Alpine Immune Sciences Announces Amendment of Acazicolcept Option and License Agreement with AbbVie
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Stopping enrollment in a phase 2 clinical trial can have significant implications for the company involved, particularly in the biotechnology and pharmaceutical sectors. In this case, Alpine Immune Sciences' decision to halt enrollment for acazicolcept in systemic lupus erythematosus (SLE) suggests a strategic pivot that could affect the company's resource allocation and potential revenue streams. The amendment of the agreement with AbbVie, including the reduction of the option exercise fee and future milestones and royalties, indicates a renegotiation of terms that likely reflects changes in the perceived risk-reward profile of the drug's development.
For stakeholders, the immediate impact is mixed. The reduction in the option exercise fee from $75 million to $10 million significantly lowers the near-term cash inflow Alpine Immune Sciences might have anticipated upon AbbVie's exercise of the option. However, the removal of a pre-option development milestone could alleviate some financial burden on Alpine. Long-term implications hinge on the final analysis of the trial data, which will determine the drug's viability and the likelihood of AbbVie exercising its licensing option. A positive outcome could lead to eventual product commercialization and revenue, albeit at the reduced milestone and royalty rates now agreed upon.
From an industry perspective, early trial data assessment is not uncommon in clinical development, particularly when interim results may inform go/no-go decisions. However, the financial adjustments suggest that either the initial terms were overly optimistic or that emerging data has prompted a recalibration of expectations. The focus on advancing another candidate, povetacicept, indicates a strategic shift that may be informed by internal data and portfolio prioritization.
The announcement by Alpine Immune Sciences regarding the amendment of their agreement with AbbVie carries potential financial ramifications. The reduction in the option exercise fee, milestone payments and royalties by 25 percent can be perceived as a devaluation of acazicolcept's future market potential. This could impact Alpine's future earnings and valuation, as the anticipated revenue from these streams is now forecasted to be lower than previously expected.
Investors will need to consider the implications of this renegotiation on Alpine's cash flow projections and the company's ability to fund ongoing operations and research. The early data assessment strategy may expedite decision-making processes, potentially leading to cost savings on further development if the data is unfavorable. Conversely, if the data is positive and AbbVie exercises its licensing option, the reduced financial terms will affect the long-term return on investment.
It is also crucial to note that Alpine has received $105 million in non-refundable upfront and milestone payments to date, which provides a cushion for operational funding. The strategic shift to focus on developing povetacicept could be indicative of management's confidence in that asset's potential or a response to portfolio balancing in light of the amended terms with AbbVie.
The pharmaceutical industry closely monitors changes in clinical trial enrollment and partnership agreements, as these can be leading indicators of a drug's prospects. Alpine Immune Sciences' decision to cease enrollment in the Synergy study for acazicolcept represents a notable development within the context of SLE treatment research. Systemic lupus erythematosus is a chronic autoimmune disease with a need for more effective therapies and any shifts in the development of potential treatments are of high interest to medical professionals, patients and investors.
The amended terms with AbbVie suggest a recalibration of the partnership's expectations, which could be due to a variety of factors including emerging clinical data, competitive landscape shifts, or portfolio strategy changes. The implications for the broader industry include potential alterations in competitive dynamics, as the perceived value and timeline of acazicolcept's entry to the market may change. Additionally, the industry will be watching to see how Alpine reallocates its resources towards povetacicept and whether this signals a new strategic direction for the company's pipeline.
-- Enrollment in the phase 2 study of acazicolcept in systemic lupus erythematosus (Synergy) will be stopped to allow for early assessment of data --
-- Final analysis after last patient completes study protocol expected to occur by the end of 2024 --
Key terms of the amended agreement:
- Company will stop enrollment under the amended agreement in the phase 2 study of acazicolcept in systemic lupus erythematosus within 30 days. Currently enrolled patients will be allowed to complete the study. Patients who are currently in the screening process and meet eligibility requirements will be allowed to enter and complete the study.
- Final analysis will be conducted after the last patient completes the study protocol which is expected to occur by the end of 2024.
