authorization to beforehand and commercialize navicixizumab. Mereo will accept an upfront acquittal of $4 actor with an added acquittal of $2 actor codicillary on a CMC (Chemistry, Accomplishment and Controls) milestone. Oncologie will be amenable for all approaching research, development and commercialization of navicixizumab. Additionally, Mereo will be acceptable to accept up to $300 actor in approaching clinical, authoritative and bartering milestones, tiered royalties alignment from the mid-single-digit to sub-teen percentages on all-around ceremony net sales of navicixizumab, as able-bodied as a adjourned allotment of sublicensing revenues from assertive sublicensees.
“We accept Oncologie is expertly positioned to added beforehand navicixizumab through analytic development and appear abeyant commercialization,” said Dr. Denise Scots-Knight, Chief Executive Officer of Mereo. “While we accept navicixizumab is an agitative oncology asset, we abide to focus our primary efforts on the development of our avant-garde attenuate ache portfolio including our beforehand artefact applicant setrusumab for the assay of osteogenesis imperfecta, which continues to beforehand appear a cardinal Phase 3 pediatric study.”
“We accept navicixizumab is a able cardinal fit with our portfolio of avant-garde oncology assets, and we are aflame to access into this acceding with Mereo,” said Laura E. Benjamin, Ph.D., Chief Executive Officer of Oncologie. “Navicixizumab has approved able-bodied action back accumulated with paclitaxel in a Phase 1b abstraction in platinum-resistant ovarian blight patients including those who accustomed above-mentioned bevacizumab. Navicixizumab has additionally approved able action in a Phase 1b monotherapy abstraction of heavily pretreated ovarian blight patients, as able-bodied as in added bump types. We seek to advantage the able development and authoritative advance Mereo has already fabricated to abide its development and ultimately accomplish this investigational assay accessible to patients as bound as possible.”
As a aftereffect of the Authorization Acceding with Oncologie, and in accordance with the acceding and altitude of the Accidental Bulk Rights Acceding for former stockholders of OncoMed Pharmaceuticals, Inc. (“OncoMed”), dated April 23, 2019, by and amid Mereo and Computershare Inc., as rights agent, (the “Mereo CVR Agreement”), holders of accidental bulk rights (“CVRs”) pursuant to the Mereo CVR Acceding will be advantaged to accept assertive acceptable banknote ceremony payments fabricated to Mereo beneath the Authorization Acceding apropos to navicixizumab. Details of the bulk payable to holders of CVRs from the upfront acquittal will be appear aural thirty canicule of the able date of the Authorization Agreement. Pursuant to the acceding of the Mereo CVR Agreement, if a ceremony occurs above-mentioned to the fifth ceremony of the closing of Mereo’s alliance with OncoMed, again holders of CVRs will be advantaged to accept an bulk in banknote according to 70% of the accumulated arch bulk accustomed by Mereo afterwards answer of costs, accuse and expenditures set out in detail in the Mereo CVR Agreement. Such ceremony payments are additionally accountable to a banknote application cap, pursuant to which the accumulated arch bulk of all banknote payments fabricated to holders of CVRs beneath the Mereo CVR Acceding shall in no case beat $79.7 million.
About NavicixizumabNavicixizumab is an anti-DLL4/VEGF bispecific antibiotic advised to arrest both Delta-like ligand 4 (“DLL4”) in the Notch blight axis corpuscle alleyway as able-bodied as vascular endothelial advance agency (“VEGF”) and thereby abet almighty anti-tumor responses while mitigating assertive angiogenic-related toxicities. In preclinical studies, navicixizumab approved able-bodied in vivo anti-tumor action above a ambit of solid bump xenografts, including colon, ovarian, lung and pancreatic cancers, amid others. In a Phase 1a abstraction with single-agent navicixizumab, 19 of 66 patients with assorted types of adverse solid tumors had bump abbreviating afterward assay with navicixizumab. Notably, 3 of the 12 (25%) ovarian blight patients advised in the balloon accomplished an bottomless fractional acknowledgment with single-agent navicixizumab therapy.
A Phase 1b dosage accretion and amplification abstraction of navicixizumab added paclitaxel has completed acceptance of 44 platinum aggressive ovarian blight patients who had bootless >2 above-mentioned therapies and/or accustomed above-mentioned bevacizumab. As of the aftermost acting abstracts assay at the end of Q1 2019, the bottomless acknowledgment amount was 41%. The bottomless ORR for bevacizumab-naïve patients was 64% and 30% for bevacizumab pre-treated patients. The average PFS for all patients was 7.3 months. The best accepted accompanying adverse contest of any brand were hypertension (68%), fatigue (46%), cephalalgia (25%), neutropenia (21%), diarrhea (18%), pulmonary hypertension (14%), dyspnea (14%) and borderline edema (14%). Added accompanying adverse contest of appropriate absorption were one Brand 1 accompanying affection failure, one Brand 3 and one Brand 4 accompanying thrombocytopenia, and one Brand 4 accompanying gastrointestinal perforation.
The FDA has accepted Fast Track appellation to navicixizumab for the assay of aerial brand ovarian, primary peritoneal or fallopian tube blight in patients who accept accustomed at atomic 3 above-mentioned therapies and/or above-mentioned bevacizumab. Afterward a Type B End of Phase 1 affair with the FDA captivated in July 2019, the FDA agreed in assumption on an outline for a Phase 2 analytic balloon that could potentially abutment accelerated approval of navicixizumab in this ovarian blight accommodating population.
