US Market News
1日前
Immunome Announces First Patient Dosed in Phase 1 Trial Evaluating IM-1617, a Potential First-in-Class ADC, in Patients with Advanced Solid TumorsJune 11, 2026 7:30 AM
Business Wire IM-1617 is a potential first-in-class solid tumor antibody-drug conjugate (ADC) that incorporates HC74, Immunome’s proprietary topoisomerase I (TOP1) inhibitor payload Immunome ADC pipeline momentum anticipated to continue with investigational new drug (IND) submissions for IM-1340 and IM-1335 planned for mid- and late 2026, respectively Immunome, Inc. (Nasdaq: IMNM), a biotechnology company committed to developing first-in-class and best-in-class targeted cancer therapies, today announced that the first patient has been dosed in the Phase 1, first-in-human trial of IM-1617, a potential first-in-class ADC directed at an undisclosed solid tumor target and incorporating HC74, Immunome’s proprietary TOP1 inhibitor payload. “The first patient dosed with IM-1617 is a significant milestone for Immunome’s ADC platform and a meaningful step toward our mission of delivering targeted therapies for patients with cancer,” said Clay Siegall, Ph.D., President and Chief Executive Officer of Immunome. “We are encouraged by the pace of progress across our portfolio and look forward to advancing IM-1617 while continuing to expand the clinical potential of our proprietary HC74 payload through additional ADC programs.” The Phase 1 trial is an open-label, multicenter dose escalation and expansion study designed to determine the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of IM-1617. The study is expected to include participants with advanced solid tumors, including colorectal cancer, non-small cell lung cancer, and breast cancer. About IM-1617 IM-1617 is a clinical-stage solid tumor ADC. It targets an undisclosed receptor tyrosine kinase that promotes tumor cell survival and mediates immune cell exclusion, and it incorporates HC74, Immunome’s proprietary TOP1 inhibitor. Preclinical in vivo efficacy studies showed impressive tumor regression after a single, clinically relevant dose of IM-1617 in a variety of solid tumor models. About Immunome, Inc. Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, supported by a leadership team with deep experience in the design, development, and commercialization of cutting-edge therapies, including antibody-drug conjugates. Our pipeline includes varegacestat, an investigational gamma secretase inhibitor for which an NDA has been submitted to the U.S. FDA; IM-1021, a clinical-stage ROR1 ADC; IM-1617, a clinical-stage solid tumor ADC; and IM-3050, an IND-cleared FAP-targeted radiotherapy. We are also advancing a broad portfolio of early-stage ADCs pursuing undisclosed solid tumor targets. 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 “potential,” “anticipated,” “planned,” “look forward to,” “expected,” and similar expressions to identify these forward-looking statements. These forward-looking statements include statements regarding: the advancement, development, clinical evaluation and therapeutic benefits of IM-1617; Immunome’s expected timing for IND submissions for IM-1340 and IM-1335; the potential of Immunome’s ADC platform; the potential of Immunome’s targeted oncology therapies to be first-in-class or best-in-class therapies; and other statements regarding management’s intentions, plans, beliefs, expectations and 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 the risk that clinical development of IM-1617 or other product candidates may be delayed or unsuccessful; the risk that preclinical results may not be predictive of clinical performance or that initial clinical results may not be indicative of subsequent results; the risk that regulatory approvals for Immunome’s product candidates are not obtained, are delayed or are subject to unanticipated conditions; the risk that Immunome will not be able to realize the benefits of its strategic transactions; uncertainties related to Immunome’s capital requirements and Immunome’s expected cash runway; Immunome’s ability to grow and advance its pipeline and successfully execute on its business plan; and other risks and uncertainties included under the caption “Risk Factors” in Immunome’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, filed with the Securities and Exchange Commission on May 12, 2026. These documents can also be accessed on Immunome’s website at www.immunome.com by clicking on the link “Financials” under the “Investors” tab. The forward-looking statements included in this press release are made only as of the date hereof. Except as required by law, Immunome assumes no obligation and does not intend to update any forward-looking statements included in this press release. View source version on businesswire.com: https://www.businesswire.com/news/home/20260611016477/en/ Investor Contact:
Max Rosett
Chief Financial Officer, Immunome
investors@immunome.com Original: Immunome Announces First Patient Dosed in Phase 1 Trial Evaluating IM-1617, a Potential First-in-Class ADC, in Patients with Advanced Solid Tumors
