Absci Initiates IND-Enabling Studies for ABS-101, a Potential Best-in-Class Anti-TL1A Antibody de novo Designed and Optimized Using Generative AI
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Insights
From a biotechnology perspective, the initiation of IND-enabling studies for ABS-101 is a significant event for Absci Corporation. The IND, or Investigational New Drug application, is a critical regulatory step in the United States, allowing a drug candidate to be tested in humans. The anti-TL1A antibody ABS-101, designed using generative AI, represents an innovative approach to drug discovery, potentially reducing the time and cost associated with traditional methods.
The use of de novo generative AI to target specific epitopes could lead to therapies with improved efficacy and safety profiles. The preclinical data suggesting high affinity and potency, favorable developability and extended half-life of ABS-101 indicates a product that could stand out in the competitive landscape of biologic drugs. If these attributes translate into clinical benefits, it could lead to a significant market advantage.
Furthermore, the ability to potentially expedite the drug development process, as claimed by Absci's CEO, could be a game-changer for the industry. The usual timeline for drug development can span over a decade, so a reduction to less than half the industry standard is noteworthy. However, it is important to remain cautious as the drug still needs to pass through the rigorous phases of clinical trials to ensure safety and efficacy before reaching the market.
For investors, Absci Corporation's announcement regarding ABS-101 could signal a robust pipeline progression, which may be reflected in the company's stock valuation. The market often reacts positively to advancements in a company's asset pipeline, especially when it involves novel technology such as AI-driven drug discovery platforms. The potential for a 'best-in-class' drug candidate can attract investor interest due to the promise of a competitive edge and market share capture.
However, the actual financial impact will depend on the outcomes of the IND submission and subsequent clinical trials. Investors should consider the inherent risks in drug development, including the possibility of trial failures or regulatory setbacks. Moreover, the biopharmaceutical industry is highly competitive and the success of ABS-101 will also depend on the therapeutic landscape, including existing treatments and other drugs in development.
It's also worth noting that the company's ability to deliver on the promise of reducing drug development timelines could lead to long-term cost savings and a faster time to market, potentially improving the company's return on investment in R&D. Nevertheless, the financial implications will become clearer as the drug progresses through clinical trials and closer to commercialization.
The progression of ABS-101 into IND-enabling studies is a critical juncture in the clinical development pathway. The focus on cytokine biology and the targeting of the TL1A pathway could address unmet medical needs, as cytokines play a significant role in inflammatory and autoimmune diseases. The mention of 'high bioavailability' suggests that the drug could be efficiently absorbed and utilized by the body, which is crucial for clinical efficacy.
The mention of 'less frequent dosing' implies an improved therapeutic regimen that could enhance patient compliance and quality of life, a key factor in the treatment of chronic conditions. However, it is essential for the clinical research community to scrutinize the upcoming pharmacokinetic (PK) studies and later phase clinical trials to validate these preclinical findings and to assess the safety profile of ABS-101 in humans.
While the preclinical data appears promising, the transition from preclinical to clinical stages is a significant hurdle, with many candidates failing to demonstrate the same level of efficacy or safety in humans. The clinical research community will be watching closely for the Phase 1 trial results to assess the true potential of ABS-101.
IND submission expected in Q1 2025; Phase 1 trials anticipated to initiate shortly after
VANCOUVER, Wash. and NEW YORK, Feb. 21, 2024 (GLOBE NEWSWIRE) -- Absci Corporation (Nasdaq: ABSI), a data-first generative AI drug creation company, today announced the initiation of IND-enabling studies for ABS-101, a potential best-in-class anti-TL1A antibody designed using Absci’s de novo generative AI foundation model. Given a target structure, Absci uses this model to designate a specific epitope of interest, allowing for the engineering of epitope-specific antibodies to access novel biology. Absci then uses its AI lead optimization models to further engineer candidates to have an optimal clinical development profile.
