Latest news with #IL-12
Yahoo
27-05-2025
- Business
- Yahoo
IMUNON Invited to Present Translational Data in Supporting Remarkable Phase 2 Ovarian Cancer Survival Results at ESMO Gynaecological Cancers Congress 2025
Presentation at ESMO will follow oral 2025 ASCO Annual Meeting presentation highlighting unprecedented survival data from Phase 2 OVATION 2 Study of IMNN-001 Simultaneously publication in leading peer-reviewed journal Gynecologic Oncology details IMNN-001's outstanding safety and efficacy across multiple analyses and subgroups Treatment with IMNN-001 could represent new promise for estimated 40,000 women newly diagnosed with advanced ovarian cancer yearly in EU and 300,000 globally LAWRENCEVILLE, N.J., May 27, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in Phase 3 development of its DNA-mediated immunotherapy, today announced that an abstract highlighting IMNN-001 data based on an immune biomarker analysis from the Phase 2 OVATION 2 Study in women with newly diagnosed advanced ovarian cancer was accepted for poster presentation at the European Society for Medical Oncology (ESMO) Gynaecological Cancers Congress 2025, being held June 19-21, 2025 in Vienna, Austria. The abstract, titled 'Immune biomarker analysis of the OVATION-2 trial, a randomized Phase I/II study of IL-12 gene therapy IMNN-001 in combination with Neo/Adjuvant Chemotherapy (NACT) in newly-diagnosed advanced Epithelial Ovarian Cancer (EOC),' will be presented by Premal H. Thaker, M.D., Interim Chief of Gynecologic Oncology, David & Lynn Mutch Distinguished Professor of Obstetrics & Gynecology, Director of Gynecologic Oncology Clinical Research at Washington University School of Medicine, OVATION 2 Study Chair and Study Chair of the Phase 3 OVATION 3 trial. IMUNON also recently announced that new positive data from the OVATION 2 Study will be highlighted in an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in the peer-reviewed journal Gynecologic Oncology. Results include continuous clinically significant improvement in the IMNN-001 treatment group, with median 13-month and 3-month increases in overall and progression-free survival, respectively. IMNN-001, based on IMUNON's proprietary TheraPlas® technology platform, is an interleukin-12 (IL-12) DNA plasmid vector encased in a nanoparticle delivery system, enabling cell transfection followed by persistent, local production and secretion of the IL-12 protein in the tumor microenvironment. IL-12 is a powerful pluripotent cytokine known for inducing strong anti-cancer immunity by promoting T-lymphocyte and natural killer cell proliferation while inhibiting tumor-mediated immune suppression. IMNN-001 is the first and only IL-12 immunotherapy to achieve a clinically effective response including overall survival benefit in frontline treatment in patients with advanced (stage III/IV) ovarian cancer. 'We are very pleased to be invited to present OVATION 2 biomarker analysis data at ESMO's Gynaecological Cancers Congress, especially in light of the remarkable IMNN-001 survival data that we reported from the study, which are being presented at the ASCO Annual Meeting and in the journal Gynecologic Oncology,' said Stacy Lindborg, Ph.D., president and chief executive officer of IMUNON. 'It is highly encouraging to see the global scientific community's strong interest in our promising and novel IMNN-001 immunotherapy including enthusiasm from leading researchers from the European Union and Latin America in participating in our pivotal Phase 3 trial. There is a significant opportunity to improve the standard of care for thousands of women diagnosed with advanced ovarian cancer, and we look forward to advancing this program in our Phase 3 trial and positioning IMNN-001 for regulatory review in the European Union and markets around the world.' The pivotal Phase 3 OVATION 3 Study of IMNN-001 will include women with newly diagnosed advanced ovarian cancer (stage IIIC or IV) who are eligible for neoadjuvant and adjuvant chemotherapy (N/ACT) (the ITT population), with a sub-group of HRD+ women including those with BRCA1 or BRCA2 mutations. Study participants will be randomized 1:1 to receive either IMNN-001 plus standard of care N/ACT or standard of care N/ACT alone. The primary endpoint of the study is overall survival, and secondary endpoints are surgical response score, chemotherapy response score, clinical response and time to second-line treatment. The study will