About Oncologie Oncologie is a abutting generation, oncology analysis company. Oncologie leverages its different biomarker belvedere to beforehand targeted therapies that are akin to alone tumors based on the ascendant analysis of the bump microenvironment. The accepted activity is focused on mid-stage analytic programs that adapt the allowed arrangement to enhance adeptness of accepted standards of affliction and arising immunotherapy agents. Headquartered in Boston, Massachusetts and Shanghai, China, Oncologie is alive with all-around ally to access and beforehand avant-garde drugs for blight patients about the world. For added advice on Oncologie, Inc., amuse appointment WWW.ONCOLOGIE.INTERNATIONAL.
About Mereo BioPharmaMereo BioPharma is a biopharmaceutical aggregation focused on the development and commercialization of avant-garde analysis that aim to advance outcomes for patients with attenuate diseases. Mereo’s action is to selectively access artefact candidates for attenuate diseases that accept already accustomed cogent advance from biologic and ample biotechnology companies and that accept abundant preclinical, analytic and accomplishment abstracts packages. Mereo’s beforehand attenuate ache artefact candidate, setrusumab, has completed a Phase 2b dosage alignment abstraction in developed patients with osteogenesis imperfecta (“OI”). Mereo’s added beforehand artefact candidate, alvelestat, is actuality advised in a Phase 2 proof-of-concept analytic balloon in patients with alpha-1 antitrypsin absence (“AATD”) with topline abstracts accepted in mid-2020.
Mereo’s broader activity consists of four added clinical-stage artefact candidates; acumapimod for the assay of astute exacerbations of abiding adverse pulmonary ache (“AECOPD”), leflutrozole for the assay of hypogonadotropic hypogonadism (“HH”) in adipose men, navicixizumab for the assay of platinum-resistant ovarian cancer, and etigilimab for patients with avant-garde or metastatic solid tumors.
Mereo BioPharma Forward-Looking StatementsThis certificate contains “forward-looking statements.” All statements added than statements of absolute actuality independent in this presentation are advanced statements aural the acceptation of Section 27A of the United States Securities Act of 1933, as adapted (the “Securities Act”), and Section 21E of the United States Securities Exchange Act of 1934, as adapted (the “Exchange Act”). Advanced statements usually chronicle to approaching contest and advancing revenues, earnings, banknote flows or added aspects of our operations or operating results. Advanced statements are generally articular by the words “believe,” “expect,” “anticipate,” “plan,” “intend,” “foresee,” “should,” “would,” “could,” “may,” “estimate,” “outlook” and agnate expressions, including the abrogating thereof. The absence of these words, however, does not beggarly that the statements are not forward-looking. These advanced statements are based on the Company’s accepted expectations, behavior and assumptions apropos approaching developments and business altitude and their abeyant aftereffect on the Company. While administration believes that these advanced statements are reasonable as and back made, there can be no affirmation that approaching developments affecting the Aggregation will be those that it anticipates.
Factors that could account absolute after-effects to alter materially from those in the advanced statements include, amid others, risks apropos to hasty costs, liabilities or delays in affiliation with the Authorization Acceding and the development and commercialization of navicixizumab; abortion to apprehend advancing allowances of the Authorization Agreement; abortion or delays in assay and development programs; hasty changes apropos to aggressive factors in the Company’s industry; the abeyant abortion to accomplish any of the applicative milestones and/ or royalties beneath the Authorization Agreement; the aftereffect of any acknowledged affairs accompanying to the Authorization Agreement; risks accompanying to the adeptness to accurately appraisal operating costs associated with the Authorization Agreement; the abeyant appulse of advertisement of the Authorization Acceding on relationships with third parties; changes in law or regulations affecting the Company; international, civic or bounded economic, amusing or political altitude that could abnormally affect the Aggregation and its business; and risks associated with assumptions the Aggregation makes in affiliation with its analytical accounting estimates and added judgments.
All of the Company’s advanced statements absorb risks and uncertainties (some of which are cogent or above its control) and assumptions that could account absolute after-effects to alter materially from the Company’s absolute acquaintance and its present expectations or projections. The above factors and the added risks and uncertainties that affect the Company’s business, including those declared in its Ceremony Report on Form 20-F, Reports on Form 6-K and added abstracts filed from time to time by the Aggregation with the United States Securities and Exchange Commission (the “SEC”) and those declared in added abstracts the Aggregation may broadcast from time to time should be anxiously considered. The Aggregation wishes to attention you not to abode disproportionate assurance on any advanced statements, which allege alone as of the date hereof. The Aggregation undertakes no obligation to about amend or alter any of our advanced statements afterwards the date they are made, whether as a aftereffect of new information, approaching contest or otherwise, except to the admeasurement appropriate by law.
THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION AS DEFINED UNDER THE MARKET ABUSE REGULATION (EU) NO. 596/2014. UPON PUBLICATION OF THIS ANNOUNCEMENT THIS INFORMATION IS NOW CONSIDERED IN THE PUBLIC DOMAIN.
Mereo BioPharma Contacts:
44 (0)333 023 7300
Denise Scots-Knight, Chief Executive Officer
Richard Jones, Chief Financial Officer
Cantor Fitzgerald Europe (Nominated Adviser and Broker to Mereo)
44 (0)20 7894 7000
Burns McClellan (US Public Relations Adviser to Mereo)
01 (0) 212 213 0006
FTI Consulting (UK Public Relations Adviser to Mereo)
44 (0)20 3727 1000
Heather Savelle or Ryan Baker
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