Absci presented early preclinical data on ABS-101 in January, with three advanced leads showing properties consistent with a potentially superior product profile, including demonstrated high affinity, high potency, favorable developability, and extended half-life. Absci used its de novo AI model to design ABS-101 toward a specific epitope with the objective for superior potency and lower immunogenicity. This target product profile, combined with anticipated high bioavailability, could ultimately improve patient experience with easier, less frequent dosing. Following further confirmatory PK studies in February, Absci selected a development candidate to advance into IND-enabling studies.
“The initiation of IND-enabling studies for ABS-101 represents a major milestone for Absci,” said Sean McClain, Founder and CEO of Absci. “The progress we have made on this program demonstrates the ability of our platform to create a differentiated antibody drug candidate in less than half the time of industry standards, as we expect to submit our IND approximately two years after beginning this program. This achievement illustrates the power of using generative AI to improve the drug discovery process to bring better medicines to patients, faster.”
ABS-101 is Absci's lead asset from its internal AI Drug Creation asset pipeline focused on cytokine biology. The initiation of IND-enabling studies represents an important step forward in Absci's efforts to bring potentially transformative therapeutics to patients, faster.
Absci expects to submit an IND for ABS-101 in the first quarter of 2025. Subject to clearance of the IND, Absci expects to initiate Phase 1 studies for this program shortly thereafter.
About Absci
Absci is a data-first generative AI drug creation company that combines AI with scalable wet lab technologies to create better biologics for patients, faster. Our Integrated Drug Creation™ platform unlocks the potential to accelerate time to clinic and increase the probability of success by simultaneously optimizing multiple drug characteristics important to both development and therapeutic benefit. With the data to train, the AI to create, and the wet lab to validate, we can screen billions of cells per week, allowing us to go from AI-designed antibodies to wet lab-validated candidates in as little as six weeks. Absci’s headquarters is in Vancouver, WA, with our AI Research Lab in New York City and an Innovation Center in Zug, Switzerland. Visit www.absci.com and follow us on LinkedIn (@absci), X (Twitter) (@Abscibio), and YouTube.
Availability of Other Information about Absci
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Forward-Looking Statements
Certain statements in this press release that are not historical facts are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements containing the words “will,” “may,” “pursues,” “anticipates,” “plans,” “believes,” “aims,” “potential,” “forecast,” “estimates,” “extends,” “expects,” “objective,” and “intends,” or similar expressions. We intend these forward-looking statements, including statements regarding timing of IND submission for ABS-101 and Phase 1 trials thereafter; the significance of preclinical results for ABS-101, including comparisons of ABS-101 preclinical data to the Company’s estimated performance of putative competitor molecules; drug candidate and target profile characteristics, including potency, developability, affinity and other PK characteristics; and internal asset development efforts and the application of those efforts, including acceleration of drug development timelines, reducing the time and costs related to drug development, developing a diverse, high-value portfolio of novel drug treatments, and the anticipated value to us, to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Securities Exchange Act, and we make this statement for purposes of complying with those safe harbor provisions. These forward-looking statements reflect our current views about our plans, intentions, expectations, strategies, and prospects, which are based on the information currently available to us and on assumptions we have made. We can give no assurance that the plans, intentions, expectations, or strategies will be attained or achieved, and furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond our control, including, without limitation, risks and uncertainties relating to obtaining and maintaining necessary approvals from the FDA and other regulatory authorities; replicating in clinical trials positive results found in preclinical studies; our dependence on third parties to support our internal asset programs, including for the manufacture and supply of preclinical and clinical supplies of our product candidates or components thereof; our ability to effectively collaborate on research, drug discovery and development activities with our partners or potential partners; our existing and potential partners’ ability and willingness to pursue the development and commercialization of programs or product candidates under the terms of our partnership agreements; and overall market conditions and regulatory developments that may affect our and our partners’ activities under these agreements, along with those risks set forth in our most recent periodic report filed with the U.S. Securities and Exchange Commission, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the U.S. Securities and Exchange Commission. Except as required by law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events, or otherwise.
Investor Contact
Alex Khan
VP, Finance & Investor Relations
investors@absci.com
Media Contact
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