ROR1

BOTHELL, Wash.--( BUSINESS WIRE )--Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies, today announced that it will present a poster with updated results from the RINGSIDE Phase 2 clinical trial of AL102 for the treatment of desmoid tumors at the European Society of Medical Oncology (ESMO) Congress, being held in Barcelona from 13-17 September 2024. Enrollment in the Phase 3 portion of RINGSIDE was completed in February 2024, and Immunome expects to report topline data from that trial in the second half of 2025. Following the presentation, a copy of the poster will be made available in the “Events & Presentations” portion of Immunome’s website. Poster Presentation Details: Title: Updated Results of the RINGSIDE Phase 2 Trial and Open-Label Extension of AL102 for the Treatment of Desmoid Tumors (Abstract #1766P) Presenter: Bernd Kasper, MD, PhD, Mannheim Cancer Center at the Mannheim University Medical Center, Date: September 14, 2024 About Immunome, Inc. Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted therapies designed to improve outcomes for cancer patients. We are advancing an innovative portfolio of therapeutics, drawing on leadership that previously played key roles in the design, development and commercialization of cutting-edge targeted cancer therapies, including antibody-drug conjugates (ADCs). In addition to a portfolio of discovery-stage ADCs, our pipeline includes AL102, a gamma secretase inhibitor currently in a Phase 3 trial for treatment of desmoid tumors, as well as IM-1021, a ROR1 ADC, and IM-3050, a FAP-targeted radioligand, both of which are the subject of INDs expected to be submitted in the first quarter of 2025. For more information, visit www.immunome.com . Cautionary Statement Regarding Forward-Looking Statements Statements in this press release that are not purely historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. We use words such as “will,” “expects” and similar expressions to identify forward-looking statements. These forward-looking statements include, but are not limited to, Immunome’s expected timing for providing topline data for the Phase 3 RINGSIDE Part B trial and other statements regarding management’s intentions, plans, beliefs, expectations or forecasts for the future. These forward-looking statements are based on Immunome’s current expectations and involve assumptions that may never materialize or may prove to be incorrect; 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 Immunome will not be able to realize the benefits of its strategic transactions; the risk that regulatory approvals for Immunome’s 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 Immunome’s product candidates fail to achieve their intended endpoints; and other risks and uncertainties indicated from time to time described in Immunome’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, filed with the SEC on August 12, 2024, and in Immunome’s other filings with the SEC. Except as required by law, Immunome assumes no obligation and does not intend to update any forward-looking statements included in this press release.

After disappointing efficacy data and a patient death, Oncternal Therapeutics is discontinuing two trials and looking for strategic alternatives. The San Diego company said it would end a Phase 1 trial investigating ONCT-534, a dual-action androgen receptor inhibitor, in patients with metastatic castration-resistant prostate cancer. In the early-stage study, the drug did not show clinically meaningful improvements in disease like prostate-specific antigen levels, the company said Thursday. Its other candidate, the ROR1-targeting autologous CAR-T dubbed ONCT-808, showed anti-tumor activity at all doses in aggressive B cell lymphoma. That included a complete metabolic response lasting eight months and long-term persistence of the CAR-T cells. While the asset also came with “expected treatment-emergent adverse events” for a CAR-T therapy, a patient died from “complications of shock” at the highest dose. Based on these results, the company said it would stop development, cut its workforce and look for other options, including asset sales, licensing or a merger or acquisition. “In light of these data and the challenging financing environment, we intend to explore strategic options with the hope of advancing and realizing value from our pipeline including ONCT-534, ONCT-808, zilovertamab and ONCT-216,” president and CEO James Breitmeyer said in a statement. Oncternal’s stock $ONCT dipped nearly 3% on Friday morning, trading at $1.65. Zilovertamab is a monoclonal antibody designed to inhibit the function of ROR1. It is in separate investigator-led studies in metastatic castration-resistant prostate cancer and chronic lymphocytic leukemia . ONCT-216 is currently not listed in the company’s R&D pipeline . In April 2022, it discontinued recruiting subjects in a Phase 1/2 trial in Ewing sarcoma to “reallocate resources.”

iStock, Moor Studio Oncternal Therapeutics will lay off about 10 workers as it explores “strategic alternatives” that could include asset sales or an M&A. To reduce operating expenses while it considers “strategic alternatives” for its future, Oncternal Therapeutics is laying off about 10 employees, representing roughly 37% of its workforce, according to a Sept. 12 SEC filing . In connection with that reduction, Salim Yazji will be out as chief medical officer, effective Oct. 1. In the SEC filing, the San Diego–based clinical-stage company, which focuses on novel oncology drugs, estimated it will incur workforce reduction-related charges of about $1 million. It expects to mostly complete the layoffs in the third quarter. Also on Sept. 12, Oncternal announced it’s discontinuing clinical trials for two drugs: ONCT-534, its dual action androgen receptor inhibitor for patients with metastatic castration-resistant cancer, and ONCT-808, its ROR1-targeting autologous CAR T program for patients with aggressive B cell lymphoma. According to the announcement, interim Phase I results for ONCT-534 did not show clinically meaningful disease improvements. Interim Phase I results for ONCT-808 showed anti-tumor activity at all doses, including “a complete metabolic response lasting eight months and long-term persistence of the CAR-T cells, with expected treatment emergent adverse events for a CAR-T therapy.” There was one death from complications of shock at the highest dose of ONCT-808. The company also noted that it is ceasing all product development activities and is exploring options that could include asset sales as well as a merger, reverse merger or acquisition. In an Aug. 8 SEC filing , Oncternal reported that as of June 30, it had $21.4 million in cash, cash equivalents and short-term investments and an accumulated deficit of $214.7 million. The company also noted that since inception, it’s had recurring operating losses and negative cash flows from operations. Oncternal stated that it expects to continue to incur net losses “for the foreseeable future” and believes it will need to raise substantial additional capital to accomplish its business plan during the next several years.