also assess several exploratory endpoints. IMUNON recently initiated the first two sites for the OVATION 3 Study. About the Phase 2 OVATION 2 Study OVATION 2 evaluated the dosing, safety, efficacy and biological activity of intraperitoneal administration of IMNN-001 in combination with neoadjuvant and adjuvant chemotherapy (N/ACT) of paclitaxel and carboplatin in patients newly diagnosed with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer. Treatment in the neoadjuvant period is designed to shrink the tumors as much as possible for optimal surgical removal after three cycles of chemotherapy. Following N/ACT, patients undergo interval debulking surgery, followed by three additional cycles of adjuvant chemotherapy to treat any residual tumor. This open-label study enrolled 112 patients who were randomized 1:1 and evaluated for safety and efficacy to compare N/ACT plus IMNN-001 versus standard-of-care N/ACT. In accordance with the study protocol, patients randomized to the IMNN-001 treatment arm could receive up to 17 weekly doses of 100 mg/m2 in addition to N/ACT. As a Phase 2 study, OVATION 2 was not powered for statistical significance. Additional endpoints included objective response rate, chemotherapy response score and surgical response. About IMNN-001 Immunotherapy Designed using IMUNON's proprietary TheraPlas® platform technology, IMNN-001 is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system that enables cell transfection followed by persistent, local secretion of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anticancer immunity acting through the induction of T-lymphocyte and natural killer cell proliferation. IMUNON previously reported positive safety and encouraging Phase 1 results with IMNN-001 administered as monotherapy or as combination therapy in patients with advanced peritoneally metastasized primary or recurrent ovarian cancer and completed a Phase 1b dose-escalation trial (the OVATION 1 Study) of IMNN-001 in combination with carboplatin and paclitaxel in patients with newly diagnosed ovarian cancer. IMUNON previously reported positive results from the recently completed Phase 2 OVATION 2 Study, which assessed IMNN-001 (100 mg/m2 administered intraperitoneally weekly) plus neoadjuvant and adjuvant chemotherapy (N/ACT) of paclitaxel and carboplatin compared to standard-of-care N/ACT alone in 112 patients with newly diagnosed advanced ovarian cancer. About Epithelial Ovarian Cancer Epithelial ovarian cancer is the sixth deadliest malignancy among women in the U.S. There are approximately 20,000 new cases of ovarian cancer every year and approximately 70% are diagnosed in advanced Stage III/IV. Epithelial ovarian cancer is characterized by dissemination of tumors in the peritoneal cavity with a high risk of recurrence (75%, Stage III/IV) after surgery and chemotherapy. Since the five-year survival rates of patients with Stage III/IV disease at diagnosis are poor (41% and 20%, respectively), there remains a need for a therapy that not only reduces the recurrence rate but also improves overall survival. The peritoneal cavity of advanced ovarian cancer patients contains the primary tumor environment and is an attractive target for a regional approach to immune modulation. About IMUNON IMUNON is a clinical-stage biotechnology company focused on advancing a portfolio of innovative treatments that harness the body's natural mechanisms to generate safe, effective and durable responses across a broad array of human diseases, constituting a differentiating approach from conventional therapies. IMUNON is developing its non-viral DNA technology across its modalities. The first modality, TheraPlas®, is developed for the gene-based delivery of cytokines and other therapeutic proteins in the treatment of solid tumors where an immunological approach is deemed promising. The second modality, PlaCCine®, is developed for the gene delivery of viral antigens that can elicit a strong immunological response. The Company's lead clinical program, IMNN-001, is a DNA-based immunotherapy for the localized treatment of advanced ovarian cancer that has completed multiple clinical trials including one Phase 2 clinical trial (OVATION 2). IMNN-001 works by instructing the body to produce safe and durable levels of powerful cancer-fighting molecules, such as interleukin-12 and interferon gamma, at the tumor site. Additionally, the Company has completed dosing in a first-in-human study of