- AbbVie retains an exclusive option to obtain an exclusive worldwide license to acazicolcept which is exercisable by AbbVie at any time and will expire 90 days from delivery of an agreed upon data package by the Company to AbbVie.
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The previously disclosed option exercise fee of
$75 million $10 million - Potential future development, commercial, and sales-based milestones and sales-based royalties have been reduced by 25 percent from the originally agreed upon amounts.
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Company has received
$105 million
“AbbVie has been a tremendous partner, and we appreciate their flexibility in amending our agreement for the development of acazicolcept. While enrollment in the Synergy study will be stopped early, we still anticipate that sufficient clinical and pharmacodynamic data will be available to enable a thorough evaluation of the study,” said Mitchell H. Gold, MD, Executive Chairman and Chief Executive Officer. “We plan to focus our development resources to advance povetacicept into a broad development plan.”
About Acazicolcept and the Synergy Study
Acazicolcept is a first-in-class, dual inhibitor of the CD28 and ICOS T-cell costimulatory pathways being developed for treatment of systemic lupus erythematosus (SLE). By simultaneously blocking two key costimulatory pathways, acazicolcept has the potential to improve outcomes in patients suffering from severe autoimmune/inflammatory diseases. Preclinical studies have demonstrated efficacy in models of SLE, Sjögren’s syndrome, arthritis, inflammatory bowel disease, multiple sclerosis, type 1 diabetes, uveitis, and graft versus host disease.
Synergy (NCT04835441) is a global, randomized, double-blind, placebo-controlled Phase 2 clinical study of acazicolcept in moderate-to-severe systemic lupus erythematosus (SLE) that initiated enrollment in June 2021.
About Alpine Immune Sciences
Alpine Immune Sciences is committed to leading a new wave of immune therapeutics. With world-class research and development capabilities, a highly productive scientific platform, and a proven management team, Alpine is seeking to create first- or best-in-class multifunctional immunotherapies via unique protein engineering technologies to improve patients’ lives. Alpine has entered into strategic collaborations with leading global biopharmaceutical companies and has a diverse pipeline of clinical and preclinical candidates in development. For more information, visit www.alpineimmunesciences.com. Follow @AlpineImmuneSci on X and LinkedIn.
Forward-Looking Statements
This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not based on historical fact and include statements regarding our platform technology and potential therapies; the potential efficacy, safety profile, future development plans, addressable market, regulatory success, and commercial potential of our product candidates; the timing of and results from clinical trials and pre-clinical development activities; clinical and regulatory objectives and the timing thereof; our ability to achieve milestones in our collaboration with AbbVie; the efficacy of our clinical trial designs; and our ability to successfully develop and achieve milestones in our development programs. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions and include words such as “may,” “will,” “should,” “would,” “expect,” “plan,” “intend,” and other similar expressions, among others. These forward-looking statements are based on current assumptions that involve risks, uncertainties, and other factors that may cause actual results, events, or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: clinical trials may not demonstrate safety and efficacy of any of our product candidates; our ongoing discovery and preclinical efforts may not yield additional product candidates; our discovery-stage and preclinical programs may not advance into the clinic or result in approved products; any of our product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; we may not achieve additional milestones in our proprietary or partnered programs; the impact of competition; adverse conditions in the general domestic and global economic markets; we may be unable to advance povetacicept directly into a pivotal trial in IgA nephropathy or a phase 2 study in systemic lupus erythematosus in 2024; the impact of pandemics, or other related health crises on our business, research and clinical development plans and timelines and results of operations, including the impact on our clinical trial sites, collaborators, and contractors who act for or on our behalf; as well as the other risks identified in our filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof and we undertake no obligation to update forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.
Source: Alpine Immune Sciences, Inc.
View source version on businesswire.com: https://www.businesswire.com/news/home/20231221900461/en/
Media and Investor Relations Contact:
Temre Johnson
Alpine Immune Sciences, Inc.
ir@alpineimmunesciences.com
media@alpineimmunesciences.com
Source: Alpine Immune Sciences, Inc.
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