Immunome Recognizes Ayala Pharmaceuticals’ Announced Completion of Enrollment in Phase 3 RINGSIDE Study Evaluating AL102 in Desmoid Tumors
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Insights
The completion of patient enrollment in the Phase 3 RINGSIDE study is a significant milestone for the development of AL102 as a treatment for desmoid tumors. Desmoid tumors, while rare, can be aggressive and difficult to treat, often requiring surgery or radiation. The potential of AL102, a gamma-secretase inhibitor, lies in its mechanism of action, which targets the Notch signaling pathway, a known player in cell proliferation and differentiation. Inhibiting this pathway could therefore limit tumor growth and possibly offer a non-invasive treatment alternative.
From an oncological perspective, the 'robust enrollment' and 'rapidity and depth of tumor responses observed in Phase 2' are encouraging signs. These suggest a strong interest from the medical community and a possible positive impact on patient outcomes. However, the true efficacy and safety profile of AL102 will only be confirmed upon the completion and analysis of the Phase 3 data. If the results are favorable, AL102 could become a significant addition to the oncology arsenal, especially for a patient group with limited treatment options.
The acquisition of AL102 by Immunome represents a strategic move in the biotechnology sector, potentially expanding Immunome's portfolio into a new therapeutic area. The financial implications of such a deal hinge on the successful completion of clinical trials and subsequent FDA approval. Investors will be closely monitoring the progress, as positive Phase 3 results could lead to significant value creation for Immunome. The transaction's timing, expected to close 'later this quarter or early in the second quarter,' provides a clear timeline for stakeholders to watch for potential stock volatility.
It's important to note that biotech investments are inherently high-risk due to the uncertainty of clinical trial outcomes. The mention of 'customary closing conditions' suggests that while the deal is definitive, there are still hurdles that could affect its finalization. Stakeholders should consider the financial health of Immunome and its capacity to integrate AL102 into its pipeline effectively, including the costs associated with further development, marketing and potential commercialization.
The market for desmoid tumor treatments is relatively niche due to the rarity of the condition. However, being a part of such a specialized market can be advantageous for a company like Immunome if AL102 proves to be successful. The drug's market potential will depend on various factors, including the competitive landscape, pricing, insurance coverage and the ability to secure a sufficient market share. The observed 'rapidity and depth of tumor responses' in Phase 2 trials could position AL102 favorably in the eyes of healthcare providers and patients seeking effective treatments.
Furthermore, the successful acquisition and development of AL102 may open doors for Immunome to leverage its technology for other indications within oncology, thus diversifying its risk and potential revenue streams. Market analysts will be interested in observing how the integration of AL102 into Immunome's portfolio might influence the company's long-term strategy and market positioning, especially given the current trends towards personalized and targeted cancer therapies.
– Immunome entered into a definitive asset purchase agreement with Ayala to acquire AL102 earlier this month –
Earlier this month, Immunome announced that it entered into a definitive asset purchase agreement with Ayala to acquire AL102 and related drug candidate AL101. Completion of the transaction remains subject to customary closing conditions.
“We are pleased with the progress of the RINGSIDE trial,” said Bob Lechleider, M.D., Chief Medical Officer of Immunome. “The robust enrollment of the Phase 3 portion affirms our excitement for the potential of AL102. We are also encouraged by the rapidity and depth of the tumor responses observed in Phase 2. We look forward to closing the purchase of AL102 later this quarter or early in the second quarter.”
About Immunome, Inc.
Immunome is a biotechnology company dedicated to developing first-in-class and best-in-class targeted cancer therapies. Our portfolio pursues each target with a modality appropriate to its biology, including immunotherapies, radioligand therapies and ADCs. We believe that pursuing underexplored targets with appropriate drug modalities leads to transformative therapies. Our proprietary memory B cell hybridoma technology allows for the rapid screening and functional characterization of novel antibodies and targets.
For more information, visit www.immunome.com or follow us on Twitter and LinkedIn.
Cautionary Statement Regarding Forward-Looking Statements
Certain statements contained in this communication regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities and Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995 (the “PSLRA”). We use words such as “encourage,” “look forward,” “excitement,” potential,” “will,” “plan,” “believe,” “goal,” “optimistic,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions of the PSLRA. These forward-looking statements include, but are not limited to, statements regarding Immunome’s expectation that the purchase of assets from Ayala will close; the clinical efficacy and potential commercial success of the AL102 program; the expected benefits of the Ayala transaction; and other statements regarding management’s intentions, plans, beliefs, expectations or forecasts for the future. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Such forward-looking statements are based on Immunome’s expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including, but not limited to, the risk that the transaction with Ayala will not be completed; potential litigation relating to the proposed transaction that could be instituted against Immunome, Ayala or their respective directors; possible disruptions from the proposed transaction that could harm Immunome’s and/or Ayala’s respective businesses; Immunome’s ability to grow and successfully execute on its business plan, including the development and commercialization of its pipeline; changes in the applicable laws or regulations; the possibility that Immunome may be adversely affected by other economic, business, and/or competitive factors; the risk that regulatory approvals for Immunome’s programs and product candidates are not obtained, are delayed or are subject to unanticipated conditions; the risk that pre-clinical data may not be predictive of clinical data; the risk that interim results of a clinical trial do not necessarily predict final results; potential delays in the commencement, enrollment and completion of clinical trials and the reporting of data therefrom; the complexity of numerous regulatory and legal requirements that Immunome needs to comply with to operate its business; the reliance on Immunome’s management; the prior experience and successes of the Immunome’s management team not being indicative of any future success; uncertainties related to Immunome’s capital requirements and Immunome’s expected cash runway; the failure to obtain, adequately protect, maintain or enforce Immunome’s intellectual property rights; and other risks and uncertainties indicated from time to time described in Immunome’s Annual Report on Form 10-K for the year ended December 31, 2022 filed with Securities and Exchange Commission (“SEC”) on March 16, 2023, Immunome’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2023 filed with the SEC on November 9, 2023, and in Immunome’s other filings with the SEC. Immunome cautions that the foregoing list of factors is not exclusive and not to place undue reliance upon any forward-looking statements which speak only as of the date made. Moreover, Immunome operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Except as required by law, Immunome does not undertake any obligation to update publicly any forward-looking statements for any reason after the date of this press release to conform these statements to actual results or to changes in their expectations.
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Immunome Contact:
Max Rosett
Interim Chief Financial Officer and EVP, Operations
mrosett@immunome.com
Source: Immunome, Inc.
FAQ
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