its COVID-19 booster vaccine (IMNN-101). The Company will continue to leverage these modalities and to advance, either directly or through partnership, the technological frontier of plasmid DNA to better serve patients with difficult-to-treat conditions. For more information, please visit Forward-Looking Statements IMUNON wishes to inform readers that forward-looking statements in this news release are made pursuant to the 'safe harbor' provisions of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including, but not limited to, statements regarding the timing and enrollment of the Company's clinical trials, the potential of any therapies developed by the Company to fulfill unmet medical needs, the market potential for the Company's products, if approved, the potential efficacy and safety profile of our product candidates, and the Company's plans and expectations with respect to its development programs more generally, are forward-looking statements. We generally identify forward-looking statements by using words such as 'may,' 'will,' 'expect,' 'plan,' 'anticipate,' 'estimate,' 'intend' and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances). Readers are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, uncertainties relating to unforeseen changes in the course of research and development activities and in clinical trials, including the fact that interim results are not necessarily indicative of final results; the uncertainties of and difficulties in analyzing interim clinical data; the significant expense, time and risk of failure in conducting clinical trials; the need for IMUNON to evaluate its future development plans; possible actions by customers, suppliers, competitors or regulatory authorities; and other risks detailed from time to time in IMUNON's filings with the Securities and Exchange Commission. IMUNON assumes no obligation, except to the extent required by law, to update or supplement forward-looking statements that become untrue because of subsequent events, new information or otherwise. Contacts: Media Investors Jenna Urban Peter Vozzo CG life ICR Healthcare 212-253-8881 443-213-0505 jurban@ in to access your portfolio
Yahoo
05-05-2025
- Business
- Yahoo
IMUNON to Hold First Quarter 2025 Financial Results and Business Update Conference Call on Monday, May 12, 2025
LAWRENCEVILLE, N.J., May 05, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in late-stage development with its DNA-mediated immunotherapy, announces that the Company will host a conference call at 11:00 a.m. ET on Monday, May 12, 2025 to discuss financial results for the first quarter ended March 31, 2025 and provide an update on its clinical development program with IMNN-001, a DNA-based interleukin-12 (IL-12) immunotherapy, including progress in advancing the IMNN-001 development program toward initiation of a Phase 3 clinical trial in advanced ovarian cancer. To participate in the call, interested parties may dial 833-816-1132 (Toll-Free/North America) or 412-317-0711 (International/Toll) and ask for the IMUNON First Quarter 2025 Financial Results Call. A live webcast of the call will also be available here. The call will be archived for replay until May 26, 2025, and can be accessed at 877-344-7529 (U.S. Toll Free), 855-669-9658 (Canada Toll Free) or 412-317-0088 (International Toll) using replay access code 2322959. An audio replay of the call will also be available here for 90 days. About IMUNON IMUNON is a clinical-stage biotechnology company focused on advancing a portfolio of innovative treatments that harness the body's natural mechanisms to generate safe, effective and durable responses across a broad array of human diseases, constituting a differentiating approach from conventional therapies. IMUNON is developing its non-viral DNA technology across its modalities. The first modality, TheraPlas®, is developed for the gene-based delivery of cytokines and other therapeutic proteins in the treatment of solid tumors where an immunological approach is deemed promising. The second modality, PlaCCine®, is developed for the gene delivery of viral antigens that can elicit a strong immunological response. The Company's lead clinical program, IMNN-001, is a DNA-based immunotherapy for the localized treatment of advanced ovarian cancer that has completed multiple clinical trials including one Phase 2 clinical trial (OVATION 2). IMNN-001 works by instructing the body to produce safe and durable