Full Press Release Details
Immunome To Acquire AL102, A Phase 3 Asset for
the Treatment of Desmoid Tumors, From Ayala Pharmaceuticals
- AL102 is a small molecule gamma secretase
inhibitor with a differentiated clinical profile -
WA and MONMOUTH JUNCTION, NJ, Feb. 6, 2023 - Immunome, Inc. (Nasdaq: IMNM), a biotechnology company
dedicated to developing first-in-class and best-in-class targeted cancer therapies, today announced that it entered into a definitive
asset purchase agreement with Ayala Pharmaceuticals, Inc. (OTCQX: ADXS), a clinical-stage oncology company, to acquire AL102 and
related drug candidate AL101 from Ayala. Based on the terms of the agreement, Immunome will pay Ayala $20 million in cash and $30
million in Immunome common stock (valued at 30-day VWAP as of February 1, 2024) at the closing and will pay up to an additional
$37.5 million in development and commercial milestone payments. Completion of the transaction is subject to customary conditions including
Ayala obtaining the requisite stockholder approval.
AL102 is an investigational small molecule gamma secretase inhibitor
currently being evaluated in the randomized Phase 3 RINGSIDE international trial for the treatment of desmoid tumors - a debilitating
soft tissue malignancy. AL102 is a potential once-daily oral treatment for desmoid tumors. Data from clinical trials have shown AL102
may be more effective in treating desmoid tumors than OGSIVEO (nirogacestat), which recently became the first treatment approved
for desmoid tumors by the U.S. Food and Drug Administration (FDA) in November 2023.
The Phase 2 portion of the RINGSIDE study demonstrated clinically meaningful
anti-tumor activity across multiple parameters. The data showed high objective response rates, including 75% of evaluable patients (and
64% of intent-to-treat patients) in the 1.2 mg once daily arm, the dose being evaluated in the current Phase 3 trial. Furthermore, patients
receiving the 1.2 mg daily dose experienced a median best reduction in tumor volume of 88% as measured by serial MRI exams, as of the
previously reported July 5, 2023 data cut-off, and also demonstrated improvement in other radiographic parameters.
"Immunome is committed to advancing therapies with best-in-class
potential. We are especially optimistic about the rapidity and depth of the tumor responses observed in the Phase 2 portion of RINGSIDE,"
said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Immunome. "AL102 will complement our existing portfolio of
targeted cancer agents that are approaching Phase 1 trials. As we complete the work required to advance AL102 to NDA submission, our goal
is to bring clinical benefit to an underserved patient population while generating substantial value for stockholders. We also plan to
investigate other populations of cancer patients that could benefit from treatment with AL102."
Ken Berlin, CEO of Ayala Pharmaceuticals, stated, "We are pleased
that this exciting molecule will be advanced by Immunome and its team of highly-experienced drug developers which, we believe, maximizes
the ability to conclude the RINGSIDE study and bring our lead asset to commercialization. I am proud of the work Ayala has done over the
last several years to assemble compelling clinical data and reach this point."
that as many as 1,650 people in the U.S. are diagnosed annually with desmoid tumors, also known as aggressive fibromatosis, and
the population prevalence is much higher. Desmoid tumors, which occur predominantly in young adults, can cause significant pain and disability.
Available non-pharmacologic therapies such as surgery or radiation are often ineffective and can lead to long term complications, and
unapproved targeted therapies lack long-term potency. In November 2023, AL102 was granted Orphan Drug Designation
A.G.P./Alliance Global Partners is acting as strategic advisor to Ayala
Pharmaceuticals, Inc. in connection with the transaction.
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.
About Ayala Pharmaceuticals, Inc.
Ayala Pharmaceuticals, Inc.
is a clinical-stage oncology company primarily focused on developing and commercializing small molecule therapeutics for people living
with rare tumors and aggressive cancers. The Company's lead candidates under development are the oral gamma secretase inhibitor,
AL102, for desmoid tumors, and aspacytarabine (BST-236), a novel proprietary anti-metabolite for first line treatment in unfit acute
myeloid leukemia (AML). AL102 has received Fast Track Designation from the U.S. FDA and is currently in the Phase 3 segment of a pivotal
study for patients with desmoid tumors (RINGSIDE). For more information, visit www.ayalapharma.com.
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 "may,"
"could," "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 and, if closed, will complement Immunome's development pipeline, as well as assessments
of the clinical efficacy and potential commercial success of the AL102 program; Immunome plans to evaluate other populations of cancer
patients that may benefit from AL102; 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.
Interim Chief Financial Officer
Ayala Pharmaceuticals:
LifeSci Advisors, LLC