US Market News
1週前
Immunome Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)June 4, 2026 4:02 PM
Business Wire Immunome, Inc. (the “Company”) (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies, announced today that on June 1, 2026, the Compensation Committee of the Company’s Board of Directors (the “Compensation Committee”) granted inducement awards consisting of non-statutory stock options to purchase an aggregate of 353,000 shares of common stock to twenty new employees under the Company’s 2024 Inducement Plan. The Compensation Committee approved the stock options as an inducement material to such employees’ employment in accordance with Nasdaq Listing Rule 5635(c)(4). Each stock option has an exercise price per share equal to $20.78, the Company’s closing sales price on June 1, 2026, and will vest over four years, with 25% of the underlying shares vesting on the one-year anniversary of the applicable vesting commencement date and the balance of the underlying shares vesting monthly thereafter over 36 months, subject to the new employee’s continued service relationship with the Company through the applicable vesting dates. The stock options are subject to the terms and conditions of the Company’s 2024 Inducement Plan and the terms and conditions of an applicable stock option agreement covering the grant. About Immunome, Inc. Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, supported by a leadership team with deep experience in the design, development, and commercialization of cutting-edge therapies, including antibody-drug conjugates. Our pipeline includes varegacestat, an investigational gamma secretase inhibitor for which an NDA has been submitted to the U.S. FDA; IM-1021, a clinical-stage ROR1 ADC; IM-3050, an IND-cleared FAP-targeted radiotherapy; and IM-1617, an IND-cleared solid tumor ADC. We are also advancing a broad portfolio of early-stage ADCs pursuing undisclosed solid tumor targets. For more information, visit www.immunome.com. View source version on businesswire.com: https://www.businesswire.com/news/home/20260604913331/en/ Investor Contact
Max Rosett
Chief Financial Officer
investors@immunome.com Original: Immunome Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
US Market News
2週前
Immunome Announces Detailed Phase 3 RINGSIDE Data for Varegacestat in Adults with Progressing Desmoid Tumors at the 2026 ASCO Annual MeetingMay 30, 2026 8:00 AM
Business Wire Varegacestat treatment resulted in statistically significant improvements in primary and all key secondary efficacy endpoints Varegacestat demonstrated statistically significant improvement in worst pain intensity at week 12, with a clinically significant difference observed as early as the first evaluation at week 4 Progression-free survival benefit was consistent across prespecified patient subgroups, including tumor location, baseline tumor size, patient age and prior systemic desmoid tumor therapy New Drug Application (NDA) for varegacestat submitted to the U.S. Food and Drug Administration (FDA) in April 2026, with Marketing Authorization Application (MAA) submission to the European Medicines Agency (EMA) planned by the end of 2026 Immunome, Inc. (Nasdaq: IMNM), a biotechnology company committed to developing first-in-class and best-in-class targeted cancer therapies, today announced detailed efficacy and safety results from RINGSIDE, the global, randomized, double-blind, placebo-controlled Phase 3 trial of varegacestat in patients with progressing desmoid tumors. The data are being presented today in an oral abstract session at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. Immunome submitted an NDA for varegacestat to the FDA in April 2026. “Desmoid tumors can be locally aggressive, painful and unpredictable, creating a high disease burden for patients and a continued need for new treatment options,” said Mrinal M. Gounder, M.D., sarcoma medical oncologist and drug development specialist at Memorial Sloan Kettering Cancer Center, and the RINGSIDE primary investigator who is presenting the data. “The RINGSIDE data show a compelling progression-free survival benefit with varegacestat that is consistent across relevant patient subgroups, complemented by a high response rate and reduction in tumor volume. The data also show a rapid, clinically meaningful reduction in worst pain intensity, which is an important element for patients. These findings confirm varegacestat could become standard of care in the treatment of desmoid tumors.” “The detailed RINGSIDE data presented at ASCO reinforce varegacestat’s differentiated efficacy and manageable safety profile,” said Clay Siegall, Ph.D., President and Chief Executive Officer of Immunome. “The depth and consistency of benefit observed across RINGSIDE point to varegacestat’s potential to deliver a meaningful advance for patients with desmoid tumors. These results form the basis for the NDA we submitted in April 2026 and the planned MAA submission for Europe.” RINGSIDE Key Clinical Data Presented at 2026 ASCO Meeting As previously reported, the RINGSIDE trial met its primary endpoint and all key secondary endpoints. Varegacestat demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) vs. placebo, with an 84% reduction in the risk of disease progression or death (hazard ratio [HR] = 0.16, 95% confidence interval [CI]: 0.071, 0.375; p