levels of powerful cancer-fighting molecules, such as interleukin-12 and interferon gamma, at the tumor site. Additionally, the Company has completed dosing in a first-in-human study of its COVID-19 booster vaccine (IMNN-101). The Company will continue to leverage these modalities and to advance, either directly or through partnership, the technological frontier of plasmid DNA to better serve patients with difficult-to-treat conditions. For more information, please visit Forward-Looking Statements IMUNON wishes to inform readers that forward-looking statements in this news release are made pursuant to the 'safe harbor' provisions of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including, but not limited to, statements regarding the timing for commencement of a Phase 3 trial of IMNN-001, the timing and enrollment of the Company's clinical trials, the potential of any therapies developed by the Company to fulfill unmet medical needs, the market potential for the Company's products, if approved, the potential efficacy and safety profile of our product candidates, and the Company's plans and expectations with respect to its development programs more generally, are forward-looking statements. We generally identify forward-looking statements by using words such as 'may,' 'will,' 'expect,' 'plan,' 'anticipate,' 'estimate,' 'intend' and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances). Readers are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, uncertainties relating to unforeseen changes in the course of research and development activities and in clinical trials, including the fact that interim results are not necessarily indicative of final results; the uncertainties of and difficulties in analyzing interim clinical data; the significant expense, time and risk of failure in conducting clinical trials; the need for IMUNON to evaluate its future development plans; possible actions by customers, suppliers, competitors or regulatory authorities; and other risks detailed from time to time in IMUNON's filings with the Securities and Exchange Commission. IMUNON assumes no obligation, except to the extent required by law, to update or supplement forward-looking statements that become untrue because of subsequent events, new information or otherwise. Contacts: Media Investors CG Life ICR Healthcare Jenna Urban Peter Vozzo 212-253-8881 443-213-0505 jurban@ # # #Sign in to access your portfolio
Associated Press
29-04-2025
- Health
- Associated Press
Microbiotica reveals novel mechanisms showing how the microbiome can improve immunotherapy response based on MB097, a clinical-stage drug candidate being evaluated in combination with KEYTRUDA® (pembrolizumab) in patients with advanced melanoma
CAMBRIDGE, United Kingdom, April 29, 2025 (GLOBE NEWSWIRE) -- Microbiotica, a clinical-stage biopharma company developing a pipeline of oral precision microbiome medicines called live biotherapeutic products (LBPs), has presented new data on the mechanism of action of MB097 at the American Association for Cancer Research (AACR) annual meeting held in Chicago, April 25-30. MB097 is an LBP in development as a co-therapy for immune checkpoint inhibitors (CPI) such as MSD's (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA® (pembrolizumab). The composition of a patient's intestinal microbiome is known to impact the response to immunotherapies, most noticeably CPI, but the mechanisms are poorly understood. MB097 comprises nine different species of gut commensal bacteria, all linked to positive CPI response in multiple clinical studies. Microbiotica has developed in vitro human systems using primary immune cells to investigate how gut bacteria modulate the immune response to cancer. These assays have demonstrated that three of the MB097 strains induce dendritic cells to produce high levels of IL-12, which in turn stimulates Cytotoxic T Lymphocytes and NK cells with potent tumour cell killing activity. Dr Mat Robinson, Microbiotica's Senior Vice-President Research, presented these novel findings in a poster entitled 'Clinical response to immune checkpoint inhibitors in melanoma is associated with distinct gut bacterial species that promote anti-tumour immunity by different mechanisms'. The poster can be accessed here. Dr Mat Robinson, Microbiotica's SVP Research, said, 'These exciting results start to unravel the complex biology of how gut commensal bacteria drive immune checkpoint inhibitor