"Our preclinical partnership with Clovis reflects our ongoing efforts to explore the numerous combination options afforded to ALKS 4230. The collaboration will allow us to examine combinations in two areas of keen interest, PARP and tyrosine kinase inhibition pathways," said
"The unique profiles of rucaparib, lucitanib and ALKS 4230 may offer the potential for complementary therapies that could represent a meaningful opportunity for the development of new anti-cancer combination treatment options," said Patrick J. Mahaffy, President and CEO of
Under this collaboration agreement,
About ALKS 4230
ALKS 4230 is an investigational, novel, engineered fusion protein designed to selectively activate tumor-killing immune cells while avoiding the expansion of immunosuppressive cells by preferentially binding to the intermediate-affinity interleukin-2 (IL-2) receptor complex. The selectivity of ALKS 4230 is designed to leverage the proven anti-tumor effects of existing IL-2 therapy while mitigating certain limitations.
About Rucaparib
Rucaparib is an oral, small molecule inhibitor of the poly (ADP-ribose) polymerase (PARP) enzymes PARP-1, PARP-2, and PARP-3, which play a role in DNA repair. Rucaparib stimulates an anti-tumor immune response through the activation of the stimulator of interferon (STING) pathway and tumor cell death, resulting in the infiltration of multiple immune subsets including CD8 positive T-cells.1
Rucaparib is being developed in multiple tumor types, including ovarian, metastatic castration-resistant prostate, and bladder cancers, as monotherapy, and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway. Clovis holds worldwide rights for rucaparib. Rucaparib is an unlicensed medical product outside of the U.S. and
About Lucitanib
Lucitanib is an oral, potent inhibitor of the tyrosine kinase activity of vascular endothelial growth factor receptors 1 through 3 (VEGFR1-3), platelet-derived growth factor receptors alpha and beta (PDFGRα/β) and fibroblast growth factor receptors 1 through 3 (FGFR1-3).
Emerging clinical data support the combination of angiogenesis inhibitors and immunotherapy to increase effectiveness in multiple cancer indications.2 Angiogenic factors, such as vascular endothelial growth factor (VEGF), are frequently up-regulated in tumors and create an immunosuppressive tumor microenvironment.3 Use of antiangiogenic drugs reverses this immunosuppression and can augment response to immunotherapy.
Lucitanib is an unlicensed medical product.
About
About
Alkermes Note Regarding Forward-Looking Statements
Certain statements set forth in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the potential therapeutic and commercial value of ALKS 4230, including in combination with rucaparib and/or lucitanib; and development plans for ALKS 4230 in combination with rucaparib and/or lucitanib, including preclinical studies and potential future clinical studies of such combinations. You are cautioned that forward-looking statements are inherently uncertain. Although the company believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, the forward-looking statements are neither promises nor guarantees and are subject to a variety of risks and uncertainties, many of which are beyond the company's control, which could cause actual results to differ materially from those expressed or implied in the forward-looking statements. These risks and uncertainties include, among others, whether preclinical and early clinical results for ALKS 4230, including ALKS 4230 in combination with rucaparib and/or lucitanib, will be predictive of future clinical study results; whether ALKS 4230, alone or in combination, could be shown to be unsafe or ineffective; whether future clinical trials or future stages of ongoing clinical trials for ALKS 4230, whether alone or in combination, will be initiated or completed on time or at all; changes in the cost, scope and duration of development activities for ALKS 4230; and those risks and uncertainties described under the heading "Risk Factors" in the company's Annual Report on Form 10-K for the year ended
Clovis Oncology Note Regarding Forward-Looking Statements
To the extent that statements contained in this press release are not descriptions of historical facts regarding Clovis Oncology, they are forward-looking statements reflecting the current beliefs and expectations of management. Examples of forward-looking statements contained in this press release include, among others, statements regarding our expectations regarding the timing and pace of commencement of and enrollment in our clinical trials, including those being planned or conducted in collaboration with partners. Such forward-looking statements involve substantial risks and uncertainties that could cause our future results, performance or achievements to differ significantly from that expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in our clinical development programs for our drug candidates, including rucaparib and lucitanib, and those of our partners, whether preclinical results will be predictive of future clinical study results, whether safety and efficacy results from monotherapy trials are predictive of safety and efficacy in combination with other compounds, the corresponding development pathways of our companion diagnostics, the timing of availability of data from our clinical trials and the results, the initiation, enrollment and timing of our planned clinical trials, actions by the FDA, the EMA or other regulatory authorities regarding whether to accept or approve drug applications that may be filed, as well as their decisions regarding drug labeling, reimbursement and pricing, and other matters that could affect the development, availability or commercial potential of our drug candidates or companion diagnostics. Clovis Oncology does not undertake to update or revise any forward-looking statements. A further description of risks and uncertainties can be found in
1Nguyen, et al. "Rucaparib Induces IFN Type 1 Regulated Genes and Enhances Immune-Associated Tumor Suppression," presented at the 2018
2Makker et al. "Lenvatinib + Pembrolizumab in Advanced Endometrial Cancer: Updated Results." Presented at the 2018
3Fukumara, et al Nat Rev
Alkermes Contacts: |
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For Investors: |
Sandy Coombs |
+1 781 609 6377 |
For Media: |
Sherry Feldberg |
+1 781 609 6276 |
Clovis Oncology Contacts: |
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For Investors: |
Anna Sussman |
+1 303 625 5022 |
Breanna Burkart |
+1 303 625 5023 |
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For Media: |
Lisa Guiterman |
+1 301 217 9353 |
Christy Curran |
+1 615 414 8668 |
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