US Market News
1月前
Immunome Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)May 5, 2026 4:00 PM
Business Wire Immunome, Inc. (the “Company”) (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies, announced today that on May 1, 2026, the Compensation Committee of the Company’s Board of Directors (the “Compensation Committee”) granted inducement awards consisting of non-statutory stock options to purchase an aggregate of 450,000 shares of common stock to nineteen new employees under the Company’s 2024 Inducement Plan. The Compensation Committee approved the stock options as an inducement material to such employees’ employment in accordance with Nasdaq Listing Rule 5635(c)(4). Each stock option has an exercise price per share equal to $22.73, the Company’s closing sales price on May 1, 2026, and will vest over four years, with 25% of the underlying shares vesting on the one-year anniversary of the applicable vesting commencement date and the balance of the underlying shares vesting monthly thereafter over 36 months, subject to the new employee’s continued service relationship with the Company through the applicable vesting dates. The stock options are subject to the terms and conditions of the Company’s 2024 Inducement Plan and the terms and conditions of an applicable stock option agreement covering the grant. About Immunome, Inc. Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. 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 therapies, including antibody-drug conjugate therapies. Our pipeline includes varegacestat, a late-clinical stage gamma secretase inhibitor; IM-1021, a clinical-stage ROR1 ADC; and IM-3050, a FAP-targeted radiotherapy that recently received IND clearance. We are also advancing a broad portfolio of early-stage ADCs pursuing undisclosed solid tumor targets. For more information, visit www.immunome.com. View source version on businesswire.com: https://www.businesswire.com/news/home/20260505490944/en/ Investor Contact Max Rosett
Chief Financial Officer
investors@immunome.com Original: Immunome Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
US Market News
2月前
Immunome Announces Oral Presentation of Phase 3 RINGSIDE Data at 2026 ASCO Annual MeetingApril 21, 2026 10:30 AM
Business Wire
Immunome, Inc. (“Immunome”) (Nasdaq: IMNM), a biotechnology company dedicated to developing first-in-class and best-in-class targeted cancer therapies, today announced that data from RINGSIDE, its global, Phase 3, randomized, placebo-controlled trial of varegacestat in patients with progressing desmoid tumors, has been selected for presentation in an oral abstract session at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 29–June 2, 2026, in Chicago.
“The selection of the Phase 3 RINGSIDE trial for oral presentation at ASCO reflects the importance of advancing new treatment options for patients with desmoid tumors,” said Clay B. Siegall, Ph.D., President and Chief Executive Officer. “We look forward to sharing detailed results that build on the positive topline data reported in December 2025.”
Oral Presentation Details
Abstract Title
RINGSIDE: A phase 3 randomized, placebo-controlled trial of varegacestat for treatment of progressing desmoid tumors
Session Type/Title
Oral Abstract Session – Sarcoma
Date and Time
May 30, 2026, 3:00 PM–6:00 PM CDT
Presenter
Mrinal M. Gounder, M.D., Memorial Sloan Kettering Cancer Center
Abstract Number
11506
About the RINGSIDE Trial
The global, randomized, double-blind, placebo-controlled Phase 3 RINGSIDE trial (NCT04871282) evaluated the efficacy and safety of varegacestat in patients with progressing desmoid tumors. A total of 156 patients were randomized to receive varegacestat 1.2 mg daily or placebo until disease progression or death, representing the largest randomized study in this population. The primary endpoint of the trial was progression-free survival as assessed by blinded independent central review. Statistically controlled secondary endpoints were confirmed ORR using RECIST v1.1 and change in tumor volume at week 24, both determined by blinded independent central review, as well as change in pain intensity at week 12 as determined using a patient reported outcome instrument. Additional secondary endpoints included duration of response, best reduction in tumor volume, patient-reported outcomes, and safety and tolerability. RINGSIDE includes an open-label extension phase, which is ongoing.
About Varegacestat
Varegacestat (formerly AL102) is an investigational, oral, once-daily gamma secretase inhibitor. In December 2025, Immunome reported positive topline results for the Phase 3 RINGSIDE trial of varegacestat in adults with progressing desmoid tumors. Immunome plans to submit a New Drug Application for varegacestat to the U.S. Food and Drug Administration in Q2 2026.