responses. The induction of dendritic cells to produce IL-12 complement the recently reported data showing that other MB097 strains release metabolites that enhance immune-mediated cancer cell killing. Together, these findings demonstrate that the different strains within MB097 can interact with the immune system of cancer patients in multiple ways to enhance immunotherapy efficacy.' MB097 is being tested in an international Phase 1b clinical study, in combination with KEYTRUDA® (pembrolizumab), MSD's anti-PD-1 therapy, in patients with cutaneous melanoma who have failed to respond to immunotherapies. Data readout is expected by the end of 2025. Notes to Editors KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. About Melanoma – MB097 and the MELODY-1 study Melanoma is a life-threatening skin cancer that can spread to other parts of the body in its advanced stages. PD-1 inhibitor immunotherapies have revolutionised cancer treatment and are now commonly used to treat melanoma. However new treatment options are still needed to extend the benefit to patients for whom immunotherapies do not work (treatment-resistant patients). This can be up to 50% of all advanced melanoma patients. MB097 is a once daily, orally administered LBP consisting of a defined consortium of nine strains of commensal bacteria designed to enhance the efficacy of immune checkpoint inhibitors (ICIs). Microbiotica announced the start of its first clinical trial with MB097, in November 2024 the MELODY-1 study. The study is investigating the safety, tolerability, and initial signals of efficacy of MB097 in advanced (metastatic) melanoma, in combination with KEYTRUDA® (pembrolizumab), MSD's (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, in patients with cutaneous melanoma who have failed to respond to immunotherapies. MSD will supply KEYTRUDA (study identifiers NCT06540391; MSD KEYNOTE-E75; 023-507377-17). The bacterial strains in MB097 were identified by analysing the microbiome of patients in multiple studies of ICIs in melanoma, including the MELRESIST study carried out with the company's collaborators at Cambridge University Hospitals, UK. Collectively, the MB097 bacterial consortium provides microbiome signalling that appears to be needed for ICI response. About Microbiotica Microbiotica is a private, clinical-stage, biopharma company developing a pipeline of oral precision microbiome medicines called live biotherapeutic products (LBPs) with lead programmes in immuno-oncology and inflammatory bowel disease. The company has a clinic-led, purpose-built, proprietary, microbiome profiling platform to support drug discovery based on clinical data, which enables precision identification of bacteria associated with favourable clinical trial outcomes in specific patient populations. The company has significant expertise in microbiology, bioinformatics, translational biology and LBP manufacturing and development. The Company is creating a novel pipeline of programmes in immuno-oncology (MB097 for advanced melanoma), and inflammatory bowel disease (MB310 for ulcerative colitis). It has a major partnership with Cancer Research UK and Cambridge University Hospitals in immuno-oncology. The company has a clinical trial supply agreement with MSD (Merck & Co., Inc., Rahway, NJ, USA) for use of KEYTRUDA in evaluating MB097 in melanoma patients with primary resistance to anti-PD-1 immunotherapy. MB310 was developed in collaboration with the University of Adelaide. Both programmes have data read-outs in 2025. Spun out of the Wellcome Sanger Institute in 2016, the Company is based in purpose-built facilities at the Chesterford Research Park near Cambridge, UK. Microbiotica has raised more than £62 million equity investment, including a £50 million Series B in 2022, with venture investors including British Patient Capital, Cambridge Innovation Capital, Flerie Invest, IP Group plc, Seventure Partners and Tencent. The company has also received financial support from the US-based Crohn's and Colitis Foundation. For more information, please visit and follow us on LinkedIn. Media contacts Microbiotica Ro Gardner, [email protected], +44 7801 480569 Scius Communications Sue Charles, [email protected], +44 7968 726585 Katja Stout, [email protected], +44 7789 435990 Daniel Gooch, [email protected], +44 7747 875479
Yahoo
28-04-2025
- Business
- Yahoo
Ankyra Therapeutics Announces Phase 1 Clinical Data at the 2025 AACR Annual Meeting and the first patient has been dosed with tolododekin alfa and cemiplimab
Ankyra Therapeutics announced preliminary clinical data today from Part 1 of their Phase 1 ANCHOR study evaluating an anchored IL-12 drug conjugate, tolododekin alfa, as monotherapy in patients with solid tumors Ankyra also announced the first patient has been dosed with tolododekin alfa and cemiplimab CAMBRIDGE, Mass., April 28, 2025--(BUSINESS WIRE)--Ankyra Therapeutics, a leading clinical-stage company developing anchored drug conjugates for the treatment of cancer, today presented preliminary data highlighting the safety and biologic activity of their lead asset, tolododekin alfa (ANK-101), an anchored interleukin-12 (IL-12) drug conjugate. The data was derived from Part 1 of the first-in-human (FIH) ANCHOR Phase 1 clinical trial. The study was designed to evaluate the safety and feasibility of tolododekin alfa, as monotherapy in patients with advanced solid tumors. Dr. Howard Kaufman, Ankyra President and CEO stated that "We are extremely pleased with the data which provided support for the potential of the anchored drug conjugate platform." He added "The study demonstrates for the first time that IL-12 can be delivered to tumors at therapeutic doses higher than previously achievable without systemic toxicity." Systemic delivery of IL-12 has been evaluated in previous clinical studies, but development was halted after a maximum tolerated dose of 500 ng/kg prevented further dose escalation of IL-12 in cancer patients. Dr. Joe Elassal, Ankyra Chief Medical Officer added that tolododekin alfa "Phase 1 data are encouraging and we have seen that IL-12 anchoring has resulted in 6-fold higher local IL-12 delivery to established cancers compared with what has been achieved with systemic administration." Furthermore, biomarker analysis of tumor-treated biopsies showed increased CD8+ T cell infiltration and induction of local PD-L1 expression. Dr. Elassal added "The high levels of PD-L1 seen provide strong justification for our expansion cohort combining tolododekin alfa with immune checkpoint blockade." Ankyra reports that on March 25, 2025 the first patient with advanced cutaneous squamous cell carcinoma was treated with a combination of tolododekin-alfa and Regeneron's PD-1 inhibitor, Libtayo® (cemiplimab), in an expansion cohort to the current Phase 1 trial. Results from Part one of the Phase 1 FIH study are being presented on Monday, April 28, 2025 at the American Association of Cancer Research (AACR) Annual Meeting in Chicago, IL. Abstract Title: Results of a first-in-human phase 1 trial of anchored IL-12 drug conjugate (ANK-101). Session Title: Phase 0 and Phase I Clinical Trials Session Start: 4/28/2025 9:00:00 AM Session End: 4/28/2025 12:00:00 PM Location: Poster Section 49 Poster Board Number: 18 Abstract Presentation Number: CT039 The poster will be available on the publications section of Ankyra's website after the meeting at Key Study Findings Fifteen (15) patients with metastatic solid tumors who had progressed on standard therapy and had accessible lesions for injection were enrolled across four study sites in the U.S. and Canada Primary tumor histology included melanoma (n=7), head and neck cancer (n=4), breast cancer (n=2), bladder cancer (n=1), and apocrine adenocarcinoma (n=1) ANK-101 monotherapy was well-tolerated at doses up to 250 µg/mL with no DLTs or Grade 3 or greater treatment-related treatment-emergent adverse events (TEAEs) Highly efficient tumor retention with low (generally <1%) systemic IL-12-ABP ANK-101 induced CD8+ T cell recruitment, PD-L1 expression, and inflammatory gene signatures consistent with biologic IL-12 activity Initial results suggest clinical activity with 2 PRs and a disease control rate of 80% by modified RECIST v1.1 About Tolododekin alfa (ANK-101)Tolododekin alfa (ANK-101) is an anchored drug conjugate composed of interleukin-12 (IL-12) linked to aluminum hydroxide. ANK-101 enables local delivery of functional IL-12 to the tumor microenvironment where it remains biologically active for several weeks but does not diffuse into the systemic circulation, thereby avoiding systemic toxicity. Treatment with ANK-101 in animal models has been associated with recruitment and retention of CD8+ T cells, NK cells and M1 macrophages activating innate and adaptive anti-tumor immunity. ANK-101 is being evaluated for the treatment of advanced solid tumors alone and in combination with anti-PD-1 