About Immunome
Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. 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 therapies, including antibody-drug conjugate therapies. Our pipeline includes varegacestat, a late-clinical stage gamma secretase inhibitor; IM-1021, a clinical-stage ROR1 ADC; and IM-3050, a FAP-targeted radiotherapy that recently received IND clearance. We are also advancing a broad portfolio of early-stage ADCs pursuing undisclosed solid tumor targets. 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 “advancing,” “look forward,” “plans” and similar expressions to identify these forward-looking statements. These forward-looking statements include statements regarding: the potential of varegacestat; Immunome’s presentation of data related to varegacestat; and Immunome’s expected timing for submitting an NDA for varegacestat with the U.S. Food and Drug Administration; 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 risks and uncertainties included under the caption “Risk Factors” in Immunome’s Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Securities and Exchange Commission on March 3, 2026. These documents can also be accessed on Immunome’s website at www.immunome.com by clicking on the link “Financials” under the “Investors” tab. The forward-looking statements included in this press release are made only as of the date hereof. Except as required by law, Immunome assumes no obligation and does not intend to update any forward-looking statements included in this press release.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260421372136/en/
Immunome Contact:
Max Rosett
Chief Financial Officer
investors@immunome.com
Original: Immunome Announces Oral Presentation of Phase 3 RINGSIDE Data at 2026 ASCO Annual Meeting
US Market News
2月前
Immunome Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)April 2, 2026 4:00 PM
Business Wire
Immunome, Inc. (the “Company”) (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies, announced today that on April 1, 2026, the Compensation Committee of the Company’s Board of Directors (the “Compensation Committee”) granted inducement awards consisting of non-statutory stock options to purchase an aggregate of 188,500 shares of common stock to thirteen new employees under the Company’s 2024 Inducement Plan. The Compensation Committee approved the stock options as an inducement material to such employees’ employment in accordance with Nasdaq Listing Rule 5635(c)(4).
Each stock option has an exercise price per share equal to $22.45, the Company’s closing sales price on April 1, 2026, and will vest over four years, with 25% of the underlying shares vesting on the one-year anniversary of the applicable vesting commencement date and the balance of the underlying shares vesting monthly thereafter over 36 months, subject to the new employee’s continued service relationship with the Company through the applicable vesting dates. The stock options are subject to the terms and conditions of the Company’s 2024 Inducement Plan and the terms and conditions of an applicable stock option agreement covering the grant.
About Immunome, Inc.
Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. 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 therapies, including antibody-drug conjugate therapies. Our pipeline includes varegacestat, a late-clinical stage gamma secretase inhibitor; IM-1021, a clinical-stage ROR1 ADC; and IM-3050, a FAP-targeted radiotherapy that recently received IND clearance. We are also advancing a broad portfolio of early-stage ADCs pursuing undisclosed solid tumor targets. For more information, visit www.immunome.com.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260402578641/en/
Investor Contact
Max Rosett
Chief Financial Officer
investors@immunome.com
Original: Immunome Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
US Market News
3月前
Immunome Reports Full Year 2025 Financial Results and Provides Business UpdateMarch 3, 2026 4:02 PM
Business Wire
New Drug Application submission for varegacestat in patients with desmoid tumors planned for 2Q 2026
IM-1021 Phase 1 ongoing with initial data expected in 2026
Three IND submissions for solid tumor-targeted ADC programs planned in 2026
Underwritten public offering in December 2025 raised $460.5 million in gross proceeds, extending projected cash runway into 2028
Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies, today announced financial results for the full year ended December 31, 2025, and provided a business update.
“Immunome made substantial progress in 2025. The positive Phase 3 RINGSIDE results represent a significant milestone for patients living with desmoid tumors and will support our planned NDA submission for varegacestat in the second quarter of 2026,” said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Immunome. “We are focused on the regulatory, manufacturing, and commercial readiness activities necessary to position the program for approval and launch.”
“We continue to advance our antibody-drug conjugate pipeline, with the Phase 1 study of IM-1021 ongoing. Over the course of 2026, we expect to submit INDs for three differentiated solid tumor ADCs. These programs have substantial potential to benefit cancer patients, and we intend to rapidly advance them.”
Pipeline Highlights
Varegacestat:
In December 2025, Immunome announced positive topline results from the global pivotal Phase 3 RINGSIDE trial of varegacestat in patients with progressing desmoid tumors.
The registrational trial met its primary endpoint of improving progression-free survival vs. placebo, with a statistically significant and clinically meaningful 84% reduction in the risk of disease progression or death (hazard ratio = 0.16, p