agents. The first-in-human, open-label clinical trial of ANK-101 as a monotherapy (NCT:06171750) consists of a dose escalation portion that will evaluate the safety and tolerability of ANK-101, followed by dose expansion cohorts. Additional clinical trials are being planned in different cancer types. ANK-101 will be prominently featured on an upcoming documentary "The Cancer Pioneers" as part of the Public Broadcasting System (PBS) series "Shelter Me". The program will air nationally on local PBS television stations on May 1, 2025 and more information can be found at About Ankyra TherapeuticsAnkyra Therapeutics is a biotechnology company that has developed a highly differentiated technology platform that expands the therapeutic window of therapeutic drugs by forming a stable depot after local administration leading to prolonged immune activation and potent local and systemic immunity with reduced systemic toxicity. Ankyra was founded in 2019 and is headquartered in Cambridge, Massachusetts. For more information, please visit View source version on Contacts For Investor and Media Inquiries: Howard L. Kaufman, MDPresident and CEOinfo@ Sign in to access your portfolio
Associated Press
28-04-2025
- Business
- Associated Press
Ankyra Therapeutics Announces Phase 1 Clinical Data at the 2025 AACR Annual Meeting and the first patient has been dosed with tolododekin alfa and cemiplimab
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Apr 28, 2025-- Ankyra Therapeutics, a leading clinical-stage company developing anchored drug conjugates for the treatment of cancer, today presented preliminary data highlighting the safety and biologic activity of their lead asset, tolododekin alfa (ANK-101), an anchored interleukin-12 (IL-12) drug conjugate. The data was derived from Part 1 of the first-in-human (FIH) ANCHOR Phase 1 clinical trial. The study was designed to evaluate the safety and feasibility of tolododekin alfa, as monotherapy in patients with advanced solid tumors. Dr. Howard Kaufman, Ankyra President and CEO stated that 'We are extremely pleased with the data which provided support for the potential of the anchored drug conjugate platform.' He added 'The study demonstrates for the first time that IL-12 can be delivered to tumors at therapeutic doses higher than previously achievable without systemic toxicity.' Systemic delivery of IL-12 has been evaluated in previous clinical studies, but development was halted after a maximum tolerated dose of 500 ng/kg prevented further dose escalation of IL-12 in cancer patients. Dr. Joe Elassal, Ankyra Chief Medical Officer added that tolododekin alfa 'Phase 1 data are encouraging and we have seen that IL-12 anchoring has resulted in 6-fold higher local IL-12 delivery to established cancers compared with what has been achieved with systemic administration.' Furthermore, biomarker analysis of tumor-treated biopsies showed increased CD8+ T cell infiltration and induction of local PD-L1 expression. Dr. Elassal added 'The high levels of PD-L1 seen provide strong justification for our expansion cohort combining tolododekin alfa with immune checkpoint blockade.' Ankyra reports that on March 25, 2025 the first patient with advanced cutaneous squamous cell carcinoma was treated with a combination of tolododekin-alfa and Regeneron's PD-1 inhibitor, Libtayo ® (cemiplimab), in an expansion cohort to the current Phase 1 trial. Results from Part one of the Phase 1 FIH study are being presented on Monday, April 28, 2025 at the American Association of Cancer Research (AACR) Annual Meeting in Chicago, IL. Abstract Title: Results of a first-in-human phase 1 trial of anchored IL-12 drug conjugate (ANK-101). The poster will be available on the publications section of Ankyra's website after the meeting at Key Study Findings ANK-101 will be prominently featured on an upcoming documentary 'The Cancer Pioneers' as part of the Public Broadcasting System (PBS) series 'Shelter Me'. The program will air nationally on local PBS television stations on May 1, 2025 and more information can be found at View source version on CONTACT: For Investor and Media Inquiries: Howard L. Kaufman, MD President and CEO [email protected] KEYWORD: UNITED STATES NORTH AMERICA ILLINOIS MASSACHUSETTS INDUSTRY KEYWORD: ONCOLOGY HEALTH CLINICAL TRIALS RESEARCH SCIENCE PHARMACEUTICAL BIOTECHNOLOGY SOURCE: Ankyra Therapeutics Copyright Business Wire 2025. PUB: 04/28/2025 09:40 AM/DISC: 04/28/2025 09:39 AM
